Cooperative Agreement 2212869

SBIR PHASE II: LAPAROSCOPIC DEVICE FOR TREATMENT OF VARICOCELE AND RELATED CONDITIONS -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT SEEKS TO DEVELOP OF A SAFE AND CURATIVE, MINIMALLY INVASIVE PROCEDURE LEADING TO LONG-LASTING OUTCOMES FOR PATIENTS WITH VARICOCELE. VARICOCELE IS THE MOST COMMON CAUSE OF MALE INFERTILITY AND IS ALSO ASSOCIATED WITH TESTICULAR PAIN, ERECTILE DISFUNCTION, AND LOW FREE TESTOSTERONE. VARICOCELE AFFECTS APPROXIMATELY 30 MILLION MEN IN THE US ALONE AND IS THE DIRECT CAUSE OF OVER 1.5 MILLION INFERTILE COUPLES. CURRENT METHODS OF TREATMENT HAVE LOW SUCCESS RATES, WITH ONLY 50% OF PATIENTS NOTICING > 50% IMPROVEMENT IN SPERM PARAMETERS AND UP TO 37% OF PATIENTS SHOWING NO CHANGE AFTER TREATMENT. 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. EVEN THOUGH SURGICAL LIGATION PROCEDURES HAVE SHOWN PROMISING CLINICAL EFFICACY, THE TECHNICAL DIFFICULTY IN PERFORMING THE PROCEDURES AND LOW SUCCESS RATES LEAVE ROOM FOR IMPROVEMENT. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT SEEKS TO LEVERAGE A HIGHLY EFFECTIVE PROCEDURE PROPOSED TO TREAT VARICOCELE. THIS PROCEDURE WAS PROPOSED IN THE 1980S AND WAS BASED ON AN ADVANCED UNDERSTANDING OF HEMODYNAMICS RESPONSIBLE FOR PATHOPHYSIOLOGY OF VARICOCELE. THROUGH INITIAL STUDIES, THIS PROCEDURE SHOWED GROUNDBREAKING RESULTS AND HAS BEEN USED IN MULTIPLE INDEPENDENT STUDIES TO TREAT PATIENTS WITH CLOSE TO 100% SUCCESS RATES. ADDITIONALLY, THE COMPLICATION RATES ARE SIGNIFICANTLY LOWER, WITH COMPLETE ELIMINATION OF HYDROCELE FORMATION, RECURRENCE RATES OF < 0.2% AND FASTER RECOVERY TIMES. HOWEVER, THIS PROCEDURE HAS NOT CAUGHT WIDESPREAD ADOPTION DUE TO THE HIGH SKILL REQUIRED TO PERFORM THIS PROCEDURE. THIS SBIR PROJECT SEEKS TO DEVELOP A TECHNOLOGY THAT WILL LOWER THE BARRIER TO PERFORM THE HIGHLY CHALLENGING PROCEDURE, THEREBY MAKING THE PROCEDURE A REALITY FOR PATIENTS OF VARICOCELE AND INFERTILITY. THE RESULTING DEVICE MAY AFFORD PATIENTS THE BENEFITS OF SURGERY, WITHOUT THE RISK, ULTIMATELY REDUCING OVERALL COST OF CARE ASSOCIATED WITH PATIENTS OF INFERTILITY. 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.