Cardiovascular Systems, Inc. Announces FDA 510(k) Submission of Innova Vascular, Inc.’s Thrombectomy System

Rhea-AI Summary

Cardiovascular Systems, Inc. (CSII) has announced that Innova Vascular, Inc. has submitted a 510(k) Premarket Notification to the FDA for thrombectomy devices to treat peripheral vascular disease. CSI plans to acquire and commercialize these devices, which will enhance its existing portfolio. Commercialization could begin in about 6 months, pending FDA clearance. The acquisition agreement includes financing for Innova, contingent on meeting development milestones. This partnership aims to expand treatment options for deep vein thrombosis and pulmonary embolism.

Positive

• Abililty to commercialize thrombectomy devices within approximately six months pending FDA clearance.
• Opportunity to expand product portfolio, including treatments for DVT and PE.
• CSI's strong commercial presence with over 150 peripheral sales representatives.

Negative

• Regulatory clearance is still pending, posing a risk to commercialization timeline.
• Dependence on Innova meeting key technical and regulatory milestones for acquisition.

System includes mechanical and aspiration thrombectomy devices to treat peripheral vascular disease

ST. PAUL, Minn.--(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 that Innova Vascular, Inc. (Innova) has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA) for its thrombectomy devices intended to treat peripheral vascular disease.

Thrombectomy is a rapidly growing interventional procedure performed to remove blood clots from arteries and veins. CSI intends to acquire and commercialize each of the novel thrombectomy devices from Innova targeting peripheral vascular disease. 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, “The FDA submission of the thrombectomy devices for use in the peripheral vasculature marks an important milestone in our commitment to develop innovative technologies targeting large, underserved markets. 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 this thrombectomy system.”

Pending regulatory clearance in the United States and completion of the acquisition of the first Innova system, CSI could begin to commercialize a portfolio of aspiration catheters and clot retrieval devices for use in peripheral vasculature in approximately 6 months. The portfolio and corresponding indications for use will be expanded to include the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following completion of the respective clinical trials and subsequent 510(k) clearances. These trials are expected to begin enrolling later in calendar 2023.

Scott R. Ward, Chairman, President and CEO, said, “CSI’s strong commercial presence, with over 150 peripheral sales representatives, will make thrombectomy an excellent fit as we seek to reach more patients and drive increased revenue through our sales channel beginning later this year.”

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, the Laguna Clot Retriever^TM System and the Malibu Aspiration Catheter^TM System. 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, including FDA clearance and commercialization, 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230104005717/en/

Cardiovascular Systems, Inc.

Jack Nielsen

Vice President, Investor Relations & Corporate Communications

(651) 202-4919

j.nielsen@csi360.com

Source: Cardiovascular Systems, Inc.

FAQ

What recent submission did Cardiovascular Systems Inc. make regarding thrombectomy devices?

Cardiovascular Systems Inc. announced that Innova Vascular submitted a 510(k) Premarket Notification to the FDA for thrombectomy devices aimed at treating peripheral vascular disease.

When could Cardiovascular Systems Inc. begin commercialization of the thrombectomy devices?

Commercialization of the thrombectomy devices could begin in approximately six months, pending FDA clearance.

What are the potential new uses for the thrombectomy devices from Cardiovascular Systems Inc.?

The thrombectomy devices are expected to be expanded for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) after clinical trials.

What is the significance of the partnership between Cardiovascular Systems Inc. and Innova Vascular?

The partnership aims to develop innovative thrombectomy devices, enhancing CSI's product portfolio and addressing unmet needs in vascular disease.

What financing agreement has been made between Cardiovascular Systems Inc. and Innova Vascular?

CSI has provided financing to Innova for the development of thrombectomy devices, with an option to acquire them upon meeting specific milestones.