ZEO ScientifiX to Expand Umbilical-Cord Stem Cell Offerings to Georgia and Tennessee as New Regenerative Medicine Laws Take Effect
The move is aimed at helping providers meet the new states’ rules on sourcing, consent, documentation and safety reporting, which do not replace federal requirements or FDA approval.
Key Points
- ZEO ScientifiX plans to expand into Georgia and Tennessee after both states enacted new laws covering certain stem cell and regenerative medicine therapies.
- The new state frameworks set requirements for product sourcing, documentation, patient disclosures, informed consent, and safety oversight.
- The company says it will support healthcare providers with regenerative biologics, physician education, scientific resources, and implementation support as providers navigate these laws.
ZEO ScientifiX announced plans to expand into Georgia and Tennessee following the enactment of new state laws establishing frameworks for certain stem cell and regenerative medicine therapies. The company said the expansion is intended to broaden its Southeast presence and support healthcare professionals working within the new state requirements. It follows the company’s existing work with healthcare professionals in Florida after that state’s 2025 law.
Georgia House Bill 1275, signed on May 11, 2026, and Tennessee House Bill 2246, signed on May 19, 2026, establish state-level requirements under which qualifying therapies may be performed by authorized healthcare professionals. The laws include provisions related to:
- Product sourcing and documentation
- Patient disclosures and informed consent
- Professional scope of practice
- Safety oversight
Tennessee’s framework also includes certain exosome-based regenerative products within its definition of regenerative medicine therapy when statutory product and manufacturing criteria are met.
The state laws do not constitute approval by the FDA and do not displace applicable federal law. Providers remain responsible for determining whether a therapy, product, advertisement, and clinical protocol comply with applicable federal and state requirements, professional licensing rules, and standards of care.
“Expansion into Georgia and Tennessee represent an important next step in the growth of regenerative medicine across the Southeast,” said Ian Bothwell, CEO of ZEO ScientifiX. “As more states develop frameworks for responsible physician-led access, ZEO is prepared to expand alongside them. Our goal is to earn the trust of healthcare professionals by pairing high-quality biologics with scientific transparency, education, and the operational support needed to navigate a rapidly changing field.”
Provider Support Plans
ZEO ScientifiX said it plans to expand its commercial and provider-support presence in Georgia and Tennessee to serve healthcare professionals operating within the states’ evolving regulatory environments. The company expects to support market development through provider education, product support, clinical collaboration, and access to regenerative biologics accompanied by quality and manufacturing documentation appropriate to the applicable product and jurisdiction.
The company said it intends to support Georgia and Tennessee providers in a manner similar to its Florida operations through an approach centered on:
- Scientific and clinical education regarding regenerative biologics
- Product-specific quality, sterility, and manufacturing documentation, as applicable
- Provider resources designed to support informed decision-making and responsible implementation
- Ongoing engagement with clinicians, researchers, and regulatory professionals
- Market support that can scale as additional states adopt regenerative medicine frameworks
“These laws create opportunity, but they also reinforce the importance of education, documentation, and responsible clinical decision-making,” said George Shapiro, MD, FACC, Chief Medical Officer of ZEO ScientifiX. “ZEO is expanding into Georgia and Tennessee with the infrastructure and expertise to support providers beyond the product itself. As more states come online, we intend to be ready-and to become the trusted supplier healthcare professionals rely on for quality, consistency, and support.”
State Frameworks and Company Background
Georgia HB 1275 authorizes qualifying human stem cell therapy within the scope established by Georgia law and includes provisions for physician involvement, lawful delegation to certain licensed practitioners, product sourcing, patient disclosures, informed consent, and oversight.
Tennessee HB 2246 authorizes physicians to perform qualifying stem cell or regenerative medicine therapy within their scope of practice, subject to statutory sourcing, documentation, disclosure, consent, and adverse-event requirements. The release states that healthcare professionals should consult qualified legal and regulatory counsel before implementing any therapy under either framework.
ZEO ScientifiX is a clinical-stage biopharmaceutical company focused on the research, development, and manufacturing of regenerative biologics. The company operates from Nova Southeastern University’s Center for Collaborative Research in Davie, Florida, and describes its work as spanning scientific initiatives, educational programming, clinical collaborations, and relationships with healthcare professionals.
Want to keep up on regenerative medicine? Get the weekly newsletter here.
