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Compliance-aware operational infrastructure

The structural layer regenerative medicine has been missing.

Governance frameworks, documented systems, scientific alignment, and operational infrastructure for organizations operating across regenerative medicine, stem cell science, and other regulated healthcare environments.

GOVERNANCE
SCIENTIFIC ALIGNMENT
DOCUMENTED SYSTEMS

Important scope note: HarmoniXCell is not involved in stem cell or regenerative treatments. Where individual medical team members provide clinical care, they do so in their personal professional capacity, independent of HarmoniXCell. Contact us to get in touch with our medical professionals for education and advice.
Scientific AdvancementStudies are in the pipeline, developed in collaboration with research partners. HarmoniXCell has not started any clinical trials. Draft study designs include Knee Osteoarthritis, Heart Disease, and Post-MI.
FL · TN · GAState stem cell medicine frameworks are part of a changing legislative landscape that requires disciplined operational interpretation.
Happening in Other StatesLegislative activity continues in additional states, increasing the need for adaptable education, documentation, and governance systems.

Legislative & Compliance

Infrastructure has to move as the law moves.

HarmoniXCell’s role is non-clinical: helping organize the educational, documentary, and operational implications of evolving state frameworks.

A brief history

These frameworks build on federal law. They don’t replace it.

The FDA finalized its regulatory framework for human cell and tissue products in 2005, following an eight-year process. In 2014, a federal appeals court affirmed that certain cell-based procedures are regulated as drugs, reinforcing that unapproved products require federal authorization regardless of state law. Texas passed one of the first state-level frameworks in 2017 (HB 810). Florida followed with SB 1768 in 2025. Georgia (HB 1275) and Tennessee (HB 2246) both signed new frameworks in May 2026, effective that July. Tennessee’s law includes specific product-viability and documentation standards; Georgia’s extends qualifying roles to physician assistants and nurse practitioners under physician designation.

We describe these as authorization frameworks rather than “deregulation.” Federal FDA authority over these products hasn’t changed. What states have done is build defined, conditional legal pathways on top of it, with real requirements around consent, documentation, sourcing, and licensure. That distinction matters to how we build infrastructure: the goal isn’t operating around federal law, it’s helping clinics operate correctly within a more specific state layer of it.

FL
Enacted framework

Florida

Florida’s evolving regenerative-medicine framework adds state-level requirements that may affect disclosures, physician responsibilities, sourcing, documentation, and patient-facing education. HXC’s focus is translating applicable requirements into structured operational materials.

TN
Enacted framework

Tennessee

Tennessee has moved toward a state framework addressing access to certain regenerative medicine services. For operators, the practical issue is converting statutory requirements into disciplined workflows, compliant education, recordkeeping, and governance.

GA
Enacted framework

Georgia

Georgia’s legislative activity reflects the broader state trend toward defining how regenerative medicine may be discussed, documented, and governed. HXC is building systems intended to help clinics understand and operationalize changing requirements.

Ongoing legislative agenda

The map is still moving.

Additional states continue to debate, study, or refine regenerative-medicine legislation. HarmoniXCell’s infrastructure is intended to remain adaptable as state requirements evolve, with emphasis on approved education, version-controlled content, documentation, sourcing controls, disclosures, and escalation to qualified regulatory or legal review when required.

About / Team

The Management Team

Jimi Sta. Maria

Jimi Sta. MariaFounder
Dr. Felix Lurye, MD

Dr. Felix Lurye, MDChief Executive Officer
Dr. Frank Kuwamura, MD

Dr. Frank Kuwamura, MDPresident
Lisa Speer, RN

Lisa Speer, RNChief Nursing Officer
Stacy Wright, RN

Stacy Wright, RNChief Aesthetic Officer
Todd Hoisek

Todd HoisekExecutive Vice President
Katrina Starr

Katrina StarrChief Relationship Officer
Bradley Fox

Bradley FoxChief Regulatory Officer
Denny Roja, Esq.

Denny RojaChief Legal Officer
David Keller

David KellerChief Financial Officer

Scientific Advancement

Study designs are being prepared for the next stage.

HarmoniXCell collaborates with research partners on studies in the pipeline; HarmoniXCell has not started any clinical trials. Draft study designs have been developed for Knee Osteoarthritis, Heart Disease, and Post-MI.

The purpose of this work is to establish disciplined, reviewable research concepts before any future clinical activity is initiated.

Research Alignment

Drafting research papers is normal groundwork. That’s what this stage is.

Before any study begins, the responsible path is to draft it carefully first: protocol development, sponsor alignment, site readiness, consent design, and the full set of required approvals. That drafting work is exactly what’s underway. No HarmoniXCell clinical trials have begun.

Research disclosure

Diagnostics collaboration in development.

HarmoniXCell is actively working with pioneers of a portable, rapid, quantitative, and point-of-care diagnostics technology.

This work is developmental and exploratory and should not be interpreted as a commercial product claim, clinical recommendation, or statement that a clinical trial is underway.

Corporate scope

Infrastructure, not treatment.

HarmoniXCell’s corporate role is focused on governance, education infrastructure, documented systems, platform deployment, scientific alignment, and institutional coordination. Clinical care by individual physicians remains outside HarmoniXCell’s corporate scope.

What We Do

Building the operational layer clinics don’t have.

HarmoniXCell is licensed to use and deploy an Agentic AI MSO platform. The platform will help educate clinics interested in regenerative medicine about legislation, deregulation, clinical and regulatory requirements, and compliant educational materials for their communities. It will provide access to a library of published scientific literature and content generated within the bounds of that literature.

The Agentic AI infrastructure at the core of this platform was designed and is being developed by HarmoniXCell’s Founder, and is licensed to HarmoniXCell for use at negligible cost. Ownership of the platform itself remains with the Founder. What matters operationally is what it does: it turns scientific literature, legislative tracking, and clinic-specific context into the education and documentation a clinic actually needs, kept inside approved, version-controlled boundaries. The underlying architecture is not published here.

Important scope note: The platform is not intended to replace licensed medical judgment, legal advice, regulatory counsel, or independent clinical decision-making.

It is designed and being developed for national scaling.

Focus areas

Where that infrastructure is applied.

1

Legislative education

Organize state-by-state information so clinics can understand the difference between enacted legislation, changing regulatory frameworks, and areas that still require qualified legal or compliance review.

2

Scientific literature

Provide access to published scientific literature.

3

Community education

Help clinics create structured, compliant educational materials for patients and communities without turning informational content into unsupported clinical claims.

Compliance-first

The structural role is the product.

HarmoniXCell is building systems for governance, version control, review, documentation, approved terminology, content boundaries, and escalation, so educational and operational materials can be managed responsibly as laws and evidence change.

Research disclosure

Pipeline-stage research only.

HarmoniXCell has drafted study designs and is developing research alignment, but has not begun clinical trials. Any future study would require the applicable approvals and controls before initiation.

Working with clinic partners

This infrastructure is being built with real clinics, not in the abstract.

HarmoniXCell is working closely with MD Spine Care and Coastal MD, building the educational infrastructure their communities need to understand regenerative medicine responsibly. That partnership is where the platform gets tested against how clinics actually operate, not just how they’re designed to operate on paper.

Contact

Get in touch.

For institutional, partnership, or clinic inquiries, reach us directly.

Direct contact

Corporate inquiries

Contact Us

Use this channel for institutional, strategic, partnership, research-development, or clinic-operations inquiries.

Clinical scope

Clinical consultations are not provided by HarmoniXCell’s corporate team.

Where members of the medical team provide clinical care, they do so through their independent professional practices.

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