eClinical Technology and Industy News

Efemoral Medical Awarded Phase II SBIR Grant from NIH to Advance Treatment for Peripheral Artery Disease

Excerpt from the Press Release:

LOS ALTOS, Calif., Sept. 22, 2022 /PRNewswire/ — Efemoral Medical, developer of advanced interventional bioresorbable therapies, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health. SBIR grants are intended to stimulate technological innovation and encourage small United States businesses to engage in 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. Funds from Efemoral’s award will be applied towards conducting studies aimed at characterizing the pre-clinical safety, efficacy, and foundational mechanism of action of its unique device.

The Efemoral® Vascular Scaffold System (EVSS) with FlexStep™ Technology offers a new approach for treating peripheral arterial disease (PAD) by addressing the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg. Using a combination of rigid scaffolds and inter-scaffold spaces, the patented FlexStep Technology combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system easily opens vessels and sustains healthy blood flow. The novel 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.

“Current treatment options for patients with peripheral occlusive disease are woeful as early failures are common and the results continue to degrade over time,” said Lewis B. Schwartz, MD, Co-Founder and CMO of Efemoral Medical.

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