Procept BioRobotics today released early results from a study of its AquaBeam waterjet ablation therapy system designed for the endoscopic resection of prostate tissue exploring its use in treating benign prostatic hyperplasia, touting that it already met its primary safety and efficacy endpoints.
Results were presented at the American Urological Association’s annual meeting in San Francisco by study co-principal investigator Dr. Mihir Desai of the Keck School of Medicine of USC, the Redwood Shores, Calif.-based company said.
The AquaBeam system uses a robotically controlled waterjet to ablate prostate tissue without needing heat, Procept said. The 101-patient trial sought to explore its ability to treat urinary symptoms due to BPH at 16 sites across the US and Canada.
Data from the trial indicated that use of the AquaBeam system in men with prostate volumes between 80 mL and 150 mL resulted in significant improvements in both symptom scores and urinary flow rates while meeting its safety profile endpoints with statistical significance.
“On the heels of the Water study, the results of the Water II study confirmed aquablation delivers predictable and reproducible results regardless of the size of the prostate. These results suggest that aquablation can be a minimally invasive, transurethral option for patients with larger prostates who would otherwise only be candidates for simple prostatectomy. The pooled analysis demonstrated that, despite the increased prostate size in Water II, hemostasis can be successfully achieved following aquablation without the use of heat. Given the range of prostate sizes treated and studied, the procedural consistency and overall safety profile of aquablation is unlike any other single surgical technique for BPH,” Dr. Desai said in a prepared statement.
The company also presented data from a pooled analysis of 364 patients with prostates between 20 mL and 150 mL who were treated with the device across five trials, which showed a very low rate of major bleeding events and a peri-operative transfusion rate of less than 3% in prostates up to 150mL in volume. Results also indicated that heat-free hemostasis techniques had no difference in overall bleeding events when compared to procedures with cautery after aquablation.
“Procept BioRobotics is committed to sound clinical research and we are excited to have the results of our second pivotal study presented as part of the AUA late-breaking abstracts for the second year in a row. The results again confirm aquablation can offer men a significant improvement in quality of life with a low risk of sexual side effects and the potential of becoming the treatment of choice for men suffering from BPH, independent of the size and shape of their prostate,” co-founder & CEO Nikolai Aljuri said in a press release.
In February, Procept BioRobotics said that it raised $118 million in an equity round it plans to use on the commercialization of its Aquablation system.