Perimeter Medical Imaging AI (TSX:PINK; OTC:PYNKF; FSE:4PC) highlighted several positive developments and achievements in its Q2 report and conference call yesterday.
Perimeter is a medical technology company working to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Its FDA-cleared Perimeter S-Series OCT system provides real-time, cross-sectional visualization of excised tissues at the cellular level. The company’s breakthrough-device-designated investigational Perimeter B-Series OCT with ImgAssist AI represents its next-generation artificial intelligence technology. B-Series OCT with ImgAssist AI is currently being evaluated in an ongoing pivotal clinical trial in breast-conserving cancer surgeries (BCS).
Surgeons have worked for years to innovate every step in the diagnosis and treatment plan for their cancer patients, with the ultimate goal of improving survivability and quality of life. Yet, intraoperative margin assessment remains one of their most pressing problems.
Perimeter is working to change this. The hope is that combining OCT technology with a surgeon’s decision making in the OR can offer greater peace of mind. Both to the surgeon, who no matter how skilled, currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins; and to their patient, who under the current treatment pathway, typically needs to wait (and worry) for 2-7 days for their surgeon to receive a post-op pathology report which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind.
Indicated for general tissue imaging, the company’s S-Series OCT technology gives surgeons:
- The most advanced intraoperative margin visualization technology available
- Clarity on margin status in the OR versus waiting days for pathology results to confirm; and
- Actionable, real-time insights to tailor clinical decisions to each patient.
Some of Perimeter’s recent highlights and announcements included:
- The company has already achieved six (6) new S-Series OCT system placements year-to-date, compared to a total of three (3) for all of 2023, and Q2-2024 revenues grew 83% over Q2-2023.
- Perimeter announced that, based on current trends, it now expects patient enrollment in the ongoing pivotal clinical trial evaluating the use of its B-Series OCT system during BCS to be completed in Q3-2024, rather than later in the 2024 fourth quarter as originally anticipated.
- In June 2024, a white paper authored by Amelia A. Gunter, M.D. from the Center for Cancer and Blood Disorders, Weatherford, TX, reported results from a retrospective, quantitative assessment of reoperation rates among 72 patients in her practice who underwent OCT imaging during BCS in order to gain insight into the potential benefits and limitations of OCT for patient outcomes.1 While not designed to guide clinical practice, the research demonstrated that:
- Dr. Gunter’s reoperation rate with OCT was 5.6%, compared to the national rate of 19.9% as determined from a national claims database study conducted by MD Anderson and University of Texas researchers that included 24,106 patients;
- While the national reoperation rate in commercial insurance patients with ductal carcinoma in situ (“DCIS”) was 30.8%, the Perimeter S-Series OCT reoperation rate in patients with DCIS was 13.3%; and
- In commercial insurance patients with invasive ductal carcinoma (“IDC”), the national rate of reoperation was shown to be 18.0%, while Perimeter’s S-Series OCT reoperation rate in patients with IDC was 0.0%.1, 2, 3
- In July 2024, the 1,000th paid Perimeter S-Series OCT patient scan was performed, representing an important clinical and commercial milestone achievement by the company.
- Finally, Perimeter revealed that, in July, its product innovation team had completed the first-of-its-kind installation of the recently developed “ImgClear” AI image enhancement algorithm with a commercial Perimeter S-Series OCT system. Internal testing has demonstrated ImgClear enables users to achieve better quality images (up to 441% signal-to-noise ratio increase) and reduce scan time (28% reduction). The company said that it expects to upgrade all installed Perimeter S-Series OCT systems with ImgClear before the end of the year.
In a statement, Adrian Mendes, Perimeter’s Chief Executive Officer, said, “It is exciting to see the scale, scope and speed with which the growth pillars we have been laying down since last year’s management transition are starting to produce tangible results,” said.
“Chief among these are restructuring our sales organization, driving both record recurring revenues and new system placements; regimenting our real-world data collection, facilitating the recent publication of Dr. Gunter’s OCT white paper; improving clinical trial execution, resulting in the anticipated completion of patient enrollment in the ongoing OCT Series-B with ImgAssist AI pivotal trial now tracking well ahead of schedule; and finally, continuing to innovate, bringing exciting product enhancements like our ImgClear AI image enhancement algorithm successfully to market,” Mr. Mendes said.
“With these key pillars of our new growth strategy now firmly established, we expect that positive momentum to continue, and we are energized by the many potential value enhancing inflection points we see ahead,” he added.
Sources
1 Gunter, Amelia. Adjunct intraoperative optical coherence tomography imaging and reoperation rates after breast-conserving surgery. The Center for Cancer and Blood Disorders, Weatherford, TX. June 3, 2024
2 National reoperation rate calculated based on weighted rates in Commercial and Medicare cohort in MD Anderson study3 and overall percent of U.S. patients covered by Commercial versus Medicare insurance in U.S. Census health insurance coverage report. https://www.census.gov/library/publications/2023/demo/p60-281.html
3 Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery. Ann Surg Oncol. 2024; doi: 10.1245/s10434-024-14902-z
Editor’s Note:
This information is intended for an investor audience and not for use by healthcare professionals. The information contained herein should not be used to guide clinical practice.
S-Series OCT
The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
The S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established.
For full information on unapproved/off-label uses, visit: perimetermed.com/disclosures or contact [email protected].
B-Series OCT
The Perimeter B-Series OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. Selene is intended for use in conjunction with other standard methods for evaluation of the margins of an excised lumpectomy specimen during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.
Perimeter B-Series OCT is not available for sale in the United States. CAUTION – Investigational device. Limited by U.S. law to investigational use.
