American BioMed Receives Order for Its OmniCath Atherectomy
Catheter to Begin Clinical Trials in Japan
Company Signs Additional International Distribution Agreements
THE WOODLANDS, Texas--(BW HealthWire)--April 15, 1998--American BioMed, Inc. (OTC Bulletin Board: ABMI -news), a manufacturer of minimally invasive medical devices for the treatment of cardiovascular disease, today announced that it has received initial orders from Japanese distribution partners K's Projects of San Francisco, CA and Medical Leaders of Tokyo, Japan, for the company's OmniCath(R) Atherectomy Catheter product. This purchase will be used in upcoming clinical trials needed for the products' registration process in Japan. Medical Leaders is currently finalizing the clinical protocols to be used with the Japanese Ministry of Health.
Masayoshi Kokunbun of K's Projects stated, ''We expect to finalize plans with the Ministry within the next month to expedite the completion of clinical trials for American BioMed's OmniCath(R) Atherectomy Catheter product.'' Clinical trials must be completed prior to registration in Japan, which the company anticipates will take approximately six to eight months. The Japanese protocols will be similar to U.S. requirements, and will be overseen by the company's Principal Clinical Investigator, Dr. Samuel S. Ahn of the University of California, Los Angeles.
Medical Leaders has also purchased and is currently registering the company's full-line of 100% silicone balloon catheter product line.
Marshall Kerr, American BioMed's Vice President, Sales and Marketing, added, ''The company expects to see increased international sales activity for the OmniCath(R) later this year as a result of the clinical trials conducted by our Japanese partners. The clinical data collected for the Japanese registration process for the OmniCath(R), combined with the company's continuing U.S. clinical trials, will enhance and support our international sales efforts.''
In addition, Shin Shin Medical Co., Ltd. and Anki Medical have joined American BioMed's expanding international distributor network. Shin Shin Medical of Seoul, Korea has begun the registration process needed for the promotion of American BioMed's 100% silicone-based balloon catheter products in the Korean market. The company has fulfilled initial product orders for the registration process, which is anticipated to take several months, and for upcoming promotional activities with key hospitals throughout Korea. Anki Medical of Ankara, Turkey has also placed initial orders for American BioMed's silicone balloon catheter product line to support their introductory sales efforts throughout the Turkish market.
Steven B. Rash, president and chief executive officer, stated, ''The addition of Shin Shin Medical and Anki Medical to our growing distribution network allows us to broaden our customer base in select, international markets. It is our continued objective to establish additional relationships with specialty healthcare distributors to enhance the exposure of our innovative product technologies in the marketplace.''
American BioMed, Inc. utilizes state-of-the-art technology to develop, manufacture and market minimally invasive medical devices for the treatment of cardiovascular disease. The company's products include: 100% silicone-based catheters, through its Cathlab subsidiary; the Evert-O-Cath(TM), a toposcopic catheter for site-specific drug delivery and fluid removal; the OmniCath(R), an atherectomy catheter designed to remove atherosclerotic plaque from obstructed blood vessels throughout the body; the OmniStent(TM), which uses stent technology for angioplasty and atherectomy procedures; and the OmniFilter, which is used to prevent blood clots from reaching various organs of the body. The company has over twenty-five patents
covering its product portfolio, and the combined worldwide market is estimated at over $10 billion annually. The company received ISO 9001 certification for its manufacturing facility in September 1997.
''Safe Harbor'' Statement under the Private Securities Litigation Reform Act of 1995: The statements which are not historical facts contained in this release are forward looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by the United States Food and Drug Administration (FDA) and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, the results of financing efforts, the effect of the Company's accounting policies, and other risks detailed in the Company's Securities and Exchange Commission filings.
Just thought I would paste the entire text of the release here.
Go ABMI!
Regards, Jeff |
