Editor: What To Know
- 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.
- 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.
- Commercialization of the thrombectomy devices will be highly complementary to CSI's broader portfolio of advanced technologies used in the treatment of cardiovascular disease.
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.
Cardiovascular Systems notes 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.
