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The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.
The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life (QoL), according to an announcement from Avenda Health, the developer of the artificial intelligence (AI)–enabled focal therapy system.1
The regulatory designation is only granted to devices that possess the potential to transform the field, providing a new way to treat serious diseases that could be more effective than existing approaches.
The system was designed to spare healthy tissue and minimize toxicity. By using patient-specific data and AI, the device delivers a precise and individualized treatment that only targets the tumor. The treatment can be delivered in a physician’s office with local anesthesia, thus minimizing the downtime of the patient and potentially cutting healthcare costs.
“We are working to advance the treatment of prostate cancer by giving patients and their doctors more options,” Shyam Natarajan, cofounder and chief executive officer of Avenda Health, stated 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.”
With the device, physicians are able to precisely ablate tissue and monitor treatment progress in real time.2 They utilize diagnostic data to create an individualized treatment plan. Targeted therapy is then administered through focal laser ablation in the physician’s office with anesthesia. Treatment progress is monitored in real time using sensors to reduce the impact on healthy tissue and preserve QoL.
“Using large datasets of imaging and pathology, Avenda uses AI to calculate precisely where treatment should be applied, sparing healthy tissue so men can maintain urinary and sexual function,” Natarajan stated in a prior release on the device.3 “Diagnosis and treatment can be done in-office by a urologist, rather than multiple specialists and procedures, saving time and costs and offering potentially quick recovery.”
Previously, the FDA granted 510(k) clearance to the device for ablation of soft tissue.
A grant from the National Cancer Institute helped to fund a phase 1 study done in 10 patients, which has recently completed enrollment. Data indicate that the device is safe, with no decline in urinary or sexual function observed in patients over the follow-up period.