Technology Transfer Center (MTTC) and the Massachusetts...

April 14, 2011

Welcome to the Seventh Early-Stage Life Sciences Technology Conference – a showcase for platform technologies and recently formed companies that are based on research at Massachusetts research

institutions, hospitals and universities.

The Conference continues to be one of the most important events organized by the Massachusetts Technology Transfer Center (MTTC) and the Massachusetts Association for Technology Transfer Offices (MATTO). The program is designed to provide an introduction for the investment and corporate com-munity to some of the earliest stage life-science start-ups as well as a review of some available platform technologies that are in the process of spinning-out of local institutions.

The interaction of our research community, biotech and biomed firms, as well as the investment community makes Massachusetts the most vibrant life sciences community in the world. This conference highlights technologies that are emerging from the research labs and are the building blocks for new companies and products. Today’s presenters will describe to you a broad range of discoveries that could each make a significant difference in healthcare. The technologies range from pain management and newly discovered drug candidates to wound healing, bioinformatics solutions and diagnostics.

We again feature a large number of presenting companies and researchers. The strength of our applicant pool represents the robustness of the Massachusetts Life Sciences Cluster. We are also featuring a few startups that have presented at this conference before as they have made significant progress in their technology and business strategy.

We hope you enjoy today’s program. Please stay for this evening’s closing networking reception that will include 23 poster presentations and will allow all attendees the opportunity to meet individually with the presenting companies as well as additional exhibitors.

The Massachusetts Life Sciences Cluster continues to thrive. By supporting the early stage companies and researchers, you will ensure that the cluster continues to grow within the Commonwealth. We would like to express our sincere gratitude to Merck for hosting our event this year and our heartfelt thanks go to both Nutter and Merck for their generous sponsorship.

Dr. Abigail A. Barrow, Director, Massachusetts Technology Transfer Center

The 7th Annual Early Stage Life Sciences Conference

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April 14, 2011Merck Research Laboratories ∙ Boston, MA

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Table of ContentsConference Agenda .................................................................................................................vSpeaker Biography ....................................................................................................................7

Dr. Gary O’Neill , Merck Research Laboratories ...................................................................................... 7Dr. Donna Ambrosino, MassBiologics, UMass Medical School .......................................................... 7

Sponsors, Affiliate & Host ........................................................................................................9Sponsors ...........................................................................................................................................................10Nonprofit Affiliates .........................................................................................................................................12Media Sponsor .................................................................................................................................................14Organizer ..........................................................................................................................................................15

Presenter Profiles .................................................................................................................. 17About the Investor Pitches ..........................................................................................................................19AcuityBio, Inc. ..................................................................................................................................................20Advirna ..............................................................................................................................................................22Aquilus Pharmaceuticals ..............................................................................................................................24Avaxia Biologics, Inc. .....................................................................................................................................26Bryan Oncor, Inc. ............................................................................................................................................28Cellgenex Diagnostics ...................................................................................................................................30CMB Science, Inc. ............................................................................................................................................32Massachusetts Eye and Ear Infirmary .......................................................................................................34NobleGen Biosciences, Inc. .........................................................................................................................36ONCoPEP, Inc. .................................................................................................................................................38Optasia Medical, Inc. ......................................................................................................................................40Perfusion Technology LLC ...........................................................................................................................42Pharyx, Inc. ........................................................................................................................................................44Segterra ..............................................................................................................................................................46Thermedical ......................................................................................................................................................48Translational Sciences Corporation ..........................................................................................................50

Additional Exhibitor Profiles .............................................................................................. 53Boston University ............................................................................................................................................54University of Massachusetts Amherst ......................................................................................................55Ekam Imaging, Inc. .........................................................................................................................................56GeneKey Corporation ...................................................................................................................................58MedicaMetrix, Inc. ..........................................................................................................................................60Seign LLC ...........................................................................................................................................................62University of Massachusetts Dartmouth .................................................................................................64


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April 14, 2011 Merck Research Laboratories ∙ Boston, MA

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CONFERENCE AGENDA

12:45 – 1:15

Registration, Dessert Bar, Networking, and Exhibits

1:15 – 1:45 Welcome Dr. Gary O’Neill

Vice President and Discovery Site Head, Merck Research Laboratories

KeynoteDr. Donna Ambrosino

Executive Director, MassBiologics, UMass Medical School“Development of Therapeutic Monoclonal Antibodies for Unmet Medical Needs”

1:45 – 3:00 Company Pitch Presentations - Session OneAcuityBio, Inc.

NobleGen Biosciences, IncAdvirna

Perfusion Technology LLCBryan Oncor, Inc

Optasia Medical, IncSegterra

3:00 – 3:30

Coffee Break

3:30 – 5:00Company Pitch Presentations - Session Two

ONCoPEP, IncPharyx, Inc

Aquilus PharmaceuticalsCellgenex Diagnostics

CMB Science, Inc.Translational Sciences Corporation

Massachusetts Eye and Ear InfirmaryThermedical

Avaxia Biologics, Inc.

5:00 – 7:00 Networking Reception and Poster Session

April 14, 2011Merck Research Laboratories Laboratories ∙ Boston, MA

Biographies 7

Speaker BiographyDr. Gary O’Neill Vice President and Discovery Site Head, Merck Research Laboratories

Opening Speaker

Gary O’Neill is Vice President in Discovery and Preclinical Sciences and serves as the Site Head for the Boston Merck Research Laboratories. In this role, Gary leads the MRL Boston site in their efforts in the discovery of new therapeutic drugs, primarily small molecules, for diseases in the areas of oncology, im-munology and respiratory indications. Research efforts at the Boston MRL site span all phases of drug discovery from target identification and validation through small molecule lead identification and optimiza-tion and support of programs in the clinic.

Gary holds a Ph.D. in Microbiology and Immunology from the University of British Columbia and was a postdoctoral fellow at Yale University in the department of Molecular Biophysics and Biochemistry. From 1990 to 2008, Gary held various leadership positions in research at the Merck Frosst Research Laborato-ries in Montreal, Canada. In 2009, he assumed the Site Lead position for Respiratory and Immunology at the Merck Boston site until his appointment in March 2011 as the MRL Boston Site Head. Gary’s research interests have included prostanoid biology and immunoregulatory mechanisms in diseases such as asth-ma and arthritis. In 2008, Gary was named as a Merck Presidential Fellow for his scientific contributions to the area of prostanoid biology. As a Merck research scientist Gary has coauthored over 65 scientific manuscripts and is a co-inventor on several patents related to his research.

Dr. Donna AmbrosinoExecutive Director, MassBiologics, UMass Medical School

Keynote Speaker

Dr. Ambrosino is a graduate of Harvard University and Dartmouth Medical School. She has been a pro-fessor of Pediatrics at Harvard Medical School and is currently Professor of Pediatrics at UMass Medical School. She has held clinical positions at Children’s Hospital Boston, Brigham & Women’s Hospital, and Dana Farber Cancer Institute. In 1998, Dr. Ambrosino was appointed the Executive Director of the Mas-sachusetts Biologics Laboratory.

The Massachusetts Biologics Laboratory, also known as MassBiologics, was originally established in 1894 as the Massachusetts Public Health Laboratories. MassBiologics is now the only nonprofit, licensed vaccine and biologics manufacturer and research center in the country, giving the laboratory a unique position to tackle diseases that many commercial companies are unwilling to work on. Dr. Ambrosino’s research, and that of Mass Biologics, is focused on the application of monoclonal antibodies on infectious disease targets – an unmet medical need that still represents a significant public health need.

Dr. Ambrosino attributes the Mass Biologics’s uniqueness to its history of having licensed products, be-ing a manufacturer, being a research facility and having additional research funds from product royalty streams. MassBiologic’s licenses include Cytogam, an immune globulin isolated from human blood prod-uct against cytomegalovirus which is licensed to CSL Behring; Synagis which is a monoclonal antibody to protect babies from respiratory syncytial virus and manufactured by AstraZeneca’s MedImmune; and an experimental Clostridium difficile product which has been licensed to Merck. MassBiologics will soon start a clinical trial on a new rabies vaccine in India.

Dr. Ambrosino has a distinguished publishing record. In 1995 she was nominated as an Outstanding Phy-sician Mentor at Harvard Medical School and in 2006 she received the Manuel Carballo Governor’s Award for Excellence in Public Service.


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Sponsors & Host 9


Sponsors, Affiliates & OrganizerSponsors ................................................................................................................................... 10

Merck Research Laboratories BostonNutter McClennen & Fish LLP

Nonprofit Affiliates ................................................................................................................. 12Massachusetts Biotechnology CouncilMassChallengeMassachusetts Life Scences Center

Media Sponsor ......................................................................................................................... 14Mass High Tech - The Journal of NE Technology

Organizer .................................................................................................................................. 15The Massachusetts Technology Transfer Center

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Sponsors & Host 11


Nutter in the Life Sciences Nutter McClennen & Fish LLP has a long track record of working with clients in the life sciences throughout the enterprise lifecycle to meet their legal and strategic needs. With in-depth legal and scientific credentials as well as experience in executive, in-house counsel, and other industry capacities, our attorneys take responsibility for knowing the client’s needs and objectives, and for partnering to achieve successful outcomes and competitive advantage. Our roster of life sciences clients is international and diverse, including:

U.S. and multinational medical device, biotechnology and pharmaceutical companies

Renowned medical institutions and research universities

Major hospitals and other health care providers

Emerging growth companies

Venture capital firms and entrepreneurs Nutter’s experience and knowledge cover a wide range of technologies and products, from medical devices such as implants, surgical instruments, and diagnostic and therapeutic products, to research instrumentation and tools, to biopharmaceuticals ranging from functional genomics and immunology to diagnostics and gene therapy. Our services include:

Corporate matters, financing and securities

Intellectual property and IP litigation

Government regulation, including clinical trials, SEC and marketing/pricing compliance, and privacy

Health care

Litigation, including product liability defense, commercial disputes, white collar and employment

Nutter Strategic Planning Program A Boot Camp for Technology Entrepreneurs and Early Stage Companies

The Nutter Strategic Planning program is designed to meet the needs of start-up and early stage companies that are ready to undergo sophisticated strategic planning and take important next steps in the formation and growth of their businesses. The program consists of one-on-one customized counseling sessions between the selected company and select Nutter attorneys.

Seaport West 155 Seaport Boulevard

Boston, MA 02210 617.439.2000

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Non-profit affiliate

UPCOMING EVENTS

May 2, 2011Innovation 2011 at Cambridge Marriott

May 3, 2011MassBio Legislative Reception at Bio Fly In at Charlie Palmer Steak, Washington, DC

June 2, 2011Massachusetts Life Sciences Innovation Day 2011

June 27-30, 2011BIO International Convention, Washington, D.C.Visit the Massachusetts Pavilion!

September 7-9, 2011BioPharm America and the MassBio Investors Forum at Westin Waterfront

September 9, 2011MassBioEd Foundation Golf Classic at The Pinehills

One Cambridge Center | Cambridge, MA 02142 | TEL: 617-674-5100 | FAX: 617-674-5101 www.massbio.org

EVENT

011 at Cambridg

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27-30, 2BIO InternationVisit the Massa

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Sponsors & Host 13



2011April 11

APRIL 1

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Media Sponsor

www.masshightech.com

Sponsors & Host 15


Organizer

[email protected]

www.MaTTCenter.org

www.MassTechPortal.org

The Massachusetts Technology Transfer Center is funded by the Commonwealth of Massachusetts. Its goal is to support technology transfer activities from public and private research institutions to companies in Massachusetts. To achieve this goal, the Center works with technology transfer offices at Massachu-setts research institutions; faculty, researchers, and students who have commercially promising ideas; and companies across the Commonwealth.

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The Center: facilitates and accelerates technology transfer between research institutions and Massa-• chusetts companies;promotes collaboration between research institutions and the Commonwealth’s technol-• ogy industry; assists in the growth of Massachusetts companies, including startups, by enhancing tech-• nological leadership; andsupports regional and statewide economic development priorities. •

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The Center supports the commercialization of research technologies through a variety of programs:

The Center provides mentoring to researchers who believe they have a technology that could serve as the basis of a new company. The process includes the development of a business presentation for an expert board of external reviewers.

Commercialization and Entrepreneurial Education seminars and workshops enable researchers to un-derstand the process of commercializing technologies.

Expert technology reviews provide opportunities for Massachusetts research institutes to have external industry experts evaluate technologies and give advice regarding their commercial potential.

Technology Forums allow investors and potential corporate partners to meet with companies formed around technologies developed in Massachusetts research institutes.

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Startup Companies 17

Presenter ProfilesAbout the Investor Pitches .................................................................................................. 19AcuityBio, Inc. .......................................................................................................................... 20

John ‘Jay’ Schwartz, President and CSO

Advirna ....................................................................................................................................... 22Alexey Wolfson, Founder and CEO

Aquilus Pharmaceuticals ...................................................................................................... 24Irving Sucholeiki, President

Avaxia Biologics, Inc. ............................................................................................................. 26Barbara Fox, CEO

Bryan Oncor, Inc. .................................................................................................................... 28Christopher Adams, CEO

Cellgenex Diagnostics ........................................................................................................... 30Eric J. Evans, Acting CEO

CMB Science, Inc. .................................................................................................................... 32Stephen McCarthy, Co-Inventor

Massachusetts Eye and Ear Infirmary ............................................................................... 34Joseph Ciolino, Instructor of Ophthalmology

NobleGen Biosciences, Inc. ................................................................................................. 36Frank Feist, CEO, President, Co-Founder

ONCoPEP, Inc. ......................................................................................................................... 38Doris Peterkin, CEO

Optasia Medical, Inc. .............................................................................................................. 40Joel Weinstein, VP of Corporate Development

Perfusion Technology LLC ................................................................................................... 42Al Kyle, President & CEO

Pharyx, Inc. ................................................................................................................................ 44Harry Lee, President

Segterra ...................................................................................................................................... 46Gil Blander, CEO

Thermedical .............................................................................................................................. 48Michael G. Curley, President

Translational Sciences Corporation .................................................................................. 50Howard Pinsky, CEO


18 Startup Companies



About the Investor Pitches

IntroductionThe Massachusetts Technology Transfer Center hosts several conferences a year, each to showcase early stage entrepreneurs in a different technology or industry sector. The heart of each showcase is the ten-minute investor pitches given by selected entrepreneurs followed by a reception in an exhibit hall at which interested attendees can meet the entrepreneurs and network with other participants.

The pool of applicants to present has grown since our inaugural conference in 2005, so we have selected as broad a range as possible, from technologies still in the university laboratory to companies starting to sell product; from the most polished and experienced presenters to those who have never presented to the business community before; from the most cutting edge technology to established technologies that still support an innovative business model.

Business and Technology MaturityThe mandate of the MTTC is to help entrepreneurs based in Massachusetts nonprofit research institu-tions to commercialize their technologies. Thus, we always give priority to applicants from our hospitals and universities. However, we are also working toward economic development in the state, so we also welcome entrepreneurs already working in startup companies, giving preference to those who are collabo-rating. Those who have already received significant venture capital are beyond the scope of this section of the conference.

Some presenters are alumni of prior Conferences. They are invited to participate only if they have signifi-cant business updates to incorporate into their investor presentation.

Life Sciences TechnologiesA broad range of technologies are represented at this conference. This year, the pitches include innova-tive drug discovery and development technologies, wound healing, anesthesia, diagnostics and bioinfor-matics.

MTTC CoachingEach presenter participates in a coaching session prior to the Conference to ensure that no pitch is longer than ten minutes and that each contains critical business information along with high-level data on the technology. Our purpose is to provide investors in the audience with a timeefficient opportunity to learn of the latest technologies being made available for commercialization and to be able to evaluate their busi-ness potential at a preliminary level.



AcuityBio, Inc.Presented by:John ‘Jay’ Schwartz, President and CSO

Company Overview AcuityBio’s mission is to prevent post-surgical cancer recurrence in early stage cancer patients using novel drug delivery technologies. Localized delivery circumvents systemic toxicity while still delivering therapeutic levels of drug directly to the site of residual disease en-hancing the therapeutic index of difficult to administer, hydrophobic drugs. Our biocompatible, biodegradable drug delivery polymer plat-form is a “drop-in” solution to the current standard of care paradigm for non small cell lung cancer and can be used with existing procedures, devices and generic first line approved drugs.

ABC polymer implant™ delivers a predictable, sustained therapeutic dose of paclitaxel for over 60 days and is based on a proprietary com-position developed by cofounders Drs. Mark Grinstaff, Professor in the Chemistry and Biomedical Engineering Departments, and Jesse Wo-linsky, polymer scientist, at Boston University (BU) along with thoracic oncologic surgeons from the Brigham and Women’s Hospital (BWH). Dr. Grinstaff has spun out three other life science companies based on his prior work. Dr. Jay Schwartz is AcuityBio’s Chief scientific Of-ficer, President, and fellow cofounder. Dr. Schwartz has over 20 years in Life Sciences technology development and entrepreneurship. He co-founded and helped develop the technology platform for venture-backed engeneOS/ ADNEXUS, then acquired by Bristol Myers Squibb.

Product/Technology ProfileLung cancer is the number one cancer killer in the US. Locoregional tumor recurrence is a primary mode of treatment failure for early stage lung cancer patients, afflicting 3060% of the ~50,000 patients per year who receive surgical treatment with curative intent. Systemic chemotherapy is not effective and is harmful to early stage lung cancer patients. AcuityBio’s product (ABC polymer implant™) is the first of its kind, designed to be surgically attached at the surgical resection margins using standard surgical procedures, to deliver sustained chemotherapy locally to eradicate occult tumor cells remaining following surgery. Our approach focuses drug therapy at the site residual disease without inducing systemic toxicity. This application of AcuityBio’s technology for this indication will improve the quality of life, reduce the cost of care, increase the length of diseasefree progression and significantly improve cure rates for early stage lung cancer patients.

Market and ApplicationAcuityBio is commercializing a first in class therapeutic drug delivery technology for soft tissue malignancies. We will charge $5,000 per treatment pack and anticipate that one treatment pack will suffice for the average patient. Existing intrasurgical billing and procedure codes can be used for reimbursement. Our first market is the approximately 50,000 patients per year that present with early stage lung cancer which are already

Officers and Directors:John ‘Jay’ Schwartz, CSO and PresidentJesse Wolinsky, Director of R&D

Contact Information:John ‘Jay’ Schwartz200 Upland RoadNewton, MA 02460Phone: 617-515-9671Fax: [email protected] www.acuitybio.com



operated on in the US (~$250M). Our secondary market includes the estimated additional 50,000 additional stage II colorectal (~$250M) and 71,000 breast cancer lumpectomy patients (~$355M) that could benefit from localized chemotherapy. The market opportunity will grow as better diagnostic and screening technolo-gies emerge and more early stage patients will be identified. We are targeting lung cancer first because of its particularly high locoregional recurrence rates and poor survival statistics.

Commercial Opportunity The primary customers for our polymer device are thoracic surgeons and oncologists. The second “cus-tomer” is the health insurance organization who would prefer a longer patient prognosis and avoiding the expensive costs of palliative care. Demonstrated equivalent efficacy of our device with reduced side effects and costs will drive adoption.

Competitive AdvantagesThere is currently no widely available, standard of care for locoregional recurrence preventative therapy for lung cancer. Brachytherapy is the main competitor and, while effective at significantly improving disease free progression, its adoption has been precluded due to its handling, radiation exposure and placement chal-lenges. Our key advantages include:

Demonstrated efficacy in preventing cancer recurrence in two animal models• Demonstrated prolonged residence time and localized high therapeutic concentrations of drug at • margins Minimizes systemic toxicity associated with direct intravenous bolus injections.• “Drop in solution” to current standard of care devices and procedures• Continuous elution of local therapeutic concentration of chemotherapy directly to lesion margins • Polymer acts as a stable depot for the long term delivery of hydrophobic and water sensitive drugs• Easily manufactured with standard scalable processes • Biocompatible, biodegradable polymer platform •

There is one issued patent covering the composition of matter for the polymer and a PCT covering its uses.

Future Financial PlansThe company will raise capital from sublicensing for noncore applications and indications like veterinary oncology. We will also attempt to win non-dilutive grants and apply for university, state and SBA matching loans and grants. We will also need to attract “at risk capital” in three tranches. The first tranche ($2M) will fund remaining key preclinical studies including characterization of drug diffusion into lung tissue, biodistribu-tion, toxicity and device manufacturing, which will significantly derisk the opportunity. The second tranche ($2.5M) will fund a Phase I safety and prepare us for our efficacy trial in humans. The third tranche will be between $5M and 10M to conduct our pivotal trials depending on what the regulatory authorities FDA/EMEA require us to do. Successful completion at each of preclinical, first in human safety trial and pivotal efficacy trial each are significant milestones and will make AcuityBio an attractive strategic partner, or acquisition.



Advirna Presented by:Alexey Wolfson, Founder and CEO

Company OverviewAdvirna is a biotechnology start-up focusing on commercialization of a next generation of RNAi reagents. RNAi is a Nobel prize winning technology to selectively manipulate genes activity in living cell for re-search and clinical applications. The major limitation of current RNAi technology is lack of efficient and non toxic delivery. RNAi reagent (short double-stranded RNA) requires a lipid formulation to penetrate cells. This method is applicable to a limited number of cell types, which significantly restricts research and clinical applications. In collaboration with RXi Pharmaceutical, Advirna has developed a next generation of RNAi reagents- self delivering RNAs(sdRNA). sdRNAs do not require formulation for efficient cellular uptake and work in all cell types and in vivo. sdRNAi is disruptive technology significantly expanding the utility of RNAi in research and clinic and substantially increasing the addressable market. Advirna obtained from RXi Pharmaceuticals an exclusive license for sd-RNAi technology in research tool business and functional genomics. Advirna’s goal is make sdRNAi technology available to a broad scientific community. Advirna’s founders and advisors are experts in nucleic acid technologies and have been key players in the creation of three successful RNAi companies (Dharmacon, part of ThermoFisher, Sequitur, part of Life Technoloiges, and Rxi Pharmaceuticals).

Product/Technology Profile Advirna is a biotech research tool business company providing the technological solutions and reagents for the specific knockdown of gene activity in animal and human cells using RNA interference. The RNAi technology is widely used in Life Science research and has a broad customer base including academia and industry. The major limitation of the current RNAi technologies is inability to efficiently knockdown genes in primary and stem cells as well as in vivo and in ex-vivo systems. In recent years it became clear that study-ing functions of genes in their natural environment (i.e in the primary cells or inside the organism) is crucial for understanding of their functions and for successful target validation and drug development. Advirna has developed a proprietary RNAi technology which significantly expands the limits of the currently used tech-niques into these application areas. Advirna’s self-deliverable RNAi technology is a simple tool to regulate gene expression in the most important cells lines (stem cells, primary cell lines) as well as in vivo and ex-vivo. Advirna’s technology effectively enables the entrance of researchers into the new area of in vivo functional genomics. On top of that self-deliverable RNAi is a disruptive technology capable to substitute currently ex-isting technologies in almost all current applications.

The currently addressable market for RNAi technologies is estimated at $250-300 million and is expanding with 15% CAGR. In addition to existing market, Advirna’s selfdeliverable RNAi technology enables efficient delivery to all cell types, including primary cells and in vivo target validation. These two additional market seg-ments are essentially not addressed and represent Advirna’s immediate market opportunity. Recent market reviews indicated that ability to deliver RNAI to primary cells and efficacy in ex-vivo and in vivo applications are the two major desired RNAI product features, where customer satisfaction is low. These two niche mar-ket sizes are estimated to be between 10-80M$ and expected to grow fast with availability of appropriate

Officers and Directors:Alexey Wolfson, Founder and CEOAnastasia Khvorova, Co-founder

Contact Information:Alexey Wolfson10 Rocklawn Rd.Westborough MA 01581Phone: 720 -936- [email protected]



research tools. These niche markets represent a great entry opportunity due to unmet demand, low competi-tion, and significant population of highly enthusiastic, not price sensitive customers (“Early adapters type”). Initial penetration through this niche market will be followed by expansion into traditional RNAi market.

The aim of Advirna is to eventually bring the self-deliverable RNAi technology to every research bench. To penetrate the market Advirna will work with opinion leaders in industry and academia to create a group of influential early adopters, produce peerreviewed publications and gain name recognition. Initial Advirna’s customers are big academic labs and biotech companies working with biological systems where self-deliv-erable RNAi technology provides an efficient solution (i.e in vivo target validation and functional genomics is primary cells and ex-vivo systems). With development of technology, gained name recognition and increase sales volume Advirna will expand to a broad research market.

Future Financial PlansAdvirna is seeking seed/round A financing to start operations and penetrate the market at the amount of $2M in two years. The funds will be used to develop operations (outsourcing model), marketing, partial subsidizing the cost of reagents for early adopters and creating a catalog of reagents. Advirna is expected to deliver the first products in 2011 and achieve sales of $100,000 and $1M in the first and second years of operations and transition to profitability in the third year. The exit strategy is an acquisition by a major research tool business company on the fourth or fifth year of operations.



Aquilus PharmaceuticalsPresented by:Irving Sucholeiki, President

Company OverviewAquilus Pharmaceuticals, Inc. is a biotechnology start-up company specializing in the treatment and management of pain. The company will leverage its unique and proprietary platform of potent matrix metal-loproteinase (MMP) inhibitors to develop medicines that will remove some of the root causes behind acute and chronic pain without the detrimental side-affects commonly found in many leading prescription pain medications. Currently, Aquilus Pharmaceuticals has two main research programs:

1) A dual acting MMP-2/MMP-9 inhibitor program for the treatment of neuropathic pain; and

2) A selective MMP-13 inhibitor program for the treatment of os-teoarthritis pain and inflammation.

The ultimate aim of the company is to develop safe and effective medicines to address both of these patient populations.

Many of Aquilus Pharmaceutical’s employees have extensive experience in not only the area of MMPs but also in progressing compounds through pre-clinical and clinical development.

Dr. Irving Sucholeiki, Ph.D., Founder & President of Aquilus Pharmaceuticals has seventeen years of industrial experience as a medicinal chemist, the last eight years being in the area of MMPs.

Dr. Darrell J. Nix, Ph.D., Vice President of Research & Development at Aquilus Pharmaceuticals, Inc. has over fifteen years industrial experience as a Pharmacologist in the pharmaceutical industry. Dr. Nix has extensive experience in pre-clinical DMPK, toxicology, pharmacology and clinical pharmacology.

Dr. Roy Sucholeiki, M.D. Senior Director of Clinical Development at Aquilus Pharmaceuticals, Inc. is a Board Certified practicing Neurologist. Dr. Roy Sucholeiki has had several years experience as principle investigator on various clinical trials.

Product/Technology Profile

Aquilus Pharmaceuticals is a biotechnology start-up company specializing in the treatment and manage-ment of pain associated with lower back pain, diabetic neuropathic pain, arthritis, cancer induced pain and post-operative pain. The company will leverage its unique and proprietary platform of potent matrix metal-loproteinase (MMP) inhibitors to develop medicines that will remove some of the root causes behind acute and chronic pain without the detrimental side-affects commonly found in many leading prescription pain medications.

Officers and Directors:Irving Sucholeiki, Founder & Presi-dent

Darrell J. Nix, VP of R&D

Roy Sucholeiki, Senior Director of Clinical Development

Contact Information:225 Mystic Valley ParkwayWinchester, MA 01890Phone: 617-759-6590Fax: [email protected]



Review of the Pain Market

The patient populations for neuropathic and nociceptive pain are large, and are driven by separate disease trends that necessitate pain relief. In 2005, it was estimated that about 37 million individuals suffered from neuropathic pain and 170 million suffered from nociceptive pain. The major constituents of the neuropathic pain market are lower back pain, neuralgia/fibromyalgia, diabetic neuropathic pain and pain associated with multiple sclerosis. The nociceptive pain market is driven by the prevalence of the major indications of arthritic pain, particularly osteoarthritis and rheumatoid arthritis, post operative pain, and cancer-related pain.

The current management of pain mostly involves the use of opioids, non-opioids and non-steroidal anti-inflammatory drugs (NSAIDs), as well as adjuvant therapies such as antidepressants and anticonvulsants. It is forecast that the prevalence of the neuropathic pain market will increase to 39 million individuals and the nociceptive market to increase to about 164 million individuals by the end of 2011.

Within the pain therapy market there remains a substantial unmet need for drugs with improved efficacy and superior sideeffect profiles, however there are few novel drugs in the pipeline and companies are heavily dependent on reformulations of existing drugs targeting better drug delivery, more convenient dosing sched-ules and specific patient populations.

Background of Technology Platform:

Matrix metalloproteinases (MMPs) are a family of structurally related zinc containing enzymes that have been reported to mediate the breakdown of connective tissue in normal physiological processes such as embryonic development, reproduction, and tissue remodelling. Over-expression of MMPs or an imbalance between MMPs has been suggested as factors in inflammatory, malignant and degenerative disease pro-cesses characterized by the breakdown of extracellular matrix or connective tissues. MMPs are, therefore, targets for therapeutic inhibitors in several inflammatory, malignant and degenerative diseases such as ar-thritis, osteoporosis, multiple sclerosis, gingivitis, corneal epidermal and gastric ulceration, atherosclerosis and tumor metastasis.

Matrix metalloproteinase have been tested clinically in a few indications. Most predominantly in arthritis and cancer. Currently there has been no MMP inhibitors tested to address specifically either the neuropathic or nociceptive pain markets. The vast majority of MMP inhibitors that have been clinically tested have incor-porated a hydroxamic acid moiety and have exhibited very broad toxicities in humans. Aquilus Pharmaceu-ticals has amassed an intellectual property portfolio of very potent, non-hydroxamic acid containing MMP inhibitors. Aquilus Pharmaceuticals plans to test these various novel inhibitors in both the neuropathic and nociceptive pain models with the ultimate aim of developing safe and affective medicines to address both of these patient populations.

Future Financial PlansWe are looking to raise up to 6 million dollars to support both the company’s neuropathic and osteoarthritic pain programs. Specifically, 4 million of the funds will go toward completing preclinical development of Aq-uilus’s lead, dual active MMP2/9 inhibitor for the treatment of neuropathic pain. We expect to file an IND (Investigation New Drug) application with the FDA within 3 years of funding. The company has received communications from a specific pharmaceutical company and a venture capital group of their interest in as-sisting Aquilus in progressing its lead compound into the clinic once an IND as been filed. The remaining funds will be directed towards the company’s Osteoarthritic program where the funds will go toward animal efficacy studies on the company’s optimized lead compounds to determine best formulation and route of administration.



Avaxia Biologics, Inc.

Presented by:Barbara Fox, CEO

Company OverviewAvaxia Biologics has developed its Oral Antibody Platform to create new biotech drugs for a variety of gastrointestinal (GI) diseases. Oral antibodies can be delivered safely and effectively, creating large op-portunities in a $35 billion market. AVX470 is Avaxia’s first drug in de-velopment for Inflammatory Bowel Disease (IBD). Avaxia will continue its low cost, virtual development through Phase 1 studies in IBD in Q1 2012. Avaxia will sell AVX-470 to a pharma company in 2012, retaining manufacturing rights. Avaxia will continue to develop a pipeline of oral antibody drugs by self-funding and partnering development of potential blockbuster drugs in diabetes, obesity and other indications.

Barbara S. Fox, PhD, CEO, Founder. She founded and served as President and CSO of Recovery Pharmaceuticals, and was VP Immu-nology at ImmuLogic. She was a tenured professor at University of Maryland and holds a Chemistry PhD. from MIT.

David Dlesk, COO. He has 20 years of life sciences executive experi-ence, having served as VP Operations of Biogen, CEO of three start-ups and as a GM at Baxter.

Eileen F. Bostwick, PhD, VP Product Development. She served as VP of R & D at GalaGen, a biotech that brought bovine oral antibodies into Phase 2 trials.

Product/Technology ProfileAvaxia’s Oral Antibody Platform will produce drugs to treat IBD, diabetes, obesity and GI radiation sickness. AVX470 is the first drug being developed using antTNF polyclonal antibodies to treat IBD. The antiTNF antibodies act by neutralizing TNF, the primary driver of inflammation. Avaxia’s oral antiTNF antibody is delivered directly to the gut – treating the disease at its source while minimizing systemic side effects. AVX-470 is a bovine milk-derived antibody that is designed to be both safe and active when given orally. AVX-470 effectively treats IBD in standard mouse models of IBD, with superior efficacy in comparison to oral steroids. With a strong safety profile, compelling animal data, and a low cost of goods, AVX470 is ready to move into clinical trials.

Market and ApplicationOver 2.5 million people suffer from Crohn’s Disease and Ulcerative Colitis, the diseases collectively known as IBD. Symptoms of IBD include chronic abdominal pain, diarrhea and malnutrition; seriously reducing a patients’ quality of life. The pharmaceutical market for IBD products is currently $3.5 billion and growing. The most critical unmet need in the IBD market is a safe oral drug to induce and sustain remission.

Officers and Directors:Barbara Fox, CEODavid Dlesk, COOEileen F. Bostwick, VP Product DevelopmentDavid Poorvin, DirectorJonathan Fleming, Director

Contact Information:David Dlesk, COO26 Pemberton RoadWayland, MA 01778Phone: 978-621-9870Fax: [email protected]



Commercial OpportunityAvaxia will sell AVX-470 to a large pharmaceutical company after the Phase 1 trial. There are many pharma firms currently in the IBD market including: J&J/Centocor, Merck, Abbott, UCB and Glaxo. Avaxia has already mounted a business development effort and is in conversation with these firms.

Competitive AdvantagesThere are currently 2 major classes of drugs used to treat moderate to severe IBD:

Steroids – Highly effective, but associated with dangerous side effects; only for short-term use• Anti-TNF MAbs – Injected anti-TNF antibodies (Remicade, Humira, Cimzia) are highly effective in • many patients, but cause systemic immunosuppression (black box warning). They also have a high cost, over $18K per year, and are used as 2nd and 3rd line therapies

AVX470 is derived from milk, giving it a safe product profile and allowing it to be dosed orally for long term chronic treatment. It uses the wellestablished antiTNF approach for treating inflammation, so it has a high probability of being effective in humans as it has been in animals. AVX-470 has a low cost of goods, allowing a price point significantly below monoclonal antiTNF drugs.

Future Financial Plans Avaxia is currently raising $2 million to fund the following:

Production of clinical drug supply in Q3 2011 for the Phase 1 trial• Submission of an IND in Q4 2011• Expansion of the IP portfolio•

Another $3 million will be raised at the end of 2011 to fund the Phase 1 trial to be run in Q1 2012. This fund-ing should get the company to a point where a deal can be completed with a significant upfront payment to provide for ongoing funding.



Bryan Oncor, Inc.

Presented by:Christopher Adams, CEO

Company OverviewBRYAN ONCOR PHARMACEUTICALS is a clinical stage company de-veloping targeted treatment for lung, breast and other cancers based on a proprietary somatostatin peptide conjugate (P2045). Extensive research has demonstrated that Somatostatin receptors are highly up-regulated on several solid tumors, particularly lung cancers. The Com-pany was founded by Christopher Adams in July 2009 to develop the radiolabeled somatostatin drug (P2045) for lung and other cancers.

Initial financing from the founders has enabled the Company to continue with therapeutic and clinical de-velopment of the P2045 program. Additional funding will enable the completion of a phase II clinical trial in lung cancer patients. The Company plans to strengthen its board with members representing investors and experts in specialty pharmaceutical and device oncology imaging products.

COMPANY HIGHLIGHTS

Incorporated July 2009.• Experienced development team, board members and technology advisors. • Successfully completed 3 Phase I studies of the targeted peptide therapy in lung cancer patients. • Open IND for continuing FDA clinical studies – ready to enter Phase II studies. • Issued US and worldwide patents. • The targeted therapy has additional application in Breast and other cancers. •

Team

Christopher P. Adams, Founder and CEO. Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in raising venture capital, forming scientific and business advisory boards, negotiating key corporate agree-ments and research collaborations.

Rhonda Wallen, Chief Operating Officer. Ms. Wallen is a partner with Cygnet Venture Management, a firm specializing in venture financing and operations for early stage life science companies. She was a founder of Caveo Therapeutics, a biotechnology company focused on the development of new therapies for cancers and blood disorders.

Product/Technology ProfileThe company is developing a targeted therapy for lung and other cancers. The peptide drug P2045 is a synthetic highaffinity somatostatin analog which binds to somatostatin receptors (SSTR). The hexapeptide domain on P2045 contains the pharmacophore tyrosine-D-tryptophan-Iysinethreonine, which binds to soma-tostatin receptors (SSTR). Studies on the binding affinity of the P2045 peptide to somatostatin receptor rich tumor membranes and CHO cells transfected with the human somatostatin receptor have shown that P2045 has a high affinity for somatostatin receptors (ICso 0.09 to 0.2nM), similar to that of native somatostatin. In addition, it is highly specific for somatostatin receptor SST2. Studies have shown the somatostatin receptors, and SSTR2 in particular, are up-regulated in lung cancer.

Officers and Directors:

Christopher Adams, CEORhonda Wallen, COO

Contact Information:Bryan Oncor141 Powderhouse Blvd.Somerville, MA 02144Phone: 617-273-2466Fax: [email protected]



Market

Lung cancer is the leading cause of cancer mortality in the United States for both men and women. In 2009, there were an estimated 174,470 new diagnoses of non-small cell lung cancer (NSCLC) and 162,460 deaths attributable to this disease. Lung cancer causes more deaths than the next three most common cancers (breast, colon and prostate). Currently the best opportunity for cure is surgical excision of the primary tumor and of any regional lymph nodes that contain metastases. If the cancer has spread to contralateral lymph nodes or beyond the chest, surgery alone is not useful and chemotherapy and/or external beam radiation therapy are usually applied.

Late stage lung cancer, which accounts for over 60% of newly diagnosed lung cancers, is not resectable; chemotherapy has only led to modest increases in overall survival (4-5 additional months of survival com-pared to no therapy) and has severe side effects. External beam radiotherapy is used extensively in this group of patients for control of localized disease, but is not applicable to all lung cancer patients. The Bryan Oncor targeted radiotherapy may be able deliver more radiation directly to tumor cells while reducing dam-age to normal tissue.

Three clinical trials with P2045 have been completed. An exploratory imaging trial using 99mTc-P2045 showed that tumor uptake was rapid and substantial and that the agent was well tolerated. A second bi-odistribution study comparing 99mTc-P2045 and 188Re- P2045 showed similar biodistribution for and rapid clearance of both agents. Finally, a dose escalation trial with 188Re-P2045 indicated that 188Re-P2045 was well tolerated and demonstrated early signs of efficacy. The maximum tolerated dose was not reached and there was prolonged stable disease in 50% of treated patients. Overall median survival was 11.5 months.

Competitive AdvantagesThere are a number of competitors in the field seeking to develop therapies for nonsmall cell lung cancer (NSCLC). The key difference between most of the competitors and Bryan Oncor is the ability to identify pa-tients who may be more responsive to the P2045 therapy by an initial imaging screen. The ability to target individuals based on the imaging results gives the company a significant competitive advantage.

Future Financial Plans The company will use the financing to further the clinical development of P2045 peptide and begin recruit-ment of clinical sites for the Phase II study. Specific milestones to be met with the financing include:

Finalize production of GMP clinical supplies of P2045• Complete key hires• Achieve development milestones including recruiting 4 clinical sites, enrolling all patients for the phase • 2 clinical study, and obtaining initial efficacy results

Business model

The Company’s business model is to partner with, and license its technology to leading pharmaceutical mar-keting and sales organizations in several markets on a worldwide basis. Such deals may include up-front development fees and downstream royalties.



Cellgenex DiagnosticsPresented by: Eric J. Evans, Acting CEO

Company Overview The Company develops genomic tests in the field of cardiology to aid in the selection of appropriate therapies. The lead product determines a patient’s suitability for either drug-eluting stents or bare metal stents.

The scientific founders are professors of medicine, with specialties in cardiology and genomics.

The Acting CEO has led several life sciences launches.

Product/Technology Profile Cellgenex Diagnostics is developing proprietary genomic based diagnostics in the area of cardiovascular disease for commercial application worldwide. The Company’s initial product offering is the CardioStentTM

test. The CardioStentTM test is a proprietary expression profiling (RNA) based molecular signature embed-ded in an Affymetrix GeneChip for automated processing. This test determines which patients, on an indi-vidual basis, will or will not be best treated with drug eluting stents vs. bare metal stents for coronary artery disease.

The Company is an interesting example of developing a “personalized medicine” technology. By receiving the correct type of stent, patients can avoid adverse incidents and can greatly reduce the costs to the health care system.

Today, because there is no such diagnostic, the overwhelming majority of patients in the U.S. receive a drug-eluting stent, although this can lead to adverse events in many cases, and is far more expensive than a bare metal stent, in both product cost and ongoing pharmaceutical regimen.

Over 1 million angioplasties are performed in the U.S. each year. The CardioStentTM test would be indicated in the large majority. Since choosing the correct stent will save thousands of dollars, it is reasonable to ex-pect to be able to price the test at perhaps $500, suggesting a market size of perhaps $400 million in the U.S. It is appropriate to quadruple that number if one considers not just the patients who ultimately receive stents, but the 4 million patients annually who receive an angiogram that may result in immediate stent placement.

Cellgenex has completed a clinical trial in Argentina which demonstrated dramatically the ability to “predict” which type of stent was preferred. These results will be presented at the meeting.

Future Financial PlansCellgenex Diagnostics now seeks $3-5 million to conduct pivotal clinical trials of its lead product.

Officers and Directors:Eric J. Evans, Acting CEO

Contact Information:Eric J. Evans290 Beacon StBoston, MA 02116Phone: [email protected]



CMB Science, Inc.Presented byStephen McCarthy, Co-Inventor

Company Overview CMB Science Inc. is a biomedical engineering company focused on the synthesis and fabrication of biomaterials to design, patent, and mar-ket medical devices. With the support of the M2D2 Research Center, this startup company was spun-off from the research of bio-resorbable polymers as wound dressings conducted at the University of Massa-chusetts Lowell and Tufts University. The platform technology is cur-rently in animal trials at the UMass Medical School. The immediate and long term vision for this technology is successful completion of regulatory compliant pre-clinical and clinical trials for FDA approval. The final objective is to gain a significant market share from the $15 bil-lion worldwide industry in Burn, Skin Ulcer and Surgical/Trauma wound care management.

Product/Technology ProfileThis novel wound dressing technology will provide patients suffering from full-thickness burn wounds, skin ulcers, and surgical trauma with an alternative wound healing approach that provides an impermeable bar-rier to bacterial pathogens, manages wound site edema and administers antibiotic, immunological and tissue regeneration biotherapies. The biologically active wound dressing has been designed to biodegrade concur-rently with the skin regeneration resulting in complete healing of approximately 21 days.

Market and ApplicationThe worldwide wound care industry is estimated at $15 billion in 2011 with the market share divided by Skin Ulcers ($6.3), Burn wounds ($2.5) and Surgical/Trauma wound care management at 6.6 billion dollars. Within the wound treatment market, this platform technology will target the following six major segments: AntiInfectives, Moist Dressings, Biological Dressings, Pressure Relief Devices, Specific Wound Treatments and Wound Management.

Commercial Opportunity The markets for wound dressings are readily accessible through large medical companies such as Johnson & Johnson, Smith & Nephew, Molnlycke, Convatec and Coloplast, as well as second tier companies such as Medline, Tristate, DermaRite and others. Materials (usually absorbent/wound contact layers, backings and adhesives) sold to the dressing manufacturers typically earn margins of between 40% 70% with higher percentages occurring in cases where a platform technology enables significant gains in share or price for the manufacturer and/or improvements in clinical outcomes for the practitioner.

Officers and Directors:Scott Wharram, President Stephen McCarthy, Co-Inventor

Contact Information:Scott Wharram46 West StPepperell, MA 01463Phone: 978-433-8474Fax: [email protected]



Competitive AdvantagesBiomaterials exhibit flat pliable membrane conformations with a sustainable shelflife and suitable for costef-fective distribution of sterile wound healing systems. Impermeable to bacteria, this platform technology dem-onstrates water absorption, water vapor transmissibility, oxygen permeability and biodegradability properties which emulate the epidermal layer of the skin. An affinity for invitro cell proliferation and drug release, these scaffolds can be embedded with antibiotics and mitogens for delivery of re-epithelialization therapeutics.

Future Financial PlansSuccessful in-vivo trials are essential to obtaining an exclusive license and secure funding. This funding would either be from the NIH STTR/SBIR program or from Angel investors. The Department of Defense will also be approached for funding based on the successful in-vivo results. Military use sales can be utilized while FDA approval is obtained for civilian use.



Massachusetts Eye and Ear Infirmary

Presented by:Joseph Ciolino, Instructor of Ophthalmology

Company overviewWe have developed a drug eluting contact lens, initially targeting the glaucoma market, a $2B industry. The close partnership between Dr. Ciolino (ophthalmologist from Mass. Eye and Ear), Dr. Dan Kohane’s laboratory at Children’s Hospital Boston and Dr. Bob Langer’s Labora-tory at MIT has produced the first and only contact lens capable of con-trolled drug release of a therapeutically meaningful amount of drug for an extended period of time (months). Containing a drugpolymer film encapsulated in standard contact lens hydrogel material, our device has the ability to release a drug with a constant release rate (zero-order release kinetics). All of the polymers and drugs used to manufacture the lens are currently FDA approved for use on or in the eye. The inven-tors are working with the MIT”s venture mentoring service, Despande Center, and TLO to license the technology as the basis for founding a new company. A committee, consisting of experienced entrepreneurs, has been formed to help identify a business partner to help start the company.

Product/Technology ProfileOur therapeutic contact lens (TCL) overcomes the historical challenges inherent to using contact lenses for drug delivery, such as the requirement for the same rate of drug release over a period of time. Previous de-signs have typically demonstrated a large burst of drug in the first several hours followed by subtherapeutic levels of drug release in the subsequent hours. In contrast, our TCL has demonstrated a controlled and a constant release rate of a therapeutic level of drug for more than a month. We are currently targeting the glaucoma market.

Market and ApplicationThe world market for Ophthalmic pharmaceutical industry was valued over $15 billion in 2009. Driven by demographic trends, such as an increasingly older population, the global ophthalmic pharmaceutical market has nearly doubled since 2004 and is growing at 2 ½ times the rate of the overall pharmaceutical industry.

Glaucoma is the leading non-reversible cause of blindness worldwide. Two million Americans are currently diagnosed with glaucoma. In 2009, glaucoma medications recorded $5.8B in world wide sales and over $2B in U.S. sales. Leading all ophthalmic pharmaceuticals in revenue, Xalatan (latanoprost) accounted for $1.7B in U.S. sales and goes off patent in March 2011.


Joseph Ciolino, MEEIDan Kohane, Children’s Hospital BostonBob Langer, MIT

Contact Information:243 Charles StreetBoston, MA 02114Phone: [email protected]



Commercial Opportunity Our lenses are a platform, which can be used to deliver a range of ophthalmic medications. The contacts can be used to expand the lifecycle of branded drugs and offers the possibility of delivering medications that cannot otherwise be delivered topically, such as drugs intended for the back of the eye.

A business plan for the drug eluting contact lens won the life sciences section of the MIT 100K business plan competition. The technology has been covered by both scientific journals and by the popular press (CNN, Scientific American, Boston Globe, and others). MIT is the lead institution managing the licensing of the pat-ent, which was published in September of 2010.

Competitive AdvantagesGiven their ability to greatly increase regimen compliance, drug-eluting contact lenses are an industry goal. However, no other contact lens design has demonstrated the ability to deliver a therapeutically relevant amount of medication for a prolonged period of time and no such product currently exists in the market.

Future Financial Plans

We project completing the FDA ophthalmic clinical trials in 3 years, at a cost of $8 MM. The leading inde-pendent ophthalmic research firm has been working with us to identify the regulatory path and its costs. It is estimated an investment of $3MM is enough to bring the technology through phase II clinical trials, at which time we could be a target for a potential acquisition. Although we anticipate establishing early strategic part-nerships, we projected our financial position using a buildfromscratch business model. This decision was made due to the early stage of our company. Our revenue projections are based on a conservative penetra-tion, using penetration rates for silicone-hydrogel contact lenses and Xalatan (latanoprost) as guidance. Our business will require $22MM of investment over 6 years and will become cashflow positive two years after FDA approval.



NobleGen Biosciences, Inc.

Presented by:Frank Feist, CEO, President, Co-Founder

Company OverviewCo-founded by an experienced molecular diagnostics entrepreneur and a top NIH-funded biophysicist, NobleGen Biosciences is building a novel DNA sequencing instrument to enable cost effective personal-ized medicine, based on highly differentiated IP exclusively licensed from Harvard University and Boston University, positioned for exit with-in 3-4 years.

Product(s)/TechnologyNobleGen’s ‘Optipore’ DNA sequencing platform will be the first to take advantage of a highly effective nanopore-based DNA separation method, which incorporates high-speed optical detection. Low instru-ment cost and sub micro-liter sample volumes are possible through the use of custom solidstate nanochips, imaged by a simple optical configuration that employs state of the art sCMOS technology, and an off-line chemical DNA conversion process. The Optipore solution enables high accuracy and throughput providing a cost effective solution for whole genome sequencing. Noblegen’s goal is to offer the best cost and performance of any single molecule instrument truly transforming medical prevention, diagnosis and therapy.

Currently, whole genome base sequencing clinical molecular diagnostics for personalized medicine is not yet feasible due to unmet needs in cost, accuracy, and speed. NobleGen’s instrument will meet the require-ments of personalized medicine, addressing a $20B+ clinical diagnostics opportunity. Additionally, sequenc-ing is a $1.2B market today, growing to $3.6B by 2014 (Source: Scientia Advisors). As such, NobleGen will be a highly attractive acquisition target for current vendors of clinical diagnostic equipment such as Abbott, Roche, Siemens, or Qiagen, or life sciences companies such as Life Technologies, Illumina, Agilent, Bio-Rad, or Thermo Fisher in need of instrument platforms to offer sequencing based clinical diagnostics tests in oncology, infectious disease, and personal medicine. Historic multiples suggest a target exit valuation in excess of $200M.

Prof. Meller invented the Optipore optical nanopore sequencing technology at Harvard University between 2001 and 2005 and has been developing a prototype sequencer at Boston University since 2006. Prof. Meller has won multiple NIH/NHGRI and NSF awards for Optipore development ($8.3M total). First to pub-lish results obtained from a laboratory prototype demonstrating very accurate, single molecule, multiplex reads of all 4 nucleotide bases from a nanopore array in May 2010, Prof. Meller has been awarded a $4.2M/ 4 year extension grant in the latest (September 2010) round of NHGRI funding, the highest amount awarded to any individual investigator. NobleGen was incorporated in Febuary2010 and exclusively licensed the Opti-pore technology from Harvard University and Boston University in August 2010. NobleGen has raised $540K in seed funding including a highly competitive $200K Launch Award from Boston University.

Officers and Directors:Dr. Amit Meller, CTOFrank Feist, CEO, PresidentDr. Wolfgang Oster, ChairmaDr. Ory Zik

Contact Information:58 Elsinore St.Concord, MA, 01742Phone: 978 405-2533Fax: 978 [email protected]



Future Financial PlansNobleGen seeks $15M of funding to complete the prototype sequencing instrument and consumables to specifications attractive to strategic acquirers by 2014. NobleGen’s goals for 2011 are to demonstrate con-version of 1020 bases, complete the system design, file applicationrelated IP, and draft a nanopore manu-facturing plan.



ONCoPEP, Inc.

Presented by:Doris Peterkin, CEO

Company OverviewONCoPEP, Inc was formed in January, 2010, to commercialize novel, targeted therapeutics for the treatment of cancer. The first candidate is a proprietary peptide cancer vaccine developed in the laboratory of Dr. Kenneth Anderson, MD, at the Dana Farber Cancer Institute, Bos-ton, MA. The technology employs a unique method of formulating a combination of proprietary peptides (antigens) in a cancer vaccine (PVX-410) to stop the progression of cancer in patients with early stage disease. The vaccine is designed to stimulate the patient’s immune system through an optimized combination of disease specific peptides and known adjuvants (immune response stimulators). PVX-410 may provide the basis for a new line of cancer vaccines across a broad spectrum of cancers.

The management team is led by Doris Peterkin, an experienced CEO with twenty years of experience in the development and commercialization of cutting edge biotherapeutics and medical devices. The team includes an outstanding scientific advisory group consisting of leading researchers in the field of peptide vac-cine development as well as the original group of scientific founders, Drs. Anderson, Munshi and Bae from the Dana Farber Cancer Institute.

Product/Technology ProfileONCoPEP’s lead product, PVX-410 is a therapeutic cancer vaccine consisting of a combination of synthetic peptides specifically designed to target multiple myeloma cells. The objective is to stop the progression of the disease by stimulating the patient’s immune system to destroy their cancer cells without impacting the quality of the patient’s daily life.

Multiple myeloma is a fatal cancer of the plasma cells in the bone marrow. It is the second deadliest he-matologic cancer and affects about 20,000 new patients a year in the US. ONCoPEP is initially targeting Smoldering Multiple Myeloma (SMM), a clinically well defined precursor to Multiple Myeloma. There are approximately 3,000 newly diagnosed patients with SMM per year in the US. Approximately half of these patients will progress to MM within 5-8 years.

While there are a number of therapeutic options for the treatment of MM, none of these treatments cure the disease. Moreover, the majority of patients are not able to withstand the toxic side effects of the medications or are not eligible for other treatment options such as a stem cell transplant. The current treatment for SMM is “watchful waiting” The worldwide treatment market for MM is projected to be $2.5 billion by 2013.

ONCoPEP has chosen SMM as the initial clinical target because this patient group is an ideal treatment group for an immunotherapeutic like PVX-410. In general, these patients have a functioning immune system, are asymptomatic and are treatment naïve to chemotherapeutic agents for this cancer. Since their disease progression is usually slow, the vaccine has an opportunity to appropriately stimulate their immune system to


Doris Peterkin, CEO

Contact Information:Doris Peterkin520 Boston StreetNorth Andover, MA 01845Phone: [email protected]



generate a response to the diseased cells. The vaccine approach is an attractive option for both the clinician and patient in that it is designed as a targeted therapy against the patient’s disease while generally present-ing a benign safety profile. The patient is able to maintain their quality of life throughout their treatment.

PVX-410 has demonstrated the ability to stimulate a strong cytotoxic lymphocyte (CTL) response against patient multiple myeloma cell lines in in vitro testing. The next step is to demonstrate that these positive in vitro studies translate to a significant immune and clinical response in humans. A phase 1/2a trial is sched-uled to begin enrollment in patients with SMM in Q4’2011.

Future Financial Plans ONCoPEP is currently is seeking to raise $4.5 million in a Series A round. The company was originally funded by a small group of private investors who are participating in the Series A round. The funds will be used for formulation development, pre-clinical testing, manufacturing and the conduct of a phase 1/2a trial. The company expects to conduct a Series B round to complete phase 2 development for SMM and other indications. ONCoPEP currently plans to seek a pharmaceutical partner for the late stage development and commercialization of PVX-410.



Optasia Medical, Inc.

Presented by:Joel Weinstein, VP of Corporate Development

Company OverviewOptasia Medical is a medical device company that has developed a suite of software tools that can automatically extract key features and assess medical images. The company’s three current products ad-dress musculoskeletal diseases including osteoporosis, rheumatoid arthritis and osteoarthritis. Almost 1 billion patients worldwide suffer from these three diseases. Treatment of these diseases entails a long-term pharmaceutical regimen and the global cost of these therapies is approximately $23B. X-rays are accepted as a “standard of care” for establishing an initial qualitative diagnosis for these disease states. Optasia Medical’s technologies enable radiologists and primary care physicians to access patient x-rays through existing image networks, quickly confirm disease status, determine if therapy is effective and facilitate communication with patients to improve compliance with ther-apy. The company’s products are already well-accepted and utilized in clinical trials to evaluate new treatments for osteoporosis, rheumatoid arthritis and osteoarthritis. The company currently seeks $2M of growth capital to fully launch its products into the primary care market.

Product/Technology ProfileOptasia Medical’s products are all derived from the same patent pending platform technology – Optasia® Model-Based Vision. The technology is based on the use of statistical analysis to synthesize data from medi-cal images and construct a model that can be used repetitively to detect, measure, classify and compare features of images. While the current products address osteoporosis (spine), rheumatoid arthritis (hands and feet) and osteoarthritis (knees) derived from x-ray images, the core technology can be readily adopted to other skeletal sites and can also support feature extraction on MRI, CT, PET and ultrasound images.

Market and ApplicationOpasia Medical’s initial three products address osteoporosis, rheumatoid arthritis and osteoarthritis. The following table summarizes the number of patients with each of these diseases and the cost of therapies prescribed for treatment:

Officers and Directors:Peter Steiger, CEOJoel Weinstein, VP of Corporate Development Alan Brett, Founder, CTOJane Chadwick, VP –FinanceRanjeet Bahtia, Non-Executive DirectorJean C. Chaintreuil, Non-Execu-tive Director

Contact Information:365 Boston Post Rd. #340 Sudbury, MA 01776Phone: 508-4054392joel.weinstein@optasiamedical.comwww.optasiamedical.com



In 7 major markets alone (US, Japan, France, Germany, Italy, Spain, and the UK) there are over 195 million patients who would benefit from Optasia Medical’s products.

Commercial Opportunity Optasia’s customers are comprised of radiologists, rheumatologists, endocrinologists and orthopedists based in hospitals and private practices. The Company currently has distribution capability in the UK, Italy, Germany and The Netherlands and has initially launched its first product (SpineAnalyzer).

Competitive AdvantagesX-rays of the spine, hands, knees and feet play a pivotal role in managing the diseases addressed by Opta-sia Medical and represent one of the highest demands for medical imaging. With the growing availability of PACS (Picture Archiving and Communication i.e. digital image management), x-rays are routinely viewed not only by the interpreting radiologists, but increasingly by referring clinicians (endocrinologists, rheumatolo-gists and orthopedists) who rely on them for making treatment decisions, evaluating a patient’s response to therapy, and discussing findings with their patients. The viewing software currently available to referring clinicians is primitive, cumbersome and time consuming and is not capable of performing objective and per-sonalized quantitative assessment of musculoskeletal pathology on x-rays (called scoring) – a cornerstone of all three Optasia products.

Future Financial Plans The Company is currently seeking to raise $2M of growth capital. Optasia Medical plans to deploy funds from this investment round to:

a. finalize release of two additional products (RApidScore and KneeAnalyzer) b. initiate a full product launchc. establish a marketing program including international trade show participation, customer education

and awareness and promotiond. build out its distribution network in Europe and Asiae. establish a direct sales presence in the U.S.



Perfusion Technology LLCPresented by:Al Kyle, President & CEO

Company Overview

Perfusion Technology’s device enables drug delivery to the brain. Five compounds have been safely delivered across the blood brain barrier (BBB) in preclinical studies, including viral vectors, IgG and Avastin.

The company’s vision is treatment of patients suffering from brain tumors, using a low cost, non-invasive device in the outpatient setting. The core technology is electronics with unique proprietary signal processing methods. In 2010, an NIH-sponsored study demonstrated safe opening of the BBB in nonhuman primates, and our first patent issued with a priority date of 2004.

Al Kyle is President & CEO. He has founded three medical device startups, was General Manager of Hewlett Packard’s Ultrasound business and a Captain in the U.S. Marines. He holds a BSEE from Duke, and MBA and MPA degrees from Harvard.

Ulrich Herken MD PhD is Chief Scientific Officer. He was Director of R&D and Chief Scientist for two medical device startups, and was PI/Co-PI for eight research studies. He holds MD & PhD degrees from the Free University of Berlin.

Product/Technology ProfileThe product is a console & headset with ultrasound transducers & disposable contact sensors that monitor the delivered energy during a one-hour treatment session.

Market and ApplicationThe treatment is non-invasive ultrasound exposure of the penumbra around a brain tumor to penetrate the BBB and deliver therapeutics to healthy tissue. The rationale is that malignant brain tumors are difficult to treat medically, partly because of the cells that have migrated away from the bulk tumor, and that cannot be reached by most therapeutics or removed surgically. Non-invasive ultrasound can safely and reversibly pen-etrate the BBB to enable drug delivery that reduces or eliminates the spread of cancer throughout the brain. The patient is exposed to the combined ultrasound and drug therapy during normally scheduled outpatient infusion sessions.

This treatment is aimed at primary tumors such as glioblastoma multiforme (GBM) and metastatic lesions (CNS mets). CNS mets patients constitute the majority of brain tumor population, and there are no approved chemotherapeutic agents for treatment of CNS mets. A wide variety of therapeutics is approved for cancers that metastasize to the brain, and these may be good candidates for delivery with ultrasound. GBM patients may be easier to treat with the proposed method. All gliomas are infiltrative, and the approach to deliver therapeutics to the penumbra of a glioma is potentially highly effective. Several agents are approved for GBM treatment.

Officers and Directors:Al Kyle, President & CEO Ulrich Herken, CSO

Contact Information:117 Elm StAndover, MA 01810 Phone: 617-834 [email protected]



Commercial Opportunity The initial addressable clinical market is 165,000 patients with single primary & metastatic brain tumors, chosen because of limited therapeutic options and the availability of approved drugs for use in a combination drug-device approach. The total addressable market is $1.65 Billion in the US alone. The business model is a combination of disposable contact sensors and capital equipment. The disposable sales price is $200/use, 2 disposables/treatment, 25 weekly treatments = $10,000/patient. The system sales price is $50,000.

Competitive Advantageshere are no good alternatives for drug delivery to the brain:

1. Mannitol is injected via catheter in the carotid artery, causing the BBB to open temporarily. Disadvan-tages include seizures & hemorrhages; advantage is limited results in a few centers.

2. Convection enhanced delivery requires an infusion pump and catheters inserted into the brain dur-ing surgery. Advantage is delivery of higher concentration of drug at the target site; disadvantage is limited distribution of delivered drug.

3. Focused ultrasound combined with microbubbles and guided by MRI can open the BBB. Advantage is the ability to target a small region; disadvantages are cost & complexity.

4. Gliadel wafer containing BCNU is inserted in the brain during surgery. Advantage is proven results; disadvantage is a limited distribution of drug and results (+2.3 months).

5. Liposomes & viruses might transport therapeutics. Advantages are low risk and ease of preparation (liposomes), direct transport into cells (viruses); disadvantages are low efficiency, difficulties in target-ing & possible neuro-toxicity.

The proposed method is an easy to use, safe, effective and relatively inexpensive approach to penetrate the BBB. Our competitive advantage includes an issued patent with priority date of 2004.

Future Financial PlansThe company is seeking $500,000 to complete pre-clinical testing and prepare to begin clinical trials.



Pharyx, Inc.Presented by:Harry Lee, President

Company Overview We are striving to develop the de facto standard automated parallel bioreactor system for high throughput bioprocess development. Our core technology is a microfluidic integration platform that enables the fabrication of disposable application specific bioreactors that provide the functionality of conventional bioreactors. These bioreactors can be tailored for batch, fed-batch, or continuous operation and for any cell type including mammalian cells for biopharmaceuticals, aerobic mi-crobes for industrial biotechnology products, or anaerobes for biofuels. Combined with our compact digital bioreactor controllers, we envision producing bioreactor systems that enable a single user to setup, oper-ate, and control more than twenty complex bioprocesses.

Harry Lee (President and Co-Founder) received his Ph.D. in electrical engineering from MIT where he de-veloped integrated microfluidic bioreactor systems. He was a member of the winning team in the MIT $50K Entrepreneurship competition in 2005. He has been responsible for electrical and mechanical engineering and product development.

Paolo Boccazzi (CSO and Co-Founder) has a broad experience in microbial fermentation and cell culture, developed during his Ph.D. graduate and post graduate work at Purdue University, the University of Illinois Urbana-Champaign, and at MIT. He has been responsible for biological validation of prototype reactor sys-tems and model systems for bioprocess development.

Product/Technology ProfileThere is a need for automated parallel bioreactor systems that can execute complex, controlled bioprocess-es to reduce development costs and timelines. To meet this need, we are developing a technology platform comprising microfluidic devices that are integrated to create bioreactors, with complex fluid control capability, in a disposable plastic device the size of a deck of cards.

Parallel bioreactor systems based on this platform can be customized and scaled for different applications including bioprocess development for biopharmaceuticals, biofuels, and industrial products; and basic re-search such as synthetic biology, metabolic engineering, and directed evolution that employ continuous culture experiments.

Milliliter scale bioreactors for continuous culture are uniquely enabled by our technology. The volume reduc-tion by three orders of magnitude can fundamentally change how people perceive continuous culture and open the door for more widespread use of this important experimental method.

Market and ApplicationA recent review paper from Merck Research Laboratories (Biotech. Prog. 27:1, 2011) highlighted the impor-tance of reducing product development costs and timelines. A typical cell culture process development cam-paign requires 75 experiments over the period of 12 weeks, costing an estimated $1000-$2000 per experi-ment. With approximately 600 biologics under development per year, operating expenditures for early stage biologic process development are estimated to be $50-$100M/year relative to $70B total biopharmaceutical sales. In industrial biotechnology, organic feedstocks such as starches or simple sugars are converted into specialty bulk chemicals by fermentation. Examples include Vitamin B2, amino acids, ethanol, hydrocar-bons, and bioplastics. Already, an estimated $280B of chemical sales is generated from biotechnological

Officers and Directors:Harry Lee, PresidentPaolo Boccazzi, CSO

Contact Information:801 Albany St., Suite 112CBoston, MA 02119Phone: 617-297 7422Fax: 617-297 [email protected]://www.pharyx.com



processes. Assuming a similar percentage of process development spending relative to revenues as for biopharmaceuticals, this is potentially a $180M/year opportunity.

To estimate the academic research market, we aggregated research spending from the NIH and NSF on projects that would benefit from our technology. This amounted to a total of approximately $100M/yr, with an estimated 10% spent on materials or a $10M/yr addressable market.

Commercial Opportunity Target customers are companies and research laboratories that develop bioprocesses, regardless of the product or organism. Marketing a bioreactor system to these customers will depend on successful demon-stration and validation that shows equivalent, or better results when compared to conventional tools. Initially we expect beta testing relationships with potential customers will be required to establish confidence in our system.

Competitive AdvantagesNew instruments are occasionally introduced to improve experimental throughput for bioprocess develop-ment. These have come in the form of racks of miniature conventional bioreactors, instrumented well plate based systems, or large scale robotic systems.

All of these approaches require compromises in performance or operating characteristics. Miniature biore-actors require similar setup and maintenance time to the conventional approach. Instrumented well plates lack fluid control features, and large scale robotic systems have limitations in gas transfer and fluid control.

Using our integrated microfluidic bioreactor platform we have demonstrated comparable performance to bench scale stirred tanks for aerobic and anaerobic microbes in a compact disposable form factor. Our tech-nology has the potential to deliver the required performance and ease of use that competing technologies have not been able to achieve. The core fluidic devices and bioreactor architecture is protected by issued and pending patents.

Future Financial PlansWithin the next six months, we expect to complete the design, fabrication, and initial testing of our first beta test system that can be deployed to potential customers and easily replicated to support multiple beta testing sites. Additional funding is sought to support beta testing sites, develop a scalable manufacturing process for the disposable bioreactors, and continued product development for first commercial sale.

Beta test support will be critical for validating the performance of our bioreactor system. This will involve both experimental design and technical support, and fabrication of disposable bioreactor devices, using our prototype fabrication process. This work will require one full time equivalent (FTE) scientist and one (FTE) technician. Milestones = internal validation of data (comparability to conventional bioreactors), publication of validation experiments for each beta testing site.

Development of a scalable manufacturing process for the disposable bioreactor devices will be required for the success of the company. Bioreactor manufacture involves fabrication of the plastic and elastic layers, layer bonding, and sensor calibration. This work will require two FTE engineers. Milestones = device layer and mold design, high quality bonding of molded device layers, fabrication of 100 devices.

Product development will include continuous improvement of the bioreactor system based on beta test feed-back, software and user interface design, and design for cost considerations and manufacturability. This work will require one FTE engineer. Milestones = design completion, selection of sources and contract manufacturer, documentation, testing of manufactured system. In total, we estimate that $950K will be required for technology licensing and to support 4 FTE scientists/engineers and one FTE technician for 12 months including overhead and materials. This investment will position the company to make its first com-mercial sale.



SegterraPresented by:Gil Blander, CEO

Company Overview We are a group of physicians, scientists, exercise physiologists, and nu-tritionists from MIT, Harvard, and Tufts University who started Segterra to develop a web-based personalized nutrition and exercise product called SegPlan. This plan is designed for people who want to enhance their athletic performance, increase energy, feel better and achieve a healthy weight.

SegPlan is a web-based, personalized path to health, wellness and performance. SegPlan is the only science-based plan that analyzes a sample of blood and, in conjunction with your individual goals for health or athletic achievement, provides a diet, nutrition, and exercise plan, which is best for your signature biochemistry.

SegPlan provides superior value to its customers by combining highly relevant diagnostic biomarker panels with locally available food, exer-cise and supplement recommendations. It is priced competitively with fitness club memberships and personal training.

Our vision is to build a truly scientific product, and every recommenda-tion is based on publicly available research publications and clinical trials results. SegPlan is simple and easy to use. Unlike many fitness and weight management plans, the foods you incorporate in your diet can be found at the local grocery and the exercise plan is tailored to the activities and equipment that are already available to you. It can be used as a one-time recommendation, or as an on-going plan.

Product/Technology Profile SegPlan™, IS a web-based, personalized PATH TO HEALTH, WELLNESS AND PERFORMANCE. SegPlan is the only SCIENCE-BASED plan that analyzes a sample of blood and, in conjunction with your INDIVIDUAL goals FOR HEALTH OR ATHLETIC ACHIEVEMENT, provides a diet, nutrition, AND exercise plan, which is best for your SIGNATURE BIOCHEMISTRY.

SegPlan provides superior value to its customers by combining highly relevant diagnostic biomarker panels with LOCALLY AVAILABLE FOOD, exercise AND SUPPLEMENT recommendations. SegPlan includes the following components:

Measurement of ten key blood biomarkers• Analysis using Segterra’s proprietary algorithms based on scientific, peerreviewed, clinical trial pub-• lications

Market and ApplicationTarget audience and market size

Amateur Athletes 10.5 million customers; $0.9B total market size• Fit Consumers 50 million customers; $2.9B total market size• Committed Dieters; 36 million customers, $1.3B total market size•

Officers and Directors:Gil Blander, CEO, FounderDavid Lester, FounderChristian Reich, Founder, VP Health ITRick Arnstein, Founder, Chief Engagement Officer

Contact Information:425 Woburn St., Unit 42Lexington, MA 02420Phone: 781-526-0938Fax: [email protected]://www.segterra.com



Commercial Opportunity Brand Development

Digital Marketing

Endorsements

Print Advertisements

Partnering

Competitive Advantages




ThermedicalPresented by:Michael G. Curley, President

Company Overview Thermedical is developing thermal therapies for the treatment of a variety of diseases. Our patented core technology, SERF™ Ablation Therapy, is a dramatic improvement over conventional radiofrequency thermal ablation that can treat up to 100 times the volume of tissue that conventional ablation can. We are therefore uniquely capable of treating many significant diseases. Our product consists of a system to generate the therapeutic energy, and disposable applicators designed for specific diseases. The first two diseases that we are developing therapy for are liver cancer, which kills 1.36 million people world-wide each year, and ventricular tachycardia (VT), which kills 600,000people world-wide annually. Thermedical is led by Michael G. Curley, Ph.D., who invented and developed the business for the AcuNav™ diagnostic ablation catheter, which has generated $500M in revenue for Acuson, now part of Siemens. Katharine Stohlman, MBA, has eight years of experience at regulatory affairs while at Viacor and will lead the US and world-wide regulatory clearances. Patrick S. Hamilton, Ph.D., is responsible for electronic hardware and software design. Thermedi-cal expects that its first product, SERF Ablation for liver cancer, will be cleared for sale in the United States in 2011.

Product/Technology ProfileSimilar to some devices already on the market, SERF Ablation uses radiofrequency electrical energy to heat tissue. Conventional ablation can treat small tumors and cardiac arrhythmias in the atrium, the thinnest part of the heart. Our patented improvement is to use injection of saline into the treated tissue to spread the heat around and thereby treat large volumes of tissue—up to 100 times larger. Our technology is useful for diseases that require a large amount of tissue be treated. Our product has a system that generates and controls the therapeutic energy, and applicators designed for specific disease states, e.g. a needle for liver cancer and a catheter for VT.

Market and ApplicationThe first markets we will address are liver cancer and VT. Liver Cancer: 1.7 million people develop liver cancer annually, and 20% of these patients are eligible for surgery. These patients’ life expectancy is rea-sonable. The remaining 1.3 million people have no therapeutic alternative, and live only 18 months. Liver cancer responds to conventional ablation, but the tumors are too large (>5 cm diameter) to be treated. SERF Ablation can treat up to 10 cm diameter tumors, so we can treat these patients. The addressable market is smaller than 1.3 million patients since many patients live in parts of the world that are difficult to reach. Removing those patients leaves an addressable market of 585,000 cases annually, or $1.14B in sales. Ven-tricular Tachycardia: There are 600,000 people who die from VT each year. The standard of care for VT is an implantable Cardioverter defibrillator (ICD). This is expensive and painful. SERF Ablation can cure VT at only 20% of the cost of an ICD. We therefore have a second addressable market of 600,000 cases annually, an additional $1.5B.

Officers and Directors:Michael G. Curley, CEO & Founder

Katharine M. Stohlman, COO and VP of Regulatory Affairs

Patrick S. Hamilton, Founder

Contact Information:Thermedical35 Medford Street, Suite 204Somerville, MA 02143Phone: 617-623-3157 x111Fax: [email protected]



Commercial Opportunity We will sell to the doctors who treat these conditions. Surgical oncologists or interventional radiologists treat liver cancer. VT is treated by electrophysiologists. We are fortunate that these medical subspecial-ties are highlytrained and technically competent, and are small communities. There are ~900 labs that carry out each procedure in the United States. These doctors attend dedicated annual meetings such as the Heart Rhythm Society. We will use these meetings for demonstrations and educational seminars to reach and educate our customers. Training will be accomplished using peer-to-peer training at sites that have adopted SERF ablation. Dr. Curley used this strategy to sell the AcuNav catheter.

Competitive AdvantagesLiver Cancer: for the 1.3 million patients who are not eligible for surgery there are no effective therapies, so the market is not currently helping these patients. Our competitive advantage is therefore our ability to effectively treat large (up to 10 cm) diameter tumors effectively.

Ventricular Tachycardia: the current standard of care for treating VT is to implant an ICD. These devices are expensive—the two year cost of an implant is nearly $75,000, while SERF™ Ablation will cost only $17,000. The United States spends $4B annually on implanting ICDs, so SERF™ Ablation could save the US healthcare system $3B annually.

Future Financial PlansWe are using our existing funding to complete our first application for clearance to market in the United States for our liver cancer ablation system and needle. We are now looking for funds to begin to market and sell that system, to carry out clinical trials to expand the claims for our cancer ablation product, to seek world-wide clearance for our cancer ablation products, and to complete the development of our catheter for ablation of VT. We will carry out this work with three phases of funding.

Series A Venture Funding: We seek to secure funding in Q3 2011 for staffing our sales and marketing team and for obtaining a CE mark for our liver cancer ablation product so that we can begin world-wide sales. Second, we will carry out clinical trials to add a second indication for use that SERF ablation and receive our second 510(k) clearance to sell in the United States with this claim in Q2 2013. Finally, we will complete the preclinical testing for treating VT, obtain the necessary regulatory qualifications of that cath-eter, and obtain an IDE for treating VT in Q4 2012. We project that $10.0M will meet our needs through Q4 2012. The CE mark and our IDE approval to start our VT clinical trial will establish our value as we seek Series B funding.

Series B Venture Funding: This funding round, to be completed in Q1 2013, will fund three activities. First, we will continue to staff our sales and marketing organizations based on our additional indications for use in our second 510(k) clearance and to launch world-wide sales following our CE Marking. In ad-dition we will carry out a United States based clinical trial for SERF Ablation of Ventricular Tachycardia. We project that $15.0M will be required for this phase to supplement the profits from the sales of the liver cancer ablation products. We expect that in mid 2014 we will apply for a PMA from the FDA for treatment of VT, establishing our value for ongoing financing.

Ongoing Funding: In 2014 we will have world-wide clearance for treatment of liver cancer and we will have completed our clinical trial for treatment of VT. Through careful management of expenses we expect to reach profitability and positive cash flow in 2014. We will use the techniques that Michael Curley used to make AcuNav a profitable business within two years of product introduction—we will primarily sell using peer-to-peer techniques such as dedicated symposia, on-site demonstrations and concentrating on the smaller shows dedicated to these physicians. While the business will be cashflow positive at this time, we expect that we will need additional funds to begin world-wide sales of the VT ablation product and will fund that expansion either through a Series C round of venture capital or else an IPO in 2015.



Translational Sciences Corporation

Presented by:Howard Pinsky, CEO

Company overviewTranslational Sciences Corporation (“TSC”), a Delaware “C” corpora-tion, was founded in May, 2010 by an experienced scientific, regulatory, and business development team to develop and market medical im-agingbased diagnostic software products in a field sometimes known as “diagnostic medical imaging”. TSC’s business model is to license intellectual property from academic research institutions and develop new diagnostic imaging products which can be brought to market in a rapid timeline (in about one year) in a manner which comports with FDA quality systems regulations and other requirements. TSC believes it can license and/or create defensible intellectual property, proprietary know-how, and novel marketing methods that should provide a sus-tained competitive advantage in the marketplace.

TSC has already licensed IP components from several leading research institutions in the U.S. and abroad (the German Cancer Research Center, the Hebrew University of Jerusalem, National Institute of Health--Human Biology Laboratory) which have demonstrated utility in the evaluation of progression of metastatic tumors, acute and chronic liver failure, and the early detection of Alzheimer’s disease. TSC plans to launch its first commercial product at the American Society of Clinical Oncology in June, 2011.

Product/Technology ProfileTSC’s first product is intended to address methods and workflow for the objective measurement and report-ing of metastatic disease progression according to standardized (RECIST 1.1, WHO) criteria. The product is intended for use as an enterprise clinical research management product as well diagnostic patient evaluation software product intended to facilitate and produce precise quantitative assessment of disease by manual, semi-automated, and automated image analysis methodologies.

Market and ApplicationThe quantitative evaluation of metastatic disease is perhaps the most widely accepted medical imaging bio-marker in humans and is a key endpoint in the evaluation of many new anticancer therapies. TSC’s first imaging software product is intended to improve clinical workflow and reader efficiency while at the same time enforcing rigorous and reproducible measurement techniques which address the highest research and clinical standards. In order to achieve this, a significant amount of both informatics and imaging IP has been developed to appropriately address the requirements of the research market.

Officers and Directors:Howard Pinsky, CEOAllan M. Green, CMO

Contact Information:Translational Sciences Corp.One Mifflin Place, Suite 400Cambridge, MA 02138Phone: 617-331 4014Fax: 617-297 [email protected]



Commercial Opportunity TSC plans to pursue two related markets. The first market addresses the specific needs of the some 400 US-based academic cancer research centers which receive $5 billion in R01 funding from the National Can-cer Institutes (NCI) and the NIH.TSC’s initial product addresses this market. Work is underway to adapt the first product to the workflow requirements of daytoday clinical practice, and a followon software product planned for introduction in Calendar 2011 is intended to support routine clinical usage in diagnostic radiology and medical informatics, which represents a $30 billion market.

Competitive AdvantagesTSC believes that its founders, principals, and consultants have sufficient requisite skills and experience to build a medical imaging software business. Management has shown, in past activities, the skills to efficiently develop imaging products, obtain FDA regulatory clearances and approvals, and market, sell, and support the products TSC intends to commercialize. As such, TSC is unique as a small company in its ability and demonstrated track record to accomplish these activities, as witnessed by demonstration of completing these tasks for a significant and important product offering in its first nine months of operations, without any external capital. TSC management believes they can continuously innovate a commercial stream of new scientific IP for subsequent releases of this software product through well executed licensing and sponsored research agreements, as well as develop other products currently in pipeline.


The company is currently completing a Series A friends and family round of $400K and is seeking a Series B round of $750K for working capital use in launching sales and marketing of its tumor assessment and report-ing product into the research market, and to complete engineering and marketing activities on to launch this product into the diagnostic radiology market. In 2012 and upon demonstration and initial launch into these markets, TSC will seek to obtain a Series C round of $6MM in additional operating capital from institutional in-vestment sources to implement scaled marketing, sales, and support activities, and to develop two additional products. Management believes that no additional financing will be required after the Series C round.

52 Exhibitors


Exhibitors 53


Additional Exhibitor ProfilesBoston University .................................................................................................................... 54

April Effort, Technology Transfer Officer

University of Massachusetts Amherst .............................................................................. 55T.J. (Lakis) Mountziaris, Professor

Ekam Imaging, Inc. ................................................................................................................. 56Mark Nedelman, President

GeneKey Corporation ........................................................................................................... 58Raphael Lehrer, Chief Scientist and Acting CEO

MedicaMetrix, Inc.................................................................................................................... 60Christopher LaFarge, CEO

Seign LLC ................................................................................................................................... 62Lawrence M. Casha, Director of Research

University of Massachusetts Dartmouth ......................................................................... 64Bal Ram Singh, Professor and Director

54 Exhibitors


Boston UniversityPresented by:April Effort, Technology Transfer Officer

Novel Small Molecule Inhibitors of Hepatitis C VirusSuccessful antiviral treatments are rare and for many viruses, non-ex-istent. More commonly is the phrase “allow the virus to run its course” applied, rather than an effective medicine. For many non-life threat-ening infections, symptomatic support may be an adequate response. Unfortunately, several emerging viruses, such as hepatitis C virus (dis-covered in 1989), are considerably more debilitating and quite often lethal. Hepatitis C affects 130 million people worldwide and is the main cause of liver disease in the United States. There is no vaccine and the only available treatment--based on a combination of pegylated in-terferon and ribavirinis only effective in 50% of the patients and con-tinues to be plagued by sideeffects. The ongoing search for specific treatments relies on finding novel targets. Described herein are unique compounds that inhibit such a target; specifically, a core protein, which is responsible for viral assembly and release, and subsequent prolif-eration of hepatitis C virus. These putative hits were shown to reduce or eliminate virus growth in cells while at the same time having no ob-servable toxic effects on cells. Additional compounds were synthesized in an effort to improve the activity and to identify a lead compounds for developing both viral pathogenic research tools and therapeutic agents.

Center for Regenerative Medicine and Human iPS Cell BankThe Center for Regenerative Medicine (CReM) is a collaborative effort among scientists on both campuses of BU that aims to advance stem cell research with an eye to therapeutic techniques. This includes a focus on induced pluripotent stem (iPS) cells, embryonic stem cell-like lines derived from adult somatic cells by in-troducing a cocktail of transcription factors. A bank containing characterized iPS lines allows the international research community to work to advance the therapeutic potential of these cells. In 2009, the CReM founded its Human iPS Cell Bank, with a focus on heritable diseases treated or studied by BUMC investigators and physicians. Disease types include cystic fibrosis, amyloidosis, sickle cell, and others. Since some of these diseases result from single base pair mutations, disease phenotypes can presumably be modeled in vitro upon differentiation to the affected tissue or can undergo gene correction for cell-based therapies. For clinical relevance, lines must be free of exogenous transgenes. Many of our iPS lines were reprogrammed using a lentiviral cassette encoding the necessary transgenes (STEMCCA), and when flanked by LoxP sites, STEM-CCA can be excised using Crerecombinase.

.

Contact Information:

Lisa Marie Sturk, PhDPhone: [email protected]

April Effort 53 Bay State RoadBoston MA 2215Phone: [email protected]/otd

Exhibitors 55


University of Massachusetts AmherstPresented by:T.J. (Lakis) Mountziaris, Professor

Product/Technology ProfileWe are developing a platform technology for medical diagnostics based on the discovery of a new class of biomolecular sensors, whose opti-cal spectrum changes upon binding to a specific biological target. The sensors are based on functionalized semiconductor nanocrystals (with size less than 10nm) that respond to changes in the charge distribu-tion around them when a biomolecular probe that is covalently bonded to the nanocrystal binds its intended target. The technology has been demonstrated in rapid quantitative detection of DNA sequences and mutations (screening for disease-causing genes), and in homogeneous immunoassays (antigen-antibody interactions).

Markets and ApplicationsThe technology targets the growing Point-of-Care Diagnostics market and additional growing markets, including rapid sensing of biological threats for homeland security applications, rapid screening of the gen-eral population for public health applications, high-throughput screening of immune system irritants for drug development, etc.

Commercial OpportunityTarget customers for this technology are health-care providers, pharmaceutical and biomedical research laboratories, first responders, and the military. The technology can be commercialized in the form of diagnos-tic kits and a portable opto-electronic devices that perform the analysis.

Competitive Advantage The competitive advantages of our technology are: high sensitivity, high specificity, small probe size, robust-ness, multiplexing capability, and instantaneous detection of the binding of the probe to its target via an opti-cal signal.

Future Financial PlansThe technology can be brought to market in 23 years (or sooner) with a modest investment of ~$5million for a start-up company (less for an existing company).


T.J. (Lakis) Mountziaris, Ph.D.Professor and Department HeadDept of Chemical Engineering &UMass NanoMedicine InstituteUniversity of MassachusettsAmherst, MA 01003Phone: 413-545-6145Fax: [email protected]://www.ecs.umass.edu/nano-med/

56 Exhibitors


Ekam Imaging, Inc.Presented by:Mark Nedelman, President

Company Overview

Ekam Imaging Inc. is a pre-clinical contract research organization that provides imaging services, data analysis, and information synthesis to pharmaceutical and biotechnology companies worldwide. Ekam’s primary focus is on central nervous system diseases and auto-immune disorders, where the imaging of awake, un-anesthetized animals is critical to successful drug discovery and development. The company’s vision is to become an Imaging Center of Excellence collaborating with the biomedical industry to enhance the drug development process.

Ekam Imaging is lead by Mark Nedelman, President. Mark began his research and development career in the nuclear medicine laboratory at Massachusetts General Hospital in Boston from 1983-1987. From there, he was recruited to start and head Preclinical Pharmacology at Centocor, Inc. in Malvern, PA where he was an Associate Director from 1987-1996 playing key roles in leading the preclinical development and approval of a number of novel drugs. He joined the CRO industry in 1996 and held a number of leadership positions within Charles River Laboratories’ preclinical services business including Senior Director of Pharmacology, Surgery and Toxicology from 2000-2003 and General Manager of the Interventional and Surgical Services business unit from 2003-2006. In addition to senior roles in Business Development and consulting, his additional accomplishments includes one patent, over 90 abstracts and invited presentations, 30 original publications and three book chapters covering the fields of cardiology, oncology, imaging, infectious diseases and inflammation. Mark has a B.S. (‘80) and M.S. (’85) in Biology and Physiology from the University of Cincinnati and a M.B.A. (’07) from Northeastern University.

Product/Technology ProfileAnimal imaging is crucial in early drug discovery, however the use of anesthesia creates an artificial situa-tion that masks true drug activity and pharmacokinetics. In addition, animal behavior, the traditional means of evaluating drug efficacy, does not reliably translate to the human condition, ultimately costing drug com-panies hundreds of millions dollars when they discover the drug doesn’t work in clinical trials. The testing we are now able to perform examines the patterns of brain activity and integrated neural circuits in rodents and nonhuman primates that are activated with drugs and compares these to human imaging data on brain activity.

Officers and Directors: Mark Nedelman, President and DirectorShiv Tasker, Director

Contact Information:Mark Nedelman12 Long Drive Westborough, MA 01581Phone: [email protected]

Exhibitors 57


Market and ApplicationUntil now, preclinical imaging use has been limited by the ambiguities surrounding the use of anaesthetized animals. Once you remove that limitation, its use at various points along the drug development process will grow, substantially reducing the cost of development by eliminating more expensive or less efficient alter-native methods. Further, certain applications of imaging in preclinical development will only now become available with the capability to study conscious animals. The ability to deliver accurate, translational data will greatly assist our drug developers in faster and more informed decision making. As such, the size of the market is substantial including all companies developing CNS based therapeutics for psychiatric and neuro-degenerative indications.

Commercial OpportunitiesThrough scientific publication, strategic partnerships, symposium and scientific tradeshows, Ekam will seek to target companies that can leverage its unique capabilities and expertise in awake animal imaging.

Competitive AdvantagesEkam’s sustainable competitive advantage is based on its technology and expertise in awake animal imag-ing. The rest of the industry continues to do imaging the same way it has for years, anesthetizing animals. In addition, Ekam is one of the only CROs world-wide capable of awake animal imaging in nonhuman pri-mates.

Future Financial PlansEkam is seeking strategic partners and/or investors interested in helping fund the further development of Ekam as a stand-alone CRO.

58 Exhibitors


GeneKey CorporationPresented by:Raphael Lehrer, Chief Scientist and Acting CEO

Company OverviewGeneKey is a company breaking new ground in personalized medicine for metastatic cancers. We generate full-genome data and perform deep systems biology analysis on individual patient samples to identify key mechanisms of carcinogenicity, and therefore match patients to approved drugs or investigational agents.

We have piloted this approach with 17 patients and found that we were able to identify at least one statistically significant candidate mecha-nisms with accessible treatments for every patient.

Through this work we have attracted the interest of top oncologists throughout the country and have established ongoing collaborations with oncologists at Dana Farber, Mass General Hospital, UCLA, UCSF, and University of Washington.

Raphael Lehrer, Ph.D., is Chief Scientist and Acting CEO. He is the lead inventor of this technology and previously practiced it at CollabRx, Inc., a company that he co-founded. Originally trained as a statistical physicist at Harvard, Dr. Lehrer has spent 12 years working in the genom-ics/pharmaceutical R&D space. His deep knowledge of genomics and statistics drove creation of a hybrid approach based on statistical methodologies that can be used to validate mechanistic hypotheses with only a few samples.

Product/Technology ProfileWhen metastatic cancer patients fail their initial 1-2 lines of therapy, there is no longer data to support thera-peutic decisions, so physicians are forced to rely on “medical guesswork.” This is because each cancer type (e.g., lung cancer) is composed of up to hundreds of different subtypes, the vast majority of which have not yet been identified. Personalized medicine aims to identify the appropriate subtype into which a patient falls and then give an appropriate therapy. However, the solutions essentially amount to testing for the few sub-types that are already characterized – so for the majority of patients, the answer is “none of the above.”

GeneKey’s personalized oncology program is designed to transcend these limitations. We do real-time, fun-damental analysis to understand the drivers of the cancer at a molecular level, and then match to approved or investigational drugs designed to target these mechanisms. This approach is designed to uncover new subtypes in the event that the patient does not fit in one of the wellunderstood ones, and can draw from over 2000 possible therapies. In our pilot program of 17 stage IV patients, we were able to identify at least one new therapeutic strategy for every patient, and in 80% of these cases, it was a strategy not even considered by the oncologist previously.

As subtypes and therapies that match them emerge from the analysis, we file patents on novel ones where there is evidence of efficacy. We have filed a provisional method of use patent application on a Pfizer drug for use in a subset of patients not previously anticipated, and we plan to file our first diagnostic patents in the next 12 months.

Officers and Directors: Raphael Lehrer, Chief Scientist and Acting CEO

Contact Information:1340 Centre St, Suite 207Newton, MA 02459Phone: 240-460-7650Fax: [email protected]

Exhibitors 59


Commercial OpportunitiesWe anticipate revenue to come primarily from 3 sources:

Hospitals and oncology practices (starting mid-2012)• Insurance companies/reimbursement (starting mid 2013)• Milestones and royalties from IP (starting late 2013)•

The end market for our program consists of all patients with metastatic or recurrent cancer – estimated to be 1-2 million in the US and several million more abroad. In 2011 – 2012, before insurance reimbursement the addressable market will be limited to the wealthiest 10% of patients who can afford to pay out of pocket.

We plan to capture patients primarily through hospital and community oncology practices. These relation-ships will be forged by collaboration on performing clinical studies of the efficacy of the program, and clinical adoption will occur as results being to become available.

Competitive AdvantagesOther personalized medicine companies can be classed into three approaches:

A gene panel of a few dozen genes to match to one of about 30 drugs• Chemosensitivity – in vitro testing of cancer cells against 10-20 drugs• Xenograft (mouse model) testing against approximately 5 drugs •

Our approach is differentiated primarily by a far lower probability of getting a “negative” result. For the ma-jority of patients, the answers that come back from these approaches is “none of the above.” The scope of our search (over 2000 possible drugs) reduces that risk substantially – so far we have been able to provide answers to every patient we have worked with.

We have a patent application in process (filed November 2008) covering the methodology, and there is a large amount of know-how required to successfully perform these analyses.

Future Financial PlansWe are currently seeking $1 M in seed funding to allow us to establish the team, mature the technology, and build key relationships in order to raise a second tranche of funding.

We will need approximately $6 M between now and 2013 to conduct clinical trials, achieve reimbursement eligibility, and generate additional diagnostic and method-of-use IP. By the end of 2013, we expect to have secure insurance reimbursement of the analyses, be the key personalized medicine provider for 5-10 hospi-tals, and to have filed 1215 method of use applications and 45 diagnostic patent applications.

In addition to seed financing, we are seeking a seasoned entrepreneur highly familiar with genomics tech-nologies and analyses to take the role of CEO.

60 Exhibitors


MedicaMetrix, Inc.Presented by:Christopher LaFarge, CEO

Company OverviewMedicaMetrix specializes in urological medical devices that demon-strate comparative effectiveness. MedicaMetrix has developed a point of care, medical device for the quantitative measurement of prostate volume and calculation of PSA density at a cost that is a fraction of the current “gold standard,” transrectal ultrasound.

The Management Team:

Christopher LaFarge, CEO, founded IIC which developed Micro-Rig, an autonomous robot for oil & gas wells which was sold to Halliburton. Christopher is a graduate of Harvard College and Yale School of Man-agement (MBA).

Richard Trembowicz, President, is an attorney who specializes in healthcare reimbursement systems, comparative effectiveness analy-sis, and early stage company funding. He was VP Business Develop-ment and General Counsel of AMD Telemedicine. Richard is a gradu-ate of Harvard College and BU School of Law.

Ute Schwiderski, PhD, VP-Clinical Research, formerly served as VP, BDM at Indevus Pharmaceuticals and multiple positions at Bristol My-ers Squibb. Ute received a PhD in Biostatistics from Medical College of Virginia.

Robert Horne, Director, held executive positions at medical device companies Accuray, Inc. and Given Imaging, Inc. (GIVN). Robert ob-tained a Master’s in Chemical Engineering from Cambridge University and an MBA from Harvard Business School.

Robert Fanning, Director, was formerly the CEO of Northeast Health Systems (Beverly Hospital) and serves as a Director/Advisor on a num-ber of early stage healthcare companies.

Product/Technology ProfileMedicaMetrix’s first product, ProstaGloveTM, is a multi-patented, medical device with a clear path to com-mercialization. ProstaGloveTM is similar to a standard exam glove used during a Digital Rectal Exam but has sensors that enable a physician to measure the palpable surface of the prostate, improving diagnosis of prostate cancer by enabling the use of PSA Density (PSAD) to reduce unnecessary prostate biopsies with a potential net savings in prostate cancer diagnosis (after ProstaGloveTM sales) of more than $350M US and $750M globally.


Christopher LaFarge, CEO, Chairman, and TreasurerRichard Trembowicz, President and DirectorJudson Pratt, Director and Sec-retaryRobert Horne, DirectorRobert Fanning, Director


Christopher LaFarge, CEOMedicaMetrix, Inc.1 Old Sudbury Rd.Wayland, MA 01778Phone: [email protected]

Exhibitors 61


Today patients with PSA>4.0ng/ml are referred for prostate biopsy. Approximately 75% of these biopsy pa-tients do not have cancer, wasting more than $1.2 Billion in the US annually. PSA Density (PSAD) allows 35%50% of biopsies to be eliminated while capturing substantially all prostate cancers identified under prevailing diagnostic methods.

Markets and Commercial OpportunityMedicaMetrix will serve a >$350M worldwide ProstaGloveTM market for prostate cancer diagnosis. Insurers/governments will pay for ProstaGloveTM because of its high comparative effectiveness.

Marketing and sales of ProstaGloveTM will be driven by its demonstrated comparative effectiveness relative to existing diagnosis/treatment methods. Because of its high comparative effectiveness, insurers will recom-mend, even mandate, the use of ProstaGloveTM for: 1) diagnosis of prostate cancer; and 2) assessment of prostate volume to manage urinary tract/bladder conditions resulting from an enlarged prostate (BPH). Sales efforts will be directed at insurer medical directors, CMS, health systems/medical groups (e.g., the VA, and staff/group model HMOs) which have a high percentage of Global Payments or direct financial responsibility for medical costs (these parties can realize immediate financial benefits of ProstaGloveTM before the issu-ance of reimbursement codes), and state Medicaid agencies. The company will seek sales and distribution partnerships to reach individual physicians/small group practices. The Company will make money though repeat sales of ProstaGloveTM’s disposable glove component.

Competitive Advantage The current method of determining prostate volume, transrectal ultrasound (TRUS) is cost prohibitive and In-surers/Government do not reimburse this use of TRUS. Our strong comparative effectiveness also provides considerable pricing leverage and sets a high bar to potential competition.

Future Financial PlansMedicaMetrix plans development in 3 welldefined phases with defined milestones:

PreFunding, NonHuman Verification and Validation Studies – Underway • Measurement Study – Accuracy and Repeatability of ProstaGloveTM in DRE simulator; Prelimi- -nary physician usability assessmentVolume Algorithm Validation Study -

Post-Funding, Human Clinical Studies• FDA 510(k) Study 1- Measurement - $750,000 tranche. Design validation on accurate and re- -peatable measurement of the palpable surface of the prostate in a clinical settingFDA 510(k) Study 2 - Algorithm and Comparative Effectiveness - $1,750,000 tranche. Validation -of our proprietary algorithm for volume calculation in a clinical setting

Commercialization ~$3M tranche. MedicaMetrix will commence scalable product manufacturing and, • while awaiting reimbursement code issuance, will conduct sales initially to Key accounts, e.g., the VA, and staff/group model HMOs.

62 Exhibitors


Seign LLCPresented by:Lawrence M. Casha, Director of Research

Company OverviewSeign LLC is currently developing a device called Ajjolos. Ajjolos ef-fectively and safely stretches muscle by applying force to an extremity while measuring the force applied. It will be used by physical therapists, patients, and athletes to assist in the recovery of injuries/surgeries, or stretch muscles before/after athletic activities.

Product/Technology ProfileThe product contains an inflatable bladder. The bladder is placed against the extremity to be stretched. The pressure applied by the bladder is measured and displayed on a computer interface. The therapist and or patient controls the inflation of the bladder which in turn measures the force applied to the extremity. This in turn measures the passive mus-cle tension and the associated stress relaxation. These two measures allow for a safe and effective stretch of an extremity.

Markets and ApplicationsAjjolos will establish the first and only standard for passive stretching. Stretching relaxation curves document the quality and improvements made while stretching. Seign LLC will sell or lease Ajjolos to physical thera-pists, fitness centers, and personal trainers worldwide.

The U.S. fitness equipment manufacturing industry consists of about 100 companies with combined annual revenue of more than $3 billion. The top five account for more than 50% of revenue. Ajjolos is the only device that can quantify passive stretching.

Commercial OpportunityTarget customers are patients under physical therapists supervision, home therapy programs, rehabilitation centers, and athletic teams. Ajjolos has a patent pending and a prototype. Our engineering company is presently drawing plans for a manufacturing device. Seign LLC continues to present Ajjolos at conferences and tradeshows. It continues to demonstrate Ajjolos at different physical therapy programs, universities, medical clinics, and fitness centers. The device is compact and portable and can also be sold to the regular consumer.


Lawrence M. Casha M.D., Director of Research

Mary Patricia Casha


Professor Russell WoodmanQuinnipiac University275 Mt. Carmel AvenueHamden, CT 06518Phone: 203-582-8234Fax: [email protected]

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Competitive Advantage Presently, Ajjolos is the only passive stretching device that actually measures force applied to muscle versus displacement. In addition, the device is portable and compact.

The U.S. fitness equipment manufacturing industry consists of about 100 companies with combined annual revenue of more than $3 billion. Ajjolos is portable and compact and will appeal to the regular consumers aiding in stretching before/after exercise or activity.

Seign LLC would focus on insurance company reimbursement. This is based, in part, on a similar device, the Continuous Passive Motion Device (CMD). Currently, the CMD is used in physical therapy facilities and home therapy programs for patients recovering from injuries/surgeries and is listed as “reimbursable” by insurance companies such as United Healthcare/Oxford and Blue Cross Blue Shield.

Ajjolos would be used in the same manner: available at physical therapy facilities to aid in the recovery of in-juries/surgeries; and leasing the device to assist post-operative patients enrolled in home therapy programs. A clinical study has shown that the recovery results have yielded the same outcomes but at significantly dif-ferent cost values. Using the device constituted less than half of the cost of utilizing the expertise and time of a physical therapist.

Future Financial PlansPresently, Seign LLC is looking for funds up to the amount of $400,000 to fund the engineering plans to manufacture Ajjolos devices for distribution. Ajjolos will be used to begin studies on passive stretching for the normal population at Quinnipiac University. In addition, Ajjolos will be distributed to different facilities to aid patients in rehabilitation and/or athletic activities.

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University of Massachusetts DartmouthPresented by:Bal Ram Singh, Professor and Director

Product/Technology ProfileEffective drug delivery to the central nervous system (CNS) is one of the biggest challenges in treating neurological disorders like Amyo-trophic lateral sclerosis (ALS), multiple sclerosis (MS), etc.

“Many drugs in testing for ALS do not attain high concentrations in the spinal cord, even if given directly into the ventricular spaces within the brain, reported Mukur Gupta, Ph.D., of the ALS Therapy Development Foundation in Cambridge, Mass., who studied the problem in SOD1 mice. New routes of drug delivery should be considered and investi-gated to achieve a true answer to therapeutic questions in ALS.”

Currently, drugs may be administered directly into the CNS or adminis-tered systematically (e.g., by intravenous injection) for targeted action in the CNS.

Prof. Singh has successful cloned the full length non-toxic mutant of BoNT/A and expressed and purified this protein in reasonable quantity. He has initially characterized DR BoNT/A for molecular size, and ami-no acid sequence, which match with the native BoNT/A. According to Prof. Singh, DR BoNT/A lacks the characteristic endopeptidase activ-ity against SNAP-25 (synaptosome-associated protein of 25 kDa), and SNARE (soluble N-ethylmaleimide-sensitive factor attachment protein receptor). The cleavage of anyone of these proteins results in blockage of acetylcholine release at the neuromuscular junctions, resulting in flaccid muscle paralysis.

Markets and Applications5 potential applications:

1. Safe drug delivery system to nerve cells. 2. Botulism therapeutic product.3. Effective (oral, inhalational, and IP) vaccine against botulism.4. Botulinum surrogate for testing and drug development.5. Tracer for study of botulinum as well as other protein pharmacokinetics.

We believe that the most lucrative and best quality opportunity would be as a vector for safe drug delivery to nerve cells. The method of delivery of any drug to the CNS has a profound impact on the drug’s commercial potential. “The market for CNS drug delivery technologies is directly linked to the CNS drug market. The multibillion dollar CNS drug market (US$ 58 billion) is rapidly growing (14%/year) and bears significant unmet medical needs. Many (biopharmaceutical) drugs are currently not available to the brain because they are not able to enter the brain due to the presence of a so called blood-brain barrier.”


Bal Ram Singh, Director


Professor Bal Ram Singh 285 Old Westport RoadDartmouth, MA 02747Phone: 508-999-8588Fax: [email protected]://www.umassd.edu/cas/chemistry/singh/

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Commercial OpportunityWe are currently seeking licensees who can perform the development work and testing that would be re-quired to commercialize this technology. Potential licensees include pharmas who work on Parkinsonism and related diseases like: Bristol-Myers Squibb, GlaxoSmithKline, UCB Pharma, Roche, Novartis, etc.

Competitive Advantage As noted above, currently, drugs are either administered directly into the CNS or administered systematically (e.g., by intravenous injection) for targeted action in the CNS, but these techniques are often reduce a treat-ment’s effectiveness because of the blood/brain barrier. Our technology helps utilize natural ability of the botulinum to penetrate the blood/brain barrier AND eliminate the toxicity normally associated with botulinum derivations. We have a portfolio of botulinum patents and patent applications that will help protect this com-petitive advantage for a licensee.

Future Financial PlansWe are currently searching for a biotechnology or pharmaceutical CNS company licensee who could provide the development, resources and commercialization funding and royalties in return for reaping the benefits of introducing a potential blockbuster drug delivery technology.

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