Wednesday, December 7, 2022

Enrollment Completed for Multi-Center Study for Diabetic Foot Ulcers

Spectral MD, a predictive analytics company that develops proprietary AI algorithms and optical technology to hopefully provide faster and more accurate treatment decisions in wound care, announces the completion of enrollment for its IRB-approved multi-center training study to support the development of its DFU application for the DeepView® Wound Imaging System.

The data collected from the study will bolster the existing clinical database of DFU images and clinical data to train and increase the current 83.3% decision support accuracy of the DeepView® algorithm for DFU.

The IRB-approved multi-center study enrolled a total of 150 adult subjects and was executed successfully and on schedule across six clinical sites in the U.S. The training study with data from all study subjects is expected to complete in December 2021.

The DFU images and clinical data collected will be incorporated into the database for the development of DeepView®’s DFU algorithm. It will also inform on key data points that will be captured in a planned validation study, which is expected to start around late Q1 2022 following the successful completion of the training study. Importantly, data collected will support the Company’s applications for FDA and CE mark approval for DeepView®’s DFU indication, one of the necessary milestones required in order to commercialize DeepView®‘s DFU application which is targeted towards the end of 2022.

The completion of enrollment for the multi-center study is an important milestone for the Company and illustrates that it is delivering on its expected milestones outlined at the time of its AIM IPO in June 2021. Proceeds raised at IPO will continue to support the development of DeepView® for the DFU application with its current training study and eventual validation study.

DFU is a severe chronic diabetic complication that consists of lesions in the deep tissues associated with neurological disorders and peripheral vascular disease in the lower limbs. It is the most frequently recognized, complex and costly symptom of diabetes and can lead to limb amputation if left undiagnosed, misdiagnosed or untreated. Due to U.S. reimbursement rules, physicians are currently typically required to wait 30 days to designate a DFU as non-healing before using advanced wound care therapies, resulting in potential higher probability of infections, longer healing times and significant lifetime medical costs for the patient. DeepView®’s early healing assessment for DFU has the potential to provide a significant improvement to the current standard of care, potentially resulting in faster application of advanced therapy, better wound healing and reduced overall hospital visits and utilization.

Wensheng Fan, Chief Executive Officer of Spectral MD, said: “We are pleased to now complete the enrollment for the multi-center training study to further develop DeepView® for the DFU application. DFU images and data collected from the 150 subjects will be instrumental in improving the early healing assessment of DeepView® for DFU, which currently has a clinical accuracy of 83.3% based on early data observed in our training studies.

“Crucially, the enrollment completion highlights that we are on track regarding the Company’s expected milestones outlined at the time of our June 2021 IPO. I look forward to providing further updates for investors as we continue to develop Spectral MD’s ground-breaking Would Imaging System for both the DFU and burn wound indications.”

Dr. Jeffrey Thatcher, Chief Scientist of Spectral MD, said: “Meeting our 150-subject enrollment goal is a huge step in the process of obtaining regulatory approval and commercializing our transformative technology. The study is collecting valuable DFU wound images that will be used to build a database for the development of a Machine Learning algorithm for DFU healing assessment, as well as exploring other DFU questions using images and clinical data obtained with the DeepView® technology.”

Spectral MD devices are in various stages of research and development including pre-clinical testing and clinical investigations. At this time, no SMD devices have received marketing authorization and, therefore, are not available for sale.

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