Cardiovascular Systems, Inc. Announces Partnership With Innova Vascular, Inc. to Develop Full Line of Thrombectomy Devices
February 23 2022 - 7:00AM
Business Wire
Mechanical and aspiration devices to treat
peripheral vascular disease, deep vein thrombosis and pulmonary
embolism
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, announced today it has partnered with
Innova Vascular, Inc. (Innova) to develop a full line of novel
thrombectomy devices.
Thrombectomy is a rapidly growing interventional procedure
performed to remove blood clots from arteries and veins. CSI
intends to acquire and commercialize novel thrombectomy devices
from Innova targeting peripheral vascular disease, including deep
vein thrombosis (DVT) and pulmonary embolism (PE).
Commercialization of the thrombectomy devices will be highly
complementary to CSI’s broader portfolio of advanced technologies
used in the treatment of cardiovascular disease.
Sanjay Shrivastava, Ph.D., CEO of Innova said, “We strive to
bring solutions that are easy to use, safe, and highly effective in
treating potentially devastating diseases. We are excited to
partner with CSI, which has been serving the interventional
cardiology, interventional radiology, and vascular surgery
communities that will be the primary users of Innova products.
CSI’s commercial presence in this space makes it an excellent fit
for accelerating the commercialization of Innova’s products post
regulatory clearances.”
Pending regulatory clearance in the United States, CSI could
begin to commercialize a portfolio of manual aspiration and clot
retrieval devices for the treatment of peripheral vascular disease
in its fiscal 2023. The portfolio and corresponding indications for
use are expected to be expanded to include treatment of DVT and PE
following completion of subsequent clinical trials.
Scott R. Ward, Chairman, President and CEO, said, “The
commercialization of these thrombectomy devices will be an
important addition to our growing pipeline of products. In total,
developing novel drug coated balloons, intravascular lithotripsy,
mechanical circulatory support, and thrombectomy devices target
some of the fastest growing segments within interventional
cardiology. Supplementing our core orbital atherectomy devices with
these technologies will greatly increase the number of patients we
will reach while simultaneously expanding our total addressable
market to over $18 billion in the coming years.”
Under the terms of the agreements signed with Innova, CSI has
provided financing to Innova for the development of the
thrombectomy devices. Under an acquisition option agreement, upon
Innova’s completion of key technical, regulatory and clinical
milestones in the development program, CSI will have exclusive
rights to acquire the thrombectomy devices, subject to the
satisfaction of closing conditions set forth in the agreement.
About Innova Vascular
Innova Vascular, Inc. is a medical device company based in
Irvine, Calif. engaged in the development of innovative minimally
invasive solutions to treat arterial and venous thromboembolism.
Its product portfolio includes, but is not limited to, Laguna™ clot
retrievers and Malibu™ aspiration catheters. Additional information
about the company can be found at www.innovavascular.com.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
innovative solutions for treating vascular and coronary disease.
The company’s orbital atherectomy system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
Safe Harbor
Certain statements in this news release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and are provided under the protection of the
safe harbor for forward-looking statements provided by that Act.
For example, statements in this press release regarding (i) the
development of new thrombectomy devices, including the specific
devices and indications; (ii) targeted milestones in fiscal 2023
and potential subsequent expansion of indications and clinical
trials; (iii) the benefits of thrombectomy and the new thrombectomy
devices; (iv) the ability of Innova and CSI to successfully develop
and commercialize the thrombectomy devices; (v) the future impact
of adding the thrombectomy devices to CSI’s portfolio; (vi) the
expansion of CSI’s portfolio of products, including the specific
products and benefits thereof; (vii) potential addressable market
sizes and expansion of market opportunities; and (viii) the
potential acquisition of the thrombectomy devices by CSI, are
forward-looking statements. These statements involve risks and
uncertainties that could cause results to differ materially from
those projected, including, but not limited to, successful
collaboration on the development of the new thrombectomy devices;
agreements with Innova and other development partners, advisors and
other third parties; the ability of CSI and these third parties to
meet development, contractual and other milestones; contractual
rights and obligations; technical challenges; satisfaction of
milestones and conditions to CSI’s rights to acquire the
thrombectomy devices; regulatory developments; clinical trial
requirements and results; FDA requirements, clearances and
approvals; the experience of physicians regarding the effectiveness
and reliability of products sold by CSI; the reluctance of
physicians, hospitals and other organizations to accept new
products; the impact of competitive products and pricing;
intellectual property protections; general economic conditions; and
other factors detailed from time to time in CSI’s SEC reports,
including its most recent annual report on Form 10-K and subsequent
quarterly reports on Form 10-Q. CSI encourages you to consider all
of these risks, uncertainties and other factors carefully in
evaluating the forward-looking statements contained in this
release. As a result of these matters, changes in facts,
assumptions not being realized or other circumstances, CSI's actual
results may differ materially from the expected results discussed
in the forward-looking statements contained in this release. The
forward-looking statements made in this release are made only as of
the date of this release, and CSI undertakes no obligation to
update them to reflect subsequent events or circumstances.
CSI is a registered trademark of Cardiovascular Systems, Inc.
All other trademarks cited herein are owned by their respective
owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20220223005244/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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