Perimeter Medical Imaging Ai Inc Stock Price, News & Analysis

Perimeter Medical Imaging AI presented detailed results from their pivotal trial of B-Series OCT with ImgAssist AI 2.0 for breast cancer surgery margin assessment at ASBrS 2025. The trial met its primary endpoint with statistically significant results (p=0.0050), demonstrating super-superiority compared to standard care. Key findings include: - Among 206 patients, the system correctly detected residual disease in 40% of cases (14/35 patients) after standard care - Completely cleared residual disease in 20% of additional patients - Achieved 88.1% overall margin accuracy - Required minimal additional tissue removal (only 3.8% of total volume) - Benefited 26 patients clinically, including 6 cases where the system detected disease missed by both standard care and histopathology The company has submitted a Premarket Approval application to the FDA in March 2025 for use during breast-conserving surgeries.

Perimeter Medical Imaging AI announced that HonorHealth, a major healthcare system in Phoenix and Scottsdale, has become Arizona's first to implement their S-Series OCT technology for visualizing tissue margins during surgery.

The groundbreaking Optical Coherence Tomography technology offers superior resolution compared to traditional imaging methods, enabling visualization at the cellular level. It creates 3D images with 10 times the resolution of ultrasound and X-ray, and 100 times that of MRI, helping surgeons make real-time decisions during procedures.

Key advantages include:

• 2mm resolution optimization for tissue microstructures
• Real-time visualization of surgical margins
• FDA clearance for general tissue imaging since 2021

This deployment represents a significant expansion of Perimeter's commercial presence in the Southwest, potentially reducing the need for follow-up surgeries that typically result from waiting up to 10 days for traditional pathology results.

Perimeter Medical Imaging AI (TSXV: PINK) (OTCQX: PYNKF), a commercial-stage medical technology company, has announced its upcoming participation at the 2025 Bloom Burton & Co. Healthcare Investor Conference.

Key details:

• Event Date: Monday, May 5, 2025
• Time: 9:30 a.m. Eastern Time
• Location: Metro Toronto Convention Centre

The company's management will deliver a business update presentation at the conference. For those unable to attend in person, the presentation will be available through a live broadcast and will also be archived on the company's website. Interested parties can access the presentation recording in the "News/Events" section under the Investors tab of Perimeter's website.

Perimeter Medical Imaging AI (PYNKF) reported its Q4 and full-year 2024 financial results, highlighting significant commercial growth. The company achieved nine new S-Series OCT system placements in 2024, up from three in 2023, with Q4-2024 revenues increasing 303% year-over-year to $293,000.

The company's pivotal study for its next-generation B-Series OCT with ImgAssist AI 2.0 met its primary endpoint, demonstrating statistically significant reduction in patients with residual cancer during breast-conserving surgeries. Perimeter recently submitted a Premarket Approval (PMA) application to the FDA for this technology.

Financial highlights for FY2024 include:

• Revenue of $846,000, up 110% from 2023
• Operating expenses of $19.4 million
• Net loss of $13.4 million ($0.19 per share)
• Cash position of $6.2 million as of December 31, 2024
• Additional $2.0 million CPRIT grant receivable

Perimeter Medical Imaging AI (TSXV: PINK) (OTCQX: PYNKF), a commercial-stage medical technology company, has announced it will release its fourth quarter and full year 2024 financial results after market close on March 26, 2025. The company's management team will subsequently host a webcast and conference call to discuss the results and provide a corporate update. The call will be broadcast live and archived on the company's website in the Investors section under 'News/Events'.

Perimeter Medical Imaging AI (TSXV: PINK, OTCQX: PYNKF) announced that Covenant Health Fort Sanders Regional has become the first hospital in Tennessee to implement their S-Series OCT (Optical Coherence Tomography) technology for visualizing tissue margins during surgery.

The S-Series OCT technology provides real-time margin visualization with resolution 10 times higher than ultrasound and X-ray, and 100 times more powerful than MRI. It can visualize tissue microstructures down to 2mm in ducts, vessels, and glands, potentially reducing the need for follow-up surgeries by eliminating the traditional 10-day wait for pathology results.

Dr. Ana Wilson, a surgical oncologist at Covenant Health Fort Sanders Regional, highlighted how the technology enables patient-specific surgical decisions in real-time. The implementation represents a significant milestone in Perimeter's nationwide expansion strategy and aligns with their goal of improving surgical outcomes while reducing healthcare costs.

Perimeter Medical Imaging AI (TSXV: PINK, OTCQX: PYNKF) announced that its pivotal trial results for the B-Series OCT with ImgAssist AI 2.0 will be presented at the 2025 American Society of Breast Surgeons Annual Meeting. The trial, focused on breast-conserving surgeries, met its primary endpoint with a statistically significant reduction in patients with residual cancer during surgery (p-value = 0.0050).

The detailed results are under embargo until May 1, 2025, 1:00 pm PST, and will be presented by Dr. Alastair Thompson, the trial's Primary Principal Investigator from Baylor College of Medicine. The full abstract will be published in the Annals of Surgical Oncology.

Following positive topline results reported in November 2024, Perimeter plans to submit its FDA premarket approval (PMA) application in early 2025 to market the AI-enabled OCT system in the United States. The technology provides real-time, high-resolution visualization of margins in the operating room.

Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) announced that its common shares will begin trading on the OTCQX® Best Market under the symbol "PYNKF" on February 27, 2025. This upgrade from the Pink® market aims to increase visibility and broaden the company's U.S. shareholder base.

CEO Adrian Mendes noted this move aligns with their U.S.-focused business strategy, as many shareholders are based there and it's the primary target market for their S-Series OCT system and upcoming AI-enabled B-Series product.

In November 2024, Perimeter reported positive topline results from a pivotal study supporting their planned FDA premarket approval submission. The trial met its primary endpoint with a statistically significant reduction (p-value = 0.0050) in patients with residual cancer during surgery, demonstrating super-superiority of their B-Series OCT with ImgAssist AI 2.0 system. The company plans to submit its FDA PMA in early 2025.

Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) has announced an upcoming investor webcast scheduled for February 6, 2025, at 2:00 PM ET. The event, hosted by Bristol Investor Relations, will feature presentations from key executives including CEO Adrian Mendes, CIO Andrew Berkeley, and CFO Sara Brien, covering essential aspects of the company's business.

The webcast will include an interactive Q&A session where investors can engage with management. Pre-registration is required for participation. Following the live event, an archived version of the webcast and presentation materials will be made available on the company's website in the Investors Section under 'News/Events'.