Securities and Exchange Commission

 

washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer

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

the Securities Exchange Act of 1934

 

 

For the month of

May   2021

 

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): ¨

 

 

 

 

 

 

DOCUMENTS INCLUDED AS PART OF THIS REPORT

 

Exhibit 99.1   Material Change Report, dated April 28, 2021.  

 

Exhibit 99.1 of this Report on Form 6-K is incorporated by reference, as an exhibit, into the Registration Statement on Form F-10 of the Registrant, which was originally filed with the Securities and Exchange Commission on December 14, 2020 (File No. 333-251330), and the Registration Statement on Form S-8 of the Registrant, which was originally filed with the Securities and Exchange Commission on July 6, 2018 (File No. 333-226075).

 

 

 

 

SIGNATURES

 

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.
      (Registrant)
       
Date: May 3, 2021   By:  /s/ Chris Clark
        Name: Chris Clark
        Title: Chief Financial Officer  

 

 

 

 

Exhibit 99.1

 

FORM 51-102F3
MATERIAL CHANGE REPORT

 

Item 1: Name and Address of Company

 

Neovasc Inc. (“Neovasc” or the “Company”)

13562 Maycrest Way, Suite 5138

Richmond, BC V6V 2J7

 

Item 2: Date of Material Change

 

January 15, 2021

 

Item 3: News Release

 

A news release announcing the material change was issued on January 15, 2021 through Newsfile Corp. and a copy was subsequently filed on SEDAR and EDGAR.

 

Item 4: Summary of Material Change

 

On January 15, 2021, the Company announced that it that it had received a "not-approvable" letter from U.S. Food & Drug Administration (the “FDA”) regarding its PMA submission for the Neovasc ReducerTM (“Reducer”).

 

Item 5: Full Description of Material Change

 

On January 15, 2021, the Company announced that it that it had received a "not-approvable" letter from the FDA regarding its PMA submission for Reducer.

 

The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

 

Item 6: Reliance on Subsection 7.1(2) of National Instrument 51-102

 

Not applicable.

 

Item 7: Omitted Information

 

Not applicable.

 

Item 8: Executive Officer

 

Chris Clark, Chief Financial Officer

Phone: 604-248-4138

 

Item 9: Date of Report

 

This Material Change Report is dated as of April 28, 2021