What changed in this filing

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Item 1. Business

2023-02-28 compared with 2022-02-28 · 300 added, 202 removed, 329 unchanged (60% of the section changed)

MiMedx is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.

As a pioneer in placental biologics, we are focused on addressing unmet clinical needs in the areas of advanced wound care, surgical recovery applications, and musculoskeletal conditions.

We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process.

MIMEDX is a pioneer and leader in placental biologics, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.

The Company is focused on addressing unmet clinical needs in the areas of Advanced Wound Care (“ AWC ”), Surgical Recovery, and osteoarthritis.

We derive our products primarily from human placental tissues and process these tissues using our proprietary methods, including the PURION ® process.

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

MIMEDX provides products primarily for use in the wound care, burn, and Surgical Recovery sectors of healthcare.

All of our products are regulated by the U.S.

Food & Drug Administration (“ FDA” ).

All of our products sold in the United States are regulated by the U.S.

Food & Drug Administration (“ FDA ”), and to the extent we sell our products outside the United States, by other regulatory agencies in such international markets.

At MIMEDX, our vision is to advance regenerative science and innovative biologics that restore quality of life.

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MIMEDX is a leading supplier of human placental allografts, which are human tissues that are derived from one person (the donor) and used to produce products that treat another person (the recipient).

MiMedx has supplied over two million allografts, through both direct and consignment shipments.

Our primary platform technologies include EPIFIX®, AMNIOFIX®, EPICORD®, and AMNIOCORD®.

AMNIOFIX and EPIFIX are our tissue allografts derived from the amnion and chorion layers of the human placental membrane.

EPICORD and AMNIOCORD are tissue allografts derived from umbilical cord tissue.

Our EPIFIX and EPICORD products are marketed for external use, such as in advanced wound care applications, while our AMNIOFIX and AMNIOCORD products are positioned for use in surgical recovery applications, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstructions.

We describe these in greater detail below under the heading “ Our Product Portfolio.

MIMEDX has supplied over two million allografts, through direct shipments.

Our primary platform technologies include tissue allografts derived from human placental membrane (EPIFIX®, AMNIOFIX®, and AMNIOEFFECT®), tissue allografts derived from human umbilical cord (EPICORD® and AMNIOCORD®), and a particulate extracellular matrix derived from human placental disc (AXIOFILL®).

EPIFIX and EPICORD products are marketed for external use, such as in Advanced Wound Care applications, while our AMNIOFIX, AMNIOEFFECT, AXIOFILL, and AMNIOCORD products are positioned for use in Surgical Recovery applications, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstructions.

We describe these in greater detail below under the heading “ - Our Product Portfolio & Pipeline.

2017 FDA Guidance .

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

However, in November 2017 the FDA published a series of related guidances, including one entitled “ 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 ” (the “ Guidance ”).

The Guidance established an updated framework for the FDA’s regulation of cellular and tissue-based products.

However, in November 2017 the FDA published a series of related guidance documents, including one entitled “ 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 ” (collectively, the “ Guidance ”), which established an updated framework for the FDA’s regulation of cellular and tissue-based products.

Among other things, the Guidance clarified the FDA’s views about the criteria that differentiate those products subject to regulation solely under Section 361 (“ Section 361 HCT/Ps ”) from 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.

Effect of Guidance on Our Products.

Under the Guidance, we expect that the FDA will continue to regulate certain of our placental tissue products (EPIFIX, AMNIOFIX, EPICORD, AMNIOCORD and AMNIOBURN) as Section 361 HCT/Ps so long as the claims we make for them are consistent with the Section 361 framework.

However, the FDA is now regulating certain of our other products, such as our micronized products (AMNIOFIX Injectable and EPIFIX Micronized, collectively “ mdHACM ” or “ micronized dehydrated human amnion chorion membrane ”) and our particulate product (AMNIOFILL), as Section 351 HCT/Ps and/or medical devices.

Under the Guidance, we expect that the FDA will continue to regulate certain of our placental tissue products (EPIFIX, AMNIOFIX, EPICORD, AMNIOCORD, AMNIOBURN, AXIOFILL and AMNIOEFFECT) as Section 361 HCT/Ps so long as the claims we make for them are consistent with the Section 361 framework.

Beginning in May 2021, the FDA began regulating certain of our other products, including our micronized dehydrated human amnion chorion membrane (“ mDHACM ”) products that we previously marketed in the United States as Section 351 HCT/Ps.

Enforcement Discretion .

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We continued to market our micronized products (mDHACM) and our particulate product (AMNIOFILL) under this policy of enforcement discretion in the United States until May 31, 2021, while at the same time pursuing Biologics License Applications (“ BLAs ” ) for certain of our micronized products in specific clinical applications.

After May 31, 2021, we no longer sell our micronized and particulate products in the United States, and do not intend to sell such products in the United States until the FDA grants pre-market approval.

After May 31, 2021, we no longer sell our products that were impacted by enforcement discretion in the United States, and do not intend to sell such products in the United States until the FDA grants pre-market approval.

As a result, we will only be able to market such products for indications that have been cleared or approved by the FDA.

Similarly, we are engaged with the FDA regarding the classification of our umbilical cord products, EPICORD, EPICORD Expandable, and AMNIOCORD, which are tissue allografts derived from the structural, protective covering and extracellular matrix cushioning layers of the umbilical cord.

If the FDA makes a final determination that our umbilical cord-derived products do not meet the requirements for regulation solely under Section 361, then the products will require additional pre-market clearance or approval.

If the FDA makes a final determination that our umbilical cord-derived products do not meet the requirements for regulation solely under Section 361, then, in order to continue to market the products, we would be required to obtain the appropriate FDA clearance or approval.

In 2022, revenues from US sales of our umbilical cord-derived products were $23.2 million.

See discussion below – “ Risk Factors ” under the heading “ Certain of our products do not qualify for regulation as human cells, tissues and cellular and tissue-based products solely under Section 361 of the Public Health Service Act, which has resulted in removal of the applicable products from the market, made the introduction of

some new tissue products more expensive, significantly delayed the expansion of our tissue product offerings and subjected us to additional post-market regulatory requirements.

See discussion below in Item 1A, Risk Factors under the heading “ Certain of our products do not qualify for regulation as human cells, tissues and cellular and tissue-based products solely under Section 361 of the Public Health Service Act, which has

resulted in removal of the applicable products from the market, made the introduction of some new tissue products more expensive, significantly delayed the expansion of our tissue product offerings and subjected us to additional post-market regulatory requirements.

Additional regulatory requirements may be imposed in the future.”

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Current Business Priorities and Strategy

As a pioneer in placental biologics, we are focused on addressing the needs of patients with acute and chronic non-healing wounds in the areas of advanced wound care and surgical recovery.

We have a promising late-stage pipeline platform aimed at decreasing pain and improving function in patients with degenerative musculoskeletal conditions.

There is significant unmet patient need due to an aging population, an increasing incidence of obesity and diabetes, and other contributing comorbidities that result in a higher susceptibility to non-healing across each of these therapeutic areas.

An increasing number of patients require advanced treatment, which represents a significant cost burden on the healthcare system.

By incorporating a strategy to advance the scientific and therapeutic potential of placental tissue and more rigorously establish the clinical and economic effectiveness of our products, we believe the Company can differentiate the value of our portfolio and address multiple areas of significant unmet clinical need.

We have focused our priorities on initiatives across our Commercial, Operations and Research & Development organizations that position the Company to achieve its goal of sustainable double digit annual percentage growth in our business and advance our late-stage musculoskeletal pipeline.

We believe there are a number of large, underpenetrated market opportunities in the areas of advanced wound care and surgical recovery, including across multiple international markets.

We anticipate receiving reimbursement approval in Japan in mid-2022, and plan to launch EPIFIX in Japan as the first amniotic tissue approved for wound treatment across a broad range of conditions.

Domestically, we are expanding our addressable markets from the treatment of diabetic foot ulcers, venous leg ulcers, pressure ulcers and complex wounds into areas of surgical recovery where the use of our tissue products could help reduce complications across several specialties, including plastic surgery, general surgery, gynecology, urology, orthopedics, spinal surgery, lower extremity repair and sports medicine procedures.

After studying the landscape of surgical procedures, we are targeting certain procedures based on potential complication rate, clinical relevance, economic factors and business priorities.

We have a robust pipeline of organic products in development, and have a goal of improving the Company’s Product Vitality Index by launching two new organic products per year, beginning with AMNIOEFFECT™ and our Placental Collagen Matrix (“ PCM ”) product in 2022.

We believe we have a sustainable competitive advantage with our customer focused ecosystem, consisting of a leading portfolio of products, proprietary technology, and best-in-class sales and support organization, together with our broad access and coverage, robust clinical support and medical education efforts, and record of proven outcomes focused on improving patient care.

The Company is also pursuing FDA approval for mdHACM as a platform technology to treat musculoskeletal degeneration across multiple indications, beginning with knee osteoarthritis (“ KOA ”).

In late 2021, we reviewed the results of our Phase 2B KOA clinical trial, which did not meet its primary endpoints, but did yield significant outcomes from the “Pre-Interim Analysis Cohort” consisting of 190 patients.

The 190 subjects enrolled prior to an interim analysis performed for sample size correction in July through August 2019 showed a statistically significant and clinically meaningful difference in favor of mdHACM in Western Ontario and McMaster Universities Arthritis Index (“ WOMAC ”) total scores, and in each of the pain and function subscales compared to the placebo.

However, subjects enrolled after this interim analysis did not show separation from the placebo.

Root-cause analysis determined that the potency of the investigational product faded as it aged, resulting in the study’s failure to meet its primary endpoints.

Based on the data from the Pre-Interim Analysis Cohort in the Phase 2B trial, published retrospective data, extensive real-world clinical use, and ongoing scientific mechanism of action research, the Company expects to initiate a Phase 3 KOA program in 2022, with a BLA filing anticipated in late 2025, and will work closely with the FDA in advancing this program.

Our Product Portfolio

We sell our placenta-based allograft products under our own brands and, on a limited basis, through a private label or original equipment manufacturer (“ OEM ”).

We combine a large donor network developed over multiple years that sources donated birth tissue from consenting mothers, with our proprietary tissue manufacturing process and significant research and development expertise to develop innovative placental-derived products that address a wide range of chronic and acute health conditions affecting large patient populations.

Our core business delivers innovative products that help clinicians treat patients suffering from acute and chronic non-healing wounds.

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

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 treatment of chronic wounds is often referred to as wound care.

Chronic wounds are defined and characterized as those that do not progress through the normal process of healing and remain open for over a month.

Patients, typically in the elderly population, with conditions such as diabetes, obesity and other comorbidities, are among those with the highest risk of developing chronic wounds, which include diabetic foot ulcers (“ DFUs ”), venous leg ulcers (“ VLUs ”), and pressure ulcers, among others.

Studies estimate that in 2022 roughly 2.1% of the U.S.

population was affected by chronic wounds 1 .

Complications from non-healing chronic wounds can result in significant, life-altering adverse outcomes, such as limb amputation.

Today, up to one-fifth of diabetic patients who develop a DFU will require some form of amputation 2 .

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 many forms of cancer 3 .

Acute wounds are defined as those that are recent, are acquired from an incision or trauma and have yet to progress through the sequential stages of wound healing.

Acute wounds can be caused accidentally or they can arise in the normal course of a wide-range of surgical procedures.

When acute wounds present in patients with similar comorbidities to those of chronic wound patients, the risk of a slow or ineffective healing wound increases, and the risk of a surgical site infection or other similar complication increases for the patient.

We refer to the combination of a wide variety of surgical procedures on patients with these comorbidities, who could thus see slow or ineffective healing, as the Surgical Recovery market.

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

We estimate that the combined U.S.

wound and surgical market for our products is currently $2.0 billion ($1.1 billion in wound;

$0.9 billion in surgical) and is largely under-penetrated 4 .

We expect the U.S.

wound and surgical market will grow at an annual rate of 7-10% over the next 3 to 5 years 5 .

The prevalence of both acute and chronic wounds has grown not only in the U.S.

but also globally.

While historically we have focused primarily on the U.S.

market, we are now in the process of expanding our footprint internationally, most notably with the recent launch of our EPIFIX product in Japan.

In 2021, we secured regulatory approval for EPIFIX in Japan followed by reimbursement approval in 2022.

We also announced an exclusive distribution agreement with Gunze Medical Limited (“ Gunze Medical” ), a subsidiary of Gunze Limited, for sales of EPIFIX in the Japanese market, and expect to commence sales in the region in 2023.

In Japan, EPIFIX is the first and currently the only amniotic tissue product approved for wound treatment across a broad range of conditions.

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 GlobalData:

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

Updated May 2022

2 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

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

4 GlobalData Tissue Engineered-Skin Sub Data Model Wound Management Year 2020 – retrieved Sept 2021

5 GlobalData Tissue Engineered-Skin Sub Data Model Wound Management Year 2020 – retrieved Sept 2021

Additionally, we have a regenerative medicine pipeline led by an injectable placental biologic product candidate, for which we are targeting an indication to help decrease pain and improve function in patients suffering from knee osteoarthritis (“ KOA ”), also known as degenerative joint disease of the knee.

KOA is the most prevalent form of osteoarthritis and is a leading source of chronic pain and disability in the U.S.

Our KOA program is in late-stage clinical trials and we are working toward the filing of a BLA in order to obtain regulatory approval for this product and a subsequent commercial launch in the U.S.

By incorporating a strategy to advance the scientific and therapeutic potential of placental tissue and rigorously demonstrate the clinical and economic effectiveness of our products, we believe we can differentiate the value of our portfolio and address multiple areas of significant unmet clinical need.

We have focused our priorities on initiatives across our organization that position us to realize our commercial ambitions over the long-term while also generating a profitable, cash flow positive business capable of self-funding our future growth objectives.

Business Segments

Beginning in the third quarter of 2022, the Company manages itself as two reportable segments:

Wound & Surgical and Regenerative Medicine.

Wound & Surgical focuses on the Advanced Wound Care and Surgical Recovery markets through the sale of the Company’s existing product portfolio and product development to serve these end markets.

Its platform technologies include tissue allografts derived from human placental membrane (EPIFIX, AMNIOFIX, and AMNIOEFFECT), tissue allografts derived from human umbilical cord (EPICORD and AMNIOCORD), and a particulate extracellular matrix derived from human placental disc (AXIOFILL).

This segment is also responsible for the international sales of the Company’s Section 351 products.

The Regenerative Medicine business focuses solely on Regenerative Medicine technologies, specifically progressing the Company’s placental biologics platform towards registration as an FDA-approved biological drug.

mDHACM is the lead product candidate in its late-stage pipeline targeted at achieving FDA approval for specific clinical indications, including degenerative musculoskeletal conditions, beginning with KOA.

Our Product Portfolio & Pipeline

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

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

Our Quality Management System is focused on compliance with the American Association of Tissue Banks’ (“ AATB ”) standards and the FDA’s CGTP, and we are implementing CGMP.

We believe the application of CGMP will provide benefits throughout our entire product portfolio, and add to our competitive differentiation.

EPIFIX is a semi-permeable, protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of chronic wounds, including diabetic foot ulcers (“ DFUs ”), venous leg ulcers (“ VLUs ”), and pressure ulcers.

Our Quality Management System is focused on compliance with the American Association of Tissue Banks’ (“ AATB ”) standards and the FDA’s CGTP and CGMP regulations.

EPIFIX is a protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of chronic wounds, including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure ulcers.

EPIFIX is available in an assortment of sheet configurations and sizes to accommodate various wounds.

MiMedx also has a micronized version of this product that it no longer markets or sells in the United States.

As further discussed below under the heading “ Government Regulation - Recent FDA Guidance and Transition Policy for HCT/Ps ,” the FDA clarified in its 2017 guidance that it regards micronized placental membrane products as subject to FDA licensure as biological products under Section 351.

AMNIOFIX is a semi-permeable, protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in surgical recovery applications.

MIMEDX also has a micronized version of this product that it no longer markets or sells in the United States, but does sell outside the United States.

As further discussed below under the heading “ Government Regulation - 2017 FDA Guidance and Transition Policy for HCT/Ps ,” the FDA clarified in its 2017 guidance that it regards micronized amniotic membrane products as subject to FDA licensure as biological products under Section 351.

AMNIOFIX is a protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in Surgical Recovery applications.

AMNIOFIX is available in an assortment of sheet configurations and sizes for internal use, including in the areas of lower extremity repair, spine, orthopedic, sports medicine, gastrointestinal, urologic, and other general surgery applications.

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This product is our lead BLA candidate.

We completed three late-stage randomized controlled studies under open INDs, evaluating mdHACM in plantar fasciitis, Achilles tendonitis and knee osteoarthritis.

While the trials did not meet their primary endpoints, we intend to initiate our Phase 3 clinical trial program for knee osteoarthritis in 2022.

For further details, see “-- Clinical Trials .”

AMNIOBURN is a semi-permeable, protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of partial-thickness and full-thickness burns.

We completed four late-stage randomized controlled studies under open INDs, evaluating mDHACM in plantar fasciitis, Achilles tendonitis and KOA.

While the KOA Phase 2B trial did not meet its primary endpoints, we initiated a post-Phase 2B registrational clinical trial for KOA in February 2023.

For further details, see “- Clinical Trials ” below.

AMNIOBURN is a protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of partial-thickness and full-thickness burns.

EPICORD and AMNIOCORD

EPICORD and AMNIOCORD are dehydrated human umbilical cord allografts that may be used to provide a protective environment for the healing process and are used in the areas of advanced wound care and surgical recovery.

EPICORD and AMNIOCORD are dehydrated human umbilical cord allografts that may be used to provide a protective environment for the healing process and are used in the areas of Advanced Wound Care and Surgical Recovery, respectively.

These products are thicker than our amniotic membrane allografts and can be applied in deeper wounds or in areas where suturing the allograft in place may be advantageous.

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The thickness of the product allows for suturing as needed to keep the graft in place, and it provides healthcare professionals a new option to support the Advanced Wound Care needs of their patients with larger, chronic, and hard-to-heal wounds.

The Company launched AXIOFILL during the third quarter of 2022.

AXIOFILL is an extracellular matrix derived from human placental disc, and is designed to provide a cost-effective human collagen scaffold that is conducive for use in large, complex wounds and those of irregular geometries.

Our AXIOFILL product has seen initial adoption by clinicians primarily focused on Surgical Recovery applications.

The Company also launched AMNIOEFFECT during the third quarter of 2022.

AMNIOEFFECT is a tri-layer placental tissue allograft that contains amnion, intermediate layer, and chorion membranes.

This product is designed to meet the needs of surgeons performing procedures where a more robust allograft with expansive size offerings is desired.

The Company ceased marketing and selling AMNIOFILL in the United States in May 2021, following the end of the FDA’s period of enforcement discretion.

We have not yet initiated any clinical trials in furtherance of any regulatory approvals for this product.

We sell a selection of allografts on an OEM basis pursuant to an agreement under which we have granted a third party an exclusive license to some of our technology for use in dental applications.

Antimicrobial Wound & Surgical Products

In December 2022, we announced an in-licensing and distribution agreement with Global Health Solutions, Inc.

Turn Therapeutics or “ Turn ”), providing us with worldwide exclusive rights to Turn’s proprietary antimicrobial technology platform, PermaFusion®, for the development of future products focused on Advanced Wound Care and Surgical Recovery applications.

PermaFusion® is petrolatum-based, liquid-in-oil suspension technology that involves the creation of nanodroplets without binding agents or emulsifiers and also includes a process to coat materials with antimicrobial-infused petrolatum.

Turn’s intellectual property estate includes “mixing” and “coating” intellectual property and provides protection up to 20 years.

MIMEDX expects this technology to be included in the creation of a number of new antimicrobial products for the Wound & Surgical markets.

In addition to the exclusive license obtained to Turn’s intellectual property, MIMEDX will acquire the commercial rights to Turn’s FleX™ Antimicrobial Collagen Matrix product, contingent upon its receipt of FDA 510(k) clearance and other conditions.

FleX™ is a bovine collagen powder product that incorporates antimicrobial properties to aid in the management of partial and full thickness wounds.

Under the terms of the agreement, MIMEDX has exclusive rights to develop future products for the wound care, burn, and surgical fields using Turn’s intellectual property.

Turn received an upfront cash payment from MIMEDX and is entitled to future payments upon completion of regulatory and product commercial milestones, along with royalties on the sales of products covered by the licensed intellectual property.

We sell a selection of allografts on an Original Equipment Manufacturer ( “OEM” ) basis pursuant to an agreement under which we have granted a third party an exclusive license to some of our technology for use in dental applications.

This agreement is concluding during 2023, after which we do not anticipate generating sales of our allograft products on an OEM basis.

We continue to research new opportunities for amniotic and other placental tissue, and we have additional offerings in various stages of conceptualization and development.

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Through our donor program, a mother who delivers a healthy baby via Caesarean section can donate her placenta and umbilical cord tissue in lieu of having it discarded as medical waste.

After consent for donation is obtained, a blood sample from each donor is tested for communicable diseases, and

the donor is screened for risk factors in order to determine eligibility in compliance with federal regulations and AATB standards.

After consent for donation is obtained, a blood sample from each donor is tested for communicable diseases, and the donor is screened for risk factors in order to determine eligibility in compliance with federal regulations and AATB standards.

We operate a licensed tissue bank that is registered as a tissue establishment with the FDA, and we are an accredited member of the AATB.

All donor records and test results are reviewed by our Medical Director and staff prior to the release of the tissue for distribution.

However, see discussion below, “ Risk Factors ” under the heading “ The products we manufacture and process are derived from human tissue and therefore have the potential for disease transmission.”

We have developed a large, geographically diverse, network of hospitals that participate in our placenta donation program, and we employ a dedicated staff that work with these hospitals.

We also utilize a third-party provider of placenta donations on an as- needed basis to mitigate business risk.

We have developed a large, geographically diverse, network of hospitals across the United States that participate in our placenta donation program, and we employ a dedicated staff that work with these hospitals.

We also utilize third-party providers of placenta donations on an as- needed basis to mitigate business risk.

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

However, see discussion below “Risk Factors” under the heading “ Our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business.

Processing (Manufacturing)

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Our patented and proprietary processing method employs aseptic processing techniques in addition to terminal sterilization for increased product safety.

Despite starting with similar placental tissues, all placental tissue products and processes are not the same – we believe that our proprietary tissue engineering process preserves more of the natural beneficial characteristics of the tissue than the processes used by many of our competitors.

Despite starting with similar placental tissues, all placental tissue products and processing methods are not the same – we believe that our proprietary process preserves more of the natural beneficial characteristics of the tissue than the processes used by many of our competitors.

The PURION process produces an allograft that retains the tissue’s inherent biological properties and regulatory proteins (including cytokines, chemokines, and growth factors) found in the placental tissue and produces an allograft that is safe and easy for healthcare providers to use.

The allograft can be stored at room temperature and has a five-year shelf life.

Each sheet allograft incorporates specialized visual embossments that assist the health care practitioner with allograft placement and orientation.

Each sheet allograft incorporates specialized visual markings that assist the health care practitioner with allograft placement and orientation.

To ensure the safety of human tissue products, the FDA enforces CGTP manufacturing regulations.

We believe that MiMedx has developed mature systems to comply with, and is in compliance with, these regulations.

We believe that MIMEDX has developed robust systems to comply with, and is in compliance with, these regulations.

As an important part of the Company’s product safety compliance, MIMEDX products are terminally sterilized to an internationally recognized industry standard in addition to having been processed via the PURION process.

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The FDA also categorized its December 2019 inspection of our Marietta, Georgia facility as VAI.

The Company believes it has significantly progressed its CGMP compliance and maintains a proactive dialogue with the FDA regarding its continued application of CGMP throughout its portfolio.

The Company believes it has made progress in its CGMP compliance and continued to make quality improvements through its quality plan.

Intellectual Property

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patents related to our amniotic tissue technology and products, and 30 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.

See discussion below – “ Risk Factors ” under the heading “ Risks Related to Our Intellectual Property .”

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.

Market Overview

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In the United States, our primary areas of clinical use include Advanced Wound Care and Surgical Recovery applications.

The broad wound care category includes traditional dressings such as bandages, gauzes and ointments, which are used to treat non-severe or non-chronic wounds, and advanced wound care products such as medical devices, advanced dressings, xenografts, biological products, and HCT/Ps, which are used as skin substitutes to treat severe wounds or chronic wounds that have not appropriately closed after four weeks of treatment with traditional or standard of care dressings.

Advanced Wound Care

The Advanced Wound Care market is comprised of products such as medical devices, advanced dressings, xenografts, biological products, and HCT/Ps, which are used as skin substitutes to treat severe wounds or chronic wounds that have not appropriately closed after four weeks of treatment with traditional or standard of care dressings.

Not included in Advanced Wound Care are traditional wound care dressings, such as bandages, gauzes and ointments, which typically are used in the treatment of non-severe or non-chronic wounds.

In the United States, estimates indicate that in 2022 the prevalence of chronic wounds was 2.1% of the total U.S.

population, or approximately 6.9 million people suffering from chronic wounds.

Of these chronic wounds, approximately 58% or 3.9 million are categorized as chronic leg ulcers (which include DFUs and VLUs), with 43% treated with advanced wound care dressings such as skin substitutes (GlobalData:

2021 Wound Care Management- Tissue Engineered Skin Subs - US - 2015-2030).

Of these chronic wounds, approximately 58% or 4.0 million are categorized as chronic leg ulcers (which include DFUs and VLUs), with 47% treated with Advanced Wound Care dressings such as skin substitutes 6 .

MIMEDX is a leader in the cellular tissue products/skin substitute segment of the Advanced Wound Care category and the amniotic tissue allograft sub-category.

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Surgical Recovery

We are expanding beyond advanced wound care into areas of surgical recovery where the use of our tissue products could help reduce complications across several specialties, including plastic surgery, general surgery, gynecology, urology, orthopedics, spinal surgery, lower extremity repair and sports medicine procedures.

We are expanding beyond Advanced Wound Care into areas where the use of our tissue products could help reduce complications across several surgical specialties, including plastic surgery, general surgery, gynecology, urology, orthopedics, spinal surgery, lower extremity repair and sports medicine procedures.

Collectively, we refer to these areas as the Surgical Recovery segment of the market.

Certain surgical procedures can have an increased likelihood of complications such as dehiscence, adhesions, and others that may affect both the recovery of the patient and the outcome of the surgery.

The rate of complications can depend on a number of factors, including the complexity of the procedure and patient specific issues, such as obesity, diabetes or advanced age.

Surgical recovery applications focus on the use of tissue products to augment tissue, serve as a barrier membrane in procedures where scar tissue formation may be problematic or where a second surgery may be required, or aid in incisional closure with the goal of preventing or reducing procedural complications.

In the Surgical Recovery setting, applications of our products are used to augment tissue, serve as a barrier membrane in procedures where scar tissue formation may be problematic or where a second surgery may be required, or aid in incisional

6 GlobalData:

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

Updated May 2022

7 Chronic Wounds:

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

closure with the goal of preventing or reducing procedural complications.

Following a thorough review of surgical procedures and potential clinical applications across several specialties, we have identified those areas where we believe our tissue products could be incorporated.

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As in Advanced Wound Care, we believe this market is expanding as a result of demographic trends, including an aging population, increasing incidence of obesity and diabetes and the associated higher susceptibility to non-healing chronic wounds.

The Company launched AXIOFILL during the third quarter of 2022.

Our AXIOFILL product has seen initial adoption by clinicians primarily focused on Surgical Recovery applications.

The Company also launched AMNIOEFFECT during the third quarter of 2022.

AMNIOEFFECT is a tri-layer placental tissue allograft that contains amnion, intermediate layer, and chorion membranes.

This product is designed to meet the needs of surgeons performing procedures where a more robust allograft with expansive size offerings is desired.

AMNIOFIX is a semi-permeable, protective barrier allograft comprised of dehydrated human amnion/chorion membrane that may be used in Surgical Recovery applications.

International

The Company is actively pursuing international expansion, with an initial focus in Japan.

2021 estimates indicate that within a total Japanese population of approximately 126 million people, there are approximately 626,000 chronic leg ulcers, 100,000 of which are potential candidates for an advanced wound care product (GlobalData Tissue Engineered-Skin Sub Data Model

Wound Management Year).

The Japanese population has the largest proportion of people 65 or older in the world, estimated to be approximately 36.2 million (28.8%) in 2020, increasing the potential need for healthcare products and services (Statistics Bureau of Japan, https://www.stat.go.jp/english/data/handbook/c0117.html).

The Company is actively pursuing international expansion, with an initial focus on Japan.

Estimates for 2022 indicate that within a total Japanese population of approximately 126 million people, there are approximately 629,000 chronic leg ulcers, 100,000 of which are potential candidates for an Advanced Wound Care product 8 .

We believe these demographic trends, along with an increasing incidence of obesity and diabetes and the associated higher susceptibility to non-healing chronic wounds, present a significant unmet patient need and underpenetrated market opportunity.

MIMEDX received regulatory approval from the Japanese Ministry of Health, Labor and Welfare in June 2021 to market EPIFIX in Japan, as the first amniotic tissue approved for hard-to-heal chronic wounds, such as DFUs and VLUs, which do not respond to conventional therapy.

We expect to secure reimbursement approval in mid- 2022, and are putting in place the necessary structure, medical education programs, and market development initiatives to operationalize our commercial strategy.

MIMEDX received regulatory approval from the Japanese Ministry of Health, Labor and Welfare (“ JMHLW ”) in June 2021 to market EPIFIX in Japan, as the first amniotic tissue approved for hard-to-heal chronic wounds, such as DFUs and VLUs, which do not respond to conventional therapy.

We secured reimbursement approval in September 2022, and are putting in place the necessary structure, medical education programs, and market development initiatives to operationalize our commercial strategy.

In December 2022, we announced an exclusive distribution agreement with Gunze Medical for sales of EPIFIX in the Japanese market.

Under the terms of the agreement, Gunze Medical and its team of dedicated sales representatives will work to distribute EPIFIX for clinicians to treat patients with hard-to-heal DFUs and VLUs across Japan.

MIMEDX will be responsible for the supply of EPIFIX to Gunze Medical, which will sell the products locally, pursuant to the indications for use and reimbursement rates secured for the product.

The parties will collaborate to continue physician education activities and drive further key opinion leader engagement in-country.

The Company is also evaluating opportunities for geographic expansion in the United Kingdom and certain other countries in Europe and the Middle East.

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In 2017, the FDA released guidance clarifying its views that certain cellular and tissue-based products, including certain products marketed by MIMEDX, are considered drugs, devices, and/or biological products subject to Section 351 requirements under the federal Food, Drug and Cosmetic Act (the “ FD&C Act ”).

In order to conform to this regulatory guidance, MiMedx is pursuing indications under the BLA pathway, although there can be no assurance that we will obtain a BLA and we may ultimately decide not to pursue a BLA for these products or indications.

See Risk Factors - “ Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time consuming and may impede our ability to fully exploit our technologies.”

mdHACM is our lead BLA product candidate.

We conducted three IND programs in the areas of plantar fasciitis (Phase 3 clinical trial conducted), Achilles tendonitis (Phase 3 clinical trial conducted) and knee osteoarthritis (Phase 2B clinical trial conducted).

In order to conform to this regulatory guidance, MIMEDX is pursuing an indication under the BLA pathway, although there can be no assurance that we will obtain a BLA and we may ultimately decide not to pursue a BLA for this product or indication.

8 GlobalData:

2022 Wound Care Management – Tissue Engineered Skin Subs, Japan, updated May 2022;

management estimates

9 Statistics Bureau of Japan, https://www.stat.go.jp/english/data/handbook/c0117.html

mDHACM is our lead BLA product candidate and we are currently focused on conducting a post-Phase 2B registrational clinical trial for the KOA market, which we initiated in February 2023.

See Clinical Trials, below, for more information.

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The knee is the most commonly affected joint and knee OA represents the leading cause of disability in the adult population.

Estimates indicate that approximately 17.5 million people suffered from symptomatic knee osteoarthritis in 2020 (GlobalData:

2020 Orthopedic Devices Knee Reconstruction - US - 2015-2030), and this number is expected to increase to 19 million people by 2025 (GlobalData:

2020 Orthopedic Devices - Knee Reconstruction - US - 2015-2030).

Estimates indicate that approximately 18 million people suffered from symptomatic knee osteoarthritis in 2022 10 , and this number is expected to increase to 19 million people by 2025 11 .

According to the Arthritis Foundation, more than half of knee osteoarthritis sufferers are younger than 65 years old.

Current treatment options include analgesics, non-steroidal anti-inflammatory drugs (“ NSAIDs ”), injectable corticosteroids, viscosupplements, platelet rich plasma, and other emerging therapies.

Approximately 80% of symptomatic knee OA patients fail conservative therapy (GlobalData:

2020 Orthopedic Devices - Viscosupplementation - US - 2015-2030).

Approximately 80% of symptomatic knee OA patients fail conservative therapy 12 .

When conservative and non-operative treatment options fail, patients often consider surgical intervention.

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However, mDHACM has not yet been approved by the FDA for any such use.

See Item 1A - Risk Factors - “ Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time consuming and may impede our ability to fully exploit our technologies.”

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 Department of Veterans Affairs (the “ VA ”) and Department of Defense (“ DoD ”) hospitals.

Our direct sales force focuses on the advanced wound care and surgical recovery category through multiple sites of service.

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

We also maintain a network of independent sales agents that focus on Surgical Recovery 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.

Distributors purchase products from us at wholesale prices and resell products to end users.

See Note 15 to our consolidated audited financial statements included in Item 8 of this Annual Report, “ Revenue .” As discussed above, we sell allografts for certain applications on an OEM basis pursuant to an agreement under which we grant a third party an exclusive license to some of our technology for use in certain fields.

Distributors purchase products from us at wholesale prices and resell products to providers and end users.

For example, in Japan, our distribution partner, Gunze Medical, purchases products from us and is responsible for sales to the end users for the approved indications of use and at the prevailing reimbursement rate for the product.

See Note 12, Revenue to our consolidated audited financial statements included in Item 8 of this Annual Report.

Coverage and Reimbursement

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In the U.S., such payers include U.S.

federal healthcare programs ( e.g.

, Medicare and Medicaid), private insurance plans, managed care programs and workers’ compensation plans.

federal healthcare programs (e.g., Medicare and Medicaid), private insurance plans, managed care programs, and workers’ compensation plans.

Federal healthcare programs have prescribed coverage criteria and reimbursement rates for medical products, services, and procedures.

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Ultimately, however, each third-party payer determines whether and on what conditions they will provide coverage for our products, and such decisions often include each payer’s assessment of the science and efficacy of the applicable product.

A portion of our products are purchased by U.S.

government accounts ( e.g.

, the VA and the Public Health Service (including the Indian Health Service), which do not depend on reimbursement from third party payers.

In order for us to be eligible to have our products purchased by such federal agencies and paid for by the Medicaid program, federal law requires us to participate in the VA Federal Supply Schedule (“ FSS ”) pricing program.

A portion of our products is purchased by U.S.

government accounts (e.g., the VA and the Public Health Service, including the Indian Health Service), which do not depend on reimbursement from third-party payers.

In order for us to be eligible to have

10 GlobalData:

2022 Orthopedic Devices — Knee Reconstruction – US – 2015-2030

11 GlobalData:

2020 Orthopedic Devices – Knee Reconstruction – US – 2015-2030

12 GlobalData:

2020 Orthopedic Devices – Viscosupplementation – US – 2015-2030

our products purchased by such federal agencies and paid for by the Medicaid program, federal law requires us to participate in the VA Federal Supply Schedule (“ FSS ”) pricing program.

Medicare Coverage

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Medicare Administrative Contractors (“ MACs ”) are private insurance companies that serve as agents of CMS in the administration of the Medicare program and are responsible for making coverage decisions and paying claims for the designated Medicare jurisdiction.

There are seven Part A/B MACs in the U.S., which cover 12 jurisdictions, each with its own geographical jurisdictions, and each MAC has its own standards and process for determining coverage and reimbursement for a procedure or product.

There are seven Part A/B MACs in the U.S., which cover 12 unique geographical jurisdictions.

Each MAC also has its own standards and process for determining coverage and reimbursement for a procedure or product.

Private payers often follow the lead of governmental payers in making coverage and reimbursement determinations.

Therefore, achieving favorable Medicare coverage and reimbursement is usually a significant gating factor for successful coverage and reimbursement for a new product or clinical application by private payers.

Therefore, achieving favorable Medicare coverage and reimbursement is usually a significant gating factor for successful adoption of a new product or clinical application by private payers.

The coverage and reimbursement framework for products under Medicare is determined in accordance with the Social Security Act and pursuant to regulations promulgated by CMS, as well as the agency’s coverage and reimbursement guidance.

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

Currently, skin substitutes are reimbursed under a “packaged” or “bundled” methodology along with the related application procedure under a two-tier payment system.

In the HOPD and ASC setting, providers receive a single payment that reimburses them for the application of the product as well as the product itself.

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, based on a geometric mean unit cost and per day cost.

For 2022, the geometric mean unit cost threshold applicable to both our EPIFIX and EPICORD allograft products was $48 per square centimeter, and the per day cost threshold was $949.

The national HOPD average packaged (“bundled”) rate for our EPIFIX and EPICORD allograft products was $1,568 in 2018, was $1,549 in 2019, was $1,623 in 2020, was $1,715 in 2021, and is $1,749.26 in 2022.

This “bundled” payment structure applies only to the HOPD and ASCs settings.

For 2023, the geometric mean unit cost threshold applicable to both our EPIFIX and EPICORD allograft products was $47 per square centimeter, and the per day cost threshold was $949.

The national HOPD average packaged (“bundled”) rate for our EPIFIX and EPICORD allograft products was $1,549 in 2019, $1,623 in 2020, $1,715 in 2021, $1,749.26 in 2022, and is $1,725 in 2023.

CMS assigns 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.

Currently, providers that administer EPIFIX or EPICORD allografts and other skin substitutes in the physician office setting are reimbursed based on the size of the graft, computed on a per square centimeter basis.

The payment rate is calculated using the manufacturer’s reported average sales price (“ ASP ”) submitted quarterly to CMS.

This payment methodology applies only to physician offices.

The Medicare payment rates are updated quarterly based on this ASP information for many skin substitute

products but not all.

This payment methodology applies to physician offices, as well as places of service such as patient home, assisted living and nursing home.

The Medicare payment rates are updated quarterly based on this ASP information for many skin substitute products but not all.

EPIFIX and EPICORD are included on the Medicare national ASP Drug Pricing File.

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Reimbursement for products not included on the Medicare national ASP Drug Pricing File are at the discretion of each MAC, which typically is invoice cost or wholesale acquisition cost (“ WAC ”) plus 6%.

Medicare payments for all items and services, including EPIFIX and EPICORD sheet products, since 2013 have been reduced by 2% under the sequestration required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012.

Subsequent legislation extended the 2% reduction to 2030 (although the sequestration was suspended from May 1, 2020 through December 31, 2020 due to COVID-19).

This 2% reduction in Medicare payments affects all parts of the Medicare program.

The law allows for additional sequestration orders, potentially resulting in up to a 4% reduction in Medicare payments under a statutory PAYGO sequestration order.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended the sequestration payment adjustment percentage of 2% applied to all Medicare Fee-for-Service (FFS) claims from May 1 through December 31, 2020.

The Consolidated Appropriations Act, 2021, extended the suspension period to March 31, 2021.

An Act to Prevent Across-the-Board Direct Spending Cuts, and for Other Purposes, signed into law on April 14, 2021, extended the suspension period to December 31, 2021.

Recently, several wide-ranging proposals have been published for public comment, including relating to payment methodology within the physician office, and are under consideration by the CMS.

In addition, three MACs have recently published for public comment changes to their Local Coverage Determinations (“ LCDs ”) that they are considering.

If adopted, these proposals would significantly change Medicare policies governing the reimbursement of skin substitute products principally when used for wound treatment in the private physician office setting.

The LCDs in the proposals could adopt a new standard of clinical evidence required as a prerequisite to coverage.

In addition, the proposals all require a confirmation that the products are regulated solely under Section 361 of the Public Health Service Act as a prerequisite to continued coverage.

We have the required confirmation for EPIFIX, but not currently for EPICORD.

The proposed LCDs also include language that could lower the number of allowed applications of a product below what is commonly used in standard practice by physicians today (supported by clinical evidence) and reflected by LCDs currently in force with the MACs.

The Company as well as stakeholders across the wound care industry do not support lowering the applications.

Private Payers

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We have established and continue to grow a reimbursement support group to educate providers and patients with regard to accurate coverage and reimbursement information regarding our products, and plan to continue investing in clinical data supportive of coverage for our products in additional clinical areas of use.

See discussion below – “ Risk Factors ” under the heading “ Our revenues depend on adequate reimbursement from public and private insurers and health systems.

Products administered in the hospital inpatient setting are bundled when submitted as part of the hospital’s claim under a diagnosis-related group (“ DRG ”).

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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.

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.

Satisfaction of patient deductibles through the course of the year also results in increased revenues later in the year.

In general, our first quarter usually has lower revenues than the preceding fourth quarter, the second and third quarters have higher revenues than the first quarter, and the fourth quarter revenues are the highest in the year.

Customer Concentration

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government accounts comprised approximately 2%, 3% and 5% of our net sales, respectively.

We have contracted with a third party as our indefinite delivery/ indefinite quantity channel partner into the VA and DoD markets.

See discussion below – “ Risk Factors ” under the heading “ A portion of our revenues and accounts receivable come from government accounts.

See discussion below in Item 1A, Risk Factors under the heading “ A portion of our revenues and accounts receivable come from government accounts.

Due to lower barriers of entry in the Section 361 HCT/P regulated market, competition in the placenta-based and allograft tissue field is intense and subject to new entrants and evolving market dynamics.

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This important government assessment highlights our commitment to providing unbiased level 1 clinical evidence in advanced wound treatment.

This dedication to elevating the standard of care is further underscored by the fact that the AHRQ points out in its assessment that MiMedx was the only entity

to provide two studies out of the 22 evaluated that performed a subgroup analysis of patients with diabetic foot ulcers that received adequate debridement.

This dedication to elevating the standard of care is further underscored by the fact that the AHRQ points out in its assessment that MIMEDX was the only entity to provide two studies out of the 22 evaluated that performed a subgroup analysis of patients with DFUs that received adequate debridement.

Both studies reported an increase in wounds healed with adequate debridement.

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Our main competitors in the skin substitute market include Integra LifeSciences Holdings Corporation, Organogenesis, Inc., and Smith & Nephew plc, which sell a variety of Advanced Wound Care products, including skin substitutes and placental tissue allografts.

In addition, the overall market is competitive, with a large number of other competitors that compete regionally and nationally.

See discussion below – “ Risk Factors ” under the heading “ We are in a highly competitive and evolving field and face competition from well-established tissue processors and medical device manufacturers, as well as new market entrants.

In addition, the overall market is competitive, with a large number of other, smaller competitors that compete regionally and nationally.

Our Regenerative Medicine efforts around KOA are also subject to a wide range of potential future competitors.

Based on published information from across the medical device and biotherapeutics industry, there are over 70 other active R&D programs currently developing potential treatments for KOA using a variety of different scientific approaches.

The speed with which we can successfully develop our product, complete clinical trials, obtain regulatory clearance, and begin commercialization efforts for our KOA offering will influence our ability to succeed in this market.

Government Regulation

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Our Section 351 HCT/Ps are also tissue products, but are regulated as biological products, and, in order to be lawfully marketed in the United States, require FDA pre-market approval.

See discussion below – “ Risk Factors ” under the heading “ Risks Related to Regulatory Approval of Our Products and Other Government Regulations .”

Tissue Products

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The CGTP govern, as may be applicable, the facilities, controls, and methods used in the manufacture of all HCT/Ps, including processing, storage, recovery, labeling, packaging, and distribution of Section 361 HCT/Ps.

CGTP require us, among other things, to maintain a

quality program, train personnel, control and monitor environmental conditions as appropriate, control and validate processes, properly store, handle and test our products and raw materials, maintain our facilities and equipment, keep records and comply with standards regarding recovery, pre-distribution, distribution, tracking and labeling of our products and complaint handling.

CGTP require us, among other things, to maintain a quality program, train personnel, control, and monitor environmental conditions as appropriate, control and validate processes, properly store, handle and test our products and raw materials, maintain our facilities and equipment, keep records and comply with standards regarding recovery, pre-distribution, distribution, tracking and labeling of our products, and complaint handling.

21 CFR Part 1271 also mandates compliance with adverse reaction and CGTP deviation reporting and labeling requirements.

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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.

See Item 1A Risk Factors, “ Our business is subject to continuing regulatory compliance by the FDA and other authorities, which is costly, and our failure to comply could result in negative effects on our business, results of operations and financial condition.”

2017 FDA Guidance and Transition Policy for HCT/Ps

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This enforcement discretion applied across our industry, and during the period, the Company continued to market its products under this policy of enforcement discretion.

After May 31, 2021, the Company no longer markets or sells its micronized and particulate products in the United States.

After May 31, 2021, the Company no longer markets or sells its products that were impacted by enforcement discretion in the United States.

We are pursuing the BLA pre-market approval process for certain uses of mDHACM.

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Phase 1 trials typically involve a small number of healthy volunteers and are designed to provide information about the product safety and to evaluate the pattern of drug distribution and metabolism within the body.

Phase 2 trials are conducted in a larger but limited group of

patients afflicted with a particular disease or condition in order to determine preliminary efficacy, dosage tolerance and optimal dosing, and to identify possible adverse effects and safety risks.

Phase 2 trials are conducted in a larger but limited group of patients afflicted with a particular disease or condition in order to determine preliminary efficacy, dosage tolerance and optimal dosing, and to identify possible adverse effects and safety risks.

Dosage studies are typically designated as Phase 2A, and efficacy studies are designated as Phase 2B.

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sending a warning letter or untitled letter;

issuing an order of retention, destruction, or cessation of marketing;

issuing an order of retention,

destruction, or cessation of marketing;

imposing civil money penalties;

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Trial Overview

The Company recently completed three IND studies investigating the use of mdHACM to reduce pain and increase function in patients with plantar fasciitis, Achilles tendonitis, and knee osteoarthritis.

As previously disclosed, the trials were developed and initially overseen by senior managers, many of whom are no longer with the Company.

The Company previously completed four IND studies investigating the use of mDHACM to reduce pain and increase function in patients with KOA, as well as plantar fasciitis and Achilles tendonitis.

The Company is not currently pursuing the use of mDHACM to treat plantar fasciitis or Achilles tendonitis.

The Company continues to pursue the use of mDHACM to treat KOA.

The Company has instituted several actions with respect to its ongoing and anticipated clinical trials to address the resources, capabilities, and expertise needed for an effective dialogue with the FDA regarding our BLA progress.

However, there can be no assurance that we will obtain BLA approval and we may ultimately decide not to pursue a BLA for certain products or indications.

See Risk Factors - “Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time consuming and may impede our ability to fully exploit our technologies.”

Plantar Fasciitis

In March 2015, we initiated a Phase 2B prospective, single-blinded, RCT investigating a single injection of 40 mg of mdHACM as compared to a single intra-plantar injection of saline (placebo control) in the treatment of patients with recalcitrant plantar fasciitis pain and foot dysfunction.

This trial enrolled 145 patients at 15 study sites.

In September 2017, we announced the trial had met its efficacy endpoints, and the three-month endpoint data were published in 2018.

In April 2017, we met with the FDA and informally discussed preliminary data from the Phase 2B study, our progress toward achieving CGMP compliance, and our proposed Phase 3 study design.

Formal FDA feedback from this meeting was incorporated into our development plans.

Based on this feedback and the Phase 2B interim data, in January 2018 we initiated a Phase 3 prospective, double-blinded, RCT to assess the safety and efficacy of a single 40 mg intra-plantar injection of mdHACM as compared to a single intra-plantar injection of saline (placebo control) to treat patients with recalcitrant plantar fasciitis pain.

The trial plan was initially to enroll 164 patients, with an interim analysis to assess adequacy of this sample size built into the statistical plan.

In July through August 2019, we conducted an interim analysis on subjects representing 50% of total enrollment that had reached the primary efficacy endpoint, to assess adequacy of the sample size to assess differences between the two treatment groups.

This analysis indicated that a significant increase in sample size would be required to observe clinically and statistically significant improvement and separation between treatment and control groups.

We determined that increasing the sample size to 276 patients would provide sufficient power to observe an efficacy result with statistical and clinical significance.

We instituted these changes and amendments and completed enrollment of 277 subjects in September 2020.

Following completion of the study, initial review of the trial data during the third quarter of 2021 revealed that the study did not meet its endpoints.

The data from the study continue to be the subject of extended analyses, however, as previously disclosed, we do not expect to file a BLA or pursue further studies in this indication at this time.

Knee Osteoarthritis

However, there can be no assurance that we will obtain BLA approval and we may ultimately decide not to pursue a BLA for this or for other products or indications.

Knee Osteoarthritis Trial Overview

In March 2018, the FDA granted mDHACM the Regenerative Medicine Advanced Therapy (“ RMAT ”) designation for use in the treatment of osteoarthritis of the knee.

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This trial was planned to enroll 318 patients, with an interim analysis to assess adequacy of this sample size built into the statistical plan.

This blinded interim analysis was performed in July through

August 2019 and revealed that while differences in the treatment groups were observed, the power to observe statistically and clinically significant results would be enhanced by increasing the sample size to 466 patients.

This blinded interim analysis was performed in July through August 2019 and revealed that while differences in the treatment groups were observed, the power to observe statistically and clinically significant results would be enhanced by increasing the sample size to 466 patients.

Amendments to the protocol to allow this increase were subsequently approved.

It should be noted that during the first half of 2020 in particular, study enrollment slowed considerably due to the ongoing COVID-19 pandemic , although this did begin to resolve in the third quarter of the year.

It should be noted that during the first half of 2020 in particular, study enrollment slowed considerably due to the ongoing COVID-19 pandemic, although this impact did begin to resolve in the third quarter of the year.

Due to actual dropout rates observed in the study being lower than planned, in September 2020 we completed enrollment of 447 patients.

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The six months blinded efficacy visits in this study were completed during the second quarter of 2021, and analyses were completed during the third quarter of 2021.

The final study visits are expected to occur (open label extension) during the second quarter of 2022.

As previously announced, the trial did not meet its primary endpoints, however it revealed that the 190 subjects enrolled prior to an interim analysis performed for sample size correction in July through August 2019 showed a statistically significant and clinically meaningful difference in favor of mdHACM in WOMAC total scores and both the pain and function subscales compared to the placebo.

However, subjects enrolled after this interim analysis did not show separation from the placebo.

The final study visits occurred (open label extension) during the second quarter of 2022.

The final endpoint of the study was at 12 months.

All 12-month visits have now been completed, and data analysis has been accomplished.

MIMEDX is currently evaluating these results and preparing a clinical report.

As previously announced, the trial did not meet its primary endpoints at six months.

However, in a cohort of 190 subjects enrolled prior to a planned interim analysis performed for sample size correction in July through August 2019, a statistically significant and clinically meaningful difference in favor of mDHACM in WOMAC total scores and both the pain and function subscales compared to the placebo was observed.

Subjects enrolled after this interim analysis did not show separation of results from the mDHACM treated from those of the placebo arm.

Third-party biostatisticians validated the improvement in WOMAC Pain at three and six months, respectively (p=0.032 and p=0.009), WOMAC Function (p=0.046 and p=0.009), and WOMAC Total (p=0.038 and p=0.008) for the Pre-Interim Analysis Cohort of 190 patients.

Our root-cause analysis has determined that the potency of the investigational product faded as it aged, resulting in the study’s failure to meet its primary endpoints.

The Company’s proprietary biochemical and biological tests detected this reduced potency, related to the age of the investigational product used in the Phase 2B KOA study.

Based on the clinically meaningful and statistically significant data from the Pre-Interim Analysis Cohort of 190 patients in the Phase 2B trial, published retrospective data, extensive real-world clinical use, and ongoing scientific mechanism of action research, the Company expects to initiate a Phase 3 KOA program in 2022, with a BLA filing anticipated in late 2025, and will work closely with the FDA in advancing these trials.

There can be no assurance, however, that our anticipated time frame for commencing the Phase 3 KOA program and submitting a BLA will be achieved or that we will receive FDA approval for mdHACM and be able to commercialize this product, or that such approval will not be delayed for a variety of reasons, including failure of the studies to achieve their endpoints;

the impact of the COVID-19 pandemic on study enrollment and FDA operations;

A root-cause analysis determined that the potency of the investigational product decreased as it aged, which we believe caused the study to fail to meet its primary endpoints.

The Company’s proprietary biochemical and biological tests, along with the clinical observations, detected this reduced potency.

Based on the clinically meaningful and statistically significant data from the Pre-Interim Analysis Cohort of 190 patients in the Phase 2B trial, published retrospective data, extensive real-world clinical use, and ongoing scientific mechanism of action research, the Company initiated the first of two registrational KOA trials in February 2023 and has been working closely with the FDA in advancing this program.

There can be no assurance, however, that our anticipated time frame for the registrational KOA trials and submitting a BLA will be achieved or that we will receive FDA approval for mDHACM and be able to commercialize this product, or that such approval will not be delayed for a variety of reasons, including failure of the studies to achieve their endpoints;

the impact of the COVID-19 pandemic or other public health emergencies on study enrollment and FDA operations;

the potential that the results of the clinical studies do not merit further investment;

and the work required to achieve commercial and manufacturing readiness.

See discussion in Item 1A - “ Risk Factors ” under the heading “ Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time-consuming and may impede our ability to fully exploit our technologies.”

Achilles Tendonitis

In January 2018, we initiated a Phase 3 prospective, double-blinded RCT investigating a single intra-tendon injection of 40 mg of mdHACM as compared to a single injection of saline (placebo control) in the treatment of Achilles tendonitis.

The planned trial enrollment was 158 patients, with an interim analysis to assess adequacy of the sample size built into the statistical plan.

We analyzed data received from this sample size analysis, conducted on patients representing 50% of total enrollment that had reached the primary efficacy endpoint.

This analysis indicated that a substantial increase in sample size would be required to observe clinically and statistically significant improvement and separation between treatment and control groups.

With this in mind, we determined that the most reasonable approach was to continue the study to completion with the originally planned sample size, and analyze the final results to determine the adequacy of the measures employed and time points of observation to show meaningful clinical and statistical analyses.

Enrollment for this study was completed and the last patient visit occurred in the first half of 2021.

The data from this study are currently being prepared for analysis.

We plan to review our options for this program after we have assessed the results of this study;

however, as previously disclosed, we do not expect to file a BLA or pursue further studies in this indication at this time.

Prior to May 31, 2021, the date the FDA’s period of enforcement discretion ended, we filed appropriate investigational applications for AMNIOFILL and EPIFIX Micronized.

Two INDs were approved for EPIFIX, one in chronic wounds, another in surgical incisions, and an investigational device exemption (“ IDE ”) was filed for AMNIOFILL.

We have not yet initiated any clinical trials for AMNIOFILL or EPIFIX Micronized related to these applications, and have no immediate plans to advance these programs.

If study results support potential product approval and potential for commercialization, we intend to file BLAs as described above.

The process of obtaining an approved BLA requires the expenditure of substantial time, effort and financial resources and may take years to complete.

Prior to May 31, 2021, the date the FDA’s period of enforcement discretion ended, we also filed investigational applications for additional indications for AMNIOFIX Injectable and EPIFIX Micronized.

These two INDs were allowed to proceed for the injectable products, one in chronic wounds, another in surgical incisions.

We have not yet initiated any clinical trials related to these applications, and have no immediate plans to advance these programs.

If study results support potential product approval and potential for commercialization, we intend to file a BLA as described above.

The process of obtaining an approved BLA requires the expenditure of substantial time, effort and financial resources, and may take years to complete, including costs incurred on top of those fees incurred as part of conducting various clinical studies.

The fee for filing a BLA and the annual user fees payable with respect to any establishment that manufactures biologics and with respect to each approved product are substantial.

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Significant improvements include a newly built, validated processing suite applying CGMP that is utilized for processing of Section 351 products.

See discussion in Item 1A – “ Risk Factors ” under the heading “ Certain of our products no longer qualify for regulation as human cells, tissues and cellular and tissue-based products solely under Section 361 of the Public Health Service Act (“Section 361”), which has resulted in removal of the applicable products from the market, made the introduction of some new tissue products more expensive, significantly delayed the expansion of our tissue product offerings and subjected us to additional post-market regulatory requirements.

Additional regulatory requirements may be imposed in the future.”

Other Regulation Specific to Tissue Products

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Procurement of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act (“ NOTA ”), which prohibits the transfer of certain human organs, including skin and related tissue, for valuable consideration, but permits the reimbursement of reasonable expenses associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of human tissue and skin.

Our wholly-owned subsidiary, MiMedx Tissue Services, LLC, is registered with the FDA as an establishment that manufactures human cells, tissues and cellular and tissue- based products and is involved with the recovery and storage of donated human amniotic membrane.

Our wholly-owned subsidiary, MiMedx Tissue Services, LLC, is registered with the FDA as an establishment that manufactures human cells, tissues, and cellular and tissue- based products and is involved with the recovery and storage of donated human placental tissues.

We reimburse tissue banks, hospitals, and physicians for their services associated with the recovery and storage of donated human tissue.

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AATB standards include specific requirements for recovery, screening, testing, labeling, processing, and storing of birth tissue.

We believe we are compliant in all material respects with AATB standards and our state licensure requirements.

We maintain compliance with AATB standards and our state licensure requirements.

To the extent we sell our products outside of the United States, we also are subject to laws and regulations of foreign countries.

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These regulations include those described below.

See also the discussion under “ Risk Factors - We and our sales representatives, whether employees or independent contractors, must comply with various federal and state anti-kickback, self-referral, false claims and similar laws, any breach of which could cause an adverse effect on our business, results of operations and financial condition.”

• The federal Anti-Kickback Statute, which is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward referrals, purchases or orders, or arranging for or recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program, such as the Medicare and Medicaid programs.

• The federal Anti-Kickback Statute (“ AKS ”), which is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward referrals, purchases or orders, or arranging for or recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program, such as the Medicare and Medicaid programs.

The term “remuneration” has been broadly interpreted to include anything of value.

The Patient Protection and Affordable Care Act amended the intent requirement of the federal Anti-Kickback Statute, so that a person or entity no longer needs to have actual knowledge of this statute or

specific intent to violate it.

A conviction for violation of the Anti-Kickback Statute results in criminal fines and requires mandatory exclusion from participation in federal health care programs.

Although there are a number of statutory exceptions and regulatory safe harbors to the federal Anti-Kickback Statute that protect certain common industry practices from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor.

The Patient Protection and Affordable Care Act amended the intent requirement of the federal AKS, so that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.

A conviction for violation of the AKS results in criminal fines and requires mandatory exclusion from participation in federal health care programs.

Although there are a number of statutory exceptions and regulatory safe harbors to the federal AKS that protect certain common industry practices from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor.

• The federal False Claims Act (“ FCA ”) imposes significant civil liability on any person or entity that knowingly presents, or causes to be presented, a claim for payment to the U.S.

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As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S.

See also Item 3, “Legal Proceedings.”

• The federal Health Insurance Portability and Accountability Act of 1996 (“ HIPAA ”) fraud and abuse provisions prohibit executing a scheme to defraud any healthcare benefit program, willfully obstructing a criminal investigation of a health care offense, or making false statements or concealing a material fact relating to payment for healthcare benefits, items or services.

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In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

International Regulation (Japan)

MIMEDX received regulatory approval from the Japanese Ministry of Health, Labour and Welfare (JMHLW) to market EPIFIX in Japan.

Under JMHLW guidelines, EPIFIX is classified as a Class IV Medical Device and “Specified Biological Product” and is approved for the treatment of refractory ulcers, such as DFUs and VLUs that do not respond to conventional therapy.

As a condition of the final approval, MIMEDX will conduct post-market surveillance, consisting of a limited study over 75 participants.

The JMHLW has the ultimate responsibility of granting final approval on all Class III and IV Medical Devices and “Specified Biological Products.” All approved products in Japan, including EPIFIX, are regulated by the Pharmaceuticals and Medical Devices Agency (“ PMDA ”), which acts as the technical arm of the JMHLW.

The PMDA serves in a similar function as the FDA in the United States, and is responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices in Japan.

The PMDA provides review and approval of medical devices, QMS/GLP/GCP inspections, and collection and analysis of adverse event reports.

MIMEDX also secured reimbursement approval from JMHLW on September 1, 2022 with an awarded rate of 35,100 Yen/cm 2 , and subsequently entered into an exclusive distribution agreement with Gunze Medical for sales of EPIFIX in Japan.

Insurance coverage for EPIFIX will provide doctors and patients in Japan with new treatment options and optimal wound care.

Research and Development

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See Part II, Item 7, below, for information regarding expenditures for research and development in each of the last three fiscal years.

Environmental, Social & Governance Matters (“ESG”)

At MIMEDX, we are committed to improving people’s health and lives through innovation that makes healing possible.

Our product offering is derived from donated human placental and umbilical cord tissue, which are processed into products used by health professionals to treat patients suffering from both acute and chronic hard-to-heal wounds.

We are continuously looking to expand the breadth of our product offering, further leveraging birth tissue that would otherwise become medical waste, and have a product pipeline that includes innovations for wound and surgical end markets as well as a potential treatment option for other conditions such as knee osteoarthritis (KOA).

Our Core Values define how we lead the field with rigorous science, help clinicians elevate the standard of care, provide a safe and healthy environment for our employees, and work and grow as a company.

In an effort to deliver long-term value to all of our stakeholders, we incorporate environmental, social, and governance (ESG) objectives that are relevant to our business.

These ESG objectives are informed by a combination of feedback from our stakeholders as well as leading ESG frameworks, such as the Sustainability Accounting Standards Board (SASB) Medical Equipment & Supplies standards, under the oversight of our Board of Directors.

Environmental Matters

Our tissue preservation activities generate a small amount of chemical and biomedical waste, consisting primarily of diluted alcohols and acids and human biological waste, including human tissue and body fluids removed during laboratory procedures.

The biomedical waste generated by our tissue processing operations are placed in appropriately constructed and labeled containers and are segregated from other waste.

We contract with third parties for transport, treatment, and disposal of our biomedical waste.

Stewardship is a Core Value at MIMEDX.

We are stewards of a precious, life-protecting and life-giving resource – human birth tissue – which currently represent the biological source material for all of our products.

Without our placental donation and recovery program, this material would most likely be discarded as medical waste at the hospital.

We do not produce a significant amount of emissions from our operations.

Environmental Management

We recently worked with a third-party to conduct an environmental, health, and safety gap assessment in order to accurately benchmark our environmental impact.

The review looked at several areas including:

• Air Pollution Control Management

• Battery Handling and Disposal

• Community Right-to-Know (Hazardous Material Reporting)

• Hazardous Waste Management

• SARA Title III (Release Reporting)

• Solid Waste Management

• Spill, Prevention, Control and Countermeasure

• State Pollutant Discharge Elimination System (SPDES)

• Storm Water Management

• Universal Waste Management

• Waste Oil Management

We are evaluating the results of this exercise in order to consider implementation of measures in support of our Environmental Management program.

Waste Management

We work with waste removal providers to responsibly dispose of medical waste and biohazardous waste and have a program in place for the management of all medical and biohazardous waste processed in our facilities.

In addition, we follow applicable packaging requirements for regulated medical waste, and conduct regular required training for all employees responsible for packaging medical waste for shipment.

Our waste management initiatives also include the shredding and recycling of paper waste from our facilities, our transition to digital systems where possible to reduce print waste, and the distribution of electronic tablets to our sales teams to minimize printing needs, shipping costs, and printed materials.

Our facilities management team collects recyclable and reusable material when possible, including for cardboard, plastics, batteries, fluorescent lamps, and ballasts.

We have significantly reduced the use of plastic and aluminum materials with the installation of filtered water and soda machines within our facilities.

The packaging of our product cartons is recyclable and, since 2015, has been reduced in size by 50%.

Human Capital

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Generally, we consider our relationships with our employees to be good, and none of our employees are covered by a collective bargaining agreement.

We conduct an annual survey of employees to monitor engagement levels and act on feedback received through this process.

We strive to promote diversity, inclusion and equal opportunity across the organization.

In 2020, we formed an Inclusion and Diversity Council with the goal of supporting strategic initiatives and practices to foster an inclusive, diverse and equitable organization in order to better serve our customers and their patients.

Women and minorities hold a third of the seats on our Board of Directors, including the Chair of the Board.

As of December 31, 2021, 55% of our employees are women, and women comprised 56% and 57% of our new hires in 2021 and 2020, respectively.

Additionally, as of December 31, 2021, approximately 22% of our workforce self-identifies as Black or African American, 7% as Hispanic or Latino, and 4% as other non-White (including American Indian, Alaskan Native, Asian, Native Hawaiian, or Other Pacific Islander).

We track turnover and retention for all employees.

We also track time-to-hire and time-to-train for certain departments.

In the last year, turnover has been elevated relative to historical trends.

We have adopted specific measures and incentives to improve retention within the most affected organizational areas.

The health of our workforce is important to us, particularly that of our processing employees and other employees who, based on their specific job tasks and requirements, have not been able to work remotely during the ongoing COVID-19 pandemic.

We employ approximately 77 highly-trained employees in our processing area.

While we process donated tissue using aseptic techniques in a controlled environment, the manufacturing space is a confined space in which an employee with COVID-19 may spread the virus to other employees despite the use of personal protective equipment in all required areas at MiMedx.

To date, we have been successful in mitigating these risks through a variety of measures, including screening employees for COVID-19 prior to entering our facilities at earlier stages of the pandemic, implementing a number of safety protocols, partnering with a testing facility to provide test kits and rapid results for employees that have symptoms or have a known risk of exposure, and supplying employees with appropriate personal protective equipment.

However, there can be no assurance that we will continue to be successful.

See Item 1A., Risk Factors, “ The COVID-19 pandemic and governmental and societal responses thereto have adversely affected our business, results of operations and financial condition, and the continuation of the pandemic or the outbreak of other health epidemics could harm our business, results of operations, and financial condition.”

We conduct regular surveys of employees to monitor engagement levels and act on feedback received through this process.

Our Diversity and Inclusion

MIMEDX values the diversity of perspective, experience, and background within our Company.

We have stated goals to promote diversity, inclusion, and equal opportunity regardless of race, gender, nationality, ethnic origin, religion, age, or sexual orientation.

Intimidation or harassment of any kind are not acceptable in our workplace.

Our business requires a workforce with a wide range backgrounds, experiences, skills, and knowledge and a culture that blends this diversity into an effective team.

In order for our employees to do their best work, and for us to achieve our mission, everyone at MIMEDX must feel respected, valued, and included.

Comprised of employees across the company, our Inclusion and Diversity Council implements programs to create greater visibility to work environment challenges, champion diversity, and provide an intentional link for each employee to the company values and goals.

The table below provides an overview of MIMEDX’s diversity as of December 31, 2022:

Board of Directors Women and minorities hold one-third of the seats on our Board, including the Chair of the Board.

Employee Gender Diversity Women represented 57% of our workforce as of December 31, 2022.

Women represented 61% of our new hires in 2022.

Employee Ethnic/Racial Diversity Black or African American:

Hispanic or Latino:

Other Non-White (including American Indian, Alaskan Native, Asian, Native Hawaiian, or Other Pacific Islander):

Recruiting, Retaining, and Engaging Talent

Talent is our greatest asset and we are dependent on being able to recruit, develop, and retain talent that share our Core Values.

We use tools, such as an interview guide and a process reviewed by our Inclusion and Diversity Council, designed to prevent us from bias in our hiring decisions.

We are currently in compliance with affirmative action reporting.

As part of our Affirmative Action Plan, we leverage targeted outreach in our hiring process to ensure our postings reach underrepresented groups.

We are focused on retaining our talented professionals who we believe are key to the Company’s success.

Our human resource group continuously monitors and benchmarks employee turnover and other trends in our industry and on a regional level to ensure MIMEDX is competitive and responsive to changes in the broader marketplace.

Combining this data with feedback from exit interviews in any instances of voluntary employee turnover, we are able to use these actionable insights to improve

employee engagement, provide opportunities for career development, evolve our total rewards offering and evaluate implementation of additional resources to enhance the employee experience at MIMEDX.

Training and Development

We provide financial assistance to employees earning certifications through our Tuition Reimbursement Plan.

Internally, we provide personal development and goal setting courses and counsel to help our employees understand how to grow their careers and learn new things.

Compensation and Benefits

We offer all full-time employees a comprehensive benefits package, including:

• Health coverage, including Medical, Dental, Vision insurance, a wellness incentive program and virtual and text-based healthcare

• Paid Parental and Caregiver leave

• Employee Assistance Program

• Paid company holidays, recently adding Juneteenth

• Tuition Reimbursement Program

• 401(k) plan, including Employer match

• Employee Stock Purchase Plan

Available Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business