FYI..
Tri-Point Medical Corporation Files PMA Submission With The FDA for Traumaseal Under Special Expedited Processing
Topical Tissue Cohesive Product Alternative for Surgical Sutures
RALEIGH, N.C., Dec. 23 /PRNewswire/ -- TRI PT MEDCL CP today announced the filing of a premarket approval application (PMA) with the Food and Drug Administration (FDA) for TraumaSeal(TM), a topical tissue cohesive. Tri-Point was informed by the Office of Device Evaluations on December 17, 1996 that its TraumaSeal(TM) premarket approval application (PMA) will receive "expedited processing."
TraumaSeal(TM) is a topical tissue cohesive product used to close wounds caused by skin lacerations and incisions, minimally invasive surgery, and plastic surgery. Nearly 45 million such procedures are
performed annually in the U.S. Currently, the vast majority of these procedures use surgical sutures or staples.
Pivotal clinical trials of TraumaSeal(TM), with patients in ten medical institutions across the country, were completed in October 1996. Participating physicians included those with clinical expertise in procedures such as emergency room wound closure, plastic surgery and orthopedic surgery. The trials compared the effectiveness of TraumaSeal(TM) to that of sutures with respect to the progress of
wound healing; frequency of wound reopening; the presence and extent of infection; the cosmetic outcome and healing time requirements. Biometric Research Institute of Arlington, Virginia, Tri- Point's
regulatory organization, compiled the data and prepared the analysis for the submission of the PMA.
"The completion of our clinical trials and the positive and consistent results we achieved allowed us to submit our PMA ahead of schedule," said Robert Toni, President and Chief Executive Officer of Tri-Point Medical. "We are encouraged and look forward to working with the FDA on its evaluation of TraumaSeal(TM)."
In March 1996, Tri-Point entered into a marketing agreement with Ethicon, Inc., a division of Johnson & Johnson, for the exclusive worldwide marketing and distribution rights to TraumaSeal(TM).
Tri-Point Medical develops, commercializes and manufactures medical tissue cohesive products based on its proprietary cyanoacrylate technology. Tri- Point's nonabsorbable tissue cohesive products may
be used to replace sutures and staples for certain topical wound closure applications, while its absorbable tissue cohesive products can potentially be used as surgical sealants and tissue cohesives for internal wound closure and management. Currently marketed tissue cohesive products include Octyldent(TM), used as an adjunct in the treatment of adult periodontal disease and Nexaband(TM), a line of topical tissue cohesives used in veterinary wound closure and management.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties or other factors not under the Company's control which may cause actual results,
performance or achievements of the Company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not
limited to, those detailed in the Company's periodic filings with the Securities and Exchange Commission.
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