Efemoral Medical has today announced the closing of its US$4.9 million preferred Series A1 round. Supported by existing investors as well as an experienced cohort of new investors, the proceeds will further Efemoral’s device development and expand enrolment in its ongoing first-in-human clinical trial, EFEMORAL I, investigating the Efemoral vascular scaffold system (EVSS) with FlexStep technology.
The new funds will also complement Efemoral’s recently announced phase II Small Business Innovation Research (SBIR) grant award, which will support pre-clinical studies.
The EVSS with FlexStep technology offers a new approach to treating peripheral arterial disease (PAD) by addressing the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg, Efemoral states in a press release. Through the use of inter-scaffold spaces, the patented FlexStep technology combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system is designed to open vessels and sustain healthy blood flow. The novel bioresorbable scaffold with long-term Sirolimus elution aims to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind, the company’s statement adds.
“The implantation of strong, balloon-expandable, drug-eluting stents has conclusively been shown to be the best therapy for diseased human arteries. Their results in the coronary arteries of the heart have been no less than spectacular,” said Lewis B Schwartz, co-founder and chief medical officer (CMO) of Efemoral Medical. “However, these rigid devices cannot be safely implanted into the arteries of the legs because they would be crushed as the patient walks or sits. The EVSS uses a unique design of alternating dissolvable scaffolds and spaces that, for the first time, allows the long arteries of the legs to be treated with the same, effective, balloon-expandable technology proven to be successful in other human vascular beds.”
“The initial clinical experience in EFEMORAL I has demonstrated that the EVSS has the potential to be a highly effective treatment for femoro-popliteal disease,” said Christopher Haig, co-founder and chief executive officer (CEO) of Efemoral Medical. “This new funding will allow us to build additional confidence in our device by taking it to multiple hospitals and enrolling more patients. We remain committed to advancing the science behind our device and are excited about the potential of our technology to offer a durable clinical solution to patients and physicians.”