Novel procedure and technology for treatment of BPH

Benign Prostatic Hyperplasia (BPH) is the most common urologic disorder in men over 40, affecting ~40 million men in the U.S. Most therapies provide only temporary symptomatic relief in exchange for substantial risks, including repeat procedures, urinary complications, and sexual dysfunction. As Charles B. Huggins, MD, Nobel Prize Winner for Medicine, established, prostate growth is driven by chronic androgen exposure over time. Yet no procedural therapies directly target the vascular and endocrinological pathways delivering testosterone to the prostate. Vivifi Medical proposes a paradigm shift: closing the venous pathway that delivers undiluted, testosterone-rich (T-rich) blood to the prostate. Our approach induces natural prostatic involution rather than tissue resection, thereby avoiding urinary and sexual complications. We will validate this biology in a canine BPH model using open surgical ligation of the T-rich vessels, while in parallel developing a percutaneous bipolar ablation system with custom insulated needles designed to selectively ablate these vessels without any incisions. Phase I aims to: (1) demonstrate proof-of-concept that selective ligation of T-rich vessels induces prostate regression in canines with spontaneous BPH, and (2) design and optimize insulated bipolar ablation needles for controlled ablation zone. Successful completion will establish a novel therapeutic pathway for BPH and generate a device platform ready for survival studies and human translation.