Cardiovascular Systems, Inc. Announces Partnership With Innova Vascular, Inc. to Develop Full Line of Thrombectomy Devices
Cardiovascular Systems, Inc. (CSII) has partnered with Innova Vascular, Inc. to develop and commercialize a new line of thrombectomy devices aimed at treating peripheral vascular diseases, including deep vein thrombosis and pulmonary embolism. This partnership aligns with CSII’s strategy to enhance its product portfolio and address the growing interventional procedure market, projected to be worth over $18 billion in the coming years. CSII plans to begin commercialization pending regulatory clearance in fiscal 2023.
- Partnership with Innova Vascular to develop thrombectomy devices expands CSII's product offerings.
- Thrombectomy devices target a lucrative market, potentially increasing CSII's total addressable market to over $18 billion.
- Pending regulatory clearance could lead to commercialization of devices in fiscal 2023.
- Dependence on regulatory clearance for commercialization may introduce delays.
- Potential risks associated with the development and approval process for new devices.
Mechanical and aspiration devices to treat peripheral vascular disease, deep vein thrombosis and pulmonary embolism
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.
Pending regulatory clearance in
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
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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
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Vice President, Investor Relations & Corporate Communications
(651) 202-4919
j.nielsen@csi360.com
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FAQ
What is the partnership between Cardiovascular Systems, Inc. and Innova Vascular, Inc. about?
What market opportunity do the new thrombectomy devices represent for CSII?
When is CSI planning to commercialize the new thrombectomy devices?