Efemoral Medical Awarded Phase II SBIR Grant From NIH for Vascular Scaffold System

September 22, 2022—Efemoral Medical, developer of interventional bioresorbable therapies, announced that it has been awarded a phase II Small Business Innovation Research (SBIR) grant, which is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH).

According to the company, funds from the grant will be used to conduct studies aimed at characterizing the preclinical safety, efficacy, and foundational mechanism of action of the Efemoral vascular scaffold system (EVSS) with FlexStep technology for the treatment of peripheral arterial disease (PAD).

Efemoral explained in the press release that the EVSS with FlexStep is designed to address the specific anatomic challenges and complex biomechanics of patients with athero-occlusive disease in the leg. The FlexStep technology uses a combination of rigid scaffolds and interscaffold spaces to provide flexibility with support, accommodating tortuosity, and skeletal movement. The balloon-expandable deployment system easily opens vessels and sustains healthy blood flow.

The bioresorbable scaffold with long-term sirolimus elution aims to restore normal vessel diameter during the procedure; deliver therapeutic benefits across all lesion lengths and morphologies; prevent restenosis; and maintain patency while leaving no permanent implant behind, stated the company.

Lewis B. Schwartz, MD, Cofounder and CMO of Efemoral Medical, commented in the press release, “Current treatment options for patients with peripheral occlusive disease are woeful as early failures are common and the results continue to degrade over time. The EVSS uses a unique design of alternating dissolvable scaffolds and spaces that enables 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. It's time that we stopped implanting metal into our patient's arteries.”

As noted in the company’s press release, SBIR grants are intended to stimulate technological innovation and encourage small United States businesses to engage in research and development (R&D) with the potential for commercialization. The objective of phase II grants is to continue the R&D efforts started under phase I, in which the technical merit, feasibility, commercial potential of a project, and the quality of performance of the small business awardee have been established.

Christopher Haig, Cofounder and CEO of Efemoral Medical, added, “We are honored and grateful to receive this competitive award that came as a result of a rigorous scientific assessment of the technical and commercial potential of our device from a panel of subject-matter experts.”

Mr. Haig continued, “Funding from this award will allow us to complement our ongoing clinical work with additional preclinical evidence as we endeavor to bring this intravascular technology to the United States. We are looking forward to building a robust body of evidence that demonstrates the potential of our device to reliably and durably treat PAD without the need for a permanent implant.”