SBIR Phase I: Novel Laparoscopic Device for treatment of Varicocele

Vivifi Medical Llc, Houston TX

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to advance translation of a new procedure to address varicocele, the most common cause of male infertility. Varicocele affects approximately 30 million men in the US alone and is the direct cause of over 1.5 million involuntary infertile couples. It is also associated with testicular pain, erectile disfunction, and low free testosterone. Current treatments have varying success, with only 50% of patients noticing >50% improvement in sperm parameters and up to 37% of patients showing no change. The treatment for varicocele has not changed since 1929 and consists of ligation or occlusion of the internal spermatic vein, the primary route of drainage for the testis. This project will advance a new method of treatment. This Small Business Innovation Research (SBIR) Phase I project aims at leveraging a highly effective procedure proposed to treat Varicocele. Even though surgical ligation procedures have shown promising clinical efficacy, the technical difficulty and low success rates motivate other treatment modalities. This procedure was proposed in the 1980s based on an advanced understanding of hemodynamics responsible for the pathophysiology of varicocele. Preliminary tests suggest lower complication rates and complete elimination of hydrocele formation, recurrence rate of up to 0.2%, and faster recovery times. This project will advance a technology to simplify the procedure. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.