2013 Htx Annual Report

7/23/2019 2013 Htx Annual Report

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Financing innovative medtech companies

from development to international sales

HTX ANNUAL REPORT | 2012 – 2013

www.htx.ca



From the EditorsThis report reects work completed or in progress between April 2012 and early 2014.

Materials in this report may be reproduced with the written consent of htx.ca – The Health Technology Exchange.

This is to ensure an awareness of the manner in which these materials may be used for other purposes.

Editor: Rob Hall

Assistant Editor: Cheryl Verscheure

Design, Layout & Print: Slant Creative Group

Photos: provided courtesy of project partners and aliate organizations.

Additional copies of this report in book form are available upon request.

The report in its entirety can be downloaded by visiting www.htx.ca.

HTX is an independent, not-for-prot corporation funded by the Government

of Ontario through the Ministry of Research and Innovation.

© Copyright 2014

HTX i i ddt, ot-for-rot orortio fudd y th

Govrmt of Otrio through th Miitry of Rrh d Iovtio.

VIsIOn & MIssIOn

HTX: Team, Board of Directors, Observers,

Business Advisory Committee

04-05

MessaGes

From the President & CEO 06

From the Chair 09

FInancInG & acTIVITIes

Health Technology

Commercialization Program

10

2012–13 HTX FInancIalsTaTeMenTs CENTRE PULLOUT

seTTInG THe sTaGe FORGlObal cOMpeTITIVeness

32

The Harmony Project 33

So Landing Program 34

Medtech RISE

34

HIGHlIGHTs

22 HInext

24 Profound Medical Inc.

26 Therapeutic Monitoring Systems

28 Octane Biotech Inc.

30 Sensory Technologies

INSIDE

Health Technology Exchange (HTX)

522 University Avenue, Suite 1201

Toronto, ON M5G 1W7

General Enquiry: [email protected]

Tel: 647-258-0381

Fax: 647-258-0390

www.htx.ca3INV ENT | INNOV AT E | INV OICE ™




HTX BOARD OF DIRECTORS

DAVID AMES

Retired, Ex-Director of

Emerging Technologies

and Health Economics,

Johnson & Johnson

Medical Products

PETER GOODHAND

Board Chairman,

Executive Director (Acting),

The Global Alliance for

Genomics and Health

GARY HODGINS

President, Pharmax Ltd.

DAMIAN LAMB

Co-Founder & Managing

Director, Genesys Capital

KEN LAWLESS

President, Epitope

Capital Corp.

MORRIS (MICKEY) MILNER

Former CEO HTX, Former

CEO Ontario Rehab

Technology Consortum

MICHAEL SEFTON

University Professor, Institute

of Biomaterials & Biomedical

Engineering, University of

Toronto

DAVID SHINDLER

Former CEO of

BioDicovery Toronto

PHIL SPENCER

Life Sciences Counsel

HTX OBSERVERS*

BILL MANTEL

Assistant Deputy Minister,

Research, Commercialization

& Entrepreneurship Division

ALLEN PAUL

Life Science Programs

MARK ROSEMAN

Manager, Innovation

Strategy and Programs

DIMITRI PROKOPIEV

Senior Policy Advisor

HTX BUSINESS ADVISORY COMMITTEE

DAVID AMES

Retired, Ex-Director of

Emerging Technologies

and Health Economics,

Johnson & Johnson

Medical Products

FRANK BAYLIS

President, Baylis

Medical Canada

JEREMY BRIDGE COOK

Senior Vice President,

Assay Group, Luminex

Molecular Diagnostics, Inc.

JOHN BUCKINGHAM

Founder & Partner,

Buckingham

Alliance Partners

TED HEWITT

Former Vice President,

Research & International

Relations, The University

of Western Ontario

FREDERIC LACHMANN

CTO, Medipattern

DAMIAN LAMB

Co-founder & Managing

Director, Genesys Capital

GENEVIEVE LAVERTU

Director, Legal Aairs,

Business Development

& Clinical Research,

Medtronic of Canada

JOHN MACRITCHIE

Regional Director, Central

Region, Ontario Centres

of Excellence

KIERAN MURPHY

Vice Chair & Chief

of Medical Imaging,

University of Toronto

THOMAS REEVES

President & CEO,

Interface Biologics, Inc.

CHERYL REICIN

Partner, Torys LLP

LifeScience M&A

Practice Lead

KRIS SHAH

Vice President, Technical

Division Manager, Baylis

Medical Canada

BILL MCCLEAN

Former GM, IBM Canada

DOUG TESSIER

Former Acting Senior

Vice President of Development

& Implementation, eHealth

Ontario

HTX TEAM

JOHN SOLONINKAPresident & CEO

CHERYL VERSCHEUREExecutive Assistant/ Oce Coordinator

SHAHIRA BHIMANIManager, StrategicInitiatives

ROB HALLVice President,Finance

NORMAN PYOSenior Director,Business Development

From Invention through Innovation

to International Invoice,

HTX provides non-dilutive

project nancing to emerging

and established Ontario-based

companies to develop, produce

and commercialize innovative

market-leading advanced

health technologies.

Through the Health Technology Commercialization

Program (HTCP) and HTX’s MedTech ecosystem support

activities, HTX is the leading resource and catalyst for

accelerating the growth of Ontario’s MedTech industry,

and enhancing Canada’s position as a global leader

in commercializing innovative medical technologies.With 33 recipient companies in its nancing portfolio

conducting 38 projects supporting commercialization

and exports, HTX strives to promote connectivity,

eciency and impact across all healthcare system

silos. HTX manages a $21.4M fund on behalf of the

Ontario Ministry of Research and Innovation and is a

member of the Canadian Venture Capital Association.

The HTCP program has levered more than $65M in

spending from industry and strategic partners, for

total program funding exceeding $86M.

VISIONHTX otiu to th dig rour

d tyt for rtig th growth

of Otrio’ mdi thoogy idutry

utr, d hig cd’ oitio

go dr i ommriizig

iovtiv thoogi.

MISSIONHTX uort th growth of dymi,

rorou Otrio mdth tor

tht ig with d dv word

hthr, ig hd

hthy ivig for it itiz.

HTX AIMS TO GENERATE THE

FOLLOWING RESULTS FOR ONTARIO:

• An enhanced Small and Medium Sized

Enterprise (SME) base, creating export

ready products and companies and

ultimately more high growth international

marketing companies;

• More well founded and nanced start-up

companies with the capability of negotiating

global marketing partnerships and attracting

inward investment and research collaborations;

• Greater capitalization of publicly funded

research, creating more market focused

innovative medical and assistive technology

products validated by eective utilization

of technology evaluation, appraisal

and assessment.

*Ministry of Research and Innovation

4


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Over this last year

we reviewed 36

applications and

selected another 11

projects to ace,

bringing our total to

38 funded projects

for the last 4 years.

JOHN SOLONINKA, PEng, MBA

President and CEO, The Health

Technology Exchange

As I write, it is February 2014, 3.5 years into my mandate as President and CEO of HTX. With virtually

all of our current round of investment funds committed, we can now forecast more accurately the

impact of the Health Technology Commercialization Program (HTCP) on Ontario medtech…and it is

considerable! We are also deep into our planning for “what’s next” for HTX as our investment phase

of HTCP draws to a close in December 2014, and we embark on exciting new initiatives.

38 Medtech Financings –

$86M in Total Project Value – 4x Leverage

Over this last year we reviewed 36 applications and selected another 11 projects to nance,

bringing our total to 38 funded projects for the last 4 years. We have committed approximately

$21.4M into strategic medtech commercialization and ecosystem projects, which was matched

by $65M from private sector companies, their investors and strategic public and private-sector

partners. The companies have been aggressively hiring and advancing their products to market.

HTX’s project-based funding is designed to help companies “de-risk” both their business models

and technologies for follow-on investment.

New Financing Approvals:

• ApneaDx – An inexpensive sleep apnea detector designed to be easily used by patients at home

that can greatly increase access to care for sleep apnea suerers, and reduce the proportion of

patients requiring expensive polysomnography (sleep clinics).

• Intellijoint Medical Inc. (formerly Avenir Medical Inc.) – Intra-operative hip-to-femur positioning

technology to improve outcomes and reduce revision rates for hip replacement surgery.

• Imagistx – Ultra-high frequency ultrasound imaging for prostate cancer.

• Harmonic Medical – The next generation of high focused ultrasound technology being

pioneered by one of the world’s leading inventors in this space, Dr. Kylervo Hynynen.

• Myndtec – First-in-class electrical neuromodulation therapy that promotes the restoration of

voluntary movement in patients paralyzed by stroke, spinal cord injury (SCI) or traumatic brain injury.

• Perimeter Medical – A spin-o of Tornado Medical, this technology provides intra-operative

assessment of surgical margins during breast cancer surgery.

• Synaptive – Intra-operative visualization, simulation and brain access for neurosurgery.

• Vascularix – A safe technology using CO2 gas to perform cardiac stress testing. Vascularix’s

technology has the promise to dramatically reduce side eects of current drugs, reduce cost

and increase access to this increasingly important diagnostic procedure.

Fllw-n nancings:

• Infonaut – Expanding the footprint of this Hospital Acquired Infection monitoring

technology into US markets customers.

• Profound Medical – Pursuing the next phase of clinical trials in Ontario, the US and Germany

of a novel technology for prostate cancer – the entire prostate gland can be ablated from inside

the urethra, in one treatment session, destroying cancer while sparing surrounding tissue.

• SensoryTech – Implementing their mobile care management platform into US Hospice and

palliative homecare provider customers.

We continue to be impressed by the disruptive potential of these world-class medical technologiesemerging from Ontario: as sophisticated and competitive as any internationally.

Growing the Medtech Ecosystem

In addition to our nancing, HTX is very pleased to support and drive creation of medtech

commercialization capacity in Ontario. We collaborate with a large number of public and private

entities enhancing the sector, including:

• MaRS EXCITE – As a founding member of EXCITE’s Management Board, HTX is very pleased to

see EXCITE’s portfolio grow to 15 companies undertaking eld evaluations and health technology

assessments in the pre-market space. HTX is also working in collaboration with EXCITE in providing

funding support to two EXCITE projects; the rst one being with Rna Diagnostics in supporting eld

studies and clinical trials with leading cancer centers in Ontario and Quebec, and the second with

ApneaDx, described above.

• Harmony – A collaboration with Hull and Associates and an international advisory board,

Harmony will enable medtech companies to select attractive export markets for their technologies

and to reduce the cost, time and risk of evidence development supporting global market access.

Our related So-landing initiative has identied a roster of highly qualied regulatory and

reimbursement consultants internationally to assist companies achieving global market access.

• CORTECHs – HTX led the creation of a 40-organization neuro-imaging, simulation, navigation,

surgery and assessment consortium, capitalizing Canada’s strong global positioning in

neuroscience research. HTX and the Ontario Brain Institute are now exploring further funding

potential for the CORTECHs initiative.

• Medtech RISE – A coalition of 12 organizations across the country coming together to create

a single, comprehensive registry of over 3000 medtech innovators, suppliers and exporters.

• Medtech Working Group and Innovation Procurement Initiatives – public-private

collaborations aimed at improving Ontario’s ability to speed adoption of benecial technologies.

• New Horizons for Medtech - Last year we reported creating a collaboration between HTX,

MEDEC and FEDDEV to provide $1M to support Ontario companies pursuing global markets.

We are very pleased to report that 29 companies were awarded funding for global market

development initiatives that will increase export sales for Ontario’s medtech companies.

Message from the

PRESIDENT & CEO

6






As the Chair of the Board, it is hard not to sound repetitive: we have completed yet another

outstanding year, driving towards the completion of the HTCP mandate. As we approach this

nal year of the current HTCP funding program, it’s helpful to take stock on just how far the

Ontario Medtech Ecosystem has progressed since 2002, and the impact HTX has had.

In that year, as the president of MEDEC, I helped to lead the creation of the multi-stakeholder

Medical and Assistive Technologies Consortium (MATC). Its goal: to understand why we were so

good at medical research, and yet so poor at commercialization, adoption and export of medicaltechnologies compared with other industrial clusters around the world. An industry cluster analysis

was conducted and recommendations made which included the creation of an entity like HTX, and

a focus on breaking down the silos dividing providers, innovators, nanciers, regulators, and payers.

My enthusiasm for the creation of HTX was so strong that I became the founding Managing

Director and have stayed fully engaged for more than a decade as the Chair of the Board.

Look at the Ontario medtech ecosystem now: the commercialization awareness, processes,

supports and funding we now have in place would have seemed unimaginable in the medtech

climate of 2002. And with the creation of the Ontario Health Innovation Council, a government/

health system/industry collaboration with a specic mandate to accelerate evidence-based

adoption of benecial technologies, we have all of the necessary players and infrastructure

engaged. But there is still work to do. We have built the infrastructure, but now we need to use

it to ramp up private sector investment levels, commercialization and adoption rates of Ontario

medical technology, increasing exports and reducing our trade decit. When we move the

needle on those, we have accomplished our goals from 2002.

Our President and CEO, and his team have again performed extremely well, and made the Board’s

job very easy. It is indeed a pleasure to see the level of commitment, engagement, collaboration

and accomplishment, all within a lean, professionally managed team. But I must equally say that

the unstinting commitment and creative vision of Bill Mantel and the team within the Ministry of

Research and Innovation, supported so strongly by Minister Moridi and Deputy Minister Tilford,

has been critical to HTX’s success.

Again, the HTX Board saw a steady stream of high quality technologies brought forward by the HTX

team, its external reviewers and the Business Advisory Committee. The continued discipline and

rigour of the due diligence and investment management gave the Board great condence in the

process. The Board appreciates and thanks all involved for their eorts.

On behalf of the HTX Board I am pleased to be supporting HTX’s CEO, the team and the Ontario

Medtech ecosystem in their continued success with a model that has demonstrated its value.

PETER GOODHAND, Chairman of the

Board, The Health Technology Exchange,

Executive Director (acting), The Global

Alliance for Genomics and Health

Message from the CHAIR

What’s Next?

HTX has developed deep experience in medtech company creation, nancing, evidence

generation, market access and adoption issues facing medtech companies. Our tag line

is from “Invention through Innovation to International Invoice”: our early years incented

academic/industry collaborations; our middle phase focused on innovation investments

through the HTCP program; and now we have entered our phase focused on adoption,

foreign market access and export revenue growth.

HTX is well positioned to pursue several areas of additional core and

program funding, including:

• Redistribution of repayments from our $14.2M loan portfolio;

• Funding programs for innovation procurement, incubator and virtual company infrastructure;

• Completion of Harmony and delivery of local and foreign market access services;

• Continued collaboration with OCE, MaRS Innovations, FEDDEV, OBI, CIIRDF, ISTP Canada and

International innovation and funding partners.

In recognition of this next phase of HTX’s trajectory, we are pleased to unveil our new logo

and branding, dropping the imagery of a limited focus on Canada, and presenting international

symbolism combining medical technology, rapid growth, and our continued focus on the need

to invent, innovate, and most importantly, invoice!

Again, this outstanding year would not have been possible without

the contributions of many:

• Our extremely capable and experienced colleagues and sta at HTX;

• Our Board and Business Advisory Committee;

• Our partners at the Ministry of Research and Innovation, the Ontario Brain Institute, MaRS

EXCITE and CIMTEC; my colleagues on various national and provincial medtech working

groups, the Canada Israel Industrial R&D Foundation (CIIRDF); and most importantly

• Our investee and collaborator companies.

Thank you all.

JOHN SOLONINKA, PEng, MBA

President and CEO, The Health Technology Exchange

HTX has developed

deep experience in

medtech company

creation, fnancing,

evidence generation,

market access and

adoption issues facing

medtech companies.

8






Financing & Activities

Health TechnologyCommercialization Program Launched in the spring of 2010, the Health Technology Commercialization Program (HTCP)

completed its fourth year of operation in December 2013. HTCP runs for a total of ve

years to December 2014.

As of early 2014, HTCP has committed all of its funding for disbursements to companies

($14.25M). There are a total of 37 projects with small/medium-sized Ontario companies and

1 project with a multinational company. 23 projects have been successfully completed to date.

Over the ve-year life of HTCP, HTX is on-track to disburse $14.25M to its recipient companies

and to spend $7.15M on operations and ecosystem support. Recipient companies and their

partner organizations will spend more than $65M (in addition to HTX funding) on the 38 projects.

Overall, the total value of HTCP, including all recipient and partner spending, will exceed $86M.

Cumulative Spending, HTCP Projects

90,000,000

Total Project Value

Companies and Partners

HTX Disbursements,Operations andEcosystem Support

80,000,000

70,000,000

60,000,000

50,000,000

40,000,000

30,000,000

20,000,000

FY 2011 FY 2012 FY 2013 FY 2014 FY 2015

10,000,000

0

10






HTX FINANCING PORTFOLIO: as of early 2014

Interface Biologics

Commercial stage, privately held, venture-backed company

that develops biomedical polymer technologies to improve

the safety and eectiveness of medical devices.

PROJECT: Endovascular Stent Gra Materials with

Improved Blood Compatibility

TOTAL PROJECT VALUE: $136,836

HTX VALUE: $68,283

LifeLike BioTissue

Uses proprietary technology to manufacture articial so

tissues such as skin, veins, and aortas that have the same

feel, texture and mechanical properties as real tissue.

Lifelike provides medical trainees with realistic products to

enhance skills training at a price not previously available.

PROJECT: Focus Marketing & Sales eort on the

US Training Hospital and Medical Device Market


HTX VALUE: $50,000

Medworxx

Provides an integrated suite of soware solutions for

patient ow, compliance and education. Combining

soware with clinical consulting and best practices to

serve the hospital marketplace, the integrated product

suite allows hospitals to increase competency, improve

quality, reduce costs and simplify distribution of

information to sta.

PROJECT: Marketing in the UK and Europe


HTX VALUE: $50,000

OtoSim Inc

OtoSimTM produces and sells an otoscopy training and

simulation system using a clinical image database that

has been shown to improve the accuracy of diagnosingear pathologies by 44%.

In partnership with The Hospital for Sick Children

PROJECT: Initial Sales Program


HTX VALUE: $50,000

Calavera Surgical Design

Delivers customized maxillofacial implants that utilize

dierent imaging modalities and materials to generate

custom surgical implant solutions following cancerexcision, trauma or plastic surgery.

In partnership with Stryker Canada Inc. & Sunnybrook

Health Sciences Centre

PROJECT: Surgical Forming Tool


HTX VALUE: $117,500

Colibri Technologies

By creating versatile, disposable and inexpensive catheters

that use proprietary technology to create 3D images inside

the body, Colibri will enable a range of cardiovascular

procedures with improved safety and cost.

In partnership with Sunnybrook Research Institute

PROJECT: 3D Probe-Based Imaging

TOTAL PROJECT VALUE: $1,926,468

HTX VALUE: $250,000

Baylis Medical

A developer, manufacturer and distributor of high-technology

medical devices for minimally invasive orthopedic,

cardiology, and radiology applications.

In partnership with Sunnybrook Health Sciences

Centre and the University of Waterloo

PROJECT: Intervertebral Disc Augmentation and RepairTOTAL PROJECT VALUE: $1,403,854

HTX VALUE: $248,750

Infonaut Inc.

The company has developed a proprietary platform that

utilizes Hospital Information Systems, RFID tagging of

hospitals assets, people and epidemiological analyticsoware called ‘Hospital Watch Live’ to address and

reduce infectious outbreaks within hospitals.

In partnership with University Health Network

PROJECT: Hospital Watch Live –

Implementation & Assessment


HTX VALUE: $749,750

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Profound Medical Inc.

Profound is developing a minimally-invasive treatment

for prostate cancer based on MRI-guided high frequency

ultrasound therapy that is designed to reduce the

collateral damage and side eects associated with

current treatments.

In partnership with Western University,

Siemens AG and York University

PROJECT: Manufacturing and testing of prostate

cancer treatment devices for clinical testing


HTX VALUE: $750,000

Qvella

A privately-held, medical device company developing an

automated laboratory system for the rapid identication

of bacterial species. The Qvella bacteria identication

platform is aimed to provide a more accurate and faster

bacterial identication while improving workow and

reducing costs for the microbiology lab.

In partnership with University of California, Los Angeles

PROJECT: Rapid Species Identication of Bacteria


HTX VALUE: $726,708

PatientOrderSets.com Ltd.

Canada’s only provider of a comprehensive evidence-based

orderset solution to hospitals and other health care

institutions. PatientOrderSets.com oers a web-based

collaborative model for its clients, that improves patient

safety and healthcare delivery while reducing costs.

In partnership with the Trillium Health Centre and

the Ontario Hospital Association

PROJECT: Commercializing the world’s only

web-collaborative patient order set technology

built in Ontario for export markets


HTX VALUE: $750,000

Rna Diagnostics

A molecular diagnostics company that is developing the

RNA Disruption Assay (RDA), a diagnostic test to determine

whether or not chemotherapy is eective early in the

treatment of breast cancer so that non-responders can be

spared the toxic side eects of ineective chemotherapy,

and the opportunity to switch to more appropriate therapy.

In partnership with Sudbury Regional Hospital and

the University of Waterloo

PROJECT: Optimize RNA Disruption Assay


HTX VALUE: $100,000

Scisense

Develops miniaturized sensing technology for measuring

cardiac function in animal models. The patented Scisense

ADVantageTM system features consistent and accurateresults, real time data anal ysis, reduced research time

and high delity pressure sensing.

PROJECT: Sales Team Expansion


HTX VALUE: $50,000

Segasist

A soware company developing contouring productivity

tools for medical imaging analysis oering clinicians

signicant time savings and greater accuracy for diagnosis,

monitoring and treatment of prostate cancer.

In partnership with Lawson Health Research Institute,

London Health Sciences Centre, and Sunnybrook

Health Sciences Centre

PROJECT: Clinical Validation for Segasist PMR Soware


HTX VALUE: $38,000

RoweBots

The production of embedded soware that runs on small

eld programmable gate array (FPGA) based processors

or microcontrollers for medical devices.

PROJECT:Development of FPGA based OS

for Medical Devices


HTX VALUE: $25,000

Sensory Technologies

Develops and implements mobile smartphone-based

enterprise systems for the home health care market. The

company oers a mobile remote clinician managementsystem that allows for increased capacity, a reduction in

treatment costs and reduced hospital readmissions.

In partnership with the SWCCAC

PROJECT: eShi Community Care Commercialization


HTX VALUE: $750,000


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Tornado Medical Systems

A medical imaging and spectroscopy company with

operations in Toronto. The Company develops and

markets high-performance devices and technologies formedical imaging applications with a focus on improving

key systems performance in areas where limited

performance is a barrier to clinical utility.

In partnership with Thunder Bay Regional Research

Institute and the University Health Network

PROJECT: Tumour Margin Assessment Machine


HTX VALUE: $319,432

Xagenic

Xagenic has developed a revolutionary direct detection

platform for molecular analysis enabling rapid, on-demand

diagnostic testing.

In partnership with the University Health Network

PROJECT: Development of Probe Set for

Point-of-Care Diagnostic Platform


HTX VALUE: $299,985

Spartan™

A privately held molecular diagnostics company that

develops, manufactures, and markets DNA testing systems

for on-demand applications. The company is focusing on

point-of-care applications where rapid and convenient DNA

testing is particularly important, such as pharmacogenetics,

infectious diseases, and food and water safety testing.

In partnership with Ottawa Heart Institute

PROJECT: Point-of-care DNA testing for Plavix


HTX VALUE: $58,032

XLR Imaging

A London, Ontario-based company developing a

complete paediatric-optimized MRI workow solution

to directly address the unique challenges in paediatricimaging. The product will provide high resolution

images with reduced scan times, improving the safety

and eciency of the imaging procedure.

In partnership with Kangaroo Design and Innovation

PROJECT: Paediatric MRI System


HTX VALUE: $103,472


Perimeter Medical Imaging

Perimeter Medical Imaging is a spin-out of Tornado Medical

Systems and will be continuing Tornado’s earlier work in

developing a novel imaging device for intra-operative

assessment of surgical margins in breast cancer surgery.

In partnership with University Health Network

PROJECT: Margin Assessment Machine: Reducing

Re-Excision Rates for Breast Conservation Surgery


HTX VALUE: $300,000

ApneaDX

ApneaDX is conducting an EXCITE-led clinical trial of an

inexpensive sleep apnea detector designed to be easily

used by patients at home that can greatly increaseaccess to care for sleep apnea suerers, and reduce

the proportion of patients requiring expensive

polysomnography (sleep clinics).

In partnership with EXCITE, THETA

PROJECT: Home Sleep Study with ApneaDxTM

for the Diagnosis of Obstructive Sleep Apnea:

A Pragmatic Randomized Controlled Trial


HTX VALUE: $165,000

Profound Medical Inc. (2nd Project)

Profound Medical Inc. is developing a minimally-invasive

treatment for prostate cancer based on MRI-guided high

frequency ultrasound therapy that is designed to reduce

the collateral damage and side eects associated with

current treatments.

In partnership with Western University,

Siemens AG and York University

PROJECT: Commercialization Phase and Launch

of Prostate Ablation System


HTX VALUE: $750,000

Harmonic Medical

Developing a focused ultrasound therapy system for

non-invasive surgery with treatment of uterine broids

and palliation of bone metastases as the lead indications.Harmonic’s technology is designed to oer the precision

and ablation monitoring capabilities of MRI-guided

focused ultrasound but in a portable, easy to use, lower

cost system originated from Dr. Kullervo Hynyen, a

recognized leader in focused ultrasound.

In partnership with Sunnybrook Research Institute

PROJECT: Harmonic Ultrasound Guided Focused

Ultrasound Therapy


HTX VALUE: $489,270

16






Huron Technologies

A Waterloo-based global leader in imaging solutions for

digital pathology, Huron Technologies Inc. is developing

a clinical pathology scanner with unprecedented scanningspeed and image quality. Digital pathology is a high-growth

eld that will provide signicant improvements for patient

care, healthcare costs, and pathology resource constraints.

In partnership with Sunnybrook Health Sciences Centre,

Southlake Regional Health Centre, and CIMTEC

PROJECT: Digital Pathology Solution


HTX VALUE: $585,000

HInext

A Toronto-based soware company focused in the

area of clinical management of mental health. The

agship product TREAT is a mental-health specic

electronic health record that optimizes the delivery of

care by reducing the time and eort to document clinical

outcomes, standardizing assessments and creating and

tracking multi-disciplinary care plans.

In partnership with Rouge Valley Health System,Maimonides Medical Centre (Brooklyn NY) and

North Bay Regional Health Centre

PROJECT: TREAT Expansion in Canada and the US


HTX VALUE: $387,000

Octane Biotech Inc.

Octane Biotech, based in Kingston, ON, is developing

and commercializing ACTES, an automated tissue

culture system designed to standardize protocols incellular therapy development and stem cell manipulation

in regenerative medicine and tissue culture.

In partnership with Aesculap (B. Braun), Queen’s

University, University Hospital Basel (Switzerland),

Hospital Maisonneuve, and the University of Toronto

PROJECT: Advancing the development of

ACTES towards commercialization


HTX VALUE: $452,050

Imagistx

Imagistx delivers unique high resolution imaging for the

screening, biopsy and potential treatment of cancer. The

company’s rst product, Imagistx Prostate, is currently

in clinical studies. Study results to date have been

overwhelmingly positive, demonstrating Imagistx’s

superior ability to potentially identify prostate cancer

versus current low resolution ultrasound methods.

In partnership with the Brady Urology Institute, JohnsHopkins Medical Institutions; and the Southern Alberta

Institute of Urology

PROJECT: Imagistx Prostate Commercialization Project


HTX VALUE: $750,000

GE Healthcare

Provides transformational medical technologies and

services that are shaping a new age of patient care.

Their broad expertise in medical imaging and informationtechnologies, medical diagnostics, patient monitoring

systems, drug discovery, biopharmaceutical manufacturing

technologies, performance improvement and performance

solutions services help customers to deliver better care to

more people around the world at a lower cost. In addition,

they partner with healthcare leaders, striving to leverage

the global policy change necessary to implement a

successful shi to sustainable healthcare systems.

In partnership with the University Health Network

PROJECT: Pathology Innovation Centre of Excellence (PICOE)


HTX VALUE: $514,279

Therapeutic Monitoring Systems

TMS develops clinical decision support (CDS) soware for

critical care sta in the hospital intensive care unit (ICU)

to make better clinical decisions resulting in saving lives

and money. Their proprietary CIMVA soware transforms

patient vital sign monitoring from its current “reactive”

status quo into a “predictive” tool, thereby oering deeper

insights into the changing health status of patients.

In partnership with Phillips Healthcare, OttawaHospital Research Institute, and Cooper University

Hospital (New Jersey)

PROJECT: Novel Application of Anticipatory

Monitoring to the Hospital ICU & ER


HTX VALUE: $496,912


Vascularix

Developing the RespirAct system, which controls ga s

concentrations in the lungs and blood, to use as a

non-invasive, drug-free, stress agent for use in cardiac

stress testing. Current cardiac stress agents, including

the market leading Lexiscan, a $700M drug, are associated

with a high incidence of side eects, some of which are

considered life threatening.

In partnership with the Cedars-Sinai Medical Center,the University Health Network, and the Ottawa

Heart Research Institute

PROJECT: Commercialization of a novel,

non-invasive cardiac stress test system


HTX VALUE: $390,511

Rna Diagnostics – EXCITE (2nd Project)

A molecular diagnostics company that is developing the

RNA Disruption Assay (RDA), a diagnostic test aimed to

determine whether or not chemotherapy is eective earlyin the treatment of breast cancer. The RDA test is aimed to

identify non-responders early in treatment so that they can

be spared the toxic side eects of continued dosing with

ineective chemotherapy.

In partnership with EXCITE, THETA

PROJECT: Study of RNA Disruption Assay as a Predictive

tool for Response to Neoadjuvant Chemotherapy in Breast

Cancer – A Prospective Mixed Methods Study – to be carried

out under the MaRS EXCITE program


HTX VALUE: $300,000

18







Morris (Mickey) Milner Award Winner Dr. Milos Popovic, PhD, PEng, Toronto Rehabilitation Institute (TRI)

At or 2013 Aa Ope Hose, we aoced the secod award wier, Dr. Mios Popovic of Toroto Rehabiitatio Istitte

for his otstadi achievemets i the deveopmet of assistive techooies, ad devisi the fctioa eectrica stimatio

(FES) i the treatmet of cervica spia erve ijries. Dr. Popovic is the Toroto Rehab Chair i Spia Cord Ijry Research.

Mickey Milner Award Presentation

HTX Open House | Fm l t ight:

Dr. Mios Popovic, Toroto Rehab Chair, Spia

Cord Ijry Research, Morris (Mickey) Mier,

Former Presidet ad CEO, HTX, Joh Sooika,

Presidet ad CEO, HTX

Interface Biologics (2nd Project)

The major objective of Interface Biologics Inc. II is to

evaluate the compatibility and anti-thrombotic potential

of Endexo technology in several antimicrobial polymers

developed by BASF.

In partnership with BASF Future Business GmbH

PROJECT: Central Venous Catheters with Combination

Antimicrobial and Anti-thrombogenic Properties


HTX VALUE: $61,700

Intellijoint Surgical Inc.

Intellijoint Surgical Inc. (formerly Avenir Medical) is developing

PelvAssist™, a low cost and easy to use surgical navigation

tool that allows surgeons to properly align the articial

implant in hip replacement surgery without disruption to

surgical workow. PelvAssist™ improves clinical outcomes

in hip replacement surgery, reduces surgical revision rates,

and reduces healthcare costs while improving patient care.

In partnership with Mount Sinai Hospital, Oakville

Trafalgar Memorial Hospital, Grand River Hospital,

Rush Presbyterian Hospital, Thomas Jeferson

University Hospital, Massena Memorial Hospital

PROJECT: Post Limited Market Release Development

and Commercialization of PelvAssistTM (Gen II)


HTX VALUE: $750,000

Infonaut Inc. (2nd Project)

Infonaut’s agship product, Hospital Watch Live (HWL),combines business intelligence soware with RFID (radio

frequency identication) tagging of personnel and equipmentto identify, measure, monitor and predict the spread ofinfections in hospitals. This allows for real-time disease

mapping in hospitals to better manage outbreaks and reducerates of hospital acquired infections. The project focuses on

the implementation and evaluation of HWL in the neuro ICU ofthe Gates Vascular Institute which is a member site of Kaleida

Health, the largest healthcare provider in Western New York.

In partnership with Kaleida Health and Dapaso

PROJECT: Kaleida Health Hospital Watch Live –

Infonaut US Market Entry


HTX VALUE: $125,083

Sensory Technologies (2nd Project)

Develops and implements mobile smartphone-based

enterprise systems for the community and home health

care market. The company oers a mobile remoteclinician management system that allows for increased

capacity in the overall healthcare system, a reduction

in treatment costs, reduced hospital readmissions,

resulting in improved care.

In partnership with the Hospice of Michigan and SWCCAC

PROJECT: US Pilot and Privacy Certication

for Market Expansion


HTX VALUE: $200,000

MyndTec Inc.

Myndtec is commercializing MyndMoveTM, a rst-in-class

electrical neuromodulation therapy that promotes the

restoration of voluntary movement in the upper extremities

of patients severely paralyzed by stroke, spinal cord injury

(SCI) or traumatic brain injury.

In partnership with Toronto Rehabilitation Institute, the

Heart and Stroke Foundation, and ICC HealthNet Inc.

PROJECT: MyndMoveTM Implementation, Integration,

Adoption, and Reimbursement


HTX VALUE: $749,600

Synaptive Medical Inc.

Synaptive Medical is developing advanced visualization

soware and imaging equipment for surgical navigation

and intervention in neurosurgery.

In partnership with Colibri Technologies Inc.,

Clear Canvas Inc., and P&P Optica Inc.

PROJECT: In-vivo multimodality imaging system


HTX VALUE: $741,800

20






HTCP PROJECT HIGHLIGHTS

HInext Inc.Helping the mental health & addictions

community take care-delivery to the next level

In both Canada and the U.S., the market for Electronic Health Records (EHRs) and health information

exchange in the community mental health and addictions sector (known in the U. S. as behavioral

health) is greatly underserved. As a result, provider organizations operate many processes

manually, and diagnosis and treatment are based largely on subjective personal analysis rather

than objective assessment.

However, ObamaCare and initiatives such as the Aordable Care Act and Meaningful Use Certication

are prompting the mental health community to nd ways to provide additional higher-quality care

at a lower cost. As a result, this community is increasing automation, including implementation

of EHRs and improvement in the quality of electronic clinical documentation and the ability to

exchange it amongst providers.

To capture this market opportunity, HInext is proceeding quickly with signicant enhancements

to its agship product TREAT.

Specically designed for mental healthcare providers, TREAT provides integrated healthcare clinical

documentation (e.g. EHRs), including: powerful clinical assessments; screening and management tools;

comprehensive care planning and clinical documentation; simplied data collection and submission;

and detailed reporting and graphing. The product, which has already been successfully implemented inmore than 30 provider organizations, achieved Meaningful Use Certication in the U.S. in August, 2013.

The enhancement project, expected to be completed by the end of Q1, 2014, includes patient and

resource scheduling, and patient billing. As a result, TREAT will be a fully integrated, market-ready

solution that meets U.S. regulatory requirements. Equally important, it will meet the needs of

standalone mental health organizations and large community organizations, such as those

participating in emerging multi-provider Accountable Care Organizations.

TREAT’s unique value proposition is based on key dierentiators, such as scientically designed,

best-practice diagnosis and screening assessment tools. TREAT’s screening assessment tools take

the determination of a patient’s mental condition from being a subjective, personal analysis to

one that is based on objective measures. HInext has spent years researching and rening these

tools with the help of medical experts. Another dierentiator of TREAT is its focus on the “Recovery

Model” – the idea that, through a multi-disciplinary treatment plan, a person with behavioral

health issues can achieve a level of recovery that is coordinated, managed and measured.

Partners from the mental health community play a key role in contributing to TREAT’s continued enhancement. A prototype for the typical standalone,

community-based mental health organization, for example, is Manhattan’s Village Care, with 30 psychologists and psychiatrists treating outpatients.

The mental health department of New York’s Maimonides Medical Center (MMC), a large acute-care hospital, is a prototype for the use of TREAT

in a typical Accountable Care Organization. MMC is part of a cooperative organization of 50 healthcare providers comprising a network called the

Brooklyn Health Home. This network is responsible for the care and management of about 25,000 people with Bipolar Disease and Schizophrenia.

MMC is particularly excited about TREAT’s Metabolic Monitor, a sophisticated soware algorithm that uses data from standard medical monitors and

measuring devices to calculate a patient’s risk of developing one of the metabolic disorders that oen arise as a side eect of their medications.

HInext’s strategy is to oer TREAT as a fully hosted, Web-based application based on the Soware-as-a-Service (SaaS) delivery model in

which customers pay a monthly subscription fee to access the application via the Internet, using any standard Web browser. The SaaS value

proposition is widely accepted and eld-proven – anywhere, anytime user access; no IT infrastructure for customers to buy and maintain;

fast start-up and little or no upfront costs; and regular, predictable subscription fees. This deployment model will facilitate greater adoption

of TREAT across a broader geographic area.

As part of the healthcare ecosystem, HInext’s goal is to help mental health patients get their disorders addressed and move them out of

high-cost, acute-care into community- or home-based care, where they can live and function like other members of society. As a business,

HInext’s goal is to grow the company as an Ontario-based entity, adding new jobs and new investment in Ontario. At this point, just prior to

full commercialization of TREAT, HInext has 22 sta, with a target of 30. Executive management is grateful for the HTX funding assistance,

particularly because it is dicult to raise money in a secondary, stigmatized, underserved and under-funded niche market such as mental health.

And with TREAT live in numerous provider facilities in the U.S., including a large, nationwide insurance company, HInext has a viable foothold

and has begun to establish credibility in the U.S. market. Completion of the enhancement project will yield a product that is positioned strongly

against any competition and uniquely meets the needs of U.S. mental healthcare providers.

HInEXT InC.“Providing a high quality of care

for our clients whose array of

needs is complex has been made

quite easy with TREAT.”

RICARDO SANTIAGO,

chif Iformtio Or,

Vig cr of nw York

22






Profound Medical Inc.Innovative MRI-guided ultrasound ablation

technology sets new standard of care for the

treatment of prostate cancer

Prostate cancer is the most common form of cancer in men. One man in every six in North Americadevelops prostate cancer, and one in every 28 dies from the disease. Although advances in early

detection and treatment have dramatically improved survival rates (99%) for those diagnosed with

this disease, the side-eects commonly associated with current treatments can severely undermine

quality of life for survivors. Loss of healthy bladder, bowel and erectile function are oen part of the

treatment outcome, along with fear of recurrence and long recovery periods.

Profound Medical has developed a safe, accurate, minimally-invasive and non-surgical treatment

for localized prostate cancer that potentially eliminates complications and long-lasting side-eects.

The treatment uses an innovative Ultrasound Applicator (UA) to ablate an entire prostate gland

from inside the urethra, in just one treatment session. This novel technology, combined with

state-of-the-art MRI image guidance, delivers highly accurate and precise treatment, destroying

cancer while sparing surrounding tissue.

The procedure takes place with the patient inside an MRI scanner, which provides image-guidance

for the UA positioning, treatment planning and live monitoring of the prostate being ablated.

During treatment, the UA is inserted into the prostate and rotated 360 degrees, emittingultrasound energy toward the prostate boundary, heating and killing the prostate tissue. Real-time

temperature images from the MRI are used to automatically adjust the energy intensity and rate

of rotation of the UA, resulting in precise conformal targeting of the prostate tissue, while sparing

surrounding structures. The actual ablation takes only about 30 minutes, and early trials show

that subjects are regaining urinary function very quickly.

Following successful completion of a pre-clinical canine study conducted at the University of

Western Ontario, a Phase 1 trial was approved for Canada, U.S. and Germany. The trial is being

conducted at London Health Sciences Centre in Canada and William Beaumont Hospital in the U.S.,

as well as at Heidelberg University Hospital in Germany to facilitate subsequent commercialization.

Following successful completion of the Phase 1 trials in early 2014, a Phase 2 trial of the ecacy of

the Trans-Urethral Ultrasound Ablation (TULSA) procedure in treating cancer is expected to begin.

The 30 patients from the Phase 1 study will be enrolled in the Phase 2 trial and monitored for up to

ve years to ensure they remain cancer-free.

Partnerships continue to be a key success factor in the development of Profound’s technology, which grew out of early work by two scientists

at Sunnybrook Research Institute in Toronto. Of particular note is Toronto’s York University, which has been very accommodating and exible

in making its research MRI scanner available at a very reasonable cost for initial concept validation and testing. Siemens Medical has also been

very helpful, providing technical support and facilitating introductions to the German hospitals where trials are taking place. The project is also

beneting from the ongoing advice and guidance of leading experts in urology and radiology at such prestigious institutions as the Cleveland

Clinic, Vienna University Medical School, Harvard Medical School and Sunnybrook Health Sciences Centre.

In addition to Genesys Capital, the Business Development Bank of Canada and the MaRS Investment Accelerator Fund, HTX has provided

substantial early funding and support for Profound Medical, and management at Profound has been taking full advantage of HTX partnerships

and resources. The rm hopes to provide a return through job creation, the potential for local manufacturing and by helping other emerging

rms learn about clinical trial design, sourcing of complex manufacturing and navigating the FDA’s Class 3 approval process. Perhaps most

important of all, Profound is poised to make a ground-breaking contribution to a new standard of care for men with prostate cancer and to

cost-reduction in the Canadian healthcare system.

“Everything has returned to normal and in some

cases is better tha what it has bee for ve years.”

BRIAN DENTER, TULSA patient

DR. JOSEPH CHIN, Chief of Surgical Oncology at London Health Science Centre,

removed cancer from Brian Denter’s prostate using a world rst procedure.

Derek Ruttan, The London Free Press/QMI Agency


PROFOunDMEDICAl InC.“This minimally invasive procedure

has been very well tolerated by

the patients so far. I think it will

be a valuable tool within the

repertoire for the treatment

of this disease.”

DR. SASCHA PAHERNIK,

Uivrity Hoit Hidrg,

Drtmt of Uroogy,

Hidrg, Grmy

24






TherapeuticMonitoring SystemsClinical Dcisin Sppt swa hlps

critical-care clinicians predict outcomes

for complex procedures in the ICU

Currently, critical-care vital signs monitors in hospital intensive care units (ICUs) only have cursory

analytical capability, and as a result oer little, if any, point-of-care clinical decision support for

physicians and nurses facing dicult decisions. Despite round-the-clock vital signs monitoring for

the critically ill patient, hospitals commonly resort to a ‘wait and see’ approach to assess how a

patient will respond (improve/deteriorate) to therapeutic treatment. This clinical uncertainty

leads to thousands of unnecessary deaths annually, longer hospital stays and billions of dollars

of avoidable cost to the health system.

Therapeutic Monitoring Systems (TMS) is addressing this critical problem with CIMVA™ clinical

decision support (CDS) soware that incorporates novel predictive analytics that can determine

a patient’s health status in advance of current, standard-of-care clinical indicators.

CIMVA technology was conceived by TMS founder Dr. Andrew Seeley, a practicing ICU clinician

and thoracic surgeon at The Ottawa Hospital. Development has been funded by angel and venture

investors and timely strategic funding from agencies such as the Health Technology Exchange and

the Federal Economic Development Agency. The strategic funding has enabled TMS to l everage

investor money in an eective manner.

Using data collected from patient monitors, CIMVA employs complex mathematics to illuminate

hidden information in patient vital signs and predict the outcome of a patient undertaking a risky

procedure that may result in increased harm and a costly increased length of hospital stay. Presented

to a doctor using a tablet at the patient bedside, CIMVA calculates a ‘risk score’ that, when used in

combination with other clinical metrics and the care team’s judgement and experience, enables

better treatment decisions that can improve patient care and cut hospital costs. TMS envisions

physicians invoking CIMVA episodic CDS applications similar to the way physicians currently order

patient lab tests. CIMVA transforms patient data into actionable information for use by doctors

and nurses at the point-of-care to improve decision-making and the delivery of patient care.

CIMVA consists of two components: 1) the CIMVA Universal™ soware platform, which is the

engine for the complex mathematics and predictive analytics; and 2) individual CIMVA clinical

applications running on top of the platform that address specic clinical interventions andprocedures. The CIMVA Universal platform received U.S. FDA clearance in 2013.

The rst clinical application – CIMVA Extubation Advisor™ – helps the care team better determine

when to take patients o mechanical ventilation (by removing their breathing tube) prior to their

release from the ICU. In the U.S. alone, 1.4 million ICU patients annually are on ventilation and

about 15% of these patients fail the extubation procedure, resulting in increased risk of death and

almost $7 billion of avoidable cost. Other CIMVA applications in the development pipeline include

one for assessing the risk a patients will deteriorate rapidly from infection (sepsis), and another

for determining when to decrease the level of sedation in critically ill patients.

A key partner for TMS has been the Ottawa Hospital Research Institute, which has been very

supportive and its three associated hospitals have been CIMVA soware study sites. Other

noteworthy Canadian and U.S. teaching hospital sites supporting CIMVA testing to date include:

St. Michael’s Hospital (Toronto), Mount Sinai Hospital (Toronto), London Health Sciences Centre,

University of Michigan Hospital, Columbia University in New York City, the Billings Clinic in

Montana and the University Hospital of Case Western Reserve University in Cleveland.

CIMVA Extubation Advisor recently completed a 12-hospital U.S./Canada clinical study involving

700 patients. Comparison of predicted outcomes with the subsequent real-life outcomes showed

that using CIMVA may lead to a 75% reduction in extubation failures. A second study is in the

planning stages to conrm the results seen in the initial study, and once the results data is

complete, an application will be led with the FDA for clearance to market CIMVA Extubation

Advisor, which is anticipated for 2016.

CIMVA will be initially deployed on an OEM basis, as soware embedded within monitors, ventilators

and electronic medical records (EMR) systems from leading healthcare product vendors. This will

give TMS a strong, well-established and far-reaching channel into the marketplace, which, in the

U.S. alone, includes more than 3,500 acute-care hospitals and almost 70,000 ICU beds. In mid-2013,

TMS signed a device integration partnership agreement with Cerner Corporation, a leading vendor

of EMR systems to acute-care hospitals.


THERAPEuTIC

MOnITORIngSYSTEMS“CIMVA technology ofers a novel

approach to help me take care

of our institution’s critically ill

patients, and I look forward to

its further development and

eventual commercialization.”

DR. FRANK JACONO,

aitt profor of Mdii,

Diviio of pumory, criti

cr & s Mdii, c

Wtr Rrv Uivrity

shoo of Mdii, cvd

26




HTX ANNUAL REPORT | 2012 2013 HTX ANNUAL REPORT | 2012 2013



Octane Biotech Inc.Automated Cocoon™ bioreactor systems overcome

‘living implant’ production barriers and accelerate

adoption of regenerative medicine

Regenerative medicine – the use of cell therapy and tissue engineering to treat trauma and to stop,and even reverse, the progression of disease – is not new, and is becoming increasingly successful

in neurology, cardiology, orthopaedics and numerous other areas.

In orthopaedics, for example, where hip and knee cartilage degeneration leading to joint replacement

has become common, regenerative medicine can be especially eective on two fronts. The

introduction of new cells can stop degeneration by repairing cartilage lesions early, following

detection, thereby delaying or even eliminating the need for full-joint replacement using implants.

Even severe cartilage disease aecting the underlying bone can be successfully treated u sing

advanced ‘living implant’ technology incorporating cells and scaolds to form repair tissue that

integrates with the surrounding cartilage. These biological solutions avoid further medical intervention,

unlike conventional metal or polymer hip and knee implants that have a limited lifetime.

Although clinical trials throughout the world continue to demonstrate the medical ecacy of cell

therapy and living implants, manufacturing is a major barrier to widespread clinical and commercial

adoption. Cell production, which traditionally takes place in a specialized clean-room environment,

is very complicated and expensive. It also requires an extremely capital-intensive infrastructure to

eciently make cells in sucient number – typically hundreds of millions – to be clinically eective.In addition, today’s centralized approach to manufacturing cells and implants creates considerable

transportation complexities and cost associated with delivering living implants to the point of care

in a timely fashion.

With funding assistance from HTX, Kingston, Ontario-based Octane Biotech has overcome these

manufacturing barriers to the adoption for cell/tissue therapy and living implants.

Octane’s innovative Cocoon™ bioreactors allow the automated production of la rge populations of

cells and tissue outside of a traditional clean-room facility. The patented Cocoon technology provides

a complete environment for cell and tissue growth, while protecting the cells from any external

hazards that may be present due to the bioreactor location. Provision of support resources required

to maintain a living environment inside the container is fully automated and soware controlled.

Part of the innovation is in the use of bioreactors within a disposable ‘cassette’ for processing the

cells and allowing the entry/exit of support resources. The cassette, which sits inside the Cocoon

instrument, consists of snap-together modules customized to each clinical application.

The patient’s entire cell production process, including all inputs (donor cells, reagents, stimulatory

chemicals) and outputs (waste products, resulting new cell population), is managed via the patient’s

single-use cassette, in which the patient’s cells are nurtured, grown and directed in terms of their

biological function.

The use of automation and bioreactors not only provides greater control over production, thus

enabling greater cell performance, but also reduces production cost signicantly by eliminating

a lot of the manual labour previously required for the production of cells and tissue. Use of small,

portable and relatively inexpensive Cocoon bioreactors also allows cell production to be dispersed

geographically. As a result, the manufacture of living implants can take place closer to the point

of care, thus eliminating transportation problems and related costs associated with a centralized

manufacturing model.

Octane’s primary channel to market for the Cocoon platform is through partnerships with

large, multinational regenerative medicine companies that have cell therapy and living implant

products on the market or in development but are struggling with manufacturing scalability.

The Cocoon technology and cell production process is incorporated by those companies into

their manufacturing process.

For example, the Israeli company BrainStorm Cell Therapeutics is using the Cocoon platform to

grow, and enhance the performance of, an expanded population of stem cells that can be used

to stop further neurologic degradation for those suering from ALS (a.k.a. Lou Gehrig’s Disease)

by repairing and re-establishing key neurological processes interrupted by the disease. Other

clinical areas being addressed by Octane partners include diabetes, blood-related diseases such

as leukemia, and a host of orthopaedic applications.

While all the product development activity on the Cocoon platform is undertaken in-house,Octane fosters close collaborations with n umerous academic partners, including the Centre for

Commercialization of Regenerative Medicine based at th e University of Toronto, the Centre of

Excellence for Cell Therapy based at Hôpital Maisonneuve-Rosemont in Montreal, the University

of Basel in Switzerland, KU Leuven University in Belgium, the University of Zagreb, the U niversity

of Bristol, and the University of Genoa and the Rizzoli Institute in Italy.

Apart from the obvious clinical benet of Cocoon technology for patients across Canada and

throughout the world, Octane is also bringing value to Ontario and the local economy in the form

of job creation (the company has grown from eight to 24 employees) and local manufacturing

(the rm has recently expanded its production footprint from 17,000 square feet to 50,000).

Octane also provides a signicant amount of training for summer/co-op students and is involved

in multiple collaborations through Centres of Excellence across Canada.

Octane has taken Cocoon from functional prototype to a pilot production run of roughly 20

complete systems that have been successfully tested internationally. The company is currently

preparing its marketing launch package, and plans full commercialization by mid-2014.

Automated Productionf Allga and

Atga Implants

• Versatie

• Atomated• Ecoomica

• Stadardized

Cocoon™ Instrument

OCTANEBIOREACTORTECHNOLOGY

Sterile Cassette

Cell Source


OCTAnEBIOTECH InC.“Octane possesses the technology,

multidisciplinary expertise and

stem cell experience we require

to scale-up the production of

our NurOwn stem cell therapy

candidate. Cocoon technology

could signicantly accelerate

the commercialization of this

promising therapy.”

DR. ADRIAN HAREL,

Dirtor of Rrh,

bristorm c Thruti

28




HTX ANNUAL REPORT | 2012–2013 HTX ANNUAL REPORT | 2012–2013



Sensory TechnologiesNew model for home care delivery leverages

limited nurse resources and cuts health system

costs by reducing hospitalizations

With the continually increasing costs of healthcare, whether from economics or demographics, thedesire to manage more patients at home and prevent admissions (& re-admissions) is a growing

and necessary trend for health systems. However, home care delivery today follows an extremely

inecient human resource model. While a hospital may be expensive, it is relatively resource

‘ecient’ because varying levels of medical skill (specialist, GP, nurse, allied health) are available

and thus reasonably accessible; community care is extremely inecient in this manner as one

professional is generally responsible for the home visit. This ineciency, coupled with an increasing

shortage of nurses for home care complicates the capacity to deliver home care at lower costs.

Sensory Technologies has worked with the Community Care Access Centre (CCAC) in Southwestern

Ontario to look closely at home care in that region. The CCAC, which is responsible for orchestrating

home care service providers for the region, was struggling with the problem of insucient nurses to

deliver care, and wanted to gure out how to expand the reach of the nurses it does have within the

region. Based on this work, Sensory Technologies created a new clinical service model called “eShi”

for treating and managing end-of-life patients at home that optimizes nurse utilization, lowers costs,

increases capacity and improves patient care.

The new service model is based on hybrid virtual home care teams, which are led by a delegating nurse

(DRN) that directly supervises four personal support workers (PSWs). The DRN manages, mentors and

monitors the PSWs during home care visits, in-home patient data-collection and medical tasks. eShi

allows the DRN to work at home or a telemedicine centre with a laptop, and connect to the PSWs via

smartphones and provide constant communication and care while the PSWs visit patients’ homes.

The service model enabled by eShi better leverages available nurse resources by expanding each

nurse’s reach by managing multiple PSWs at one time. PSWs are delivering near-nursing level care

under guidance of that specialized and experienced DRN. By using the DRN’s skills to remotely guide

any additional interventions required, the capacity to adjust the level of care needed at the bedside

is greatly expanded. This approach allows both DRNs with eShi and visiting nurses to cover many

more patients than compared to existing service models.

This new hybrid home-care team, enabled by eShi, delivers a higher level of complex care

management to considerably more patients. eShi enables higher-acuity patients that could

otherwise be in an institution to be cared for at home and reduces hospital re-admissions. In

Southwestern Ontario, for example, hospitalizations for palliative care patients were reduced

from 50% to 2%, which is a signicant impact on health system cost as well as patient satisfaction.

In the US, eShi can deliver even greater value, given the higher cost of healthcare. This is especially

true under the recently enacted Accountable Care Act, whereby Accountable Care Organizations

(ACOs) that create eciency and process improvements that save money for the health system

receive signicant incentive bonuses, which is a signicant driver of innovation adoption. Using

eShi to reduce expensive hospital stays through better home care allows ACOs and their partners

to deliver these cost-savings.

With this strategy in mind, Sensory Technologies has entered the U.S. through its relationship

with Hospice of Michigan (HOM) headquartered in Detroit. HOM is a member of one of the leading

Accountable Care Organizations in the U.S. HOM, through eShi, is actively pursuing adult patients

with complex care needs, such as Type II diabetes, congestive heart failure or chronic obstructive

pulmonary disease (COPD). Again, the new hybrid home-care team enabled by eShi can manage

those patients better, reducing the risk of hospitalization where the really expensive care kicks in.

The eShi home care model and soware is an ideal t for groups like HOM and other ACOs, and

Sensory Technologies has used nancing from HTX to localize the soware for the U.S. and

international markets. This includes modications allowing for regional requirements for privacy and security of patient data collected at home,

and added functionality to make the eShi application and the mobile client used by the PSWs on their iPhones suitable for use with adult

complex-care patients.

HTX nancing has been critical in leveraging the investment of local Angel investors and founders. As Sensory Technologies transitions from

a company that was primarily focused on developing soware to a company that is delivering healthcare technology and services, it will be

expanding its current sta of 18 to include technical sales & support, training and quality assurance professionals.

In addition to the HTX nancing, S ensory currently has one local angel investor and will be raising more capital with Series A funding, likely

late-2014 or early 2015. This will allow the company to increase internal development, deliver more services within Canada and expand its

reach internationally. This will include securing HIPPA certication in the U.S. by mid-2014, and delivering eShi pilots in the U.K. and France

with leading healthcare organizations f rom each country.

The eShi soware is a full y hosted, Web-based application based on the Soware-as-a-Service (SaaS) delivery model in which customers pay a

monthly subscription fee to access the application via the Internet, using any standard Web browser. For Canadian customers, the application is

hosted at a third-party datacentre site in Ontario to ensure patient data remains within Cana da; similarly for HOM, eShi is hosted at a secure

datacentre in Detroit to ensure clinical data generated or accessed within the U.S. stays within the borders.

Overall, Sensory Technologies, through the development of eShi, is a good example of the application of technology and service innovation

to transform care and deliver better service at lower cost.

Delegating

Nurse

Visiting

Nurse

FamilyPortal

CaseManager

s ClinicalAnalyt ics


Tritioig to shi

DelegatingNurse

VisitingNurse

Physicians

CaseManager

ClinicalAnalytics

FamilyPortal

NurseAide

1 Nurse

1 Patient

DelegatingNurse

NurseAide

Ciica Data Coectio

30

HTX ANNUAL REPORT | 2012 2013


HTX ANNUAL REPORT | 2012 2013

HTX ANNUAL REPORT | 2012 – 2013 HTX ANNUAL REPORT | 2012 – 2013



Setting the Stage forGlobal CompetitivenessHTX expands its services to promote international

sales of Ontario medical technologies

In 2012, purchases of medical technology by Canadian healthcare providers were ~$7B, of which ~$5B was imported and only ~$2B

was met by Canadian suppliers. In addition, Canadian companies exported ~$2.3B, mostly to the slow-growing US market. Canada

represents only about 2% of the global medtech market, but we perform on the order of 3-7% of global medtech clinical trials, and

are the 3-5th ranked globally in medical research productivity. Canada has about the same domestic medtech revenue per capita as

France and the UK, about 20% less than Italy, but only 1/3rd as productive as Germany and the US, with Switzerland a startling 11 times

more productive! A large factor in this is that the Ontario health care system, like those of other Canadian provinces, is not a leading

adopter of innovation. The implications of this are critical to Canadian medtech success:

• We are ivesti i medica research, bt ot reaizi the beets from that research

i terms of Caadia compay domestic saes, job rowth ad exports.

• Or domestic market mst become more strateic for Caadia medtech compaies,

providi beets to Caadia patiets ad eary revee to compaies.

• Caadia medtech compaies MuST aim to icrease their focs ito oba markets,

especiay to hih-rowth markets sch as Korea, Chia, Idia ad Brazi.

HTX’s tag-line is “Invent, Innovate, Invoice”. HTX’s early evolution focused on “Invention” and “Innovation”; Now, increasingly HTX is building

capacity for companies to pursue “International Invoices”. Here are several initiatives that HTX has either led or actively participated in

over the past year, that will help Ontario companies reduce the risk, cost and time to access both domestic and foreign markets.

The Harmony ProjectNavigating the complex world of foreign market regulatory, reimbursementand health technology assessment requirements.

Regulatory and reimbursement environments globally are becoming increasingly stringent and complex to navigate for medical technology

companies. Overcoming the hurdle of safety and ecacy alone is no longer sucient to ensure access to foreign markets. The demand to

demonstrate value for money and comparative eectiveness is increasing evidentiary requirements on manufacturers, as more and more

jurisdictions are relying on Health Technology Assessment (HTA) as a gateway to market access. In the past, companies with limited knowledge

and experience might generate sucient data for their rst market, only to nd out that data proves insucient for subsequent markets,

necessitating additional trials, delays and expense. MaRS EXCITE, of which HTX was a founding collaborator, uses a highly innovative and ecientapproach to consolidate regulatory, reimbursement and HTA requirements into a single integrated pre-market process for Ontario. What is

needed is an integrated, strategic approach to evidence development across multiple foreign markets.

The Proposed Solution

The Harmony Project, led by HTX in collaboration with MaRS EXCITE, is the rst step in developing a process and related content to assist

medtech companies in anticipating a nd simultaneously addressing regulatory, reimbursement and HTA evidentiary requirements for

multiple jurisdictions and payers. Harmony’s strategic approach is intended to reduce medtech product time-to-market, reduce investor

risk, eliminate redundant evidence generation and speed product adoption. Although isolated components of this concept have been

developed in select medtech and bi opharma eco-systems, to our knowledge, there are no companies currently oering the integrated

scope and value proposition of the proposed Harmony Methodology. Harmony will be a “world’s rst”, and has received extremely positive

reception from the medtech industry to-date.

The Project

Through a Request for Qualications (RFQ) and Request for Proposals (RFP) process, several highly qualied global market access

specialists were identied for the purposes of Harmony. A combination of an internal due diligence process with support from an

international Advisory Board, led to the retention of Hull Associates – a global medtech consultancy, as a key partner for HTX in the

development of the Harmony Methodology.

Harmony will focus on key markets of interest to the medtech community – Canada, US, UK, France, Germany and Australia. Using

a combined pathway and case-study based approach, Harmony is identifying regulatory, reimbursement and HTA requirements for

a cross-section of medical devices, and optimal evidentiary coverage across multiple target markets.

Harmony’s goal is to identify areas of similarities and dierences in the commercialization pathway of medical devices across the target

markets, providing end-users with a practical and heuristic based approach in developing and planning their market access strategy.

Additionally, through collaboration and partnerships, Harmony will provide insight, education, and connectivity for medical device

innovators and enable expedited access to key international resources and individuals versed in market access. HTX anticipates

launching a web-accessible Harmony collaboration service in late 2014.

32 33INV ENT | INNOV AT E | INV OICE ™

HTX ANNUAL REPORT | 2012 – 2013 HTX ANNUAL REPORT | 2012 – 2013



Medtech Working Group,

The Ontario Health Innovation Council

and Innovation Procurement

Canada, and Ontario are rightfully proud of their world-class levels of medical

research funding – a fundamental input to global medical technology innovation.

Canada represents only 1.5-4% of the global market for various medical

technology sectors, yet we perform a strong 3-7% of global clinical trials in those

sectors. Canada is one of the world leaders in medical research, and Ontario

represents about 60% of Canada’s medical technology ecosystem. However, weneed to become as eective in medtech commercialization as we are in research.

HTX is very pleased to have played a key role in several initiatives, which will

fundamentally change the dialogue between the health system, research, industry,

and Ontario’s eectiveness as a medtech commercialization cluster. MaRS EXCITE

was the rst initiative arising several years ago from the Open-For-Business

process between the Ontario Government and the Medtech industry. The second

is the Medtech Working Group-a multi-stakeholder public/private forum that

identies priorities and recommends changes to facilitate a more rapid adoption

of medical technologies benetting patients, reducing costs to the health system

and increasing economic growth in the province. The third is an Innovation

Procurement and Adoption working group initiated by the Ministry of Government

Services and Ontario Buys, seeking to reform the procurement process for

medical technology, transforming it into a highly collaborative process, where

dialogue on priorities and technical feasibility occurs early and oen in the

evolution of medical technologies.

Most recently, the Ontario Government has created the Ontario Health Innovation

Council (OHIC), representing Government, the health system, and industry, with a

goal of transforming Ontario into one of the leading adopters of benecial health

technology. Virtually all of HTX’s past and planned programs align with OHIC’s

mandate. Collectively, these initiatives represent an inection point for Ontario,

positioning it to become as strong in commercialization as it is in research, and

one of the leading medtech clusters globally.

Medtech RISE (Registry of Innovators, Suppliers and Exporters)

A comprehensive pan-Canadian medtech ecosystem database

Access to accurate data on the number and type of medtech companies and entities in Canada, along with other industry statistics, is critical for

aligning innovation and import/export opportunities with companies that can use them. In addition, a strong need exists to increase connectivity

between researchers, customers, collaborators, suppliers and talent at a global scale. Over 20 medtech databases have been created in Canada

within the last decade to address subsets of this overall challenge however, all suer from single-organization mandates, limited data sets, and

atrophy over time due to a lack of regular maintenance and updates.

This year, HTX in conjunction with key Canadian medtech ecosystem partners, led the

development and establishment of a national, shared, online registry containing all identied

players within Canada’s medtech ecosystem. Medtech RISE – Registry of Innovators, Suppliers

and Exporters, is accessible online and provides the most up-to-date portrayal of Canada’s

medtech ecosystem. Medtech RISE is maintained on a cloud-based platform provided by

Biotechgate of Switzerland, a company operating similar databases for BIOTECanada, Life

Sciences Ontario, and many of the world’s leading medical technology clusters. To support

the growth of our medical and assistive technology industry, Medtech RISE provides a

platform to monitor the growth, trends, and needs of a constantly changing medtech

market, and exposes Canadian medtech companies to the rest of the world.

There are currently over 2500 entities that have been identied through this collaborative endeavour, ranging from medtech manufacturers

and distributors to research and government organizations, investors and service providers. Over the next twelve months, combined eorts of

HTX and its partners will foster continued expansion of this iterative database, making it a robust and comprehensive tool of high value to the

local, national and international medtech community. Medtech RISE is accessible through the HTX website as well as through partner websites.

HTX CoAuTHorS THeCANADIAN MEDTECHMARKET ACCESS

PATHWAY FOR ISPORThis year, HTX in conjunction with a select

group of Canadian academics and market

access experts, jointly contributed to the

Global Health Care Systems Road Map,

published online by ISPOR (International

Society for Pharmacoeconomic Outcomes

and rsach). As a st stp in nd-

standing the Canadian Health Care system

as it relates to commercialization of

medical devices, this tool provides an

overview of the Canadian regulatory,

reimbursement and health technology

assessment pathways and acts as a

valuable preliminary resource for medtech

companies. This publication marks thest f sval pblicatins that hav

been planned for this coming year. Access

to the Canadian Health Care System Road

Map for medical devices can be found at

www.ispor.org.

So Landing ProgramA critical milestone for medtech companies that are seeking to expand into international

markets, is establishing sound relationships with key individuals within local settings.

Through the So Landing Program, HTX oers an international registry of partners in

specic geographic areas that can deliver the services required to reduce the time, cost and

risk of market entry and/or provide collaboration opportunities for Ontario-based companies.

As a component of Harmony, the HTX led So Landing Program is designed for small and medium enterprises (SMEs) seeking assistance with

all, or a subset of regulatory, reimbursement and HTA compliance, corporate representation, manufacturing and clinical research, sales and post

market support, within their priority foreign markets. The program is aimed at decreasing the cost and risk associated with premature pursuitof foreign markets, as well as minimize the burden and challenge of identifying the optimal commercialization pathway in unfamiliar regions.

HTX envisions that the So Landing Program will also provide reciprocal resources and bilateral introductions to the Canadian market for

innovative international companies seeking to gain market access into Canada.




•


•

Centre for Addiction & Mental Health

• MaRS

•

Mount Sinai Hospital

• Princess Margaret Hospital

•

Ontario Legislature

•

The Hospital for Sick Children

•

Toronto General Hospital

•

Women’s College Hospital

•

University of Toronto


522 uiversity Avee, Site 1201

Toroto, On M5g 1W7

geera Eqiry: [email protected]

Te: 647-258-0381

Fax: 647-258-0390

www.htx.ca



SUMMARIZED FINANCIAL STATEMENTS 2013

2013

SUMMARIZED FINANCIAL STATEMENTS 2013 SUMMARIZED FINANCIAL STATEMENTS 2013




To the Board of Directors of htx.ca – The Health Technology Exchange

The accompanying summarized nancial statements, which comprise the summary statements of nancial position as at March 31,

2013, March 31, 2012 and April 1, 2011 and the summary statements of operations and changes in net assets and cash ows for

the years then ended are derived from the audited nancial statements of htx.ca – The Health Technology Exchange for the years

ended March 31, 2013 and March 31, 2012. We expressed an unmodied audit opinion on those nancial statements in our report

dated July 17, 2013. Those nancial statements, and the summarized nancial statements, do not reect the eects of events that

occurred subsequent to the date of our report on those nancial statements.

The summary nancial statements do not contain all the disclosures required by Canadian accounting standards for not-for-prot

organizations. Reading the summary nancial statements, therefore, is not a substitute for reading the audited nancial statements

of htx.ca – The Health Technology Exchange.

Management’s responsibility for the nancial statements

Management is responsible for the preparation of a summary of the audited nancial statements in accordance with

Canadian accounting standards for not-for-prot organizations.

Auditor’s responsibility

Our responsibility is to express an opinion on the summary nancial statements based on our procedures, which were

conducted in accordance with Canadian Auditing Standard 810, “Engagements to Report on Summary Financial Statements”.

Opinion

In our opinion, the summary nancial statements derived from the audited nancial statements of htx.ca – The Health

Technology Exchange as at March 31, 2013, March 31, 2012 and April 1, 2011 are a fair summary of those nancial

statements, in accordance with Canadian accounting standards for not-for-prot organizations.

Grant Thornton LLP | Suite 200 | 15 Allstate Parkway | Markham | ON | L3R 5B4 | T +1 416 366 0100 | F +1 905 475 8906 | www.GrantThornton.ca

HTX.CA | THE HEALTH TECHNOLOGY EXCHANGE

Report of the Independent Auditoron the Summary Financial Statement

CHARTERED ACCOUNTANTS, LICENSED PUBLIC ACCOUNTANTS | Toronto, Canada | August 30, 2013

2013 2012Revenue

Ontario Ministry of Research and Innovation grant $ 4,844,906 $ 3,462,171

Educational seminar grant 4,000 10,000

Interest 42 9

4,848,948 3,472,180

Expenses

Health technology commercialization program 3,643,516 2,192,854

Commercial market development program 490,423 463,076

Research and development program 339,485 437,690

General and administrative expenses 332,807 313,851

Amortization 40,512 69,071

4,846,743 3,476,542

Excess (deciency) of revenue over expenses 2,205 $ (4,362)

See accompanying notes to the nancial statements.


Summary Statements of Operations Years ended March 31





March 31, 2013 March 31, 2012 April 1, 2011ASSETS (Note 2)

Current

Cash $ 460,363 $ 1,649,121 $ 184,337

Accounts receivable 69,350 29,214 32,191

Prepaids 13,448 9,276 5,792

Contributions receivable – – 717,489

543,161 1,687,611 939,809

Property and equipment 55,521 94,628 108,895

$ 598,682 $ 1,782,239 $ 1,048,704

LIABILITIES

Current

Accounts payable and accrued liabilities $ 106,089 $ 95,932 $ 79,028

Payable to Ontario Ministry of Research and Innovation 307,290 302,065 302,065

Deferred contributions – 1,201,144 480,151

413,379 1,599,141 861,244

Net assets

Invested in equipment 55,521 94,628 98,986

Unrestricted 129,782 88,470 88,474

185,303 183,098 187,460

$ 598,682 $ 1,782,239 $ 1,048,704



Summary Statements of Financial Position Years ended March 31

2013

Invested in property

Total and equipment Unrestricted

Balance, beginning of year $ 183,098 $ 94,628 $ 88,470

Excess (deciency) of revenue over expenses 2,205 (40,512) 42,717

Purchase of capital assets – 1,405 (1,405)

Balance, end of year $ 185,303 $ 55,521 $ 129,782

2012

Invested in

Total equipment Unrestricted

Balance, beginning of year $ 187,460 $ 98,986 $ 88,474

Deciency of revenue over expenses (4,362) (59,162) 54,800

Purchase of capital assets – 54,804 (54,804)

Balance, end of year $ 183,098 $ 94,628 $ 88,470



Summary Statements of Changes in Net Assets Years ended March 31





2013

2012

Increase (decrease) in cash

Operating

Excess (deficiency) of revenue over expenses $ 2,205 $ (4,362)

Items not affecting cash 40,512 59,162

Change in non-cash working capital items (1,230,070) 1,464,788

(1,187,353) 1,519,588

Investing

Purchase of property and equipment (1,405) (54,804)

(Decrease) increase in cash (1,188,758) 1,464,784

Cash

Beginning of years 1,649,121 184,337

End of years $ 460,363 $ 1,649,121



Summary Statements of Cash Flows Years ended March 31


Notes to Financial Statements March 31, 2013

1. Criteria for presentation of summary nancial statements

The information selected by management for presentation in the summary nancial statements has been identied as being the

most pertinent and useful nancial data for inclusion in the htx.ca – The Health Technology Exchange annual report.

Audited nancial statements are available upon request from management of htx.ca – The Health Technology Exchange.

2. Impact of the change in the basis of accounting

These summary nancial statements are HTX’s rst summary nancial statements prepared in accordance with Canadian accounting

standards for not-for-prot organizations (“ASNPO”). The date of transition to ASNPO is April 1, 2011. These accounting standards

were used to prepare the summary nancial statements for the year ended March 31, 2013, the comparative information and the

opening statement of nancial position as at the date of transition.

The adoption of ASNPO did not result in adjustments to the previously reported assets, liabilities, fund balances and excess of

revenue over expenses of HTX. Accordingly, the reconciliations and disclosures required by Section 1501, First-time adoption for

not-for-prot organizations, for the net assets at the transition date, and the comparative period statements of operations and

cash ows are not necessary and have not been presented in these summary nancial statement notes.



SUMMARIZED FINANCIAL STATEMENTS 2013

HTX is an independent, not-for-prot corporation funded by the

Government of Ontario through the Ministry of Research and Innovation.


522 University Avenue, Suite 1201

Toronto, ON M5G 1W7

General Enquiry: [email protected]

Tel: 647-258-0381

Fax: 647-258-0390

www.htx.ca

2013 Htx Annual Report

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