Exablate MR-guided focused ultrasound launched in US prostate cancer market
February 3, 2022
Urology Times staff
The first commercial patient in the United States has been treated for prostate disease with the Exablate Prostate system, according to Insightec, the developer of the technology.1
The patient received the treatment at Stanford Health Care, which had previously participated in the clinical trials examining the efficacy and safety of Exablate.
The FDA granted Exablate 510K clearance in 2021 for treating prostate tissue with high-intensity magnetic resonance (MR)–guided focused ultrasound (MRgFUS). The 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove that its device is “substantially equivalent” to a device already being legally marketed.2
"We are deeply committed to continuing to transform patient care with minimally invasive, innovative surgical procedures. The Exablate Prostate system will help support a better quality of life for people diagnosed and living with prostate disease," Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors, stated in a news release.
Clinical support
Clinical findings from a phase 2b study (NCT01657942) supporting the use of Exablate MRgFUS in men with intermediate-risk prostate cancer were shared at the 2021 AUA Annual Meeting.3 Overall, the study included 101 men who were treated at 7 academic centers and 1 private practice.
The average patient age was 63 years and 86% of the cohort was White. The median PSA was 5.7 ng/mL. Eighty-four patients had at least clinical stage T1c disease. Seventy-eight percent of patients were in grade group 2 and 22% were in grade group 3.
At 24 months, 88% of men had no evidence of grade group 2 or 3 prostate cancer in the treatment area according to targeted prostate biopsy. Additionally, 60% of men had no evidence of grade group 2 or 3 disease anywhere in the prostate gland, including outside of the treatment area. Serum PSA levels decreased by almost 50% after treatment and stabilized after 6 months.
Erectile function scores were slightly worse at 24 months compared with baseline (HR, -3.5; 95% CI, -5.4 to -1.6). Ten (13%) reported no sexual activity and 81% of patients achieved erections adequate for intercourse. Lower urinary tract symptoms were similar at baseline and 24 months (mean score difference, 1.1; 95% CI, 0.33-1.8).
“Overall, approximately 75% of men were able to achieve functional reactions after treatment at 24 months without starting a new erectile function medication,” Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center and Exablate trial PI, said at the time of the AUA presentation of the results. “No patients reported urinary incontinence and the estimated probability of urinary continence over time was excellent.”
References
1. First US commercial patient treated for prostate disease with Insightec incisionless focused ultrasound system. Published online February 3, 2022. Accessed February 3, 2022. https://prn.to/3AV92VY.
3. Ehdaie B, Tempany C, Holland F, et al. MRI-guided focused ultrasound (MRgFUS) focal therapy for intermediate-risk prostate cancer: final results of a phase IIb multicenter study. Presented at: 2021 American Urological Association Annual Meeting; September 10-13, 2021; virtual. Abstract LBA02-12.
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Transcript edited for clarity.
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Designation and approvals mark key milestones in advancing Insightec Blood Brain Barrier (BBB) clinical roadmap using Acoustic Therapy
HAIFA, Israel & MIAMI, Florida, March 9, 2022 — Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval of two pivotal investigational device exemptions (IDE) for its Exablate Neuro system – one for primary non-small cell lung cancer (NSCLC) that has metastasized to the brain in conjunction with standard-of-care Keytruda®, and one for enhanced efficacy of liquid biopsy for recurrence monitoring of patients with primary brain cancer. The FDA has also granted “Breakthrough Device” designation for the NSCLC treatment, helping to expedite its development and review.
Insightec plans to launch the LIMITLESS study (NSCLC) to assess the clinical benefit of using noninvasive, low-intensity focused ultrasound combined with systemic immunotherapy in the treatment of patients with brain metastases from lung cancer.
“The use of low-intensity focused ultrasound (LIFU) with microbubbles to open up the blood brain barrier (BBB) is an exciting advance in neuro-oncology that holds promise to become a paradigm shift in the treatment of patients with brain tumors,” said study Principal Investigator Dr. Manmeet Ahluwalia, MD, MBA, Chief of Solid Tumor Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida. “The unique synergy of LIFU BBB opening for improved drug delivery, neoantigen release and immune priming is a potential game-changer in our field that will help us build on current treatment options available for these patients.” Liquid biopsy is a new approach for noninvasive cancer subtyping, treatment selection, monitoring residual disease, early identification of treatment responders versus non-responders, and assessment of tumor progression versus pseudoprogression.
“Despite remarkable progress in other cancers, liquid biopsy has had limited success in brain tumors due to the presence of the blood brain barrier, which limits signal detection in the bloodstream,” said Dr. Achal Singh Achrol, MD, FAANS, Chief Medical Officer of Insightec. “Preclinical and early human studies have demonstrated that low-intensity focused ultrasound (LIFU) can transiently increase the permeability of the blood brain barrier and allow passage of region-specific biomarkers to enable noninvasive liquid biopsy in brain tumors. This pivotal clinical trial will investigate for the first time the clinical benefit to this approach as a novel alternative to invasive neurosurgical biopsies.”
“Insightec continues to collaborate with leading researchers to advance the use of acoustic therapy in the brain,” said Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board. “This work focuses on safely opening the blood brain barrier using low frequency acoustic energy and has the potential to transform current therapeutic and diagnostic approaches for conditions like brain cancer. Our ultimate goal is, as always, to positively impact patient lives.”
The Exablate Neuro device is already FDA approved for the treatment of medication-refractory Essential Tremor and Parkinson’s Disease. At the close of 2021 there were 42 medical centers in the United States using the Insightec Exablate Neuro device to treat patients with these conditions. The Insightec Exablate Prostate system has received FDA 510K clearance for ablating prostate tissue with high intensity Focused Ultrasound.
About Insightec Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai, and Tokyo.
Follow us on Facebook, LinkedIn and Twitter or visit www.insightec.com for more information.
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