SBIR Phase I: Development of a device for permanent relief of urinary obstruction related to benign prostatic hyperplasia

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to finalize the design of an office-based implant for permanent relief of urinary obstruction related to benign prostatic hyperplasia (BPH or enlarged prostate). This condition affects over 14 million men in the US and imposes a significant quality of life burden. Established treatments include only drugs, which have limited efficacy, and surgery, which has a high complication risk. The investigational device is intended to provide permanent symptom relief in a ten-minute procedure under local anesthesia, at a cost far lower than all existing options. Expected pricing based on established reimbursement codes suggests a $3-4 billion annual market opportunity. The proposed project involves finalizing design of the aforementioned implantable device and its deployment system. The device must be easily deployable, provide sufficient circumferential force to hold back the prostate, fit within the delivery system without excessive strain or the potential for damage, and carry a low risk of adverse events. Bench tests, cadaver studies, and animal studies will drive device design to ensure satisfaction of these aims.