New funding will support increasing enrollment in its ongoing first-in-human trial, EFEMORAL I
LOS ALTOS, Calif., Dec. 13, 2022 /PRNewswire/ -- Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced the closing of its $4.9M 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 enrollment in its ongoing first-in-human clinical trial, EFEMORAL I. These new funds will complement Efemoral's recently announced Phase II SBIR award, which will support pre-clinical studies.
The Efemoral Vascular Scaffold System (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. 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 easily opens vessels and sustains 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 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, MD, Co-Founder and 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."
PAD, also known as "poor circulation" or "hardening of the arteries," is a global plague. Worldwide, it affects approximately 200 million people1, including an estimated 20 million people in the United States2. Left untreated, PAD can lead to severe disability and extremity amputation. The effectiveness of current interventional treatment remains limited, with up to 50% of conventional endovascular procedures complicated by failure or recurrence within the first year.3
"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 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."
Efemoral Medical, Inc. is developing 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 interventions. The Efemoral Vascular Scaffold System (EVSS) is an OUS Investigational Device only.
To learn more, please visit efemoralmedical.com.
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377796/
2 Yost, The True Prevalence of PAD and the Economics of Major Amputation Endovascular Today, May 2021
3 https://www.researchgate.net/publication/260118801_Nitinol_Self-Expanding_Stents_vs_Balloon_Angioplasty_for_Very_Long_Femoropopliteal_Lesions
SOURCE Efemoral Medical
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
Newsrooms &
Influencers
Digital Media
Outlets
Journalists
Opted In
Share this article