Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product.
Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release.
The Avenda Health focal therapy system spares healthy tissue and minimizes side effects while using patient-specific information and AI to offer a precise and personalized treatment that targets only the tumor. The procedure can be performed in a physician’s office with local anesthesia alone, minimizing downtime and potentially reducing the cost to the healthcare system, the company said.
Avenda, a spinout of UCLA with support from a National Cancer Institute grant, conducted a Phase 1 study on 10 patients. That study recently completed enrollment and has demonstrated safety and no decline in urinary or sexual function in patients over the follow-up period, the company noted.
“We are working to advance the treatment of prostate cancer by giving patients and their doctors more options,” Avenda Health co-founder & CEO Shyam Natarajan said in the 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.”
With the breakthrough nod, the FDA will provide Avenda Health with a priority review for clinical trial protocols and commercialization decisions while also potentially facilitating Medicare reimbursement following the approval of the platform.
“The FDA has not approved a new device for the treatment of localized prostate cancer in more than 40 years,” Avenda co-founder & COO Brit Berry-Pusey said. “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.”