LimFlow has raised $40m in an oversubscribed Series D financing round to support the completion of the clinical programme until commercialisation for its LimFlow System designed for the prevention of amputations in patients.

The funding round included new investors Soleus Capital Management and Longitude Capital, as well as an undisclosed strategic investor.

LimFlow’s existing major shareholders, Sofinnova Partners, Bpifrance and Balestier, also participated in the round.

The LimFlow System has been developed for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD).

It is designed to bypass blocked arteries in the leg and provide oxygenated blood to the foot through veins.

The device uses a minimally invasive family of transcatheter products to potentially avoid major amputation, resolve pain and promote wound healing.

LimFlow intends to use the funding to pass the PROMISE II pivotal trial, which is required to obtain approval from the US Food and Drug Administration (FDA).

Recently, the company completed subject enrolment in the trial, which will be conducted in the US.

It has also completed enrolling participants in the natural history CLariTI study of high-risk and no-option CLTI patients.

LimFlow CEO Dan Rose said: “We are thankful for the support of so many industry-leading investors, both new and existing, who recognise the potential of the LimFlow System to address a major clinical need in saving patients from amputation.

“We look forward to sharing results from our pivotal trial later this year, and to the prospect of being able to make the LimFlow system commercially available as early as next year to the patients in the US and Europe who desperately need it.”

The company stated that it also included the second-generation of LimFlow System into its clinical programme last year and announced positive data from its PROMISE I feasibility trial.

In 2019, LimFlow received approval from the FDA for an investigational device exemption (IDE) pivotal study of its Percutaneous Deep Vein Arterialization (pDVA) System.