The Avenda Health Focal Therapy System will help treat localised prostate cancer in a urologist’s office under local anaesthesia

FDA device

The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Avenda Health has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its artificial intelligence (AI) based male lumpectomy product to treat prostate cancer.

The Avenda Health Focal Therapy System is claimed to be the only AI-enabled focal therapy system being developed for the treatment of localised prostate cancer in a urologist’s office under local anaesthesia.

Designed to spare healthy tissue and reduce side effects, the system uses patient-specific information and AI to provide accurate and personalised treatment. It helps to target only the tumour.

Avenda Health will secure priority review for clinical trial protocols and commercialisation decisions, as part of the FDA breakthrough device programme.

The designation is also expected to support Medicare reimbursement following FDA approval of the technology.

Avenda Health co-founder and COO Brit Berry-Pusey said: “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.”

The system also uses a laser and an advanced optical and thermal sensor to accurately target and treat prostate tumour. Its AI-based margin prediction algorithms use a large database of imaging and pathology.

Avenda stated that the system’s targeted ablation enables to minimise the impact on healthy tissues without compromising urinary or sexual function.

The Avenda Health Focal Therapy System already secured 510(k) clearance from the FDA for ablation of soft tissue. It is not yet commercialised in the US.

In addition, the firm is working to advance clinical trials to secure PMA for the technology and system as a class III medical device to treat localised prostate cancer.