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American Burn Association Study Highlights Inequities in Access to Specialized Burn Care

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Spectral AI (Nasdaq: MDAI) highlights a study by the American Burn Association (ABA) revealing inequities in access to specialized burn care. The study shows rural and pediatric patients face significant barriers to timely treatment. Key findings include:

1. Pediatric patients travel 30.5 miles further than adults to burn centers, increasing transport costs.
2. Rural patients face 50.02% longer travel distances and nearly double transportation costs.
3. Mountain West and Southeastern U.S. have critically low access to burn centers.

Spectral AI's DeepView® System aims to address these disparities by providing rapid, objective burn wound assessments. The company recently completed enrollment for its U.S. Burn Pivotal Study and plans to submit a De Novo classification request to the FDA in Q2 2025.

Spectral AI (Nasdaq: MDAI) evidenzia uno studio dell'American Burn Association (ABA) che rivela le disuguaglianze nell'accesso alle cure specializzate per le ustioni. Lo studio mostra che i pazienti pediatrici e quelli delle aree rurali affrontano barriere significative per ricevere trattamenti tempestivi. I principali risultati includono:

1. I pazienti pediatrici viaggiano 30,5 miglia in più rispetto agli adulti per raggiungere i centri ustioni, aumentando i costi di trasporto.
2. I pazienti delle aree rurali affrontano distanze di viaggio più lunghe del 50,02% e quasi il doppio dei costi di trasporto.
3. Le regioni del Mountain West e del Sud-Est degli Stati Uniti hanno un accesso criticamente basso ai centri per le ustioni.

Il DeepView® System di Spectral AI mira a ridurre queste disparità fornendo valutazioni rapide e oggettive delle ferite da ustione. L'azienda ha recentemente completato l'arruolamento per il suo Studio Pivotal sugli Ustioni negli Stati Uniti e prevede di presentare una richiesta di classificazione De Novo alla FDA nel secondo trimestre del 2025.

Spectral AI (Nasdaq: MDAI) destaca un estudio de la American Burn Association (ABA) que revela inequidades en el acceso a la atención especializada de quemaduras. El estudio muestra que los pacientes rurales y pediátricos enfrentan barreras significativas para recibir tratamiento a tiempo. Los hallazgos clave incluyen:

1. Los pacientes pediátricos viajan 30.5 millas más que los adultos hacia los centros de quemaduras, aumentando los costos de transporte.
2. Los pacientes rurales enfrentan distancias de viaje 50.02% más largas y casi el doble de los costos de transporte.
3. El Mountain West y el Sureste de EE.UU. tienen un acceso críticamente bajo a los centros de quemaduras.

El DeepView® System de Spectral AI tiene como objetivo abordar estas disparidades al proporcionar evaluaciones rápidas y objetivas de las heridas por quemaduras. La empresa recientemente completó la inscripción para su Estudio Pivotal sobre Quemaduras en EE.UU. y planea presentar una solicitud de clasificación De Novo a la FDA en el segundo trimestre de 2025.

스펙트럴 AI(Nasdaq: MDAI)는 미국 화상 협회(ABA)의 연구 결과를 강조하며, 전문 화상 치료에 대한 접근의 불평등을 드러냅니다. 이 연구는 시골 지역 및 소아 환자들이 적시 치료를 받는 데 큰 장벽에 직면해 있다고 보여줍니다. 주요 결과는 다음과 같습니다:

1. 소아 환자들은 성인보다 화상 센터까지 30.5마일 더 멀리 이동하며, 이로 인해 운송 비용이 증가합니다.
2. 시골 환자들은 50.02% 더 긴 이동 거리와 거의 두 배에 달하는 운송 비용을 겪습니다.
3. 마운틴 웨스트 및 미국 동남부 지역은 화상 센터에 대한 접근이 critically 낮습니다.

스펙트럴 AI의 DeepView® System은 이러한 불균형을 해결하기 위해 신속하고 객관적인 화상 상처 평가를 제공하는 것을 목표로 하고 있습니다. 이 회사는 최근 미국 화상 주요 연구의 참여자를 모집 완료했으며, 2025년 2분기에 FDA에 De Novo 분류 요청을 제출할 계획입니다.

Spectral AI (Nasdaq: MDAI) met en avant une étude de l'American Burn Association (ABA) qui révèle des inégalités d'accès aux soins spécialisés pour les brûlures. L'étude montre que les patients ruraux et pédiatriques font face à des barrières significatives pour recevoir des traitements en temps voulu. Les principales conclusions comprennent :

1. Les patients pédiatriques parcourent 30,5 miles de plus que les adultes pour se rendre aux centres de brûlures, ce qui augmente les coûts de transport.
2. Les patients ruraux font face à des distances de voyage 50,02 % plus longues et presque le double des coûts de transport.
3. Le Mountain West et le Sud-Est des États-Unis ont un accès critiquement faible aux centres de brûlures.

Le DeepView® System de Spectral AI vise à remédier à ces disparités en fournissant des évaluations rapides et objectives des blessures par brûlure. L'entreprise a récemment terminé l'inscription pour son étude pivot sur les brûlures aux États-Unis et prévoit de soumettre une demande de classification De Novo à la FDA au deuxième trimestre 2025.

Spectral AI (Nasdaq: MDAI) hebt eine Studie der American Burn Association (ABA hervor), die Ungleichheiten beim Zugang zu spezialisierten Brandverletzungsbehandlungen aufzeigt. Die Studie zeigt, dass ländliche und pädiatrische Patienten erhebliche Barrieren für eine zeitnahe Behandlung haben. Zu den wichtigsten Ergebnissen gehören:

1. Pädiatrische Patienten müssen 30,5 Meilen weiter reisen als Erwachsene, was die Transportkosten erhöht.
2. Ländliche Patienten haben 50,02% längere Reisestrecken und fast doppelt so hohe Transportkosten.
3. Der Mountain West und der Südosten der USA haben einen äußerst niedrigen Zugang zu Brandverletzungszentren.

Das DeepView® System von Spectral AI zielt darauf ab, diese Ungleichheiten zu adressieren, indem es schnelle und objektive Bewertungen von Brandwunden bietet. Das Unternehmen hat kürzlich die Einschreibung für seine bedeutende Brandstudie in den USA abgeschlossen und plant, im 2. Quartal 2025 einen De Novo-Klassifizierungsantrag bei der FDA einzureichen.

Positive
  • Spectral AI's DeepView® System received UKCA Authorization in February 2024
  • Commercial sales of DeepView® System in the UK expected to commence this year
  • Completed enrollment for U.S. Burn Pivotal Study, one of the largest domestic burn studies
  • Plans to submit De Novo classification request to FDA in Q2 2025
Negative
  • Number of certified burn centers in the U.S. has declined from 180 to approximately 125 over the last three decades
  • Significant disparities in access to specialized burn care, particularly for rural and pediatric patients
  • Higher transportation costs for rural and pediatric patients seeking burn treatment

Insights

The ABA study underscores a critical healthcare disparity in burn care access, disproportionately affecting rural and pediatric populations. This gap in specialized care access could lead to increased morbidity and mortality rates for these vulnerable groups. The 50.02% increase in travel distance for rural patients and 30.5 additional miles for pediatric patients highlight a systemic issue in healthcare resource allocation.

From a policy perspective, this situation calls for innovative solutions to bridge the care gap. Spectral AI's DeepView® System, if proven effective, could be a game-changer in democratizing access to specialized burn care. By enabling accurate assessments at local facilities, it could reduce unnecessary transfers, potentially saving millions in healthcare costs while improving patient outcomes. However, implementation would require careful consideration of training, infrastructure and reimbursement policies to ensure widespread adoption and effectiveness.

Spectral AI's DeepView® System represents a significant technological advancement in burn care diagnostics. The system's use of multispectral imaging and AI analysis, trained on a vast dataset of 340 billion clinically validated data points, positions it as a potentially powerful tool for objective wound assessment. This technology could revolutionize triage processes in non-specialized facilities, enabling more informed decisions about patient transfers.

However, the success of this technology hinges on several factors: accuracy in real-world settings, ease of integration into existing healthcare workflows and cost-effectiveness compared to current practices. The ongoing U.S. Burn Pivotal Study will be important in validating the system's efficacy. If successful, Spectral AI could see significant market potential, not just in the U.S. but globally, especially given the recent UKCA Authorization in the UK. Investors should closely monitor the results of the pivotal study and subsequent FDA decision.

While Spectral AI's DeepView® System shows promise, its financial impact remains speculative. The burn care market, affecting 400,000 individuals annually in the U.S., represents a significant opportunity. However, the company's revenue potential depends on factors like pricing strategy, adoption rates and reimbursement policies.

The recent UKCA Authorization is a positive step, potentially opening up the UK market. The upcoming FDA submission in Q2 2025 is a critical milestone that could significantly impact the company's valuation. Investors should note that medical device approval processes are often lengthy and uncertain. Additionally, while the technology addresses a clear need, the declining number of burn centers (from 180 to 125) might pose challenges in market penetration. The company's ability to demonstrate clear cost savings and improved patient outcomes will be important for widespread adoption and financial success.

Spectral AI’s DeepView® System Designed to Provide Equity in Burn Care Access While Optimizing Healthcare Resources

DALLAS, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today provided an overview of a study conducted by the American Burn Association (“ABA”) highlighting the physical and economic barriers to burn care access faced by rural and pediatric patients.

The Company also discussed how its DeepView® System for burn indication can help broaden equity in access to burn treatment while optimizing healthcare resources.

Each year, approximately 400,000 individuals in the United States receive medical treatment for burn injuries, necessitating immediate access to specialized care to minimize morbidity and mortality. Unfortunately, the number of certified burn centers has declined from 180 to approximately 125 over the last three decades, revealing an alarming contraction in access to specialized critical treatment.

A recent study published in the Journal of Burn Care & Research January/February 2024, titled "Access to Certified Burn Centers in the United States: The Geospatial and Transport Cost of Transfer," conducted by the American Burn Association (ABA), highlights the uneven distribution of ABA-verified burn centers across the nation. The findings indicate significant disparities, particularly affecting rural populations and pediatric patients, who face additional barriers to timely care.

Key findings of the study include:

  • Geographical Disparities: Pediatric patients travel an average of 30.5 miles further than adults to reach the nearest burn center. This distance increases the cost of transport significantly, with pediatric air transport costing $947.30 more and ground transport $245 more compared to adults.
  • Rural vs. Urban Access: Rural patients face a 50.02% increase in travel distance to burn centers compared to their urban counterparts. Transportation costs for rural patients are nearly double those for urban patients, with air transport costing $5,678 more and ground transport $491.20 more.
  • Economic Burden: The study estimates that rural patients encounter higher costs due to longer distances and less efficient transportation options. Air transport, often necessary in remote areas, contributes substantially to these increased costs.

These disparities are particularly pronounced in the Mountain West and Southeastern regions of the United States, where access to both adult and pediatric burn centers is critically low. The limitations in specialized burn care access not only hinder timely treatment but also exacerbate the long-term health outcomes for those affected.

“Specialized burn centers are critical to minimizing burn-associated morbidity and mortality, and the disparity in access to these facilities, especially in rural areas and among children, poses a significant risk to our communities,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “A compounding factor of this care gap is the associated increase in transportation costs. For both adults and pediatric patients, an accurate wound assessment is critical in determining the appropriate treatment protocol. Whether the patient is seen at a specialized burn center or local emergency department, we believe that empowering healthcare providers with a technology that provides an immediate, objective, and binary wound healing assessment is a vital piece of the wound care puzzle.”

Spectral AI’s DeepView® System image processing algorithm utilizes multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points, to deliver a rapid and objective assessment that aids healthcare providers in assessing the healing potential of a burn wound. The DeepView® System wound healing assessment platform empowers clinicians at all levels with the insights necessary for timely and informed treatment decisions.

Spectral AI’s DeepView® System for burn indication received UKCA Authorization in February 2024 and commercial sales in the UK are expected to commence this year.

The Company recently announced the completion of adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration for use of the DeepView® System in burn centers and expects to submit the request in the second quarter of 2025.

The ABA emphasizes the critical need for better burn care, particularly in underserved regions, to ensure that all individuals have equal access to critical treatments. For more information on burn injury statistics and the need for equitable access to care, please visit ABA.org.

About Spectral AI
Spectral AI, Inc. is 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.  The DeepView® System is a predictive 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 to change the current standard of care, the DeepView® System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView® System, visit www.spectral-ai.com

Forward Looking Statements 
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. 

These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. 

Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. 

Investors: 
The Equity Group 
Devin Sullivan 
Managing Director 
dsullivan@equityny.com 

Conor Rodriguez 
Analyst 
crodriguez@equityny.com


FAQ

What are the key findings of the American Burn Association study on burn care access?

The study found that pediatric patients travel 30.5 miles further than adults to burn centers, rural patients face 50.02% longer travel distances, and there are significant disparities in access to specialized burn care, particularly in the Mountain West and Southeastern U.S.

How does Spectral AI's DeepView® System (MDAI) address burn care disparities?

The DeepView® System provides rapid, objective burn wound assessments, empowering healthcare providers with immediate insights for timely and informed treatment decisions, potentially improving access to specialized care.

When does Spectral AI (MDAI) plan to submit its De Novo classification request to the FDA?

Spectral AI plans to submit its De Novo classification request to the FDA for the DeepView® System in the second quarter of 2025, following the completion of its U.S. Burn Pivotal Study.

What recent milestone did Spectral AI (MDAI) achieve for its DeepView® System in the UK?

Spectral AI's DeepView® System for burn indication received UKCA Authorization in February 2024, with commercial sales in the UK expected to commence this year.

Spectral AI, Inc.

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