LimFlow Raises Funds to Support Completion of CLTI Device Clinical Program

April 5, 2022—LimFlow SA announced it has closed a $40 million (€36 million) oversubscribed Series D financing round that will fund follow-up for the PROMISE II United States pivotal trial and commercialization of the transcatheter LimFlow system for deep vein arterialization treatment of chronic limb-threatening ischemia (CLTI).

According to LimFLow, new investors in the financing round include Longitude Capital, Soleus Capital Management, and an undisclosed strategic investor, who join current major shareholders of the company including Sofinnova Partners, through its Crossover Strategy fund; Bpifrance, the French sovereign investment bank; and Balestier, a Singaporean family fund.

On March 15, 2022, the company announced it had completed enrollment in PROMISE II, which is being conducted to support FDA approval of the LimFlow system.

LimFlow also completed enrollment in CLariTI, a natural history study of high-risk and no-option CLTI patients that is evaluating outcomes from patients treated with the current standard of care.

In the last year, the company integrated the second generation of its LimFlow system into its clinical program, advised the company.

In October 2021, Daniel Clair, MD, presented 2-year results from the PROMISE I trial during a late-breaking clinical trials session at VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

In the United States, the LimFlow system has received FDA Breakthrough Device designation and is available for investigational use only. The LimFlow system has received CE Mark approval and is currently available commercially in Europe. It has not been approved for sale in the United States, Canada, or Japan, advised the company.