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IRVINE, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced that it has entered into a definitive agreement to acquire LimFlow, S.A., a privately held pioneer in limb salvage for patients with chronic limb-threatening ischemia (CLTI). Under the terms of the agreement, Inari will pay $250 million in cash at closing and LimFlow will be eligible to receive additional cash payments based on certain commercial and reimbursement milestones. The transaction is expected to close in the fourth quarter of 2023.
LimFlow is transforming the treatment of CLTI, an advanced stage of peripheral artery disease that is associated with increased mortality, risk of amputation and impaired quality of life. CLTI is a large and underpenetrated market, impacting more than 1.5 million patients each year globally, approximately 560,000 of which are in the United States. CLTI represents one of the most significant unmet needs in vascular medicine. The minimally-invasive LimFlow System is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in no-option CLTI patients, those who are facing major amputation and have exhausted all other therapeutic options.
LimFlow recently received FDA approval for its Transcatheter Arterialization of Deep Veins (TADV) system based upon the strength of the results of the PROMISE II study which were published in the New England Journal of Medicine. LimFlow has already trained and deployed an initial team of sales representatives in targeted U.S. markets who are executing the launch of the LimFlow therapy. Inari anticipates continuing to expand this team as a focused, dedicated sales force separate from Inari’s existing VTE sales organization.
“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,” said Drew Hykes, CEO of Inari. “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 firsthand the life-changing impact this technology has on patients, as well as how complementary our two businesses are.”
“I am incredibly proud of the LimFlow team and our clinical investigators who have developed our novel solution that can provide a better life to CLTI patients,” said LimFlow CEO Dan Rose. “By joining with Inari and benefitting from their exceptional resources and capabilities, we expect to be well-positioned to increase access to our technology and advance our shared mission of creating better outcomes for patients.”
Compelling Strategic Benefits
Inari believes the LimFlow acquisition provides several strategic benefits, including:
- Aligns with Inari’s mission to address unmet patient needs: As a mission-driven company, Inari is compelled by the opportunity to deliver improved outcomes for no-option CLTI patients. LimFlow provides an innovative offering to patients who suffer in unimaginable ways and deserve better options and outcomes.
- Brings clinically differentiated CLTI solution: LimFlow received FDA approval for its LimFlow System in September 2023, and is the first and only FDA-approved system for no-option CLTI. In March 2023, results from LimFlow’s PROMISE II U.S. pivotal trial were published in the New England Journal of Medicine, demonstrating that the LimFlow System achieved 70% improvement in amputation-free survival over the current standard-of-care. LimFlow has generated compelling clinical evidence across multiple clinical trials, demonstrating the safety and efficiency of the LimFlow System as a treatment option for CLTI patients.
- Enhances avenues for growth: As its commercial launch matures, Inari expects LimFlow to become a meaningful contributor to revenue growth with robust gross margins at scale. LimFlow enriches Inari’s portfolio and adds new capabilities in a large and underpenetrated market. Of the approximately 560,000 patients suffering from CLTI in the United States each year, Inari conservatively estimates that approximately 55,000 patients currently have no treatment options other than amputation. Inari believes that these patients represent a $1.5 billion annual opportunity for LimFlow’s device in the United States alone, and that there is significant potential for expansion by targeting patients with less severe disease and by commercializing LimFlow’s device internationally.
- Leverages Inari’s core competencies: Inari has a proven track record of performance in the VTE space, including training and education, development of a novel procedural technique, building awareness among non-interventionalist stakeholders, patient pathway and program development, clinical evidence generation, and refinement of a purpose-built toolkit. Inari plans to leverage these same capabilities to successfully commercialize the LimFlow System in the United States.
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