Trade Secrets for DPMs: Keep Calm and Implant On

You may know that I work very closely with AIMx Podiatry. They are a major sponsor of PodiatryMeetings.com, and have become very good friends of mine.

AIMx Podiatry is the company that offers DPMx – a human birth tissue implantable allograft, as well as several other products including Liposana, Synapep BPC-157, and Redvive Red Light Therapy.

Recently they have been getting many inquiries regarding the use of DPMx for Florida podiatrists. I am sharing the legal statement below from Vitti Labs, the manufacturer of DPMx, to help provide some clarification.

If you have questions, reply to this email and I'll pass your message along to the AIMx Podiatry team.

Thank you for reaching out regarding the recent Florida Podiatric Medical Association (FPMA) communication related to SB1768 and its impact on the use of human cellular tissue products in Florida. I want to provide clarity and reassurance with respect to how this law relates to Vitti Labs’ products and your continued clinical use of them.

In short, SB1768 does not apply to the use of our products. The focus of the legislation is to authorize physicians and osteopaths to administer “stem cell therapy that is not approved by the United States Food and Drug Administration [FDA]” as long as the therapy is “related to orthopedic, wound care, and pain management.” The objective is to open up currently-unavailable treatments as additional options for patients and their doctors to consider as more choices in treatment plans.

Importantly, this legislation does not restrict or otherwise affect the lawful use of Section 361 human cells, tissues, or cellular or tissue-based products (Section 361 HCT/Ps) for homologous use in the State of Florida. Vitti Labs’ products remain fully compliant and permissible under the FDA’s Section 361 HCT/P framework in 21 CFR Part 1271 when they are intended for homologous use. Since such products are authorized for sale under FDA’s regulations, they do not fall within the scope of SB1768 as products that are “not approved” and which may not generally be sold or used.

Even when allowing the use of otherwise-unapproved treatments, SB1768 recognizes the importance of partnering only with fully validated, compliant tissue manufacturers and establishes several conditions that must be met to use the unapproved treatments under the statute.

SB1768 reinforces what Vitti Labs already prioritizes: high-standard tissue sourcing, regulatory compliance, and ethical clinical practice. To reassure you, our Section 361 HCT/Ps are:

· Processed under current Good Tissue Practices (cGTPs)

· Registered with the FDA as Section 361 HCT/Ps

· Manufactured at an AATB-accredited tissue establishment

· Supported by full traceability, donor screening, and regulatory documentation

· Positioned exclusively for homologous use, consistent with FDA guidance

We are closely monitoring the legislative process and FPMA’s efforts to clarify podiatric authority. We fully support FPMA’s initiative and will continue to keep you informed as updates unfold.

If you have any questions or would like copies of regulatory documentation, FDA registration confirmation, AATB certification, or homologous-use guidance, we are happy to provide it.

Thank you for your continued commitment to compliant care and outstanding patient outcomes.

-Annie