VTEQ Presentation july 2014
-
Upload
redchip-companies-inc -
Category
Health & Medicine
-
view
330 -
download
1
description
Transcript of VTEQ Presentation july 2014
July 2014
Safe Harbor Statement
2
Statements made in this presentation regarding VeriTeQ Corporation (“VeriTeQ” or “Company”) and VeriTeQ thatare not historical facts are forward-looking statements based on our current expectations, assumptions, estimatesand projections about VeriTeQ and our industry. These forward-looking statements are subject to risks anduncertainties that could cause actual future events or results to differ materially from such statements. Theseforward-looking statements include, without limitation, statements about our proposed name change and reversestock split, our commercialization activities, market opportunities, our strategy, our competition, FDA regulation,partnership opportunities, market penetration, and all other forward-looking statements. You should not placeundue reliance on any of the forward-looking statements made in this presentation. Our actual results could differmaterially from those expressed or implied by these forward-looking statements as a result of various factors,including risks and uncertainties related to the timing or successful completion of our product commercializationactivities, VeriTeQ’s ability to raise capital, and other various risks and uncertainties. Additional information aboutthese and other factors that could affect VeriTeQ’s business is set forth in its various filings with the Securities andExchange Commission, including those set forth in its Form 10-K filed on April 15, 2014, and Forms 10-Q filedon July 16, 2013 and November 14, 2013, and May 14, 2014 under the caption "Risk Factors." The Companyundertakes no obligation to update publicly any forward-looking statements for any reason, even if newinformation becomes available or other events occur in the future.
This presentation does not constitute a prospectus or form part of any offer or invitation to sell or issue, or anysolicitation of any offer to purchase or subscribe for, or any offer to underwrite or otherwise acquire any shares inthe Company or any other securities, nor shall they or any part of them nor the fact of their distribution orcommunication form the basis of, or be relied on in connection with, any contract, commitment or investmentdecision in relation thereto, nor does it constitute a recommendation regarding the securities of the Company.
Company Background
3
VeriTeQ originated as a private company founded in 2011 to acquire and develop core implantable RFID intellectual property for healthcare
Acquired/licensed/developed 100+ patents (issued or
pending)
Multiple regulatory clearances: FDA and CE Mark
Completed share exchange agreement with Digital Angel Corporation on July 8, 2013; company changed its name to VeriTeQ
VeriTeQ shareholders own ~88% of resulting company
Closed $1.5m bridge financing on Nov. 13
Ticker changed to “VTEQ” on Nov. 19
Unique Value Proposition
4
In July 2012, the Healthcare Safety and Innovation Act was signed into law and in Sept. 2013, the FDA issued a Final Rule requiring all medical devices in the U.S. that are re-usable and re-processed to carry a unique device identifier, or UDI, with direct part marking
VeriTeQ’s FDA cleared UDI, called Q Inside Safety Technology, can serve as a direct part marking to help device manufacturers comply with the Final Rule, and can also identify a permanent implantable medical device, in vivo, on demand
Q Inside Safety Technology goes beyond device identification and provides clinical and healthcare benefits via customizable software and data analytics
VeriTeQ also offers FDA cleared radiation dose measurement technologies to protect patients undergoing cancer treatment
VeriTeQ’s implantable and wearable dosimetry products provide radiation levels from the patient to help prevent overdose and under-dose
Company Overview
5
VeriTeQ provides proprietary, innovative healthcare solutions for Unique Device Identification and Bio-Sensing/Radiation Dosimetryapplications
Core Technology: implantable radio frequency (RF) microchip technologyCleared by the FDA as the Predicate Class II medical device in the industry
UDI products enable access to UDI information, in-situ, on demand, at the point of use
A leading industry position to enable compliance with FDA Final Rule
Q Inside Safety Technology also enables data analytics for evidence-based medicine
Bio-sensing technologies for radiation dosimetry provide real-time measurements of received radiation dose from the patient, not the machine
External and internal product applicationsHelps prevent radiation overdosing and under-dosing
Lead Business Areas
6
Medical Device UDI/Q Inside
Safety Technology
Breast Implants and Breast
Implant Sizers
Vascular Ports
Other Reusable and Implantable Medical Devices
Bio-Sensing/Radiation
Dosimeter Technologies
External Radiation Dosimeter
Implantable Radiation Dosimeter
The VeriTeQ UDI System
Medical Devices with
Inside Safety Technology
7
FDA Final Rule
8
The Final Rule requires devices intended to be used more than once and intended to undergo any form of reprocessing before each use, i.e. re-useable/reprocessed medical devices to have a direct part marking (vs. basic labeling on device packaging)
Requires the direct part marking to be provided through either or both of the following:
Easily readable plain text;
Automatic Identification and Data Capture (AIDC), or an alternative technology, that will provide the UDI of the device on demand
Benefits of a UDI System
Allows more accurate reporting and analysis of adverse events to quickly identify problem devices
Reduces medical errors by quickly and accurately identifying a device and its characteristics
Provides a standardized identifier that allows manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls
Provides a consistent way to enter information about devices in electronic health records and clinical information systems
Provides a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies
Implantable RFID Microchips Patented and FDA
cleared
Provides the primary key information
Pocket Readers
Patented and FDA Cleared
Pocket Reader
Pocket Reader EX
VeriTeQ’s UDI System: Inside
Database Customization
for device manufacturer
Informatics
Integration with FDA database
9
UDI Business Model
10
VeriTeQ acts primarily as a supplier of its proprietary microchips and readers to medical device manufacturers
Manufacturers incorporate VeriTeQ’s products into their manufacturing processes/distribution strategy (to hospitals, physicians, etc.)
Price per chip = $12-15; gross margin per chip = 65 - 75% marginsPrice per reader = $300-500; gross margin per reader = 40 – 60% margins
VeriTeQ also provides development services to medical device manufacturersPrimary development areas include design and manufacturing process to include chip in their medical device, i.e. new encasement technologies such as special polymers and heat resistant microchips
Avg. price for development per manufacturer = $250,000; gross margin = 50%
Data services include database connectivity to manufactured microchips, application software to collect microchip/medical device model implanted, FDA data base registry and informatics analytics. Priced on per project development ranging from $25,000 to several hundred thousand dollars
Targeted Customers
11
Breast Implant/SizersManufacturers
Vascular Port Manufacturers
Artificial Joint/Sizers
Manufacturers
Heart Value Sizers, Endo/ Surgical
Equipment
Breast Implants
12
VeriTeQ’s Q Inside Safety Technology can be embedded within breast implants and sizers to automatically identify the medical device in situ or after re-sterilization.
Ex-US: Agreement with Establishment Labs/MotivaLeading global breast, body and facial aesthetic company that manufactures advanced silicone-filled breast implants, marketed under the Motiva Implant Matrix brand name
Manufacturing completed and CE Mark certifications achieved
Launched Q1-2014 (EU and UK); Over 500 women implanted
US: Market leading breast implant manufacturer is testing feasibility to integrate the Q Inside in its silicone implants and sizers
Discussions ongoing with the two leading global breast implant manufacturers regarding need to identify their sizers to comply with FDA Final Rule
Company estimates sizer market at 600,000 devices annually
Vascular Ports
13
Partnership with Medcomp (a leading manufacturer of vascular ports) to utilize Q Inside for Medcomp’s FDA-cleared vascular ports
$3 million initial contractual PO commitment from Medcomp
Enables accurate device identification and medication dosage
Hospital studies expected to begin at:Northwestern Memorial in ChicagoNew York-Presbyterian – University Hospital of Columbia and Cornell in NYCleveland Clinic in Cleveland, OH or MD Anderson Cancer Center in Houston, TX
Medcomp /VeriTeQ targeting to set clinical UDI standard to incentivize other port manufacturers to use Q Inside – e.g. C.R. Bard, Smiths Medical, etc.
Artificial Joints and Sizers
14
Identification of implantable and reusable medical devices such as sizers used in joint replacements (subject to Final Rule)
Artificial hips in the U.S.:Number of procedures: 230,000Total annual expenditure: $10.5 billionAverage cost per procedure: $45,000Major manufacturers: Zimmer (24%), Stryker, DePuy/J&J, Biomet, Wright Medical
Artificial knees in the U.S.Number of procedures: 543,000Total annual expenditure: $12 billionAverage cost per procedure: $22,000Major manufacturers: Zimmer (24%), Depuy/J&J, Stryker, Biomet, Smith & Nephew
Active initial meetings/dialog with lead target device manufacturers
Clinical benefits: Q Inside Safety Technology allows for immediate data retrieval; can help quickly resolve adverse event reporting and recalls
As published on July 18, 2011 in 24/7 Wall St.’s Eleven Most Implanted Medical Devices In America
VeriTeQ Bio-Sensors
In Situ Measurement of Radiation Dosages
15
Sensing Technologies
16
VeriTeQ owns Patent 7,125,382 for an “Embedded Bio-Sensor System,” a biological sensor on the end of a radio frequency chip
Temperature (current)
Radiation levels (current)
Blood oxygen (future)
Pulse (future)
Medication levels (future)
i.e. post surgery
Glucose (licensed to a third party)
Others
VeriTeQ Dosimetry
OneDoseExternal Technology
Q Inside SmartMarkerImplantable Technology
Radiation Dose Verification
17
Maximize Tumor Control(High Dose)
MinimizeHealthy Tissue
Toxicity(Low Dose)
The greatest challenge for radiation therapy or any cancer therapy is to attain the highest probability of cure with the least morbidity.1
1) Bucci MK, Bevan A and Roach M. Ca Cancer J Clin 2005;55:117-134
Objective of the Radiation Oncologist
18
Patient Safety & Radiation Overdose
19
2013: #3 Unnecessary exposures and radiation burns from diagnostic radiology procedures
2012: #2 Exposure hazards from radiation therapy and CT
2011: #1 Radiation overdose and other errors during radiation therapy
2009-10: #4 CT radiation dose
2008: #8 CT radiation dose
2007: #5 Radiation therapy errors
According to the ECRI Institute, radiation or CT overdose make the list of the Top 10 Technology Hazards each year going back at least five years
VeriTeQ OneDose ®
20
OneDose® is an FDA-cleared single-use, external dosimetry system used in the radiation oncology suite to verify radiation dose quickly and conveniently at the skin level
Significant IP protection
CE Mark to market products in the E.U.
OneDose is the only wireless, pre-calibrated, disposable, surface sensor on the market that provides an instant readout of the dose delivered
Reimbursement rate per patient (4-6 dosimeters used during treatment) ranges between $260 and $380
In 2010, 1.1 million patients received radiation therapy in the U.S.* with new indications for use in CT and fluoroscopy markets
Researchers at the National Cancer Institute estimate that 29,000 future cancer cases could be attributed to the 72 million CT scans performed in the country in 2007
Over 5 million fluoroscopic procedures performed annually in the U.S.**
* According to a study published by IMV Medical Information Division**National Council on Radiation Protection and Measurements, report No. 168 (2010)
Q Inside SmartMarker
21*Source = ASTRO, American Society of Radiation Oncology
World’s first and only implantable wireless radiation dosimeter; FDA cleared for use in prostate and breast cancer radiotherapy
Enables radiation oncologists to immediately measure the dose of radiation penetrating a tumor or tumor area
Cleared for use in photon external beam and hypo-fractionated treatment protocols
Potential additional new indications for use include lung, colorectal and pancreatic cancer
Only device that confirms radiation dose delivered to tumor
Can also be used as a fiducial marker for localization of the tumor
Device is reimbursable by both Medicare and private insurance
FDA cleared & CE mark; significant patent protection
Approximately 81,580 patients receive seed implants per year in the U.S. and more than 425,000 patients are diagnosed with prostate and breast cancers total each year in the U.S.*
Bio-Sensor Business Model
22
To be sold to radiation oncology centers in the U.S. and E.U.Radiation oncologists, therapists, physicists, dosimetrists
Over 4,400 radiation oncologists in the U.S., with 4 states representing 33% of the U.S. market
To be sold through direct sales, worldwide distribution partners, product specific website, trade associations
Price for One Dose Reader Kit = $499; gross margin = 80%
Price for Q Inside SmartMarker Kit = $1,200; gross margin = 80%
Potential distribution partners:
Intellectual Property
23
VeriTeQ has a robust portfolio of more than 100 patents, patents pending and licenses in the U.S. and abroad. VeriTeQ’s foundation patents are an Embedded Bio-Sensor System on the end of a RF microchip (Patent 7,125,382 issued in 2006), and the use of implantable sensors for monitoring tumors in oncology applications (Patent 6,402,689 issued in 2002). A partial list of the Company’s key patents follows.
Patent No. Title
7,125,382 Embedded Bio-Sensor System
6,402,689 Methods, Systems and Associated Implantable Devices for Dynamic Monitoring of Physiological and Biological Properties of Tumors
7,378,056 Methods, Circuits, and Compositions of Matter for In Vivo Detection of Biomolecule Concentrations Using Fluorescent Tags
7,011,814 Systems, Methods And Devices For In Vivo Monitoring Of A Localized Response Via A Radiolabeled Analyte In A Subject
7,479,108 Implantable Sensor Housing, Sensor Unit And Methods For Forming And Using The Same
7,495,224 Disposable Single-Use External Dosimeters For Use In Radiation Therapies
7,966,054 Disposable Single-Use External Dosimeters For Detecting Radiation In Fluoroscopy And Other Medical Procedures/Therapies
7,491,942 Disposable Single-Use Internal Dosimeters For Detecting Radiation In Medical Procedures/Therapies
7,010,340 Methods, Systems, and Computer Program Products for Providing Dynamic Data of Positional Localization of Target Implants
7,510,699 In Vivo Fluorescence Sensors, Systems, And Related Methods Operating In Conjunction with Fluorescently Labeled Materials
7,557,353 Single-Use External Dosimeters for Use in Radiation Therapies and Related Methods, Systems and Computer Program Products
Leadership Team
24
Scott R. SilvermanChairman & CEO
Mr. Silverman has been Chairman and CEO of VeriTeQ since its inception in Dec. 2011. He served as Chairman and CEO of PositiveID Corp. (OTC:PSID) from 2008 to Aug. 2011, and Chairman and CEO of VeriChip Corp. (NASDAQ:CHIP) from Dec. 2006 to Jul. 2008. He was Chairman of Digital Angel Corp. from 2003 to 2007. From 2003 to 2006, Mr. Silverman served as Chairman and CEO of Applied Digital Solutions (NASDAQ:ADSX). Mr. Silverman is an attorney licensed to practice in NJ and PA, and has more than 15 years of executive experience with technology companies. He is a graduate of the University of Pennsylvania and Villanova School of Law.
Randolph K. GeisslerPresident
Mr. Geissler has been President of VeriTeQ since July 2012. He developed the implantable microchip, with more than 150 million microchips implanted in animals for identification and tracking. He previously served as CEO of Geissler Technologies(2004 - 2008) when he sold the company's product development pipeline. Prior to that, he served as CEO of Digital Angel Corp. (Amex: DOC) (2000 - 2003) and Destron Fearing (Nasdaq: DFCO) (1993 - 1999), a company he founded. He has taken companies public and has broad experience in product development, electronic miniaturization, application of advanced technologies in new markets, and extensive experience in establishing strategic intellectual property and patent portfolios.
Michael KrawitzChief Legal and Financial Officer
Mr. Krawitz was most recently the CEO of Pear Energy, a renewable energy company that finances renewable energy and energy efficiency projects. He previously served as CEO of Florida Sunshine Investments I, Inc., which manages more than $1 billion worth of properties throughout the United States. He is also a member of the Company's Board of Directors. Mr. Krawitz earned a bachelor of arts degree from Cornell University and a Juris doctorate from Harvard Law School.
Allison TomekSr. VP IR & CorporateCommunications
Ms. Tomek has served as Sr. VP of VeriTeQ since its inception and has served as Sr. VP, IR and Corp Comm of PositiveID since January 2007. From Jan. 2007 to Jun. 2008 she was also VP of IR at Applied Digital Solutions and Digital Angel. From 2003 to 2006, Ms. Tomek was Director of IR and Corp Comm at Andrx Corp. (NASDAQ:ADRX). Ms. Tomek is the former President of the National Investor Relations Institute, South Florida chapter and a current member of its Board.
Capitalization
25
SharesHeld
Percent Ownership
Officers and Directors 6,680,854 61%
Float 4,287,988 39%
TOTAL 10,968,842 100%
Near-Term Goals
26
First product launched; marketing of Motiva breast implants with Q Inside Safety Technology in EU/UKEnter into more partnership/supply agreements post Final RuleEnter into partnership for data analytics platform development
Continued expansion of patent portfolio surrounding Q Inside Safety Technology for medical devices
Additional future partnerships
Investment Highlights
27
Unique industry technology and market position for its Q Inside Safety Technology unique device identification products
FDA cleared device that meets the UDI direct marking mandate for reusable medical devices under the FDA Final Rule provides for “first to market” capabilityIP provides strong competitive position for long term strategic advantage
Launch of Q Inside breast implants in Q1 2014Commercial partnership with Establishment Labs/Motiva for ex-US markets
More than 500 women have received Motiva implants with Q Inside Safety Technology Major US manufacturer currently in prototype stagePreparing for immediate expansion into markets for Vascular Ports and Orthopedic Implants Commercial partnership with MedComp in place
VeriTeQ Radiation Dosimetry products – ready to move into commercialization
Radiation dosimeters used in the treatment of cancer
Unique patented technologies with multiple regulatory approvals provide competitive advantage in respective markets
Q&A
Thank you!