top of page
Search

Florida’s New Stem Cell Legislation: A Landmark Shift in Regenerative Medicine Access

  • Writer: PB Distributors
    PB Distributors
  • Jul 21
  • 3 min read
Modern Florida medical clinic with large windows overlooking palm trees, featuring doctors in white coats consulting and working at a sleek white counter with blue vials and brochures, bright natural lighting and clean, contemporary interior design.

Florida Opens the Door to Regenerative Medicine Innovation


On July 1, 2025, Florida will implement groundbreaking legislation that could reshape the future of regenerative medicine. Through the passage of House Bill 1617 and Senate Bill 1768, the state now permits licensed physicians to administer certain non-FDA-approved stem cell therapies under specific conditions. This is a major win for medical professionals, patients seeking advanced treatment options, and companies like Platinum Biologics, which specialize in cutting-edge regenerative products such as Nano Flex, Nano Xsomes, and Nano EX.


What the New Florida Law Means for Stem Cell Therapy


The legislation aims to strike a delicate balance between innovation and patient protection. It allows stem cell therapies for orthopedic conditions, wound care, and chronic pain—areas where regenerative solutions are already gaining traction. However, the use of these therapies is tightly regulated to ensure patient safety and ethical sourcing.


Key Provisions Physicians Must Follow


  • Use of Non-FDA-Approved Stem Cell Therapies

    Physicians can only offer treatments that align with their professional scope and must clearly disclose that these therapies are not FDA-approved.

  • Ethical Sourcing Required

    The law prohibits the use of cells derived from aborted fetuses, aligning with the regenerative medicine industry’s push for ethically sourced materials such as:

    • Wharton’s Jelly (used in Nano Flex)

    • Cord Blood-derived exosomes (found in Nano Xsomes)

  • Strict Safety & Compliance Standards

    To ensure the highest standard of care, the new law mandates:

    • Informed Consent: Patients must be fully informed of risks and benefits.

    • Facility Standards: All stem cells must be handled in FDA-registered facilities that meet quality standards according to Lengea Law.

    • Transparency in Advertising: Ads must clearly state when a treatment is not FDA-approved.

    • Adherence to CGMP: Clinics must follow Current Good Manufacturing Practices, ensuring product safety and consistency.

  • Why This Matters for Regenerative Medicine Distributors

    For distributors like PB Distributors, this legal shift marks a pivotal opportunity to meet rising demand with safe, compliant, and effective biologic products. Florida’s law opens the market to trusted solutions like:

    • Nano Flex: The most concentrated Wharton’s Jelly product available (300mg/2mL), designed for superior clinical outcomes in orthopedic and pain management cases.

    • Nano Xsomes: Cord blood-derived exosomes loaded with growth factors like IGFBPs and VEGF for tissue regeneration and repair.

    • Nano EX: Aesthetic-focused lyophilized exosomes with 30 billion vesicles, ideal for dermatologic and cosmetic procedures.


These offerings meet high standards of manufacturing, traceability, and performance—making them ideal for clinics navigating Florida’s new compliance landscape.


Penalties for Non-Compliance

Physicians who do not follow the outlined regulations face serious consequences, including:

  • Criminal penalties

  • Administrative fines

  • Loss of license to practice


This enforces a clear message: patient safety is non-negotiable, even in the pursuit of innovation.


A Step Forward for Ethical Innovation


Florida’s new legislation doesn’t just expand access—it raises the bar for how stem cell therapies are introduced and managed. By insisting on ethical sourcing, transparent patient communication, and strict adherence to manufacturing guidelines, the state has created a model that other regions may soon follow.

For clinics, providers, and distributors, this is a critical moment to align with best-in-class products and practices.



Ready to Align with Florida’s New Stem Cell Law? Contact PB Distributors today to learn how our regenerative medicine products—Nano Flex, Nano Xsomes, and Nano EX—can support your practice while meeting all compliance and safety standards. Whether you’re a physician, clinic administrator, or healthcare distributor, we’re here to help you navigate the future of stem cell therapy with confidence.


Ready to enhance your regenerative medicine practice? Contact us to learn how our products can help elevate your patient outcomes - sales@pb-distributors.com



bottom of page