October 09, 2014 11:15am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK )
announced that its investee, Neovasc, has received conditional
Investigational Device Exemption (IDE) approval from the U.S. Food and
Drug Administration (FDA) to initiate the U.S. arm of its TIARA-I Early
Feasibility Trial for the Company’s Tiara™ transcatheter mitral valve.
The TIARA-I Early Feasibility Trial is a multinational, multicenter
trial being conducted to assess the safety and performance of Neovasc’s
Tiara mitral valve system and implantation procedure in high-risk
surgical patients suffering from severe mitral regurgitation (MR).
Severe MR is a critical condition that affects millions of patients and,
if left untreated, can lead to heart failure or death. This FDA
conditional approval allows clinical investigators to begin enrolling
patients at participating U.S. medical centers once local hospital and
related approvals are in place.
“This is a significant affirmation of Neovasc’s Tiara device as we
believe that Neovasc is the first company to start a feasibility trial
with a transcatheter mitral valve in the US,” stated Phillip Frost,
M.D., Chairman and Chief Executive Officer of OPKO. “FDA’s conditional
approval and the commencement of the feasibility trial in the US is an
important step towards Tiara becoming one of the first transcatheter
mitral valve replacement devices available for treating U.S. patients.”
The TIARA-I Early Feasibility Trial will enroll up to 30 patients
globally and is being overseen by a multidisciplinary committee of
internationally recognized physicians co-chaired by Dr. Martin Leon
(Director, Center for Interventional Vascular Therapy Columbia
University Medical Center / New York-Presbyterian Hospital) and Dr.
Anson Cheung (Professor of Surgery and Director of Cardiac Transplant at
St. Paul’s Hospital, Vancouver Canada). With this FDA approval, TIARA-I
is expected to enroll patients at three highly respected U.S. medical
centers: Columbia University Medical Center / New York-Presbyterian
Hospital (New York), Lenox Hill Hospital (New York) and Cedars-Sinai
Medical Center (Los Angeles). The Company is now focusing on training
participating clinical teams and obtaining institutional approvals with
the goal of enrolling the first U.S. patients by early 2015.
TIARA-I also has received ethics committee approval at Antwerp
Cardiovascular Center / ZNA Middelheim in Belgium and competent
authority notification is pending. First European enrollment is expected
before the end of the year. Applications are underway for additional
centers in Europe and Canada.
Tiara is a self-expanding mitral bioprosthesis specifically designed to
treat mitral valve regurgitation (MR) by replacing the diseased valve.
Significant MR can lead to heart failure and death. Conventional
surgical treatments are only appropriate for about half of MR patients,
who number an estimated four million in the U.S. alone. Tiara is
implanted in the heart using a minimally invasive, transapical
transcatheter approach and is designed to replace the diseased native
mitral valve without the need for open-heart surgery or use of a cardiac
bypass machine.
The first human implantations of Tiara were completed successfully
earlier this year under Canadian Special Access, by the medical team at
St. Paul’s Hospital in Vancouver, Canada. Early clinical results of
Tiara implantations have been promising, resulting in fully functional
valves, with complete resolution of mitral regurgitation, and no valve
leakage. There have been no device related complications observed to
date in patients treated with Tiara.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and 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 Tiara
transcatheter mitral value, whether the device will be successful in
treating mitral valve regurgitation, whether trials will be successful
and whether the device will be commercialized at all, the timing for
enrollment in U.S. and European trials, and whether the device will be
one of the first transcatheter mitral valve replacement devices
available in the U.S., as well as other non-historical statements about
our expectations, beliefs or intentions regarding 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 Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released October 9, 2014
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