Avenda Health announced that it received FDA investigational device exemption (IDE) for its FocalPoint ablation system power by iQuest.
The IDE will allow Avendra to combine the two technologies in a randomized, controlled trial to show superiority over the standard of care for the treatment of prostate cancer.
iQuest uses artificial intelligence (AI) and deep learning to map prostate cancer and provide physicians with a precise location of cancer within the gland, plus a better understanding of the extent of the disease to help with treatment planning.
According to a news release, a retrospective study of 50 patients demonstrated that iQuest improved tumor margin creation over conventional treatment planning from 56% to 80%.
California-based Avenda designed its FocalPoint laser ablation system to treat localized prostate cancer in-office while preserving quality of life. Avendra’s system received FDA breakthrough device designation last year.
“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.”
Avenda, a spinout of UCLA with support from a National Cancer Institute grant, aims for its FocalPoint system to re-imagine laser ablation to enable a prostate cancer treatment outside an MRI under ultrasound guidance in a doctor’s office. The company said it is building a “more personalized and targeted standard of care for prostate cancer.”
“This clinical trial will play a key role in advancing our breakthrough technology to improve prostate cancer care,” said Brittany Berry-Pusey, Avenda co-founder and COO. “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.”