CellTivity Scientific Receives CE Registration for the Van Gogh™ Microscopy System, Enabling Real Time Diagnostic Sampling Support Across Europe

WALTHAM, Mass.--(BUSINESS WIRE)--CellTivity Scientific, a leader in point of care disease detection, today announced that the Van Gogh Microscopy System has received CE registration, enabling clinical use and commercial distribution across the European Union. This Class A IVDR designation is a regulatory milestone which validates the safety, performance, and reliability of Van Gogh allowing for broad applications across all biopsy types. Its real time sampling technology, Dynamic Cell Imaging™, which captures metabolic activity at the point of care, is designed to support clinicians during biopsy acquisition. Using light, the cell shape, size, and activity are highlighted in a heatmap, making it easier to assess tissue adequacy. This helps clinicians confirm adequacy at the point of care and improve collaboration with pathology for diagnosis.

"Van Gogh gives clinicians immediate clarity on the quality of collected samples, helping reduce nondiagnostic specimens and support a faster path to diagnosis. Since receiving CE registration in October 2025, CellTivity has initiated early deployments and partner-led introductions across Europe, generating strong initial interest and paving the way for expanded collaboration with leading clinical teams and distribution partners. This is a significant achievement for our team and an important step forward for clinicians and patients across Europe,” said Greg Bowles, CEO. “Van Gogh equips physicians with actionable information at the point of care, and strengthens collaboration with pathology. This milestone reinforces our mission of empowering proceduralists to improve patient outcomes.”

Designed to integrate seamlessly into existing procedural workflow, Van Gogh supports a wide range of biopsy types and clinical environments, including high volume centers, community hospitals, and facilities adopting advanced technologies such as robotic assisted bronchoscopy. By providing real time insight into sample quality, Van Gogh helps clinicians collect higher quality tissue, which reduces delays that impact patient anxiety and treatment timelines.

“CE Marking for the VanGogh System represents an important milestone in the European market,” said Franco Papa, President & CEO of MOSS, CellTivity Scientific's premium partner in Europe, recently appointed to introduce and distribute this groundbreaking concept in the medical arena in the European scenario. “Through our strategic partnership with CellTivity Scientific, at this early stage we have already seen strong engagement and promising interest in the utilization from leading physicians and institutions of excellence across Europe, including Italy, Germany, Austria and Slovenia. This allows us to move forward with confidence and confirm our commitment to supporting teams with technology that aligns with evolving workflows.”

With CE now in place, CellTivity has begun expanding availability of the Van Gogh System across key European markets. The company will partner closely with clinicians, hospitals, and distribution teams to ensure smooth adoption, training, and integration into diagnostic pathways.

This milestone also significantly broadens CellTivity’s commercial footprint. CE registration positions the company to enter a multi-billion-euro diagnostic market, unlock new partnerships, and accelerate ongoing discussions with European hospitals and industry groups.

It further validates the maturity of the Van Gogh platform and strengthens CellTivity’s global position as demand grows for point-of-care disease detection. As CellTivity scales internationally, CE registration serves as both a clinical and strategic inflection point, expanding global access to Van Gogh while supporting the company’s long-term growth trajectory.

About the VanGogh System

The VanGogh System is a point of care disease detection platform that provides real time clarity during biopsy sampling. By giving clinicians immediate feedback on the quality of collected tissue, the system supports improved diagnostic confidence, reduces repeat procedures, and enhances workflow efficiency across a variety of biopsy driven specialties.

About CellTivity Scientific

CellTivity Scientific is a medical technology company dedicated to empowering clinicians with advanced diagnostic tools that improve patient care, streamline workflow efficiency, and expand access to high quality diagnostic support. The company develops innovative solutions for real time sampling guidance and point of care decision support, with a core mission to empower the proceduralist to improve patient outcomes through better diagnostic cancer sampling.

For more information, visit www.celltivity.com.