-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, F9uI1TrWgsnz2ClP5DicKZlMMHUHw0EbTvnMJ8ef5URsFluzVHKvH4KA14P9Zj+l sTarRX3UYAYggi9VuW2dYw== 0001279569-09-000688.txt : 20090514 0001279569-09-000688.hdr.sgml : 20090514 20090514135002 ACCESSION NUMBER: 0001279569-09-000688 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090514 FILED AS OF DATE: 20090514 DATE AS OF CHANGE: 20090514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOVASC INC CENTRAL INDEX KEY: 0001399708 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-53363 FILM NUMBER: 09825656 BUSINESS ADDRESS: STREET 1: 2135 13700 Mayfield place CITY: RICHMOND STATE: A1 ZIP: 00000 BUSINESS PHONE: 604-270-4344 MAIL ADDRESS: STREET 1: 2135 13700 Mayfield place CITY: RICHMOND STATE: A1 ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: Medical Ventures Corp DATE OF NAME CHANGE: 20070516 6-K 1 neovasc6k.htm FORM 6-K neovasc6k.htm
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
 
For the month of May, 2009
 
Commission File Number: 000-53363
 
NEOVASC INC.
(Exact name of Registrant as specified in its charter)
 
Suite 2135 - 13700 Mayfield Place
Richmond, British Columbia, Canada, V6V 2E4
(Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
x Form 20-F   o Form 40-F
 
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): o
 
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): o
 
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes o   No x
 
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _________
 
 
 
 
 
 
SUBMITTED HEREWITH
 
Exhibits
   Description
     
99.1
   News Release Dated May 14, 2009 - Neovasc Announces Positive Preliminary Clinical Results for its Reducer Product in Refractory Angina Patients
 
 
 
 
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 14, 2009 By: /s/ Alexei Marko
   
Alexei Marko
  Title: Chief Executive Officer
 
 
EX-99.1 2 ex991.htm NEWS RELEASE DATED MAY 14, 2009 ex991.htm 
Exhibit 99.1
News release via Canada NewsWire, Vancouver 604-669-7764

	    Attention Business Editors:
	    Neovasc Announces Positive Preliminary Clinical Results for its Reducer
	    Product in Refractory Angina Patients

	    <<
	    TSX Venture Exchange: NVC

	    --Three-year Follow-Up Study on Patients Implanted with the Neovasc
	    Reducer Shows Continued Excellent Safety Profile and Encouraging Signs of
	    Efficacy--
	    >>

	    VANCOUVER, May 14 /CNW/ - Neovasc Inc. (TSXV: NVC), a developer of novel
technologies used to treat vascular disease, today announced top-line positive
preliminary results from the follow-up phase of a clinical trial of its
Neovasc Reducer(TM) for the treatment of refractory angina. The data shows
that after three years, the majority of patients implanted with the Reducer
device continue to show measurable improvement in angina symptoms and safety
continues to be excellent. These preliminary results update positive six-month
data previously reported in the Journal of the American College of
Cardiology(1).
	    Refractory angina is a painful and debilitating condition that results
from lack of adequate blood flow through the coronary arteries that feed the
heart. It currently affects over two million patients worldwide who typically
lead severely restricted lives, and its incidence is growing. The Neovasc
Reducer is a unique device that is implanted in the coronary sinus vein. By
altering the pattern of blood flow perfusing the heart, the Reducer is
intended to provide relief of refractory angina symptoms. Implantation of the
Reducer is performed using a minimally invasive percutaneous procedure that is
similar to implanting a coronary stent and takes approximately 20 minutes.
	    "The preliminary results from this three-year follow-up confirm the
positive data seen in the initial study and are very promising," said Dr.
Shmuel Banai, principal investigator of the study and medical director of
Neovasc. "We are encouraged by the continuing excellent safety profile of the
Reducer and its apparent ability to maintain improvement in angina symptoms
over time. This data suggests that the Reducer may offer a viable long-term
treatment option for refractory angina patients who have failed other
therapies. We look forward to sharing the full results from this study in a
peer-reviewed scientific forum in the coming months."
	    In the trial, 15 patients with refractory angina were implanted with the
Reducer device. One patient was subsequently excluded from the original
six-month efficacy analysis due to an unrelated condition. All 14 of the
remaining patients have continued in follow-up for three years or more.
Preliminary results of the three-year follow-up showed that there were no
device-related adverse events or complications reported in these patients,
confirming the excellent safety profile observed in the initial six-month
follow-up period. Treatment with the Reducer also appears to be durable -
after three or more years, the majority of the 14 patients continued to
maintain an improvement in angina symptoms.
	    "While these results are still preliminary, they support our expectations
that the Reducer could greatly benefit patients suffering from refractory
angina and allow them to resume a more active lifestyle," said Neovasc CEO,
Alexei Marko. "We look forward to completing final analysis of the data from
this study and continuing to advance Reducer through the clinical and
regulatory review process."

	    <<
	    (1) Banai S, Ben Muvhar S, Parikh KH, et. al. Coronary Sinus Reducer
	        Stent for the Treatment of Chronic Refractory Angina Pectoris.
	        J Am Coll Cardiol 2007;49: 1783-9
	    >>

	    About Neovasc Inc.

	    Neovasc Inc. is a new specialty vascular device company that develops,
manufactures and markets medical devices for the rapidly growing vascular and
surgical marketplace. The company's current products include the Neovasc
Reducer(TM), a novel product in development to treat refractory angina, as
well as a line of advanced biological tissue technologies that are used to
enhance surgical outcomes and as key components in a variety of third party
medical products. For more information, visit: www.neovasc.com.

	    Statements contained herein that are not based on historical or current
fact, including without limitation statements containing the words
"anticipates," "believes," "may," "continues," "estimates," "expects," and
"will" and words of similar import, constitute "forward-looking statements"
within the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the actual results, events or
developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such
factors include, among others, the following: general economic and business
conditions, both nationally and in the regions in which the Company operates;
history of losses and lack of and uncertainty of revenues, ability to obtain
required financing, receipt of regulatory approval of product candidates,
ability to properly integrate newly acquired businesses, technology changes;
competition; changes in business strategy or development plans; the ability to
attract and retain qualified personnel; existing governmental regulations and
changes in, or the failure to comply with, governmental regulations; liability
and other claims asserted against the Company; and other factors referenced in
the Company's filings with Canadian securities regulators. Although the
Company believes that expectations conveyed by the forward-looking statements
are reasonable based on the information available to it on the date such
statements were made, no assurances can be given as to the future results,
approvals or achievements. Given these uncertainties, readers are cautioned
not to place undue reliance on such forward-looking statements. The Company
does not assume the obligation to update any forward-looking statements except
as otherwise required by applicable law.

	    %CIK: 0001399708

	    /For further information: Corporate contact: Neovasc Inc., Chris Clark,
(604) 248-4138; U.S. media & investor contact: GendeLLindheim BioCom Partners,
Barbara Lindheim, (212) 918-4650/
	    (NVC.)

CO:  Neovasc Inc.

CNW 07:32e 14-MAY-09
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