Spectral AI Inc Stock Price, News & Analysis

Spectral AI (NASDAQ: MDAI) has completed pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. The study aims to validate the AI-driven algorithm used in the company's DeepView® System, which received FDA Breakthrough Device Designation in 2018.

The DeepView System combines multispectral imaging with an AI algorithm trained on over 340 billion clinically-validated data points to assess burn healing potential. The system provides immediate, binary predictions of wound healing to support clinical decision-making for treatment plans.

The company plans to submit a De Novo classification request to the FDA in the first half of 2025 based on the study's data.

Spectral AI (NASDAQ: MDAI), developer of the DeepView® System for burn healing prediction, has announced positive preliminary financial results for 2024. The company expects to report annual revenue surpassing its $28 million market guidance, marking the highest revenue in its history. The growth is attributed to increased focus on completing its BARDA contract, which has also led to improved gross profit margins. The company anticipates reporting over $5.0 million in cash. The DeepView® System, which received FDA Breakthrough Device Designation in 2018, utilizes multi-spectral imaging and algorithms to predict burn healing potential.

Spectral AI (NASDAQ: MDAI), developer of the AI-driven DeepView® System for burn healing prediction, has provided detailed instructions for retail investors on exercising publicly-traded warrants (NASDAQ: MDAIW). The process requires investors to: contact their broker's corporate actions department, ensure sufficient funds for the $2.75 per warrant exercise price plus fees, submit an exercise request with warrant details, and wait for MDAI common shares to be deposited into their account. If exercising fewer warrants than owned, investors will receive a new warrant for remaining shares. The company notes that individual brokers may have additional requirements.

Spectral AI (NASDAQ: MDAI), developer of the DeepView® System for burn healing prediction, announced receiving a 'moot' letter from Nasdaq on December 20, 2024, confirming its compliance with all applicable listing standards for continued listing on the Nasdaq Capital Market. The company's DeepView® System, which received FDA Breakthrough Device Designation in 2018, uses multi-spectral imaging and algorithms to predict burn healing potential. Dr. Michael DiMaio, Chairman of the Board, expressed satisfaction with maintaining compliance and highlighted ongoing progress towards FDA submission.

Spectral AI (NASDAQ: MDAI) announced it believes it has regained compliance with Nasdaq Listing Rule 5550(b)(2) by maintaining a market value of listed securities above $35 million for 10 consecutive business days. The company, which develops the DeepView® System (an AI-driven technology with FDA Breakthrough Device Designation for burn healing prediction), has notified Nasdaq and awaits official confirmation of compliance.

Spectral AI (NASDAQ: MDAI) announced significant progress in the development of its DeepView® System, an AI-driven wound diagnostics platform. National burn care leaders have contributed over 511 in-person physician days for training and validation studies, plus 250 additional days in proof-of-concept studies. The collaboration includes three former/current presidents and ten board members of the American Burn Association, along with two editors-in-chief of leading burn journals.

The DeepView® System, which received FDA Breakthrough Device Designation in 2018 and UKCA mark for burn indications, combines advanced algorithms with medical imaging to predict wound healing potential. This unprecedented level of expert participation enhances the dataset's credibility and reliability, positioning DeepView® as a potential future standard in burn care diagnostics.

Spectral AI (NASDAQ: MDAI) has completed software enhancements for its DeepView SnapShot® M and DeepView AI-Burn® system in the UK. The updates, based on real-world clinician feedback, aim to improve diagnostic accuracy, workflow integration, and patient care.

The regulatory milestone allows implementation of updated software on currently deployed systems in the UK, where the devices are authorized as separate products. The enhancement also benefits Australian burn centers operating under the Approved Prescriber Program, ensuring access to Spectral AI's advanced diagnostic technology.

According to Board Chairman Dr. J. Michael DiMaio, UK authorization and technical documentation support device usage in both UK hospitals and Australian TGA approval processes. The company reports encouraging feedback from UK implementations.

Spectral AI (NASDAQ: MDAI) has completed the truthing process for all burn center images across the US, a important step in training its DeepView® System for wound healing prediction. The company is now expanding to emergency department image review. The truthing process involves gathering 'ground truth' data through early treatment images, biopsies, 21-day assessments, and expert evaluations. The company has assembled over 3,000 biopsied images in its tissue dataset. Having completed enrollment and image collection for the BARDA burn study, Spectral AI expects data results in late December to support an FDA De Novo submission in H1 2025, aiming for Class II medical device classification for the DeepView AI®-Burn system.

Spectral AI (NASDAQ: MDAI) announced the repricing of its 8,433,333 publicly-traded common share purchase warrants from $11.50 to $2.75 per share. The warrants, trading under symbol MDAIW, will be repriced following a twenty-day notice period to warrant holders. If all warrants are exercised for cash, the company could receive up to $23 million in net proceeds. The repricing applies uniformly to all outstanding warrants and was executed under the Company's discretion as permitted by the Warrant Agreement.