NMT Medical Initiates Patient Enrollment in Migraine Headache Study, Expects Earlier Completion Company to Discuss Clinical Study Update on 10:30 AM (ET) Conference Call Today; Announces Preliminary 2004 Results in Line With Expectations BOSTON, Mass., Jan. 7 /PRNewswire-FirstCall/ -- NMT Medical, Inc. (NASDAQ:NMTI), a leader in designing, developing and marketing minimally invasive solutions for the treatment of cardiac sources of migraine headaches, stroke and other potential brain attacks, announced today that the Company has initiated patient enrollment in its MIST (Migraine Intervention with STARFlex(R) Technology) clinical study in Europe. The study is designed to evaluate the effectiveness of NMT's proprietary STARFlex(R) implant technology in the treatment of certain migraine headaches. John E. Ahern, NMT's President and Chief Executive Officer, said, "The initiation of our MIST trial is a landmark event for NMT as we expand our PFO (patent foramen ovale) closure focus beyond stroke to other brain attacks. We believe that PFO closure for migraine represents a substantial and more immediate revenue growth opportunity for NMT as compared to stroke." Ahern continued, "Patient recruitment for MIST has progressed more quickly than originally anticipated, so we now expect to complete enrollment in the third quarter of 2005, one quarter ahead of our initial year-end target." Near-Term Milestones: NMT has outlined the following objectives for its migraine program: * Complete MIST patient enrollment in Q3 2005; * Strengthen European sales organization to pursue migraine opportunity in second half of 2005; * Meet with the FDA in Q1 2005 regarding design of a U.S. migraine study; and * Commence U.S. migraine study in the second half of 2005. As previously announced in November 2004, NMT received approval in the United Kingdom for the MIST study. MIST is a double-blinded study randomizing migraine patients with a PFO to either PFO closure with the STARFlex(R) implant or a control arm. Study patients will be followed for six months. MIST is the first prospective, randomized, controlled study to evaluate the potential relationship between PFO, a common structural heart defect, and certain migraine headaches. A PFO allows venous blood, unfiltered by the lungs, to shunt, or flow, into the arterial circulation of the brain. This unfiltered venous blood may contain elements that possibly trigger migraine headaches or other brain attacks in some patients. NMT's STARFlex(R) septal repair technology closes the PFO in a minimally invasive procedure. More than 15,000 PFOs have been closed globally with NMT's implant technology. MIST is a multi-center study involving approximately 15 centers, with an expected enrollment of fewer than 200 patients. The study was designed by a scientific advisory board comprised of some of the top European and North American migraine specialists and cardiologists. The MIST study's patient recruitment process is supported by the Migraine Action Association (MAA), a migraine headache advocacy group representing more than 14,000 members in the United Kingdom. Ann Turner, director of the MAA, said, "Patient interest level in NMT's MIST study has been extremely high and further underscores our observation that a large number of migraine headache sufferers are not satisfied with current treatment options and are willing to seek alternatives." Dr. Andrew J. Dowson, Director of the Kings Headache Service, Kings College Hospital, London, and co-primary investigator for MIST, stated, "There are several classes of pharmaceutical agents available to patients. All have side effects and all work with varying degrees of success. Although much progress has been made in the past 15 years with rescue medications, less progress has been made with preventative medications. Many patients continue to live severely disrupted lives in which these attacks impair their ability to work or even function despite the use of medication." Dowson continued, "NMT's MIST study is designed to determine whether PFO closure offers these patients an alternative to lifelong medical therapy. Ideally, the study will establish that PFO closure not only helps reduce the frequency and severity of migraine attacks, but has the potential to eliminate some migraines completely for some people. The headache specialist community is watching the MIST study with great interest." "We believe that our initial target patient population for PFO closure with our technology would be 5% of all migraine sufferers," says Ahern. This is based on statistics from the World Health Organization and the American Council for Headache Evaluation, which indicate the prevalence of migraines in the United States, Europe and Japan is about 10% of the general population. Also, published medical research indicates that approximately 20% of migraine sufferers have migraine with aura, often referred to as the classic migraine, and that up to 50% of those suffering from migraine with aura are unresponsive to current medications. Within that patient subset, the prevalence of PFO is 50%, or twice what would be expected in a normal population according to Anzola et al in the May 1999 issue of Neurology. Ahern concluded, "If the MIST trial is successful in demonstrating that PFO closure with STARFlex(R) shuts down a process that may be triggering or contributing to certain migraine attacks, it would represent a potential breakthrough treatment for patients currently not responding to other therapies. It also would provide NMT with a very promising opportunity that we could aggressively pursue in the near-term. Based on our current implant selling price and the 5% initial target population, which represents 3.8 million migraine sufferers, we estimate this opportunity to be in excess of $15 billion." NMT has designed a website specifically relating to its MIST study. It can be accessed at http://www.migraine-mist.org/ or through NMT's website at http://www.nmtmedical.com/. Preliminary 2004 Results: NMT also announced today that the Company expects its results for the full year to be in line with the guidance the Company provided in its third-quarter news release. The Company announced on November 10, 2004 that it expected total revenues of greater than $21 million for 2004, a decrease of approximately 6% compared to 2003, and worldwide cardiac septal repair implant sales for the full year 2004 to decrease by approximately 20-25% compared to 2003. The Company currently expects to end 2004 with approximately $35 million in cash, cash equivalents and marketable securities, ahead of its previous guidance of $32 million. Conference Call Information: Management will conduct a conference call at 10:30 a.m. (ET) today to discuss the MIST trial. The conference call will be broadcast live over the Internet. Individuals who are interested in listening to the webcast should log onto the "Investor Relations" section of NMT Medical's website at http://www.nmtmedical.com/. The conference call also may be accessed by dialing (913) 981-5509 or (800) 289-0730 prior to the start of the call. For interested individuals unable to join the live conference call, a replay will be available through midnight (ET) on January 14, and may be accessed by dialing (719) 457-0820 or (888) 203-1112 (Passcode: 130694) or by visiting the Company's website. About NMT Medical, Inc. NMT Medical designs, develops and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter-based procedures. NMT Medical is investigating the potential connection between a common cardiac defect called a patent foramen ovale (PFO) and brain attacks such as stroke, transient ischemic attacks (TIAs) and migraine headaches. A PFO can allow venous blood, unfiltered by the lungs, to enter the arterial circulation of the brain possibly triggering a cerebral event or brain attack. NMT is a leader in designing and developing implants to seal the PFO defect in a minimally invasive, catheter-based procedure performed by the interventional cardiologist. 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 500,000 Americans experience a TIA. The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, three out of four are women. The Company also serves the pediatric interventional cardiologist with a broad range of cardiac septal repair implants delivered with nonsurgical catheter techniques. For more information about NMT Medical, please visit http://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 timing and outcome of the Company's MIST trial, expected patient enrollment levels and timing thereof, the achievement of its near-term milestones, anticipated migraine market opportunity, the Company's financial, sales, profitability and liquidity expectations, and expansion of the Company's cardiovascular business and market opportunities, including migraines and any other new applications for our technology or products -- involve known and unknown risks, uncertainties or other factors which 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 "Certain Factors That May Affect Future Results" included in Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's Annual Report on Form 10-K for the year ended December 31, 2003, as amended, Quarterly Report on Form 10-Q for the period ended September 30, 2004, and subsequent filings with the U.S. Securities and Exchange Commission. Contact: John E. Ahern President and Chief Executive Officer NMT Medical, Inc. (617) 737-0930 DATASOURCE: NMT Medical, Inc. CONTACT: John E. Ahern, President and Chief Executive Officer of NMT Medical, Inc., +1-617-737-0930, Web site: http://www.nmtmedical.com/ http://www.migraine-mist.org/

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