Inari Medical has signed on to a $415 million deal to acquire LimFlow, just weeks after the company received an FDA approval for its minimally invasive approach to re-establish oxygenated blood flow in the legs of people potentially facing amputation.
LimFlow’s treatment for chronic, limb-threatening ischemia is aimed at patients who have exhausted all other therapeutic options. Its transcatheter-based implant bypasses blocked arteries by instead redirecting the blood through the veins of the leg.
The LimFlow system obtained a green light from the FDA in mid-September, and previously received a CE Mark approval in Europe. The results of a clinical trial—showing about two-thirds of treated patients were able to avoid the loss of limbs after 6 months, for a 70% improvement over the standard of care—were published this past March in the New England Journal of Medicine.
Inari estimates that this dangerously hampered blood flow can affect up to 1.5 million people internationally, and about 560,000 in the U.S. About 10% to 20% of CLTI patients may have no other revascularization options, leading to amputations above-the-ankle.
“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,” Inari CEO Drew Hykes said in a statement. “We see the CLTI market as poised for durable growth, driven by compelling technology, outstanding clinical results, and multiple opportunities for expansion.”
The acquisition agreement includes $250 million in upfront cash plus up to $165 million in milestones tied to commercial sales and reimbursement coverage, the first of which would come due in 2025, according to the companies. The deal is slated to close before the end of this year.
While LimFlow has already deployed an initial sales team in selected U.S. markets, Inari said it plans to expand those efforts and build out a dedicated sales force separate from its existing organization focused on venous thromboembolism.
Inari’s portfolio also includes blood clot removal devices designed for large and small veins, including deep vein thrombosis, as well as for pulmonary embolisms, with its FlowTriever and ClotTriever systems, among others.
“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 Hykes.
Alongside the acquisition announcement, Inari delivered its third-quarter earnings report, with revenues of $126.4 million resulting in a 31.4% gain over the previous year. Operating expenses totaled $109.8 million, resulting in a net income of $3.2 million.
The Irvine, California-based company also raised and tightened its guidance for the full year, forecasting revenues between $490 million and $493 million, up from its previous predictions of $482 million to $492 million.