Spectral MD and BARDA Agree to Start Enrollment in Clinics for Expanded Proof Of Concept Study (ePOC) Stage II Using the Company’s Improved DeepView SnapShot® Device
03 June 2020
Enrollments to Start in Wake Forest Baptist Medical Center, University Medical Center New Orleans, and Two other Leading Medical Burn Centers in the United States Over the Next Two Months
DALLAS, Texas, June 3, 2020: Spectral MD, Inc. (SMD) announced today that the Biomedical Advanced Research and Development Authority (BARDA) has agreed with SMD to proceed with Stage II enrollment for the ePOC after reviewing the performance of their next-generation imaging head in their Stage I ePOC study.
The DeepView SnapShot Device (DV-SS) includes the Company’s multispectral imaging sensor designed to replace the current multispectral sensor which offers a larger field-of-view, rapid image acquisition time and integration into the future portable DeepView DV-SSP imaging head that will be smaller and lighter. Results were presented utilizing data from the DV-SS and the Company’s prior imaging technology that included 553 images of 54 burn injuries from 25 subjects. The DV-SS met statistical endpoints for its approval for continued investigation in Stage II of the ePOC study. The Company plans to commence studies at the Wake Forest Baptist Burn Center, University Medical Center New Orleans, which conducted the Stage I study, and two other leading medical burn centers in the United States over the next two months.
“Our technology continues to evolve in a very positive direction. The improvements in DV-SS better meet the needs of clinicians and we look forward to its continued development toward commercialization,” stated Dr. Jeffrey Thatcher, Spectral MD’s Chief Scientist and BARDA Project PI. “We work with great partners in BARDA and the clinical trial sites at Wake Forest Baptist Medical Center and University Medical Center New Orleans and are extremely proud to have their ongoing support. The core team at Spectral MD is looking forward to commencing this Stage II ePOC.”
Commenting on recent developments, Wensheng Fan, Chief Executive Officer and Co-Founder of Spectral MD stated, “With the help of a dedicated team, the Company continues to make incredible progress. Over the next few months we will hire our first full time Chief Medical Officer and will be seeking additional team members to support our amputation, burn, CLI and DFU initiatives and likely initiatives in the EU to begin the CE Marking process.”
About Spectral MD:
We are a dedicated team of forward-thinkers striving to revolutionize the management of wound care by “Seeing the Unknown” with our DeepView® Wound Imaging System. This work is fully supported by BARDA contract # 75A50119C00033"