Author: Dr. Abubaker Khalifa

Institution: Moonrise Medical

Summary

This presentation showcases the application of an automated AI-assisted venous ultrasound diagnostic system developed by Moonrise Medical, designed for diagnosing and guiding treatment in patients with chronic limb-threatening ischemia (CLTI). The core feature, “Plantar Acceleration Time” (PAT) technology, uses AI algorithms for real-time blood flow analysis, accurately predicting healing potential and guiding revascularization treatment.

Challenges of CLTI and AI System Innovation

•Challenges in CLTI Diagnosis and Treatment: CLTI is associated with high mortality and amputation risks. Current diagnostic methods (such as ABI and TBI) perform poorly in cases of severe vascular obstruction, especially in diabetic patients, lacking real-time flow information.

•PAT Technology Innovation: Discovered by Jill Sommerset, PAT technology uses AI to automatically identify and quantify blood flow characteristics in the plantar artery, directly correlating with wound healing potential. A PAT time exceeding 215ms indicates a more severe level of ischemia, with real-time PAT analysis guiding surgical decision-making.

Device Design and Clinical Validation

•Device Architecture: The system integrates a custom ultrasound sensor and AI-driven computer vision analysis software, providing real-time blood flow data during surgery. This helps physicians assess blood supply effectiveness in various vessels and determine the surgical endpoint.

•Clinical Validation and Progress: Initial human trials show that the system effectively monitors blood flow changes in CLTI patients, significantly reducing the average hospital stay for revascularization procedures.

Market Outlook and Commercial Model

•Market Demand: With a large global population of CLTI and diabetic patients, Moonrise’s AI diagnostic system provides an efficient diagnostic tool for multiple vascular diseases, with an estimated market potential of billions over the next five years.

•Commercialization Plan: The company plans to submit a 510(k) FDA application in 2025, advancing the product’s clinical application worldwide.

Conclusion

1.Moonrise Medical’s AI-assisted venous ultrasound diagnostic system offers a novel approach to CLTI diagnosis and surgical guidance, enhancing blood flow monitoring with real-time PAT technology.

2.The system has shown significant potential for treatment guidance in preliminary clinical trials and is poised to become a standard tool in revascularization treatment for CLTI patients.

3.With accumulating clinical data and progress toward FDA approval, the system is expected to become a market leader, bringing revolutionary change to venous ultrasound diagnostics.

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