via NewMediaWire – Shockwave Medical, Inc. (NASDAQ: SWAV)
(“Shockwave”), a pioneer in the development of Intravascular
Lithotripsy (IVL) to treat severely calcified cardiovascular
disease, today announced the completion of its previously announced
acquisition of Neovasc Inc. (“Neovasc”).
The Neovasc Reducer System (the “Reducer”) is a
first-of-its-kind technology to address refractory angina.
Refractory angina is a chronic condition in which a patient suffers
chest pain that cannot be controlled by conventional therapies. It
is estimated that each year, in the U.S. and the E.U. alone, up to
300,000 new patients with obstructive coronary disease who are
ineligible for conventional revascularization experience refractory
angina, despite guideline-directed medical therapy. In addition, it
is estimated that up to another 500,000 new patients present with
angina and non-obstructive coronary artery disease in the U.S. and
the E.U. each year. The Reducer has been granted Breakthrough
Device designation by the FDA, is CE-marked and is currently
enrolling patients in the COSIRA-II study, a randomized clinical
trial being conducted under an Investigation Device Exemption
intended to support FDA approval for patients with coronary
obstructive refractory angina.
Shockwave has acquired all of the outstanding common shares of
Neovasc (the “Common Shares”) for US$27.25 per share in cash (the
“Cash Portion”) upfront by way of a statutory plan of arrangement
(the “Arrangement”). Consideration for the purchased shares has
been paid to Computershare Investor Services Inc. as depositary
under the arrangement (the “Depositary”) and will be provided to
former shareholders of Neovasc (the “Shareholders”) as soon as
reasonably practicable after the date hereof, in accordance with
the terms of the arrangement agreement and subject to the ruling by
the Israel Tax Authority issued in connection with the Arrangement
(the “Withholding Tax Ruling”) as described below. In addition, the
Shareholders will also receive a potential deferred payment in the
form of a non-tradeable contingent value right (a “CVR”, and
together with the Cash Portion, the “Consideration”) entitling the
Shareholders to receive up to an additional US$12.00 per share in
cash if certain regulatory milestones are achieved within specified
timeframes.
As a result of the completion of the Arrangement, Neovasc’s
Common Shares will be delisted from the Toronto Stock Exchange.
Neovasc has also requested that the Nasdaq Stock Market LLC
(“Nasdaq”) file a delisting application on Form 25 to report the
delisting of the Common Shares of Neovasc from Nasdaq. An
application will be made for Neovasc to cease to be a reporting
issuer in the applicable Canadian jurisdictions as a result of
completion of the Arrangement. Neovasc expects to terminate the
registration of its Common Shares under the U.S. Securities
Exchange Act of 1934, as amended (the “Exchange Act”),
approximately 10 days after the closing of the transaction.
Pursuant to the Withholding Tax Ruling, in order to receive the
Consideration free of withholding pursuant to the Israeli Income
Tax Ordinance (New Version), 5721-1961 (the “Ordinance”),
Shareholders are required to make the Israeli Tax Certification
described below. Shareholders that hold Common Shares through a
broker and who meet the requirements of the Israeli Tax
Certification will be able to provide such certification and
submit the supporting documents described below through an online
portal that will be made available by the Depositary; such
Shareholders with questions about the Consideration or this portal
are encouraged to call their brokers with any questions. Registered
Shareholders (that is, Shareholders that, as of the closing of the
Arrangement, hold shares directly in Neovasc, and not through a
broker) will be contacted by the Depositary with instructions on
how to receive the Consideration. In order to avoid withholding of
Israeli tax, Registered Shareholders (as well as any Shareholder
whose consideration exceeds US$500,000) will need to obtain a
withholding exemption certificate issued by the Israel Tax
Authority and such Shareholders are encouraged to seek guidance
from an Israeli tax lawyer or accountant to help with the process
of obtaining such an exemption certificate. Registered Shareholders
with questions may contact the Depositary directly by calling
888-852-1154 (within North America) or 514-982-7478 (outside North
America).
The “Israeli Tax Certification” will require that Shareholders
certify that: (i) they are not (and from the date they purchased
the Common Shares until the closing of the Arrangement, were not) a
“resident of Israel” as defined under Section 1 of the Ordinance;
(ii) the Common Shares held by such Shareholder were acquired on or
after January 1, 2009, and to the extent the Common Shares were
transferred to such Shareholder pursuant to a tax-free transfer
(under Israeli law), which includes transactions such as gifts or
inheritances, the transferor acquired the Common Shares on or after
January 1, 2009; (iii) they did not acquire the Common Shares from
a “relative” (as defined under Section 88 of the Ordinance) and the
Common Shares were not subject to the provision of Part E2 of the
Ordinance or Section 70 of the Israeli Land Taxation Law
(Appreciation and Acquisition), 5723-1963, which relate to tax-free
reorganizations; (iv) the gain from the sale of the Common Shares
is not derived through a permanent establishment they have in
Israel; and (v) such Shareholder is the beneficial owner (directly
or indirectly) of less than 5% of the Common Shares. In support of
the Israeli Tax Certification, Shareholders will be required to
upload to the portal described above: (i) for Shareholders who are
individuals, a copy of such Shareholder’s valid non-Israeli
passport or a valid government-issued identification card or IRS
Form W-9; and (ii) for Shareholders who will receive consideration
in excess of US$300,000 but no more than US$500,000 or are Israeli
citizens, a tax residency certificate from the applicable tax
authority in such Shareholder’s country of residence or a
withholding exemption certificate issued by the Israel Tax
Authority.
About Shockwave Medical, Inc.
Shockwave Medical is focused on developing and commercializing
products intended to transform the way calcified cardiovascular
disease is treated. Shockwave Medical aims to establish a new
standard of care for the interventional treatment of
atherosclerotic cardiovascular disease through differentiated and
proprietary local delivery of sonic pressure waves for the
treatment of calcified plaque, which the company refers to as
Intravascular Lithotripsy (IVL). IVL is a minimally invasive,
easy-to-use and safe way to significantly improve patient outcomes.
To view an animation of the IVL procedure and for more information,
visit www.shockwavemedical.com.
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 within the myocardium of the heart and 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. While the Reducer is not approved
for commercial use in the United States, the FDA granted
Breakthrough Device designation to the Reducer in October 2018, and
it is being studied in the COSIRA-II clinical trial.
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 Reducer, for the
treatment of refractory angina, which is under clinical
investigation in the United States and has been commercially
available in Europe since 2015. For more information visit:
www.neovasc.com.
Media Contact:Scott
Shadiow+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kasterdkaster@shockwavemedical.com
Forward-Looking Statement Disclaimer
This press release contains 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. When used herein, the words “expect”,
“anticipate”, “estimate”, “may”, “will”, “should”, “intend”,
believe”, and similar expressions, are intended to identify
forward-looking statements. Forward-looking statements include, but
are not limited to, the amounts potentially payable under the CVRs;
the achievement of the CVR milestones within the payment timeline;
and the expected timing for Neovasc’s deregistration under the
Exchange Act.
Forward-looking statements are based on estimates and
assumptions made by Shockwave and Neovasc, current conditions and
expected future developments, as well as other factors that
Shockwave and Neovasc believe are appropriate in the circumstances.
Many factors and assumptions could cause the actual results,
performance or achievements to differ materially from those
expressed or implied by the forward-looking statements, including,
without limitation, risks around Neovasc or Shockwave's ability to
reach the CVR milestones within the payment timeline; whether the
COSIRA-II clinical trial is completed and achieves its endpoints;
whether the Reducer receives FDA approval for the treatment of
angina; the inherent risks, costs and uncertainties associated with
integrating the businesses successfully and risks of not achieving
all or any of the anticipated benefits of the transaction, or the
risk that the anticipated benefits of the transaction may not be
fully realized or take longer to realize than expected; and other
risks and uncertainties discussed in Shockwave’s and Neovasc’s
filings with the Securities and Exchange Commission (the “SEC”)
and/or the Canadian Securities Administrators (the “CSA”),
including Part I, Item 1A – Risk Factors in Shockwave’s most recent
Annual Report on Form 10-K filed with the SEC and Part I, Item 3 –
Key Information in Neovasc’s most recent Annual Report on Form 20-F
filed with the SEC and CSA and in Shockwave’s and Neovasc’s other
reports filed with the SEC and/or CSA. These factors should be
considered carefully, and readers should not place undue reliance
on these forward-looking statements. Shockwave and Neovasc have no
intention and undertake no obligation to update or revise any
forward-looking statements beyond required periodic filings with
securities regulators (copies of which may be obtained at
www.sedar.com or www.sec.gov), whether because of new information,
future events or otherwise, except as required by law.
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