Dallas-based Spectral MD—a predictive AI company focused on medical diagnostics and treatment guidance in wound care—was listed on Nasdaq earlier this month as Spectral AI. Now it’s making news again after landing a big new contract.
The company announced Thursday that it’s been awarded a new contract valued at up to $149 million by the Biomedical Advanced Research and Development Authority (BARDA).
BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response.
The contract is for the advanced development of Spectral MD’s DeepView System, an AI-driven burn wound imaging device designed to be used at emergency departments, trauma centers, and burn centers. The tech is used for both routine burn care and as a medical countermeasure for use in burn mass casualty incidents (BMCI), the company said.
The multi-year contract includes an initial award of nearly $55 million to support the clinical validation and FDA clearance of DeepView for commercial marketing and distribution purposes, Spectral MD said, enabling the technology to become “a key component of the U.S. government’s BMCI preparedness efforts.”
Initial award will place 30 DeepView devices at burn centers and ERs
The initial award will see up to 30 DeepView devices placed at various burn centers and emergency rooms to support the clinical validation study. The devices would transition to being used in routine care once they’re cleared by the FDA.
The contract also includes options with an additional total value of around $95 million and can be exercised for additional product development, procurement, and deployment of DeepView at U.S. emergency departments, trauma centers, and burn centers in a phased approach, Spectral MD said.
“We appreciate that our DeepView platform has been selected to address a critical need in preparing our country for possible BMCI events,” Wensheng Fan, Spectral MD’s CEO, said in a statement. “This is a significant contract award that enables us to accelerate the late-stage clinical development and commercialization of our DeepView System.”
“We’re most grateful to BARDA for enabling us to help physicians and their burn patients who will benefit from the use of DeepView,” Fan added. “For the first time, there will be an accurate and objective solution in burn wound healing assessment to guide treatment. Spectral MD is committed to the development of impactful medical technologies, and we’ll aim to bring DeepView to market as quickly as possible.”
Spectral MD has snagged BARDA contracts before. In 2013 and 2019, it was awarded contracts totaling $123 million, $101 million of which has been committed to date. The new contract brings the company’s total potential support from BARDA to nearly $251 million, and represents the largest contract Spectral MD has ever been awarded.
The company says its work supports BARDA’s mission “to identify medical countermeasures which help counter the effects of a BMCI and address the current limitations within the United States’ burn care infrastructure.”
A critical need for burn care in the U.S.
According to the American Burn Association, 1.1 million Americans suffer from burn injuries each year, with 500,000 presenting to emergency departments, and 40,000 requiring hospitalization. However, only 2% of U.S. hospitals have burn centers, and there are only about 250 burn surgeons in the U.S., Spectral MD noted.
To bridge this gap in care, Spectral MD says its DeepView System, which received Breakthrough Device Designation from the FDA in 2017 for its burn indication, “integrates proprietary imaging technology and AI-enabled algorithms to see deep below the surface of the skin to distinguish between healthy and damaged tissue.”
“By seeing what the human eye cannot,” the company says, “DeepView delivers a binary wound healing prediction to assist physicians in determining whether a burn will heal on its own or if surgery is required. Studies with DeepView have demonstrated a burn diagnostic accuracy rate of 92% on Day 1, well above the estimated >50% accuracy of non-specialists and even the estimated 70% accuracy of burn specialist assessments.”
Jeffrey Carter, M.D., Spectral MD’s chief medical consultant, said that diagnostic accuracy in burn wound assessment using physicians’ clinical judgment alone “can be as low as 50%.”
“This unmet clinical need is dramatically magnified in the event of a BMCI, where the ability to triage burn patients rapidly and properly would be crucial in allocating valuable resources and managing the surgical burden,” Carter said in a statement. “The DeepView technology represents a new paradigm in the assessment of burn wounds and can provide meaningful clinical guidance to physicians in their diagnosis and treatment recommendations.”
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