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Blood Test to Specifically Diagnose ALS

 

Rednova NEWS | Power3 Medical Submits Pre-IDE Application to FDA for NuroPro(TM) Blood Test to Specifically Diagnose Lou Gehrig's Disease (ALS)

THE WOODLANDS, Texas, Aug. 17 /PRNewswire-FirstCall/ -- Power3 Medical Products, Inc. (Pink Sheets: PWRM) has submitted its second pre-IDE (Investigational Device Exemption) application with the Division of Hematology of the U.S. Food and Drug Administration for the Company's NuroPro(TM) Blood Tests for the early detection and differentiation of the neurodegenerative disease, ALS from the ALS-like disorders that have similar symptoms but different treatments and prognoses. The basis for submission is the analysis of blood serum from over 600 patients.

Power3 submitted the pre-IDE documentation to the FDA in order to obtain the Agency's guidance regarding: the appropriate regulatory pathway to pursue; the proper approach to refine and/or define its data and statistical analyses; and the study design for the Company's pending diagnostic tests in support of these blood tests. A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. The Pre-IDE process is designed to help companies obtain early, informal input on aspects of a future IDE application and offers assistance in establishing the parameters for official IDE applications when unique diagnostic tests involving innovative technologies are being pursued.

This test represents the Company's second in a series of NuroPro(TM), blood-based diagnostic tests for neuromuscular and neurodegenerative disorders. The test involves monitoring the concentration of a panel of proteins in blood serum followed by a discriminant biostatistical analysis of the proteins ("biomarkers"), to distinguish between subjects with ALS and those with other neurological disorders (ALS-like) having clinical symptoms resembling them.

"There is a pronounced need for reliable and definitive diagnostic blood tests for the early detection of neurodegenerative diseases," said Steven Rash, Chairman and Chief Executive Officer. "We believe our NuroPro(TM) blood tests will provide the means for early detection by allowing clinicians to more rapidly discriminate between patients with specific neurodegenerative diseases and disease-like disorders. Ultimately, with early diagnosis the physician will be able to design therapeutic treatments and interventions that are the most effective for the neurological disease classification of the patient."

According to Dr. Stan Appel, renowned opinion leader on ALS and chairman of Power3's scientific advisory board, "an ALS biomarker that is reliable and sensitive may offer the opportunity for earlier intervention. What initiates ALS may not be the same as what sustains and exacerbates disease, and therapies that do not work late in the disease may work at earlier stages. Furthermore, biomarkers that track progression may provide objective ways to monitor how well therapies are working."

The pre-IDE process is essentially a "pre-submission" process that may involve sending analytical or clinical protocols to the FDA for review and comment before proceeding with studies. The process may also involve a meeting with the FDA to discuss protocols and/or possible regulatory pathways. Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the Agency or the Sponsor.

About Power3 Medical Products

Power3 Medical Products, http://www.power3medical.com/, is a leading proteomics company engaged in the discovery of protein footprints, pathways, and mechanisms of diseases. The Company's patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and treatment of disease. The Company's identified protein biomarkers, drug targets, and diagnostic tests are targeted toward markets with critical unmet needs in areas such as breast cancer and neurodegenerative disease. The Company operates a state-of-the-art proteomics laboratory in The Woodlands, Texas.

This press release contains "forward-looking" statements, including statements related to the commercial development of Power3's products and associated development activities. The Company provides no assurances that it will submit an IDE application or that any IDE application will be approved by the FDA. Any statements in this press release, which are not statements of historical fact, may be deemed to be forward-looking statements. Words such as "will," "expects," "anticipates," "plans," and similar expressions are intended to identify these forward-looking statements. There are a number of important factors and uncertainties that could cause results to differ materially from those indicated by these forward-looking statements, including risks inherent in research and development activities; the ability to raise sufficient capital and obtain financing for the development activities; uncertainties associated with regulatory approvals; as well as other risks detailed from time to time in Power3's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2003, and its reports on Form 10-QSB and Form 8-K. Power3 assumes no obligation to update forward-looking statements as a result of new information, future events or otherwise.

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