Perimeter Medical Imaging Ai Stock Price, News & Analysis

Perimeter Medical Imaging AI, Inc. (OTCQX: PYNKF) is a commercial-stage medical technology company focused on advanced imaging tools intended to transform cancer surgery. Based in Toronto, Canada and Dallas, Texas, the company is described in multiple disclosures as being driven to develop ultra-high-resolution, real-time imaging technologies that address areas of high unmet medical need in the operating room.

Perimeter’s core platform is its Perimeter S-Series OCT system, an optical coherence tomography (OCT) device that is FDA-cleared under a general imaging indication. According to the company’s news releases, the S-Series OCT provides real-time, cross-sectional visualization of excised tissues at the cellular level. It is available across the U.S. and is used as an imaging tool in the evaluation of excised human tissue microstructure, providing two-dimensional, cross-sectional, real-time depth visualization with review manipulation software for identifying and annotating regions of interest.

The company also highlights an investigational, next-generation platform called Perimeter B-Series OCT with Assist AI. This device combines OCT with artificial intelligence and is described as a breakthrough-device-designated technology that has been evaluated in a pivotal clinical trial, supported by a grant of up to US$7.4 million from the Cancer Prevention and Research Institute of Texas. Perimeter states that the B-Series OCT is limited by U.S. law to investigational use, is not available for sale in the United States, and is under U.S. Food and Drug Administration (FDA) review through a Premarket Approval (PMA) application process specifically related to intraoperative breast cancer imaging.

The company’s communications emphasize the use of its S-Series OCT system in the operating room for tissue visualization. Perimeter reports that surgeons at a growing number of medical centers are using the S-Series to support intraoperative decision-making. For example, news releases describe adoption of the S-Series OCT at HCA HealthONE Rose in Colorado and its deployment at hospitals within Intermountain Health through a systemwide agreement that enables any Intermountain Health hospital to acquire the technology. These announcements underscore that Perimeter’s installed base of S-Series devices is expanding and that the technology is being used in surgical settings for real-time imaging of excised tissue.

Perimeter also notes that its S-Series OCT is the only wide-field OCT technology used in surgical procedures referenced in its disclosures. The system incorporates wide-field OCT to visualize tissue microstructures and features such as blood vessels, ducts, and glands, and is described as being optimized down to 2 mm for identifying regions of interest. Company statements and physician commentary in news releases indicate that surgeons use the S-Series OCT to visualize margins in real time and to obtain additional insights that can enhance surgical precision and decision-making. However, Perimeter explicitly states that the S-Series OCT has not been evaluated by the U.S. FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, or reducing re-excision rates, and that the safety and effectiveness of these uses have not been established.

The investigational B-Series OCT with Assist AI is positioned by the company as its next-generation AI-enabled platform. Perimeter describes this device as combining proprietary AI technology with OCT, with the goal of providing an AI-powered advancement for intraoperative imaging. The B-Series has received Breakthrough Device Designation from the FDA and has been evaluated in a pivotal clinical trial. Company updates indicate that Perimeter is working closely with the FDA on the PMA review of the B-Series and that the technology is intended to build on clinical and commercial experience with the S-Series.

Beyond product development, Perimeter’s news releases describe activities aimed at engaging with the clinical community, particularly in breast surgery and breast cancer care. The company participates in professional forums and conferences, including the American Society of Breast Surgeons’ Annual Strategic Futures Forum and Aptitude Health/TME’s "Take the Lead in Breast Cancer Care" summit, where its imaging technology is showcased to breast surgeons and other specialists. Presentations by practicing breast surgical oncologists, such as those at the American College of Osteopathic Surgeons’ Annual Clinical Assembly, have highlighted the use of Perimeter’s wide-field OCT for margin visualization during breast conserving surgery as scientific exchange.

Perimeter’s disclosures also describe corporate and capital markets activities consistent with a small- or micro-cap public company listed on the TSX Venture Exchange under the symbol PINK and quoted on the OTCQX under PYNKF. The company reports raising capital through offerings and private placements, with proceeds intended for commercialization of its technology, continued product development, and general corporate purposes. It also notes participation in investor-focused events such as the Planet MicroCap Showcase and the Small Cap Growth Virtual Investor Conference, where management presents updates on commercial strategy and upcoming milestones.

The company repeatedly explains that its ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month, which aligns with its emphasis on applications in breast cancer surgery and breast care, although its FDA-cleared indication for the S-Series OCT remains general tissue imaging. Across its communications, Perimeter positions itself as a medical technology company focused on ultra-high-resolution, real-time imaging tools designed to support surgeons in the operating room and to address unmet needs in cancer surgery, while clearly distinguishing between cleared uses of its S-Series OCT and the investigational status of its B-Series OCT with Assist AI.

Business focus and technology

According to the company’s own descriptions, Perimeter’s business centers on the development and commercialization of OCT-based imaging systems for use on excised human tissue in surgical settings. The S-Series OCT is characterized as a commercial product with FDA 510(k) clearance under a general indication, and the B-Series OCT with Assist AI as an investigational platform under regulatory review. The company’s news releases indicate that revenue is associated with S-Series system leases, capital equipment sales, consumables, and extended service programs, although detailed revenue breakdowns are provided only in specific financial releases and are subject to change over time.

Perimeter’s communications emphasize that its technologies are intended to provide real-time, cross-sectional visualization of tissue microstructure at the cellular level, with the goal of giving surgeons additional information during operations. The company highlights the potential for AI-enabled imaging in the B-Series platform, supported by data collection efforts such as the OCT-Tissue Surveillance Registry, which is described as a database to collect images and data from surgical procedures performed using its wide-field OCT imaging technology to inform future product development and enhance its AI deep-learning model.

Regulatory status and indications

Perimeter clearly distinguishes between the regulatory status of its platforms:

• Perimeter S-Series OCT: FDA 510(k) clearance under a general imaging indication for use as an imaging tool in the evaluation of excised human tissue microstructure, providing two-dimensional, cross-sectional, real-time depth visualization with review manipulation software for identifying and annotating regions of interest.
• The company states that the S-Series OCT has not been evaluated by the U.S. FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, or reducing re-excision rates, and that the safety and effectiveness of these uses have not been established.
• Perimeter B-Series OCT with Assist AI: Described as a breakthrough-device-designated investigational technology that is limited by U.S. law to investigational use, not available for sale in the United States, and under FDA PMA review related to intraoperative breast cancer imaging.

These regulatory disclosures are repeated across multiple company news releases and form a central part of how Perimeter presents its products to investors, clinicians, and other stakeholders.

Engagement with clinicians and professional organizations

Perimeter’s news flow shows ongoing engagement with breast surgeons, oncologists, and multidisciplinary care teams. The company participates in events hosted by organizations such as the American Society of Breast Surgeons, the American College of Osteopathic Surgeons, and Aptitude Health/TME. At these events, Perimeter’s technology is discussed in the context of breast conserving surgery, intraoperative margin visualization, and broader breast cancer care. These activities are presented as opportunities for scientific exchange and for gathering feedback from clinicians who are at the forefront of surgical innovation and breast care.

Public listing and capital markets

Perimeter Medical Imaging AI, Inc. is listed on the TSX Venture Exchange under the symbol PINK and trades on the OTCQX market under the symbol PYNKF. Company news releases describe capital raising transactions, including non-brokered private placements and prospectus offerings of units consisting of common shares and warrants. The stated uses of proceeds include commercialization of its imaging technology, continued product development, working capital, and other general corporate purposes.

FAQs about Perimeter Medical Imaging AI (PYNKF)

• What does Perimeter Medical Imaging AI do?
  Perimeter Medical Imaging AI is a medical technology company that develops and commercializes advanced imaging tools for use in cancer surgery. Its primary focus is on optical coherence tomography (OCT) systems that provide real-time, cross-sectional visualization of excised tissue at the cellular level in the operating room.
• What is the Perimeter S-Series OCT system?
  The Perimeter S-Series OCT system is an FDA-cleared imaging device indicated for use as an imaging tool in the evaluation of excised human tissue microstructure. It provides two-dimensional, cross-sectional, real-time depth visualization with software that allows users to review images and annotate regions of interest.
• How is the S-Series OCT used in surgery?
  Company disclosures state that the S-Series OCT is used in operating rooms for tissue visualization, giving surgeons real-time imaging of excised tissue microstructure. Surgeons and hospitals referenced in Perimeter’s news releases use the system to obtain additional information during procedures, including visualization of margins in real time, although these uses have not been specifically evaluated by the U.S. FDA.
• What is the Perimeter B-Series OCT with Assist AI?
  The Perimeter B-Series OCT with Assist AI is an investigational, next-generation platform that combines OCT imaging with artificial intelligence. It has received Breakthrough Device Designation from the FDA and has been evaluated in a pivotal clinical trial supported by a grant from the Cancer Prevention and Research Institute of Texas. It is limited by U.S. law to investigational use and is not available for sale in the United States.
• Is the S-Series OCT approved specifically for breast cancer surgery?
  No. Perimeter states that the S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by the U.S. FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, or reducing re-excision rates. The safety and effectiveness of these specific uses have not been established.
• Where is Perimeter Medical Imaging AI based?
  According to its news releases, Perimeter Medical Imaging AI is based in Toronto, Canada and Dallas, Texas.
• On which exchanges does Perimeter trade and under what symbols?
  Perimeter Medical Imaging AI is listed on the TSX Venture Exchange under the symbol PINK and trades on the OTCQX market under the symbol PYNKF.
• What does the ticker symbol "PINK" represent?
  The company states that its ticker symbol "PINK" is a reference to the pink ribbons used during Breast Cancer Awareness Month.
• How does Perimeter work with hospitals and health systems?
  Perimeter’s news releases describe commercial adoption of its S-Series OCT by hospitals and health systems, including agreements that enable deployment of the technology in operating rooms. These arrangements allow surgeons at participating centers to use the S-Series OCT for real-time tissue visualization during surgery.
• What is the focus of Perimeter’s clinical and research activities?
  Perimeter’s clinical and research activities, as described in its communications, focus on evaluating its OCT technologies in surgical settings, including intraoperative imaging in breast conserving surgery, and on developing AI capabilities for the B-Series platform. The company also references initiatives such as an OCT-Tissue Surveillance Registry to collect data that can inform future product development and AI model enhancement.