Perimeter Medical Imaging AI (PINK.V) Expands Study to Include Additional Site

Perimeter Medical Imaging AI Inc. (PINK.V) announced today that it will be expanding its ongoing pivotal study to include an additional clinical trial site. This site will be located at Baylor College of Medicine in Houston, Texas, under the direction of Dr. Alastair Thompson, the study’s Principal Investigator. Perimeter’s pivotal study will assess the Company’s Perimeter B-Series OCT imaging platform combined with ImgAssist AI and its impact on positive margin rates during breast conservation surgery.

“We are proud to partner with leading cancer centers like Baylor to enable the late-stage clinical development of our breakthrough-device-designated Perimeter B-Series OCT platform that includes AI-assisted software…

We are also grateful for the grant funding that we received from the Cancer Prevention and Research Institute of Texas (CPRIT), which has supported our ATLAS AI project across multiple stages, culminating in this important pivotal study now underway,” commented Jeremy Sobotta, Perimeter’s Chief Executive Officer.

Atlas AI Project

User Interface prototype showcasing AI detection (development version)

Perimeter’s AI technology, dubbed ImgAssist, is a powerful tool intended to aid physicians with real-time margin visualization. For context, a margin refers to the edge or border of the tissue removed in cancer surgery. This margin is defined as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. On the contrary, if cancer cells were to be found at the edge of the tissue, this margin would be referred to as positive.

With this in mind, Perimeter is advancing the development of its proprietary, next-gen artificial intelligence technology under its ATLAS AI project, which is made possible, in part, by a USD$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT) on May 4, 2020. The funding granted by CPRIT has since supported the continued development of Perimeter’s AI technology. On July 15, 2020, Perimeter announced the initiation of its ATLAS AI project, whereby images of breast tumors are collected to both train and test the Company’s ImgAssist AI.

Paired with Perimeter’s B-Series Optical Coherence Tomography (OCT), the Company’s ImgAssist has the potential to aid surgeons in identifying regions of interest on scanned samples, enabling them to make key decisions regarding margin status in real-time. It is worth noting that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for Perimeter’s B-Series OCT with ImgAssist AI. However, Perimeter B-Series with ImgAssist AI is currently approved for Investigational Use Only in the United States (US), indicating that only select surgeons have access to this technology via Perimeter’s ongoing pivotal clinical trial.

Perimeter’s Optical Coherence Tomography (OCT) is a non-invasive optical imaging technique that produces images of subsurface tissue structures. With this in mind, OCT as a whole is similar to ultrasound, however, this technique utilizes light instead of sound, resulting in 10 times higher resolution. That being said, OCT is an exceptional tool for visualizing blood vessels, ducts, glands, and surrounding structures. In addition to Perimeter’s B-Series OCT with ImgAssist, the Company has also developed its Perimeter S-Series OCT.

Perimeter’s S-Series OCT is a novel medical imaging system that provides clinicians with cross-sectional, real-time margin visualization 1-2 mm below the surface of an excised tissue specimen. As a result, Perimeter S-Series OCT is capable of providing physicians with the ability to visualize microscopic tissue structures in the operating room, resulting in better long-term outcomes for patients and lower costs to the healthcare system.

The Study

Perimeter’s ongoing pivotal study is a multi-center, randomized, two-arm clinical trial to measure the effectiveness of the Perimeter B-Series OCT imaging platform combined with ImgAssist AI technology. More specifically, the study will assess this combination’s ability to reduce the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.

For context, a lumpectomy, also referred to as breast-conserving surgery (BCS), is a procedure performed to remove cancer from one’s breast. With this in mind, approximately 300 patients undergoing breast conservation surgery (BCS) across eight US clinical sites are expected to participate in the pivotal trial, with study completion expected for the end of 2022.

Keep in mind, the Global Breast Cancer Treatment Market is expected to grow from USD$19.24 billion in 2019 to USD$34.06 billion by 2026, expanding at an impressive compound annual growth rate (CAGR) of 8.5% during the forecast period. Furthermore, in a study published by JAMA Surgery, researchers from the University of Texas MD Anderson Cancer Center looked at the record of 727,927 women diagnosed with early-stage breast cancer between 1998 and 2011.

The study revealed that rates of lumpectomy to treat early-stage disease went up from 48.4% in 1998 to 58.8% in 2011. With this in mind, there is an undeniable need for technologies like Perimeter’s OCT to reduce the prevalence of positive margins in breast lumpectomy procedures. For a closer look at Perimeter, check out this article or take a look at Equity Guru’s exclusive interview with Jeremy Sobotta, Perimeter’s CEO, above.

Perimeter’s share price opened at $3.67, down from a previous close of $3.84. The Company’s shares were down -2.08% and were trading at $3.76 as of 10:52 AM EST.

Full Disclosure: Perimeter is a marketing client of Equity Guru.