LimFlow, a developer of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), has entered into a definitive agreement to be acquired by Inari Medical, a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases.
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Under the terms of the agreement, LimFlow will receive $250 million in cash at closing and be eligible to receive up to $165 million in additional payments based on certain commercial and reimbursement milestones, for a total potential transaction value of up to $415 million. The transaction is expected to close in the fourth quarter of 2023.
LimFlow’s acquisition by Inari Medical is expected to increase patient access to its LimFlow System for Transcatheter Arterialization of the Deep Veins (TADV), which is designed to re-establish blood flow in deep veins for “no-option” CLTI patients who have no other suitable endovascular or surgical treatment options and are facing major amputation.
FDA approval for the LimFlow System was received in September 2023 based on successful outcomes seen in the PROMISE II pivotal trial, recently published in The New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment. The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.
LimFlow CEO Dan Rose, said: "We are thrilled to join forces with Inari Medical, expanding the reach of our remarkable technology to bring renewed hope to patients who are currently suffering. Our heartfelt gratitude goes out to the exceptional LimFlow team, our dedicated clinical partners, and our investors who believed in our mission. Together, we eagerly anticipate advancing our shared vision of addressing crucial unmet needs in the realm of vascular disease.”
LimFlow investors include Sofinnova Partners (through its Crossover Strategy), Bpifrance, Balestier (an affiliate of M&L Healthcare Investments), Longitude Capital, Soleus Capital and Inari Medical. LimFlow was incubated by MD Start and co-founded by Martin Rothman, MD and Tim Lenihan.
Drew Hykes, CEO of Inari, said: “The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform into our portfolio. We see the CLTI market as poised for durable growth, driven by compelling technology, outstanding clinical results, and multiple opportunities for expansion. As a minority investor and board observer in LimFlow since early 2022, we have seen first-hand the life-changing impact this technology has on patients, as well as how complementary our two businesses are.”
