Live Call/Webcast Today at 5 pm ET
Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, provided a corporate update today on its progress towards achieving key corporate objectives, as well as commercial, clinical and product development milestones.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “I believe 2021 was a transformative year for Perimeter, and today’s update summarizes the key milestones achieved across all areas of our business. Importantly, we received 510K clearance from the FDA enabling the commercial launch of our flagship Perimeter S-Series OCT platform, and we have started to place this innovative technology in the hands of influential thought leaders at leading hospitals and healthcare institutions. In addition, we initiated a multi-center, randomized, two-arm clinical trial of our investigational Perimeter B-Series OCT imaging platform combined with ImgAssist AI, which continues to enroll patients and is expected to be completed later this year.”
Mr. Sobotta continued, “Backed by strong support from our existing shareholders, we recently closed a successful equity financing, which included Social Capital, that we anticipate will fuel our commercial efforts and enable us to leverage their expertise in technology and AI. We believe we have the capital and expertise in place to support us in our journey to deliver best-in-class advanced imaging technologies, with the aim of improving health outcomes and reducing costs. This is an incredibly exciting time for Perimeter, and we look forward to building upon the positive momentum already generated at the beginning of this year.”
Company Milestones
Financial Highlights
- In January 2022, Perimeter closed a private placement resulting in gross proceeds of C$48.7 million to the Company, which included a C$43.4 million strategic investment in the Company by Social Capital.
Commercial Highlights
- Perimeter received 510(k) clearance for its S-Series OCT imaging platform from the U.S. Food and Drug Administration (FDA), enabling its commercial launch in the U.S. Subsequently, under the leadership of Steve Sapot, Chief Commercial Officer, Perimeter continues to build upon its sales and marketing infrastructure – including key hires of market development managers to cover regions across the U.S.
- Perimeter partnered with Minnetronix Medical, a leading medical technology and operations partner to global medical device companies, to secure commercial-scale manufacturing of Perimeter S-Series OCT imaging systems.
Clinical and Product Development Highlights
- Perimeter received U.S. FDA Breakthrough Device Designation for Perimeter B-Series OCT combined with proprietary ImgAssist artificial intelligence (AI) software – providing a potential expedited pathway for development and adoption of this innovative technology.
- Perimeter initiated a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter B-Series OCT with ImgAssist AI for use during breast conservation surgery, with study completion anticipated by the end of 2022.
Company Outlook
Perimeter’s sales and marketing efforts will continue to focus on placing its commercially available, flagship Perimeter S-Series OCT at leading hospitals where key opinion leaders can act as champions of this innovative technology. The commercial team has an aggressive schedule of trade shows, webinars and other targeted industry events to showcase Perimeter S-Series OCT in the coming months. In parallel, Perimeter’s clinical team will focus on the continued enrollment of patients and onboarding of healthcare institutions in the ongoing pivotal trial evaluating its next-gen investigational Perimeter B-Series OCT with ImgAssist AI when used in breast lumpectomy procedures, with the goal of gathering data from approximately 300 patients across 8 sites and completing the study in 2022.
Conference Call
To participate in the call, please dial (877) 407-0789 or (201) 689-8562 for international callers and provide conference ID number 13727220. A listen-only audio webcast will be broadcast live on the Investors section of the Perimeter website. The webcast will also be archived on the Investors section of the Perimeter website for at least 90 days and a telephonic playback of the conference call will be available for 14 days following the event by dialing (844) 512-2921 or (412) 317-6671 for international callers and referencing conference ID 3727220.
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