DALLAS, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) ("Spectral AI" or the "Company"), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the successful completion of truthing for all images gathered from burn centers across the United States. This milestone represents a pivotal step in training the Company's proprietary DeepView System to predict wound healing outcomes accurately. Having completed the process for burn centers, Spectral AI is now initiating truthing for images collected from emergency departments and emergency rooms nationwide, expanding the scope of the DeepView System's capabilities.
Truthing is the rigorous process of gathering 'ground truth' data that verifies whether portions of a wound did or did not heal and then using this data for training of its AI-powered algorithm. For each patient, images are collected during the early stages of treatment and correlated with biopsies, 21-day wound assessments, and expert evaluations. This combination of data creates a "ground truth" dataset, enabling the DeepView System to distinguish between wounds likely to heal and those requiring intervention.
"By completing the truthing process for burn centers, this adds to Spectral AI's largest comprehensive tissue dataset, encompassing over 3,000 biopsied images," said Dr. J. Michael DiMaio, Chairman of Spectral AI's Board of Directors. "This achievement reflects collaboration between internationally recognized burn experts, skilled dermatopathologists, and our dedicated engineers and data scientists. This multidisciplinary effort ensures that our technology evolves with precision and reliability, surpassing the limitations of traditional diagnostic methods."
The Company's Burn Biopsy Algorithm (BBA), developed alongside leading experts, integrates advanced machine learning with clinical insights, allowing the DeepView System to identify healing trajectories with unprecedented effectiveness. By leveraging data from the largest burn tissue bank ever assembled, the DeepView System is designed to provide clinicians with actionable information and reducing guesswork.
Now, Spectral AI is expanding its focus to emergency departments, where the stakes are equally high. The truthing process will include data collected during the critical early stages of care, enabling the DeepView System to adapt to a broader range of clinical scenarios.
"Our team is committed to ensuring the DeepView System delivers unparalleled diagnostic accuracy," said Dr. DiMaio. "By incorporating data from diverse care settings, we aim to create a solution that seamlessly integrates into workflows across the spectrum of acute care."
Spectral AI has successfully enrolled and completed image collection for the BARDA burn study, a critical step in training the AI algorithm for the DeepView AI-Burn device. The Company anticipates data results in late December to support an FDA De Novo submission in the first half of 2025, which seeks to classify the DeepView AI-Burn system as a Class II medical device. Designed for use in multiple medical settings, the DeepView AI-Burn system provides fast and accurate burn-depth assessments, empowering clinicians to make informed, early treatment decisions and improving care for both adult and pediatric burn victims.
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 wound care management by "Seeing the Unknown" with its DeepView System. DeepView 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 of exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight toward value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, visit .
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 intention to separate its Spectral IP subsidiary from the Company, and each Company's strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. 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. Spectral AI undertakes no obligation to update any forward-looking statements except as otherwise required by law.
For Media and Investor Relations, please contact:
David Kugelman
Atlanta Capital Partners LLC
(866) 692-6847 Toll Free - U.S. & Canada
(404) 281-8556 Mobile and WhatsApp
Email: dk@atlcp.com
ダラス、2024年12月2日（グローブニュースワイヤー）-- スペクトラルAI（ナスダック：MDAI）（「スペクトラルAI」または「会社」）は、医療診断を革新することに焦点を当てた人工知能（AI）企業で、創傷管理において迅速かつ正確な治療決定を可能にします。本日、米国全土の火傷センターから収集されたすべての画像の真実性確認を成功裏に完了したことを発表しました。このマイルストーンは、会社の独自のDeepViewシステムをトレーニングし、創傷治癒の結果を正確に予測するための重要なステップを表しています。火傷センターのプロセスを完了したスペクトラルAIは、全国の救急部門や救急治療室から収集された画像の真実性確認を開始し、DeepViewシステムの能力の範囲を広げています。
真実性確認は、創傷の一部が治癒したかどうかを確認するための「地上真実」データを収集する厳密なプロセスであり、そのデータをAI駆動のアルゴリズムのトレーニングに使用します。各患者について、治療の初期段階で画像が収集され、組織検査、21日間の創傷評価、および専門家の評価と相関関係を持っています。このデータの組み合わせが「地上真実」データセットを作成し、DeepViewシステムが治癒の可能性が高い創傷と介入を必要とするものを区別できるようにします。
「火傷センターの真実性確認プロセスを完了することで、スペクトラルAIの最大の包括的組織データセットに追加され、3,000以上の生検画像を網羅しています。」と、スペクトラルAIの取締役会の会長であるJ. マイケル・ディマイオ博士は述べました。「この成果は、国際的に認識される火傷の専門家、熟練した皮膚病理学者、そして私たちの献身的なエンジニアやデータ科学者との協力を反映しています。この学際的な努力により、私たちのテクノロジーは精度と信頼性を持って進化し、従来の診断方法の限界を超えています。」
会社の火傷生検アルゴリズム（BBA）は、主要な専門家と共に開発され、臨床的洞察と高度な機械学習を統合しており、DeepViewシステムが前例のない効果で治癒の軌道を特定できるようにします。史上最大の火傷組織バンクからのデータを活用することにより、DeepViewシステムは臨床医に実用的な情報を提供し、推測を減らすように設計されています。
現在、Spectral AIは、緊急部門への焦点を広げています。ここでもリスクは同様に高いです。真実のプロセスには、ケアの重要な初期段階で収集されたデータが含まれ、DeepViewシステムがより広範な臨床シナリオに適応できるようになります。
"私たちのチームは、DeepViewシステムが比類なき診断精度を提供することを確実にすることに全力を尽くしています。"とディマイオ博士は述べました。"さまざまなケア設定からのデータを取り入れることで、急性ケアの範囲全体にわたってワークフローにシームレスに統合されるソリューションを作成することを目指しています。"
Spectral AIは、DeepView AI-BurnデバイスのAIアルゴリズムのトレーニングにおける重要なステップであるBARDAの火傷研究のための画像収集を正常に enrollmentと完了しました。同社は、2025年上半期にDeepView AI-BurnシステムをクラスIIのmedical deviceとして分類することを目指したFDA De Novo提出をサポートするデータ結果を12月下旬に期待しています。複数の医療関連環境での使用のために設計されたDeepView AI-Burnシステムは、高速で正確な火傷深さ評価を提供し、臨床医が早期の情報に基づいた治療決定を行えるようにし、成人および小児の火傷被害者のケアを改善します。
Spectral AIについて
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 wound care management by "Seeing the Unknown" with its DeepView System. DeepView 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 of exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight toward value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, visit .
将来を見通す記述
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 intention to separate its Spectral IP subsidiary from the Company, and each Company's strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. 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.
これらの前向きな見通しに関する声明は、将来の業績、条件、結果を保証するものではなく、多数の既知のリスク、不確実性、前提条件、およびその他の重要な要因、これらのほとんどは同社の制御の外にあり、実際の結果や成果が前向きな見通しに関する声明と異なる可能性があることを示唆しています。これらの前向きな見通しに頼らずに、読者は慎重に行動し、個々の場合において適切と思われるリスクや不確実性を検討すべきです。
投資家は、前述の要因及び会社がSECに提出した「リスク要因」セクションに記載されているその他のリスクや不確実性を慎重に考慮するべきです。これらの提出書類は、実際の出来事や結果が先行き見通しの記載と実質的に異なる原因となる可能性がある他の重要なリスクや不確実性を特定し、対処しています。Spectral AIは、法律で要求されない限り、いかなる先行き見通しの記載を更新する義務を負いません。
メディアおよび投資家関係に関するお問い合わせは、以下までお願いします:
デビッド・クーゲルマン
アトランタキャピタルパートナーズ LLC
yes
（404）281-8556、携帯電話およびWhatsApp
メール: dk@atlcp.com
