Spectral MD Awarded $149M BARDA Project BioShield Contract

Spectral MD Inc. has been awarded a new contract worth up to $149 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. The contract will help advance development of the company’s DeepView System—an artificial intelligence-driven burn wound imaging technology—which is designed for use at emergency departments, trauma centers and burn centers, for both routine burn care and as a medical countermeasure for use in burn mass casualty incidents (BMCI).

“The current standard of care for burn wound assessment that is crucial in determining next-step treatment relies largely on the clinical judgement of physicians. However, diagnostic accuracy can be as low as 50%,” SMD Chief Medical Consultant Jeffrey Carter, M.D., said. “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. 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.”
 
This multi-year contract includes an initial award of nearly $55 million to support DeepView’s clinical validation and U.S. Food and Drug Administration (FDA) clearance, a major milestone that enables the technology to become a key component of the U.S. government’s BMCI preparedness efforts. The initial award places up to 30 DeepView devices at various burn centers and emergency rooms to support a clinical validation study and for eventual transition to being used in routine care. The contract also includes options with ann additional $95 million in total value and can be exercised for additional DeepView product development, procurement, and deployment at U.S. emergency departments, trauma centers and burn centers in a phased approach. These deployments will enable SMD to conduct health economic and outcome research to support the DeepView System’s broader clinical adoption.
 
In 2013 and 2019, SMD was awarded BARDA contracts totaling $123 million, of which $101 million has been committed to date. With this new contract, BARDA’s total potential support jumps to nearly $251 million. This new contract represents the largest contract ever awarded to SMD.
 
“We appreciate that our DeepView platform has been selected to address a critical need in preparing our country for possible BMCI events,” SMD CEO Wensheng Fan stated. “This is a significant contract award that enables us to accelerate the late-stage clinical development and commercialization of our DeepView System. We are most grateful to BARDA for enabling us to help physicians and their burn patients who will benefit from the use of DeepView. 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 will aim to bring DeepView to market as quickly as possible.” 
 
This 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. According to the American Burn Association, 1.1 million Americans suffer from burn injuries annually, with 500,000 presenting to emergency departments, and 40,000 requiring hospitalization. In contrast to this demand, only 2% of U.S. hospitals have burn centers, and there are only about 250 burn surgeons in the United States.
 
To bridge this gap in care, the company’s DeepView System, which received FDA Breakthrough Device Designation 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, 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.
 
This project is being supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00049. 

Spectral MD Inc. is a subsidiary of Spectral AI, Inc., a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The company is working to revolutionize the management of wound care by “Seeing the Unknown” with its DeepView System, a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.