Recognized Multinational Senior Executive Poised
to Drive Commercialization and Clinical Advances
NASDAQ, TSX: NVCN
VANCOUVER, Jan. 22, 2018 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (Nasdaq, TSX: NVCN), a
front-runner in minimally invasive transcatheter mitral valve
technologies today announced that its board of directors (the
"Board") has appointed Fred A. Colen
as president and chief executive officer effective immediately.
This leadership transition is a key element of the Company's
strategy to support plans for the commercialization of its
new-to-market Reducer™ ("Reducer") product in Europe and the advancement of its Tiara™
("Tiara") mitral valve clinical program. Alexei Marko,
Neovasc's outgoing CEO, will maintain his role as a Director on the
Neovasc Board of Directors and continue to serve as an advisor to
the Company.
"Neovasc has reached an important turning point, and, as such,
we have conducted a search for a leader with the experience and
skill set to build on the progress made by Alexei Marko during his tenure as CEO," said
Paul Geyer, chairman of Neovasc.
"Fred Colen is a seasoned medical
device executive with an outstanding track record and reputation as
a strong leader. We believe he is exceptionally well
qualified to lead Neovasc in its next phase of growth."
"Based on a strong belief in the promise of Neovasc's products,
I am thrilled to join the Neovasc team and to lead the Company at
this exciting time," said Fred
Colen. "I will begin with a deep dive in all aspects of the
Company, including its products and operations, during the next few
months, with the goal of determining the right strategy to create
the most value for the Company's various stakeholders. I look
forward to working with our investors, employees, suppliers, and
customers to expand commercial utilization and to bring the Tiara
mitral valve to the market for the benefit of patients."
"Alexei Marko has been a very
capable leader since the Company's inception ten years ago. His
considerable expertise, determination, and focus have been
instrumental in executing Neovasc's corporate goals and achieving
key milestones," added Mr. Geyer. "The Board is grateful for his
dedication to the Company and his continued guidance as a trusted
advisor in achieving a smooth leadership transition."
"After ten years building Neovasc, I am convinced that now
is the time for new leadership to take the Company to the next
level. I am especially pleased that an industry leader of
Fred Colen's caliber has accepted
this opportunity," said Alexei Marko, outgoing CEO of Neovasc.
"I look forward to my continued involvement as a board member."
Fred Colen has contributed to
many significant turnarounds in his career, including the
post-acquisition Guidant Company, which became the CRM division of
Boston Scientific, a firm with which he held progressively
senior executive roles over 11 years, including Chief Technology
Officer from 2001-2008 and Member of the Executive Committee from
2001-2010. During his tenure at Boston Scientific, Mr. Colen is
credited with numerous successes. As President of the
company's Cardiac Rhythm Management (CRM) Group his team regained
trust and confidence in the division's implantable pacemakers,
leads, defibrillators and re-synchronization devices, increasing
annual product revenue growth by over 10% in a flat US market and
growing global divisional operating income from below 10% to 25% of
sales, exceeding the planned annual free cash flow goals. As
Chief Technology Officer, he led the development and global
commercial launch for the Company's first- and second-generation
implantable drug-eluting coronary stents (the Taxus Express and
Taxus Liberte), leading to global market leadership with
incremental revenues of US$2 billion
annually. The Taxus Express market introduction is viewed as
one of the most successful launches ever in the medical device
industry.
Prior to joining Boston Scientific, Mr. Colen, in his role
as Executive Vice President in the Pacesetter division, played
a key role in the execution of St. Jude Medical's diversification
strategy, which resulted in its evolution from a successful heart
valve company to a broad-based medical device company with a highly
successful cardiac rhythm management business. In addition to
restructuring organizational processes, he introduced the "Fast
Cycle Time" approach in R&D to reduce development cycle times
and optimize timing of new product introductions and manufacturing
processes. During this time period, St. Jude also achieved a sharp increase in
European sales through business focus, additional sales capacity,
and marketing campaigns.
Mr. Colen most recently served as the President and Chief
Executive Officer of BeneChill, building its early stage business
in Europe and developing its
clinical, regulatory and marketing strategy for the US market.
He oversaw financing rounds E and F before the company was
acquired by a Swedish firm that specializes in brain
cooling.
Mr. Colen has also held a number of Board Directorships or
Advisory roles, including Mölnlycke Healthcare, Biim
Ultrasound, and GTX Medical. He served on the Board
of Middle Peak Medical, a company developing a mitral valve
replacement device, until its acquisition by Symetis, which in turn
was acquired by Boston Scientific.
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 the commercialization
of the Reducer, the advancement of the Tiara clinical program and
bringing the Tiara to market, Mr. Marko's future service on the
Company's board of directors and Mr. Colen's future work as CEO,
the Company's next phase of growth and future performance, the
transition of leadership at the Company and the growing
cardiovascular marketplace. Words and phrases such as "drive",
"advances", "plans", "will", "maintain", "continue", "build",
"believe", "next phase", "strategy", "look forward", "continued",
"transition", "next level" and "growing", 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
Company's need for significant additional future capital and the
Company's ability to raise additional funding; risks relating to
the warrants and notes, offered pursuant to the November 2017 public offering of units and
private placement of senior secured convertible notes and warrants
(the "Financings"), resulting in significant dilution to the
Company's shareholders; 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 it being more
expensive for the Company to raise capital in the future and
dilution to investors; risks relating to the Company's Common Share
price being volatile; risks relating to the sale of a significant
number of Common Shares; risks relating to the restrictions on the
Company entering into certain transactions; risks relating to the
exercise of Warrants or conversion of Notes offered pursuant to the
Financings, which may encourage short sales by third parties; risks
relating to claims by third parties alleging infringement of their
intellectual property rights; 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 competition in the
medical device industry, including the risk that one or more
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 the Company's
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 the
Company's 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 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 the Company's 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; the Company's ability to
successfully identify and complete corporate transactions on
favorable terms or achieve anticipated synergies relating to any
acquisitions or alliances; 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 risks relating to the influence of
significant shareholders of the Company over the Company's business
operations and share price. These risk factors and others relating
to the Company are discussed in greater detail in the "Risk
Factors" sections of the Company's Annual Information Form and
Management's Discussion and Analysis of Financial Condition and
Results of Operations, each of which is included in its Annual
Report on Form 40-F, and the Company's Management Discussion and
Analysis for the third quarter of 2017 (copies of which filings 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, whether as a result of new
information, future events or otherwise, except as required by
law.
SOURCE Neovasc Inc.