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Biotech / Medical : OTC:BB- JRSE -- Ignore unavailable to you. Want to Upgrade?

To: T A P who wrote (62)	3/15/1999 12:18:00 PM
From: T A P	Read Replies (1) \| Respond to of 72

JRSE NEWS !!! Stock doing very well! Jacobson Resonance Enterprises, Inc. Receives Non-Significant Risk Status From FDA for Osteoarthritis Pain of the Knee BOCA RATON, Fla.--(BW HealthWire)--March 15, 1999--Jacobson Resonance Enterprises, Inc. (OTC BB:JRSE) announced today that the Food and Drug Administration (FDA) has reviewed the submission requesting determination of significant risk (SR) versus non-significant risk (NSR) for the Jacobson Resonator device in the treatment of knee osteoarthritis. T A P has received 50K shares of JRSE from LBI Group Inc. for services provided for a period of 6 months For a complete write-up on JRSE and other Turn Around Picks go to T A P profile and click Favorite Link. The FDA has determined that the proposed clinical investigation is non-significant risk (NSR) because it does not meet the definition of a SR device under 812.3 (m) of the investigational device exemptions (IDE) regulation (21CFR812). Jacobson Resonance Enterprises had already received FDA Registration No. 9032098, FDA device No. B-017814, and now has received NSR under p1DE514. This determination is valid for said indication specifically. The FDA said that while additional indications may be NSR, it is possible that an indication may prove to be SR. Therefore, the FDA requires that prior to initiating other studies, a determination should be requested from the FDA. In the March 11, 1999 meeting with FDA representatives, Jacobson Resonance Enterprises, Inc., outlined the various studies both planned and underway with IRB approvals. The expressed intention is to submit proposals to the FDA concerning determinations of SR or NSR for diverse studies proposed by researchers at Cornell Medical College, The University of Oklahoma, Duke University and Mississippi State University. Dr. Jerry Jacobson, Chairman and CEO said, "Clinical proposals include a speech pathology (stroke) study at Duke, migraine and pre-menstrual pain studies at Cornell, cardiac pacing studies at Oklahoma and sports medicine and healing studies at Mississippi State." Dr. Jacobson added, "FDA representatives really surprised me. The level of professionalism, genuine caring for public health, sharing of experience, and kindness in guidance were heartwarming. The truth is our government leaders do care about the fabric of society and decency.' For additional information contact: Frank A Chaviano at Jacobson Resonance Enterprises, Inc., Investor Relations Department, 561/477-8020. Forward-looking statements in this release are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties detailed in filings made by the company to the Securities and Exchange Commission. CONTACT: Jacobson Resonance Enterprises, Inc., Boca Raton Investor Relations Department Frank Chaviano, 561/477-8020