AI-powered platform officially enters US prostate cancer market

Unfold AI, an artificial intelligence (AI)–powered software application program for the management of patients with prostate cancer, is being used with patients for the first time in a commercial setting, according to Avenda Health, the developer of the technology.¹

"I am hopeful that Unfold AI will be to intraprostatic staging what prostate-specific membrane antigen PET-CT has been for extraprostatic staging,” said Wayne Brisbane, MD.

The FDA granted 510(k) clearance to Unfold AI, which was formerly known as iQuest, in December 2022. Physicians are now using the technology to work with patients on treatment selection and establishing an optimal overall management plan.

According to Avenda, Unfold AI “combines patient-specific data from prostate imaging, biopsies, and pathology into deep-learning algorithms to create a unique and tailored cancer estimation map. Its 3D, AI-generated map visualizes the location of the cancer for physicians to use in treatment decision making and interventional planning.”

"With a wide breadth of ablative options available, Unfold AI represents the first technology to improve tumor localization and patient selection," Wayne Brisbane, MD, assistant professor of urology, UCLA Health, and one of the initial physicians using the technology, stated in a press release.

"I am hopeful that Unfold AI will be to intraprostatic staging what prostate-specific membrane antigen PET-CT has been for extraprostatic staging.Additionally, there are potential applications for surgery, radiation therapy, and patient decision-making,” adding Brisbane.

Avenda reported in the release that Unfold AI has been validated in multiple clinical studies. For example, clinical data shared during the 2022 AUA Annual Meeting showed that, “Unfold AI improved tumor margin creationover conventional treatment planning from 56% to 80%.”²

"This is a major step forward for the prostate cancer community and we are beyond thrilled to see a decade of hard work and research pay off," Leonard Marks, MD, co-founder and chief medical officer of Avenda Health, stated in a press release. "Our mission at Avenda Health is to create a better quality of life for prostate cancer patients and to give urologists a clearer view of the cancer so we can better treat our patients. Unfold AI will improve clinical care and decision making."

References

1. Avenda Health Announces First Commercial Use of Unfold AI on Prostate Cancer Patients in the U.S. Published online April 25, 2023. https://prn.to/3HBhK0v

2. Avenda Health Receives FDA Investigational Device Exemption for AI-enabled Prostate Cancer Therapy. Published online August 9, 2022.