NASDAQ, TSX: NVCN
VANCOUVER, May 28, 2019 /CNW/ - Neovasc Inc. ("Neovasc" or
the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies and in the development of minimally
invasive devices for the treatment of refractory angina, today
announced that the European Heart Journal, Quality of Care and
Clinical Outcomes has published a peer-reviewed article indicating
the cost effectiveness of the Neovasc Reducer™ ("Reducer") as an
effective therapy for patients suffering from refractory angina,
and its positive impact on healthcare burden. The title of the
article is: "Cost-effectiveness of the coronary sinus Reducer and
its impact on the healthcare burden of refractory angina
patients."
The main findings of the study are that:
- the Reducer decreases healthcare burden of refractory angina
patients and the associated costs across a range of European
healthcare system perspectives; and that
- the Reducer is cost-effective according to the
cost-effectiveness thresholds of the World Health Organization
("WHO").
The study indicates that in patients with severe angina,
refractory to optimal medical therapy and not amenable for further
revascularization, the Reducer reduces healthcare resource
utilization and associated costs. In a limited one-year timeframe,
the Reducer is consistently cost-effective across the considered
countries and range of cost-effectiveness thresholds. Under both
the assumptions of a Reducer effect duration of two and three years
from implant with a 30%-year efficacy decrease, the device yields
cost-effectiveness ratios suggesting high value from all the
considered perspectives.
"This study indicates that the Reducer not only significantly
improves quality of life for patients suffering from refractory
angina, but that treatment with the Reducer also results in
improved quality-adjusted-life-year values, and in statistically
significant savings in healthcare costs related to angina-driven
hospitalizations, outpatient visits, coronary angiograms and
percutaneous coronary interventions, per patient-year," commented
Fred Colen, president and CEO of
Neovasc. "Furthermore, as of the second year, the incremental
cost-effectiveness ratio for patients with the Reducer is well
below the levels established by the WHO and well below
the even stricter Dutch threshold."
The paper considered both the cost-consequence (a comparison of
patient care before and after Reducer implantation) and the cost
effectiveness (a measure of total cost of the procedure and ongoing
care against a combined measure of quality of life and life
expectancy).
Cost-consequence
Usage of angina-related healthcare
resources and quality-of-life data were collected for 215
consecutive refractory angina patients undergoing Reducer
implantation in Belgium,
the Netherlands and Italy. Costs were assessed in each country's
healthcare system, and data from the date of refractory angina
diagnosis until Reducer implantation, the Standard-of-Care period
("SoC Time-Period") and from Reducer implantation to follow-up
("the Reducer Time-Period") were compared, with each patient
serving as its own control. The authors observed significant
reductions in angina-driven hospitalizations, outpatient visits,
coronary angiograms and percutaneous coronary interventions per
patient-year during the Reducer Time-Period, translating into
significantly reduced costs per patient-year. This translated into
a significant reduction of the associated costs per patient-year
from all three healthcare system perspectives: Belgium: €4,143 (1,970-9,347) vs. €312
(97-3,209), p<0.001; the
Netherlands: €3,079 (1,441-6,990) vs. €121 (37-2,342),
p<0.001; Italy: €4,175
(2,009-3,210) vs. €194 (58-2,786), p<0.001 during the SoC and
Reducer Time-Periods, respectively.
Cost-effectiveness
Cost-effectiveness of Reducer was
expressed in the Incremental Cost-Effectiveness Ratio ("ICER"),
defined as the difference in cumulative costs of Reducer and SoC
Time-Periods, divided by the difference in cumulative
Quality-Adjusted-Life-Year's ("QALYs") of Reducer and SoC
Time-Periods. The associated simulations under the WHO
cost-effectiveness thresholds were 99.9%, 100.0% and 93.3%,
respectively, meaning that within one year the Reducer nearly met
or exceeded the WHO guidelines and that these effects further
improved over two- and three-year estimates in the study.
Costs and utilities during a one-year SoC Time-Period were compared
with those of a one-year Reducer Time-Period to assess
cost-effectiveness. Several Reducer efficacy duration assumptions
were explored with modeled projections. The Reducer was associated
with higher QALYs: 0.665 vs 0.580, p<0.001) and incremental
costs, yielding ICERs of €53,197, €34,948, €63,146 per QALY gained
in Belgium, The Netherlands and Italy, respectively. Under the assumption of
both a two- and three-year Reducer effect duration, modeling a
30%-year efficacy decrease, the device yielded ICERs in the range
of €1,977-€20,796 per QALY gained.
About Reducer
The Reducer is CE-marked in the European
Union for the treatment of refractory angina, a painful and
debilitating condition that occurs when the coronary arteries
deliver an inadequate supply of blood to the heart muscle, despite
treatment with standard revascularization or cardiac drug
therapies. It affects millions of patients worldwide, who typically
lead severely restricted lives as a result of their disabling
symptoms, and its incidence is growing. The Reducer provides relief
of angina symptoms by altering blood flow in the heart's
circulatory system, thereby increasing the perfusion of oxygenated
blood to ischemic areas of the heart muscle. Placement of the
Reducer is performed using a minimally invasive transvenous
procedure that is similar to implanting a coronary stent and is
completed in approximately 20 minutes.
While the Reducer is not approved for commercial use in the
USA, the U.S. Food and Drug
Administration ("FDA") granted Breakthrough Device designation to
the Neovasc Reducer in October 2018.
This designation is granted by the FDA in order to expedite the
development and review of a device that demonstrates compelling
potential to provide a more effective treatment or diagnosis for
life-threatening or irreversibly debilitating diseases. In
addition, there must be no FDA approved treatments presently
available, or the technology must offer significant advantages over
existing approved alternatives.
Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options, is
estimated to affect 600,000 to 1.8 million Americans, with 50,000
to 100,000 new cases per year.1
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 commercially available in the United States and has been commercially
available in Europe since 2015,
and the Tiara™ (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.
Share Capital Update
As of today, the Company has
71,824,101 Common Shares issued and outstanding. The following
securities are convertible into Common Shares: 9,317,874 stock
options with a weighted average exercise price of US$2.90, 1,444,444 broker warrants with an
exercise price of US$0.5625,
US$11,500,000 debenture with a lowest
possible conversion price of US$0.75,
which could convert into a maximum of 15,333,333 shares and US
$8,490,000 principal amount of senior
secured convertible notes (the "Notes") issued pursuant to the
November 2017 private placement (the
"2017 Financing"), which Notes could convert into
18,866,667 Common Shares (not taking into account the
alternate conversion price or anti-dilution mechanisms). Our fully
diluted share capital as of the same date is 116,786,419. Our fully
diluted share capital, adjusted on the assumption that all of the
outstanding Notes are converted using the alternate conversion
price at the closing price on May 24,
2019, is 117,581,633.
Forward-Looking Statement Disclaimer
Certain
statements in this news release contain forward-looking statements
within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995 and applicable Canadian securities laws that may not be
based on historical fact, including without limitation statements
containing the words "believe", "may", "plan", "will", "estimate",
"continue", "anticipate", "intend", "expect" and similar
expressions. Forward-looking statements may involve, but are not
limited to, beliefs and expectations relating to the future
performance and/or success of the Reducer, including statements
about the results of the study suggesting that the Reducer provides
high-value from all considered perspectives, statements regarding
the growing incidence of refractory angina, the growing
cardiovascular marketplace and the Company's fully-diluted share
capital. 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 Notes issued pursuant to the 2017 Financing, 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 Notes issued
pursuant to the 2017 Financing, 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 conversion of Notes issued pursuant
to the 2017 Financing, which may encourage short sales by third
parties; risks relating to the possibility that the common shares
of the Company 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 conclusion that it
did not have effective internal control over financial reporting as
at December 31, 2018; 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 Notes 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 and in the Management's Discussion and
Analysis for the three months ended March
31, 2019 (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.
1T. J.
Povsic, S. Broderick, K. J. Anstrom et al., "Predictors of
long‐term clinical endpoints in patients with refractory angina,"
Journal of the American Heart Association, vol. 4, no. 2, article
e001287, 2015.
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SOURCE Neovasc Inc.