Efemoral Medical Receives NIH Phase II SBIR Grant to Advance Treatment of Peripheral Arterial Disease

Grant proceeds will support preclinical studies

LOS ALTOS, CA., September 22, 2022 /PRNewswire/ — Efemoral Medical, a developer of advanced interventional bioresorbable therapies, today announced that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health. SBIR grants are intended to spur technological innovation and encourage small United States companies to engage in R&D with commercialization potential. The objective of Phase II grants is to continue R&D efforts begun under Phase I, in which the technical merit, feasibility, commercial potential of a project, and quality of performance of the small beneficiary company have been established. Efemoral’s award funds will be applied to conduct studies to characterize the preclinical safety, efficacy and fundamental mechanism of action of its unique device.

The Efemoral® Vascular Scaffold System (EVSS) with FlexStep™ Technology offers a novel approach to the treatment of peripheral arterial disease (PAD) by addressing the specific anatomical challenges and complex biomechanics of patients with atherosclerotic disease. leg bite. Using a combination of rigid scaffolds and inter-scaffold spaces, patented FlexStep technology combines flexibility and support to accommodate skeletal tortuosity and movement, while the expandable balloon deployment system easily opens vessels and maintains healthy blood circulation. The novel bioabsorbable scaffold with long-term sirolimus elution aims to restore normal vessel diameter during the procedure, provide therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency without leaving any permanent implant.

“Current treatment options for patients with peripheral occlusive disease are dismal because early failures are common and outcomes continue to deteriorate over time,” said Lewis B. Schwartz, MD, co-founder and CMO of Efemoral Medical. “The EVSS uses a unique design of alternating scaffolds and dissolvable spaces that allows the long arteries of the legs to be treated with the same efficient, balloon-expandable technology that has been proven in other human vascular beds. It is time we stopped implanting metal in the arteries of our patients.”

PAD, also known as “poor circulation” or “hardening of the arteries”, is a worldwide scourge. It affects approximately 200 million people worldwide1 of which about 20 million in United States.2 Untreated, PAD can lead to severe disability and amputation of extremities. The effectiveness of current interventional treatments remains limited with up to 50% of complicated conventional endovascular procedures failing or reoccurring within the first year.3

“We are honored and grateful to receive this competitive award which is the result of rigorous scientific evaluation of the technical and commercial potential of our device by a panel of subject matter experts,” said Christopher Haig, co-founder and CEO of Efemoral Medical. “Funding from this award will allow us to supplement our ongoing clinical work with additional preclinical evidence as we strive to bring this intravascular technology to the United States. We look forward to building a strong body of evidence that demonstrates the potential of our device to reliably and sustainably treat PAD without the need for a permanent implant.”

About the price

Titled “Percutaneous Treatment of Peripheral Arterial Occlusive Disease with Implantation of Multiple Bioabsorbable, Balloon-Expandable, Drug-Eluting Scaffolds (The Efemoral Vascular Scaffold System), this SBIR Phase II award (Award Number 1 R44 HL165972-01) is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health The contents of any future publication or presentation resulting from research under this award will be the sole responsibility of the authors and do not necessarily reflect the opinions official from the National Institutes of Health.

About Efemoral Medical, Inc.

Efemoral Medical, Inc. develops next-generation bioresorbable solutions to treat patients with vascular disease. The company’s initial product, the Efemoral Vascular Scaffold System (EVSS) with FlexStep Technology, is designed to offer a dedicated strategy for PAD procedures. The Efemoral Vascular Scaffold System (EVSS) is an OUS investigational device only.

To learn more, please visit efemoralmedical.com.

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