A firm that was labeled one of Medtech’s 16 Most Promising Private Companies by Canaccord Genuity earlier this year, has strong results from a study that will help with FDA approval. LimFlow recently announced positive six-month data from the full patient cohort in its PROMISE I early feasibility study of the Percutaneous Deep Vein Arterialization (pDVA) System.
The Paris-based company presented the data during the Vascular Interventional Advances [VIVA] Conference held in Las Vegas, earlier this month. The company’s technology is used for the treatment of chronic limb-threatening ischemia (CLTI). PROMISE I was conducted at seven U.S. centers encompassing 32 end-stage – or “no option” – CLTI patients, 100% of whom had non-healing wounds on the target foot, 69% of whom had diabetes, and 34% of whom had renal insufficiency.
At six months, the LimFlow System achieved an amputation-free survival rate of 74%. A strong trend of successful wound healing was also demonstrated, with 67% of wounds classified as healed or healing at six months and 100% healed or healing at nine months. Technical success was 97%.
“We’re doing something very different,” Dan Rose, LimFlow, CEO told MD+DI. “We’re channeling blood from the artery into the vein – taking out the valves in the veins in the lower leg and feet. We’re reperfusing the blood via an alternate pathway.”
He added, “PROMISE I tells us this technique does work and it builds on the back of the first-in-human and other studies that we’ve done. We’re just gathering more evidence this is a viable pathway and ultimately we have used the results of PROMISE I to get approval to start a pivotal trial.”
The pivotal trial will have between 60 and 100 patients at 20 sites. Filing for approval is expected to happen sometime in 2021, Rose said. LimFlow was awarded breakthrough device designation for the technology in 2018. The company won CE mark for pDVA in 2016.
CLTI is the most severe form of peripheral artery disease and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and high blood pressure. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.
Jason Mills, an analyst with Canaccord Genuity, wrote in a report earlier this year, that CLTI prevalence is forecast to continue to increase behind an increasing rate of diabetes coupled with a reduction in cardiovascular disease-driven mortality as therapies continue to improve. In the report, he cited that roughly 50% of CLI patients today progress to amputation without receiving any form of vascular intervention, with about 160,000 patients today reaching “no option” status. Those are the patients LimFlow is focused on targeting.
Mills also pointed out that LimFlow's platform carries compelling health economic benefits, cutting down on high average annual costs associated with treating amputations (about $800,000 per patient estimated direct healthcare costs).