News Release

April 30, 2018

Neovasc Provides a General Update, Announces Filing of Annual Report on Form 20-F and Sets First Quarter 2018 Financial Results Conference Call and Webcast

NASDAQ, TSX: NVCN

VANCOUVER, April 30, 2018 /CNW/ – Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, today provided a general corporate update, concurrent with filing its Annual Report on Form 20-F, to highlight the Company’s progress over the last month and to confirm the date of the earnings call where these matters will be discussed further.

Operational Highlights

  • Implanted an additional six Tiaras™ ("Tiaras") since March 28, 2018 to bring the total to 56
  • Continuing progress on the Tiara transfemoral, trans-septal program
  • Additional publications and presentations supporting Neovasc Reducer™ ("Reducer") efficacy

Corporate Highlights

  • Received additional US$4.7 million in proceeds from investor-initiated exercises of Series C warrants (the "Series C Warrants") issued pursuant to the November 2017 underwritten public offering (the "2017 Public Transaction")
  • Reports 1,681,060,920 common shares of the Company ("Common Shares") issued and outstanding as at the date hereof
  • Continuing efforts to right-size the Company’s capital structure
  • Continuing efforts to resolve legal matters and strengthen intellectual property portfolio

The Company has filed its Annual Report on Form 20-F with the U.S. Securities and Exchange Commission (the "SEC"). Please visit www.sec.gov to review the filing and for further details on these highlights.

The Company has completed six Tiara implants since March 28, 2018, the date of its last update; four for the Tiara-II study in Europe ("TIARA-II") and two for the Tiara-I study in Canada ("TIARA-I"). The apical in/out procedure time for these most recent four TIARA-II implants were 9 minutes, 9 minutes, 10 minutes and 12 minutes, respectively. For the two recent TIARA-I implants, they were 11 minutes and 45 minutes (mainly due to challenging echo imaging quality). To date, a total of 56 patients have been implanted with the Tiara. The 30-day survival rate remains at 90% overall and is at 92% for the TIARA-II study.

Furthermore, the Company remains on schedule for the first, small animal feasibility study for the transfemoral, trans-septal Tiara version in the first half of May 2018.

The Company reports that the Reducer was presented in several new publications:

  • EMH Media (Schweizerischer Ärzteverlag), Cardiovascular Medicine, 2018/04, Coronary Sinus Reducer Case Report, Dr. Kahr, at all, University Hospital of Zurich.
  • Journal of the American College of Cardiology ("JACC") publication, Vol. 11, No. 8, 2018: "Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina", a single center experience, Dr. F. Giannini, et al.
  • Editorial in the same JACC edition by Dr. Wijns and Dr. Behan: "New Treatment Options for the "No Option" Patient with Refractory Angina".
  • An associated TCTMD publication from April 16, 2018 by Todd Neal, with comments from Dr. Suzanne Arnold.
  • EuroIntervention Online publication from April 24, 2018: "Coronary Sinus Reducer implantation improves symptoms, ischemia and physical capacity in patients with refractory angina unsuitable for myocardial revascularization", a single center experience, Dr. M. Konigstein, et al.

The Company has received an additional US$4,666,099 in proceeds from investor-initiated exercises of an additional 3,195,958 of the Series C Warrants. 10,273,972 Series C Warrants were originally issued in the 2017 Public Transaction, and 2,192,748 remained issued and outstanding at the close of business on April 24, 2018. Each Series C Warrant may be exercised at an exercise price equal to US$1.46 (subject to adjustment) at any time prior to 11:59 p.m. (New York time) on November 18, 2019 for a Series C unit (a "Series C Unit"), with each Series C Unit being comprised of one Common Share, one Series A warrant (a "Series A Warrant") and one Series B warrant (a "Series B Warrant").

At the close of business on April 24, 2018, there were 1,251,641 Series B Warrants outstanding and 2,192,748 Series B Warrants issuable upon exercise of the remaining Series C Warrants outstanding, if those Series C Warrants are exercised, 33,757,592 Series A Warrants outstanding and 2,192,748 Series A Warrants issuable upon exercise of the remaining Series C Warrants outstanding, if those Series C Warrants are exercised, 22,431,507 Series E warrants (the "Series E Warrants") outstanding and US$29,525,000 aggregate amount of senior secured convertible notes (the "Notes") outstanding. There were no Series D or F warrants outstanding or issuable at the same date.

There were 1,681,060,920 Common Shares issued and outstanding at the close of business on April 24, 2018.  The decline in our share price since our last earnings call has led to the future-priced warrants and Notes outstanding as at that date being more dilutive than estimated at the time of the earnings call.

The Company is continuing its efforts to reduce the warrant overhang of the last financing. The Company will also be seeking shareholder approval at the next Annual and Special General Meeting, scheduled for June 4, 2018, to carry out a share consolidation at an appropriate time. Further information will be contained in the Management Information Circular for the Annual and Special General Meeting. Management believes that this is the only path forward to re-establish compliance with the US$1.00 minimum bid price requirement for listing on the Nasdaq Capital Market.

The Company announced that it will report financial results for the quarter ended March 31, 2018 and host a conference call and webcast at 4:30pm Eastern Time on Thursday, May 10, 2018.  Management will provide a full update, including further discussion on these matters, during the call and in its filings.

Conference Call & Webcast

Thursday, May 10th @ 4:30pm Eastern Time

Domestic: 

800-239-9838

International: 

323-794-2551

Passcode: 

9386338

Webcast: 

http://public.viavid.com/index.php?id=129196

Replays available through May 24th:

Domestic: 

844-512-2921

International: 

412-317-6671

Conference ID: 

9386338

 

About the Securities Issued in the November 2017 Financings
For details concerning the terms of the securities issued pursuant to the 2017 Public Transaction and concurrent private placement (together with the 2017 Public Transaction, the "2017 Financings"), including the Series A Warrants, Series B Warrants, Series C Warrants, Series E Warrants and the Notes, see the prospectus supplement dated November 10, 2017 and the forms of such securities filed on SEDAR at www.sedar.com and with the SEC at www.sec.gov. For a description of the risks associated with these securities, including dilution to shareholders due to exercises or conversions of the Company’s outstanding warrants (the "Warrants") and Notes, and the Company’s need for significant additional funding, among other things, see the Company’s Annual Report on Form 20-F, which is available on SEDAR at www.sedar.com and as filed with the SEC at www.sec.gov.

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 Reducer, for the treatment of refractory angina, which is not currently available in the United States and has been 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 right-sizing the its capital structure, resolving legal matters and strengthening its intellectual property portfolio, progress on the Tiara transfemoral, trans-septal Tiara program, including completing the animal feasibility study in the first half of May 2018, the efficacy of the Tiara and Reducer, exercises of Warrants and Notes and related dilution to shareholders, and its ability to carry out a share consolidation and to remain listed on the Nasdaq Capital Market. Words and phrases such as "continue", "strategy", "believe", "may", "could", "should", "expect" 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, the substantial doubt about the Company’s ability to continue as a going concern; risks relating to the Warrants and Notes issued pursuant to 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 or the TSX, 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 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 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 (copies of which may be obtained at  www.sedar.com or www.sec.gov).  These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements.  The Company has no intention and undertakes no obligation to update or revise any forward-looking statements or to provide information relating to further incremental exercises of Warrants or conversion of Notes 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.