Israel's Allium Medical Solutions Ltd. (TASE: ALMD) has sold the WIRION Embolic Protection System and related assets of its subsidiary Gardia Medical Ltd. to US medical device company Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII) for $17 million.
The device, which received the EU CE Mark in June 2015 and US FDA clearance in March 2018, is a distal embolic protection filter used to capture debris that can be associated with all types of peripheral vascular intervention (PVI) procedures. Physicians typically use embolic protection devices in vessels located above the knee with long lesions, high plaque burden and poor run off.
The WIRION System is easier to use and more versatile than other available embolic protection systems because it can be used with any .014” guidewire and for all types of peripheral interventions. The WIRION System is also the only embolic protection device indicated for use with any atherectomy system. The WISE LE study also demonstrated a major adverse event (MAE) rate of 1.9%, which is lower than any other previously reported rates with other embolic filters. Importantly, no clinically significant distal embolization was observed when the WIRION System was used.
Allium Medical Solutions CEO Asaf Alperovitz said, “Allium Medical’s mission is to develop innovative products to improve outcomes for patients around the world. We believe the WIRION System from Gardia Medical, one of our portfolio companies, will be highly synergistic with CSI’s growing portfolio of products. We will continue to partner with CSI to execute a timely manufacturing transfer and get the product in the hands of physicians."
CSI chairman, president and CEO Scott Ward said, “The acquisition of the WIRION System further supports our commitment and mission of building a comprehensive portfolio of differentiated products aimed at saving limbs and improving outcomes for patients undergoing complex peripheral interventions.”
CSI plans to commercialize the WIRION System in the US following the transfer of manufacturing from Gardia Medical. CSI expects the manufacturing transfer to be completed after a 12- to 15-month transition period. Gardia will retain the rights to the WIRION System for angioplasty and stenting procedures in the carotid arteries.
Published by Globes, Israel business news - en.globes.co.il - on August 6, 2019
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