Spectral AI получила одобрение FDA для системы DeepView и начала коммерческий запуск

Spectral AI (NASDAQ:MDAI) said its second-quarter results marked a transition toward commercial operations following the U.S. Food and Drug Administration’s De Novo clearance of its DeepView System for burn assessment in May. The company reiterated its 2026 revenue guidance of approximately $18.5 million, which does not assume significant revenue from DeepView system sales. Chief Executive Officer Vincent Capone said the FDA clearance enables Spectral AI to begin a disciplined commercial rollout in the United States and international markets. The company plans to focus on increasing clinician awareness, building commercial infrastructure, advancing its software and hardware, and pursuing additional tissue-diagnostic indications. DeepView commercialization plans The FDA cleared the device through the De Novo pathway, which is used for novel devices without a predicate. Capone said Spectral AI received FDA Breakthrough Device designation in 2018 and that DeepView is among 193 devices that have obtained commercial market authorization through the De Novo process. The company’s commercial model is expected to include revenue from system capital purchases or leases, followed by recurring software and service revenue under minimum three-year terms. Capone said placements at prior clinical-study sites could move more quickly, while installations at new sites may face longer capital and procurement cycles. Spectral AI plans to deploy up to 30 DeepView systems at U.S. burn centers, trauma centers and emergency departments through June 30, 2027, under the CLIN2 component of its multiyear Project BioShield contract with the Biomedical Advanced Research and Development Authority, or BARDA. The first 30 U.S. placements are expected to receive substantial BARDA support. During the question-and-answer session, Capone said the company currently has two commercial personnel: newly appointed Chief Commercial Officer Darcy Bajko and the head of its U.K. operations and overseas sales. Spectral AI has budgeted for at least two additional hires, he said. Bajko previously held roles at Integra and Smith+Nephew, according to Capone. He said her appointment is intended to support coordination across sales, marketing, market access and reimbursement efforts. International and clinical initiatives Spectral AI is updating its U.K. Conformity Assessed, or UKCA, approval for burn assessment to incorporate the algorithm, hardware and software used in its FDA-cleared device. The company expects the expanded UKCA clearance in the fourth quarter of 2026, after which it plans to begin initial placements or sales in the United Kingdom, Australia or Gulf Cooperation Council countries. Capone said the company has conducted device evaluations in Australia and the U.K. and expects those markets, along with one or two U.K. centers, to represent the earliest international installations. He also said the company sees potential opportunities in other regions but did not provide details. In the U.K., Spectral AI has initiated a Head, Hands, and Feet study intended to support a label expansion across markets. In the U.S., the company expects to launch a 12-center triage and treatment outcome study in the fourth quarter of 2026. The study is designed to show that DeepView assessments can improve surgical precision, accelerate treatment decisions and reduce patient length of stay. Capone said procurement remains a key deployment hurdle, particularly at sites where Spectral AI has less-established relationships. New installations can require navigation of procurement, cybersecurity and AI-related review committees. However, he said the company believes it can meet its BARDA and internal rollout timelines, particularly at sites supported by key opinion leaders and prior clinical-study relationships. Second-quarter financial results Chief Financial Officer David McGuire reported second-quarter research and development revenue of $3.5 million, down from $5.1 million in the year-earlier period. He attributed the decline to BARDA’s move into a cost-sharing phase, completion of burn validation work and the completion of work under the company’s Medical Technology Enterprise Consortium, or MTEC, contract. - Gross margin was 31.6% in the second quarter, compared with 45.2% a year earlier. - Operating expenses increased to $5.4 million from $4.4 million. - Net loss narrowed to $4.2 million, or $0.13 per basic and diluted share, from $8 million, or $0.31 per share, a year earlier. - Total other income was $300,000, compared with other expense of $5.9 million in the prior-year quarter, primarily due to non-cash warrant-liability fair-value adjustments. McGuire said the company changed its expense presentation to separately report research and development, sales and marketing, and general and administrative costs. Research and development expense increased by $200,000 to $1.7 million, while selling and marketing expense rose by $300,000 to $700,000 as the company prepared for launch. General and administrative expense increased by $500,000 to $3.1 million, primarily due to non-cash stock compensation. The company completed a third-party pricing study during the quarter. McGuire said preliminary customer discussions indicate potential pricing that could support margins above those generated by its development work, though the company expects to refine pricing as commercialization progresses. Liquidity and platform development As of June 30, Spectral AI had $14 million in cash, compared with $15.4 million at the end of 2025, and total debt of $14.9 million. In June, the company drew the second $6.5 million tranche under its Avenue Capital facility, bringing total borrowings under the facility to $15 million. FDA clearance triggered an extension of the facility’s interest-only period to 24 months, with no principal payments due through March 2027 and maturity in March 2028, McGuire said. The company also cited access to more than $60 million in additional non-dilutive BARDA funding and an available equity facility with Yorkville. Beyond burns, Spectral AI is developing DeepView as a platform technology. Capone said the company delivered a handheld-device prototype to MTEC during the prior quarter and has completed all work under that contract. MTEC is evaluating its 2026 and 2027 budget allocations, while Spectral AI continues to see possible commercial and military applications for the handheld technology. The company is also working on technology to calculate total body surface area affected by burns and is evaluating potential future indications including critical ischemia, amputations and diabetic foot ulcers. About Spectral AI (NASDAQ:MDAI) Spectral AI, Inc (NASDAQ: MDAI) is a technology company focused on delivering advanced analytics and insights through the application of machine learning to multi-spectral and hyperspectral data. Its core platform ingests imagery from satellites, aerial drones and ground-based sensors, applying proprietary algorithms to identify patterns and anomalies invisible to the naked eye. The company’s solutions are designed to help clients make more informed decisions in areas such as agriculture, environmental monitoring, infrastructure inspection and resource exploration. The company offers a cloud-native software-as-a-service (SaaS) platform that enables users to visualize and analyze large volumes of spectral data via customizable dashboards.