NMT Medical reports $2.6 million net income for second-quarter 2010

NMT Medical, Inc. (NASDAQ: NMTI), 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, today announced financial results for the quarter ended June 30, 2010.

“In addition, our revenues outside of North America reflect a shortfall in our larger Western European markets.”

Second-Quarter Results

Second-quarter 2010 total revenues were approximately $2.6 million compared with approximately $3.2 million for the quarter ended June 30, 2009.

Cardiac septal repair implant sales in North America for the second quarter of 2010 were approximately $1.9 million compared with approximately $2.4 million in the second quarter of 2009. Implant sales outside of North America were approximately $700,000 in the second quarter of 2010 compared with $800,000 in the corresponding period of 2009.

For the second quarter of 2010, NMT reported net income of approximately $2.6 million, or $0.16 per diluted share, compared with a net loss of approximately $3.8 million, or $0.29 per share, for the corresponding period in 2009. Net income for the second quarter of 2010 includes a non-cash, pre-tax gain of $6.4 million related to the change in fair value of the warrants issued in February 2010 as part of the Company's $5.8 million financing. For the second-quarter of 2010, NMT reported a loss from operations of approximately $4.0 million compared with a loss of approximately $3.9 million in the same period of 2009.

Management Comments

"During the second quarter, we believe the medical community was eagerly anticipating the results of CLOSURE I, our pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial, which may have slowed the referral pattern and the number of procedures performed during the second quarter in the U.S.," said President and Chief Executive Officer Frank Martin. "In addition, our revenues outside of North America reflect a shortfall in our larger Western European markets."

"We commenced data analysis for CLOSURE I early in the quarter and announced preliminary results in mid-June, which indicated that the trial did not meet its primary endpoint," Martin said. "However, the preliminary results of CLOSURE I did confirm several positive attributes of our technology. While the trial did not demonstrate that treatment by device closure with the STARFlex® implant is superior, the results indicate that closure with STARFlex® provided a small, but not statistically significant, benefit over current best medical therapy. The primary endpoint included the incidence of a recurrent stroke/TIA confirmed by MRI imaging. In addition to a very low rate of thrombus formation, for the first time in any prospective, randomized and independent core lab adjudicated PFO related trial, the results indicate that the safety profile of the STARFlex® device had a low rate of complications, similar to that of current best medical therapy. Closure rates in the trial were 86.5%, which is consistent with NMT's previously reported results for the STARFlex® implant. We are currently in discussions with the U.S. Food and Drug Administration to evaluate our possible next steps relating to the stroke/TIA indication. We plan to provide an update, once an appropriate course of action has been determined. We currently anticipate that full trial data results will be discussed at the American Heart Association meeting in November 2010."

Chief Operating Officer, Richard E. Davis, said, "As of June 30, 2010, cash, cash equivalents and marketable securities were approximately $6.5 million. Going forward, we will continue to tightly manage expenses, preserve cash, evaluate financing alternatives and adjust our operating plan accordingly in order to support our ongoing clinical trials and development programs. We currently expect third-quarter 2010 revenues to be approximately $2.5 million."

Source NMT Medical, Inc.