A strategic pivot toward the European market has prompted Profusa to significantly upgrade its financial forecast for the current business year. The catalyst for this revised outlook is a series of new purchase orders for its Lumee tissue-oxygen monitoring platform. While this represents a notable growth spurt, questions remain about whether it can propel the company beyond its history of substantial losses.
Financial Forecasts Revised Upward
The company’s management provided updated guidance for 2026, projecting revenues to land between $1.5 million and $3.0 million. This marks a substantial increase from the prior estimate, which ranged from $0.5 million to $2.0 million. Management attributes this improved trajectory primarily to secured orders from European clients.
However, the realization of this revenue hinges on a critical regulatory milestone. Final deliveries are contingent upon the successful migration to CE marking under the European Union’s Medical Device Regulation (MDR). Profusa anticipates completing this regulatory step in the second quarter of 2026. Only after this clearance can the confirmed European orders be fully executed.
Should investors sell immediately? Or is it worth buying Profusa?
Restructuring and Operational Hurdles
These optimistic projections exist alongside an ongoing corporate restructuring. On February 9, Profusa executed a 1-for-75 reverse stock split, reducing its outstanding shares from approximately 92.4 million to about 1.2 million.
The operational landscape continues to present significant challenges despite the brighter revenue picture. For the third quarter of 2025, the company reported a net loss of $22.2 million. Key profitability metrics underscore the difficult path ahead: a return on assets (ROA) of negative 880 percent highlights the extensive capital required to reach commercial maturity. A comparison with sector peers, such as Biosig Technologies, reveals that Profusa still lags in most financial performance indicators.
US Market Ambitions and Key Partnerships
Additional milestones are slated for the remainder of the year. The company plans to present new clinical data and is targeting a commercial launch in the United States by the end of 2026. Its strategic partnership with the Mayo Clinic provides support for these ambitions. The coming months will be critical in determining whether Profusa can adhere to its timeline for US expansion while simultaneously navigating the regulatory pathway in Europe.
Ad
Profusa Stock: Buy or Sell?! New Profusa Analysis from February 22 delivers the answer:
The latest Profusa figures speak for themselves: Urgent action needed for Profusa investors. Is it worth buying or should you sell? Find out what to do now in the current free analysis from February 22.
Profusa: Buy or sell? Read more here...
