MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter

AXIOFILL’s regulatory classification remains before the FDA following the court’s order to reconsider both determinations.

Rhea-AI Summary

MIMEDX (MDXG) announced on September 23, 2026, that a federal court vacated two FDA determinations concerning AXIOFILL.

The U.S. District Court for the Northern District of Georgia set aside the finding that AXIOFILL does not qualify as a Section 361 human cell or tissue product because it is more than minimally manipulated. It also vacated the FDA’s determination that AXIOFILL should be classified as a biological product rather than a medical device. Both matters return to the FDA for reconsideration. The court held that the manipulation analysis must consider tissue characteristics relevant to reconstruction, repair or replacement in the recipient.

Positive

• Two FDA determinations concerning AXIOFILL vacated by federal court

Negative

• None.

Key Terms

hct/p, minimal-manipulation regulation, arbitrary and capricious

3 terms

hct/p regulatory

"as a Section 361 HCT/P"

hct/p stands for human cells, tissues, and cellular and tissue‑based products — biological materials derived from human donors used for medical treatments such as grafts or regenerative therapies. Investors care because these products follow distinct regulatory rules and development timelines compared with conventional drugs or devices, which affects how quickly a product can reach the market, the cost and complexity of approval, and the potential commercial risk and reward; think of it like raw ingredients versus a fully processed consumer product.

minimal-manipulation regulation regulatory

"its minimal-manipulation regulation"

A regulatory classification that describes whether a biological product made from human cells or tissues has been altered only slightly during processing. Regulators use the “minimal manipulation” test to decide which approval rules, safety checks, and marketing limits apply; like labeling food as raw versus cooked, it determines whether a simpler pathway or stricter oversight is required. Investors care because that label affects development time, regulatory costs, and how quickly a product can reach customers.

arbitrary and capricious regulatory

"was “arbitrary and capricious”"

A legal test courts use to decide whether a government or regulator made a decision without a reasonable explanation, ignored important facts, or acted inconsistently with its own rules — like a referee making a call without watching the play. For investors this matters because a finding that an action was arbitrary and capricious can void or change permits, approvals, fines or regulations that affect a company's operations, costs and share value.

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Court Vacates FDA Determinations That AXIOFILL Is Not Minimally Manipulated and Should Be Classified as a Biological Product

Order Further Holds That Minimal-Manipulation Analysis Must Consider Tissue Characteristics Relevant to Reconstruction, Repair or Replacement in the Recipient

MARIETTA, Ga., Sept. 23, 2026 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. District Court for the Northern District of Georgia issued a favorable ruling in the Company’s litigation challenging the U.S. Food and Drug Administration’s (“FDA”) regulatory classification of AXIOFILL, the Company’s human placental-derived extracellular matrix particulate product.

The Court vacated FDA’s determination that AXIOFILL is not a Section 361 HCT/P because it is more than minimally manipulated and FDA’s determination that AXIOFILL should be classified as a biological product rather than a medical device. The Court remanded both matters to FDA for further consideration consistent with its order.

“This ruling favorably addresses the central issues of this matter. We are pleased the Court found that the FDA erred in its interpretation of the minimal-manipulation regulation and that the agency did not adequately explain the reasoning behind its divergent classification of AXIOFILL compared with similar products available on the market,” stated Joseph H. Capper, Chief Executive Officer of MIMEDX. “We continue to believe that AXIOFILL meets the requirements for classification as a Section 361 HCT/P, and we look forward to engaging constructively with FDA as it reconsiders the matter consistent with the Court’s order.   Since its launch in 2022, AXIOFILL has demonstrated an impeccable safety profile and has helped countless patients navigate the surgical healing process.”

In addressing whether AXIOFILL qualifies as a Section 361 HCT/P, the Court held that FDA had incorrectly interpreted its minimal-manipulation regulation by focusing on the placental disc’s function in the donor—specifically, its function as a selective barrier between the fetal and maternal circulatory systems. The Court concluded that the applicable regulation instead requires FDA to consider the original characteristics of the tissue that are relevant to its utility for reconstruction, repair or replacement in the recipient.

The Court also vacated FDA’s determination that to the extent AXIOFILL is not a Section 361 HCT/P, it is a biological product rather than a device. The Court found that FDA had classified other commercially available human-derived particulate products, similar to AXIOFILL, as medical devices without adequately explaining why AXIOFILL should be treated differently.   The Court concluded that FDA’s classification of AXIOFILL as a biological product was “arbitrary and capricious” because the agency had not provided “a reasonable explanation or record of evidence” supporting this disparate treatment.

About MIMEDX
MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade and a half of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX provides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.

Contact:
Matt Notarianni
Investor Relations
470-304-7291
mnotarianni@mimedx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Did the MIMEDX AXIOFILL ruling classify it as a Section 361 tissue product?

No. The court vacated the FDA’s determination that AXIOFILL did not qualify as a Section 361 human cell or tissue product on minimal-manipulation grounds. It returned the matter to the FDA for reconsideration under its order.

Why did the court vacate the FDA’s biological-product classification of MIMEDX’s AXIOFILL?

The court found that the FDA had not adequately explained why it classified AXIOFILL as a biological product when it classified similar commercially available human-derived particulate products as medical devices. The FDA must reconsider the matter under the court’s order.