Company Ramps Up Commercialization of Neovasc Reducer™ and Development of Tiara™ Product Platforms, Primes for Pivotal Growth Period
VANCOUVER, Oct. 16, 2019 (GLOBE NEWSWIRE) — 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, today announced it has retained Westwicke, an ICR company (Westwicke, ICR), for integrated investor and public relations consulting services.“As we advance the development and commercialization of our products, we have engaged Westwicke, ICR to raise our visibility and convey our roadmap for success among key audiences,” said Fred Colen, President and Chief Executive Officer of Neovasc. “We are progressing our EU clinical study for the Transapical Tiara system for minimally invasive treatment of mitral valve disease. We also continue to gain feedback from the U.S. Food and Drug Administration in seeking a Humanitarian Use Device Designation (“HUD Designation”) for Reducer that in a best case scenario, if approved, may provide an expedited pathway to market for the device as an option for patients in the U.S. with the worst angina symptoms. With the $11.5M gross proceeds from our private placement in hand, and Westwicke, ICR’s deep healthcare and medical device industry expertise, we are excited to continue executing on our value creation strategy for shareholders.”Neovasc continues to drive towards strong double-digit percentage EMEA revenue growth for the Reducer during 2019, with revenue having increased 38% for the first six months this year. In a best-case scenario, contingent on an approved FDA HUD Designation and Human Device Exemption approval, the Company might be able to begin commercializing the Reducer in the U.S. for refractory angina patients suffering from the most severe symptoms in 2020.In January 2019, ICR, a leading strategic communications and advisory firm, acquired Westwicke Partners, the leading healthcare-focused investor relations firm in North America, combining preeminent healthcare IR with healthcare sector experts in public relations, crisis management, special situations and digital branding.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 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.About Westwicke PartnersWestwicke Partners provides customized strategic investor relations programs and independent capital markets advice to public and private healthcare companies. Westwicke focuses on the healthcare sector exclusively, and is headquartered in Baltimore with regional offices in Boston, New York, San Diego, San Francisco and London. For more information, please visit www.westwicke.com.About ICREstablished in 1998, ICR partners with companies to execute strategic communications and advisory programs that achieve business goals, build awareness and credibility, and enhance long-term enterprise value. The firm’s highly differentiated service model, which pairs capital markets veterans with senior communications professionals, brings deep sector knowledge and relationships to more than 550 clients in approximately 20 industries. Today, ICR is one of the largest and most experienced independent communications and advisory firms in North America maintaining offices in New York, Norwalk, Boston, San Francisco and Beijing.  ICR also advises on capital markets transactions through its ICR Capital subsidiary.  Learn more at www.icrinc.com. Follow us on Twitter at @ICRPR.ContactsInvestors:Mike Cavanaugh
Phone: +1.646.677.1838
[email protected] Westwicke, an ICR Company Media:Sean Leous
Phone: +1.646.677.1839
[email protected] Westwicke, an ICR Company Forward-Looking Statement DisclaimerCertain 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 as to a potential expedited approval pathway to market for the Reducer through the US Food and Drug Administration’s Humanitarian Device Designation, potential double-digit percentage EMEA revenue growth for the Reducer during 2019, expectations as to commercializing the Reducer in the US in 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 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 and six months ended June 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.
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