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."
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;
* 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
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
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
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
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
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
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.
John E. Ahern
President and Chief Executive Officer
NMT Medical, Inc.
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/
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