ZEO ScientifiX, Inc. (OTCQB:ZEOX) has announced plans to expand into Georgia and Tennessee following the enactment of state frameworks covering certain stem cell and regenerative medicine therapies. The company said the initiative will build on its work with healthcare professionals in Florida and form part of its broader national strategy.
#New state frameworks
Georgia House Bill 1275 was signed into law on May 11, 2026. Tennessee House Bill 2246 was signed into law on May 19, 2026. Both measures establish state-level requirements for qualifying therapies carried out by authorised healthcare professionals.
The laws address areas including product sourcing, supporting documentation, patient disclosures, informed consent, professional scope of practice and safety oversight. Tennessee’s framework also includes certain exosome-based regenerative products within its definition of regenerative medicine therapy when the applicable statutory product and manufacturing criteria are met.
Under Tennessee HB 2246, physicians may perform qualifying stem cell or regenerative medicine therapy within their scope of practice, subject to statutory requirements concerning sourcing, documentation, disclosure, consent and adverse-event reporting.
#Federal compliance remains separate
The state laws do not constitute approval by the U.S. Food and Drug Administration and do not replace applicable federal law. Healthcare providers remain responsible for assessing whether a therapy, product, advertisement or clinical protocol complies with federal and state requirements, professional licensing rules and standards of care.
The frameworks also include responsibilities relating to disclosure of non-FDA-approved status, informed consent, product sources and documentation, the professionals permitted to perform qualifying therapies and adverse-event reporting. Healthcare professionals should consult qualified legal and regulatory counsel before implementing a therapy under either framework.
#Planned support for providers
ZEO ScientifiX said it plans to develop its commercial and provider-support presence in Georgia and Tennessee for healthcare professionals working within the states’ regulatory environments. The company said its intended support will include provider education, product support, clinical collaboration and access to regenerative biologics with quality and manufacturing documentation appropriate to the relevant product and jurisdiction.
The company also described an approach involving scientific and clinical education, product-specific quality, sterility and manufacturing documentation where applicable, provider resources, and engagement with clinicians, researchers and regulatory professionals. ZEO ScientifiX said it intends to use experience from its Florida activities as it develops an adaptable model for other jurisdictions considering laws concerning stem cell and regenerative medicine therapies.
#Company statements and risks
ZEO ScientifiX CEO Ian Bothwell said the company intends to expand alongside states developing frameworks for physician-led access, with an emphasis on biologics, scientific information, education and operational support. Chief Medical Officer George Shapiro, MD, FACC, said the Georgia and Tennessee laws increase the importance of education, documentation and clinical decision-making.
The company’s statements about its expansion, anticipated provider support, market development, operations, growth and ability to scale its platform as additional states adopt regenerative medicine frameworks are forward-looking statements. ZEO ScientifiX said those statements involve known and unknown risks and uncertainties, rely on assumptions that may prove incorrect, and that actual results could vary materially.
#Key Takeaways
- ZEO ScientifiX has announced a planned expansion into Georgia and Tennessee.
- Georgia HB 1275 was signed into law on May 11, 2026, and Tennessee HB 2246 was signed into law on May 19, 2026.
- The state frameworks address sourcing, documentation, disclosures, consent, professional scope and safety-related requirements.
- The laws do not represent U.S. Food and Drug Administration approval or remove providers’ federal, licensing or standards-of-care obligations.
- The company intends to support providers through education, documentation, clinical collaboration and regenerative biologics access.
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