Neovasc Provides Corporate Update
Company outlines milestone
achievements towards value creation
VANCOUVER, BC and MINNEAPOLIS, MN - (NewMediaWire) - May 26, 2020 - Neovasc,
Inc. ("Neovasc" or the "Company") (NASDAQ, TSX:
NVCN), a leader in the development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the treatment of
refractory angina, today announced a corporate update on its progress towards
its value creation strategies.
Fred Colen, Chief Executive
Officer of Neovasc, commented, “Today’s corporate update is a testament to the
teamwork and commitment of our employees, physician partners and regulators
around the globe. We would like to thank the investors who have given us the
opportunity to advance our programs and we are thrilled to continue to advance
our value creation strategies.”
Progress on Reducer
We are beginning to see a
return of elective procedures in Germany and other European markets.
After a marked slowdown that began in March, Reducer implant rates in Germany,
where the company has a direct sales team and NUB Status 1 designation for
reimbursement, are once again approaching pre-COVID-19 levels. As previously
discussed, the company is aware of the backlog of potential Reducer patients
related to COVID-19 and the reduction in elective procedures in select European
markets and we look forward to continued acceleration.
The National Institute for
Health and Care Excellence (NICE) Interventional Procedures Programme
in the U.K. has invited Neovasc to participate in guidance development for
Reducer treatment of refractory angina. Neovasc is honored to be considered for
review by NICE and we look forward to further collaboration as
we establish the value of Reducer therapy in the United Kingdom.
In the United States, the
Reducer FDA Pre-Market Approval (PMA) milestones continue to progress, with our
“100-day Meeting” recently completed.
Progress on Tiara
The Company has applied for CE
Mark Approval under the Medical Device Directive (MDD) for the Tiara TA
transapical mitral valve replacement system. The Company is working
interactively with our Notified Body in Europe, to advance our submission.
We continue to make progress
with our transfemoral Tiara TF mitral valve replacement system program
with the completion of several recent animal implants. We remain focused
on a first-in-human implant towards the end of the year.
Progress on Capital
Structure
Following the retirement of our
2017 notes, the recently announced financing of approximately $5M will enable
the Company to support ongoing operations under terms more favorable to
the Company, including the removal of the particularly onerous provisions that
have challenged our capital structure since 2017. The Company believes our
revamped capital structure will substantially improve the Company’s ability to
raise additional equity capital to fund the company to its critical milestones
in 2020 and early 2021.
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 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 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.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
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, 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 with respect to the continued acceleration of the Reducer in
European markets, the Company establishing the value of Reducer therapy in the
United Kingdom, plans for a first-in-human implant of the Tiara TF mitral valve
replacement system towards the end of the year, beliefs that the recently
announced offering will support ongoing operations under terms more favorable
to the Company, beliefs that our revamped capital structure will allow the
Company to raise additional equity capital to fund the Company to its critical
milestones in 2020 and early 2021 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
Company's need for significant additional future capital and the Company's
ability to raise additional funding; risks relating to the sale of a
significant number of common shares of the Company; risks relating to the
conversion or exercise of the Company’s existing securities, 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 or 2019; 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; 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.