18 May 2021
FDA Breakthrough Device status allows priority review of clinical and commercial decisions.Avenda Health has been granted Breakthrough Device status by the US FDA.
The status, applied for by the company before approval by the FDA, provides Avenda with priority review for clinical trial protocols and commercialization decisions, and may also facilitate reimbursement through the US Medicare program as the platform translates into clinical use.
The Avenda Health Focal Therapy System is intended to use patient-specific information and AI to allow controlled laser ablation of prostate tumors while protecting surrounding healthy tissues.
"We see our approach as similar to that of a lumpectomy for breast cancer," said Shyam Natarajan, co-founder and CEO of Avenda Health.
"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."
A "focal" approach, and the highly localized tissue removal under image guidance that it involves, has been gaining ground in treatment of other cancers, notably kidney cancers.
In prostate therapy the focal principle has previously been employed with focused ultrasound as a means to treat prostate cancers, while a 2019 project from Nanospectra Biosciences investigated the use of gold nanoparticles as a means of localizing the action of a laser for the same purpose.
Avenda Health was founded in 2017 as a spin-out from UCLA, intended to commercially exploit complementary expertise in prostate cancer care, prostate imaging and biopsy, and artificial intelligence. The company raised $3.3 million in angel funding in April 2018. Developments in AI and image analysis are particularly significant in improving the outcomes of prostate procedures, according to Avenda.
"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," commented the company.
Prostate treatment in clinics rather than hospitals
In 2019 Avenda Health won the Startup Challenge at SPIE Photonics West for its work on a laser ablation system based on the principle of targeted image analysis to locate a tumor followed by laser treatment of the tumor while it remains in place.
"Today's standard of care has its complications," commented COO Brittany Berry-Pusey on winning the award. "We think there's a way that we can improve outcomes for men, reduce healthcare costs, and make it a win-win for everyone."
The new FDA status follows a clinical trial of the Avenda laser ablation system which commenced in March 2020. That trial, with an enrollment of ten participants, has evaluated the safety and feasibility of ultrasound-image fusion-guided focal laser ablation of prostate cancer using the Avenda Orion System, a treatment monitoring tool.
The FDA subsequently gave the system initial clearance in December 2020, an indication of the platform's potential value as a route to prostate cancer treatment carried out in clinics, rather than in hospitals.
Avenda claims that the FDA has not approved a new device for the treatment of localized prostate cancer in more than 40 years, and the company anticipates its platform having a disruptive impact on patient care.
"We look forward to working closely with the FDA to bring our product to market so that patients no longer need to choose between treating their prostate cancer and preserving their quality of life," commented Brittany Berry-Pusey.