What changed in this filing

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Item 1. Business

2026-02-25 compared with 2025-02-26 · 126 added, 91 removed, 356 unchanged (38% of the section changed)

MIMEDX is a pioneer and leader in placental biologics focused on helping humans heal.

With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX is dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare.

MIMEDX is a pioneer and leader focused on helping humans heal.

With nearly two decades 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.

With deep expertise, leading peer-reviewed data and an expansive library of additional scientific and real-world evidence in the field of placental biologics, MIMEDX develops and distributes placental tissue allografts that are manufactured using patent-protected, proprietary processes for multiple sectors of healthcare.

Additionally, we began offering animal-derived products, or xenografts, in 2024 and have plans to further expand our product offering to serve our large and growing customer base.

Today, our product offering is comprised of solutions designed to help clinicians treat patients suffering from chronic and other hard-to-heal wounds, primarily in the wound care, burn, and surgical sectors of healthcare.

These wounds can be slow to respond or unresponsive to conventional treatments and may benefit from advanced treatments, such as through the use of our products, in order to support the healing process.

Since its inception, MIMEDX has focused on leading the industry with its deep expertise, unmatched peer-reviewed scientific and clinical data, robust intellectual property portfolio and an expansive library of real-world evidence supporting the use of our products.

Historically, our sole focus has been on placental biologics.

However, in 2024, we broadened our portfolio and began offering animal-derived products, or xenografts, and in 2025 and early 2026, we entered into agreements with manufacturers of other wound care modalities to further expand our product offering to serve our large and growing customer base.

We continue to look for ways to broaden our portfolio, both inorganically and through our internal research and development efforts.

Today, our product portfolio is routinely used to help clinicians treat patients suffering from chronic and other hard-to-heal wounds, in wound care and in an increasing number of surgical specialties.

In wound care, our products are often used when a patient is either slowly responding or not responding to conventional treatments and a clinician determines they may benefit from advanced treatments.

When advanced treatments are determined to be necessary in order to continue treatment, clinicians select products from our portfolio to support the healing process.

Our placental allografts are human tissues that are derived from one person (the donor) and used to process products that treat multiple people (the recipients).

The manufacturing of our human derived product offering begins with donated birth tissue, namely the human placental membrane, umbilical cord and the placental disc, which we source through a large donor network developed over multiple years with leading hospitals and clinician groups.

In partnership with these facilities, we are able to obtain donated birth tissue from consenting mothers, which then are shipped to our manufacturing facilities in Marietta, Georgia, and undergo a series of testing followed by our proprietary tissue manufacturing workflow, which we refer to as the PURION® process.

MIMEDX has supplied over three million allografts, through all shipments, filling direct orders and consignment orders, through December 31, 2024.

The manufacturing of our human-derived product offering begins with donated birth tissue, namely the human placental membrane, umbilical cord and the placental disc, which we source through a large donor network developed over more than a decade with leading hospitals and clinician groups.

In partnership with these facilities, we are able to obtain donated birth tissue from consenting mothers, which are then shipped to our manufacturing facilities in Marietta, Georgia, and undergo a series of testing followed by our proprietary tissue manufacturing workflow, which we refer to as the PURION® process.

MIMEDX has supplied several million allografts, through all shipments, filling direct orders and consignment orders, through December 31, 2025.

Additionally, during 2024 and 2025, in response to market conditions, our portfolio included additional placental allografts, CELERA™ and EMERGE ™, that were manufactured by a contracted third party.

In 2024, we obtained the exclusive rights for and launched our first xenograft product and first U.S.

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HELIOGEN is manufactured by Regenity Biosciences, a developer and manufacturer of bioresorbable technologies.

In 2025 and early 2026, we entered into exclusive distribution agreements for several products, including:

• RegenKit®-Wound Gel, an autologous platelet-rich plasma (“PRP”) and autologous thrombin serum (“ATS”) wound gel.

• NovaForm® Wound Matrix, a proprietary bioglass and collagen-based wound dressing intended for use in the management of partial and full-thickness wounds, such as pressure ulcers, venous ulvers, diabetic ulcers and surgical wounds.

• G4Derm Plus®, a flowable peptide matrix engineered for rapid, protected wound closure.

The product forms a 3D scaffold that mimics the human extracellular matrix (ECM) and serves as an antibacterial barrier that protects the wound.

• Hydrelix Collagen Matrix, a sterile, Type 1 collagen powder, comprised of soluble modified bovine collagen.

We employ Current Good Tissue Practices (“CGTP”) and terminal sterilization to produce our allografts.

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Domestic sales currently account for the vast majority of our revenue today.

In the United States, our primary areas of clinical use include applications in surgical settings as well as for the treatment of wounds and burns.

In the United States, our primary areas of clinical use include applications in surgical settings as well as for the treatment of wounds and to a lesser extent burns.

Additionally, we continue to pursue international expansion, primarily targeting Japan, as discussed below.

The unmet need for healing solutions is large and growing, with an estimated 1-2% of the population in developed countries and worldwide experiencing a chronic wound sometime in their lives 1 .

In the U.S., the most recently available data indicates that chronic wounds affect 10.5 million Medicare beneficiaries and nearly 2.5% of the total population in the U.S.

In the U.S., the most recently available data indicates that chronic wounds affect more than 10 million Medicare beneficiaries and nearly 2.5% of the total population in the U.S.

2 The treatment of chronic wounds with advanced treatments is often referred to as Advanced Wound Care (“ AWC ”).

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These wounds require intervention and active management by clinicians and are treated in a variety of sites-of-service, with numerous products aimed at achieving healing for the patient.

The costs associated with treatment and management of patients with acute and chronic wounds is also high, with some estimates of the Medicare spend associated with such wounds approaching $100 billion annually.

The total costs associated with treatment and management of patients with acute and chronic wounds is also high, as worldwide spend associated with such wounds has historically been estimated to be approximately $150 billion annually.

The large and increasing number of patients requiring advanced treatment represents a significant cost burden on the healthcare system.

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Today, up to one-fifth of diabetic patients who develop a DFU will require some form of amputation.

Further, patients who undergo a major lower extremity amputation have an increased five-year mortality rate that is comparable to, and in some cases higher than, patients with many forms of cancer 6 .

Further, patients who undergo a

Human Wound and Its Burden:

Updated 2025 Compendium of Estimates.

Adv Wound Care (New Rochelle).

2025;14(9):429-438

2 Human Wound and Its Burden:

Updated 2022 Compendium of Estimates, https://pmc.ncbi.nlm.nih.gov/articles/PMC10615092/

3 GlobalData:

2022 Wound Care Management- Tissue Engineered Skin Subs U.S.

Updated May 2022

4 Chronic Wounds:

Economic Impact & Costs to Medicare, https://www.woundcarestakeholders.org/news/studies-and-publications/chronic-wounds-economic-impact-costs-to-medicare

5 Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092527/#CR1

major lower extremity amputation have an increased five-year mortality rate that is comparable to, and in some cases higher than, patients with many forms of cancer 6 .

Advances in managing chronic and hard-to-heal wounds with solutions such as our EPIFIX® product have been shown to help contribute to improved outcomes for these patients.

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We believe our first-mover advantage, favorable reimbursement rate, and strong distribution partner set us up for long-term success in this large and growing market.

1 Chronic Wounds Primer, https://pmc.ncbi.nlm.nih.gov/articles/PMC10352385/

2 Human Wound and Its Burden:

Updated 2022 Compendium of Estimates, https://pmc.ncbi.nlm.nih.gov/articles/PMC10615092/

3 GlobalData:

2022 Wound Care Management- Tissue Engineered Skin Subs U.S.

Updated May 2022

4 Chronic Wounds:

Economic Impact & Costs to Medicare, https://www.woundcarestakeholders.org/news/studies-and-publications/chronic-wounds-economic-impact-costs-to-medicare

5 Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092527/#CR1

6 Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease, https://www.ahajournals.org/doi/10.1161/ATVBAHA.120.314595

Traditional dressings such as bandages, gauzes and ointments, along with treatment of active infection and debridement, currently represent the “standard of care” for treating chronic wounds such as DFUs and VLUs.

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Our EPICORD, EPICORD Expandable and EPIEFFECT product lines also offer an alternative treatment option to address larger, deeper wounds in a cost-effective way at a point earlier in the treatment algorithm.

With broad commercial payor coverage, Medicare coverage under the Local Coverage Determinations (“ LCDs ”) scheduled for implementation in April 2025, the largest body of Level 1 clinical evidence among placental allograft products and a dedicated sales team calling on each of the major sites-of-service, we expect to continue to expand our presence in the AWC market, driving future growth of our business 7 .

With broad commercial payor coverage, the largest body of Level 1 clinical evidence among placental allograft products, a growing compendium of additional evidence, including our EPIEFFECT randomized controlled clinical trial (“RCT”) currently in process, and a dedicated sales team calling on each of the major sites-of-service, we expect to continue to expand our presence in the AWC market, driving future growth of our business 7 .

In addition to our presence in the AWC settings, our products are also used in a variety of surgical settings, and our strategic goals include building a body of evidence and real-world use data for our products in a wide range of procedures.

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We are working with surgeons in a range of disciplines to build the body of clinical, scientific and health outcomes evidence to support the use of our products broadly.

We believe our product offering is ideally suited for applications in a growing number of surgical specialties that we are targeting and expect the utilization of our products to continue to grow over time in this market.

Our strategy is to continue to deliver advanced products that serve patient needs within the Advanced Wound Care and Surgical markets and increase access to our products through clinical data generation and physician education.

Our Strategic Priorities

We manage our business by focusing on the following strategic priorities, which we believe are paramount to the success of MIMEDX over the short- and long-term.

Our first priority is to innovate and diversify our product portfolio to maximize growth.

Achievement of this priority is measured by our ability to maximize our commercial opportunities in the markets we serve with existing and future products, continue to introduce new products from our organic pipeline, such as the late-2023 launch of EPIEFFECT as well as the 2024 launch of HELIOGEN and accelerate market expansion internationally with a particular focus on continuing to grow our presence in Japan.

Our second priority is to develop and deploy programs to expand our surgical footprint.

We believe our ability to further penetrate the surgical setting is significant and will be enabled by our ability to leverage our existing evidence for surgical applications, invest in additional research and data in new indications and to drive market adoption of new surgical products, like our recently launched HELIOGEN offering.

Our third priority is to enhance our customer intimacy, which is a company-wide effort intended to implement programs and introduce offerings in support of lowering customer turnover.

To that end, in March 2024 we launched MIMEDX Connect, an

We believe our product offering is ideally suited for applications in a growing number of surgical specialties that we are targeting and expect the utilization of our products to continue to grow

6 Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease, https://www.ahajournals.org/doi/10.1161/ATVBAHA.120.314595

7 Zelen CM, et al.

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2019;16(3):761-767

online product ordering and account management portal available to our customers designed to streamline ordering, payment processing and reimbursement submissions,

over time in this market.

Anastomotic leaks are a serious postoperative complication of intestinal surgeries, with significant health and economic consequences that burden providers, payors and patients.

An anastomotic leak can lead to any or multiple of the following complications:

increased morbidity and mortality, higher readmission rates, extended length of stay, higher hospitalization costs, increased reoperation rates and a decreased quality of life.

Per 1,000 patients, the economic burden associated with anastomotic leaks is approximately $28 million, representing a multibillion cost to the U.S.

healthcare system.

Recent studies, including one presented in 2025 at leading gastroenterological conferences, demonstrate that AMNIOFIX recipients experienced significant reductions in leak rates and hospital readmissions.

Demonstrating reductions in complication rates such as these in common, critical surgical procedures, represents a significant opportunity for MIMEDX to continue to grow its Surgical footprint.

We believe our product offering is ideally suited for applications in a growing number of additional surgical specialties that we are targeting and expect the utilization of our products to continue to grow over time in this market.

We are working with surgeons in a range of disciplines to build the body of clinical, scientific and health outcomes evidence to support the use of our products broadly.

Our Strategic Priorities

We manage our business by focusing on the following strategic priorities, which we believe are paramount to the success of MIMEDX over the short- and long-term.

Our first priority is to innovate and diversify our product portfolio to maximize growth.

Achievement of this priority is measured by our ability to maximize our commercial opportunities in the markets we serve with existing and future products, continue to introduce new products from our organic pipeline, such as the late-2025 launch of EPIXPRESS, as well as distribution agreements for RegenKit Wound Gel, Hydrelix Collagen Matrix, NovaForm Wound Matrix and G4Derm Plus and accelerate market expansion internationally with a particular focus on continuing to grow our presence in Japan.

Our second priority is to develop and deploy programs to expand our surgical footprint.

Our third priority is to enhance our customer intimacy, which is a company-wide effort intended to implement programs and introduce offerings in support of lowering customer turnover.

To that end, in March 2024 we launched MIMEDX Connect, an online product ordering and account management portal available to our customers designed to streamline ordering, payment processing and reimbursement submissions,

We believe execution of these strategic priorities can and will differentiate the value of our portfolio, address multiple areas of significant unmet clinical need, and support our continued growth in both new and existing segments of the market.

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Our Product Portfolio & Pipeline

Our product offering is comprised of tissue allografts derived from human placental membrane, umbilical cord and the placental disc.

These products were developed and are manufactured using our proprietary processes.

We sell our placenta-based allograft products under our own brands.

Our product offering is comprised of tissue allografts derived from human placental membrane, umbilical cord, the placental disc, and, in the case of our xenograft, bovine collagen.

The majority of our products are developed and manufactured using our proprietary processes.

We sell many of our placenta-based allograft products under our own brands.

We maintain strict controls on quality at each step of the manufacturing process beginning at the time of procurement.

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The product may be used for the management of exudating wounds such as pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds, such as trauma and surgical wounds, and partial-thickness burns.

In 2025 and early 2026, we entered into exclusive distribution agreements for several additional complementary Wound and Surgical products that broaden our product offering with customers across the sites-of-care that we serve.

We continue to research new opportunities for additional human and animal derived products in a variety of configurations and sizes, and we have additional offerings in various stages of conceptualization and development.

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We believe that we will be able to obtain an adequate supply of tissue to meet anticipated demand for the foreseeable future.

Processing (Manufacturing)

Processing and Manufacturing

The Company has developed and patented a unique and proprietary technique (PURION) for processing allografts from the donated placental tissue.

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During the inspections, the FDA communicated that our product, AXIOFILL, appeared to be regulated under Section 351 of the Public Health Service Act (the “ PHS Act ”).

Based on this position, the FDA inspected the facilities related to AXIOFILL production using regulations 21 CFR 210 and 211, relating to finished pharmaceutical products in addition to 21 CFR 1271, relating to HCT/Ps (as defined below).

Based on this position, the FDA inspected the facilities related to AXIOFILL production using regulations 21 CFR 210 and 211, relating to finished pharmaceutical products in addition to 21 CFR 1271,

relating to HCT/Ps (as defined below).

The FDA issued a Form 483, which is a list of inspectional observations, at the conclusion of each inspection.

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While the Company was engaged with FDA through the formal RFD process regarding AXIOFILL, MIMEDX received a Warning Letter on December 21, 2023, relating to the inspections and classification of AXIOFILL.

In March 2024, the FDA issued a determination letter in connection with the RFD process for AXIOFILL, reaffirming its position that the product does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (“ HCT/P ”) under Section 361 of the Public Health Service Act (“ PHSA ”).

In response to the RFD determination letter, MIMEDX subsequently filed suit in the U.S.

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patents related to our amniotic tissue technology and products, and 10 additional patent applications covering aspects of this technology are pending at the United States Patent and Trademark Office.

The vast majority of our domestic patents covering our core amniotic tissue technology and products will not begin to expire until August 2027.

Globally, the Company has over 200 issued and pending patents, and from time to time seeks to enforce its intellectual property rights.

The vast majority of our domestic patents covering our core amniotic tissue technology and products and aspects of this technology will expire between August 2027 and May 2039.

Globally, the Company has nearly 300 issued and pending patents, and from time to time seeks to enforce its intellectual property rights.

Marketing and Sales

Our direct sales team includes field sales representatives and field sales management, who call on hospitals, wound care clinics, physician offices, and federal health care facilities such as the VA and Department of Defense (“ DoD ”) hospitals.

Our direct sales team includes field sales representatives and field sales management, who call on hospitals, wound care clinics, physician offices, and federal health care facilities.

Our direct sales force primarily focuses on the Wound and Surgical categories through multiple sites of service.

We also maintain a network of independent sales agents that focus on Surgical applications leveraging the complementary products in their

portfolios, and provide access to certain customers, as well as sales coverage for areas where we do not have a full-time sales representative.

We also maintain a network of independent sales agents that focus primarily on Surgical applications leveraging the complementary products in their portfolios, and provide access to certain customers, as well as sales coverage for areas where we do not have a full-time sales representative.

We also sell our products through distributors.

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As noted below under the heading “Research and Development,” we have devoted significant resources to clinical studies to provide data to the MACs, as well as other payers, in order to demonstrate the clinical efficacy and economic effectiveness of our tissue technologies.

For Medicare reimbursement purposes, our EPIFIX, EPICORD and EPIEFFECT allografts are classified as “skin substitutes.” Current reimbursement methodology varies between the hospital outpatient department (“ HOPD ”) and ASC setting versus the physician office.

Currently, within the HOPD and ASC places of service, skin substitutes are reimbursed under a “packaged” or “bundled” methodology that provides a single payment for both the application of the product as well as the product itself.

CMS classifies skin substitutes into low cost or high cost groups.

Our EPIFIX, EPICORD and EPIEFFECT products are all reimbursed under the high cost bundle in these settings.

The national HOPD average packaged (“bundled”) rate for our EPIFIX and EPICORD allograft products was $1,715 in 2021, $1,749.26 in 2022, $1,725 in 2023, and $1,738 in 2024.

The national HOPD average packaged (“bundled”) rate for our EPIFIX, EPICORD and EPIEFFECT products in 2025 is $1,829.23.

CMS assigns lower national rates to the ASC to reflect a less resource-intensive place of service.

For Medicare reimbursement purposes, products in our Wound portfolio, including our EPIFIX, EPICORD, EPIEFFECT and EPIXPRESS allografts, as well as the CELERA and EMERGE products we acquired from a third party and sold in 2025, are classified as “skin substitutes.” In 2025, the Medicare reimbursement methodology varied between the hospital outpatient department (“ HOPD ”) and ASC setting versus the physician office and associated care settings.

Within the HOPD and ASC sites of service, skin substitutes were reimbursed under a “packaged” or “bundled” methodology that provided a single payment for both the application of the product as well as the product itself.

CMS classified skin substitutes into low cost or high cost groups.

Our Wound product portfolio, including EPIFIX, EPICORD and EPIEFFECT were all reimbursed under the high cost bundle in these settings.

The national HOPD average packaged (“bundled”) rate for Wound allograft products was $1,715 in 2021, $1,749 in 2022, $1,725 in 2023, $1,738 in 2024 and $1,829 in 2025.

CMS assigned lower national rates to the ASC to reflect a less resource-intensive place of service.

Revenue in the ASC setting constitutes less than 1% of the Company’s annual net sales.

Medicare payments for most items and services, including EPIFIX and EPICORD sheet products, have been subject to sequestration reductions of approximately 2% periodically from 2013.

Medicare reimbursement in the physician office and associated care settings has been under increased scrutiny over the last couple of years and has led to changes in the manner in which products qualify for coverage and are reimbursed.

We expect additional reimbursement changes over the course of 2025 associated with skin substitutes.

Beginning in 2022, CMS announced plans to potentially change the reimbursement mechanism for skin substitutes in the physician office setting but has not proposed or enacted any national changes to the rules for these products to date.

Over the last several years, a combination of rapidly escalating prices and volumes in the industry has resulted in Medicare spending on skin substitutes to increase dramatically, with annual spending in 2020 of about $500 million to a monthly run-rate of over $1 billion per month by the end of 2024.

In response to this dramatic increase in Medicare spending, the MACs together released a proposed Local Coverage Determination (“ LCD ”) in April 2024 that was further refined and finalized in November 2024.

This policy, which is scheduled to become effective April 13, 2025 includes lists of skin substitute products which would explicitly be eligible for coverage and those which would not, based upon prospective, peer-reviewed randomized, controlled trials (“ RCTs ”).

The Company’s EPIFIX and EPICORD products are recognized in the document for having sufficient evidence for coverage, with EPIFIX listed as covered for DFUs and VLUs and EPICORD covered for DFUs.

EPIEFFECT, the Company’s other primary product for the Wound markets, will not be covered under this policy initially.

We are currently enrolling an RCT for EPIEFFECT designed to generate and publish the requisite evidence for coverage in the future.

Medicare reimbursement in the physician office and associated care settings have historically been reimbursed based upon pricing established in the Medicare Part B Drug Average Sales Price (“ ASP ”) list, which is updated quarterly based upon data submitted by manufacturers.

Under the rules that were in place through the end of 2025, skin substitute products sold in the physician office and associated care settings were reimbursed at “ASP+6%.” By way of background, over the last several years, a combination of rapidly escalating prices and volumes in the industry resulted in Medicare spending on skin substitutes increasing dramatically, with annual spending rising from about $500 million in 2020 to ~$15 billion in 2025.

The increase in Medicare spend has been driven, in part, by a proliferation of hundreds skin substitutes in the marketplace in just the last few years and a dramatic increase in the ASPs for these products.

As of the fourth quarter of 2025, ASP pricing for skin substitutes ranged from approximately $12 to $5,900 per square centimeter.

The increased spending, proliferation of Q-coded skin substitute products, and higher ASPs for these products have been under increased regulatory scrutiny over the last couple of years.

In response to these market dynamics, CMS announced sweeping changes related to the reimbursement of skin substitutes, effective January 1, 2026.

These changes include:

1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings and 2) changing the reimbursement rate for skin substitutes from the “ASP+6%” methodology to a flat rate at $127.14 per square centimeter in these care settings, subject to geographic adjustments.

The specific policies were put into effect in the Physician Fee Schedule (“ PFS ”) and Hospital Outpatient Prospective Payment System (“ OPPS ”).

Additional policies that were proposed by Medicare Administrative Contractors (“ MACs ”) related to Local Coverage Determinations (“ LCDs ”) that would have reduced the number of covered skin substitute products by CMS to 18 products, including EPIFIX and EPICORD, were withdrawn in late 2025.

To date, there have been no additional proposals.

Subsequent proposals, such as a new LCD or a National Coverage

Determination (“ NCD ”), if any, could potentially impact how and which skin substitute products could be reimbursed by Medicare in the future.

Private Payers

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We are working to develop additional health economic data to support this effort.

As a recent example, in 2025, our products were featured in an oral presentation at Digestive Disease Week highlighting the reduction in hospital readmissions and anastomotic leaks - common complications from colorectal surgery - when MIMEDX allografts were used.

As noted above, the ability to sell products in a hospital is dependent upon demonstrating to the hospital the product’s efficacy and cost effectiveness.

Our Surgical product portfolio is typically reimbursed under the DRG as are our Wound products, to a much lesser degree.

Revenues during our fourth quarter tend to be stronger than other quarters because many hospitals increase their purchases of our products during the fourth quarter to coincide with the end of their budget cycles in the United States.

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Customer Concentration

For the years ended December 31, 2024, 2023, and 2022, our top ten customers accounted for 20%, 20% and 19%, r espectively, of our net sales, and net sales to all U.S.

For the years ended December 31, 2025, 2024, and 2023, our top ten customers accounted for 22%, 20% and 20%, respectively, of our net sales, and net sales to all U.S.

government accounts comprised approximately 1%, 1% and 2%, respectively, of our net sales.

Due to lower barriers to entry in the Section 361 HCT/P regulated market, competition is intense in the skin substitute market, particularly among human-derived products and subject to new entrants and evolving market dynamics.

Companies within the industry compete on the basis of price, ease of handling, logistics and efficacy.

Companies within the industry compete on the basis of price, ease of handling, logistics, customer service and efficacy.

Another important factor is third-party reimbursement, which is difficult to obtain as it is a time-consuming and expensive process.

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In February 2020, the AHRQ published a technology assessment analyzing Skin Substitutes for Treating Chronic Wounds.

AHRQ conducted a literature search yielding 164 studies and 81 Supplemental Evidence and Data for Systematic Reviews (“ SEADs ”) submissions.

AHRQ conducted a literature search yielding 164 studies and 81 Supplemental Evidence and Data for Systematic Reviews

(“ SEADs ”) submissions.

Only 22 RCTs met the inclusion criteria to be reviewed in the AHRQ analysis, and out of the 22 RCTs MIMEDX had six RCTs included in the final brief.

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The products we sell are regulated by the FDA in the United States.

The majority of the products currently manufactured and processed by the Company are derived from human tissue.

Generally, our products currently sold in the United States are regulated as Human Cells, Tissues, and Cellular and Tissue - Based Products ( “HCT/Ps” ), and are subject solely to Section 361 of the Public Health Service Act (“ Section 361 ”) and related regulations, which do not require pre-market clearance or approval by the FDA.

The majority of the products we currently manufacture and process are derived from human tissue.

Generally, the products we currently sell in the United States are regulated as Human Cells, Tissues, and Cellular and Tissue - Based Products ( “HCT/Ps” ), and are subject solely to Section 361 of the Public Health Service Act (“ Section 361 ”) and related regulations, which do not require pre-market clearance or approval by the FDA.

We do not currently sell in the United States those cellular and tissue-based products considered to be drugs, devices, and/or biological products (“ Section 351 HCT/Ps ”) subject to licensure under Section 351 of the Public Health Service Act ( “Section 351” ) and related regulations.

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If the FDA were to find serious non-compliant manufacturing or processing practices during such an inspection, it could take regulatory actions that could adversely affect our business, results of operations, financial condition, and cash flows.

2017 FDA Guidance and Transition Policy for HCT/Ps

In November 2017, the FDA released four guidance documents that, collectively, the agency described as a “comprehensive policy framework” for applying existing laws and regulations governing regenerative medicine products, including HCT/Ps.

One guidance document in particular, “ Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue – Based Products:

Minimal Manipulation and Homologous Use – Guidance for Industry and Food and Drug Administration Staff ,” offered important clarity.

The guidance documents confirmed that sheet forms of amniotic membrane generally are appropriately regulated as solely Section 361 HCT/Ps when intended for use as a barrier or covering.

We continually evaluate our marketing materials for each of our products to align with FDA guidance.

In March 2024, the FDA issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing.

In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements under Section 361.

In response to the RFD determination letter, the Company has filed suit in the U.S.

District Court for the Northern District of Georgia and intends to exhaust all legal options available, given the arbitrary and capricious manner in which FDA is regulating like-kind products.

Notably, while these proceedings are taking place, the Company is permitted to continue marketing AXIOFILL.The FDA has broad regulatory compliance and enforcement powers.

The FDA has broad regulatory compliance and enforcement powers.

If the FDA determines that the Company has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, such as issuing an FDA Form 483 notice of inspectional observations;

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and criminal prosecution through the Department of Justice (“ DOJ ”).