AI-Enabled Prostate Ablation System Receives FDA IDE for Clinical Trial

The FocalPoint ablation system powered by iQuest, a patient management AI software, has received investigational device exemption (IDE) from the US Food and Drug Administration (FDA). Avenda Health says it plans to use the technologies together in a randomized control trial to show superiority over standard of care for the treatment of prostate cancer.

iQuest uses artificial intelligence and deep learning to map a patient's prostate cancer, providing physicians with a precise location of the cancer within the gland and a better understanding of the extent of the disease to aid in treatment planning. In a retrospective study by Priester et al of 50 patients presented at the 2022 American Urological Association annual meeting, iQuest improved tumor margin creation over conventional treatment planning from 56% to 80%.

"Our mission is to advance prostate cancer therapy so patients no longer need to choose between treatment or quality of life," said Dr Shyam Natarajan, co-founder and CEO of Avenda Health. "Using the latest deep learning technology, iQuest gives physicians and their patients more insights to identify the best treatment on an individual basis. We're thrilled to receive IDE approval so we can further prostate cancer research for the millions of men affected each year."

FocalPoint is Avenda Health's focal laser ablation system designed to treat localized prostate cancer in-office while preserving quality of life. Prostate cancer is the most common internal cancer in men, but 50 percent+ of patients treated with existing therapies lose their sexual or urinary function or both, severely impacting quality of life. In 2021, the FDA granted Avenda Health with Breakthrough Device Designation, indicating there is a high likelihood the Avenda Health technology will be better than the standard of care.

"This clinical trial will play a key role in advancing our breakthrough technology to improve prostate cancer care. With no new FDA approvals for the treatment of localized prostate cancer in more than four decades, we look forward to working alongside our clinical sites to collect the data necessary to bring iQuest and FocalPoint to market and into the patient care environment," said Brittany Berry-Pusey, co-founder and COO of Avenda Health.

Derived from experts at UCLA, Avenda Health was founded with support from a National Cancer Institute grant, which was the catalyst to fund the company's participation in many clinical trials at various prototype stages. The FocalPoint system re-imagines laser ablation, which has been used to treat thousands of patients, enabling prostate cancer treatment outside an MRI under ultrasound guidance in a doctor's office. In each of its technologies, Avenda Health is building a more personalized and targeted standard of care for prostate cancer.