FDA Breakthrough Device Designation Is Granted to Avenda Health for Laser Ablation System in Prostate Cancer


A technology that uses AI to deliver focal laser therapy to prostate tumors was granted breakthrough device designation by the FDA, which will allow for the swift development and commercialization of the product.

The Avenda Health Focal Therapy System, a product designed to deliver prostate cancer treatment in-office, was granted breakthrough device designation by the FDA, according to Avenda Health, the company responsible for developing the artificial intelligence (AI)–enabled focal therapy system.1

The product intended for use as a male “lumpectomy” device was developed as an alternative to traditional surgery or radiation, for which the adverse effects of treatment can compromise quality of life.

“We are working to advance the treatment of prostate cancer by giving patients and their doctors more options,” Shyam Natarajan, co-founder and CEO of Avenda Health, said in a press release. “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.”

By using patient-specific data and AI, the system is able to deliver accurate, tailored laser treatment to the tumor and spare healthy tissue in the process. The system uses a proprietary laser needle and thermal optical sensors to ablate the tumor.2 In turn, this offers the possibility to minimize adverse effects of therapy—such as urinary, sexual, a bowel dysfunction—and to perform procedures in a physician’s office.

The designation is for products that have the potential to transform standard-of-care treatments for serious diseases. Under the Breakthrough Device Program, the FDA delivers priority review for protocols of clinical trials as well as decisions regarding commercialization. Following FDA approval of the technology, it will also enable reimbursement by Medicare.

“The FDA has not approved a new device for the treatment of localized prostate cancer in more than 40 years,” Brit Berry-Pusey, co-founder and COO of Avenda Health, said in the release. “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.”

A phase 1 trial with 10 patients demonstrated safety of the technology, with no declines in urinary or sexual function noted during the follow-up period. The study was conducted by a multidisciplinary team of physicians and clinical scientists from UCLA and was funded by a grant from the National Cancer Institute.

“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,” said Leonard S. Marks, MD, who is co-founder and chief medical officer of Avenda Health and professor of urology at UCLA. “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.”

In December 2020, the device earned 510(k) clearance from the FDA for the ablation of soft tissue.


1. Avenda Health Granted FDA Breakthrough Device Designation for Technology to Treat Prostate Cancer. News release. Avenda Health. May 11, 2021. Accessed May 12, 2021. https://bwnews.pr/2QbcatZ

2. Avenda Health Receives FDA Clearance for their Focal Laser Ablation System. News release. Avenda Health. December 16, 2020. Accessed May 12, 2021. https://prn.to/3y86eDp

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