Healthcare Industry News: Patent foramen ovale
News Release - June 18, 2007
NMT Medical's BioSTAR(R) Receives Canadian Regulatory ApprovalCommercial Launch of New Bioabsorbable Technology is Expected Early in the Third Quarter
BOSTON--(HSMN NewsFeed)--NMT Medical, Inc. (Nasdaq: NMTI ) announced today that it has received an HPB (Health Products and Food Branch) medical device license in Canada for its BioSTAR® bioabsorbable septal repair implant technology and Rapid Transport(TM) delivery system. The approval is required in order to commence commercialization in Canada.
NMT's President and Chief Executive Officer John E. Ahern said, "The approval of BioSTAR® in Canada is an important milestone for NMT. This provides us with an opportunity to be the first company to have a commercially available bioabsorbable implant in North America for closure of Patent foramen ovale (PFO) and other septal defects. We currently anticipate initiating a market launch in Canada for BioSTAR® early in the third quarter of 2007."
BioSTAR® is designed to provide biological closure of atrial level defects using the patient's natural healing response and 90 to 95% of the implant is absorbed over time and replaced with healthy native tissue. The clinical data from the prospective multi-center BEST (BioSTAR® Evaluation STudy) trial, published in the October 2006 edition of the peer-reviewed journal Circulation, demonstrated that BioSTAR® provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months.
"This approval further underscores the advanced design and proven effectiveness of BioSTAR®," continued Ahern. "We believe the anticipated launch in Canada of this unique device, drug and biomaterial combination strengthens NMT's competitive advantage and reinforces our technology leadership position in the structural heart repair field. Receiving approval in Canada gives us another reason for increased optimism as we await CE Mark approval for BioSTAR® in Europe. In addition, we previously announced that NMT received conditional approval from the U.S. Food and Drug Administration for inclusion of BioSTAR® in the MIST II PFO/migraine headache trial currently underway in the United States."
BioSTAR® incorporates a purified acellular collagen matrix delivered on the proven STARFlex® alloy framework and uses NMT's latest Rapid Transport(TM) delivery system available. 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 will be offered in three sizes: 23mm, 28mm and 32mm.
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 Medical 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 BEST and MIST II trials, the Company's 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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