November 06, 2013 3:51pm EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and
diagnostics company, today reported that Neovasc Inc. (NVC.V), a
Vancouver-based company in which OPKO has made a strategic investment,
reported topline results for its COSIRA trial assessing the efficacy and
safety of the Neovasc ReducerTM, a novel percutaneous device for the
treatment of refractory angina. The data shows that the Reducer achieved
its primary endpoint, significantly improving the symptoms and
functioning of patients disabled by previously untreatable refractory
angina. The COSIRA trial also confirmed that the Reducer is safe and
well-tolerated, with no reports of device-related serious adverse
events. The safety and efficacy data from the randomized, controlled
COSIRA trial is consistent with results seen in previous non-randomized
pilot studies of the Reducer.
The Reducer is CE-marked in the European Union for the treatment of
refractory angina, a painful and debilitating condition that occurs when
the coronary arteries deliver an inadequate supply of blood to the heart
muscle, despite treatment with standard revascularization or cardiac
drug therapies. It affects millions of patients worldwide, who typically
lead severely restricted lives as a result of their disabling symptoms,
and its incidence is growing. The Reducer provides relief of angina
symptoms by altering blood flow in the heart's venous system, thereby
increasing the perfusion of oxygenated blood to ischemic areas of the
heart muscle. Placement of the Reducer is performed using a minimally
invasive transvenous procedure that is similar to implanting a coronary
stent and takes approximately 20 minutes.
The COSIRA (Coronary Sinus Reducer for treatment of Refractory Angina)
trial is a prospective, multicenter, sham-controlled, randomized,
double-blinded study assessing the safety and efficacy of the Reducer in
104 patients in the European Union and Canada. Patients were randomized
1:1 between treatment and sham control arms. Its primary endpoint is a
two-class improvement six months after implantation in patients' ratings
on the Canadian Cardiovascular Society (CCS) angina
grading scale , a four-class functional classification that is widely
used to characterize the severity of angina symptoms and disability.
Only patients with severe angina, CCS Class 3 or 4, were enrolled in the
COSIRA trial.
The complete results of the COSIRA trial are being submitted as a Late
Breaking Clinical Trial presentation at ACC.14, the 63rd Annual
Scientific Session & Expo of the American College of Cardiology that
will take place in Washington, DC, March 29-31, 2014.
About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing global
cardiovascular marketplace. Its products include the Neovasc Reducer™
for the treatment of refractory angina and the Tiara™ transcatheter
mitral value replacement device in development for the treatment of
mitral regurgitation. In addition, Neovasc's advanced biological tissue
products are widely used as key components in a variety of third-party
medical products, such as transcatheter heart valves. For more
information, visit: www.neovasc.com .
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging our discovery, development and
commercialization expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding expected benefits of the Neovasc
Reducer™ and whether the Neovasc Reducer™ will be commercialized at all,
as well as other non-historical statements about our expectations,
beliefs or intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could cause
actual activities or results to differ materially from the activities
and results anticipated in forward-looking statements. These factors
include those described in our filings with the Securities and Exchange
Commission, as well as the risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments, that earlier clinical results of
effectiveness and safety may not be reproducible or indicative of future
results, that compounds or diagnostic products under development may
fail, may not achieve the expected results or effectiveness and may not
generate data that would support the approval or marketing of products
for the indications being studied or for other indications, that
currently available over-the-counter and prescription products, as well
as products under development by others, may prove to be as or more
effective than our products for the indications being studied. In
addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Juan F. Rodriguez,
Source: OPKO Health, Inc.
Released November 6, 2013
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