Perimeter Medical Imaging AI develops real-time optical coherence tomography imaging systems and artificial-intelligence tools for cancer surgery. The company’s Claire OCT+AI device has FDA premarket approval for intraoperative breast cancer margin assessment, while its S-Series OCT platform provides ultra-high-resolution cross-sectional visualization of excised tissue.
Company news commonly covers FDA regulatory milestones, product demonstrations, commercialization activity, clinical and technology updates, operating and financial results, investor conference presentations, and capital-structure actions such as private placements, warrants, and stock-option matters.
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.
Perimeter Medical Imaging AI (TSXV: PINK)(OTC: PYNKF) announced it will release its third quarter 2024 financial results after market close on November 14, 2024. The company will host a conference call and webcast at 5:00 pm Eastern Time to discuss the results and provide a corporate update. Investors can access the call via 1-800-717-1738 (Canada/US) or 1-646-307-1865 (International). The webcast will be available on the company's website under the Investors section.
Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) has announced the second and final closing of its non-brokered private placement. The company issued 4,846,501 common shares at $0.42 per share, raising $2,035,530 in gross proceeds. Combined with the initial closing, Perimeter has issued a total of 28,317,061 common shares for aggregate gross proceeds of $11,893,166.
The net proceeds will be used for working capital, commercialization of Perimeter's technology, clinical studies, further technology development, and general corporate purposes. The issued securities are subject to a four-month hold period. Finder's fees of $53,285 were paid to certain arm's length finders.
Notably, CEO Adrian Mendes purchased 321,750 shares, and director Suzanne Foster acquired 70,000 shares in this closing, constituting a related party transaction under TSX Venture Exchange Policy 5.9 and MI 61-101.
Perimeter Medical Imaging AI (TSXV: PINK, OTC: PYNKF) has completed patient enrollment in a pivotal study evaluating its next-generation Perimeter B-Series OCT system during breast-conserving surgeries (BCS). The system combines artificial intelligence with optical coherence tomography for margin assessment, aiming to reduce high reoperation rates in BCS.
The study enrolled approximately 530 women across 10 U.S. clinical sites, randomized in a 2:1 ratio to device and control arms. The primary endpoint is the occurrence of at least one unaddressed positive margin. Primary endpoint results are expected in Q4-2024, potentially supporting an FDA submission in 2025.
If successful, this could lead to the first-ever marketing clearance for specific use in breast tissue, breast cancer, and margin evaluation, representing a major inflection point for Perimeter's business.