Perimeter Medical Imaging AI has received the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to study its Perimeter B-Series Optical Coherence Tomography (OCT) imaging system.

Its B-Series OCT imaging system has received FDA breakthrough device designation and leverages ImgAssist AI technology to identify the target regions.

In the study, the Perimeter B-Series OCT imaging system will be evaluated, compared with the current standard of care in breast conservation surgery.

Designed to enrol more than 300 patients across eight US clinical sites, the study will be led by Dr. Alastair Thompson from Baylor College of Medicine as principal investigator.

Alastair Thompson said: “Currently, approximately one in four women who undergo breast conservation surgery require reoperation if their surgeon fails to get ‘clear’ margins.

“The goal of this pivotal study is to compare the use of Perimeter B-Series imaging technology with artificial intelligence against the standard of care and determine if it can improve surgeon’s ability to reduce re-operation rates for breast conservation surgery.

“Importantly, Perimeter’s novel imaging technology with AI fits into the routine surgical process with no additional imposition to the patient as it examines a tissue sample that is already being extracted.

“There is a strong medical need for tools to help surgeons identify if we have adequately removed the cancerous tissue real-time in the operating room and get it right the first time.”

Perimeter Medical Imaging AI has secured the US FDA approval for its S-Series OCT system that provides cross-sectional, real-time margin visualisation of an excised tissue specimen.

The company is advancing the development of its next-generation ImgAssist artificial intelligence (AI) technology under its ATLAS AI project.

Its ATLAS AI project is partly supported by $7.4m funding provided by the Cancer Prevention and Research Institute of Texas (CPRIT).

The current IDE trial will assess the impact of its B-Series OCT imaging system on re-operation rates for patients undergoing breast conservation surgery, compared to the current standard of care, said the company.

Perimeter chief executive officer Jeremy Sobotta said: “This IDE approval marks another important milestone in our ATLAS AI project, building upon the ‘Breakthrough Device Designation’ that we received in April, as we transition into clinical validation of the AI-enabled, next generation of our commercially available flagship OCT imaging technology.

“Trial start-up activities are already underway, with world-class sites and a number of the nation’s leading breast surgeons identified to participate in Perimeter’s pivotal study, which we anticipate initiating in mid-November at our first site at West Cancer Center’s Breast Center in Germantown, Tennessee under the direction of Dr. Richard E. Fine.

“Our hope is that the data generated from this trial supports our belief that Perimeter’s innovative OCT imaging technology will become a trusted tool for surgeons, resulting in better patient outcomes and lower healthcare costs.”