Spectral AI Reports Q2 2025 Financial Results and Completes FDA De Novo Submission for DeepView System

Spectral AI reported Q2 2025 results with $5.1M R&D revenue and $10.5M cash position. The company submitted its De Novo FDA application for the DeepView® System.

Categorized in: AI News Finance
Published on: Aug 13, 2025
Spectral AI Reports Q2 2025 Financial Results and Completes FDA De Novo Submission for DeepView System

Spectral AI Reports Q2 2025 Financial Results and FDA Submission Milestone

Spectral AI, Inc. (Nasdaq: MDAI), a company specializing in AI-driven medical diagnostics for wound care, announced its financial results for the second quarter ended June 30, 2025. The company also highlighted a key regulatory milestone achieved with the submission of its De Novo application to the U.S. Food and Drug Administration (FDA) for the DeepView® System.

Q2 2025 Financial Highlights

  • Research & Development Revenue: $5.1 million for Q2; $11.8 million for the first half of 2025
  • Cash Position: $10.5 million as of June 30, 2025
  • De Novo FDA Application: Completed earlier than expected in Q2 2025

The company’s Research & Development revenue declined by 32% compared to Q2 2024, primarily due to the completion of reimbursed clinical trials under its BARDA contract in 2024. Gross margin slightly decreased to 45.2% from 46.6% in the prior year quarter, influenced by higher non-reimbursed expenses tied to the BARDA contract.

General and administrative expenses were reduced to $4.4 million, down from $5.8 million in Q2 2024, reflecting ongoing efforts to improve operational efficiency. However, other expenses increased to $5.9 million due to a significant change in the fair value of the company's warrant liability.

Net loss for the quarter was $7.9 million, compared to a loss of $2.9 million in the same period last year. Despite this, the company reported a 16.4% reduction in net loss for the first six months of 2025 versus the prior year, underscoring improved expense management.

Operational and Financial Position

Cash reserves improved to $10.5 million by June 30, 2025, up from $5.2 million at the end of 2024. This increase follows a debt financing agreement of up to $15 million with Avenue Capital Group, including an initial drawdown of $8.5 million, alongside approximately $2.7 million raised through equity financing.

The company remains focused on advancing the DeepView® System, which aims to provide clinicians with immediate, data-driven assessments to improve wound care treatment decisions. The recent FDA submission marks a critical step toward market approval in the U.S.

2025 Revenue Guidance

Spectral AI reiterated its full-year revenue guidance of approximately $21.5 million for 2025. This forecast excludes potential contributions from sales of the DeepView® System for burn indications or other commercial activities related to the device.

Conference Call Details

A conference call to discuss the results was scheduled for August 12, 2025, at 5:00 pm Eastern Time. Investors could participate via the following dial-in numbers:

  • U.S.: 833-630-1956
  • International: 412-317-1837

A live webcast was available on the company’s investor relations website.

About Spectral AI

Spectral AI develops AI-powered diagnostic tools aimed at speeding up and refining treatment decisions in wound care, especially for burn patients. Its DeepView® System offers clinicians an immediate, objective evaluation of a wound’s healing potential, helping to guide treatment and improve patient outcomes while reducing costs.

For more information, visit the Spectral AI website.


Get Daily AI News

Your membership also unlocks:

700+ AI Courses
700+ Certifications
Personalized AI Learning Plan
6500+ AI Tools (no Ads)
Daily AI News by job industry (no Ads)