CaseBioscience Advances ART Through Stem Cell Science, Uniting Innovation and Quality
FDA-Cleared CaseBio® Culture and CaseBio®Handling Media to be Introduced at ASRM 2025, Reflecting Years of Stem Cell Research and ART Innovation
September 2025 – CaseBioscience® is driving a new era of innovation in biotechnology by uniting Assisted Reproductive Technology (ART) with breakthroughs in stem cell science. Over the past three years, the company’s research and development has focused on creating stable and effective preservation methods for pluripotent stem cells, enabling advances in both cell therapy research and emerging clinical applications. In the last two years, CaseBioscience extended this expertise into ART, developing next-generation embryo culture and handling media that bridge these interconnected fields. This dual focus reflects the company’s vision to deliver innovative, high-quality solutions that shape the future of both stem cell science and reproductive medicine.
In March 2025, CaseBio® Culture and CaseBio® Handling Media received FDA 510(k) clearance for clinical use, marking a defining milestone for CaseBioscience and its ART portfolio. CaseBio® Culture has undergone extensive preclinical testing including multi-generation mouse embryo transfer studies and additional mammalian models-prior to launch, establishing an unprecedented standard of safety, effectiveness, and evidence-based validation in reproductive medicine. Multiple U.S. clinics have already initiated comparison studies, and a REB filing to support the generation of publishable, multi-clinic data. With clearance in place, CaseBioscience can now advance clinical adoption and commercialization, positioning CaseBio® Culture for its official market introduction at ASRM 2025, offering clinicians and researchers the opportunity to experience its next-generation ART media firsthand.
“CaseBio® Culture is more than a new embryo culture medium—it represents a new benchmark for how innovation in ART should be brought forward. By holding ourselves to higher standards of validation, we are not only introducing a next-generation formulation, but also helping raise expectations across the field. Our vision is to give clinicians and patients solutions they can trust with confidence, supported by rigorous science and unmatched reliability,” says the CaseBioscience Management Team
CaseBioscience’s foundation of quality drives every aspect of its innovation. The company is FDA-registered, ISO 13485:2016 certified, and MDSAP-certified, supporting access to multiple international markets, with the Medical Device Regulation (MDR) certification process now underway. In September 2025, Health Canada granted a Class II Medical Device Registration for CaseBio® Culture, further strengthening CaseBioscience’s regulatory foundation in North America. New FDA submissions are also in progress, including a Drug Master File (DMF) for CaseCryo® CTG, the company’s clinical-grade cryopreservation solution for stem cells, and for CaseStor® HSS, a specialized hypothermic storage solution for cells and tissues. Together, these regulatory milestones underscore CaseBioscience’s commitment to advancing products that meet the highest standards of safety, consistency, and performance.
CaseBioscience’s contributions are also being recognized within the scientific community. An abstract on CaseBio® Culture Media was accepted for presentation at the International Embryo Technology Society (IETS) 2026 Annual Conference. The company has also submitted new findings to the ISSCR PSC-Derived Therapies Symposium on cryopreservation strategies, highlighting its application of AI-assisted literature analysis to identify innovative, DMSO-free preservation approaches for pluripotent and neural stem cells. These scientific engagements underscore CaseBioscience’s position at the intersection of ART and stem cell research.
From pioneering pluripotent stem cell preservation technologies to delivering FDA-cleared ART solutions, CaseBioscience® continues to advance its mission: uniting stem cell science and ART to redefine what is possible in biotechnology.