Welcome to our dedicated page for Perimeter Medical Imaging Ai news (Ticker: PYNKF), a resource for investors and traders seeking the latest updates and insights on Perimeter Medical Imaging Ai stock.
Overview
Perimeter Medical Imaging AI Inc is a commercial-stage medical technology company dedicated to transforming cancer surgery through ultra-high-resolution, real-time imaging solutions. The company specializes in advanced optical coherence tomography (OCT) and artificial intelligence (AI) systems, enabling surgical teams to visualize tissues at a cellular level during operations. Its FDA-cleared S-Series OCT system and the investigational B-Series OCT with ImgAssist AI represent a significant advancement in intraoperative imaging, directly addressing the challenge of accurately determining surgical margins and reducing re-excision rates.
Core Technologies and Applications
At the heart of Perimeter's offerings is its state-of-the-art OCT technology, which leverages light to capture detailed, cross-sectional images of excised tissues. This technology provides real-time visual feedback in the operating room, offering surgeons a powerful tool for margin assessment during procedures such as breast-conserving surgeries. By integrating proprietary AI algorithms through its ImgAssist system, Perimeter enhances the imaging process to detect residual cancer with greater precision compared to traditional methods like X-ray, ultrasound, or MRI.
The company’s clinical applications focus on:
- Surgical Margin Visualization: Enabling surgeons to identify regions of interest and determine the adequacy of surgical resection in real-time.
- Intraoperative Decision Support: Assisting with margin evaluation during procedures, potentially minimizing the likelihood of repeat surgeries.
- Advanced Imaging in Oncology: Meeting a critical need in cancer surgery by providing high-resolution images that enhance clinical outcomes.
Industry Context and Market Position
Operating within the highly competitive medical imaging and surgical technology industry, Perimeter Medical Imaging AI leverages its expertise in both hardware and software to offer breakthrough diagnostic tools. The integration of AI with real-time imaging distinguishes the company from traditional imaging providers by offering enhanced decision support in the surgical environment. This dual approach not only supports more precise surgical interventions but also underlines the company’s commitment to addressing significant unmet clinical needs.
Perimeter’s technology is designed to integrate seamlessly into existing surgical workflows. Its products have been showcased at international conferences and are supported by rigorous clinical trials, which are instrumental in cementing its reputation for clinical validation and technological innovation. The company’s advancements contribute to improved patient care by potentially improving surgical outcomes and reducing healthcare costs associated with reoperations.
Business Model and Operational Excellence
Perimeter Medical Imaging AI generates revenue from several streams including direct device sales, consumables, system leases, and potential licensing opportunities. The company’s strategic focus on clinical trials and surgeon education is central to driving market adoption. By collaborating with healthcare providers and leveraging grant funding to support clinical research, Perimeter aims to validate its technology and build a robust user base within key market segments.
The operational excellence of Perimeter is underscored by its ability to integrate clinical insights with advanced technological solutions. The company continuously develops and refines its products to meet the practical needs of the surgical community, ensuring that its imaging tools remain at the forefront of innovation in cancer surgery.
Commitment to Expertise, Experience, and Trust
Perimeter Medical Imaging AI upholds stringent standards of quality and clinical validation. This commitment is reflected in its extensive efforts in clinical trials, regulatory approvals, and the incorporation of feedback from leading surgical oncologists. The company’s leadership combines rich experience in the fields of medical technology and AI, lending credibility and depth to its innovations. Detailed clinical studies and rigorous testing protocols enhance the transparency and reliability of its imaging systems.
By fostering ongoing research and maintaining a proactive approach to technological development, Perimeter establishes itself as an authoritative source of innovation in intraoperative imaging. This approach not only demonstrates deep industry knowledge but also builds enduring trust among healthcare providers, investors, and other stakeholders.
Competitive Differentiation
Unlike traditional imaging methods, Perimeter’s solutions provide surgeons with immediate, actionable insights during operations. The company differentiates itself through a combination of high-resolution imaging and AI-driven interpretation, which together enhance the accuracy and efficiency of margin assessments. This differentiation is supported by:
- Robust clinical validation through pivotal trials.
- Strategic partnerships and active participation in international medical conferences.
- An extensive proprietary image data set that fuels continuous AI model improvement.
Conclusion
Perimeter Medical Imaging AI Inc is a pioneer in employing advanced OCT and AI technologies to redefine the standards of cancer surgery. Its innovative platforms support surgeons in making well-informed, real-time decisions that potentially reduce the risk of reoperations and improve overall patient outcomes. Through its commitment to deep clinical validation, technological rigor, and continuous innovation, Perimeter maintains its position as a significant and trustworthy contributor to the field of surgical imaging.
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'.
Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) has announced contingency measures due to the ongoing Canada Post strike that may affect the delivery of Meeting Materials for their upcoming annual general meeting scheduled for December 12, 2024.
The company has confirmed that shareholders can access the Meeting Materials through their SEDAR+ profile and company website. Despite potential postal delays, shareholders can still vote either directly, by proxy, or via intermediaries.
Registered shareholders can obtain their proxy form control number through Computershare Investor Services, while those holding shares through intermediaries should contact their brokerage firms directly for voting instructions.
Perimeter Medical Imaging AI announced positive topline results from its pivotal study for the B-Series OCT system with ImgAssist AI 2.0. The trial, involving 206 breast cancer patients, demonstrated super-superiority in detecting residual cancer during breast-conserving surgeries compared to standard methods. The study met its primary endpoint with statistical significance (p-value = 0.0050). The technology aims to reduce the need for reoperation by helping surgeons achieve clear surgical margins during initial surgery. The company plans to submit an FDA PMA application in early 2025.
Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) announced it will release topline results from its pivotal study evaluating the B-Series OCT system with ImgAssist AI in breast-conserving surgeries. The results will be announced after market close on November 20, 2024, followed by a management conference call at 5:00 pm Eastern Time. The B-Series OCT system combines artificial intelligence technology with optical coherence tomography. The conference call will be accessible via phone and webcast, with archives available on the company's website.
Perimeter Medical Imaging AI reported Q3 2024 financial results, showing significant commercial growth with its FDA-cleared S-Series OCT system. Revenue reached $208,000, a 142% increase from Q3 2023, with eight new system placements year-to-date. The company completed a private placement raising C$11.9M and finished patient enrollment in its pivotal trial for the B-Series OCT system with AI technology.
Q3 2024 operating expenses were $4.5M, with a net loss of $4.6M. Cash position stood at $9.5M as of September 30, 2024, excluding C$2.0M from the second offering closing and a $1.9M CPRIT grant receivable.
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