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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