Spectral MD

Spectral MD (operating publicly as Spectral AI) is a Dallas, Texas-based medical diagnostics company that combines optical/multispectral imaging with artificial intelligence to predict wound healing potential. Its flagship product, the DeepView Wound Imaging System, is a portable imaging platform that provides clinicians with an immediate, objective, binary assessment of whether a wound will heal on its own or requires surgical intervention, using physiological information not visible to the human eye. The platform targets burn and diabetic foot ulcer (DFU) indications, with additional applications described in amputations, critical limb ischemia, venous leg ulcer, guided therapy and 3-D wound size measurement and digital wound assessment.

The technology is trained and tested against a proprietary, clinically validated database described by the company as containing over 263 billion data points. Hardware, software and AI for DeepView were built in-house at the company's Dallas office, and the company owns its cloud-based data pipeline running from patient data collection through to clinician-facing output. Key technical areas cited include multispectral, thermal, perfusion (laser Doppler), ultrasound, 3D surface and fluorescence imaging, deep learning with convolutional neural networks, image segmentation, predictive analytics for healing trajectories, clinical decision support systems, and EHR integration.

The DeepView technology received FDA Breakthrough Device Designation in 2018 for its burn indication, and the company received ISO 13485 certification for manufacture and distribution of the DeepView system in August 2023. The company also received a Commitment to Quality Achievement Award from the Texas Manufacturer Assistance Center for its UKCA Mark attainment.

Founding story

Spectral MD Holdings, Ltd. was established through the technology transfer department of the University of Texas Southwestern, with its operating subsidiary incorporated in Delaware in 2009. It was co-founded by cardiac surgeon Dr. J. Michael DiMaio to address unmet clinical needs he observed in practice, and by Wensheng Fan, who was the company's first employee. The Group's initial focus was giving clinicians the ability to understand and predict pressure ulcers in bed-ridden patients.

Business model

The company develops and seeks to commercialize a regulated medical imaging device (DeepView) for wound care. To date it has been funded substantially by non-dilutive US government contracts, principally from BARDA, and describes itself as pursuing federal procurement contracts alongside commercial product commercialization in the US, EU and UK markets. Related activities described include clinical validation studies, clinical pathway implementation and education, device systems development and production transition, and commercialization/market-access support.

Historically funded by non-dilutive US government grants and contracts (BARDA), with a stated goal of securing a substantial federal procurement contract for DeepView commercialization and expanding commercial sales in the US, EU and UK.

Traction

The company reported raising more than $125 million, and subsequently $130 million, in non-dilutive US government contracts. It conducted what it described as the largest burn image clinical trial to date, involving 12 US burn centers and 250 enrolled subjects, and reported AI accuracy of 92%. Regulatory and quality milestones include 2018 FDA Breakthrough Device Designation for the burn indication, ISO 13485 certification in August 2023, and UKCA mark attainment.

Latest developments

In April 2023 the company announced a business combination with Rosecliff Acquisition Corp I valuing Spectral MD at an estimated $170 million, intending to delist from AIM and list on Nasdaq as Spectral AI (ticker MDAI). In August 2023 it received ISO 13485 certification for the DeepView system and reported clearing SEC review of the joint S-4, with shareholder meetings set for August 31 (Spectral MD) and September 6 (Rosecliff) and a Nasdaq listing targeted for September 8 or 11, 2023. Planned participation in the American Burn Association Conference in April 2025 and the British Burn Association Conference in June 2025 was noted.