CaseBioscience Unveils Revolutionary CaseBio™ Media at ASRM 2025 After Regulatory Milestones

CaseBioscience Launches CaseBio™ Culture and Handling Media

In a groundbreaking move for biotechnology, CaseBioscience® unveiled its innovative CaseBio™ Culture and CaseBio™ Handling Media at the ASRM 2025 Annual Meeting. After achieving FDA 510(k) clearance and Health Canada Class II registration, these products represent a fusion of Assisted Reproductive Technology (ART) and stem cell research—heralding a new era of advancements in reproductive medicine.

Located in St. Petersburg, Florida, CaseBioscience has spent the past three years dedicating its research to develop effective preservation methods for pluripotent stem cells. This commitment has now translated into significant advancements in ART, with products designed specifically for embryo cultivation and handling, bridging the vital connection between cell therapy and reproductive technology.

Key Highlights of CaseBio™ Launch

1. Validation Through Research: The CaseBio™ Culture has undergone rigorous testing through multi-generational mammalian embryo transfer studies and various preclinical models prior to its clinical introduction.
2. Regulatory Approvals: The FDA's 510(k) clearance and Health Canada’s Class II registration affirm the product’s safety and efficacy in clinical settings.
3. Clinical Studies and Collaboration: Several U.S. clinics are conducting comparison studies supported by Institutional Review Board (IRB) filings, which will generate multi-clinic publishable data to validate the product's effectiveness.
4. Market Entry at ASRM 2025: Clinicians and researchers attending the annual meeting will have a unique opportunity to engage with this advanced media and explore its applications firsthand.
5. Established Vision: The launch aligns with CaseBioscience's mission to unify ART and stem cell science, ensuring that innovation and quality are at the forefront of their endeavors.

Monica Mezezi, President of CaseBioscience, emphasized the transformative role of CaseBio™ Culture in ART. “This product is not just another embryo culture medium; it's a new standard for innovation in our field. We pride ourselves on rigorous validation to enhance the reliability of what we offer to clinicians and their patients.”

Commitment to Quality and Safety

Established on a foundation of scientific rigor, CaseBioscience is dedicated to quality at every stage of product development. The company is FDA-registered and ISO 13485:2016 certified, highlighting its commitment to meet and exceed international standards. Currently planning additional FDA submissions, CaseBioscience aims to broaden its portfolio with innovative solutions such as CaseCryo® CTG, a specialized cryopreservation solution, and CaseStor® HSS for tissue storage.

Scientific Engagement and Community Contributions

The scientific community has recognized the contributions of CaseBioscience, with planned presentations at key conferences like the International Embryo Technology Society (IETS) Annual Conference in 2026. Further, the company's commitment to pioneering AI-assisted literature analysis demonstrates how it proactively seeks cutting-edge cryopreservation strategies, thereby setting the stage for future developments in both ART and stem cell research.

With an experienced team steeped in reproductive biology and cell therapy, CaseBioscience is at the forefront of creating biosolutions that not only meet clinical needs but also pave the way for future innovations in reproductive health. Their portfolio spans advanced cryopreservation formulations, embryo culture media, and custom manufacturing services, each crafted to ensure the highest standards of safety, compliance, and performance.

To discover more about CaseBio™ Culture and the company’s evolving portfolio, interested parties can visit casebioscience.com or connect with the representatives at ASRM 2025.

In summary, the launch of CaseBio™ Culture and Handling Media marks a crucial milestone for CaseBioscience, positioning them as leaders in the ART space while highlighting their dedication to advancing the field through quality, innovation, and rigorous scientific validation.