Perimeter (PINK.V) gets FDA Breakthrough Device Designation

Perimeter Medical Imaging AI (PINK.V) announced that the US Food and Drug Administration (FDA) has granted them a Breakthrough Device Designation for their Optical Coherence Tomography (OCT) Imaging System coupled with their ImgAssist AI.

The designation allows for accelerated interactions with the FDA during product development and grants PINK priority review on future regulatory submissions. It’s basically the FDA equivalent of a priority pass.

Additionally, a new Medicare policy – Medicare Coverage of Innovative Technology (MCIT) – automatically provides Medicare coverage for four years on technology that receives the FDA designation upon approval. Medicare currently covers 61 million people, all of them 65 or older. Medicare spending was over $762 billion USD in 2019, so getting onto their coverage is a really big deal.

The OCT Imaging System is designed to examine tissue structures during surgical procedures and provide the surgeons with real-time visualisations.

“Achieving a Breakthrough Device Designation from the FDA further validates our strong belief that Perimeter’s novel OCT Imaging System combined with AI has the potential to be a transformative, disruptive new technology aimed at helping surgeons treat breast cancer. This Breakthrough Designation, combined with the Centers for Medicare & Medicaid Services’ (CMS) initiatives around MCIT, have the potential to provide a pathway to expediting adoption of this innovative technology. We are committed to providing physicians with ultra-high-resolution images of excised breast tissue ‘real-time’ during a surgical procedure combined with added artificial intelligence tools to help them interpret areas suspicious for cancer, with the goal of improving patient outcomes and lowering healthcare costs,” stated Jeremy Sobotta, Perimeter’s CEO.

Today’s news comes directly on the heels of PINK’s announcement yesterday about the progress they have made on their ATLAS AI project, which has officially been trained with over 400 volumes of images.

Perimeter is making use of a $7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT) to advance their research on the ATLAS AI project.

As my Equity Guru colleague Kieran Robertson noted yesterday, “Perimeter’s proprietary algorithm has achieved key sensitivity and specificity benchmarks, including an area under the receiver operating characteristic curve (AUC) of 0.94.”

The FDA approval process is a long and difficult one, but Perimeter seems to be getting the thumbs up from the FDA to enter their fast lane.

Liz Munro, Perimeter’s co-founder and President of Canadian Operations commented, “Since company inception, the Perimeter team’s vision has been to develop imaging tools that have the potential to improve outcomes for clinicians, payors and most importantly – patients and their families. We are thrilled that FDA has granted Breakthrough Device Designation for our OCT Imaging System with ImgAssist AI, recognizing the potential of our device to offer significant advantages over existing alternatives for intra-operative evaluation of margins during breast cancer lumpectomy. We are grateful to the FDA review team for our productive interactions, as well as their timely review of this submission, and look forward to working with FDA through the final stages of development and clinical validation of this exciting product.”