Securities
and Exchange Commission
w
ashington,
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
|
July
|
|
2018
|
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:
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
Document
|
|
|
|
|
|
Document 1
|
|
News Release dated July 2, 2018 - Neovasc Announces Filing of Shelf Prospectus and Form F-10 Registration Statement
|
Document 2
|
|
News Release dated July 2, 2018 - Tiara and Reducer Featured at CSI Frankfurt 2018
|
|
|
|
|
|
|
DOCUMENT 1
Neovasc Announces Filing of Shelf Prospectus and Form
F-10 Registration Statement
NASDAQ, TSX: NVCN
VANCOUVER, July 2, 2018 /CNW/ - Neovasc Inc. ("Neovasc"
or the "Company") (NASDAQ, TSX: NVCN) announced today that it has filed a preliminary short form base shelf prospectus
with securities regulatory authorities in Canada, other than Quebec, and a corresponding shelf registration statement on Form F-10
(the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") under the U.S./Canada
Multijurisdictional Disclosure System.
"This new base shelf prospectus will replace our existing
base shelf prospectus that expires on July 9, 2018," commented Chris Clark, Neovasc's Chief Financial Officer. "The renewal
of a base shelf prospectus is a routine filing that enables us to more easily access the capital markets in the future, but we
are not actively raising new capital at the moment."
The base shelf prospectus and the Registration Statement,
once clear and effective, respectively, will allow Neovasc to offer up to U.S.$100,000,000 of common shares, preferred shares,
debt securities, subscription receipts, units and warrants from time to time over a 25-month period after Canadian securities regulatory
authorities have issued a receipt for the final short form base shelf prospectus. The terms of such future offerings, if any, will
be established at the time of such offerings and will be set forth in a prospectus supplement to the base shelf prospectus filed
with applicable Canadian securities regulatory authorities and with the SEC.
The Registration Statement filed today with the SEC has not
yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the registration statement
becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there
be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such jurisdiction.
A copy of the Registration Statement, including the related
prospectus, may be obtained by submitting a request to Chris Clark, Chief Financial Officer, at Neovasc's address at 5138-13562
Maycrest Way, Richmond, British Columbia, Canada, V6V 2J7. A copy of the preliminary short form base shelf prospectus can also
be found on SEDAR at www.sedar.com, and a copy of the Registration Statement can be found on the SEC website 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 Neovasc 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 the Tiara™, for the transcatheter
treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe.
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 clearance
of the base shelf prospectus with applicable Canadian regulatory authorities and effectiveness of registration statement, and the
ability of the Company to successfully close any future financing pursuant to the base shelf prospectus or shelf registration statement.
Words and phrases such as "believes," "may", "not yet" 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 (the "Warrants") and senior secured convertible notes (the "Notes")
issued pursuant to the November 2017 underwritten public offering and concurrent private placement (together, 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 Capital Market or the Toronto Stock Exchange, 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; risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement
with other issuers; and other factors referenced in the Company's filings with Canadian and U.S. securities regulators. 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 Management's Discussion and Analysis for the quarter ended March 31, 2018 (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.
View original content:http://www.prnewswire.com/news-releases/neovasc-announces-filing-of-shelf-prospectus-and-form-f-10-registration-statement-300675155.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/July2018/02/c3931.html
%CIK: 0001399708
For further information:
Chris Clark, Chief Financial Officer,
Neovasc Inc., 604-248-4138, cclark@neovasc.com; Jeremy Feffer, LifeSci Advisors, LLC, 212-915-2568, jeremy@lifesciadvisors.com
CO: Neovasc Inc.
CNW 07:30e 02-JUL-18
DOCUMENT 2
Tiara and Reducer Featured at CSI Frankfurt 2018
NASDAQ, TSX: NVCN
VANCOUVER, July 2, 2018 /CNW/ - Neovasc Inc. ("Neovasc"
or the "Company") (NASDAQ, TZX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement
technologies, today announced that its Tiara™ ("Tiara"), a transcatheter treatment of mitral valve disease, and
the Neovasc Reducer™ ("Reducer"), a CE-Marked medical devices used for the treatment of refractory angina, were
both featured in presentations at the CSI Frankfurt 2018 conference held on June 27-30, 2018 in Frankfurt, Germany. CSI Frankfurt
is one of the leading conferences on congenital, structural and valvar percutaneous heart interventions worldwide.
"The CSI conference is an important event for us every
year, as it brings together some of the leading cardiologists and cardiac surgeons from across the world to discuss new innovative
technologies and procedures for transcatheter treatment of structural heart diseases. This year, new Reducer clinical data was
presented in a scientific session entitled: Structural meets coronary – Reducer for the treatment of refractory angina. The
clinical data presented again demonstrated the clinical benefits of the Reducer in improving quality of life of patients suffering
from disabling angina, as well as improving exercise capability. Moreover, data was also presented demonstrating the cost effectiveness
of the Reducer therapy compared to the current standard of care," commented Fred Colen, Neovasc's Chief Executive Officer.
"An update on our Tiara – Transcatheter Mitral
Valve clinical program was also presented in the meeting, emphasizing the excellent results of the two ongoing clinical trials,
the Tiara-I early feasibility U.S./Canadian trial and the Tiara-II, a European CE Mark clinical trial," concluded Colen.
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 Neovasc ReducerTM, 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 the TiaraTM, 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 the future performance
of the Reducer and theTiara, the anticipated results of clinical trials relating to the Tiara, the cost-effectiveness of the Reducer
relative to the current standard of care and growth of the cardiovascular marketplace. Words and phrases such as "believes,",
"anticipates" "may", "not yet" 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 (the "Warrants") and senior secured convertible notes (the "Notes") issued pursuant to the
November 2017 underwritten public offering and concurrent private placement (together, 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 Capital Market or the Toronto Stock Exchange, 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; risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement
with other issuers; and other factors referenced in the Company's filings with Canadian and U.S. securities regulators. 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 Management's Discussion and Analysis for the quarter ended March 31, 2018 (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.
View
original content:http://www.prnewswire.com/news-releases/tiara-and-reducer-featured-at-csi-frankfurt-2018-300675158.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/July2018/02/c2454.html
%CIK: 0001399708
For further information:
Chris Clark, Chief Financial Officer,
Neovasc Inc., 604 248-4138, cclark@neovasc.com; Jeremy Feffer, LifeSci Advisors, LLC, 212-915-2568, jeremy@lifesciadvisors.com
CO: Neovasc Inc.
CNW 07:35e 02-JUL-18
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:
|
|
July 3, 2018
|
|
By:
|
/s/
Chris Clark
|
|
Name: Chris Clark
Title: Chief Financial Officer
|
|
|
|
|
|
|
Neovasc (NASDAQ:NVCN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Neovasc (NASDAQ:NVCN)
Historical Stock Chart
From Jul 2023 to Jul 2024