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Perimeter Medical Imaging AI, Inc. (PYNKF) is a commercial-stage medical technology company focused on transforming cancer surgery. Headquartered in Toronto, Canada, and Dallas, Texas, the company provides ultra-high-resolution, real-time, advanced imaging tools to address critical medical needs. With FDA-cleared Perimeter S-Series OCT system for cellular-level visualization and investigational Perimeter B-Series OCT with ImgAssist AI, Perimeter is at the forefront of utilizing artificial intelligence to enhance surgical outcomes and patient care.
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.
Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) has closed a non-brokered private placement, issuing 23,470,560 common shares at $0.42 per share, raising gross proceeds of $9,857,635. The company may complete additional closings for up to $13.5 million in total. Social Capital, led by Chamath Palihapitiya, was the lead investor, purchasing 14,507,453 shares. The funds will support the U.S. commercial adoption of Perimeter's FDA-cleared S-Series OCT and advance the development of their B-Series OCT system with AI technology. The offering also included participation from company insiders and early investors.
Perimeter Medical Imaging AI (TSXV: PINK) (OTC: PYNKF) has announced a non-brokered private placement of up to 32,175,032 common shares at $0.42 per share, aiming to raise up to $13.5 million. The company has secured binding agreements for approximately $9.7 million, including from its largest shareholder, Social Capital. The closing is expected around September 20, 2024, subject to conditions including TSXV approval. Proceeds will be used for working capital, commercialization, clinical studies, and technology development. The offering includes a four-month hold period and may involve cash commissions to finders. Social Capital's participation constitutes a 'related party transaction' under MI 61-101, with the company relying on exemptions from formal valuation and minority shareholder approval requirements.
Perimeter Medical Imaging AI reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- 83% revenue growth in Q2 2024 compared to Q2 2023
- Six new S-Series OCT system placements year-to-date, up from three in all of 2023
- Anticipated completion of patient enrollment for B-Series OCT pivotal trial in Q3 2024, earlier than expected
- White paper showing lower reoperation rates with Perimeter S-Series OCT compared to national averages
- 1,000th paid Perimeter S-Series OCT patient scan milestone achieved
- Introduction of ImgClear AI image enhancement algorithm
Financial results: Q2 2024 revenues of $246,000, net loss of $3.2 million (improved 35% YoY), and cash position of $6.5 million as of June 30, 2024.
Perimeter Medical Imaging AI (TSXV: PINK, OTC: PYNKF, FSE: 4PC) has announced it will report its second quarter 2024 financial and operating results after market close on Wednesday, August 14, 2024. Following the announcement, the company's management will host a webcast and conference call to discuss the results and provide a corporate update.
The conference call is scheduled for 5:00 pm Eastern Time on August 14, 2024. Investors can dial in using the following numbers: 1-800-717-1738 (Canada and the United States) or 1-646-307-1865 (International). The call will also be broadcast live and archived on the company's website under the 'News/Events' section in the Investors area.
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