LimFlow has raised $33.5 million to take its treatment for critical limb ischemia (CLI) through a pivotal trial. The device diverts blood around severely diseased arteries, potentially saving the patient and their limb.
Paris, France-based LimFlow designed its eponymous device to treat patients with the most severe grades of peripheral artery disease (PAD). Patients with these forms of PAD, known as CLI, suffer minor tissue loss and worse as a result of restricted blood supply. In some cases, all revascularization efforts fail and amputation is the only choice left.
LimFlow thinks its device can give these patients a better option. The company’s answer to the problem is a system that creates an arteriovenous channel, thereby providing the blood with a new, clear way to reach the foot.
European officials awarded the device a CE mark in 2016 but LimFlow is yet to generate the data to support a marketing application in the U.S. That is where the Sofinnova Partners-led series C round comes in. Boosted by the round, LimFlow has the cash to reach the second half of 2020, by which point it will have wrapped up a pivotal trial designed to support a filing for FDA approval.
LimFlow is hoping the data are in line with results generated in previous studies. All seven patients with no-option CLI enrolled in a pilot study survived 30 days. After 12 months, five of the participants had avoided amputation. And the wounds of five of the patients had healed.
Researchers in the U.S. are now enrolling 25 patients to add to evidence of the efficacy of the device. LimFlow is also running a separate, 50-patient European post-marketing study to gather evidence of the effect of its device on amputation-free survival.