Printer Friendly

AMERICAN BIODYNAMICS ANNOUNCES FDA ACCEPTANCE OF 510(k) NOTICE RELATED TO ITS PROCESSED TISSUE

 AMERICAN BIODYNAMICS ANNOUNCES FDA ACCEPTANCE
 OF 510(k) NOTICE RELATED TO ITS PROCESSED TISSUE
 TAMPA, Fla., April 27 /PRNewswire/ -- American Biodynamics, Inc. (NASDAQ: BDYNF) (ABI) announced today that the U.S. Food and Drug Administration (FDA) has accepted the 510(k) notice related to its processed Tutoplast(R) dura allografts, thus granting marketing clearance. The company has been distributing the product in the U.S. since 1986, but the FDA issued a guidance memorandum in December of 1990 requiring pre-market clearance of processed dura as medical devices under the federal Food, Drug, and Cosmetic Act of 1976. This guidance memorandum required processors of dura mater to submit 510(k) notices to FDA. Acceptance was necessary in order for the company to continue distributing the dura tissue.
 Tutoplast dura collagen tissue is imported from the processor, Pfrimmer-Viggo GmbH of Erlangen, Germany and distributed exclusively by ABI in the U.S. This product accounts for approximately 60 percent of the company's current revenues.
 Processed dura mater is used primarily in neurosurgical procedures such as head and neck trauma, craniotomies and duraplasties.
 Management estimates that over 125,000 of these types of procedures were done in the U.S. in 1991, growing at 9 percent per year and creating an approximate $50 million potential market for the company's processed dura. The company states that demand for Tutoplast dura should increase considerably due to this growth as well as increasing surgeon preference for tissue that has been processed utilizing Pfrimmer-Viggo's patented process. This innovative process subjects the tissue to an organic solvent wash process which incorporates agents that have been shown to inactivate certain viruses, such as HIV (AIDS) and hepatitis.
 Additionally, the company reports that the manufacturers of two synthetic dura substitute products have voluntarily withdrawn their products from the market recently.
 John V. Hargiss, president of ABI stated, "We view these developments as events which will positively impact the company's continued growth. Revenues have been positively impacted resulting in an approximate 30 percent increase in unit sales of procee product nor an official approval by FDA.
 American Biodynamics, Inc. provides high quality specialty surgical products to the neurosurgical, orthopedic, and plastic and reconstructive surgical specialties. The company is chartered in British Columbia, Canada, and has its executive offices in Tampa, Fla.
 -0- 4/27/92
 /CONTACT: John. V. Hargiss or Marti Bruce of American Biodynamics, 813-979-0016/
 (BDYNF) CO: American Biodynamics, Inc. ST: Florida IN: MTC SU:


AW-JJ -- FL016 -- 3119 04/27/92 11:58 EDT
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Apr 27, 1992
Words:413
Previous Article:SNO COUNTRY REPORTS OFFICIAL SKI REPORT FOR APRIL 27, 1992
Next Article:QUAKER FORMS WORLDWIDE GATORADE DIVISION; REALIGNS OTHER DIVISIONS


Related Articles
BIODYNAMICS INTERNATIONAL ANNOUNCES FDA ACCEPTANCE OF 510 (k) NOTICE RELATED TO AUTOTRANSFUSION SYSTEM
BIODYNAMICS INTERNATIONAL ANNOUNCES FDA ACCEPTANCE OF 510(K) NOTICE OF FORGED COBALT CHROME HIP REPLACEMENT SYSTEM
FDA IMPORT ALERT MAY AFFECT CERTAIN TISSUE PROCESSED BY BIODYNAMICS
CLARIFICATION OF NEW FDA RULES TO FACILITATE BIODYNAMICS COMPLIANCE
BIODYNAMICS INTERNATIONAL MAKES ANNOUNCEMENT
BIODYNAMICS ANNOUNCES FDA ACCEPTANCE OF 510(K) NOTICE FOR NUFFIELD TOTAL KNEE SYSTEM
BIODYNAMICS INTERNATIONAL, INC. ANNOUNCES DETENTION ORDER
BIODYNAMICS RESUMES TUTOPLAST(TM) DURA SHIPMENTS IN THE U.S.
Japanese Ministry of Health Bans Use of Human Dura Mater
Biodynamics International And Musculoskeletal Transplant Foundation Sign Dura Mater Recovery Agreement

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters