Every 30 seconds, a limb is lost to amputation somewhere in the world. Within the hospital system, a significant portion of these amputations occur in patients whose treatable vascular disease—such as blocked vessels—was not previously identified. This diagnostic gap is the driving force behind Moonrise Medical, an AI-capable medtech platform for vascular imaging.
Co-founded by Dr. Abubaker Khalifa, a McMaster University-trained physician, serial
entrepreneur Adam Gold, and renowned vascular ultrasound professional Jill Sommerset,
Moonrise’s innovation lies in its AI-capable proprietary platform. The solution automates the
measurement of Pedal Acceleration Time (PAT), a metric used to predict wound healing and
amputation-free survival.
Traditionally, vascular ultrasound is highly dependent on specialized sonographers, who are in
short supply globally, creating massive backlogs. Moonrise’s system addresses this bottleneck
by using novel algorithms and AI to guide even non-specialists through a scan.
Vascular imaging and AI
The Moonrise platform acts as an ‘intelligent layer’ that provides end-to-end automation in
vascular imaging. Using proprietary algorithms, the software identifies the exact location of tiny
foot blood vessels, optimizes the imaging, and calculates the vascular hemodynamic metrics,
including the PAT metric, in real-time. This eliminates the operator-dependency that typically
makes vascular imaging so difficult.
Dr. Khalifa explained that PAT, as a hemodynamic metric discovered by Co-founder Jill
Sommerset has been validated in 25+ peer-reviewed papers and presented on conferences
podiums worldwide. It is changing the treatment pathways for patients. Clinicians and providers
globally are widely accepting this metric and recognizing that Moonrise’s technology allows for it
to be used at scale, where there are no specialized ultrasonographers.
Dr. Khalifa also shared that in clinical studies, the software allowed users with minimal training,
including medical receptionists and retirees, to localize blood vessels and provide a diagnosis in
as little as 25 seconds. By removing the need for a specialist at the point of care, Moonrise
moves the diagnostic capability from specialized labs directly to the patient’s bedside.
“Our breakthrough isn’t just about the measurement itself, but about democratization,” says Dr.
Khalifa. “By automating the expertise of a sonographer into a 25-second workflow, we are
making life-saving diagnostics accessible in any clinic, anywhere.”
Getting regulatory ready through the CAMEDA program
Transitioning a medical innovation from a prototype to a regulated clinical tool requires
significant capital and specialized quality-assurance expertise. While the start-up had the data
and the science, there was a missing piece: creating a physical device and a rigorous
framework that could pass through regulatory approvals. At that point, Moonrise was looking for
strategic support for the development of a commercial-ready prototype and a Quality
Management System (QMS) for their FDA submission.
“As a start-up, you face real-world challenges where capital is tighter than in years past,” Dr.
Khalifa explains. “For us, the priority was finding a way to get high-level hardware and quality
support without having to recruit an entire in-house team before we were ready.” The team
turned to Innovation Factory’s CAMEDA (Canadian Medtech Alliance) program.
The CAMEDA program, backed by Innovation Factory’s Southern Ontario Pharmaceutical &
Health Innovation Ecosystem (SOPHIE) program supports collaborative initiatives for Ontario-
based life science firms in the later stages of commercialization. SOPHIE is funded by a
Government of Canada investment through the Federal Economic Development Agency for
Southern Ontario (FedDev Ontario) to help technology companies develop, test, and
commercialize innovative healthcare solutions.
Through the program, Moonrise established a strategic partnership with Inertia, a product development firm that provided the essential expertise needed to develop a product that meets
the FDA standards.
“Leveraging partners like Inertia through the CAMEDA program allowed us to focus on our core
IP while ensuring our commercial system met the rigorous standards required for the FDA
510(k) certification. That level of support is what prevents a start-up from stalling in the ‘Valley of
Death,’” said Dr. Khalifa.
Soon after becoming a CAMEDA recipient, Moonrise also received $500,000 from the Ontario
Centre of Innovation’s (OCI) Life Science Innovation Fund (LSIF). The team has been active
members of the innovation ecosystem and have been invited to speak at the AngelOne
Network, the Next Great Big Ideas summit, OBIO’s Investment Summit, and more.
The path to scale
By accessing the necessary expertise and funding through the CAMEDA program, Moonrise
Medical has accelerated its path to scale. The progress made on their commercial system and
Quality Management System (QMS) has become an essential component needed to close the
team’s current investment round, while the company focuses on finalizing its commercial unit for
FDA submission.
This regulatory milestone moves the SaMD solution one step closer to hospital integration.
Ultimately, these advancements support Moonrise’s clinical goal of becoming a comprehensive platform for the ‘foot journey,’ providing clinicians with the automated, early-detection tools
necessary to prevent amputations before they occur.
By turning complex vascular imaging into an accessible, point-of-care reality, the Moonrise team is proving that the right combination of clinical expertise and ecosystem support can impact the
quality of care offered to Canadians. Through the CAMEDA program, Moonrise has secured the
strategic foundation needed to bring this life-saving tech to clinics everywhere, ensuring that no
patient’s treatable condition goes undiagnosed due to a lack of specialized resources.
Interested in learning more about the CAMEDA program? Connect with us to learn more.