- Easy-to-use, stand-alone, single session mechanical thrombectomy for removal of venous clot in highly attractive, rapidly growing and significantly under-penetrated market
- FDA 510(k) cleared (Dec. 2020) and CE Mark Certification (May 2021)
12-month follow-up data of 19-patient feasibility trial presented at American Venous Forum (March 2021) all primary endpoints met with no safety issues1 - Positions Surmodics with two FDA-cleared mechanical thrombectomy devices to treat arterial and venous vasculature and IP for potential indication expansion
SurModics, Inc., (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that it has acquired privately-held Vetex Medical Limited. The Galway, Ireland-based medical device developer and the manufacturer has focused exclusively on venous clot removal solutions. The transaction expands Surmodics’ thrombectomy portfolio with a second U.S. Food and Drug Administration (FDA) 510(k)-cleared device, the ReVene™ Thrombectomy Catheter.
The ReVene mechanical thrombectomy catheter is specifically designed to remove large, mixed-morphology blood clots commonly found with venous thromboembolism (VTE). The device’s dual-action technology efficiently removes mixed-morphology clots in a single session, minimizing the need for thrombolytic and without capital equipment.
“This acquisition demonstrates our commitment to the expansion of our thrombectomy platform to remove thrombus in venous vascular beds, with an exciting technology that offers significant improvements over current therapies,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “Surmodics is now well-positioned with two ground-breaking, FDA-cleared mechanical thrombectomy devices to treat both arterial and venous thrombosis. The synergies between the Vetex technology and their talented team, with our capabilities on our Pounce thrombectomy technology, enables us to accelerate our thrombectomy platform development for the future treatment of pulmonary embolism (PE).”
“The ReVene Thrombectomy Catheter has the potential to significantly expand the use and accessibility of venous mechanical thrombectomy by allowing physicians to intervene early and complete the procedure in a single session,” said Stephen Black, principal investigator and leading enroller of the VETEX feasibility study and Consultant Vascular Surgeon at Guy’s and St. Thomas’ NHS Foundation Trust, London. “The ease of use, intuitive design, and efficient performance of this device enable it to become the first-line treatment and a confident choice by venous interventionalists.”
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Under the terms of the acquisition agreement, Surmodics acquired Vetex with an upfront payment of $39.9 million. Additional payments of up to $7 million, $3.5 million of which are guaranteed, may be made upon achievement of certain product development and regulatory milestones. The upfront payment was funded using cash on hand and $10 million from Surmodics’ $25 million revolving credit facility. The acquisition will be dilutive on a GAAP and non-GAAP basis in Surmodics’ fiscal 2021 and is expected to be accretive on a non-GAAP basis, excluding acquired intangible asset amortization expense, beginning the second half of fiscal 2023. The company expects fiscal 2021 acquisition-related costs and acquired intangible asset amortization expense to range from a total of $0.10 to $0.12 per share. Surmodics plans to provide updated fiscal 2021 guidance, including the impact from the Vetex acquisition, during its third-quarter earnings announcement.
Surmodics expects to initiate clinical evaluation activities for the Pounce Arterial Thrombus Retrieval System for removing clots in peripheral arteries in the second half of fiscal 2021 and for the ReVene™ Thrombectomy Catheter for removal of clot from veins in fiscal 2022. A projected timeline for further commercialization will be announced later this fiscal year.
Source: Biospace