medical product development program brochure_fa.pdf · a growing stakeholder network and...

Medical Product DevelopmentProgramProgram Results

BioAlberta is the central voice and organizing hub for the Life Sciences industry in Alberta. It is a private not-for-profit industry association, representing more than 130 member organizations in the province’s growing Life Sciences sector.

The Medical Product Development Program (MPDP) was administered by BioAlberta and jointly funded by Western Economic Diversification Canada and the Government of Alberta through the Canada-Alberta Western Economic Partnership Agreement between 2010 and 2013. The program supported the development and commercialization of new medical devices and technologies at Alberta based Small and Medium-sized Enterprises, and was the third phase of a long-standing program that began in 1998. The program was subsequently brought under BioAlberta’s administration in 2009.

MPDP Program Results 3

The goal of the BioAlberta Medical Product Development Program (MPDP) has been to provide the impetus for product innovation within Alberta’s growing medical technology sector- a sector that has flourished in recent years, and today constitutes approximately 38% of the Alberta Life Sciences industry (BioAlberta’s Life Sciences in Alberta, State of the Industry Report, 2013).

BioAlberta MPDP supported the development and commercialization of unique needs-based and consumer-focused products and technologies that will provide for better health care for Albertans and users at large, and also help grow a diverse, knowledge-based economy within the province.

MPDP funding provided Small and Medium-sized Enterprises (SMEs) the momentum they required to achieve results and position themselves favourably with customers and investors. Between 2010 and 2013, close to $2 million was jointly invested by the Governments of Alberta and Canada, and 20 Alberta-based SMEs to directly support innovative and commercially-viable projects at those companies. The outcomes have been significant.

During this period, 10 unique medical technologies have been launched within global markets, while several others are poised to enter the market within the next 12-24 months. Additionally, the critical research and development work has promoted a range of multi-disciplinary alliances across Alberta, Canada and internationally, including among top-calibre research institutions, suppliers, consultants, distributers, manufacturers, purchasers and partners. It is noteworthy that during this period close to 185 distinct prototypes were developed to support product testing and validation as a result of this shared expertise. Partnerships like these will remain critical to the growth of a thriving

medical device and technology sector in Alberta. The impact on local job creation and the highly qualified personnel (HQP) talent pool has also been notable, with over 30 highly-skilled students, and several experienced professionals being recruited, trained and in many cases permanently retained by the companies in full-time positions.

BioAlberta takes pride in recognizing the various accomplishments of the MPDP program and successes at Alberta SMEs to date. Many of these companies are in fact leading the way for the growth of the sector. Our organization remains committed to working with the government and industry to ensure that the needs of the medical devices and technology sector continue to be met, and the innovation-commercialization process be sustained.

Medical product development is a knowledge and resource-intensive, and iterative process, which warrants sustained commitment toward innovation by various stakeholder groups. This sector offers significant opportunities in terms of sustained market growth, economic diversification, and workforce expansion. BioAlberta looks forward to working alongside the various stakeholder groups and partners to ensure that we can establish an environment that is conducive to achieving these goals, here in Alberta.

Regards,

Amanda StadelPresident, BioAlberta

&

Sanah JowhariManager, Medical Product Development Program

BioAlberta Foreword

BioAlberta Foreword

March 2014

MPDP Program Results4

Program Outcomes

10 innovative medical technologies were launched and several others are well-poised to launch within global markets.

185 prototypes were developed to support product testing and validation at 20 companies.

Over 30 highly skilled students, and several professionals were recruited and trained, of which many have been permanently retained within industry.

Program Outcomes


BioAlberta MPDP...

• Accelerated needs-based medical product development

• Expanded strategic projects into new markets

• Enabled the creation of two spin-off companies

• Positioned projects for global sale and follow-on investment

• Established critical multi- disciplinary alliances

• Helped build technological capacity in Alberta

Program Participants

Alzheimer’s Innovation Institute Inc.Aquila Diagnostics Systems Inc.Bertech Pharma Ltd.Calgary Scientific Inc.Circle Cardiovascular Imaging Inc.*Cleankeys Inc.*DriveABLE Assessment Centres Inc.IMBiotechnologies Ltd.*Innervision Medical Technologies Inc.Innovative Trauma Care Inc.*Innovotech Inc.Metabolomic Technologies Inc.Orpyx Medical Technologies Inc.Prev Biotech Inc.*SmileSonica Inc.Stream Technologies Inc.Surface Medical Inc.Technology North Corporation*XSENSOR Technology Corporation*Zephyr Sleep Technologies Inc.*

* Secured more than one round of funding for incremental projects

Innovative Projects targeting ‘real’ concerns

Alzheimer’s Disease and Related DementiaInfectious DiseasesColorectal CancerCardiac ImagingMedical Imaging & Mobile HealthLiver CancerInfection Prevention and ControlPre-hospital Trauma CareInoperable Cancerous TumoursUterine fibroidsBiofilm issuesDiabetic Peripheral NeuropathyPressure UlcersAutism and General DisabilitiesObstructive Sleep ApneaLivestock Health

Program Outcomes


Alzheimer’s Innovation Institute Inc.Private, For-Profit | Founded: 2005 | Calgary, Alberta

Projects

The Ashby Memory Method (AMM) family caregiver edition

Alzheimer’s Innovation Institute (AII) is developing and commercializing therapeutic quality-of-life enrichment programs for persons with Alzheimer’s disease and Related Dementia (ADRD). AII is a sole developer of the Ashby Memory Method (AMM) program, an evidence-based, structured cognitive training program to improve quality-of-life for dementia patients. AII sells AMM program training packages to non-medical and medical, senior and elder-care service providers, as well as health care practitioners.

The MPDP project helped develop a less expensive, family-friendly version of the existing program package for families willing to use it on a loved one suffering from ADRD. The funding helped the company to develop both the therapeutic content and training material for the non-professional user. The core product was refined to target market’s vernacular, complete with design, graphics and packaging, and a small production run was undertaken for home consumer market.

AII has commercialized its product and is expanding its sales and distribution in the U.S. and Canada. This product is an effective home-use tool that assists families in making important connections with ADRD sufferers, and has been validated to improve dementia impairments and quality of life. The company has a growing stakeholder network and collaborations in Australia, and has formed a subsidiary there.

www.alzheimersinnovation.com

Over 15 million family and friends provide close to 17.5 billion hours of unpaid care to those with Alzheimer’s and related dementias in the U.S. alone – care valued at over USD 216 billion.


Aquila Diagnostics Systems Inc.Private, For-Profit | Founded: 2009 | Edmonton, Alberta

Accutas™- A field-ready diagnostic platform for detecting livestock and human infectious diseases

Aquila is developing and commercializing point-of-care (POC) diagnostic testing technologies for blood borne infectious diseases and genetic markers. The company is targeting disease markets such as livestock health and human infectious diseases including malaria. Their lead product candidate is the Accutas™, a portable diagnostic platform testing kit that will deliver low cost and high speed multi-parameter tests without the need for highly-skilled operators in both developing and developed countries.

This platform is capable of conducting highly sensitive DNA-based and pharmacogenomics tests so that multiple viral, bacterial, parasitic and genomic

genetic markers are detectable in blood samples. Fast and inexpensive testing at the point-of-care is expected to not only substantially reduce costs and testing times compared to current molecular diagnostic tests, but also widen the availability of such tests from central labs to field locations.

The MPDP project helped define the final form of the POC diagnostic for mass production, taking into consideration user interface, operating environment, production costs and regulatory requirements. The company has advanced its prototype from a lab-based to a fully functional field-tested device. Superior design sophistication has been achieved and a launch product has been readied for use in both Livestock and Infectious disease trials. Accutas™ is currently bracing for commercial production within the next 12 months.

Global Point of Care (POC) diagnostics market is expected to reach over USD 18 billion by the year 2020.

www.aquiladiagnostics.com

Projects

“MPDP helped Aquila advance its Accutas™ point-of-care diagnostic test system from a lab based prototype to a fully functional field tested device that performs on par with centralized lab services. The funding was very important for us to refine our target markets and design as well as integrate critical regulatory and compliance aspects into our commercialization plan.”

David Alton, CEO, Aquila Diagnostics Systems Inc.


Projects

A non-invasive blood-based diagnostic for early detection of Colorectal Cancer (CRC)

Bertech is developing innovative products to advance the diagnosis and treatment of CRC to help improve outcomes for patients. Their lead product, a proprietary blood-based test, detects CRC by identifying a protein that is expressed at high levels in affected patients.

Colorectal Cancer is the second leading cause of death from cancer; however, when it’s caught early there is a 90 per cent survival rate. Today only a small fraction of CRCs are diagnosed early due to low screening/detection rates. The current standard screening tests i.e., Fecal Occult Blood Test (FOBT) and Colonoscopy are uncomfortable, time consuming, less accurate (FOBT), and very costly (Colonoscopy). In comparison, Bertech’s test will have a sensitivity of greater than 80 per cent in detecting CRC, and will offer a non-invasive, cost-effective and simple solution to the diagnosis of CRC.

MPDP funding was used for the design and development of a commercial prototype for the diagnostic testing system. The funding allowed the company to develop a prototype, as well as optimize production protocols for commercial production of the diagnostic. Bertech is also developing a suite of products to enhance treatment associated with colorectal cancer, including an assay to improve treatment selection and assessment as well as the development of novel anticancer drugs, thereby branding itself as a ‘specialty company’ in this domain.

On average, 23,900 Canadians will be diagnosed with Colorectal Cancer and 9,200 will die of it every year. This is the second leading cause of death from cancer in men and women combined.

www.bertechpharma.com

Bertech Pharma Inc.Private, For-Profit | Founded: 2008 | Edmonton, Alberta


Projects

Smart-e-Pants system for pressure ulcer prevention

Prev Biotech focuses on the development of innovative technologies to assist patients suffering from mobility and sensation disorders. The company has developed a product called Smart-e-Pants, a unique system to help prevent pressure ulcers in patients.

Pressure ulcers (also known as pressure sores or bed sores) are a major medical problem; it is estimated that treating one ulcer costs the health care system over $45,000 and the annual cost in Canada alone is close to $4 billion. In fact, they are the number one hospital-acquired illness. Although passive means of preventing the condition have been introduced in recent years, the incidence of pressure ulcers remains stubbornly high.

Smart-e-Pants (based on Sensory Motor Adaptive Rehabilitation Technology) is a first-in-class approach to the prevention of pressure ulcers. The system consists of a stimulator, electrodes and an undergarment. The product provides electrical stimulation to the gluteal muscles – the area most prone to develop pressure ulcers – to cause periodic muscle contractions. These muscle contractions combat the physiological conditions that lead to pressure ulcers.

The MPDP program has helped to design, develop, test and manufacture the Smart-e-Pants equipment. Specifically, Prev Biotech was able to develop a prototype of the electrical stimulators and associated technologies that meet United States FDA and Canadian Standards Association requirements, and is ready for clinical testing and commercial scale-up.

“Projects funded by the MPDP have been crucial in developing our proprietary Smart-e-Pants system. Product development permitted us to reach the point where a subsidiary company Prev Biotech Inc. was spun off and is positioning itself for clinical trials and subsequent commercialization of the product.”

Dr. Richard Stein, President & CEO, Prev Biotech Inc.

Pressure ulcers are estimated to cost the Canadian health care system close to USD 4 billion annually.

www.prevbiotech.com

Prev Biotech Inc.Private, For-Profit | Founded: 2010 | Edmonton, Alberta


An imaging tool for Hepatocellular Carcinoma (Liver Cancer)

Calgary Scientific is developing and commercializing a suite of advanced medical visualization and mobile health products. The suite includes two successfully marketed products, ResolutionMD™ for 2D and 3D medical image viewing on both mobile device and web browsers, and ResolutionMD™ Vessel for a variety of vessel analysis protocols. The company is targeting global industries requiring secure transmission of heavy data, using their existing systems.

The MPDP project helped in the design and development of a novel analysis software for a unique medical imaging biomarker that will distinguish various types of benign liver lesions or cysts in the liver from cancerous lesions or cysts, when viewed on computerized tomography (CT) scans. Such computer-aided analysis will help radiologists – who see a large volume of these scans on a daily basis – to quickly and accurately diagnose small liver cysts and determine if further biopsy and testing is required. Early and efficient treatment is expected to increase the likelihood of patient survival and decrease cost burden to the health care system.

After extensive analyses of existing databases of CT images, various imaging biomarkers for cancerous tumours were combined into a unique single metric to convey additional information to radiologists. This will help with their determination of the nature of lesions which are otherwise difficult and time consuming to analyze. The project’s other goals were to develop a graphical user interface to visualize the information, and to adapt the tool for broader applications.

Computer-aided diagnosis (CAD) represents a USD 330 million market opportunity in the United States alone.

www.calgaryscientific.com

Projects

Calgary Scientific Inc.Private, For-Profit | Founded: 2005 | Calgary, Alberta

“Within the last 10 years significant changes have occurred within the medical device landscape, including the introduction of new health regulations and FDA standards for better product ergonomics, cleanability, and safety. Sophisticated consumer product design, like the iPhone, has translated to health professionals’ expectations for a high- quality medical product, usable across a number of technology platforms available to the health care user. By contrast, just a few years ago medical devices were still crude and dated designs, and in many cases ill-fitted for the end users.”

Travis Colley, Industrial designer and a Technical Co-Director with BioAlberta MPDP


cmr42 Smartclient solution & novel detection tools for cardiac CT imaging

Circle Cardiovascular Imaging develops and markets cardiovascular post-processing software that allows for the evaluation and analysis of MRI and CT images. The software allows cardiologists and radiologists to accurately and efficiently analyze cardiac images from any scanner, on any computer – including those located outside the hospital at the doctor’s personal office or home.

The first software in the product suite is cmr42, which is designed for use in cardiovascular magnetic resonance imaging. Since its launch in 2008, Circle has expanded its product line to include cvi42, ct42, and report42. In the process, Circle has acquired over 300 accounts in 25 countries. Numerous top hospitals and medical universities are among Circle’s clientele, including the Cleveland Clinic, the Mayo Clinic Health System, Duke, Harvard, Yale, Royal Brompton and King’s College hospitals in the UK, and the University of Leipzig in Germany.

The first project funded by MPDP was to build a client server model for cmr42. This allowed multiple clients to connect behind a hospital firewall and manage connections and patient data. This increased efficiencies in distributing and analyzing the medical images. Outcomes of this project allowed Circle to enter large enterprise markets such as the Mayo Clinic, which resulted in substantial revenue growth. Funding from the second project was assigned to the development of novel algorithms that provide quick and accurate tissue characterization of the heart in cardiac CT scanning. This capability will provide added diagnostic value in the acute environment, for example in the emergency room. The ability to match a quick scan of the heart with a greater level of tissue characteristics information will allow doctors to make faster and more effective decisions related to patient management.

The rising incidence of cardiovascular diseases due to an aging population is both expanding the patient pool and escalating demand for equipment and software that enable better diagnoses (Frost & Sullivan).

www.circlecvi.com

Projects

Circle Cardiovascular Imaging Inc.Private, For-Profit | Founded: 2007 | Calgary, Alberta


An Infection Control Management System for networks of input devices

Cleankeys Inc. provides technology-based, infection-prevention control solutions to the health-care industry. The solutions include computer keyboards and optical mice that are easy to clean and disinfect. The company designs, develops, as well as oversees the production of its own devices, which are marketed and sold in North American, Europe and Asia.

Infection control is a critical issue within hospitals and medical clinics. Organizations are aggressively spending on technologies and products that reduce or eliminate hospital acquired infections because of the legal, social and personal costs that they incur. The primary product that Cleankeys has developed with MPDP assistance is an Infection Control Management System (ICMS), which it plans to sell along with its marketed Cleankeys keyboard.

The product monitors the state of all the Cleankeys keyboards attached to a local network. As users type, it records the number and type of keyboard touches, notifying users when it’s time to execute cleaning protocols. It then monitors the progress of the cleaning activity, recording the progress, accuracy and effectiveness of the protocol. Information is summarized and presented to infection-control managers as business intelligence. This is a comprehensive product response to infection management at all levels of the issue: administrative, maintenance, and practice. It has the potential to be a significant benefit to health care systems in reducing costs and improving care.

Hospital Acquired Infections (HAIs) claim over 100,000 deaths annually and cost the health care system approximately USD 45 billion in the U.S. alone.

www.cleankeys.com

Projects

Cleankeys Inc.Private, For-Profit | Founded: 1996 | Calgary, Alberta


Competence-assessment tools for school bus drivers

DriveABLE produces science-based competence-assessment tools for motor vehicle drivers that can quickly, accurately and effectively predict cognitive competence.

These assessment tools meet the need for driver risk and safety management for the health-care industry, the insurance industry, government licensing agencies and fleets. The product solution directly supports public and transport safety.

The utility is multi-fold: as a pre-employment screening tool; to make sure drivers are currently fit and will remain fit to drive over the years; and to ensure employees returning to work after an injury are safe behind the wheel. The technology has close to 100 licensees world-wide, including Canadian provinces, the United States and Australia.

The MPDP project looked to expand DriveABLE’s proprietary methods and driver assessment capabilities to evaluate the cognitive competence of school bus drivers who may have reduced cognitive abilities due to medical conditions. Currently there are approximately 35,000 school bus drivers in Canada and close to 500,000 in the United States. Not only do young employees age, but the bus driver occupation also has appeal to an older demographic. The product will be marketed directly to existing product licensees worldwide, along with school division transportation departments and student transportation companies as an important safety and risk management product.

www.driveable.com

Medical conditions and medications can cause even the safest driver to become unsafe.

Projects

DriveABLE Assessment Centres Inc.Private, For-Profit | Founded: 1999 | Edmonton, Alberta


www.streamtechinc.com

A real-time Optical Imaging device for use in chemical detection

Stream is commercializing a new type of optical element made possible in part by the support of MPDP.

An MPDP project was originally conceived to develop a key optical part of the bacterial detection technology; however, it quickly became obvious that the optical component itself had greater value in a different use, namely hyper-spectral imaging. As a result, the project was adapted to build a proof-of-concept hyper-spectral imaging CUBE, which represented a crucial advancement and allowed Stream to develop advanced imaging technology based on this early work and start selling a product. Early adopters include researchers in the area of cancer detection in Canada and defence security applications in the U.S.

Stream Technologies Inc. was founded by local Alberta entrepreneurs who will continue developing and commercializing this new technology.

Projects

Stream Technologies Inc.Private, For-Profit | Founded: 2012 | Edmonton, Alberta

“BioAlberta MPDP has supported companies in conducting deeper analysis of the end-user and product task requirement; the environment in which the product is used; as well as significant enhancements in product manufacturing. In case of the latter, aspects have

included material characterization, component design, overall performance, material advances, product

packaging as well as user experience, to name a few.”

Darren Jakal, Technical Co-Director with BioAlberta MPDP


Almost 80% of all women in the U.S. have uterine fibroids, and one in four will require treatment.

A bio-degradable embolic device for the treatment of hypervascular tumours

IMBiotechnologies Ltd. (IMBio) is focused on commercializing medical device products in the area of embolotherapy, which involves cutting off blood flow to malignant and non-malignant hypervascularized tumours in affected patients.

IMBio’s lead product candidate, OCL 500, is a ‘first-in-class’ biodegradable embolic agent to treat unresectable and inoperable hyper-vascularized tumours including liver cancer, kidney cancer, and uterine fibroids. Unlike existing products, OCL 500 does not remain in the body permanently. After the tumour is treated, the product biodegrades, and the blood flow to the treated tissue is restored. IMBio is the first company to obtain FDA marketing clearance for a biodegradable embolic.

The MPDP funding was used to significantly advance the development and scale-up of OCL-500, as well as to develop related products. Specific objectives included testing, validating and development of quality control processes, as well as to develop procedures for technology transfer to a U.S. GMP compliant company.

www.imbiotechnologies.com

Projects

IMBiotechnologies Ltd.Private, For-Profit | Founded: 2008 | Edmonton, Alberta


Ultrasound-based, real-time volumetric imaging for prostate

Innervision was founded by Tim J. Davies and Richard Evans, who bring over 20 years of experience in the design and creation of state-of-the-art sonar technology and its many applications. The company is focused on developing high resolution ultrasound imaging by combining medical ultrasound and petroleum seismic technologies.

The MPDP project involved the design and development of a two-dimensional array transducer prototype that uses ultrasound technology to generate high-resolution, real-time volumetric imaging of the prostate.

Key applications of this technology include prostate biopsy guidance and prostate cancer therapy delivery guidance. The project allowed further advancement of technology to achieve an initial proof-of-concept demonstrating real-time volumetric images with the transducer funded by this project. Developments on this project will poise the company well for strategic partnership opportunities with large device companies.

The project reflected a balanced crossover of technology and training between Alberta’s dominant oil and gas sector and its emerging medical device sector.

www.innermed.com

One in seven men will develop prostate cancer in their lifetime; over 90% cases are curable if detected and treated in their earliest stages.

Projects

Innervision Medical Technologies Inc.Private, For-Profit | Founded: 2002 | Calgary, Alberta


iTClamp™ and iTClip™ –innovative hemorrhage control products

Innovative Trauma Care Inc. (iTraumaCare™) is a start-up medical device company with the vision to transform the field of emergency casualty care by developing, manufacturing, and commercializing point of injury solutions to treat common causes of preventable death. The company is targeting the under-exploited area of pre-hospital trauma care.

Both projects funded by the MPDP helped develop unique first-in-class wound closure devices for military, civilian and animal trauma applications. Currently, the market has no good options for hemorrhage control devices in the immediate management of severe blood loss at the point of injury. The gold standard treatment to control blood flow is direct pressure (digital pressure) to the wound or on a pressure point to compress the blood vessel until the blood clots or until the patient reaches a medical facility for more involved treatment. This method involves medical knowledge and skills that most individuals do not possess for control of severe bleeding. Also, the casualty will likely need to be moved, increasing the potential for loss of pressure, loss of a blood clot and additional blood loss. The iTClamp™ and iTClip™ presents a paradigm shift for treatment of these wounds.

The MPDP project allowed iTraumaCare™ to iterate design of the iTClamp™ product using models and testing to refine their design and usability. This resulted in a high quality prototype to support further development, regulatory approval and product scale up. Subsequently, iTClamp™ received FDA approval and was launched into global markets in 2013. iTraumaCare™ has established distribution through 30 pre-hospital distributors in 23 countries, and initiated partnerships with large Tier 1 medical device manufacturers for strategic marketing and distribution of the product.

The second project looked to develop a follow-on product, iTClip™, for sucking chest wounds. Greater than expected progress was made toward commercialization of this product; a fully functional prototype was developed and subsequently used as part of a pre-clinical cadaver pilot study to support regulatory filing of a FDA 510(K) application. This product is well-poised for commercialization in the next 18-24 months.

These projects have been a perfect example of a situation in which observations through career experience and practice in military medicine have been leveraged in a diverse and innovative way.

www.innovativetraumacare.com

“BioAlberta MPDP is the key funding that got two of our core projects off the ground. The program accelerated our product development and market adoption efforts. Without the amount of development progress achieved on each product class, we would not have been successful in getting the levels of VC and Angel investment that we have achieved. Period.”

Dr. Ian Atkinson, Co-Founder & Chief Technology Officer, Innovative Trauma Care Inc.

Projects

Innovative Trauma Care Inc.Private, For-Profit | Founded: 2010 | Edmonton, Alberta


Silver-based anti-microbial products

Innovotech develops products that address biofilm problems in a range of industries. Its primary markets are pipeline corrosion, agricultural pesticides, food processing safety, disinfectants, biofilm testing supplies, and medical devices, including susceptibility test kits (human and veterinary). The test kits aid physicians and veterinarians in the selection of the most effective antibiotic treatment for chronic infections in humans and in both large and small animals. Innovotech also has an active contract business that uses its expertise and technology to solve infection problems for clients or aid them in gaining regulatory approvals.

The MPDP project has involved the characterization and testing of Innovotech’s silver-based products InnovoSIL™ with superior antimicrobial activity, for their incorporation into medical devices such as wound dressings and urinary and blood system catheters. These products will minimize the chances of hospital-acquired infections that are mainly affiliated with medical device use. The project has enhanced their intellectual property portfolio, and positioned the company well for strategic partnership discussions. An additional line of silver based products was also developed as a result.

www.innovotech.ca

Biofilms cause over 2 million infections annually in the U.S. alone, adding an estimated USD11 billion in patient health care cost burden.

Projects

Innovotech Inc.Public, For-Profit (IOT, TSX) | Founded: 2001 | Edmonton, Alberta


Polyp Dx™ A simple urine-based test for earlier detection of Colorectal Cancer

Metabolomic Technologies Inc. (MTI) develops metabolomic-based diagnostic systems that are based on proprietary biomarker technologies. The Company is committed to developing advanced diagnostic tests for a range of gastrointestinal diseases in their early stages. MTI’s lead product is a highly sensitive diagnostic for early-stage detection of colonic adenomatous polyps- the precursor to colorectal cancer (CRC).

Currently 300,000 Albertans need to be screened for colon cancer. Existing diagnostics are either too expensive to be run as large-scale screening programs (colonoscopy), or not effective due to their accuracy profiles (Fecal Occult Blood test or Fecal Immunochemical Test). MTI’s Polyp Dx™ is a simple urine test that will detect such cancerous polyps based on a unique ‘fingerprint’ of metabolites. Given its ease of use and significant superiority over current screening tests, this test has the potential to emerge as the world’s leading screening test for colonic polyps- the precursor to CRC. This test is designed for use in individual patient testing (such as in a private or community-based physician practice), and screening program testing environments (such as overall population based colon cancer screening programs).

MPDP assisted the company to improve effectiveness of the test and prepare it for clinical trials, which were subsequently initiated in Alberta with 1200 patients. The product is positioned for a market launch within the coming 24 months. MTI has also partnered with world-class institutions such as DynaLIFE Dx, Alberta Health Services, and BGI (formerly, Beijing Genomics Institute) in China to advance its product into both local and international markets.

The molecular diagnostics market is rapidly growing and is projected to reach USD 8 billion by 2017, worldwide.

www.metabolomictechnologies.ca

Projects

Metabolomic Technologies Inc.Private, For-Profit | Founded: 2010 | Edmonton, Alberta


SurroGait Rx™ pressure-sensing system

Enormous gains have been made over recent years in understanding the human brain’s ability to rewire itself. Orpyx is harnessing this potential in medical, health and sports devices targeted at sensory substitution and augmentation. There are currently no commercially-available, user-friendly solutions for real-time force monitoring over the sole of the foot; Orpyx is doing this by developing a series of pressure-sensing insoles and feedback devices. Their first product in the series SurroSense Rx™ was launched in the North American markets in late 2013.

The MPDP project enhanced the development of the follow-on product, SurroGait Rx™, a high-tech, pressure-sensing system that tells the user when damage is being done to the feet and provides substitute sensation for “numb” feet. This device will provide a solution to patients suffering from moderate to severe peripheral neuropathy or nerve damage

such as in diabetics, where pain feedback is compromised. Additional benefits will be observed in improving gait and balance, as well as decrease in risk of falls in such patients.

SurroGait Rx™ is a highly sophisticated technology: a high-resolution foot insert collects pressure information in the shoe and wirelessly sends it in real-time to a low-profile, ergonomic back display. The back display transposes sensation that would otherwise be felt on the foot onto the back, so that the user can “feel” his or her feet through the back. With practice, through the incredible phenomenon of neuroplasticity, the user will “rewire” his or her brain so that interpreting the feeling on the back is second nature.

With MPDP’s support, the technology has been validated, tested and optimized into an aesthetically pleasing design that is currently undergoing extensive clinical trials in patients.

“The funding enabled us to produce a functional prototype of SurroGait Rx™ device, and helped to significantly optimize the product into an industrial design that will be suitable for commercial production. The flexibility of the MPDP allowed us to redefine project scope well in time so that we could push forward with critical product development milestones.”

Dr. Breanne Everette, Founder & CEO, Orpyx Medical Technologies Inc.

www.orpyx.com

Projects

Orpyx Medical Technologies Inc.Private, For-Profit | Founded: 2010 | Calgary, Alberta


Sterile ultrasound coupling gel for use in specialized medical procedures

SmileSonica Inc. is a medical device company which is focused on the development and commercialization of specialized ultrasound-based medical products. Its lead products are portable ultrasound-based medical devices for dental therapy, which are currently undergoing clinical trials.

MPDP helped the company further expand its product portfolio to fill a unique market need. SmileSonica has developed Intra-Gel™, a first-in-class sterile ultrasound gel product which is safe for use in specialized ultrasound procedures and can enhance the image quality in these procedures. Through support received from the MPDP, SmileSonica was able to accelerate the prototype development and testing phase of Intra-Gel™ and determine manufacturing and packaging parameters that follow regulatory guidelines, to a point where the product is now ready to undergo biological validation.

Intra-Gel™ offers a solution for an unmet need in a market that is worth over USD 40 million in Canada and U.S. combined, and growing at over 10% each year.

www.smilesonica.com

Projects

SmileSonica Inc.Private, For-Profit | Founded: 2008 | Edmonton, Alberta


The global market for infection control devices and products is expected to reach approximately USD 14 billion by 2016 at a compound annual growth rate of 7.7%

A product for repair of therapeutic medical surfaces

Surface Medical develops safe, simple and cost-effective products to help address the spread of hospital acquired infections. Their first product CleanPatch™, now commercially available, is a medical surface repair patch that restores damaged surfaces to an intact and cleanable state. Surface Medical is dedicated to creating innovative products that reduce the transfer of infection and facilitate the safe administration of healthcare for the benefit of practitioners and patients alike.

MPDP accelerated the development of the CleanPatch™ product-line through funding key development steps. Surface’s product-line was expanded to incorporate a proprietary anti-bacterial technology developed by Sharklet™. Functional prototypes of the product have now been developed and are gathering market feedback. The funding also assisted in the optimization of manufacturing process for large scale production and the company is targeting market launch of product within the next 12 months.

www.surfacemedical.ca

Projects

Surface Medical Inc.Private, For-Profit | Founded: 2010 | Calgary, Alberta


TN ActiveCare and TN ActiveFamily Platforms for Autism and Disability Management

Technology North (TN) has a legacy in specialized IT consulting and application development. In 2009 they identified a need with their clients in the human service space and made a strategic decision to develop and commercialize a product offering, TN ActiveCare (TNAC). TNAC provides comprehensive patient-care case management and clinical outcome- tracking solutions to providers in general human services, including autism intervention, complex-needs student services, healthcare and aging population service.

Disability services, including Autism cases, involve many forms of specialized day programming and treatment centres, standard classroom integration, as well as specialized schooling for children’s educational programming.

While there is an established market for software systems that help service organizations manage these needs, the gap lies in meeting the more specialized needs of the disabled or autistic students and programs, and general absence of shared tools and information exchange between parent and case workers. TN is filling this gap by developing software analytics to assist the treatment team in defining an optimal plan for each child, assisting with tracking, and getting families involved in the patient management.

MPDP helped in enhancement and optimization of TN ActiveCare platform, TN ActiveCare and TN ActiveFamily, for enterprise level implementation, which has in turn landed key sales accounts in Canada, U.S. and opened doors to international markets.

www.tnactivecare.com

Projects

Technology North CorporationPrivate, For-Profit | Founded: 1998 | Edmonton, Alberta

Autism cases involve a customized blend of different treatment approaches and goals that are identified based on each child’s presenting conditions, abilities and needs.


Pressure-imaging systems for patient safety

XSENSOR provides high value pressure-imaging solutions to monitor and compare pressure distribution over time. These systems find their utility in the sleep and automotive industries, as well as in the fields of patient safety. In case of the latter, clinicians, nurses and rehabilitation therapists use them to help prevent pressure ulcers (bed sores) through improved surface selection and patient positioning.

MPDP allowed the company to develop and test improvements of the manufacturing process for the sensor pads to monitor and measure accumulated pressure on the surface of hospital beds. Funding also helped accelerate the successful market launch of its patient-turn management system, as well assisted in extending their product line through design and manufacturing improvements.

XSENSOR’s pressure-imaging systems are used in more than 40 countries, and by clients that include NASA, the U.S. Air Force, Mayo Clinic, multiple car and mattress manufactures.

“In design it is often said: ‘the devil is in the details.’ Successful technology development in Alberta has often been a balance between a bold ‘can-do’ attitude and a careful attention to detail. Although MPDP funded projects have typically been only a small portion of a company’s overall product development, the support has fit well within the big picture because it has helped companies to focus effort and resources on these small but challenging problems. In the rush to get a product to market, overlooking these important steps can result in unnecessary manufacturing costs in the future, problems with regulatory approval, or product recalls after release. We see participants being better prepared for their eventual ramp-up and product commercialization.”

Travis Colley, Industrial Designer and a Technical Co-Director with BioAlberta MPDP

www.xsensor.com

In the U.S., over half a million patients a year develop pressure ulcers at a cost of over USD 11 billion per year, or an average of USD 50k per patient.

Projects

XSENSOR Technology CorporationPrivate, For-Profit | Founded: 1998 | Calgary, Alberta


MATRx – Oral appliance titration system for Obstructive Sleep Apnea

Zephyr is developing scientifically-validated medical products for the clinical sleep community – serving a population of over 80 million known sufferers of sleep-related disorders worldwide.

Sleep apnea, periodic interruption of breathing during sleep, is the most common chronic, non-communicable disease in industrialized societies, affecting approximately 20% of people. The disease has important public health implications as it conveys a significant cardiovascular risk. The predominantly prescribed therapy, Continuous Positive Air Pressure (CPAP), while life saving for patients with the most common form of sleep apnea – obstructive sleep apnea – has low adherence to the therapy; more than 40% patients give up within the first year of use. In contrast, a dental-based therapy using an oral appliance (oral appliance therapy), is equally benign and efficacious as CPAP, however it is strongly preferred by patients. The challenge is that there has been no effective

way for determining which individuals will respond to dental-based therapy, and it seems to work in only 50-60% of patients. Zephyr identified and captured this market opportunity.

With MPDP assistance, Zephyr has developed MATRx, an assessment tool to predict whether oral appliance treatment will be effective, and also what the optimal device configuration should be for the patient. The tool not only gives dentists and patients a time-saving and cost-effective solution, but also brings together dentists and sleep physicians together for the effective management of obstructive sleep apnea in patients.

MPDP contributed towards the development, launch and advancement of MATRx, the oral appliance titration system which launched in the U.S. and recently received its Health Canada approval for sale in Canada. Funding also assisted Zephyr in developing the infrastructure required by MATRx, as well laid the foundation for their second product line, NOTUS, which will shift this technology to the bedside.

Approximately 50 to 70 million Americans suffer from a chronic disorder of sleep and wakefulness, hindering daily functioning and adversely affecting health and longevity.

www.zephyrsleep.com

“The MPDP has had a significant impact on Zephyr –allowing us the flexibility to use the funds in a way that met the current needs of the company. The program, as delivered through BioAlberta, was reliable and responsive. The team took the time to understand the company’s current reality and help to make the project fit so that it provided both immediate benefit and contributed to the long term goals.”

Dr. Sabina Bruehlmann, Director, Operations and R&D, Zephyr Sleep Technologies Inc.

Projects

Zephyr Sleep Technologies Inc.Private, For-Profit | Founded: 2009 | Calgary, Alberta


Alberta Centre for Advanced MNT Products (ACAMP)Alberta Innovates Centre for Machine Learning (AICML)AJW Consultants Inc. Alberta Children’s HospitalAlberta Council of Disability Services Alberta Health Services, Clinical TrialsAlberta Innovates Technology FuturesAlta Machining & Mold Design Athabasca UniversityBenK Creative BESTT Alberta Calgary – South Health CampusCanadian Blood ServicesCanadian Joint Task Force 2 Canadian Trade Commissioners Network CBF Systems Centre for Autism Service Alberta Chenomx Inc.Clinexus* Covenant Health Cross Cancer InstituteDanCam Design & DraftingDeltatee Enterprises Ltd.DynaLIFE DxEdmonton School Board FlexCim ServicesGerman-Canadian Centre for Innovation and Research Great Things Inc.Human Services Alberta iCube DevelopmentInternational Intergovernmental Relations Alberta John Simon & Associates

Keystone Labs Mazankowski Alberta Heart InstituteNorthern Alberta Clinical Trial Research Centre (NACTRC)National Institute for Nanotechnology (NINT) novaNAITPierson Adhesive Consulting Q Industrial Design Corp.Quasarsoft Red Deer College, Applied Research & InnovationTEC Edmonton Teleflex Medical CanadaThe Excel SocietyThe Metabolomics Innovation Centre (TMIC)TRTech Tycrid Platform Technologies Inc.University of Alberta – nanoFABUniversity of Alberta – Alberta Centre for Surface Engineering & Science (ACSES)University of Alberta – Biomedical Engineering Research & Results Initiative (BERRI)*University of Alberta – Canadian Biosample Repository (CBSR)University of Alberta – Drug Development & Innovation Centre (DDIC)University of Alberta – Rehabilitation Medicine; NursingUniversity of Alberta – Various Laboratories University of Calgary – Stephenson Cardiovascular MR Centre (Foothills Hospital)University of Calgary – Human Performance Lab (HPL)University of Calgary – Various LaboratoriesUniversity of Calgary – Ward of the 21st Century (W21C)Zymetrix

AlbertaRelationshipNetwork

BioAlberta MPDP enabled companies to form key relationships with several groups and world-class experts to assist with medical technology design, development, validation, manufacturing, and distribution. The following groups in Alberta were involved as partners, service providers or supporters providing critical resources on projects.

Collaborations beyond borders Companies are actively collaborating with several testing and manufacturing facilities, suppliers, vendors, distributors and consultants worldwide in countries including: United States, Australia, Denmark, United Kingdom, Germany, Switzerland, China, Mexico, Dominican Republic, Japan, South Korea and India.

*Organization may have discontinued to exist or undergone name change since its involvement with BioAlberta MPDP participants.

BioAlberta TeamAmanda Stadel, President

Sanah Jowhari, Manager, Medical Product Development Program

Heather Pontikes, Manager, Events and Membership

Judi Bahl, Project Manager

Bev Pederson, Financial & Human Resources Coordinator

Donna Parker, Administrative Coordinator

ConsultantsTravis Colley, Technical Director, Medical Product Development Program

Darren Jakal, Technical Director, Medical Product Development Program

MPDP Review Panel (2010-2013)

Cedric Bisson, Venture Partner, Teralys Capital

Hank Mottl, Peer Reviewer, Alberta Innovation and Advanced Education

Rob Beamish, Director, Supply Chain Support Services, TransCanada

Etienne Lagace, Managing Director, Agile MV

Kip Fyfe , CEO, 4iiii Innovations

Myka Osinchuk, CEO, Alberta Cancer Foundation

Go Social with BioAlberta

LinkedInlinkedin.com/company/bioalberta-alberta-biotechnology-association

Twittertwitter.com/BioAlberta or @BioAlberta

Facebookfacebook.com/BioAlberta

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