SBIR Phase II: A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Transabdominal Hysterectomy and Myomectomy

Claria Medical, Inc., Mountain View CA

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to make minimally invasive surgeries involving tissue removal safer, faster, simpler, and more cost-effective through the introduction of a novel tissue containment and removal system. The initial target market will focus on improving procedures for hysterectomy or uterus removal, usually because of enlargement due to uterine fibroids. Gynecologic surgeons perform approximately 500,000 hysterectomies per year in the United States and there is an urgent need for improved solutions for tissue removal. The proposed system: (1) lowers the risks of morbidity and mortality during minimally invasive surgery; (2) saves substantial time; and (3) enables conversion of open hysterectomies to minimally invasive with faster and safer tools, reducing healthcare costs by thousands of dollars per patient. This Small Business Innovation Research (SBIR) Phase II project aims to provide a hysterectomy and myomectomy tissue containment and surgical extraction system. This project has three main objectives: First, demonstrate that a novel laparoscopic system is an effective barrier in preventing potential upstaging of occult cancers, passes electrical safety testing, passes sterilization validation, and passes biocompatibility testing. Second, develop an appropriate training program for surgeon users. Third, demonstrate that the laparoscopic system is intuitive to use, safe, and effective. 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.