MIMEDX Enters into Exclusive U.S. Distribution Agreement for RegenKit®-Wound Gel

Rhea-AI Summary

MiMedx (Nasdaq: MDXG) entered an exclusive U.S. distribution agreement with Regen Lab USA to distribute RegenKit®-Wound Gel, an autologous PRP and autologous thrombin serum wound gel, on Dec 22, 2025. The product concentrates growth factors, platelets, plasma proteins and nutrients in a fibrin scaffold and removes iron-laden red blood cells.

RegenKit was approved by FDA in 2022 and is covered nationally by CMS/LCD for diabetic chronic wounds under HCPCS code G0465. MiMedx says the kit adds a differentiated autologous option to its Advanced Wound Care portfolio and that upcoming LCD implementation on Jan 1, 2026 strengthens its competitive position.

Positive

• Exclusive U.S. distribution agreement for RegenKit
• FDA approval 2022 for RegenKit wound gel
• National CMS/LCD coverage under HCPCS code G0465
• Adds autologous PRP option to Advanced Wound Care portfolio
• LCD implementation Jan 1, 2026 cited as competitive advantage

Negative

• None.

News Market Reaction

-0.14%

1 alert

-0.14% News Effect

-$1M Valuation Impact

$1.04B Market Cap

0.7x Rel. Volume

On the day this news was published, MDXG declined 0.14%, reflecting a mild negative market reaction. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $1.04B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Net sales: $113.7M Wound sales: $77.1M Surgical sales: $36.6M +5 more

8 metrics

Net sales $113.7M Q3 2025, up 35% year over year

Wound sales $77.1M Q3 2025, up 40% year over year

Surgical sales $36.6M Q3 2025, up 26% year over year

Gross margin 83.5% Q3 2025, improved from 81.8%

GAAP net income $16.7M Q3 2025, with diluted EPS $0.11 vs. $0.05 prior year

Operating income $22.2M Q3 2025, doubled year over year

Cash and equivalents $142.1M End of Q3 2025; operating cash flow $49.0M YTD

CMS proposed rate $125.38 per sq. cm Proposed fixed price for skin substitutes from Jan 1, 2026

Market Reality Check

Price: $5.15 Vol: Volume 1,221,044 is 1.57x...

high vol

$5.15 Last Close

Volume Volume 1,221,044 is 1.57x the 20-day average (775,354), indicating elevated trading interest pre-announcement. high

Technical Shares traded slightly above the 200-day MA, at $7.05 vs. MA200 of $6.96, after a -2.76% session and 27.39% below the 52-week high.

Peers on Argus

While MDXG fell 2.76%, larger peers showed mixed performance: MRVI declined 1.72...

While MDXG fell 2.76%, larger peers showed mixed performance: MRVI declined 1.72%, but ATNF, MAZE, NTLA, and XERS rose between 1.93% and 5.31%, suggesting stock-specific dynamics rather than a uniform biotech move.

Market Pulse Summary

This announcement adds an FDA-approved, CMS-covered autologous PRP wound gel to MiMedx’s Advanced Wo...

Analysis

This announcement adds an FDA-approved, CMS-covered autologous PRP wound gel to MiMedx’s Advanced Wound Care portfolio, potentially complementing the strong Q3 2025 performance, where net sales reached $113.7M and gross margin was 83.5%. Investors may track how RegenKit®-Wound Gel adoption interacts with upcoming reimbursement changes, including CMS’s proposed $125.38 per sq. cm rate from January 1, 2026, and monitor future filings or updates on Wound product growth.

Key Terms

autologous, platelet-rich plasma, thrombin, fibrin scaffold, +4 more

8 terms

autologous medical

"RegenKit®-Wound Gel is an autologous platelet-rich plasma (PRP)..."

Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.

platelet-rich plasma medical

"RegenKit®-Wound Gel is an autologous platelet-rich plasma (PRP)..."

Platelet-rich plasma is a concentrated portion of a person’s own blood where platelets — the small cells that help blood clot and encourage tissue repair — are collected and returned to an injured area to speed healing. For investors, PRP is important because it creates demand for clinic services, medical devices and consumable kits; how well treatments work, regulatory clearance, and how widely clinicians adopt them can directly affect revenue potential, like selling a specialized repair kit to hospitals and clinics.

thrombin medical

"and autologous thrombin serum (ATS) wound gel that removes..."

Thrombin is a natural protein in the blood that acts like a foreman on a construction site, telling the building blocks of a clot to join together and stop bleeding. Investors care because drugs or devices that boost, block, or measure thrombin are central to treatments for bleeding and clotting disorders, and changes in safety, efficacy or regulation of those products can affect company revenues and risk profiles.

fibrin scaffold medical

"in a natural fibrin scaffold."

A fibrin scaffold is a biodegradable mesh made from fibrin, a natural blood protein, that acts like a temporary framework to support and guide new tissue growth during healing or medical procedures. Investors care because products using fibrin scaffolds can enable faster recovery, reduce complications, or allow new types of regenerative therapies, which can affect clinical trial outcomes, regulatory approval prospects, reimbursement potential, and ultimately market size and revenue.

hcpcs code regulatory

"under HCPCS code G0465."

A HCPCS code is a standard alphanumeric label used in the U.S. to identify medical services, supplies and durable equipment for billing to Medicare, Medicaid and private insurers. Think of it like a barcode or SKU that tells insurers exactly what was provided so they can decide how much to pay. Investors watch HCPCS codes because assignment, coverage or reimbursement levels tied to a code directly affect a healthcare product’s sales, revenue predictability and market access.

local coverage determination regulatory

"clarity on Local Coverage Determination (LCD) implementation on Jan 1, 2026..."

A local coverage determination is a region-specific decision by a public health insurer about whether a particular medical test, treatment, or device will be paid for in that area. Think of it like a local rulebook that says which procedures qualify for reimbursement; it matters to investors because such rules directly affect how much revenue health providers, device makers, or diagnostic companies can earn in that market and how widely a product will be adopted.

cms regulatory

"are covered nationally by CMS and LCD for the treatment..."

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that sets rules, payment rates and coverage decisions for major public health insurance programs; think of it as both a giant insurer and the rulebook maker for how many healthcare providers and drug makers get paid by government programs. Its policy changes and reimbursement decisions can materially affect revenue, profit forecasts and valuations for hospitals, insurers, device makers and drug companies, so investors watch CMS announcements closely.

advanced wound care medical

"option to the Company’s Advanced Wound Care portfolio..."

Specialized products and treatments used to heal hard-to-close or long-lasting wounds, such as advanced dressings, engineered tissue patches and devices that control infection and support tissue repair. For investors, advanced wound care matters because it is a higher-value, fast-evolving segment where clinical results, regulatory clearance and insurance reimbursement drive sales, margins and recurring revenue—similar to a specialized toolkit that can replace basic care and reduce overall healthcare costs.

AI-generated analysis. Not financial advice.

Company Continues to Broaden Leading Wound Product Offering

MARIETTA, Ga., Dec. 22, 2025 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced it has entered into an exclusive agreement with Regen Lab USA LLC to distribute their RegenKit^®-Wound Gel in the United States.

RegenKit^®-Wound Gel is an autologous platelet-rich plasma (PRP) and autologous thrombin serum (ATS) wound gel that removes iron-laden red blood cells, while concentrating essential growth factors, functional platelets, plasma proteins, and cellular nutrients in a natural fibrin scaffold. The fully autologous solution adds a differentiated option to the Company’s Advanced Wound Care portfolio and is backed by multiple published studies evaluating its effectiveness in treating chronic wounds. RegenKit^®-Wound Gel kits, developed by Antoine Turzi and approved by FDA in 2022, are covered nationally by CMS and LCD for the treatment of diabetic chronic wounds under HCPCS code G0465.

“With the addition of RegenKit, we are continuing to broaden our portfolio in Wound Care to offer patients and healthcare professionals an extensive assortment of proven solutions,” stated Kim Moller, MIMEDX Chief Commercial Officer. “We are excited to add an autologous option to our offering, and we expect it will prove to be a highly complementary addition to our expanding suite of Wound products. This agreement, in combination with the recently announced clarity on Local Coverage Determination (LCD) implementation on Jan 1, 2026, puts MIMEDX in an incredibly strong competitive position as we prepare to enter the new year.”

About Regen Lab USA LLC.
Regen Lab USA LLC. is a leader in autologous regenerative medicine based in Jersey City, New Jersey, USA. Founded in 2003 by Antoine Turzi, Regen Lab is specialized in designing and manufacturing high-quality medical devices for cell therapies and the preparation of autologous PRP from the patient's own blood for bedside procedures.

About MIMEDX
MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade 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

What did MiMedx (MDXG) announce on Dec 22, 2025 about RegenKit?

MiMedx announced an exclusive U.S. distribution agreement with Regen Lab USA to distribute RegenKit®-Wound Gel.

Is RegenKit®-Wound Gel FDA approved and when was it approved?

Yes, RegenKit®-Wound Gel was approved by FDA in 2022.

Will RegenKit® be reimbursed for diabetic chronic wounds and under what code?

RegenKit is covered nationally by CMS/LCD for diabetic chronic wounds under HCPCS code G0465.

How does the RegenKit distribution affect MiMedx's wound care lineup (MDXG)?

MiMedx says the kit adds a differentiated autologous PRP option that complements its Advanced Wound Care portfolio.

What timing did MiMedx cite related to coverage implementation?

The company referenced LCD implementation on Jan 1, 2026 as strengthening its competitive position.