SANTA MONICA, Calif.--(BUSINESS WIRE)--Breakthrough Device Designation was awarded to Avenda Health 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.
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,” said Brit Berry-Pusey, co-founder and COO of Avenda Health.
Avenda Health spun out of UCLA and was founded with support from a National Cancer Institute grant, which helped fund a Phase I study on 10 patients that recently completed enrollment. The study demonstrated safety and no decline in urinary or sexual function in patients over the follow-up period.
“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, M.D., 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.”
About Avenda Health Focal Therapy System
The Avenda Health Focal Therapy System is the only artificial intelligence (AI)-enabled focal therapy system being developed to treat localized prostate cancer in a urologist’s office under local anesthesia. In conjunction with AI-based margin prediction algorithms that rely on a large database of imaging and pathology, it uses a laser and a proprietary optical and thermal sensor to precisely target and treat just the prostate tumor – not the entire prostate. The goal is for this targeted ablation to minimize the impact on healthy tissues, without compromising urinary or sexual function.
The device has 510(k) clearance from the FDA for ablation of soft tissue. It is not yet commercially available while the company is working to advance clinical trials in pursuit of a PMA for the technology and system as a Class III medical device for the treatment of localized prostate cancer.
About Avenda Health
Avenda Health is a healthcare technology company focused on improving patient outcomes through artificial intelligence (AI). The company has developed a focal laser ablation system and continues to develop investigational AI cancer margin prediction software. Avenda Health’s vision is to expand its core technology platform to improve outcomes in prostate cancer care by addressing the full care pathway, including treatment monitoring, risk stratification, and eventually diagnosis.
1 National Cancer Institute: https://seer.cancer.gov/statfacts/html/prost.html