Cerus said it now expects CE Mark clearance for its INTERCEPT red-blood-cell system in late 2027, extending the regulatory timeline after positive top-line results from the Phase 3 RedeS study. The company said France’s ANSM is continuing its review and that Cerus is preparing responses to agency questions. Those responses will include the complete RedeS clinical study report after the company finishes its analysis.
RedeS met its primary efficacy endpoint by showing non-inferiority in adjusted hemoglobin increase compared with conventional red blood cells. Cerus also reported no statistically significant difference between treatment and control groups in treatment-emergent adverse events, including an INTERCEPT-specific antibody observed in the treatment arm. The company said the antibody findings were consistent with prior studies and had no clinical impact, while noting that secondary endpoints and further analysis remain outstanding.
Cerus plans a limited European market release aimed at a small number of leading blood centers if CE Mark approval is granted. The initial rollout would focus on centers of excellence and generate real-world experience for the company’s broader commercial strategy. In the United States, the company said FDA feedback on the INT200 platelet illuminator submission will require additional data, leaving the approval timetable less defined until Cerus aligns with the agency on the scope of that work.
The regulatory update came as Cerus reaffirmed full-year 2026 product-revenue guidance of $229 million to $231 million, representing expected growth of 11% to 12% from 2025.
IFC remained a major commercial growth driver. Ninety percent of IFC sales shipped during the quarter were kits, reflecting Cerus’ shift from selling finished therapeutic products directly to hospitals toward supplying blood centers that produce the finished therapy. The company maintained its 2026 IFC sales outlook of $23 million to $25 million and expects nearly all IFC sales to be in kit form in 2027.
Adjusted EBITDA was positive $5. 7 million, marking the company’s 10th consecutive quarter of positive adjusted EBITDA, while operating cash flow was $3 million.
Management attributed IFC momentum in part to its nationwide agreement with Blood Centers of America, whose member network accounts for more than half of nationwide blood-product distribution. Cerus said the arrangement expands access to sales, marketing and customer-fulfillment resources. Internationally, the company cited conflicts, currency movements and delayed orders as near-term pressures while reporting continued adoption of INT200 in Europe. Its INITIATE post-market platelet study in Germany continues to enroll, and Cerus said ongoing German policy work on platelet safety could support the product’s position in that market.