Spectral AI Names Stanley Micek COO to Drive FDA Submission and DeepView System Launch

Spectral AI Names Stanley Micek as Permanent COO to Drive Operations

Dallas-based AI firm Spectral AI, Inc. has officially appointed Stanley Micek as its Chief Operating Officer. After serving as interim COO since May 2024, Micek will now lead the company’s operational efforts full-time. Spectral AI focuses on creating AI-powered diagnostic tools for wound care, with a current emphasis on its DeepView® System.

The company, listed on NASDAQ as MDAI and valued at about $42 million, maintains a strong balance sheet with more cash than debt. Board Chairman Dr. J. Michael DiMaio highlighted Micek’s operational leadership and his role in advancing the company’s FDA submission process, crediting him for significant contributions to research and development.

Stanley Micek’s Leadership and Background

Before joining Spectral AI, Micek held senior roles including Senior Vice President for Business Development & Strategy at MiMedx and leadership positions at The Ohio State University Comprehensive Cancer Center. He expressed commitment to driving the operations team forward, building on progress made in the recent Pivotal Burn Study.

Micek emphasized the importance of the DeepView® System, a device designed to provide clinicians with objective, predictive insights into burn wound healing. This system aims to offer immediate, algorithm-driven assessments that can improve treatment decisions and patient outcomes.

Financial Performance and Strategic Outlook

Spectral AI reported strong first-quarter 2025 results, with revenue of $6.7 million—well above BTIG’s $4.6 million estimate. Earnings per share also beat expectations, recording $0.12 compared to the predicted loss of $0.19. Despite positive momentum, the company plans to reduce operating expenses to preserve cash, as noted by BTIG analyst Ryan Zimmerman.

The company reaffirmed its full-year 2025 revenue guidance of around $21.5 million, a 27.3% decrease from the previous year, mainly due to anticipated declines in R&D revenue ahead of the U.S. launch of DeepView. BTIG adjusted its price target from $3 to $2, maintaining a Buy rating based on confidence in Spectral AI’s progress toward key milestones.

Upcoming Milestones and Company Initiatives

• Positive data from a U.S. burn trial supports the DeepView system’s effectiveness.
• FDA submission for DeepView is expected by the end of Q2 2025, with approval anticipated in early 2026.
• Cash position has improved to over $14 million, bolstered by long-term debt financing.
• Plans are underway to spin off Spectral IP, the company’s intellectual property subsidiary, into an independent publicly traded entity.

These moves aim to strengthen Spectral AI’s operational stability and support its strategic growth initiatives.

For operations professionals following AI developments in healthcare diagnostics, Spectral AI’s progress offers insight into managing growth, regulatory processes, and operational efficiency in a specialized tech environment.

Learn more about AI applications in healthcare operations and related skills at Complete AI Training.