October 20, 2019
Venarum Medical Receives Ongoing NIH SBIR Grant Support for its EndoVenous Valve System
October 21, 2019—Venarum Medical, LLC announced receipt of a mentorship grant in further support of its awarded National Institutes of Health (NIH) Small Business Innovation Research (SBIR) phase 2 grant for the company’s EndoVenous valve system (EVVS), which is currently underway. The recently awarded supplemental grant provides funds for the mentorship and professional development of a female engineer contributing to the project.
EVVS is a patent-pending valve-replacement solution for the treatment and mitigation of serious complications of chronic venous disease, such as chronic venous insufficiency and related dysfunctional venous valves in the deep veins.
According to the company, the endovascularly delivered device is intended to reduce the risk of edema, ulcers, amputation, or other related complications. The EVVS features a novel, nitinol stent–like scaffold embedded in a biocompatible, thromboresistant polymer with integrated polymeric, flexible inner valve leaflets. The device is placed at or near the site of venous valve failure to significantly reduce reflux while promoting self-flushing (to minimize blood stagnation) and maintaining adequate forward flow.
Venarum’s CEO/CTO, Janet Burpee, stated, “The completed SBIR phase 1 development proved feasibility of the EVVS concept, including demonstration of excellent flow properties. In phase 2, Venarum intends to complete most of the preclinical testing required for FDA approval of an investigational device exemption, enabling a United States first-in-human clinical feasibility study.” Under the phase 2 work, Venarum proposes to verify the preclinical safety of the EVVS.
Venarum is also developing the United States clinical protocol for its investigational device exemption submission.
The development work described by the company is supported by the National Heart, Lung, and Blood Institute of the NIH under award number R44HL137540. Approximately 37% of funding has come from this grant and 63% from private investors, totaling more than $7 million.