Under its Phase II work, Venarum proposes to verify the preclinical safety of the EndoVenous Valve System (EVVS), a novel patent-pending valve-replacement solution for treatment and mitigation of serious complications of chronic venous disease (CVD) such as chronic venous insufficiency (CVI) and related dysfunctional venous valves in the deep veins. This endovascularly-delivered device is intended to reduce the risk of oedema, ulcers, amputation or other related complications.
The EVVS comprises 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 in order to significantly reduce reflux while promoting self-flushing to minimize blood stagnation and maintaining adequate forward flow. The recently awarded supplemental grant provides funds for the mentorship and professional development of a female engineer contributing to the project.
Venarum’s CEO and CTO, Janet Burpee, said: “The completed SBIR Phase I development proved feasibility of the EVVS concept including demonstration of excellent flow properties. In Phase II, Venarum intends to complete most of the preclinical testing required for FDA approval of an IDE enabling a US first-in-human clinical feasibility study.” In addition, Venarum is also working with its medical advisors to develop the US clinical protocol for its IDE submission.
With regards to the recent SBIR award, Burpee added: “I am both thrilled to have ongoing support for the development of our prosthetic venous valve and to be able to dedicate additional resources to mentoring a young female engineer, something that is very important to me personally. The entire team will benefit from this and other mentorship opportunities.”