Collaboration aims to evaluate AI-assisted lower extremity CT angiography and pilot GuideAI's Elevate platform in a preventive cardiology setting
October 19, 2026 – Boston, Massachusetts --- GuideAI Health Corp. (Cboe CA: GDAI) (FSE: ZN0) ("GuideAI" or the "Company") is pleased to announce that it has entered into a Clinical Study, Software License and Services Agreement (the "Agreement") with Boone Heart Institute ("BHI"), a preventive cardiology practice based in Colorado, under which GuideAI will sponsor, and BHI will serve as the clinical site for a study evaluating whether AI-assisted lower extremity CT angiography can provide diagnostic information regarding atherosclerotic plaque burden, which is sub-optimally obtained from screening lower extremity duplex ultrasound. The Agreement also provides for a concurrent pilot of GuideAI's Elevate Vascular Intelligence Platform at BHI.
The licensed software comprises GuideAI's cloud-hosted Elevate platform and VascularAssist Occlusion Triage ("VAOT"), together with VascularAssist Plaque Analysis and Detection ("VAPAD") solely for investigational use. VAOT is FDA 510(k)-cleared as a computer-aided triage and notification device that is designed to flag suspected lower extremity arterial occlusion on CT for prioritized radiologist review. VAOT is an adjunct to, and not a replacement for, radiologist interpretation and is not intended for primary diagnosis.
During the pilot period, which is expected to continue for three months, no per-scan fee will be payable to GuideAI. Following the pilot period, BHI may continue to submit study scans and clinical scans for analysis using Elevate and VAOT for a per-scan fee. The Agreement has an initial 24-month term, but either party may terminate it on 60 days' written notice.
"This Agreement provides a framework to generate clinical evidence regarding AI-assisted lower extremity CT angiography while evaluating how our technology may fit within a preventive cardiology workflow," said Raj Shah, MD, MBA, Chief Executive Officer of GuideAI Health.
"Prevention is at the heart of what we do," said Jeffrey Boone, MD, of Boone Heart Institute. "We look forward to working with GuideAI on a study designed to compare AI-assisted lower extremity CT angiography with our existing screening pathway and to evaluate the technology in our clinical workflow."
About GuideAI Health Corp.
GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease. By surfacing disease earlier, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care.
For more information, please visit https://www.guideaihealth.com/.
About Boone Heart Institute
Boone Heart Institute is a preventive cardiology practice, founded in 2008 by Jeffrey L. Boone, MD, MS, whose career in preventive medicine spans four decades. The practice has grown into a national destination for preventive health care, with a 6,500 square foot clinic offering in-house diagnostic testing, a physician team that includes board-certified cardiologists and specialists in cardiac imaging, and a comprehensive Executive Physical program. BHI provides care to professional sports organizations including the San Francisco 49ers, Denver Broncos and Colorado Rockies, and offers coronary CT heart scans to retired NFL players through the NFL GAMEFILM program. Dr. Boone is the author of A World Without Heart Attacks and has been named a Top Doctor by 5280 Magazine each year from 2023 through 2026.
For more information, please visit www.booneheart.com.
On Behalf of the Board of Directors:
Raj Shah
CEO
Contact:
Phone: (416) 309-3583
Email: info@guideaihealth.com
Cautionary Note Regarding Forward-Looking Statements
This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of applicable Canadian securities legislation. All statements in this news release, other than statements of historical fact, are forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements regarding: completion and approval of the study protocol; receipt of IRB approval; satisfaction of the insurance, imaging, integration and other conditions required before the first study scan; commencement, conduct, enrollment, timing, completion and results of the study; the ability of AI-assisted lower extremity CT angiography to provide diagnostic information not obtained from the existing screening pathway; the integration and performance of the Elevate platform in BHI's workflow; BHI's submission of scans during or after the pilot period; the payment of per-scan fees following the pilot period; the potential transition to routine use at BHI; possible peer-reviewed publication of study results; the regulatory pathway for VAPAD; and the Company's business plans and objectives generally. Forward-looking statements are often identified by words such as "expects", "anticipates", "intends", "plans", "believes", "will", "may", "potential" and similar expressions.
Forward-looking statements are based on the opinions, estimates and assumptions of management as of the date of this news release, including assumptions that: the protocol will be finalized and approved; IRB approval and required insurance coverage will be obtained; BHI will identify and enroll sufficient eligible subjects; the imaging protocol and technical integrations will be completed; the licensed software will perform as expected; BHI will submit scans following the pilot period; the Agreement will not be suspended or terminated early; VAPAD will obtain FDA clearance; and the Company will have sufficient capital to fund its obligations under the Agreement and its development activities. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially, including: delay or failure to finalize the protocol or obtain IRB approval, required insurance coverage or other prerequisites; slower than expected enrollment or failure to enroll the contemplated cohort; safety, radiation, contrast-media or operational issues; the possibility that the study does not demonstrate clinically meaningful benefits; integration, image-quality, platform availability or teleradiology issues; the risk that BHI submits few or no scans after the pilot period, does not adopt the software for routine use or terminates the Agreement on 60 days' notice; the risk that the Agreement does not generate material revenue; the risk that VAPAD does not obtain FDA clearance or that clearance is delayed; changes in regulatory requirements applicable to AI-enabled software as a medical device; reliance on third-party PACS, teleradiology and cloud infrastructure providers; compliance with healthcare, privacy and data-security laws, including HIPAA; cybersecurity and data privacy risks; competition; the Company's need for additional financing; and the other risk factors described in the Company's continuous disclosure filings available under its profile on SEDAR+ at www.sedarplus.ca.
The study described in this news release has not commenced and no results are available. FDA 510(k) clearance of VAOT does not constitute FDA approval, and VAOT is cleared only as a computer-aided triage and notification device for the indication described above. VAPAD has not been cleared or approved by the FDA for any indication, and no fee under the Agreement is consideration for VAPAD before clearance. No assurance can be given that the study will commence or be completed, that it will demonstrate any clinical benefit, that BHI will continue to submit scans after the pilot period or adopt the software for routine use, that VAPAD will obtain FDA clearance, or that the Agreement will generate material revenue for the Company. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date hereof, and the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.