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
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Domestic:
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800-239-9838
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International:
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323-794-2551
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Passcode:
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9386338
|
Webcast:
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http://public.viavid.com/index.php?id=129196
|
|
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Replays available
through May 24th:
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Domestic:
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844-512-2921
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International:
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412-317-6671
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Conference
ID:
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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.
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SOURCE Neovasc Inc.