Dive Brief:
- Inari Medical has agreed to acquire LimFlow, maker of a device to treat patients with chronic limb-threatening loss of blood flow, for $250 million in cash plus potential milestone payments, bringing the total deal value to $415 million.
- LimFlow’s technology is designed to deliver oxygenated blood back into the foot via the veins, bypassing blocked arteries in the leg, in patients with chronic limb-threatening ischemia (CLTI). The treatment is intended for people who face amputation and have exhausted other therapeutic options.
- The LimFlow system received approval from the Food and Drug Administration in September based on results from the company’s PROMISE II pivotal trial and earlier studies. The PROMISE II data was published in the New England Journal of Medicine.
Dive Insight:
CLTI, a severe stage of peripheral artery disease, affects more than 1.5 million patients a year globally, according to Inari. “CLTI represents one of the most significant unmet needs in vascular medicine,” the company said in a statement.
BTIG analyst Marie Thibault said LimFlow’s technology is complementary to Inari’s portfolio of devices to treat venous thromboembolism, or blood clots that form in veins.
“We think this is a smart, timely buy of a pioneering, much-needed technology,” Thibault wrote in a note to clients.
Inari acquired a minority stake in privately held LimFlow last year. Its treatment is the only FDA-approved system for no-option CLTI, in patients who have no other endovascular or surgical options and are facing amputation, according to the companies.
In its pivotal trial, 76% of no-option CLTI patients were able to keep their leg and saw progressive wound healing, according to LimFlow.
Inari claimed the market opportunity for the LimFlow system is $1.5 billion annually in the U.S. alone, with “significant potential” for expansion by targeting patients with less severe disease and commercializing the device internationally.
LimFlow will be eligible to receive additional cash payments based on meeting commercial and reimbursement milestones. The transaction is expected to close in the fourth quarter of 2023.
