FDA grants breakthrough device designation to AI-based focal therapy system

The targeted focal laser ablation system is intended to be an office-based treatment for localized prostate cancer delivered under local anesthesia.

The FDA has granted a breakthrough device designation to a novel artificial intelligence (AI)-enabled focal therapy system for the treatment of localized prostate cancer, according to Avenda Health, the developer of the investigational device.1

The Avenda Health Focal Therapy System combines the company’s proprietary AI-based margin prediction software algorithms and Orion System for focal laser oblation to deliver treatment directly to the prostate tumor while sparing healthy tissue in surrounding areas.

The FDA previously granted the Avenda device 510(k) clearance for ablation of soft tissue. The breakthrough device designation will expedite the development and regulatory review of this treatment system in prostate cancer. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device.

“We are working to advance the treatment of prostate cancer by giving patients and their doctors more options. We see our approach as similar to that of a lumpectomy for breast cancer—If the cancerous tumor and appropriate treatment margins can be identified, the standard approach of removing the entire prostate gland and surrounding tissue may not be necessary,” Shyam Natarajan, co-founder and CEO of Avenda Health, stated in a press release.

Brit Berry-Pusey, co-founder and COO of Avenda Health, added, “The FDA has not approved a new device for the treatment of localized prostate cancer in more than 40 years. We look forward to working closely with the FDA to bring our product to market so that patients no longer need to choose between treating their prostate cancer and preserving their quality of life.”

Avenda’s AI technology combines MRI images with pathology data to fuel its AI-based margin prediction algorithms to identify the precise tumor location in an individual’s prostate. According to the company, the technology has a 99.8% negative predictive value for identifying prostate cancer that is Gleason 7+.2

The Orion System for targeted focal laser ablation is intended to be a simple procedure by which urologists can treat patients in their office for localized prostate cancer under local anesthesia. The device has the functionality to monitor treatment progress and tissue temperature in real-time.

A successful feasibility study (NCT02357121) for Orion using a protype device was initially conducted and demonstrated that the procedure could be performed in an office-based setting. The Orion System is now being tested in men with intermediate risk prostate cancer in an investigator-initiated trial at UCLA (NCT04305925).

“Ten years ago, a group of dedicated clinical scientists at UCLA came together from urology, radiology, pathology and biomedical engineering with the goal of improving treatment for prostate cancer. Where we are today compared to when we started is remarkable,” Leonard S. Marks, MD, co-founder and chief medical officer of Avenda Health and professor of urology at UCLA, stated in the press release. “Avenda Health continues to advance in this mission, and the FDA’s recognition of the incredible impact that this technology could have on the field of urology in treating prostate cancer is encouraging.


1. Avenda Health Granted FDA Breakthrough Device Designation for Technology to Treat Prostate Cancer Published online May 11, 2021. Accessed May 11, 2021. https://bwnews.pr/3bgp80L.

2. Avenda Health. Accessed May 11, 2021. https://www.avendahealth.com.