HENRIETTA, NY--(Marketwire - October 26, 2010) -
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SensiVida Medical Technologies Inc., (PINKSHEETS: SVMT), a developer and provider of minimally invasive diagnostic technologies and devices, announced today that it has published on its website a Letter to Shareholders sent on September 22, 2010. The Letter summarizes important recent advances in the Company’s product development, business strategy, fund raising, and an expanded management team.
The full Letter to Shareholders follows and is available at www.sensividamedical.com.
September 22, 2010
Dear Shareholders:
It is a great pleasure to let you know about the progress of our Company since the start of this fiscal year (beginning March 1, 2010). SensiVida is on its way to becoming a leading provider of minimally invasive diagnostic systems that address multi-billion-dollar medical markets having unmet needs. Let me summarize what we have achieved in the past few months, then provide you with the details and discuss our plans for future growth.
Summary of 2010 accomplishments thus far:
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Focused on rapidly commercializing the Allergy Test product based on our revolutionary MEMS diagnostics platform.
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Raised money from an offering of a Series A preferred stock.
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Filed three new patents for our two lead products.
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Successfully completed the first human clinical studies for the Allergy Test System.
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Formed partnerships with key industry and academic leaders who can help us finalize the product development, speedily obtain regulatory approval, advance manufacturing capabilities, and bring our products to market in the most efficient timeframe.
Current diagnostic methods for many medical conditions are invasive, traumatic, labor intensive, expensive and often inaccurate. SensiVida is commercializing Optical Micro Electro Mechanical Systems (MEMS) technology to provide less invasive diagnostic devices, with substantially improved productivity, cost and accuracy.
Our revolutionary MEMS technology is extendable to multiple applications, each serving large, lucrative medical markets. Currently we are focused on rapidly commercializing two products:
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The initial priority is to commercialize the SensiVida Allergy Testing System -- a highly accurate, rapid, 3X productive, pain-free allergy test system addressing a $1.5 billion U.S. market growing at a compounded rate of 7%.
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The second product, based on the same MEMS technology, is the SensiVida Glucose Monitor, a pain-free automated portable glucose monitor for diabetics. Currently under development, it addresses a U.S. market of $10 billion for hospital and home use, growing at a compounded rate of 7%.
Our strategy is to rapidly commercialize our lead product, the Allergy Test System, and in doing so develop related MEMS and Image Processing Technology to demonstrate a novel painless, automated, accurate glucose monitor. We plan to significantly expand our present intellectual property portfolio, which currently consists of 8 patents pending in the areas of pain-free allergy testing and automated glucose monitoring. Our goal is to position our products as real-time, less invasive, modern alternatives to traditional diagnostic methods.
We are working with a number of experts and key opinion leaders in the areas of clinical studies and reimbursement to advance the development of our products. The objectives of these studies are to determine efficacy, clinical sensitivity and clinical specificity for the various diagnostic methods to support the development of our products and regulatory approvals from the U.S. Food and Drug Administration (the “FDA”).
We anticipate that the primary source of the Company’s revenue will be through the sale of disposable products (the razor-razorblade business model). Micro fabrication leads to low-cost consumables. In some product families, we expect to provide hardware and software free of charge to accelerate product adoption.
Recent Funding Accelerates Product Development and Commercialization
During March 2010, the Company began an offering of a maximum of $10,000,000 of Series A Preferred stock at $1.00 per share. After raising the first $1.5 million, management accelerated internal product development and commercialization activities with partners such as:
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Wi Inc., an award-winning medical device contract design and development company recognized for rapidly and successfully bringing products and disposables from concept to production. Wi’s significant expertise in the development of disposable and microfluidic devices provides critical resources to accelerate commercialization of our novel allergy test system.
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Dhurjaty Electronics Consulting LLC, a research and development firm with 35 years of experience in designing and documenting medical electronics and systems in conformance to FDA regulations. Dhurjaty provides additional support in the fields of hardware, software, regulatory and packaging.
Allergy Test System Receives Successful First Human Clinical Results
In May 2010, we announced the Company’s first human clinical results for our SensiVida Allergy Test System as cleared by the Western Institutional Review Board (WIRB) of Olympia, Washington. Under the supervision of clinical and research staff at the Allergy, Asthma, Immunology of Rochester (AAIR) Research Center, SensiVida’s test was benchmarked against the well-known “Skin Prick Text” using the same allergens and subjects. The SensiVida device was found to reduce the area of allergic reactions by a factor of 4 or more, be totally painless to the patient, reduce time required for the test to one-third of the standard test, and enable allergic reactions to dissipate rapidly following the test. In addition, SensiVida’s allergy test automatically creates an Electronic Medical Record that includes patient information, allergy reaction data and supportive image video files.
Development of Disposable Allergen Delivery Component
In May 2010, we entered a Design and Development Agreement with Wi Inc. to provide the design and prototype development of the disposable allergen delivery component for our Allergy Test system and accelerate commercialization. The disposable allergen “cartridge” will enable allergists and other medical professionals to rapidly test patients using up to 40 allergens on small areas of the patient’s skin. Clinical results from May show that our disposable allergen cartridge and digital sensing module is totally painless, less invasive, faster and more accurate than today’s skin prick test.
Development of Regulatory Plans
In May 2010, we contracted with MDC Associates to develop regulatory plans, conduct clinical studies and prepare the FDA 510k Submission for SensiVida’s Allergy Test System. In addition, MDC will prepare the clinical study plans, interact closely with all aspects of product development and production, and manage the studies at multiple sites across the U.S.
MDC Associates was established in 1989 and has worked with diagnostic and medical device manufacturers large and small to aggressively achieve FDA clearance for their products. MDC works as a partner with its clients, interacting closely with all aspects of product development helping to bring products to market while adhering to the regulatory requirements established by FDA. MDC develops and helps to monitor effective quality systems required for cGMP companies while efficiently implementing regulatory strategies during product development and production.
Glucose Monitor Development Advances with Grant from Cornell Program
Leveraging the same optical microneedle and image processing technologies as the allergy test, SensiVida’s Glucose Monitor, currently under development, has multiple, individually addressable sensors that are activated in accordance with the patient’s test schedule. Currently there are 18 million diabetics in the U.S. and 144 million worldwide. The current “standard of care” is the antiquated fingerprick text, which is invasive and often leads to noncompliance. The SensiVida Glucose Monitor is designed as an unobtrusive, wearable monitor that serves both Type I and Type II diabetics, automatically measuring the glucose level without bio-fouling, clogging or daily calibration, issues commonly experienced with other continuous glucose monitors. Test results are digital, quantitative and compatible with electronic records.
In September 2010, SensiVida Medical Technologies was awarded JumpStart program funding from the Cornell Center for Materials Research (CCMR) to advance the development of the Glucose Monitor. JumpStart projects, supported by grants from the New York State Foundation for Science, Technology and Innovation (NYSTAR), enable businesses to work collaboratively with faculty on fundamental aspects of emerging technologies in the area of materials science. The CCMR program chooses projects with the greatest potential for creating a mutually beneficial, long-term relationship with Cornell University.
Collaborating with SensiVida is Antje Baeumner, Cornell Professor of Biological and Environmental Engineering, a renowned researcher in the area of biosensors and nanotechnology. Professor Baeumner and SensiVida research scientists will seek to develop further understanding of material stability and reproducibility to help guide selection of the most reliable chemical sensing system for their innovative glucose biomedical monitor. This is expected to be the beginning of a long-term research relationship between SensiVida and the Baeumner Biosensors and Bioanalytical Microsystem Laboratory.
Outstanding Management Team Expands
The progress SensiVida Medical Technologies has made in the diagnostics arena is a direct result of the management team we have assembled. We are fortunate to be in the Rochester, NY area, home of the University of Rochester, Eastman Kodak, Bausch & Lomb, Xerox, and in close proximity to Cornell University and Corning. Our team consists of veterans of these companies and from the University of Rochester and Cornell and they have authored more than 270 patents and have commercialized several new-to-the-world, multi billion dollar products.
Recently, we added two new officers: Margy Lydon, Chief Operating Officer, and John Spoonhower, PhD, Chief Technology Officer.
Margy Lydon has over 20 years experience in general management and product development in the medical device field. She has specific expertise in the development and commercialization of polymer coated and drug-eluting medical devices. As one of the founding researchers at STS Biopolymers, Ms. Lydon developed several polymer-coating formulations that were successfully licensed to device manufacturers.
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20+ years in the medical device industry managing new product development and operations
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Deeply involved with technology innovation during her career having been granted several patents in the field of medical device coatings.
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General Manager of Angiotech BioCoatings Corp.
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Vice President of Operations and Product Development of STS Biopolymers, Inc.
Dr. John Spoonhower, PhD is the Chief Technology Officer at SensiVida Medical Technologies, Inc. His former positions include, President of Opinnovate, a management consulting firm with expertise in Open Innovation best practices and technical strategy development as well as Chief Technologist for the System Concepts Center, a new business development initiative in the Eastman Kodak Company. A two-time CTO Patent Award winner from the Eastman Kodak Company, he is a member of numerous Advisory Boards for the National Science Foundation and New York State (NYSTAR)-supported research centers.
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Ph.D (Cornell) in Applied and Engineering Physics.
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Creator of several multi-million dollar business enterprises at Kodak.
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Helped create the Kauffman Foundation-sponsored Innovation Interface -- a multi university project to investigate new business at Cornell and MIT.
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56 patents and several pending.
To learn more about these and other members of our management team, please visit our new website at www.SensiVidamedical.com. There you will also find detailed up-to-date information regarding the Company’s products and technology and business strategy.
Strategic Outlook
We are extremely pleased with the efficient progress we have made in the last few months. Our products are receiving enthusiastic support from important industry and academic leaders and institutions. We expect to bring our Allergy Testing System to market within the next 16 months, and to demonstrate a highly accurate painless Glucose Monitor within the same time frame.
SensiVida’s business strategy is based on a phased product family plan that accelerates time-to-revenue and extends the company’s technology platform across several large markets. We intend to apply our revolutionary MEMS diagnostics platform to numerous multi-billion-dollar medical markets. As we bring our first products to market and begin to generate revenue and a strong investor base, we will be in an excellent position to extend our technology into new targeted areas such as blood coagulation, tuberculosis testing, cholesterol measurement, and potentially the detection of infectious diseases such as malaria in third world countries.
We are grateful to you, our shareholders, for recognizing and supporting the potential of the Company’s talented management team, competencies and vision. We look forward to sharing with you our anticipated financial growth.
Sincerely yours,
Jose Mir
President
SensiVida Medical Technologies
About SensiVida Medical Technologies, Inc.
SensiVida is a developer and provider of minimally invasive diagnostic devices with proprietary, microsystems-based technology that automates bio-sensing and data acquisition while minimizing patient discomfort. The Company’s optical-digital platform technology addresses a number of multi-billion dollar market opportunities: allergy testing, pain-free automated glucose monitors, blood coagulation testing, TB testing, cholesterol monitoring, and more.
SensiVida has an exclusive worldwide license to nine pending patents. In addition to the SensiVida allergy test, the product pipeline, based on the same microsystem and image processing technology, includes a portable glucose monitor. This device consists of a patch or chip having multiple, individually addressable sensors that are activated in accordance with the patient’s test schedule, automatically recording the patient’s glucose level without pain, bio-fouling or clogging. For more information about SensiVida, please visit www.sensividamedical.com.
Forward-Looking Statements:
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the availability of financing; the company’s ability to implement its long range business plan for various applications of its technology; the company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the company’s reports filed with the Securities and Exchange Commission. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Quarterly Report on Form 10Q and related 8-K filings.
Company Contacts:
Jose Mir
President
585-214-2407
Email Contact
David R. Smith
Chairman of the Board
585-230-5171
Email Contact
INVESTOR CONTACT
Stanley Wunderlich
Consulting For Strategic Growth 1, Ltd.
880 Third Ave, 6th Floor
New York NY 10022
Telephone: (800) 625-2236 ext. 7770
Fax: (646) 205-7771
Email: Email Contact