Neovasc Advances New Transfemoral Trans-septal Tiara Design Concept After Further Successful Tests
25 January 2020 - 1:00AM
via NEWMEDIAWIRE -- 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, announced today that after
further successful acute animal tests conducted earlier this week,
a final design concept for the fully retrievable transfemoral
trans-septal Tiara™ (“TF/TS Tiara”) system, including a modified,
lower profile valve and a steerable delivery system, has been
established and will now move into a design freeze phase
review, in accordance with the Company’s quality system.
“The team has done an outstanding job, building on
our extensive knowledge and clinical expertise with the Transapical
Tiara (‘TA Tiara’) system, to define, what we view as, a truly
transformational TF/TS Tiara system, where the trackability
into the mitral valve annulus via single vein femoral access, the
single piece self-anchoring design and full retrievability until
the point of final release stand out as enabling key
features. Additionally, we believe our highly trackable
delivery system and lower valve profile should expand the potential
treatable patient population,” commented Aaron Chalekian, Vice
President of Product Development at Neovasc.
“We believe we are at the forefront of emerging
developments to successfully deliver a mitral valve replacement
device via the transfemoral trans-septal pathway in patients with
severe mitral valve regurgitation, a major unmet medical need,”
said Fred Colen, President and CEO of Neovasc, “Building on our
successful TA Tiara program, which has treated 82 patients
including the longest-living minimally invasive mitral valve
replacement patient who is living with a markedly improved quality
of life nearly six years post implant, we truly understand the
enormously complex clinical and technical challenges for the
transfemoral trans-septal device delivery. We are
confident that with this steerable delivery
system and modified, lower profile valve, we will be able to
successfully treat a very large patient population in need of
such a life-changing valve replacement device. We look forward to
achieving the next major development milestones in this
program.”
About the TF/TS Tiara
System
The TF/TS development program is based on a
concept that allows for a very controlled and predictable
implantation procedure similar to Neovasc’s Tiara transapical
program. Through numerous evaluations with in vitro test
methods, including system trackability, deployment accuracy, and
hydrodynamic assessment, as well as five acute animal trials, the
Neovasc team has narrowed the TF/TS Tiara system down to a system
design concept utilizing a new delivery system coupled with a
lower-profile valve implant that shows strong potential. The
Company expects to initiate a clinical feasibility study in late
2020.
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 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.
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, statements and
beliefs with respect to the TF/TS delivery system and valve profile
expanding the potential treatable patient population, the Company
being at the forefront of emerging developments to successfully
deliver a mitral valve replacement device via the transfemoral
trans-septal pathway in patients with severe mitral valve
regurgitation, the Company being able to successfully treat a very
large patient population in need of a life changing valve
replacement device and looking forward to achieving the next major
development milestones in the Tiara program, the Company expecting
to initiate a clinical feasibility study in late 2020 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 antibribery 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 and
nine months ended September 30, 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.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
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