via NEWMEDIAWIRE -- Neovasc, Inc. ("Neovasc"
or the "Company") (NASDAQ, TSX: NVCN), today provided a
corporate update on progress towards its value creation
strategies.
Fred Colen, Chief Executive Officer of Neovasc,
commented, “We are pleased to provide a corporate
update to our investors as we have made meaningful progress
against our value creation strategies. We have clear line of site
to important milestones across each of our objectives and
sufficient cash on hand to allow complete focus on advancing our
efforts through the end of the first quarter of 2021.”
Progress on Reducer™
International commercial execution on Reducer
remains strong. The Company has seen a robust rebound in Reducer
volumes beginning in mid-June. July results were on pace with
Neovasc’s original, pre-COVID-19 plan and the Company is encouraged
by the broad-based recovery in the business. Neovasc expects strong
double-digit growth in Reducer implants and revenue during the
third quarter of 2020.
Additionally, there have been important
developments supporting Reducer reimbursement across Europe.
Following the issuance of the European Society of Cardiology
Guidelines for the treatment of chronic coronary syndromes in
September 2019, Neovasc undertook a comprehensive reimbursement
advancement program in several European countries. The
Company is pleased with the progress of its reimbursement efforts
and looks forward to the possibility of expanded coverage in
multiple European markets in 2021.
In the United States, the Company is enthusiastic
about the upcoming FDA Circulatory Systems Devices Panel meeting
scheduled for October 27, 2020. During the meeting, the Company,
the FDA and clinical experts will discuss the potential benefits
and risks of Reducer therapy for patients in the United
States.
“Refractory Angina is an unmet clinical need in
the United States,” commented Dr. Tim Henry, Medical Director, The
Carl and Edyth Lindner Center for Research and Education at The
Christ Hospital. “The Reducer has been shown to reduce the symptoms
of refractory angina and I look forward to discussing its merits at
the panel meeting.”
At the meeting, members will cast a formal vote on
issues related to the approvability of the submission, however, FDA
will make the final approval decision.
Progress on Tiara™
The Company continues to advance its regulatory
submission for the Tiara TA transapical mitral valve replacement
system targeting European CE Mark approval under the Medical Device
Directive. Neovasc is in ongoing, collaborative discussions with
our notified body, and we are encouraged by the progress to date.
The Company is targeting an approval decision for Tiara TA in the
first half of 2021.
The Tiara TF transfemoral/trans-septal mitral
valve replacement program is approaching important first-in-human
implants in the first half of 2021. The Company is enthused by the
positive feedback it has received on the device. Most
notably, physicians are supportive of the system’s low profile,
device recapturability and unique implant design that set it apart
from competitive offerings in development.
“I’ve been impressed by the design and unique
features of the Tiara TF system,” said Paul Sorajja, M.D.,
Director, Center for Valve and Structural Heart Disease,
Minneapolis Heart Institute, Abbott Northwestern Hospital. “I
look forward to working with Neovasc to advance the program towards
treating critically ill patients.”
Progress on Capital Structure
Following the recently announced financing of
approximately $12.6M the Company now has sufficient cash on hand to
support the advancement of its four value creations strategies
until at least the end of Q1 2021. “I’d like to once again thank
our investors for their support of Neovasc. We are now in a
position to execute our programs without the distraction of raising
additional capital in the immediate future,” commented Fred
Colen.
As at August 12, 2020, after the impact of the
recently announced financing, the Company had 22,146,127 shares
issued and outstanding and the fully diluted share count was
37,331,314 (assuming all notes and warrants are fully converted and
exercised and without giving effect to the PIK interest).
About Neovasc Inc.
Neovasc is a specialty medical device company that
develops, manufactures and markets products for the rapidly growing
cardiovascular marketplace. The Company is a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the
treatment of refractory angina. Its products include the Neovasc
Reducer™, for the treatment of refractory angina, which is not
currently commercially available in the United States (2 U.S.
patients have been treated under Compassionate Use) and has been
commercially available in Europe since 2015, and Tiara™, for the
transcatheter treatment of mitral valve disease, which is currently
under clinical investigation in the United States, Canada, Israel
and Europe. For more information,
visit: www.neovasc.com. Click here for a link
to the most recent corporate update.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
Sean.Leous@icrinc.com
Forward-Looking Statement Disclaimer
Certain statements in this news release contain
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws that may not be based on historical fact.
When used herein, the words "expect", "anticipate", "estimate",
"may", "will", "should", "intend," "believe", and similar
expressions, are intended to identify forward-looking
statements. Forward-looking statements may involve, but are
not limited to, the belief that the rebound of Reducer implants
speaks directly to Reducer’s efficacy in treating refractory
angina, the belief that the Company is well-positioned for the
future and the statement regarding the growing cardiovascular
marketplace. Forward-looking statements are based on estimates and
assumptions made by the Company in light of its experience and its
perception of historical trends, current conditions and expected
future developments, as well as other factors that the Company
believes are appropriate in the circumstances. Many factors
could cause the Company's actual results, performance or
achievements to differ materially from those expressed or implied
by the forward-looking statements, including those described in the
"Risk Factors" section of the Company's Annual Report on Form 20-F
and in the Management's Discussion and Analysis for the three and
six months ended June 30, 2020 (copies of which may be obtained
at www.sedar.com or www.sec.gov). These
factors should be considered carefully, and readers should not
place undue reliance on the Company's forward-looking statements.
The Company has no intention and undertakes no obligation to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
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