|Surgery using Aquablation--Courtesy of Procept BioRobotics|
The standard treatment for a noncancerous enlarged prostate is to use heat-based ablation to remove it or reduce its size. But even though that treatment can improve symptoms, including the restoration of urinary flow, it can cause a loss of sexual function and other problems.
Now, Procept BioRobotics has rounded up $42 million--no small change for a medical device company--to get through a pivotal trial of its water-based ablation technology to potentially treat this condition, benign prostatic hyperplasia (BPH), without the side effects seen with heat-based ablation, which include bleeding, dysuria, incontinence and sexual dysfunction.
The startup's AquaBeam System uses image-guidance and robotics to deliver minimally invasive waterjet ablation therapy using saline, which it has dubbed Aquablation, for targeted, heat-free removal of tissue to treat lower urinary tract symptoms.
Procept expects to use the cash to start the pivotal, randomized, controlled WATER (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) trial later this year, it will also start a limited international commercial launch.
"We look forward to the initiation later this year of the WATER study, our global Phase III clinical study which will compare the safety and effectiveness of Aquablation to the current standard of care, transurethral resection of the prostate, or TURP, for the treatment of benign prostatic hyperplasia," said Procept founder and CEO Nikolai Aljuri in a statement.
In May, the Redwood City, CA-based company presented Phase II data for Aquablation to treat BPH at the American Urological Association meeting in New Orleans, LA. The procedure had a technical success rate of 100% in 21 male patients--it reduced symptoms by a 15.9 mean decrease in the International Prostate Symptom Score at 6 months.
In addition, urine flow improved with a 10.1mL/sec increase in the average peak urinary flow rate. Importantly, there was no occurrence of urinary incontinence or loss of ejaculatory or erectile function in any of the men in the study.
"The clinical data generated by Procept BioRobotics to date are very promising and we hope the pivotal trial will demonstrate Aquablation has the potential to become the new standard of care for BPH treatment," Jack Nielsen, a partner at Novo A/S, which led the financing, said in a statement. CPMG and undisclosed existing investors also participated.
Added CPMG Partner Antal Desai, "They have developed a disruptive technology that addresses a profound unmet need for millions of patients suffering from BPH."
- here is the release