Avenda Health’s Male ‘Lumpectomy’ Receives Breakthrough Device Designation
Avenda Health has been awarded Breakthrough Device Designation for a male “lumpectomy” product in development designed to treat prostate cancer in-office while preserving quality of life.
Breakthrough Device Designation by FDA is reserved for devices that are potentially transformative, offering treatment for serious diseases that may be more effective than currently available treatments. Avenda Health is a California-based software and medical device company aiming to improve cancer outcomes through artificial intelligence (AI) and minimally invasive technologies.
Precise and Personalized Treatment
Prostate cancer is one of the most common cancers, with one in eight men developing it in their lifetime.1 Prostate cancer is traditionally treated by surgery or radiation, which have well-known side effects such as urinary, sexual or bowel dysfunction. The Avenda Health Focal Therapy System, which is designed to spare healthy tissue and minimize side effects, uses patient-specific information and AI to deliver a precise and personalized treatment, targeting only the tumor. This treatment can be performed in a physician’s office with just local anesthesia, minimizing the patient’s downtime and potentially reducing cost to the healthcare system.
“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,” said Shyam Natarajan, co-founder and CEO of Avenda Health.
Under the FDA Breakthrough Device Program, the FDA will provide Avenda Health with priority review for clinical trial protocols and commercialization decisions. The designation may also facilitate Medicare reimbursement following FDA approval of the technology.
“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,” added Brit Berry-Pusey, co-founder and COO of Avenda Health.
