SBIR Phase I: A Minimally Invasive Transurethral Cryotherapy Catheter System for Benign Prostate Hyperplasia

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to provide a low-cost, safe, and durable treatment option for benign prostate hyperplasia (BPH), affecting 12.9 M Americans annually. First-line pharmacological therapy is the most common treatment for BPH, but these drugs provide modest clinical improvements and induce undesirable, and sometimes permanent, side effects that impact quality of life. This drives an estimated 62-91% of patients to discontinue treatment after 12 months. Patients who fail first-line therapy have the choice to pursue surgery, but due to the high risk of permanent complications, painful recovery, or a poor long-term prognosis associated with current surgical techniques, only 1.1% of all managed patients choose to have surgery each year. As a result, 35% of all managed BPH patients opt to not receive either medication or surgery. This watchful waiting patient population risks irreversible bladder damage if left untreated, where symptoms have been reported to worsen in ~87% of BPH patients over a four-year period. Importantly, it is estimated that sur gical intervention is necessary in 30% of all men afflicted with BPH, leaving millions of Americans without a robust option. The proposed solution treats the prostate with a minimally invasive catheter system. The proposed project advances translation of a system to provide focal cryoablation to the human prostate. By implementing directional and localized cryotherapy through a series of catheter balloons, the device can remove enlarged prostate tissue while preserving adjacent anatomical structures key for preservation of sexual function and continence. Moreover, treated prostate tissue can be monitored in real time with ultrasound imaging for enhanced safety and treatment guidance. The goal of this Phase I proposal is to optimize a directional cryotherapy system in a benchtop model and verify its use to ablate the prostate lateral lobes. To optimize cryoablative dosing, temperature isotherms will be characterized and spatially mapped in an in vitro prostate tissue model across a range of operating parameters. 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.