News Release

October 9, 2019

Neovasc and GADA® Sponsor Session at the 40th Annual (GISE) National Congress of the Italian Society of Interventional Cardiology

®NASDAQ, TSX: NVCN

VANCOUVER and MILAN, Oct. 09, 2019Neovasc, 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, and GADA Spa today announced their co-sponsoring of a major educational session at the prestigious GISE Congress, which will be held at the MICO Congress Center in Milan, Italy from October 15-18, 2019.

The symposium, titled “A Proven Evidence-Based Therapy When Angina Persists,” is scheduled for October 16th and will feature an internationally recognized scientific faculty. Moderated by Sergio Berti, M.D., and Francesco Giannini, M.D., the session will also include a presentation from Professor Shmuel Banai, M.D., Neovasc’s Medical Director.

During the symposium, results of the Italian Reducer Registry will be presented. The registry has enrolled over 180 patients and is one of the largest studies to date. Additionally, the results of a specialized third-party survey targeting cardiologists and reviewing the clinical path of patients with refractory angina will be discussed.

“As leaders in the treatment of refractory angina, we are pleased to have the opportunity to support an important educational session at one of the most prestigious European Congresses dedicated to the betterment of Cardiology practices and treatments,” said Fred Colen, President and Chief Executive Officer of Neovasc. “The panel will be a shared clinical experience of key opinion leaders, providing insights into the treatment options for the growing problem and impact on patients of refractory angina. This session is an opportunity to gain a better understanding of the Reducer rationale, and a presentation of the significant clinical evidence of the effectiveness and safety of the Reducer therapy for refractory angina.”

The Neovasc Reducer™ (the “Reducer”), which is CE Marked and available in the European Union, is expected to continue to have a significant role in treating a large and increasing population of patients suffering from refractory angina due to various degrees of coronary artery disease, who have limited options.

Biagio De Marinis, GADA CEO, underlines how the partnership between Neovasc and Gada represents an important element in the Gada group’s growth plan: “Together we work to support Italian cardiologists and provide an important opportunity for patients suffering from chronic refractory angina. We are proud to organize this symposium together with the
Italian Society of Interventional Cardiology (GISE) for the benefit of patients suffering from refractory angina.”

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.

About GADA Spa
GADA is a national leader in the distribution of innovative medical technologies on behalf of world leading manufacturers and offers a wide range of tailor-made integrated services.
The areas served are those related to cardiovascular diseases, blood collection and management, the pre-analytical laboratory phase, dialysis, intensive care, critical areas and neuromodulation. For more information, visit: www.gadagroup.com.

Media

Neovasc:
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
Sean.Leous@icrinc.com

GADA Spa:
Luca Cecchetti
Marketing & Communication
Phone: +39 349 2949315
mediarelations@gadagroup.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, expectations as to the Reducer continuing to have a significant role in treating a large and increasing population of patients suffering from refractory angina 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.

 

SOURCE Neovasc Inc.