NASDAQ, TSX: NVCN
VANCOUVER, June 17, 2019 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies and in the development of minimally
invasive devices for the treatment of refractory angina, today
announced that its Tiara™ ("Tiara") transcatheter mitral valve
replacement device was featured in a presentation at the 11th
Annual Transcatheter Valve Therapy Conference ("TVT 2019"). TVT
2019 is part of The Structural Heart Disease Summit held
June 12-15 in Chicago, Illinois.
In a presentation titled "The TIARA Program: Attributes,
Challenges, and Early Clinical Data" Dr. Anson Cheung, Clinical Professor of Surgery and
Director of Cardiac Transplant of British
Columbia, and Principal Investigator for the Tiara Early
Feasibility Study at St Paul's
Hospital, Vancouver Canada,
provided an update on the latest progress on the Tiara, including
the challenging anatomical considerations, patient
characteristics, procedural outcomes, and symptom improvement
of patients treated with Tiara.
"We are pleased to report yet another comprehensive clinical
update on our Tiara clinical studies to the Medical community, this
time in the USA" commented
Fred Colen, Neovasc's President and
Chief Executive Officer. "It continues to show solid progress, plus
consistent and encouraging clinical results. The transfemoral
trans-septal Tiara system, as showcased at the Paris EuroPCR
conference to invited Cardiologists and Surgeons earned high marks
for Neovasc's team after demonstrating complete understanding of
the complex issues associated with this delivery method and the
implemented solutions to both the Tiara valve and the delivery
system."
About Neovasc Inc.
Neovasc is a specialty medical
device company that develops, manufactures and markets products for
the rapidly growing cardiovascular marketplace. Its products
include the Neovasc Reducer (the "Reducer"), for the treatment of
refractory angina, which is not currently commercially available in
the United States and has been
commercially available in Europe
since 2015, and the Tiara, for the transcatheter treatment of
mitral valve disease, which is currently under clinical
investigation in the United
States, Canada and
Europe. For more information,
visit: www.neovasc.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, including without limitation statements
containing the words "believe", "may", "plan", "will", "estimate",
"continue", "anticipate", "intend", "expect" and similar
expressions. Forward-looking statements may involve, but are not
limited to, beliefs and expectations relating to the continued
progress and clinical results of the Tiara and the growing
cardiovascular marketplace. Many factors and assumptions could
cause the Company's actual results, performance or achievements to
differ materially from those expressed or implied by the
forward-looking statements, including, without limitation, risks
relating to the possibility that the Company's common shares may be
delisted from the Nasdaq Capital Market or the Toronto Stock
Exchange, including Nasdaq's discretionary public interest
authority to apply more stringent criteria for continued listing or
suspend or delist securities, which could affect their market price
and liquidity; the substantial doubt about the Company's ability to
continue as a going concern; risks relating to the senior secured
convertible notes (the "Notes") issued pursuant to the November 2017 private placement (the "2017
Financing"), resulting in significant dilution to the Company's
shareholders; risks relating to the Company's need for significant
additional future capital and the Company's ability to raise
additional funding; risks relating to cashless exercise and
adjustment provisions in the Notes issued pursuant to the 2017
Financing, which could make it more difficult and expensive for the
Company to raise additional capital in the future and result in
further dilution to investors; risks relating to the sale of a
significant number of common shares of the Company; risks relating
to the conversion of the senior secured convertible Notes issued
pursuant to the 2017 Financing, which may encourage short sales by
third parties; risks relating to the Company's conclusion that it
did not have effective internal control over financial reporting as
at December 31, 2018; risks relating
to the Company's Common Share price being volatile; risks relating
to the influence of significant shareholders of the Company over
the Company's business operations and share price; risks relating
to the Company's significant indebtedness, and its effect on the
Company's financial condition; risks relating to claims by third
parties alleging infringement of their intellectual property
rights; risks relating to lawsuits that the Company is subject to,
which could divert the Company's resources and result in the
payment of significant damages and other remedies; the Company's
ability to establish, maintain and defend intellectual property
rights in the Company's products; risks relating to results from
clinical trials of the Company's products, which may be unfavorable
or perceived as unfavorable; the Company's history of losses and
significant accumulated deficit; risks associated with product
liability claims, insurance and recalls; risks relating to use of
the Company's products in unapproved circumstances, which could
expose the Company to liabilities; risks relating to competition in
the medical device industry, including the risk that one or more of
the Company's competitors may develop more effective or more
affordable products; risks relating to the Company's ability to
achieve or maintain expected levels of market acceptance for the
Company's products, as well as the Company's ability to
successfully build its in-house sales capabilities or secure
third-party marketing or distribution partners; the Company's
ability to convince public payors and hospitals to include the
Company's products on their approved products lists; risks relating
to new legislation, new regulatory requirements and the efforts of
governmental and third-party payors to contain or reduce the costs
of healthcare; risks relating to increased regulation, enforcement
and inspections of participants in the medical device industry,
including frequent government investigations into marketing and
other business practices; risks associated with the extensive
regulation of the Company's products and trials by governmental
authorities, as well as the cost and time delays associated
therewith; risks associated with post-market regulation of the
Company's products; health and safety risks associated with the
Company's products and industry; risks associated with the
Company's manufacturing operations, including the regulation of the
Company's manufacturing processes by governmental authorities and
the availability of two critical components of the Reducer; risk of
animal disease associated with the use of the Company's products;
risks relating to the manufacturing capacity of third-party
manufacturers for the Company's products, including risks of supply
interruptions impacting the Company's ability to manufacture its
own products; risks relating to the Company's dependence on limited
products for substantially all of the Company's current revenues;
risks relating to the Company's exposure to adverse movements in
foreign currency exchange rates; risks relating to the possibility
that the Company could lose its foreign private issuer status under
U.S. federal securities laws; risks relating to breaches of
anti-bribery laws by the Company's employees or agents; risks
associated with future changes in financial accounting standards
and new accounting pronouncements; risks relating to the Company's
dependence upon key personnel to achieve its business objectives;
the Company's ability to maintain strong relationships with
physicians; risks relating to the sufficiency of the Company's
management systems and resources in periods of significant growth;
risks associated with consolidation in the health care industry,
including the downward pressure on product pricing and the growing
need to be selected by larger customers in order to make sales to
their members or participants; risks relating to the Company's
ability to successfully identify and complete corporate
transactions on favorable terms or achieve anticipated synergies
relating to any acquisitions or alliances; risks relating to the
Company's ability to successfully enter into fundamental
transactions as defined in the Notes issued pursuant to the 2017
Financings; anti-takeover provisions in the Company's constating
documents which could discourage a third party from making a
takeover bid beneficial to the Company's shareholders; and risks
relating to conflicts of interests among the Company's officers and
directors as a result of their involvement with other issuers.
These risk factors and others relating to the Company are discussed
in greater detail 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 months ended March
31, 2019 (copies of which may be obtained at www.sedar.com
or www.sec.gov). The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements
beyond required periodic filings with securities regulators,
whether as a result of new information, future events or otherwise,
except as required by law.
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SOURCE Neovasc Inc.