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NMT Medical Provides Preliminary Year End Financial Results and Clinical Trial Update

^{Published on 2009-01-13 05:35:03, Last Modified on 2009-01-13 05:36:51 - Market Wire}
 

BOSTON--([ BUSINESS WIRE ])--[ NMT Medical, Inc. ] (NASDAQ: NMTI) today announced that it is providing preliminary fourth-quarter and year-end financial results and updates to its clinical trial plans in 2009.

NMT currently expects to report revenues of approximately $4.4 million for the fourth quarter of 2008 and revenues of approximately $18 million for the full year 2008. At December 31, 2008, NMT had more than $17 million in cash, cash equivalents and marketable securities.

As part of its ongoing review of the business, NMT implemented a series of cost reduction initiatives, including reducing headcount throughout the organization, reprioritizing its internal programs and restructuring various departments. These changes and adjustments also include both executive management and Board of Director compensation and stipend reductions.

"Given the current economic climate and the importance of our capital resources, we determined that it was prudent for us to reduce our expense levels," said NMT Medical President and Chief Executive Officer John E. Ahern. "We remain confident that we have sufficient resources to complete our landmark [ CLOSURE I ] trial and bring the [ STARFlex ]® implant to the commercial market in the United States, pending U.S. Food and Drug Administration (FDA) approval."

Executive Vice President and Chief Financial Officer Richard E. Davis said, "As we have indicated in the past, while we do not anticipate a fundraising effort in the near-term, we continue to evaluate alternative financing options should the Company choose to increase its liquidity in the future. Looking ahead, we expect our burn rate will decrease significantly in 2009 given the completion of our clinical trial enrollment work and the actions we have recently taken to reduce costs. With that in mind, we expect cash, cash equivalents and marketable securities at December 31, 2009 to be in the range of $6 to $8 million."

Clinical Trial Update

NMT also announced today that, by the end of the first quarter of 2009, it expects a final decision relating to the timing of the data analysis of its [ patent foramen ovale (PFO) ]/stroke clinical trial in the U.S., [ CLOSURE I ]. The Company continues to work with the [ CLOSURE I ] Executive Committee, independent statistical experts and the FDA to determine an appropriate time interval to perform the study data analysis. The decision related to the data analysis timing will be determined by an evaluation of the number of recurrent events and the timing of those events and will be performed by a panel of independent statistical experts on blinded data. If the number and timing of events indicate that it is statistically appropriate to do so, data analysis will be initiated in the fourth quarter of 2009. The Company would then expect to submit a pre-market approval (PMA) application for the stroke and transient ischemic attack (TIA) indication to the FDA during the first quarter of 2010, one year earlier than the current plan.

Ahern continued, "The original design of [ CLOSURE I ] required a review of the data two years after the last patient was enrolled and randomized. However, because enrollment in the trial began five years ago, by November 2009 more than 90 percent of the data will be at or greater than two years. The final decision will determine whether, due to the length of time to complete study enrollment and the resulting amount of recurrent event data available, an earlier look at the data is statistically appropriate. We continue to believe that we were the first company to complete enrollment in a clinical trial for the PFO/stroke and TIA indication in the U.S., and we intend to be the first to submit a PMA application as well."

"We continue to be encouraged about our outlook for 2009," said Ahern. "Excitement and anticipation surrounding the [ CLOSURE I ] trial is growing as we draw closer to having an answer. Our [ BioSTAR ]® technology remains the only bioabsorbable cardiac septal repair implant currently being used in humans. We believe we are steadily gaining commercial market share in Europe and Canada with sales of [ BioSTAR ]®. In addition, we continue to fund ongoing clinical trials and development programs, including our second biological implant technology, BioTREK™, which we believe will support the long-term growth and expansion of NMT."

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 embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. PFO is a common right to left shunt that 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 30,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.

Stroke is a 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. 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.

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 timing, cost, clinical status, and outcome of the Company's CLOSURE I trial, including a decision regarding the potential acceleration of data analysis from CLOSURE I, its BioSTAR® and BioTREK™ programs, the Company's cash position and burn rate, financial and sales expectations, profitability expectations, expansion of the Company's cardiovascular business and market opportunities, including stroke, TIAs and migraines and any other new applications for the Company's technology or products, regulatory approvals for the Company's products in the United States and abroad 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, 2007, Quarterly Report on Form 10-Q for the period ended September 30, 2008, and subsequent filings with the U.S. Securities and Exchange Commission.