Cardiovascular Systems, Inc. Announces First In-Human Experience With Peripheral Everolimus Drug-Coated Balloon

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.