The FDA has granted its investigational device exemption (IDE) to Avenda Health’s FocalPoint ablation system powered by a patient-management AI software application known as iQuest. The IDE enable the launch of a new trial comparing this AI-driven treatment to standard care in patients with localized prostate cancer.1
The Avenda system combines the company’s proprietary iQuest AI-based margin prediction software algorithms with its focal laser ablation device to deliver treatment directly to the prostate tumor while sparing healthy tissue in surrounding areas.
The company previously received the FDA’s breakthrough device designation for its AI-enabled focal laser ablation system.2 The breakthrough device designation is intended to expedite the development and regulatory review of the treatment system in prostate cancer.
"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," Brittany Berry-Pusey, co-founder and COO of Avenda Health, stated in a press release.
Clinical data specifically for the iQuest AI component of Avenda’s treatment system were shared during the 2022 AUA Annual Meeting. According to Avenda, the study showed that “iQuest improved tumor margin creation3 over conventional treatment planning from 56% to 80%4.”
"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."
1. Avenda Health Receives FDA Investigational Device Exemption for AI-enabled Prostate Cancer Therapy. Accessed August 9, 2022. https://prn.to/3Qhrzmj
2. Avenda Health Granted FDA Breakthrough Device Designation for Technology to Treat Prostate Cancer Published online May 11, 2021. Accessed May 11, 2021. https://bwnews.pr/3bgp80L.
3. Priester A, Fan R, Shubert J, Colina J, Rusu M, Sulaiman V, Shao W, Khandiwala YS, Natarajan S, Sonn GA. A novel AI-derived metric identifies favorable candidates for focal therapy of prostate cancer and accurately predicts treatment margin efficacy. American Urological Association; Engineering and Urology Society. New Orleans, LA. May 15, 2022.
4. Priester A, Fan R, Shubert J, Colina J, Rusu M, Sulaiman V, Shao W, Khandiwala YS, Natarajan S, Sonn GA. Defining prostate cancer focal therapy treatment margins with a machine learning model: improvement upon hemi-gland ablation. American Urological Association; Engineering and Urology Society. New Orleans, LA. May 15, 2022.