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MicroSense International, LLC Announces Approval for Phase II Clinical Evaluations of Innovative Glucose Measurement
Technology - Pushita(TM)
MicroSense International, LLC Announces Approval for Phase II Clinical Evaluations of Innovative Glucose Measurement
Technology - Pushita(TM)
The Diabetes & Glandular Disease Clinic in San Antonio, Texas, to Conduct Phase II Clinical Evaluations of Pushita(TM)
ST. LOUIS, Jan. 14 /PRNewswire/ -- MicroSense International, LLC ( www.micro-sense.com ), a development stage privately funded medical device company
today announced that the Diabetes & Glandular Disease Clinic in San Antonio, Texas ( www.dgdclinic.com ), received Institutional Review Board ("IRB") approval
to conduct Phase II clinical evaluations of the Pushita(TM) glucose measurement technology in both Type I and Type II diabetic patients.
ST. LOUIS, Jan. 14 /PRNewswire/ -- MicroSense International, LLC ( www.micro-sense.com ), a development stage privately funded medical device company
today announced that the Diabetes & Glandular Disease Clinic in San Antonio, Texas ( www.dgdclinic.com ), received Institutional Review Board ("IRB") approval
to conduct Phase II clinical evaluations of the Pushita(TM) glucose measurement technology in both Type I and Type II diabetic patients.
William Edelman, Chairman & CEO for MicroSense commented, "We are thrilled to collaborate with the Diabetes & Glandular Disease Clinic, and Dr. Sherwyn L.
Schwartz, Endocrinologist, who leads this outstanding center and will act as the Principal Investigator for the Phase II clinical evaluations for Pushita(TM). This
center, in collaboration with several other world-class institutions will participate in a multi-center national clinical trial of Pushita(TM), leading to a submission to the
Food and Drug Administration later in 2003, as a prelude to commercialization of this revolutionary technology."
Dr. Schwartz commented, "We are excited to be part of the multi-center evaluations for Pushita(TM). The proposition of painless and bloodless glucose monitoring
for diabetics would change the paradigm of glucose monitoring, increasing compliance and lowering long-term complications of this devastating chronic disease."
Dr. Schwartz continued, "We look forward to the clinical evaluations and participation in the national trial for Pushita(TM)."
Mr. Edelman continued, "MicroSense is committed to bringing the Pushita(TM) micro-invasive glucose measurement system to market. The Pushita(TM) system is
both bloodless and painless, and has successfully concluded a Phase I clinical evaluation during 2002 in Type I and Type II diabetic patients for the measurement
of glucose levels, critical for the management of diabetes. The device consists of a single -use disposable opto/enzyme probe and a multi-use meter. The device
measures glucose levels in the interstitial space. Glucose data measured by Pushita(TM) in the Phase I clinical evaluation compared favorably to multiple control
measurements taken by commercially available glucose meters."
Current glucose detection technology requires blood samples in order to determine the concentration of glucose. Pushita(TM) measurements are painless and do
not require the lancing of the finger, a painful procedure required by patients to provide a blood sample for measurement. By measuring the interstitial fluid at the
forefinger, Pushita(TM) is intended to address reported glucose measurement deficiencies in currently available blood glucose meters, which rely on
measurements from sites other than the forefinger ("alternate sites").
William Edelman, Chairman and CEO for MicroSense, stated, "Each step we take helps to further demonstrate the value of this technology and enable us to
differentiate Pushita(TM) from existing glucose devices. Our main advantages address the universal issues faced by diabetics today, namely blood required for
glucose measurement and pain associated with the repeated ritual of sampling glucose levels. By offering an effective blood-free and painless alternative to blood
glucose systems, we hope to create a value proposition highly regarded by the financial markets, and the consumer population."
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK.), over 15.7 million people, 5.9 percent of the population has diabetes.
Of that number, 10.3 million people have had a diagnosis of either Type 1 or Type 2 diabetes, and 5.4 million people are undiagnosed. There are over 798,000
new cases diagnosed annually. The total domestic cost of diabetes (both direct and indirect) exceeds $100 billion annually, attributed to disability, work loss, and
premature mortality.
About MicroSense International, LLC
Founded in 1997, MicroSense International, LLC, is a development stage, privately funded medical device company developing painless and bloodless techniques
for the measurement of important biological markers for the management of chronic diseases. The company has development facilities in St. Louis, MO, and
offices in Boston, MA.
Pushita(TM) measures biological markers present in the interstitial fluid (ISF). MicroSense has targeted several large chronic disease populations requiring
constant spot monitoring, including diabetes, congestive heart failure (CHF), and kidney disease.
Statements in this news release looking forward in time are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that forward-looking statements involve risks and uncertainties, including general economic conditions, delays and risks associated with
the performance of contracts, uncertainties as a result of research and development, potential acquisitions, consumer and industry acceptance, litigation and/or
court proceedings, and regulatory risks including approval of pending and/or contemplated 510(k) and PMA filings.
About the Diabetes & Glandular Disease Clinic
Founded in 1979, the Diabetes & Glandular Disease Clinic in San Antonio, Texas is the largest privately-owned endocrinology practice in the United States.
Housed in a thirty thousand square foot facility, the clinic has a staff of seven adult endocrinologists, one pediatric endocrinologist and five nurse practitioners with
advanced diabetes care certification who see over 3,400 fee-for -service patients per month. Their treatment of diabetic and obese patients is complemented by the
clinic's ADA recognized education program. A CLIA approved, in-house, high complexity lab and a state of the art electronic medial record system further assist
the clinicians in their work along with a staff of 87 people.
A separate staff of over 100 people, including 27 research coordinators, is employed to conduct phase I - IV clinical trials in the field of endocrinology and has
successfully completed over 700 trials of both medications and devices. Phase I trials are conducted in a separate, 32,500 square foot facility which can house as
many as 80 subjects at a time and also has the capabilities of performing diabetic clamp studies. Additionally, the clinic has another research facility on the westside of San Antonio where metabolic syndrome is highly prevalent
SOURCE MicroSense International, LLC
/CONTACT: William Edelman, Chairman & CEO of MicroSense International,
LLC, +1-314-615-6969, fax, +1-314-615-6324, wedelman@micro-sense.com , or
Richard Pyburn, Administrator, Diabetes & Glandular Disease Clinic of San
Antonio, P.A., +1-210-615-5503, fax, +1-210-615-5596, rpyburn@dgdclinic.com /
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