NASDAQ, TSX: NVCN
VANCOUVER, Aug. 3, 2018 /CNW/ - Neovasc Inc. ("Neovasc" or
the "Company") (NASDAQ: NVCN) (TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve
replacement technologies, announced today that it has entered into a collaboration and licensing agreement relating to certain
know-how developed by Penn Medicine and the Gorman Cardiovascular Research Group at the University of
Pennsylvania (together, "Penn"). This Agreement resolves certain potential claims against the Company that were described
in the Company's Annual Report on Form 20-F and management's discussion and analysis for Q1. This agreement does not impact
either Penn or Neovasc's patent rights.
Tiara™ ("Tiara") is Neovasc's minimally invasive transcatheter device for patients who experience severe mitral regurgitation
("MR"). There are millions of patients worldwide who suffer from severe MR, a significant percentage of whom are not good
candidates for conventional surgical repair or replacement. Tiara is implanted in the heart using a minimally invasive,
transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.
This collaboration and licensing agreement contemplates a period of collaboration over the next four years with fees being
paid by Neovasc to Penn. Following the first commercial sale of the Tiara, Neovasc will pay a stepped
royalty on Tiara revenues. These royalty obligations continue after the four-year collaboration period has ended. Also
contained in the collaboration and licensing agreement are buy-out clauses that allow Neovasc, or an acquirer of Neovasc or the
Tiara assets, to buy-out these royalty obligations. For further details, please see the Material Change Report filed by the
Company on SEDAR and furnished to the SEC on EDGAR under Form 6-K.
"This agreement helps to safeguard our efforts to further develop and commercialize the Tiara. We are pleased to have resolved
this matter in a manner that allows Neovasc to advance the Tiara program development in the near term, while providing an option
to either Neovasc or an acquirer of Neovasc to buy-out these future royalty obligations," commented Fred
Colen, Neovasc's Chief Executive Officer.
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.
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act
of 1995 and applicable Canadian securities laws regarding the Company's plans and expectations concerning any potential claims
against the Company, the eventual commercialization of the Tiara, the worldwide incidence of Mitral valve dysfunction and
candidacy for the Tiara, the fees and royalties to be paid to Penn or any buyout of such royalty
obligations, any acquisition of the Company or the Tiara and the growing cardiovascular marketplace. Words and phrases such as
"potential", "continue", "believe", "may", "could", "continue", "expect", "option", "upon" and "will", and similar words or
expressions, are intended to identify these forward-looking statements. 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 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; the substantial doubt about the
Company's ability to continue as a going concern; risks relating to the warrants (the "Warrants") and senior secured convertible
notes (the "Notes") issued pursuant to the November 2017 underwritten public offering and
concurrent private placement (together, the "2017 Financings"), 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 Warrants and Notes issued pursuant to the 2017
Financings, 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 exercise of Warrants or conversion of Notes issued pursuant to the 2017 Financings, which may encourage short
sales by third parties; risks relating to the possibility that the Company's common shares may be delisted from the Nasdaq
Capital Market or the Toronto Stock Exchange, which could affect their market price and liquidity; 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 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 Series C warrants 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 Management's Discussion and Analysis for the
quarter ended March 31, 2018 (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.
View original content: http://www.newswire.ca/en/releases/archive/August2018/03/c6272.html