CaseBioscience® Launches CaseBio™ Culture and CaseBio™ Handling Media at ASRM 2025 After FDA 510(k) Clearance and Clinical Evaluation

Reflecting years of stem cell research and innovation in assisted reproductive technology, CaseBioscience® advances ART through the science of stem cells--uniting innovation and quality.

ST PETERSBURG, Fla., Oct. 20, 2025 /CNW/ -- 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 media 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.

Key Highlights

• CaseBio™ Culture validated through multi-generational mammalian embryo transfer studies and additional preclinical models prior to clinical introduction.
• FDA 510(k) clearance and Health Canada Class II registration received for CaseBio™ Culture and CaseBio™ Handling Media.
• Multiple U.S. clinics performing comparison studies, supported by an IRB filing to generate publishable, multi-clinic data.
• Official market introduction at the ASRM 2025 Annual Meeting, where clinicians and researchers can experience the new media firsthand.
• Reflects CaseBioscience's mission to unite ART and stem cell science through innovation, quality, and evidence-based development.

Clinicians, researchers, and media representatives are invited to learn more about CaseBio™ Culture and CaseBioscience's portfolio of next-generation ART and stem cell solutions by visiting casebioscience.com or connecting with the team at the ASRM 2025 Annual Meeting.

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 supports 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.

"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 provide clinicians and patients with solutions they can trust--grounded in rigorous science and unmatched reliability--providing the best possibilities science can offer," said CaseBioscience President, Monica Mezezi.

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 use 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.

CaseBioscience® is an innovative biotechnology company developing high-quality culture media and preservation solutions that unite the fields of Assisted Reproductive Technology (ART) and stem cell science. Built on a foundation of quality and scientific rigor, the company applies decades of experience in reproductive biology and cell therapy to create safer, more effective biosolutions for clinical and research use. CaseBioscience's portfolio spans advanced cryopreservation formulations, embryo culture media, and custom manufacturing services designed to meet the highest standards of consistency, regulatory compliance, and performance.

casebioscience.com

SOURCE CaseBioscience Inc.

Media Contact: Shamain Dang, Vice President, Sales and Marketing, CaseBioscience®, [email protected]