Healthcare Industry News: migraine
News Release - July 25, 2007
NMT Medical Announces the Commercial Launch of BioSTAR(R) in Europe and CanadaCompany Expects to Increase Market Share with World's Only Bioabsorbable Septal Repair Implant
BOSTON--(HSMN NewsFeed)--NMT Medical, Inc. (Nasdaq: NMTI ) announced today that it has initiated the commercial launch of the Company's bioabsorbable implant, BioSTAR®, in Europe and Canada. The unique, biomaterial, drug and device combination, which received the CE Mark in Europe and an HPB (Health Products and Food Branch) medical device license in Canada in June, has recently been implanted in several patients in both regions.
"We believe the launch of BioSTAR® is an important milestone for NMT, the medical community and its patients," said NMT President and Chief Executive Officer John E. Ahern. "BioSTAR® is the first in a new generation of biological implant devices that NMT is developing for treatment of septal heart defects such as patent foramen ovale (PFO) and other atrial level defects. Based on market research, there is a potential for more than 250,000 annual procedures in Europe and Canada for the stroke and transient ischemic attack (TIA) indications. As a recognized technology innovator with the first and only bioabsorbale implant available for commercial use, NMT is well-positioned to secure the market leadership position. It is anticipated that BioSTAR® will be widely adopted and considered the implant of choice by cardiologists for patients in need of treatment for septal heart defects. As has been previously reported, we have made increased investments in our sales and marketing efforts in preparation for this launch."
BioSTAR® is designed to provide biological closure of atrial level defects using the patient's natural healing response, and 90 to 95 percent of the implant is expected to be absorbed over time. The device incorporates a purified collagen matrix delivered on the proven STARFlex® alloy framework and uses NMT's latest Rapid Transport(TM) delivery system. The collagen used in BioSTAR® also is a platform for timed release of biological response modifiers (genes, cells, proteins and drugs). An elutable heparin substrate has been included in the BioSTAR® design and provides a means to minimize the thrombus formation that occasionally occurs in all intra-cardiac devices. The average procedure time to close a septal defect with BioSTAR® is approximately 40 minutes. The BioSTAR® bioabsorbable septal repair implant is offered in three sizes: 23mm, 28mm and 33mm.
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right to left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as migraine headaches, embolic stroke and transient ischemic attacks (TIAs). A common right to left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 24,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, those who experience aura and have a PFO may represent a three million patient subset. Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and an additional 500,000 Americans experience a TIA.
For more information about NMT Medical, please visit www.nmtmedical.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements - including statements regarding the Company's financial and sales expectations, expansion of the Company's cardiovascular business and market opportunities, its BioSTAR® program, regulatory approvals for the Company's products in the United States, Europe and elsewhere abroad, including CE Mark approval, and the Company's investment in product development - involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company's ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2006, Quarterly Report on Form 10-Q for the period ended March 31, 2007 and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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