Focal One focuses high-intensity ultrasound waves on the affected area, destroying cancerous cells in the gland without damaging surrounding healthy tissue. | Source: EDAP
Earlier this year, EDAP TMS SA published the full results of the HIFI study evaluating high-intensity focused ultrasound (HIFU) as a treatment for localized prostate cancer. The study compared the French company’s robotic Focal One system with: Radical prostatectomy (RP) is performed as the first treatment.
HIFI was the first prospective, multicenter, non-inferiority comparative study evaluating HIFU and RP in the management of prostate cancer. EDAP said it found that Focal One’s treatment methods were consistent with the Gold Star standard of surgery. The company claimed that robotic therapy could improve the quality of life for people suffering from prostate cancer.
Quality of life changes, such as reduced rates of urinary incontinence or loss of erectile function, are what brought Ryan Rhodes to EDAP as CEO. Previously, Rhodes had more than 13 years of experience with Intuitive Surgical. There he saw how Intuitive was addressing the prostate cancer issue as a business.
He said that in just one year, thorough prostatectomy using Intuitive’s Da Vinci system helped the company achieve profitability. But even with robotics, all surgery carries risks, Rhodes acknowledged.
“We know that even if you do a great surgery in the hands of a robot, there is always a risk of side effects, because surgery is still surgery whether you use a robot or not,” he said. Robot Report. “What we’ve seen is that men are experiencing loss of sexual function, loss of urinary control, and in some cases even cancer, which doesn’t always go away.”
“Around 2015, there was a lot of discussion about overtreating prostate disease with radical surgery, despite the risk of side effects,” Dr. Rose added. “Now we can better stratify the risk of patients and have other options in addition to radical surgery, such as Focal One, which uses advances in imaging and can take biopsy data to help surgeons set a targeted plan for guided precision resection. There is.”
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Focal One offers 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 preserves healthy surrounding tissue and preserves the patient’s quality of life, the company said.
Rose emphasized that even if surgeons use robots, surgery is still surgery. “Cutting, coagulation, suturing, traction evaluation, injury — all of this happens during surgery,” he said. “Our (non-invasive) approach involves no surgery, no bleeding, no incisions, no radiation.”
Focal One does not require a physician to perform the surgery, allowing the procedure to be performed in an outpatient setting. Rose said a HIFU procedure can be performed in a hospital in 40 to 60 minutes with just a urologist, an anesthesiologist and a nurse. This could significantly reduce staffing needs, which many hospitals are already struggling with.
“It’s beneficial for everyone, and certainly urologists appreciate the benefits,” Rhodes said. “Because there is no surgery, there is no surgical fatigue.”
“Physicians can perform familiar imaging tasks using the same ultrasound technology they use to perform biopsies on patients,” he added. “In many cases, they were the ones who performed the patient’s biopsy, so they remember the area of interest, where the cancer is, and the boundaries of the cancer.”
In most cases, surgery is like a puzzle, Rhodes explained. Doctors often begin surgeries without knowing exactly what to expect. Focal One is designed to eliminate much of this uncertainty with its 5-axis robot.
HIFI Study Finds Favorable Results
The study, which lasted seven years 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 technology. The French Ministry of Health funded the study with $20 million.
Physicians used Focal One in 90% of patients, and 1,361 patients underwent radical prostatectomy. All patients were followed up for 30 months. The results were published as follows: newspaper European Urology.
The adjusted salvage-free survival (STFS) at 30 months was higher in the HIFU group (90%) compared to the RP group (86%). After adjusting for various variables including age, body mass index, American College of Anesthesiologists score, grade group, and prostate volume, the risk of salvage treatment was lower in the HIFU group than RP.
EDAP said these findings remained when analyzing the intermediate-risk subgroup.
“Importantly, at 12 months, urinary incontinence was improved for patients in the HIFU treatment group compared to surgery,” Rhodes said. “Also, patients in the HIFU treatment group had higher baseline scores for erectile function compared to surgery. It is important to note that RP surgery is also often performed robotically. “Not all patients underwent robotic surgery, but a significant number of patients underwent surgery using robotic surgery,” he said.
that The International Continence Society (ICS) score, a measure of stress urinary incontinence, worsened significantly less at 29% for HIFU and 44% for RP across all ages combined. The International Index of Erectile Function-5 (IIEF-5), a validated measure of erectile function, decreased significantly after HIFU compared to after RP in all age groups.
Post-procedure benefits of HIFU on both erectile function and urinary incontinence were demonstrated, despite the average age of patients in the HIFU treatment group being 9.6 years.
“What this means in practice is that there is a treatment option that uses robotic targeted HIFU therapy that leaves the prostate in place, preserves the organ, and tracks only the area of cancer within that organ,” Rhodes said.
EDAP has plans for Focal One.
Focal One has already received regulatory approval and is available in several countries, including the United States, Europe, Canada, Korea, Russia, and Brazil. This latest study expands accessibility to the system in France.
“(This study) is about patient access,” Rhodes said. “Patients need access to new technologies to treat their disease and improve their quality of life. So, I think the most exciting thing is that this study allows us to reach not only the patients themselves, but also the urologists who treat these prostate cancer patients, the hospitals that provide point-of-care services, and even the payers. It’s about paying for treatment.”
In the future, EDAP said it is interested in applying Focal One’s technology to other procedures. The company is currently conducting a Phase 2 study across three centers in Europe to test the effectiveness of Focal One for the treatment of benign prostatic hyperplasia (BPH).
“This is a very common condition in men as they age, and we found that when we excised prostate tissue for cancer, the men’s urinary symptom scores improved after treatment,” Rhodes said. “So it would make logical sense. “If you excise the tissue and create a necrotic effect, you are displacing the pressure on the prostatic urethra.”
EDAP is also exploring the use of Focal One in the treatment of deep infiltrative endometriosis.
“We’re talking about an endometrial implant that has penetrated into the rectal wall,” Rhodes explained. “So these cause all kinds of problems, symptoms and pain for women. “We developed a method for ultrasound-guided ablation of endometrial implants using the same Focal One platform.”
