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

The FDA has granted a revolutionary device designation to a new artificial intelligence (AI) -activated 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 artificial intelligence-based margin prediction software algorithms and the Orion System for Focal Laser Oblation to deliver treatment directly to the prostate tumor while sparing healthy tissue in surrounding areas.

The FDA has previously granted approval for the Avenda 510 (k) device for soft tissue ablation. The revolutionary device designation will accelerate the development and regulatory review of this prostate cancer treatment system. Benefits of the designation include priority FDA review for clinical trial protocols and marketing 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 physicians more options. We view our approach as similar to a lumpectomy for breast cancer – If the cancerous tumor and the appropriate treatment margins can be identified, the standard approach of removing the entire prostate and surrounding tissue may not be. necessary, ”Shyam Natarajan, co-founder and CEO of Avenda Health, said 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 for over 40 years. We look forward to working closely with the FDA to bring our product to market so that patients no longer have to choose between treating their prostate cancer and preserving their quality of life.

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

The Orion System for Focal Targeted 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. The Orion system is currently being tested in men with intermediate risk prostate cancer in a trial initiated by a researcher at UCLA (NCT04305925).

“Ten years ago, a group of dedicated clinical scientists at UCLA came together in the fields of urology, radiology, pathology and biomedical engineering with the goal of improving cancer treatment. prostate. Where we are today versus when we started is remarkable, ”said Leonard S. Marks, MD, co-founder and medical director of Avenda Health and professor of urology at UCLA, said in the release. hurry. “Avenda Health continues to advance in this mission and the recognition by the FDA of the incredible impact this technology could have on the field of urology in the treatment of prostate cancer is encouraging.

The references

1. Avenda Health Granted Breakthrough Device Designation by the FDA for Prostate Cancer Treatment Technology Posted online May 11, 2021. Accessed May 11, 2021. https://bwnews.pr/3bgp80L.

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


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About Hector Hedgepeth

Hector Hedgepeth

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