SOURCE: SensiVida Medical Technologies, Inc.

SensiVida Medical Technologies, Inc.

August 25, 2010 08:30 ET

SensiVida Medical Technologies, Inc. Announces Collaboration With MDC Associates to Develop Regulatory Plans, Conduct Clinical Studies, and Prepare FDA Submission for Its Allergy Test System

HENRIETTA, NY--(Marketwire - August 25, 2010) -  SensiVida Medical Technologies (PINKSHEETS: SVMT), a developer and provider of minimally invasive diagnostic technologies and devices, announced today that it has contracted with MDC Associates to conduct clinical studies and prepare the 510k submission for SensiVida's allergy test system.

MDC will work closely with SensiVida to define quality systems requirements and direct regulatory aspects for the allergy test system. MDC will interface directly with the FDA on behalf of SensiVida. MDC will prepare the clinical study plans and manage the studies at multiple study sites across the US in addition to preparing the 510k submission for the allergy test system. 

The SensiVida allergy test system will provide Allergists and other medical professionals the ability to rapidly and painlessly test patients for 40 allergens at one time on a small area of the patient's skin. In contrast, today's skin prick test is typically performed on the patient's back or forearms using much greater amounts of allergen, and often produces large, uncomfortable reactions or "wheals" that take many hours to dissipate. The SensiVida allergy test system provides immediate, digital image results after only 10 minutes. The allergic reaction data and images can be saved as part of the patient's electronic medical record, which is expected to greatly improve the physician's ability to diagnose the patients' allergic profile over time.

"We are pleased to announce this critical collaboration with MDC," said Jose Mir, President of SensiVida Medical Technologies. "MDC brings the regulatory expertise and experience we need to bring our allergy test system to a successful product launch."

"The SensiVida product is innovative and represents a significant improvement in current allergy testing protocols in terms of patient care and accuracy of results," said Fran White, President of MDC Associates. "MDC is confident in the product's potential and looks forward to working with the SensiVida team. The regulatory strategy indicates a clear path to timely FDA clearance."

About MDC Associates, LLC

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. MDC also offers call-center services which allow their clients to offer state-of-the-art personalized customer and technical support services to their customers. For more information about MDC, visit www.mdcassoc.com.

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.

Contact Information

  • Company Contacts:
    Jose Mir
    President
    585-214-2407
    Email Contact

    David R. Smith
    Chairman of the Board
    585-230-5171
    Email Contact

    SensiVida Medical Technologies
    150 Lucius Gordon Drive, Suite 110
    West Henrietta, New York 14586

    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