Neovasc Announces Direct Sales Operations in United Kingdom
July 05 2022 - 9:05AM
via NewMediaWire – Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced that the company has expanded
its direct sales operations in Europe to include the United
Kingdom, effective July 1, 2022. The company has hired its first
two direct employees in England and plans future growth in the
sales team as the commercial requirements increase.
The decision to move to a direct sales operation in the U.K. was
driven by the Neovasc Reducer (“Reducer”) being granted national
reimbursement in England following inclusion in the most recent
High-Cost Tariff Excluded Devices (HCTED) national
catalogue. Hospitals can order the Reducer and bill the cost
of the device directly to NHS England.
Fred Colen, Neovasc President and Chief Executive Officer, said,
“We are pleased to expand our direct presence into the United
Kingdom and want to thank our partners at Healthcare 21 for their
excellent foundational efforts supporting the early growth of
Reducer. We are now poised to provide even deeper support with a
full-time dedicated team in the U.K. and intend to continue to
invest in clinical research and field personnel to support
patients, physicians, and hospitals.”
Additionally, last year the United Kingdom’s Interventional
Procedures Programme at the National Institute for Health and Care
Excellence (“NICE”) issued guidance supporting the implantation of
the Reducer in appropriate patients suffering from refractory
angina. According to the guidance document, “Coronary sinus
narrowing device implantation is indicated for people in whom [1]
other treatment options (medical or surgical) have failed, or [2]
are not possible. The aim is to reduce symptoms and to improve
quality of life.”
Prof. Jonathan Hill, MD, Consultant Interventional Cardiologist
at Royal Brompton & Harefield NHS Foundation Trust, London,
U.K, an early pioneer in the development of Reducer therapy,
commented, “An important next step in the widespread use of the
therapy is a robust program of training and proctoring. We are
looking forward to the support of Neovasc’s direct operation in the
UK in training new operators and centers and allowing them to offer
the Reducer therapy for all their indicated patients.”
About Reducer
The Reducer is CE-marked in the European Union for the treatment
of refractory angina, a painful and debilitating condition that
occurs when the coronary arteries deliver an inadequate supply of
blood to the heart muscle, despite treatment with standard
revascularization or cardiac drug therapies. Reducer is
investigational in the United States in the COSIRA-II clinical
trial. Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options,
affects millions of patients worldwide, who typically lead severely
restricted lives because of their disabling symptoms. The Reducer
is designed to alter blood flow within the myocardium of the heart
and increase the perfusion of oxygenated blood to ischemic areas of
the heart muscle, which may provide relief of angina symptoms.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops 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.
InvestorsMike CavanaughICR WestwickePhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousICR WestwickePhone:
+1.646.866.4012 Sean.Leous@westwicke.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, plans for future
growth in the sales team as the commercial requirements increase,
the growth and adoption of the Reducer, the intention to continue
to invest in clinical research and field personnel to support
patients, physicians, and hospitals and 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 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 around the Company's ability to continue as a
going concern; risks around the Company's history of losses and
significant accumulated deficit; risks related to the COVID-19
coronavirus outbreak or other health epidemics, which could
significantly impact the Company's operations, sales or ability to
raise capital or enroll patients in clinical trials and complete
certain Tiara development milestones on the Company's expected
schedule; 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; risks relating to the possibility that the
Company's Common Shares may be delisted from the Nasdaq or the TSX,
which could affect their market price and liquidity; risks relating
to the Company's conclusion that it did have effective internal
control over financial reporting as of December 31, 2021 and 2020
but not at December 31, 2019; risks relating to the Common Share
price being volatile; risks relating to the Company's significant
indebtedness, and its effect on the Company's financial condition;
risks relating to the influence of significant shareholders of the
Company over our business operations and share price; 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; risks relating to claims by
third-parties alleging infringement of their intellectual property
rights; risks relating to 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; 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
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; risks relating to 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 relating to the extensive regulation of the
Company's products and trials by governmental authorities, as well
as the cost and time delays associated therewith; risks relating to
post-market regulation of the Company's products; risks relating to
health and safety concerns associated with the Company's products
and industry; risks relating to 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; risks relating to the
possibility 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 the possibility that the Company could be treated
as a "passive foreign investment company"; risks relating to
breaches of anti-bribery laws by the Company's employees or agents;
risks relating to 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;
risks relating to 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 relating to 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
conflicts of interests among the Company's officers and directors
as a result of their involvement with other issuers; risks relating
to future issuances of equity securities by the Company, or sales
of common shares or conversions of convertible notes, and exercise
of warrants, options and restricted stock units by our existing
security holders, causing the price of the Company's securities to
fall; and risks relating to 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. 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 for the three months ended
March 31, 2022 (a copy of which may be obtained at 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 (copies of which may be obtained
at www.sedar.com or www.sec.gov), whether because of new
information, future events or otherwise, except as required by
law.
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