6-K 1 neovasc6k.htm FORM 6-K






Washington, D.C. 20549




Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934



For the month of    November    2016
Commission File Number        001-36458    



Neovasc Inc.

(Translation of registrant’s name into English)


Suite 5138 – 13562 Maycrest Way

Richmond, British Columbia, Canada V6V 2J7


(Address of principal executive offices)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:


  Form 20-F        Form 40-F    X  


Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):          


Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):           









News Release – Neovasc's Tiara and Reducer Highlighted at TCT Presentations






Document 1


Neovasc's Tiara and Reducer Highlighted at TCT Presentations


VANCOUVER, Nov. 2, 2016 /CNW/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX: NVC) announced today its notable presentations at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium, the world's largest educational meeting specializing in interventional cardiovascular medicine held in Washington, DC.

On October 31, Dr. Anson Cheung from St. Paul's hospital, Vancouver, Canada presented an update on the ongoing Tiara™ program. He presented the clinical data to date, on the 19 patients treated with the Tiara™ valve.  The 30-day survival rate for these 19 patients is 84%.  Overall, the data presented was very encouraging, in this very sick cohort of patients treated with Tiara.

Dr. Cheung elaborated that enrolment continues in the TIARA-I Early Feasibility Trial and in other compassionate use programs. The TIARA-I trial is assessing the safety and performance of the Tiara™ mitral valve system and the implantation procedure in high-risk patients suffering from severe mitral regurgitation.

Dr. Florian Deuschl from Hamburg, Germany gave a presentation entitled, Echocardiographic Guiding of a Novel Mitral Valve Replacement, which reviewed his positive experience from the Tiara implantation cases performed by the team in Hamburg. 

With respect to the Company's other cardiovascular device, the Neovasc Reducer™, for the treatment of Refractory Angina, Dr. Gregg Stone presented the Reducer as the most effective treatment option for patients suffering from refractory angina despite optimal medical therapy.  He reviewed the results of the COSIRA randomized study which was published in the New England Journal of Medicine last year.  He also outlined the design of the COSIRA II, pivotal US trial, which will include 380 patients and will be a multicenter prospective, randomized, double-blind, sham-controlled trial.

In addition, during the conference there were two posters presented from Italy, describing the positive effect of the Neovasc Reducer™.

About Neovasc Inc. 
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.  Its products in development include the Tiara™, for the transcatheter treatment of mitral valve disease and the Neovasc Reducer™ for the treatment of refractory angina. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. 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, including statements that the study found Reducer implantation to be the most effective treatment option for patients suffering from refractory angina despite optimal medical therapy and the proposed design of the COSIRA II pivotal US trial.  The words "most effective" and "will" 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, potential changes in circumstances relating to the Company's financing requirements, whether as a result of unforeseen circumstances or otherwise; the conduct or possible outcomes of any actual or threatened legal proceedings, including any post-trial motions or appeals, which are inherently uncertain; the potential benefits of the Neovasc Reducer™ and Tiara™ as compared with other products; successful enrollment of patients in studies and trials for the Neovasc Reducer™ and Tiara™; results of the trials and studies for the Neovasc Reducer™ and Tiara™ that meet the Company's expectations; the Company's receipt of any required local and institutional regulatory approvals and the timing and costs of obtaining such approvals; European enrollment in our clinical trials, studies and compassionate use cases and the success of applications in Europe; the Company's ability to protect its intellectual property; the Company's ability to raise additional funding; changes in business strategy or development plans; existing governmental regulations and changes in, or the failure to comply with, governmental regulations and general economic and business conditions, both nationally and in the regions in which the Company operates. These risk factors and others relating to the Company are discussed in greater detail in the "Risk Factors" section of the Company's Annual Information Form, which is included in its Annual Report on Form 40-F (copies of which filings 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, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Neovasc Inc.


%CIK: 0001399708

For further information: Investor Relations, Neovasc Inc., Chris Clark, 604 248-4138, cclark@neovasc.com

CO: Neovasc Inc.

CNW 07:00e 02-NOV-16







Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


  Neovasc Inc.
Date:                  November 2, 2016               By:    /s/ Chris Clark
  Name:    Chris Clark
  Title: Chief Financial Officer