Focal One focuses high-intensity ultrasound waves on affected areas, destroying cancer cells in the gland without damaging the healthy surrounding tissue. | Source: EDAP
Earlier this year, EDAP TMS SA announced the full results of a HIFI study evaluating the high-intensity focused ultrasound, or HIFU, treatment of localized prostate cancer. The study compared the French company’s robotic Focal One system against radical prostatectomy, or RP, surgery as the first line of treatment.
HIFI was the first prospective, multicenter, non-inferiority comparative study evaluating HIFU and RP in the management of prostate cancer. It found that Focal One’s treatment methods match up with the gold star standard of surgery, said EDAP. The company claimed that the robotic treatment can improve quality-of-life outcomes for those struggling with prostate cancer.
These quality-of-life changes, like a reduced rate of urinary incontinence or loss of erectile function, are what brought Ryan Rhodes to EDAP as its CEO. Previously, Rhodes spent over 13 years of his career at Intuitive Surgical. There, he saw how addressing prostate cancer had on Intuitive as a business.
In just a year, he said, radical prostatectomies performed with Intuitive’s Da Vinci system drove that company to profitability. However, every surgery comes with risks, even with robotics, acknowledged Rhodes.
“Knowing that, even in the hands of robots and doing great surgery, there was always the risk of side effects, because the surgery is still surgery, whether it’s done with a robot or not,” he told The Robot Report. “What we saw was that men suffer from loss of sexual function, loss of urinary control, and even in some instances, and we don’t always get the cancer out.”
“Around 2015, there was a lot of discussion about overtreating prostate disease with radical surgery, despite the risk of side effects, Rhodes added. “Now, we can better risk-stratify patients, and there are other options besides radical surgery, such as Focal One, which uses advances in imaging and can import biopsy data for the surgeon to set up a target plan for guided precision ablation.”
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Focal One provides a non-surgical alternative
Focal One said its HIFU Robotic System uses high-performance imaging and HIFU technology to allow urologists to target the prostate with submillimeter accuracy. This allows them to spare healthy, surrounding tissue and preserve the patient’s quality of life, the company said.
Rhodes emphasized that even when surgeons use robots, surgery is still surgery. “Cutting, coagulating, suturing, rating traction, and injury — all these things happen during surgery,” he said. “In our (non-invasive) approach, there is no surgery, no blood loss, no cutting, no radiation.”
Because Focal One doesn’t require a physician to perform surgery, it can do procedures in an outpatient setting. With just a urologist, an anesthesiologist, and a nurse, hospitals can perform HIFU procedures that take just 40 to 60 minutes, Rhodes said. This can greatly reduce staffing demands that many hospitals are already struggling with.
“That benefits everybody, and certainly urologists appreciate that benefit,” said Rhodes. “Because there’s no surgery involved, there’s no surgical fatigue.”
“Physicians can work with imaging they’re familiar with, using the same ultrasound technology they used to perform a biopsy on the patient,” he added. “In many cases, they were the ones who did the biopsy on the patient, so they remember regions of interest, where the cancer is, and the borders of that cancer.”
Much of the time, surgery is like a puzzle, Rhodes explained. Physicians often go into surgeries without knowing exactly what to expect. Focal One is intended to takes away much of that uncertainty, with a five-axis robot.
HIFI study finds favorable outcomes
The seven-year studywhich took place from April 2015 to March 2022, enrolled a total of 3,328 patients from 46 treatment centers. 1,967 consecutive patients were treated with EDAP’s robotic HIFU technologies. The French ministry of health funded the study with $20 million.
Physicians used Focal One for 90% of the patients, and 1,361 patients underwent radical prostatectomy surgery. All patients were followed for 30 months. The results were published in the journal European Urology.
At 30 months, the adjusted salvage treatment-free survival (STFS) was higher in the HIFU arm (90%) compared with the RP arm (86%). After adjusting for different variables, including age, body mass index, American Society of Anesthesiologists score, grade group, and prostate volume, the risk of salvage treatment is lower in the HIFU arm than with RP.
This result remained true when analyzing the subgroup with intermediate risk, said EDAP.
“Importantly, at 12 months, the urinary continence was better for the patients in the HIFU arm compared to surgery,” Rhodes said. “As well, patients in the HIFU arm were back to a higher baseline score on erectile function versus surgery. It is important to note that the RP surgery was often done with robotics as well. It wasn’t exclusively all robotics, but a large number of patients were operated on using robotic surgery.”
The International Continence Society (ICS) score, a measure of stress urinary incontinence deteriorated significantly less for HIFU, at 29% versus RP at 44%, for all ages combined. International Index of Erectile Function-5 (IIEF-5), a validated measurement of erectile function, decreased significantly less after HIFU than after RP, for all ages included.
Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older.
“I think really what it points to is that we now have a treatment option using robotic targeted HIFU therapy to leave the prostate gland in place, preserve the organ, and only go after the areas of cancer within that organ,” Rhodes said.
EDAP has plans for Focal One
Focal One has already received regulatory clearance and is marketed in the U.S., Europe, Canada, Korea, Russia, and Brazil, among other countries. This latest study expands access to the system in France.
“(The study) is all about patient access,” Rhodes said. “Patients need access to new technologies that treat the disease and improve quality-of-life outcomes. So what I think is most exciting, the study allows us to get in front of not only patients themselves, but (also the) urologists who treat these prostate cancer patients, the hospitals that offer point-of-care services, and even the payers that pay for treatment.”
In the future, EDAP is interested in applying Focal One’s technology to other procedures, he said. The company is currently running a Phase 2 study in Europe across three centers to test Focal One’s effectiveness in treating benign prostatic hyperplasia (BPH).
“It’s a very common disease in men as we age, and what we notice is, when we were ablating prostate tissue for cancer, men post-treatment improved in their urinary symptom scores,” Rhodes said. “So that would logically make sense. If we’re ablating tissue and creating a necrotic effect, then we’re replacing the pressure on the prostatic urethra.”
In addition, EDAP is exploring the use of Focal One to treat deep infiltrating endometriosis.
“We’re talking about endometrial implants that have evaded into the rectal wall,” explained Rhodes. “So, these create all kinds of problems, symptoms, and pain for women. We’ve developed, using the same Focal One platform, a way to ablate those endometrial implants under ultrasound guidance.”
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