Scaling Up: How Moonrise Medical is Advancing its Vascular Imaging Solution

Every 30 seconds, a limb is lost to amputation globally, often due to previously undiagnosed treatable vascular diseases like blocked vessels. Addressing this issue is Moonrise Medical, a medtech platform co-founded by Dr. Abubaker Khalifa, Adam Gold, and Jill Sommerset, specializing in AI-driven vascular imaging.

Moonrise Medical's innovation lies in its proprietary AI-capable platform that automates the measurement of Pedal Acceleration Time (PAT), a key metric for predicting wound healing and amputation-free survival. Traditional vascular ultrasound relies heavily on specialized sonographers, who are in short supply, leading to significant backlogs in diagnoses and treatment. Moonrise's system overcomes this bottleneck by employing advanced algorithms and AI, enabling even non-specialists to conduct scans effectively.

The platform acts as an "intelligent layer" that automates the imaging process from start to finish. Through proprietary algorithms, the software accurately locates tiny blood vessels in the foot, optimizes imaging quality, and computes vital vascular metrics in real-time. This automation minimizes the operator dependency that complicates traditional vascular imaging, making the diagnostic process faster and more efficient.

Dr. Khalifa highlighted that the PAT metric, developed by co-founder Jill Sommerset, boasts validation from over 25 peer-reviewed studies and has been embraced by clinicians worldwide. This broad acceptance indicates that Moonrise’s technology can scale in settings where specialized ultrasonographers are scarce. In clinical studies, users with minimal training, including medical receptionists, successfully localized blood vessels and provided diagnoses in as little as 25 seconds. This innovation shifts the diagnostic capability from specialized labs to patients' bedsides, effectively democratizing access to critical healthcare diagnostics.

Transitioning from a prototype to a regulated clinical tool, however, presents numerous challenges, particularly in securing capital and establishing quality-assurance processes. Recognizing these hurdles, Moonrise sought strategic support for developing a commercial-ready prototype and a Quality Management System (QMS) to meet FDA requirements. The company turned to the CAMEDA (Canadian Medtech Alliance) program, a Canadian initiative aimed at helping life science firms in the latter stages of commercialization.

Through CAMEDA, Moonrise formed a strategic partnership with Inertia, a product development firm that facilitated compliance with FDA standards necessary for the 510(k) certification. This collaboration allowed Moonrise to focus on its core intellectual property while ensuring that the commercial system met rigorous regulatory requirements, a crucial factor in avoiding stalling in the early startup phase, often referred to as the “Valley of Death.”

In addition to the support from CAMEDA, Moonrise received $500,000 from the Ontario Centre of Innovation’s Life Science Innovation Fund, further solidifying its financial foundation. The company has become active within the innovation ecosystem, presenting at prominent forums such as the AngelOne Network and OBIO’s Investment Summit.

By leveraging the resources and expertise available through the CAMEDA program, Moonrise Medical is accelerating its journey toward commercialization. Progress in developing its QMS is essential for closing the current investment round, while the company focuses on finalizing its commercial unit for FDA submission. This regulatory milestone is pivotal for integrating Moonrise’s software as a medical device within hospitals.

Ultimately, Moonrise aims to become a comprehensive platform for patient care by providing automated tools for early detection and prevention of amputations. By transforming complex vascular imaging into accessible, point-of-care processes, Moonrise demonstrates the significant impact that clinical expertise and supportive ecosystems can have on improving healthcare outcomes.