Health & Fitness
Health and Fitness
Health and Fitness
Fri, May 14, 2010
Thu, May 13, 2010 SensiVida Medical Technologies, Inc. Announces Promising Early Human Clinical Results Using Its Minimally Invasive Allergy Test
HENRIETTA, NY--(Marketwire - May 13, 2010) - SensiVida Medical Technologies (
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 Test" using the same allergens and subjects. Dimension and color of allergic responses produced by SensiVida's test were compared with reactions produced by the Skin Prick Test with the aim of quantifying extent of reaction, test time, and accuracy.
SensiVida's test device was found to
- significantly reduce the area of allergic reactions,
- be painless to the patient,
- significantly reduce time required for the test,
- enable allergic reactions to dissipate rapidly.
Jose Mir, President and CTO of SensiVida, said, "We are very pleased with these results. SensiVida seeks to replace today's painful, inaccurate, and laborious skin allergy test with a pain-free, productive, accurate, digital option. Although these data still represent a statistically small sample, SensiVida is encouraged by its painless test results, diminished reactions and low variability when compared with today's standard test. The company will continue to gather clinical data under WIRB clinical test guidelines as it continues product development efforts and commercialization."
Clinical Test Results: Summary
SensiVida's "non-significant risk" test device was found to reduce the area of allergic reactions by a factor of four or more when compared with today's Skin Prick Test. As a result, only small areas on the subjects' arms were tested and all reactions were accurately monitored using the company's proprietary microsystems and image science technologies. Test-to-test variation for each subject was found to be less than 10% (2-8%), significantly lower than when using the same allergens with the Skin Prick Test (14-18%). Negative control (saline) reactions with the SensiVida test were virtually absent, an indication of negligible trauma inherent in its minimally invasive technology. These early results are promising since test variation often leads to uncertain diagnosis of allergies, and at times may indicate further testing is required.
From the subject's point of view, SensiVida's test was not only totally painless, but test time was significantly shorter due to more efficient patient prep, faster allergic reaction times, and faster data acquisition. SensiVida's test was virtually complete after 10 minutes, at least one third the time required by the Skin Prick Test.
Allergic reactions (tiny bumps) resulting from SensiVida's test dissipated in less than one hour compared with several hours for large reactions produced by the standard test. In one instance involving a highly allergic patient, Skin Prick Test reactions remained visible even after 24 hours. In contrast, SensiVida test reactions dissipated in less than one hour for the same patient.
In addition to these benefits, SensiVida's allergy test automatically creates an Electronic Medical Record that includes patient information, allergy reaction data, and supportive image video files.
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.Sensividamedtech.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 & CTO: 582-230-2723
[ jmir@sensividamedical.com ]
David R. Smith, Chairman of the Board: 585-230-5171
[ drsmith@gmail.com ]
SensiVida Medical Technologies
77 Ridgeland Road, Henrietta, NY 14623
585-413-9080
