Cardiovascular Systems, Inc. Announces First In-Human Experience With Peripheral Everolimus Drug-Coated Balloon
March 09 2022 - 7:00AM
Business Wire
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 the start of enrollment in
a first in-human trial of the peripheral everolimus drug-coated
balloon (DCB) being developed by Chansu Vascular Technologies, LLC
(CVT).
DCBs are a widely accepted percutaneous interventional treatment
option for femoro-popliteal lesions in patients with peripheral
artery disease. Everolimus, the active drug in CVT’s DCB
formulation, acts as a cytostatic agent to reduce tissue
hyperplasia and associated restenosis and has a long history of
safety and efficacy in coronary drug-eluting stent
applications.
The first patient was treated by Dr. Benjamin Honton, principal
investigator at the Clinique Pasteur, Toulouse, France. The
peripheral DCB was used to successfully treat a 69 year-old male
with a 7.5 cm lesion in his superficial femoral artery (SFA).
“We are honored to enroll the first patient in the CVT-SFA
trial,” said Dr. Honton. “We believe this promising new generation
of everolimus DCBs could improve patient outcomes for those
suffering from peripheral artery disease.”
CVT intends to enroll 75 patients at a minimum of four sites in
France and Germany to support an IDE submission to the FDA and a
subsequent U.S. pivotal clinical study.
Jeffery Chambers, M.D., CSI’s Chief Medical Officer, said,
“Following the announcement of the first in-human experience with
CVT’s coronary everolimus DCB in November 2021, we are thrilled to
announce the first in-human experience with the peripheral
everolimus DCB. We believe these products could become important
new therapies in the treatment of peripheral and coronary artery
disease.”
Under the terms of the agreements signed with CVT, CSI is
providing milestone-based financing to CVT for the development of
coronary and peripheral DCBs. Under an acquisition option
agreement, upon CVT’s completion of key technical and clinical
milestones in the development program, CSI will have exclusive
rights and obligations to acquire CVT, subject to the satisfaction
of closing conditions set forth in the agreement.
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 peripheral and coronary vascular
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.
About Chansu Vascular Technologies, LLC
Chansu Vascular Technologies LLC (CVT) is a company with its
principal office located in Sunnyvale, California. CVT was founded
by Philippe Marco, MD, with the exclusive purpose to develop
peripheral and coronary DCBs using everolimus. Dr. Marco is a
25-year medical technology veteran who has spent his entire career
focused on cardiovascular device development. He was President and
COO of Epix Therapeutics Inc. (acquired by Medtronic), and
President and COO at CV Ingenuity (acquired by Covidien), where he
was responsible for the development of the Stellarex™ DCB. Dr.
Marco started working on cardiovascular drug-delivery devices while
in charge of Medical Affairs for Abbott Vascular where, following
the Perclose Inc. acquisition, he led the franchise expansion into
a diversified portfolio from closure devices to drug-coated
coronary stents, embolic protection devices, and peripheral
catheters and stents.
About Peripheral Artery Disease (PAD)
As many as eighteen (18) million Americans, most over age 65,
suffer from PAD, which is caused by the accumulation of plaque in
peripheral arteries reducing blood flow. Symptoms include leg pain
when walking or at rest. Left untreated, PAD can lead to severe
pain, immobility, non-healing wounds and eventually limb
amputation. With risk factors such as diabetes and obesity on the
rise, the prevalence of PAD is growing at double-digit rates.
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 DCBs; (ii) the benefits of DCBs and everolimus;
(iii) clinical studies and regulatory submissions relating to the
DCBs; (iv) the ability of CVT, Dr. Marco and his team to
successfully develop the DCBs; (v) future milestone-based financing
in CVT; (vi) the future impact of adding DCBs to CSI’s portfolio;
and (vii) the potential acquisition of CVT 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, the ability of CSI
and CVT to collaborate on the development of new DCBs; the ability
of CVT to meet development milestones; satisfaction of the
conditions to CSI’s additional financing obligations; satisfaction
of milestones and conditions to CSI’s rights and obligations to
acquire CVT; technical challenges; regulatory developments;
clinical trial requirements and results; FDA 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; 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/20220309005055/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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