Prostate cancer affects 250,000 men annually in the US alone, and treatments are either not definitive (watchful waiting) or too morbid (radiation or surgery). Avenda’s product enables a patient’s cancer to be treated under local anesthesia using MRI-ultrasound fusion for image guidance. Up to 60-80k men annually in the US are eligible candidates for this procedure. Avenda uses its device is lower cost (no operating room), simpler (local anesthesia), and faster (45 mins) than competing technologies. Importantly, it enables treatments to be performed by the urologist.
The device is a fiber-optic laser and a novel disposable sensor that enables treatments to be safe and precise under ultrasound guidance. This device is powered by a feedback control system containing a diode laser source, cooling pump, and control software. Our software integrates patient-specific planning based on thousands of prostate images and biopsies, gathered over a 7-year period and backed by peer-reviewed science. An exclusive agreement to license the IP has been signed with UCLA.
A phase I study (FDA IDE / UCLA IRB) on 10 patients was completed using an initial prototype, demonstrating safety and no decline in urinary or sexual function in any patient anytime over the 1-year follow-up period. We anticipate a 510(k) pathway and a CPT code exists for this procedure, but it is still investigational.