−Removed: MiMedx is an industry leader in advanced wound care and an emerging therapeutic biologics company, developing and distributing placental tissue allografts with patent-protected processes for multiple sectors of healthcare.
−Removed: We derive our products from human placental tissues processed using our proprietary processing methodologies, including the PURION® process.
−Removed: We employ aseptic processing techniques in addition to terminal sterilization to produce our allografts.
−Removed: MiMedx provides products in the wound care, burn, surgical, orthopedic, spine, sports medicine, ophthalmic, and dental sectors of healthcare.
−Removed: Our mission is to offer products and tissues to help the body heal itself.
+Added: MiMedx is an industry leader in utilizing birth tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.
+Added: As a pioneer in placental biologics, we have both a core business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions.
+Added: We derive our products from human placental tissues and process these tissues using our proprietary processing methods, including the PURION® process.
+Added: We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts.
+Added: MiMedx provides products primarily in the wound care, burn, surgical, and non-operative sports medicine sectors of healthcare.
All of our products are regulated by the FDA.
−Removed: MiMedx is the leading supplier of human placental allografts, which are human tissues that are transplanted from one person (a donor) to another person (a recipient).
−Removed: MiMedx has supplied over 1.9 million allografts, through both direct and consignment shipments.
−Removed: Our biomaterial platform technologies include AmnioFix®, EpiFix®, EpiCord®, AmnioCord® and AmnioFill®.
+Added: At MiMedx, our vision is to advance regenerative science and innovative biologics that restore quality of life.
+Added: Our mission is to improve people’s health and lives through innovation that makes healing possible.
+Added: By advancing rigorous science and increasing access to evidence-based regenerative technologies, we elevate the standard of care.
+Added: Our commitment to the highest quality standards maximizes our potential to reduce cost to the healthcare system and restore quality of life.
+Added: Character, Customer Orientation, Innovation, Collaboration and Stewardship are our core values.
+Added: 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 therapies to treat another person (the recipient).
+Added: MiMedx has supplied over two million allografts, through both direct and consignment shipments.
+Added: Our platform technologies include AmnioFix®, EpiFix®, EpiCord®, AmnioCord® and AmnioFill®.
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.
−Removed: AmnioFill is a placental connective tissue matrix, derived from the placental disc and other placental tissue.
−Removed: Our EpiFix and EpiCord product lines are promoted for external use, such as in advanced wound care applications, while our AmnioFix, AmnioCord and AmnioFill products are positioned for use in surgical applications, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstructions.
+Added: AmnioFill is a particulate product comprised of placental connective tissue matrix, derived from the placental disc and placental membranes.
+Added: Our EpiFix and EpiCord sheet product lines are promoted for external use, such as in advanced wound care applications, while our AmnioFix, AmnioCord and AmnioFill products are positioned for surgical 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.
1 unchanged sentence
The products we sell are regulated by the FDA.
−Removed: Historically, we marketed our products 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.
+Added: 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:
−Removed: Minimal Manipulation and Homologous Use – Guidance for Industry and Food and Drug Administration Staff ” (the “ Guidance ”), that established an updated framework for the FDA’s regulation of cellular and tissue-based products.
−Removed: Among other things, the guidances 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 that are considered to be drugs and biological products (“ Section 351 HCT/Ps ”) subject to licensure under Section 351 of the Public Health Service Act (“ Section 351 ”) and related regulations.
−Removed: As described below and elsewhere in this Form 10-K, the guidances clarified the FDA’s expectation that certain products such as those that MiMedx has long marketed as Section 361 HCT/Ps will be treated as Section 351 HCT/Ps moving forward.
−Removed: The Guidance also confirmed that amniotic membrane in sheet form generally can be characterized as “minimally manipulated” and therefore regulated solely under Section 361.
+Added: Minimal Manipulation and Homologous Use – Guidance for Industry and Food and Drug Administration Staff ” (the “ Guidance ”).
+Added: The Guidance established an updated framework for the FDA’s regulation of cellular and tissue-based products.
+Added: Among other things, the guidances 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 on Our Products.
−Removed: Under the Guidance, we expect that the FDA will continue to regulate our amniotic membrane sheet products (AmnioFix, EpiFix, EpiBurn and EpiXL) and umbilical cord products (EpiCord and AmnioCord) as Section 361 HCT/Ps so long as the claims we make for them are consistent with the Section 361 framework.
−Removed: We expect, however, that the FDA will regulate certain of our other products, such as our micronized products (AmnioFix Injectable and EpiFix Micronized) under Section 351 as biological products.
−Removed: We also expect other products, like AmnioFill, will be regulated as biological products under the Section 351 regulations.
+Added: Under the Guidance, we expect that the FDA will continue to regulate our amniotic membrane sheet products (AmnioFix, EpiFix, EpiBurn and EpiXL) as Section 361 HCT/Ps so long as the claims we make for them are consistent with the Section 361 framework.
+Added: We expect, however, that the FDA will regulate certain of our other products, such as our micronized products (AmnioFix Injectable and EpiFix Micronized) as Section 351 HCT/Ps.
+Added: We also expect other products, like AmnioFill, to be regulated under Section 351.
Enforcement Discretion .
The Guidance stated that the FDA intends to exercise enforcement discretion under limited conditions with respect to the Investigative New Drug (“ IND ”) application and pre-market approval requirements for certain HCT/Ps through November 2020.
−Removed: This means that, through November 2020, the FDA does not intend to enforce certain provisions as they currently apply to certain entities or activities.
−Removed: The FDA intended this period of enforcement discretion to give sponsors time to evaluate their products, have a dialogue with the agency and, if necessary, begin clinical trials and file the appropriate pre-market applications to transition products that had been marketed as Section 361 HCT/Ps into compliance with Section 351.
+Added: However, in July 2020, the FDA extended its period of enforcement discretion to May 31, 2021.
+Added: In doing so, the FDA stated, “This will give manufacturers additional time to determine if they need to submit an investigational new drug (IND) or marketing application and, if such an application is needed, to prepare the IND or marketing application.
+Added: Such additional time is warranted in light of COVID-19, which has presented unique challenges in recruiting clinical trial participants and carrying out clinical trials.”
+Added: We believe this to mean that, through May 31, 2021, the FDA does not intend to enforce certain provisions as they currently apply to certain entities or activities.
+Added: The FDA has stated that this period of enforcement discretion is intended to give sponsors
+Added: time to evaluate their products, have a dialogue with the agency and, if necessary, begin clinical trials and file the appropriate pre-market applications to transition products that had been marketed as Section 361 HCT/Ps into compliance with Section 351.
The FDA’s approach is risk-based, and the Guidance clarified that high-risk products and uses might be subject to immediate enforcement action.
During the Period of Enforcement Discretion .
−Removed: We have continued to market our micronized products under this policy of enforcement discretion, while at the same time pursuing a Biologics License Application (“ BLA ”) for certain of our micronized products.
+Added: We have continued to market our micronized products (AmnioFix Injectable and EpiFix Micronized) and our particulate product (AmnioFill) under this policy of enforcement discretion, while at the same time pursuing Biologics License Applications (“ BLAs ”) for certain of our micronized products.
We have already filed INDs for three indications for our micronized product, AmnioFix Injectable:
−Removed: plantar fasciitis, osteoarthritis knee pain, and Achilles tendonitis and have been conducting clinical trials.
−Removed: We also intend to file additional INDs for both AmnioFill and for injectable micronized EpiFix in the second half of 2020, but have not yet initiated any clinical trials under an IND in furtherance of any regulatory approvals for these indications.
−Removed: Further, as we previously announced, we will need more time than
−Removed: we originally anticipated to file our BLAs with the FDA, and clinical trial protocol amendments and enhancements, further resources, and additional capabilities and expertise will be required.
−Removed: See “ Clinical Trials ” below for information.
−Removed: We have also begun investing in additional plant and equipment and compliance personnel to allow us to manufacture and market in accordance with Section 351 requirements at scale.
−Removed: Among other things, this required us to make capital expenditures in 2019 which have continued in 2020.
−Removed: See discussion below – “ Risk Factors ” under the heading “ If any of the BLAs are approved, the Company would be subject to additional regulation which will increase costs and results in adverse sanctions for non-compliance.”
+Added: plantar fasciitis, knee osteoarthritis, and Achilles tendonitis, and have been conducting clinical trials.
+Added: We also intend to file the appropriate investigative application for both AmnioFill and for EpiFix Micronized, as well as an additional IND for AmnioFix Injectable in the first half of 2021;
+Added: we are currently in the clinical trial design and planning stage, but have not yet initiated any clinical trials in furtherance of any additional regulatory approvals for these products.
Efforts to Seek Extension of Enforcement Discretion Period.
−Removed: MiMedx has provided a recommendation to the FDA that the FDA extend its enforcement discretion period beyond November 2020 to allow for the continued marketing of the impacted products in accordance with an agreed upon transition plan.
−Removed: However, there is no guarantee that the FDA will grant an extension, and even if issued, such an extension may be limited to the products and indications that are subject to clinical trials.
−Removed: See discussion below - “ Risk Factors ” under the heading “ To the extent 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, this could result in removal of the applicable products from the market, would make the introduction of new tissue products more expensive, and would significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.”
+Added: MiMedx is actively engaging with the FDA to extend its enforcement discretion period beyond May 2021 to allow for the continued marketing of the potentially affected products in accordance with an agreed upon transition plan.
+Added: However, there is no guarantee that the FDA will grant an extension, and even if issued, such an extension may be limited to the products, doses, and indications that are subject to clinical trials.
+Added: See discussion below - “ Risk Factors ” under the heading “ To the extent 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, this could result in removal of the applicable products from the market, would make the introduction of some new tissue products more expensive, and could significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.”
Post-Enforcement Discretion.
−Removed: Following the period of enforcement discretion, we may need to cease selling our micronized products and other products regulated under Section 351 until the FDA approves a BLA, and then we will only be able to market such products for indications that have been approved in a BLA.
+Added: Following the period of enforcement discretion, we may need to cease selling our micronized products and other products regulated under Section 351 until the FDA grants pre-market approval, and then we will only be able to market such products for indications that have been cleared or approved by the FDA.
The loss of our ability to market and sell our micronized products would have a material adverse impact on our revenues, earnings and financial position.
−Removed: In addition, we expect the cost to manufacture our products will increase due to the costs to comply with the requirements that apply to Section 351 biological products such as cGMPs and ongoing product testing costs.
−Removed: See discussion below – “ Risk Factors ” under the heading “ To the extent 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, this could result in removal of the applicable products from the market, would make the introduction of new tissue products more expensive, and would significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.”
−Removed: The majority of our revenues are generated by wound care applications.
−Removed: We intend to sharpen our focus in advanced wound care, continue developing and expanding our product pipeline, and work toward continued operational excellence to support future growth and sustained productivity.
−Removed: This includes focusing on effective and efficient execution in our core advanced wound care business and maximizing clinical adoption.
−Removed: In the second half of 2020, we plan to continue executing our commercial strategy, bring our manufacturing and quality systems toward compliance with the requirements that apply to Section 351 biological products, and continue pursuing a dialogue with the FDA in advance of the end of the period of enforcement discretion.
−Removed: The Company is advancing its therapeutic biologics pipeline targeting specific FDA-approved clinical indications for the treatment of musculoskeletal degeneration and other areas of unmet clinical need.
+Added: In 2020, revenues from all micronized products and AmnioFill were $32.8 million, or approximately 13% of our total revenue.
+Added: Similarly, if the FDA determines that our umbilical cord products, EpiCord, EpiCord Expandable, and AmnioCord, do not meet the requirements for regulation solely under Section 361, then the products will be regulated under Section 351 and pre-market clearance or approval will be required.
+Added: In 2020, revenues from umbilical cord-derived products was $16.6 million.
+Added: See discussion below – “ Risk Factors ” under the heading “ To the extent 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, this could result in removal of the applicable products from the market, would make the introduction of some new tissue products more expensive, and could significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.”
+Added: Most of our revenues are generated by wound care applications.
+Added: We have focused our priorities on initiatives across our Commercial, Operations and Research & Development organizations that position us to exceed 10% year-over-year adjusted net sales growth in our core business, and enhance the probability of success for our late-stage pipeline.
+Added: In the first half of 2021, we plan to continue executing our commercial strategy, complete the conversion of our manufacturing and quality systems toward compliance with the CGMP requirements that apply to Section 351 products, and continue to maintain a dialogue with the FDA in advance of the end of the period of enforcement discretion.
+Added: We are advancing our therapeutic biologics pipeline to achieve FDA approvals for specific clinical indications, including areas of musculoskeletal degeneration and other areas of unmet clinical need.
See the discussion below – “Clinical Trials” for more information.
−Removed: Our current business began on February 8, 2008 when Alynx, Co., our predecessor company, acquired MiMedx, Inc., a development-stage medical device company, the assets of which included licenses to two development-stage medical device technology platforms, which are regulated under Section 361 and we do not currently market.
+Added: Our current business began on February 8, 2008 when Alynx, Co., our predecessor company, acquired MiMedx, Inc., a development-stage medical device company, the assets of which included licenses to two development-stage medical device technology platforms which we do not currently market.
On March 31, 2008, Alynx, Co.
merged into MiMedx Group, Inc., a Florida corporation and wholly-owned subsidiary that had been formed for purposes of the merger, with MiMedx Group, Inc.
−Removed: (the “Company”) as the surviving corporation in the merger.
−Removed: In January 2011, the Company acquired all of the outstanding equity interests of Surgical Biologics, LLC (n/k/a MiMedx Tissue Services, LLC).
+Added: as the surviving corporation in the merger.
+Added: In January 2011, we acquired all of the outstanding equity interests of Surgical Biologics, LLC (n/k/a MiMedx Tissue Services, LLC).
Recent Developments
−Removed: Delisting of Common Stock and Related Matters
−Removed: Due to our failure to remain current in our reporting obligations under SEC requirements, The Nasdaq Stock Market LLC (“ Nasdaq ”) suspended our common stock (“ Common Stock ”) from trading on The Nasdaq Capital Market on November 8, 2018, and subsequently delisted our Common Stock effective March 8, 2019.
−Removed: We are in the process of applying to relist our Common Stock after we become current with respect to our SEC reporting obligations, but we cannot guarantee when, or if, we will be able to relist our Common Stock.
−Removed: Leadership Changes to Our Management and Board of Directors
+Added: SEC Matters and Corporate Matters
+Added: On March 17, 2020, we filed our annual report for the year ended December 31, 2018 which included restated financial statements.
+Added: On July 6, 2020, we filed our annual report for the year ended December 31, 2019, three quarterly reports for 2019, and our quarterly report for the period ended March 31, 2020.
+Added: By doing so, we became current in our periodic reporting obligations with the SEC.
+Added: We also held our 2019 annual meeting of shareholders on August 31, 2020 and our 2020 annual meeting of shareholders on November 20, 2020.
+Added: Relisting of Common Stock and Related Matters
+Added: On November 4, 2020, The Nasdaq Stock Market LLC (“ Nasdaq ”) relisted our common stock (“ Common Stock ”).
+Added: Previously, Nasdaq had suspended our Common Stock from trading on November 8, 2018 and subsequently delisted our Common Stock effective March 8, 2019 due to our failure to remain current in our SEC reporting obligations.
+Added: Additions to our Management and Board of Directors
Since June 2018, most of our executive leadership team has changed.
1 unchanged sentence
Wright as Chief Executive Officer, effective as of May 13, 2019.
−Removed: In December 2019, William “Butch” Hulse joined the Company as General Counsel and Secretary.
+Added: • On December 2, 2019, William “Butch” Hulse IV joined the Company as General Counsel and Secretary.
• Effective March 18, 2020, the Board appointed Peter M.
−Removed: Carlson as Chief Financial Officer, and on May 1, 2020 the Company appointed William L.
+Added: Carlson as Chief Financial Officer.
+Added: • On May 1, 2020 the Board appointed William L.
Phelan as Chief Accounting Officer.
−Removed: Evans, the Company’s lead director, was appointed Chairman of the Board on July 2, 2018.
−Removed: In June 2019, Dr.
−Removed: Kathleen Behrens succeeded him as Chair of the Board.
−Removed: The Board is in the process of executing a plan to refresh the composition of the Board while providing important business oversight and leadership continuity.
−Removed: The Board is currently comprised of nine directors elected by holders of Company Common Stock, five of whom have joined the Board since June 2019.
−Removed: In addition, the Board agreed to nominate a mutually-agreed candidate with Prescience Partners, LP, a Delaware limited partnership (“ Prescience Partners ”), for election as a Class III director at the upcoming 2019 annual meeting of shareholders (the “ 2019 Annual Meeting ”) to succeed one of our incumbent directors.
−Removed: Pursuant to the Preferred Stock Transaction described below, the Company increased the size of the Board of Directors, and Martin P.
+Added: • On July 28, 2020, the Board appointed Rohit Kashyap, Ph.D.
+Added: Executive Vice President and Chief Commercial Officer.
+Added: • On August 10, 2020, the Board appointed Robert B.
+Added: Stein, M.D., Ph.D.
+Added: Executive Vice President, Research and Development.
+Added: In addition, we welcomed four new directors to our Board of Directors in 2020.
+Added: Pursuant to the Preferred Stock Transaction described below, we increased the size of our Board of Directors, and Martin P.
Sutter and William A.
Hawkins III were appointed to serve as Preferred Directors effective July 2, 2020.
−Removed: As a result, following the 2019 Annual Meeting, eight of our eleven directors will be new to the Board since June 2019.
+Added: At the 2020 Annual Meeting held on November 20, 2020, shareholders elected Dr.
+Added: Michael Giuliani and Dr.
+Added: Cato Laurencin to the Board.
+Added: Phyllis Gardner will join the Board effective immediately following the filing of this report.
+Added: As a result, all of our current directors have joined the Board as new members since May 2019.
Financing Transactions
−Removed: In June 2019, the Company secured $75 million of debt financing from Blue Torch Finance LLC (“ Blue Torch ”).
−Removed: Effective April 22, 2020, the Company amended its loan agreement with Blue Torch (the “ BT Loan Agreement ”) to (1) relax the Total Leverage Ratio (as defined in the BT Loan Agreement) covenant, which is a quarterly test, from a maximum Total Leverage Ratio of 3.00 to 1.00 to 5.00 to 1.00 for the quarterly periods ending on June 30, 2020, September 30, 2020, and December 31, 2020;
−Removed: and (2) to reduce the minimum Liquidity (as defined in the BT Loan Agreement) covenant, which is a monthly requirement, from $40 million to $20 million for April and May 2020 and from $30 million to $20 million for June through November 2020.
−Removed: On July 2 , 2020, the Company issued $100 million of the Company’s Series B Convertible Preferred Stock, par value $0.001 per share (the “ Series B Preferred Stock ”), to an affiliate of EW Healthcare Partners and to certain funds managed by Hayfin Capital Management LLP pursuant to the Securities Purchase Agreement, dated as of June 30, 2020 (the “ Securities Purchase Agreement ”), for an aggregate purchase price of $100,000,000 (the “ Preferred Stock Transaction ”).
−Removed: On July 2 , 2020, the Company also borrowed an aggregate of $50 million pursuant to the loan agreement, dated as of June 30, 2020 (the “ Hayfin Loan Agreement ”), by and among the Company, certain of the Company’s subsidiaries, Hayfin Services LLP and other funds managed by Hayfin Capital Management LLP and has obtained an additional committed but undrawn $25 million facility pursuant to the Hayfin Loan Agreement (collectively, the “ Hayfin Loan Transaction ”).
−Removed: A portion of the proceeds from these transactions was used to repay the outstanding balance of principal and accrued but unpaid interest, and repayment premium, under the BT Loan Agreement.
−Removed: For further information regarding the Preferred Stock Transaction, the Hayfin Loan Transaction and the repayment and termination of the BT Loan Agreement, see Item 9B, “ Other Information.
−Removed: Government Investigations Update
−Removed: On November 26, 2019, the Company announced that it finalized a settlement with the SEC resolving a previously disclosed investigation into the Company's financial accounting practices.
−Removed: The Company agreed to settle with the SEC, without admitting or denying the SEC's allegations, by consenting to the entry of a final judgment that permanently restrains and enjoins the Company from violating certain provisions of the federal securities laws.
−Removed: As part of the settlement, the Company paid a $1.5 million civil penalty.
−Removed: The SEC recognized the Company's cooperation during the investigation, as well as its remedial efforts.
−Removed: On April 6, 2020, the Company announced that it had finalized a settlement with the Department of Justice (the “DOJ”), resolving an investigation concerning the accuracy of commercial pricing disclosures to the United States Department of Veterans Affairs (the “VA”) for one of the Company’s products in connection with the Company’s Federal Supply Schedule contract, and a related qui tam action filed in Minnesota.
−Removed: The Company self-disclosed the matter to the VA Office of Inspector General (VA-OIG) in November 2018, prior to its knowledge of the qui tam suit or any underlying government investigation and, as the DOJ acknowledged in the settlement agreement, the Company cooperated with the government’s investigation into the matter.
−Removed: Without admitting the allegations, the Company agreed to pay $6.5 million to the DOJ to resolve the matter.
−Removed: The Company previously disclosed that it had accrued an amount to cover the settlement and anticipated related expenses in its annual report on Form 10-K for the year ended December 31, 2018.
−Removed: Current Business Priorities
−Removed: Advanced wound care includes products or procedures used in the treatment of acute and chronic wounds.
−Removed: The se products or procedures are used when standard wound care has failed, or after 4 weeks of non-healing.
−Removed: The advanced wound care category is expected to continue growing due to certain demographic trends, including an aging population, increasing incidence of obesity and diabetes, and the associated higher susceptibility to non-healing chronic wounds.
−Removed: Furthermore, the increasing number of patients requiring advanced treatment represents a significant cost burden on the healthcare system.
−Removed: After evaluating the potential impact of this data on the Company’s wound care franchise, we incorporated a strategy not only to participate in this market growth but also to increase the Company’s market share by demonstrating the positive health economics of our products.
−Removed: Our priorities include sharpening our focus in advanced wound care, developing and expanding our portfolio pipeline and driving continued operational excellence to support future growth and sustained productivity, with the following elements:
−Removed: Focus on effective and efficient execution in our core advanced wound care business, maximizing clinical adoption and health economics value.
−Removed: We have identified and are in the final process of aligning new sales territories to focus our sales force and drive efficiencies, enabling the MiMedx field personnel and sales infrastructure to enhance productivity and better serve our customers and patients.
−Removed: We are advancing additional health economics outcomes data to further support the use of EpiFix and have expanded efforts to best position EpiCord within the treatment paradigm, capitalizing on expanded product coverage throughout our leading technology portfolio.
−Removed: Enhance business development efforts, driving growth throughout the Company’s existing product portfolio pipeline and strategic adjacencies to create a long-term competitive advantage.
−Removed: Our long-range planning identified opportunities for innovative pipeline growth and international regulatory and product coverage expansion within targeted high growth geographies.
−Removed: Additionally, an ongoing assessment of the Company’s development programs has highlighted the need for greater cross-functional collaboration and increased investment.
−Removed: We continue to evaluate these opportunities in alignment with our focus on advanced wound care.
−Removed: We remain focused on advancing our BLA programs and are therefore aligning voice-of-customer input, industry expertise and additional resources toward seeking FDA approval for micronized dehydrated human amnion/chorion membrane (“ dHACM ”) for a potential indication to treat musculoskeletal degeneration across multiple indications.
−Removed: Enable operational and organizational excellence to support future growth and sustained productivity.
−Removed: In December 2018, we announced the launch of a broad-based organizational realignment, cost reduction and efficiency program to better ensure the Company’s cost structure was appropriate given its overall lower revenue expectations.
−Removed: This program included management changes, a realignment of the Company’s sales force, reductions in non-employee expenses and certain changes to our business practices in response to the Investigation.
−Removed: The program created business efficiencies supportive of sustained, achievable and independent growth.
−Removed: Since enactment through December 31, 2019, the Company has realized cost savings of approximately $37 million associated with the realignment program .
−Removed: Additionally, management has continued its efforts to position the business for long-term success.
−Removed: As part of our effort to continue to improve our sales force effectiveness, the Company has prioritized the alignment of various market access functions across the organization under one business functional area.
−Removed: This is aimed toward aligning with providers and patients where our payer coverage, reimbursement and Group Purchasing Organization (“ GPO ”) and Integrated Delivery Network (“ IDN ”) contract opportunities exist.
−Removed: We have re-focused our priorities on refining our near-term approach for our business and our products following the end of the enforcement discretion period, bringing our manufacturing and quality systems toward compliance with the requirements that apply to Section 351 biological products, and advancing our commercial initiatives focused on building market awareness.
+Added: On July 2, 2020, we issued shares of our Series B Convertible Preferred Stock, par value $0.001 per share (the “ Series B Preferred Stock ”), to an affiliate of EW Healthcare Partners and to certain funds managed by Hayfin Capital Management LLP pursuant to the Securities Purchase Agreement, dated as of June 30, 2020 (the “ Securities Purchase Agreement ”), for an aggregate purchase price of $100 million (the “ Preferred Stock Transaction ”).
+Added: On July 2, 2020, we also borrowed an aggregate of $50 million pursuant to the loan agreement, dated as of June 30, 2020 (the “ Hayfin Loan Agreement ”), by and among the MiMedx Group, Inc., certain of our subsidiaries, Hayfin Services LLP and other funds managed by Hayfin Capital Management LLP, and obtained an additional committed but undrawn $25 million facility pursuant to the Hayfin Loan Agreement (collectively, the “ Hayfin Loan Transaction ”).
+Added: A significant portion of the proceeds from these transactions was used to repay the outstanding balance of principal and accrued but unpaid interest, and prepayment premium, under existing indebtedness.
+Added: For further information regarding the Preferred Stock Transaction, see Item 8, Note 10 “ Equity .” For further information regarding the Hayfin Loan Agreement and the repayment of our prior indebtedness, see Item 8, Note 8 “ Long-Term Debt.
+Added: Government Investigations and Litigation
+Added: On April 6, 2020, we announced that we had finalized a settlement with the Department of Justice (the “ DOJ ”), resolving an investigation concerning the accuracy of commercial pricing disclosures to the United States Department of Veterans Affairs (the “ VA ”) for one of our products in connection with our Federal Supply Schedule contract, and a related qui tam action filed in Minnesota.
+Added: We self-disclosed the matter to the VA Office of Inspector General (VA-OIG) in November 2018, prior to our knowledge of the qui tam suit or any underlying government investigation and, as the DOJ acknowledged in the settlement agreement, we cooperated with the government’s investigation into the matter.
+Added: Without admitting the allegations, we agreed to
+Added: pay $6.5 million to the DOJ to resolve the matter.
+Added: Previously, we disclosed that we had accrued an amount to cover the settlement and anticipated related expenses in our annual report on Form 10-K for the year ended December 31, 2018.
+Added: On January 11, 2021, we provided an update regarding the United States Attorney’s Office for the Southern District of New York (“ USAO-SDNY ”) Investigation into, among other things, our recognition of revenue and practices with certain distributors and customers.
+Added: The USAO-SDNY recently advised us, based on the USAO-SDNY’s current understanding of facts, that it does not intend to pursue further action or remedies against us.
+Added: On September 9, 2020, we reached a settlement of three shareholder derivative actions ( Evans v.
+Added: Petit, et al.
+Added: filed September 25, 2018, Georgalas v.
+Added: Petit, et al.
+Added: filed September 27, 2018, and Roloson v.
+Added: Petit, et al.
+Added: filed October 22, 2018) that had been filed in the Northern District of Georgia.
+Added: On December 21, 2020, the Court approved the settlement.
+Added: Pursuant to the Florida Business Corporation Act and indemnification agreements with its former Chairman and CEO, Parker H.
+Added: “Pete” Petit, and former COO, William Taylor, the Company has advanced defense costs to Petit and Taylor in connection with certain legal proceedings arising from their corporate status as former directors and officers of the Company.
+Added: Following the jury verdict against Petit for securities fraud and Taylor for conspiracy to commit securities fraud, on January 12, 2021, the Company filed suit in the Eleventh Judicial Circuit of Florida in and for Miami-Dade County ( MiMedx Group, Inc.
+Added: Petit and Taylor ) seeking (1) a declaratory judgment that a conviction of Petit and Taylor means the Company has no further obligation to indemnify or advance expenses to them, (2) reimbursement of amounts previously advanced to Petit and Taylor, and (3) any other relief deemed just and proper by the court.
+Added: Given the inherent difficulty of predicting the outcome of litigation, the Company cannot estimate recoveries, ranges of recoveries, losses or ranges of losses in these proceedings, nor can it predict whether it may be required to continue to indemnify or advance defense costs to Petit and Taylor.
+Added: For more information see the discussion included in Item 8 -- Note 14, “Commitments and Contingencies.”
+Added: Current Business Priorities and Strategy
+Added: As a pioneer in placental biologics, we have both a core business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline of products to decrease pain and improve function in patients with degenerative musculoskeletal conditions.
+Added: Within the advanced wound care sector, 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 chronic wounds.
+Added: These demographics extend into the musculoskeletal sector as well, and the increasing number of patients requiring advanced treatment represents a significant cost burden on the healthcare system.
+Added: By incorporating a strategy to advance the underlying placental science 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.
+Added: We have focused our priorities on initiatives across our Commercial, Operations and Research & Development organizations that position the Company to exceed 10% growth in our core business, and enhance the probability of success for our late-stage pipeline.
+Added: Within our core business, the Company’s focus is on demonstrating the value of our existing portfolio, increasing the effectiveness and efficiency of our sales force using intensive analytics, and deploying clinical support and economic data to educate healthcare professionals on the efficacy of our products.
+Added: In early 2021, we completed a redesign of our sales force, intended to structure personnel and territories to capitalize on new opportunities, drive efficiencies, and reward long-term territory growth through adjustments in our sales compensation structure.
+Added: Over the course of the year, we plan to increase the number of sales personnel by approximately 10%, and to increase the number of Medical Science Liaisons to further support medical education initiatives.
+Added: Initiatives designed to expand the market include increasing disease state awareness, improving patient understanding of available treatment options, and leveraging recent reimbursement coverage and the Company’s favorable mention in a February 2020 Agency for Healthcare Research and Quality (AHRQ) report.
+Added: The Company is also focused on advancing our late-stage pipeline and accelerating efforts toward seeking FDA approval for AmnioFix Injectable, also designated as micronized dehydrated human amnion/chorion membrane (“ mdHACM ”), to treat musculoskeletal degeneration across multiple indications.
+Added: As a significant area of focus and investment for MiMedx, we are progressing clinical, manufacturing, and quality initiatives, in support of mdHACM as a biologic with broad potential across a range of large and growing clinical indications.
+Added: We are aligning voice-of-customer input, market intelligence, industry expertise and additional resources as inputs to our commercialization strategy for these products.
+Added: In parallel, we are continuing to proactively communicate with the FDA.
+Added: We are preparing to request and schedule End-of-Phase meetings with the FDA to review our progress with ongoing clinical trials, and outline the proposed next steps, including plans to accelerate a Phase 3 clinical trial for knee osteoarthritis.
+Added: The timing for this meeting will be dependent upon FDA feedback and availability.
+Added: Our planned investments in Research and Development throughout 2021 are designed to advance our late-stage pipeline and support our core market growth objectives.
+Added: We intend to publish additional peer-reviewed clinical, scientific and economic data that further reinforce the differentiation of our products and expand the utility of the Company’s placentally-derived products in other clinical applications throughout the care continuum.
+Added: In addition, we are enhancing business and product development efforts, targeting new applications and potential products that fit within our framework of innovative technologies backed by rigorous science, that elevate the standard of care.
Our Product Portfolio
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We maintain strict controls on quality at each step of the manufacturing process beginning at the time of procurement.
−Removed: Our Quality Management System has long been focused on compliance with the American Association of Tissue Banks’ (“ AATB ”) standards and the FDA’s current Good Tissue Practices (“ cGTP ”), and we are strengthening our controls for future BLA products through development of our current Good Manufacturing Practices (“ cGMP ”) program.
−Removed: Our EpiFix allograft is a semi-permeable protective barrier membrane product 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 ”), arterial ulcers, pressure ulcers and burns.
+Added: Our Quality Management System has long been focused on compliance with the American Association of Tissue Banks’ (“ AATB ”) standards and the FDA’s current Good Tissue Practices (“ CGTP ”), and we are strengthening our controls for future BLA products through the implementation of our current Good Manufacturing Practices (“ CGMP ”) program.
+Added: We believe the implementation of CGMP will provide benefits throughout our entire product portfolio, and add to our competitive differentiation.
+Added: Our EpiFix allograft is a semi-permeable protective barrier membrane product 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 ”), pressure ulcers and burns.
EpiFix is available in a variety of sizes that can be used appropriately for wounds of varying sizes.
MiMedx also has a micronized version of this product.
−Removed: 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 amniotic membrane products as being subject to FDA licensure as biological products under Section 351.
−Removed: We intend to file an IND for EpiFix micronized in the second half of 2020 for potential application in DFUs or other areas of advanced wound care, but have not yet initiated any clinical trials under an IND in furtherance of any regulatory approvals.
+Added: 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.
+Added: We intend to file the appropriate investigative application with the FDA for EpiFix Micronized in the first half of 2021 for potential application in DFUs or other areas of advanced wound care, and are currently in the clinical trial design and planning stage, but have not yet initiated any clinical trials in furtherance of any regulatory approvals.
Our AmnioFix allograft is a semi-permeable protective barrier membrane product comprised of dehydrated human amnion/chorion membrane that may be used in the treatment of wounds related to surgical procedures.
−Removed: AmnioFix is configured in a variety of sizes, appropriate for various applications for internal use.
−Removed: Currently, our AmnioFix product line consists of two main configurations, including AmnioFix sheet and AmnioFix Injectable:
+Added: AmnioFix is configured in a variety of sizes for internal use.
+Added: Currently, we offer AmnioFix as sheet products in a range of sizes and in a micronized format as AmnioFix Injectable.
• AmnioFix sheet form is used in a variety of surgical wound repair and internal surgical procedures.
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We are studying the product’s potential to address musculoskeletal degeneration across multiple indications.
−Removed: We have three clinical studies underway to support INDs:
−Removed: plantar fasciitis, Achilles tendonitis and knee osteoarthritis.
+Added: We have three on-going late-stage randomized controlled studies under open INDs, evaluating AmnioFix Injectable in plantar fasciitis, Achilles tendonitis and knee osteoarthritis.
We currently are in Phase 3 for plantar fasciitis and Achilles tendonitis and in Phase 2B for knee osteoarthritis.
3 unchanged sentences
Our cord products are thicker than the EpiFix or AmnioFix allografts and have application in deeper wounds or in areas where suturing the allograft in place may be advantageous.
−Removed: AmnioFill is a connective tissue matrix derived from placental disc, umbilical cord, and amnion/chorion tissues.
−Removed: It is used to replace or supplement damaged integumental tissue.
+Added: In September 2020, we launched EpiCord Expandable as the latest advancement in our product portfolio.
+Added: EpiCord Expandable is the first and only expandable allograft derived from the umbilical cord.
+Added: The allograft can expand to twice its size, conforming to uneven surfaces and deep wounds, and is thick enough to allow for suturing as needed to keep the graft in place.
+Added: This new placental tissue allograft provides healthcare professionals an additional option to support the advanced wound care needs of
+Added: their patients with larger, chronic, and hard-to-heal wounds.
+Added: As the wound progresses toward closure, a healthcare professional can transition to other products in our portfolio, including EpiCord or EpiFix as needed for additional sizes that can be used appropriately to best accommodate the size of the wound.
+Added: AmnioFill consists of particles of connective tissue matrix derived from placental disc and placental membranes, and is used to replace or supplement damaged integumental tissue.
Its primary application is in larger and uneven wound surfaces, or deep/tunneling wounds including pressure ulcers.
−Removed: We intend to file an IND for AmnioFill in the second half of 2020.
−Removed: However, we have not yet initiated any clinical trials under an IND in furtherance of any regulatory approvals for AmnioFill.
−Removed: We sell a selection of allografts for dental applications 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.
−Removed: Other than dental applications, we have a limited number of OEM relationships.
+Added: Similar to our other micronized products, we are transitioning AmnioFill to recognize its regulation under Section 351, per FDA’s 2017 guidance on HCT/Ps, and are working towards pre-market approval.
+Added: We are currently in the clinical trial design and planning stage but have not yet initiated any clinical trials in furtherance of any regulatory approvals for AmnioFill.
+Added: 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.
+Added: Other than dental applications, we have only a small number of OEM relationships.
We continue to research new opportunities for amniotic and other placental tissue, and we have several additional offerings in various stages of conceptualization and development.
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We partner with physicians and hospitals to recover donated placental tissue.
−Removed: Through our donor program, a mother who delivers a healthy baby via a Caesarean section can donate her placenta and umbilical cord tissue in lieu of having it discarded as medical waste.
+Added: Through our donor program, a mother who delivers a healthy baby via a scheduled 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.
1 unchanged sentence
All donor records and test results are reviewed by our Medical Director and staff prior to the release of the tissue for distribution.
−Removed: We have developed a large network of hospitals that participate in our placenta donation program, and we employ a dedicated staff that work with these hospitals.
−Removed: We also utilize third-party providers of placenta donations to mitigate risks.
+Added: 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.”
+Added: 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.
+Added: 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.
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Processing (Manufacturing)
−Removed: Over several years, we have developed and patented a unique and proprietary technique (PURION) for processing allografts from the donated placental tissue.
−Removed: This technique specifically focuses on preserving the tissue’s natural growth factor content and maintaining the structure and collagen matrix of the tissue.
+Added: The Company has developed and patented a unique and proprietary technique (PURION) for processing allografts from the donated placental tissue.
+Added: This technique specifically focuses on preserving the tissue’s natural growth factor content and regulatory proteins, and maintaining the structure and collagen matrix of the tissue.
Our patented and proprietary processing method employs aseptic processing techniques in addition to terminal sterilization for increased patient safety.
−Removed: We believe that our process preserves more of the natural characteristics of the tissue than the processes used by many of our competitors.
−Removed: The PURION process produces an allograft that retains the tissue’s inherent biological properties (cytokines, chemokines, growth factors, etc.) found in the placental tissue and produces an allograft that is easy for healthcare providers to use.
−Removed: The allograft can be stored at ambient temperature and has a five-year shelf life.
−Removed: Each sheet allograft incorporates specialized visual embossments that assist the health care practitioner with proper allograft placement and orientation.
−Removed: To ensure the safety of human tissue products, the FDA enforces current Good Tissue Practice (“c GTP ”) manufacturing regulations.
+Added: Despite starting with similar placental tissues, all placental tissue products and processes 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.
+Added: The PURION process produces an allograft that retains the tissue’s inherent biological properties (cytokines, chemokines, growth factors, etc.
+Added: ) found in the placental tissue and produces an allograft that is safe and easy for healthcare providers to use.
+Added: The allograft can be stored at room temperature and has a five-year shelf life.
+Added: Each sheet allograft incorporates specialized visual embossments that assist the health care practitioner with allograft placement and orientation.
+Added: To ensure the safety of human tissue products, the FDA enforces current Good Tissue Practice (“ CGTP ”) manufacturing regulations.
We believe that MiMedx has developed mature systems to comply with, and is in compliance with, these regulations.
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We are registered with the FDA as a tissue establishment and are subject to the FDA’s CGTP quality program regulations, state regulations and regulations promulgated by various regulatory authorities outside the United States.
−Removed: The Company’s most recent FDA inspection for compliance with GTP regulations, which took place in September 2018, resulted in no observations and a no action indicated (NAI) rating, which is the most favorable designation the FDA provides after an inspection.
−Removed: In recent years, the FDA has clarified through inspection activity, letters to industry, and guidance documents its expectation that certain human tissue products, including product types manufactured by MiMedx, meet additional requirements that apply to traditional biological products, such as BLA approval and cGMP compliance beginning in November 2020.
+Added: The Company’s most recent FDA inspection for compliance with CGTP regulations, which took place in September 2018, resulted in no observations and a no action indicated (NAI) rating, which is the most favorable designation the FDA provides after an inspection.
+Added: In recent years, the FDA has clarified through inspection activity, letters to industry, and guidance documents its expectation that certain human tissue products, including product types manufactured by MiMedx, meet additional requirements that apply to traditional biological products, such as BLA approval and CGMP compliance beginning in May 2021.
The guidance documents apply to products offered by many companies, not just MiMedx, and the guidance has implications for manufacturing processes, among other things.
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After the end of the enforcement discretion period, these products will be subject to CGMP compliance.
−Removed: The Company is developing and enhancing systems to meet these requirements, and intends to complete those efforts by November 2020, although there is no guarantee that the Company will be able to meet the requirements by such date, or at all.
+Added: The Company is developing and enhancing systems to meet these requirements, and intends to complete those efforts by May 2021, although there is no guarantee that the Company will be able to meet the requirements by such date, or at all.
In December 2019, the FDA conducted CGMP inspections at our Marietta, Georgia and Kennesaw, Georgia processing facilities.
2 unchanged sentences
MiMedx timely responded to the FDA regarding each observation, providing substantive responses to all of the observations.
−Removed: The Company’s response included completed and planned actions to address each observation, and as of the date of this filing, all of these remedial actions are now complete.
+Added: The Company’s response included completed and planned actions to address each observation, and as of the date of this filing, all of these remedial actions are now complet e.
+Added: In January 2021, the FDA classified its December 2019 inspection of our Kennesaw, Georgia facility as “VAI,” or voluntary action indicated, which means objectionable conditions or practices were found in their December 2019 inspection but the agency is not taking or recommending any administrative or regulatory actions.
+Added: The FDA has not yet categorized its December 2019 inspection of our Marietta, Georgia facility.
Intellectual Property
8 unchanged sentences
Market Overview
−Removed: Domestic sales currently account for substantially all of our revenue, and we are considering international expansion, primarily targeting Europe and Asia Pacific.
−Removed: In the United States, advanced wound care, including burns and lower extremity surgical applications, are our primary applications.
−Removed: 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 mechanical devices, advanced dressings, xenografts, biological products, and HCT/Ps, which are used to treat severe wounds or chronic wounds that have not appropriately closed after four weeks of treatment with traditional dressings.
−Removed: In the United States in 2018, third-party estimates indicate that there were 8.2 million total reported wounds, with 2.9 million of these wounds classified as chronic wounds.
−Removed: Of these chronic wounds, we estimate that 35% are candidates for advanced skin substitute product treatment regimens, providing for a total addressable opportunity of approximately $3.3 billion.
−Removed: The overall cost of treating chronic wounds is rising sharply, and the current annual estimated cost in the United States exceeds $28 billion.
+Added: Domestic sales currently account for substantially all of our revenue, and we are pursuing international expansion, primarily targeting Japan and select countries in Europe, Asia Pacific, and the Middle East.
+Added: In the United States, advanced wound care applications, including burn treatment and lower extremity surgeries, are our primary areas of clinical use.
+Added: 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.
+Added: In the United States, estimates indicate that in 2020, the prevalence of chronic wounds was 2% of the total U.S.
+Added: population, or approximately 6.7 million people suffering from chronic wounds.
+Added: Of these chronic cases, approximately 57% or 3.8 million are
+Added: categorized as chronic leg ulcers (which include DFUs and VLUs), with 39% treated with advanced wound care dressing such as skin substitutes (GlobalData:
+Added: 2020 Wound Care Management- Tissue Engineered Skin Subs - US - 2015-2030).
MiMedx is a leader in the advanced wound care category and the amniotic tissue allograft sub-category.
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Furthermore, the increasing number of patients requiring advanced treatment represents a significant cost burden on the healthcare system.
−Removed: Traditional dressings such as bandages, gauzes and ointments, along with treatment of active infection and debridement, currently represent the “standard of care” for treating chronic wounds such as DFUs, VLUs, pressure ulcers and arterial ulcers.
−Removed: If after four weeks of use, the wound has not responded appropriately to “standard of care” therapy, clinical research has shown that advanced therapy such as a skin and dermal substitute can be beneficial as part of the patient’s treatment plan.
−Removed: However, often times advanced therapies are not employed - this represents a large target market for the Company and one of the drivers for the growth of the advanced therapy market.
−Removed: According to data provided by BioMedGPS, MiMedx’s EpiFix is the current product of choice for physicians choosing to use a skin and dermal substitute product as a barrier or cover.
−Removed: EpiFix stores at ambient conditions for up to five years compared to certain cultured skin substitutes currently on the market that require cryogenic freezer storage and expire within days to months from the time of processing.
+Added: The overall cost of treating chronic wounds is rising sharply, and the current annual estimated cost in the United States exceeds $28 billion.
+Added: Traditional dressings such as bandages, gauzes and ointments, along with treatment of active infection and debridement, currently represent the “standard of care” for treating chronic wounds such as DFUs and VLUs.
+Added: If, after four weeks of standard of care therapy, the wound has not responded appropriately or improved, clinical research has shown that advanced therapy such as a skin substitute can be beneficial as part of the patient’s treatment plan.
+Added: However, often times advanced therapies are not employed due to current treatment guidelines, product access, or medical education around the clinical and economic benefits of advanced skin substitutes.
+Added: We believe this represents a large opportunity for the Company to expand the market and drive initiatives resulting in market gr owth.
+Added: According to data provided by BioMedGPS, MiMedx’s EpiFix is the current product of choice for physicians choosing to use an amniotic skin substitute product as a barrier or cover.
+Added: EpiFix store s at room temperature for up to five years compared to certain other skin substitutes currently on the market that require cryogenic freezer storage, have limited shelf life, and may not be human-derived.
In addition, we market multiple sizes of EpiFix sheets for use as protective barriers which enables a healthcare provider to select an appropriate size graft based on the size of the wound to reduce product waste.
−Removed: Our AmnioFix tissue allografts have been used in a variety of surgical applications including, but not limited to, plastic surgery, general surgery, gynecology, urology, orthopedics, spinal surgery, lower extremity repair and sports medicine.
−Removed: AmnioFix can be used as a barrier membrane in procedures where a second surgery may be required and scar tissue formation may be problematic.
+Added: The recent launch of our EpiCord Expandable product line also offers an alternative treatment option to address larger, deeper wounds in a cost-effective way earlier in the treatment algorithm.
+Added: Our AmnioFix tissue allografts have been used in a variety of surgical applications including, but not limited to, plastic surgery, general surgery, gynecology, urology, orthopedics, spinal surgery, lower extremity repair and sports medicine procedures.
+Added: AmnioFix can be used as a barrier membrane in procedures where scar tissue formation may be problematic, or where a second surgery may be required.
Biologics License Application (BLA) Programs
−Removed: The FDA clarified its expectations in late 2017 that certain cellular and tissue-based products, including types of products marketed by MiMedx, are considered drugs and biological products subject to Section 351 requirements under the federal Food, Drug and Cosmetic Act (the “ FD&C Act ”).
−Removed: In order to conform to this regulatory guidance, MiMedx is pursuing several indications under the BLA pathway, although there can be no assurance that we will obtain a BLA and may ultimately decide not to pursue a BLA for certain products or indications.
−Removed: 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.” AmnioFix Injectable is our lead BLA product candidate, and we are studying its potential to address a number of degenerative musculoskeletal conditions.
−Removed: In this regard, we have three ongoing IND programs:
−Removed: plantar fasciitis, Achilles tendonitis and knee osteoarthritis.
−Removed: We are currently completing a Phase 3 plantar fasciitis study and are well advanced in the enrollment of subjects in a Phase 2B knee
−Removed: osteoarthritis study.
−Removed: Results of double-blinded, randomized, interim analyses of these studies revealed separation between treatment and control groups, but indicated that the power to observe a result with statistical and clinical significance could be increased by increasing the sample size.
−Removed: We have since amended the protocols and have taken other steps to improve these trials.
−Removed: We also have completed subject enrollment in a Phase 3 IND study for Achilles tendonitis, and we plan to review our options for this program after we have assessed the results of this study.
−Removed: However, an interim analysis of this study indicated that the sample size needed to be significantly increased to provide sufficient statistical and clinical significance.
−Removed: We have decided not to increase the size of the study, but have chosen to continue it to completion with the original sample size as we evaluate the study endpoints for appropriateness, including appropriateness of the measures and the time required to measure differences between the treatment groups ( e.g.
−Removed: , three months, six months, etc .).
−Removed: In addition, we have begun efforts to file an IND for AmnioFill in the second half of 2020, although we have not yet initiated any clinical trials under an IND in furtherance of any regulatory approvals for this product.
−Removed: Similar activities have also been initiated toward the filing of an IND for injectable micronized EpiFix for the treatment of DFUs or other areas of advanced wound care in the second half of 2020.
−Removed: Clinical study initiation will depend on FDA feedback for both of these programs.
−Removed: Given the timelines of these proposed filings and anticipated delays at FDA in processing applications due to the COVID-19 pandemic, it is likely that studies will not begin enrollment in 2020.
−Removed: We are studying AmnioFix Injectable for a variety of uses other than wound care, and the applications described above (plantar fasciitis, osteoarthritis knee pain, and Achilles tendonitis) address unmet needs outside of traditional wound care.
+Added: The FDA clarified its expectations in late 2017 that certain cellular and tissue-based products, including types of 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 ”).
+Added: In order to conform to this regulatory guidance, MiMedx is pursuing several 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 certain products or indications.
+Added: 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.”
+Added: AmnioFix Injectable is our lead BLA product candidate, and we have three ongoing IND programs:
+Added: plantar fasciitis (Phase 3), Achilles tendonitis (Phase 3) and knee osteoarthritis (Phase 2B).
+Added: We have completed enrollment of subjects in each of these programs in their current phase.
+Added: See Clinical Trials, below, for more information.
After oral non-habit forming pain medication fails to adequately relieve a patient’s joint, ligament or tendon pain, market available injections such as corticosteroids are a commonly available treatment option.
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Additionally, in light of the current crisis with opioid abuse, non-surgical treatments and alternative approaches to musculoskeletal pain management are under consideration.
−Removed: Patients and physicians are searching for new products that are safe and effective for the management of chronic musculoskeletal conditions.
−Removed: According to data from the National Health Interview Survey 2007-2008, it was estimated that 14 million people in the U.S.
−Removed: have symptomatic knee osteoarthritis, with more than half under the age of 65.
−Removed: We are studying AmnioFix Injectable as a potential product candidate to address this unmet need, as well as in other degenerative musculoskeletal applications.
−Removed: As of the date of the filing of this Form 10-K, it has not been approved by the FDA for any such use.
+Added: Patients and physicians are searching for new products that are safe and effective for the management of chronic and degenerative musculoskeletal conditions.
+Added: More than 2.2 million people suffer from plantar fasciitis in the U.S., according to data from the National Center for Complimentary and Integrative Health, March 2018.
+Added: Plantar fasciitis can become a chronic issue causing tissue damage and continuous pain, and recurrence is common.
+Added: Approximately one million patients annually seek treatment, and available therapies include conservative options, such as ice and custom orthotics, corticosteroid injections, and potentially surgery.
+Added: Based on primary research and a conjoint analysis conducted, we estimate that approximately 20,000 to 50,000 patients per year may be candidates for AmnioFix Injectable as a non-surgical treatment option to reduce pain and improve function in patients suffering from plantar fasciitis.
+Added: Osteoarthritis (OA) is a disease characterized by progressive articular cartilage destruction, ultimately leading to disabling pain and joint dysfunction.
+Added: The knee is the most commonly affected joint and knee OA represents the leading cause of disability in the adult population.
+Added: 17.5 million people suffer from symptomatic knee osteoarthritis (GlobalData:
+Added: 2020 Orthopedic Devices -
+Added: Knee Reconstruction - US - 2015-2030) , and this number is expected to increase to 19 million people by 2025 (GlobalData:
+Added: 2020 Orthopedic Devices - Knee Reconstruction - US - 2015-2030) .
+Added: According to the Arthritis Foundation, more than half of knee osteoarthritis sufferers are younger than 65 years old.
+Added: Current treatment options include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), injectable corticosteroids, viscosupplements, platelet rich plasma, and other emerging therapies.
+Added: 80% of symptomatic knee OA patients fail conservative therapy (GlobalData:
+Added: 2020 Orthopedic Devices - Viscosupplementation - US - 2015-2030).
+Added: When conservative and non-operative treatment options fail, patients often consider surgical intervention.
+Added: According to estimates by Global Data’s United States Knee Reconstruction Model, approximately one million people required knee reconstruction surgery in 2020, with 2% needing bilateral knee replacement.
+Added: Costs for knee replacement procedures, on average, can exceed $55,000.
+Added: Based on primary research and a conjoint analysis conducted, we believe approximately 1.0 - 1.5 million patients per year may be candidates for AmnioFix Injectable as a non-surgical treatment option to reduce pain and improve function in patients suffering from knee osteoarthritis.
+Added: However, as of the date of the filing of this Form 10-K, AmnioFix Injectable has not been approved by the FDA for any such use.
+Added: 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
−Removed: Our direct sales force focuses on the advanced wound care category through multiple sites of service.
+Added: As of December 31, 2020 our direct sales team was comprised of more than 265 sales professionals, including 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 hospitals.
+Added: We plan to grow our domestic direct sales team by approximately 10% by the end of 2021.
+Added: Our direct sales force focuses on the advanced and chronic wound care category through multiple sites of service.
We also maintain a network of independent sales agents that focus on musculoskeletal applications leveraging the complementary products in their portfolios, access to certain customers, and to provide sales coverage for areas where we do not have a full time sales representative.
1 unchanged sentence
Distributors purchase products from us at wholesale prices and resell products to end users.
−Removed: Sales through distributors comprised a smaller percentage of our total sales in 2019 than in prior years.
See Note 15, “ Revenue Data by Customer Type .” As discussed above, we sell allografts for dental applications on an OEM basis pursuant to an agreement under which we granted a third party an exclusive license to some of our technology for use in certain fields in a specified field of use.
−Removed: We also sell our amnion/chorion and umbilical tissue products through a variety of agents for use in additional musculoskeletal applications on a non-exclusive basis.
Coverage and Reimbursement
9 unchanged sentences
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.
−Removed: A significant portion of our products are purchased by U.S.
+Added: A portion of our products are purchased by U.S.
government accounts ( e.g.
−Removed: , the VA, the Public Health Service (including the Indian Health Service)), which do not depend on reimbursement from third party payers.
−Removed: In order for a company to be eligible to have its products purchased by such federal agencies and paid for by the Medicaid program, federal law requires the Company
−Removed: to participate in the VA Federal Supply Schedule (“ FSS ”) pricing program.
−Removed: To participate, we are required to enter into a Master Agreement with the VA for our products and agree to certain prices.
+Added: , the VA, the Indian Health Service), which do not depend on reimbursement from third party payers.
+Added: In order for a company to be eligible to have its products purchased by such federal agencies and paid for by the Medicaid program, federal law requires the Company to participate in the VA Federal Supply Schedule (“ FSS ”) pricing program.
EpiFix Sheet Products and EpiCord
3 unchanged sentences
Department of Health and Human Services (“ HHS ”).
−Removed: 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.
−Removed: There are seven Part A/B MACs in the U.S., each with its own geographical jurisdiction, and each has its own standards and process for determining coverage and reimbursement for a procedure or product.
+Added: Medicare Administrative Contractors (“ MACs ”) are private insurance companies that serve as agents of CMS in the
+Added: administration of the Medicare program and are responsible for making coverage decisions and paying claims for the designated Medicare jurisdiction.
+Added: 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.
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 by private payers.
−Removed: 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 regulatory coverage and reimbursement determinations.
−Removed: Ultimately, however, each of the MACs determines whether and on what conditions they will provide coverage for the product.
+Added: 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.
+Added: In some cases, CMS does not specify coverage, leaving each of the MACs to determine whether and on what conditions they will provide coverage for the product.
Such decisions are based on each MAC’s assessments of the science and efficacy of the applicable product.
2 unchanged sentences
In January 2019, EpiFix and EpiCord received separate CMS HCPCS Codes, Q4186 and Q4187, distinguishing each product in coverage and reimbursement policies.
−Removed: 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 ASCs setting versus the physician office.
+Added: 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.
−Removed: In the HOPD and ASCs setting, providers receive a single payment that reimburses for the application of the product as well as the product itself.
+Added: In the HOPD and ASC setting, providers receive a single payment that reimburses for 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 2020, 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 is $790.
−Removed: The national HOPD average packaged (“bundled”) rate for our EpiFix and EpiCord allograft products was $1,427 in 2017, was $1,568 in 2018, was $1,549 in 2019, and is $1,623 in 2020.
+Added: The national HOPD average packaged (“bundled”) rate for our EpiFix and EpiCord allograft products was $1,427 in 2017, was $1,568 in 2018, was $1,549 in 2019, was $1,623 in 2020, and is $1,715 in 2021.
All skin substitute products administered in the HOPD and ASCs setting are bundled except for those that have been approved by CMS for pass-through status.
9 unchanged sentences
Medicare payments for all items and services, including EpiFix sheet products and EpiCord, 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.
−Removed: Subsequent legislation extended the 2% reduction, on average, to 2027 (although the sequestration was suspended for the remainder of 2020 due to COVID-19).
+Added: 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.
5 unchanged sentences
In 2020, numerous health plans have added EpiCord coverage for the treatment of DFUs.
+Added: On December 1, 2020, the largest U.S.
+Added: commercial payer, granted coverage for EpiFix as a proven and medically necessary option in the treatment of diabetic foot ulcers.
+Added: The Company believes that EpiFix is the only amniotic membrane product to receive coverage under this payer’s updated commercial medical policy.
+Added: Information contributing to the coverage determination included a third-party technical brief that evaluated a number of skin substitutes for treating chronic wounds, in which EpiFix was noted to have the most
+Added: Randomized Controlled Trials, a low risk of overall study bias, and statistically significant findings.
MiMedx has secured payer coverage for over 300 million covered lives, allowing a significant number of patients access to our products.
−Removed: 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.
+Added: 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 invest in furthering 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.
6 unchanged sentences
EpiFix Micronized is listed on the Medicare national ASP Drug Pricing File and, similar to most Medicare Part B drugs, is reimbursed at ASP plus 6%, effective July 2019.
−Removed: There is currently no specific third-party reimbursement available for AmnioCord or AmnioFill, except to the extent such products are bundled as part of a hospital’s claim under a DRG.
+Added: There is currently no specific third-party reimbursement available for AmnioCord, AmnioFill, or AmnioFix sheet, except to the extent such products are bundled as part of a hospital’s claim under a DRG.
See discussion below – “ Risk Factors ” under the heading “ Our revenues depend on adequate reimbursement from public and private insurers and health systems.
Customer Concentration
−Removed: A significant portion of our products are purchased by U.S.
+Added: A portion of our products are purchased by U.S.
government accounts ( e.g.
1 unchanged sentence
For the years ended December 31, 2020, 2019, and 2018, our net sales to all U.S.
−Removed: government accounts comprised approximately 6%, 15%, and 9%, respectively, of our net sales.
+Added: government accounts comprised approximately 5%, 6%, and 8% of our net sales.
We have contracted with a third party as our indefinite delivery/indefinite quantity channel partner into the VA and DoD markets.
−Removed: See discussion below – “ Risk Factors ” under the heading “ A significant portion of our revenues and accounts receivable come from government accounts.
−Removed: Due to lower barriers of entry in the 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.
+Added: See discussion below – “ Risk Factors ” under the heading “ A portion of our revenues and accounts receivable come from government accounts.
+Added: Due to lower barriers of entry in the 361 HCT/P regulated market, competition in the placenta-based and allograft tissue field is intense and subject to more frequent new entrants and evolving market dynamics.
Companies within the industry compete on the basis of price, ease of handling, logistics and efficacy.
Another important factor is third-party reimbursement, which is difficult to obtain as it is a time-consuming and expensive process.
−Removed: We believe our success in obtaining third-party reimbursement, robust GPO position and established clinical evidence for our products are competitive advantages.
+Added: We believe our success in obtaining third-party reimbursement, our strong position with group purchasing organizations, capabilities and experience with CGMP manufacturing, and established clinical evidence for our products are competitive advantages.
The Agency for Healthcare Research and Quality (“ AHRQ ”) recently published a technology assessment analyzing Skin Substitutes for Treating Chronic Wounds.
6 unchanged sentences
Advanced wound care therapies employ technologies to aid in wound healing in cases where the wound is chronic and healing progress has stalled or stopped.
−Removed: The primary competitive products in the skin and dermal substitutes category include, among others, amniotic membrane allografts, tissue-engineered living skin equivalents, porcine-, bovine- and fish skin-derived xenografts and collagen matrix products.
+Added: The primary competitive products in the skin substitutes category include, among others, placental-tissue membrane allografts, tissue-engineered living skin equivalents, porcine-, bovine- and fish skin-derived xenografts and collagen matrix products.
Xenografts, or tissue transplants from non-human species, serve mainly as an extracellular matrix and have to undergo aggressive processing to remove immunogenic animal products from the tissue.
−Removed: In addition, challenges with
−Removed: xenografts include limited clinical published data, and some products may require suturing or stapling to the wound bed, making handling more difficult.
−Removed: Our main competitors in the skin substitute market are Integra LifeSciences Holdings Corporation, Organogenesis, Inc., and Smith & Nephew plc, which sell a variety of advanced wound care products including allografts.
+Added: In addition, challenges with xenografts include limited clinical published data, and some products may require suturing or stapling
+Added: to the wound bed, making handling more difficult.
+Added: Furthermore, other skin substitutes currently on the market require cryogenic freezer storage and have limited shelf life.
+Added: Our main competitors in the skin substitute market are 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.
The primary competitive products in the surgical, orthopedic or sports medicine categories are other amniotic membrane allografts and injectable solutions, such as platelet-rich plasma, evolving cellular alternatives, or steroids.
26 unchanged sentences
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.
−Removed: 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
−Removed: 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.
+Added: CGTP require us, among other things, to maintain a quality program, train personnel, control and monitor environmental conditions as appropriate, control and validate processes,
+Added: 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.
3 unchanged sentences
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.
−Removed: FDA Letter Regarding AmnioFix Injectable and Other Micronized Products
−Removed: In August 2013, the Company received an untitled letter from the Office of Compliance and Biologics Quality (“ OCBQ ”) within the FDA’s Center for Biologics Evaluation and Research concerning AmnioFix Injectable and other micronized products (the “ Untitled Letter ”).
−Removed: The Untitled Letter asserted that our micronized products, including AmnioFix Injectable, are not properly regulated solely under Section 361 because they are more than “minimally manipulated” as that term is defined in FDA regulations.
−Removed: Accordingly, the Untitled Letter asserted that the products at issue are drugs and biological products that require valid biologics licenses to be in effect in order to be lawfully marketed.
−Removed: The Company disagreed at the time, taking the position that micronization was allowed for Section 361 HCT/Ps under the then applicable guidance.
−Removed: Because the Untitled Letter seemed to be contrary to existing guidance, the Company attempted to engage with OCBQ and ultimately pursued two levels of supervisory review.
−Removed: As part of that process, the Company agreed to pursue a biologics license for AmnioFix Injectable, and has since filed IND applications with the FDA covering clinical studies for AmnioFix Injectable that are discussed in greater detail below.
−Removed: In November 2016, following this supervisory review process, the Acting Chief Scientist of the FDA informed the Company that additional agency review of the Untitled Letter was not warranted.
+Added: 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.”
Recent FDA Guidance and Transition Policy for HCT/Ps
1 unchanged sentence
One guidance document in particular, “ Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue – Based Products:
−Removed: Minimal Manipulation and Homologous Use – Guidance for Industry and Food and Drug Administration Staff ,” offered important clarity on some of the issues that the Company raised on appeal to the Untitled Letter.
−Removed: The guidance documents confirmed that sheet forms of amniotic tissue are appropriately regulated as solely Section 361 HCT/Ps when intended for use as a barrier or covering.
−Removed: We are in the process of evaluating our marketing materials for each of our products to align with the FDA’s guidance.
−Removed: Second, the guidance documents confirmed the FDA’s stance that all micronized amniotic membrane products require a biologics license to be lawfully marketed in the United States.
−Removed: However, the guidance documents also stated that the FDA intends to exercise enforcement discretion under limited conditions with respect to the IND application and pre-market approval requirements for certain HCT/Ps through November 2020.
−Removed: This 36-month period of enforcement discretion was intended to give sponsors time to evaluate their products, have a dialogue with the agency and, if necessary, begin clinical trials and file the appropriate pre-market applications.
+Added: Minimal Manipulation and Homologous Use – Guidance for Industry and Food and Drug Administration Staff ,” offered important clarity on some of the issues that the Company had previously raised with the FDA.
+Added: The guidance documents confirmed that sheet forms of amniotic membrane generally are appropriately regulated as solely Section 361 HCT/Ps when intended for use as a barrier or covering.
+Added: We continually ev aluate our marketing materials for each of our products to align with the FDA’s guidance.
+Added: Second, the guidance documents confirmed the FDA’s stance that all micronized amniotic membrane products are more than minimally manipulated, and therefore are not Section 361 HCT/Ps.
+Added: However, the guidance documents also stated that the FDA intends to exercise enforcement discretion under limited conditions with respect to the IND application and pre-market approval requirements for certain HCT/Ps through November 2020, which was later extended through May 2021.
+Added: This period of enforcement discretion was intended to give sponsors time to evaluate their products, have a dialogue with the agency and, if necessary, begin clinical trials and file the appropriate pre-market applications.
The FDA’s approach is risk-based, and the guidance documents clarified that high-risk products and uses could be subject to immediate enforcement action.
2 unchanged sentences
There is no assurance that the FDA will grant these approvals on a timely basis, or at all, or that we will not discontinue our pursuit of a BLA for certain products or indications.
−Removed: We previously announced that we will need more time to file our BLAs with the FDA and that clinical trial protocol amendments and enhancements, further resources and additional capabilities and expertise will be required.
−Removed: See “ Clinical Trials ” below for information regarding the revised timelines.
−Removed: During the remainder of the 36-month enforcement discretion period, the Company will also continue to explore possible options for extending this enforcement discretion period.
−Removed: To this end, the Company has initiated dialogue and efforts for a further transition plan with the FDA to allow for continued marketing of the impacted products while the Company transitions to compliance with Section 351, the applicable sections of the FD&C Act, the cGMP regulations in 21 CFR Part 210 and 211, and other applicable
−Removed: FDA regulations.
+Added: See “ Clinical Trials ” below for more information.
+Added: During the remainder of the enforcement discretion period, the Company will also continue to explore possible options for extending this enforcement discretion period.
+Added: To this end, the Company has initiated dialogue and efforts for a further transition plan with the FDA to allow for continued marketing of the impacted products while the Company transitions to compliance with Section 351, the applicable sections of the FD&C Act, the CGMP regulations in 21 CFR Part 210 and 211, and other applicable FDA regulations.
This would be an extension of the current policy, and there is no guarantee that the FDA will provide more time, either for MiMedx or the industry at large.
5 unchanged sentences
• Development of purity, potency and identity tests to demonstrate consistency and reliability of the manufacturing process through a chemistry, manufacturing and control program;
−Removed: Submission to the FDA of a BLA for marketing the product, which includes, among other things, reports of the outcomes and full data sets of the clinical trials, and proposed labeling and packaging for the product;
+Added: • Submission to the FDA of a BLA for marketing the product that includes, among other things, reports of the outcomes and full data sets of the clinical trials, and proposed labeling and packaging for the product;
• Satisfactory review of the contents of the BLA by the FDA, including the satisfactory resolution of any questions raised during the review;
• Satisfactory completion of an FDA Advisory Committee review, if applicable;
−Removed: Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with FDA’s cGMP regulations, to assure that the facilities, methods and controls are adequate to ensure the product’s identity, strength, quality and purity; and
+Added: • Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with FDA’s CGMP regulations, to assure that the facilities, methods and controls are adequate to ensure the product’s identity, potency, quality and purity; and
• FDA approval of the BLA, including agreement on post-marketing commitments, if applicable.
7 unchanged sentences
The FDA has broad regulatory compliance and enforcement powers.
−Removed: If the FDA determines that MiMedx has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, such as issuing an FDA Form 483 notice of inspectional observations;
+Added: If the FDA determines that the Company has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, such as issuing an FDA Form 483 notice of inspectional observations;
sending a warning letter or untitled letter;
9 unchanged sentences
Trial Overview
−Removed: The Company is currently conducting three IND programs investigating the use of AmnioFix Injectable to reduce pain and increase function in patients with plantar fasciitis, Achilles tendonitis, and osteoarthritis of the knee.
+Added: The Company is currently conducting three IND programs investigating the use of AmnioFix Injectable to reduce pain and increase function in patients with plantar fasciitis, Achilles tendonitis, and knee osteoarthritis.
+Added: As previously disclosed, the trials were developed and initially overseen by senior managers who are no longer with the Company.
Based on a review of the studies and interim results, the Company has instituted several actions with respect to its ongoing and anticipated clinical trials to address the resources, capabilities and expertise needed for commercial launch, including our strategy around an increased dialogue with the FDA regarding our BLA progress.
−Removed: The trials were developed and initially overseen by senior managers who are no longer with the Company and, as previously disclosed, we have concluded that the trials must be improved if they are to support BLA submissions and approvals.
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.
4 unchanged sentences
In September 2017, we announced the trial had met its efficacy endpoints, and the three-month endpoint data were published in 2018.
−Removed: In April 2017, we met with the FDA and informally discussed preliminary data from the Phase 2 study, our progress toward achieving GMP compliance, and our proposed Phase 3 study design.
−Removed: We incorporated the FDA’s formal feedback into our development plans, and will plan further meetings as needed and required to achieve the goal of successful BLA submission.
−Removed: Based on 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 AmnioFix Injectable as compared to a single intra-plantar injection of saline (placebo control) to treat patients with recalcitrant plantar fasciitis pain.
+Added: 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.
+Added: Formal FDA feedback from this meeting was incorporated into our development plans.
+Added: 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 AmnioFix Injectable 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.
2 unchanged sentences
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.
−Removed: We determined that increasing the sample size to 276 patients would provide sufficient power to observe an efficacy result with statistical and clinical significance.
−Removed: We have instituted these changes and amendments and expect to complete enrollment by October 2020.
−Removed: The COVID-19 pandemic has had a major dampening effect on study enrollment.
−Removed: There can be no assurance that this effect will fully resolve and allow completion of the study in the anticipated timeframe, that a second wave of virus infections will not occur, that no further disruptions can be expected, or when completed, that the FDA will view such study as sufficient to support a BLA filing.
−Removed: If the plantar fasciitis trials are successful, determined to be adequate proof of efficacy and safety, we expect to file a BLA for AmnioFix Injectable to treat patients with plantar fasciitis in the second half of 2021.
−Removed: We expect the outcome of this trial to help inform additional areas of unmet need for potential clinical study.
−Removed: However, we now expect that FDA approval to market AmnioFix Injectable for this indication will take longer than previously expected and may take several years, and there can be no assurance that we will receive FDA approval.
−Removed: Approval may be delayed due to a variety of factors, including failure of the studies to achieve their endpoints, the extra effort and cost required to improve our clinical trials as described above, the impact of the COVID-19 pandemic on study enrollment and FDA operations, the potential that we reevaluate our commercialization strategy, and the work required to achieve commercial and manufacturing readiness.
−Removed: See discussion below - “ 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.”
+Added: We determined that increasing the
+Added: sample size to 276 patients would provide sufficient power to observe an efficacy result with statistical and clinical significance.
+Added: We have instituted these changes and amendments and completed enrollment of 277 subjects in September 2020.
+Added: We expect the last patient out in the second quarter of 2021, which will allow us to analyze the data and request a meeting with the FDA to review our clinical evidence.
+Added: If the plantar fasciitis trials are determined to be adequate proof of efficacy and safety, we expect to file a BLA for AmnioFix Injectable to treat patients with plantar fasciitis in the first half of 2022, and are evaluating ways to accelerate this program where possible.
+Added: We expect the outcome of this trial will help inform additional areas of unmet need for potential clinical study and may benefit our BLA submissions for other indications.
+Added: We also anticipate that our efforts in obtaining regulatory approval of AmnioFix Injectable for plantar fasciitis will benefit the regulatory review of AmnioFix Injectable for other indications, based on the fact that it is the same product with the same manufacturing process and other attributes relevant to approval.
+Added: However, there can be no assurance that we will receive FDA approval.
+Added: Approval may be delayed due to a variety of factors, including failure of the studies to achieve their endpoints;
+Added: the ability of the study to demonstrate clinically and statistically significant improvement between treatment and control groups;
+Added: the impact of the COVID-19 pandemic on study enrollment and FDA operations;
+Added: the potential that the results of the clinical studies do not merit further investment;
+Added: and the work required to achieve commercial and manufacturing readiness.
+Added: 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.”
Knee Osteoarthritis
4 unchanged sentences
In March 2018, we initiated a Phase 2B prospective, double-blinded RCT investigating a single intra-articular injection of 40 mg of AmnioFix Injectable as compared to a single injection of saline (placebo control) in the treatment of pain and functional impairment in patients with osteoarthritis of the knee.
−Removed: This trial was planned to enroll 318 patients, with an interim analysis to
−Removed: assess adequacy of this sample size built into the statistical plan.
+Added: 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 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.
−Removed: Amendments to the protocol to allow this increase were subsequently approved and instituted and enrollment is progressing.
−Removed: We also amended the protocol and established an open label extension to the trial, to allow patients to receive a second injection of the active treatment at six months, nine months, or 12 months subsequent to their completion of study visits, if their pain has not resolved or responded, regardless of treatment arm.
+Added: Amendments to the protocol to allow this increase were subsequently approved.
+Added: It should be noted that during the first half of 2020 in particular, the ongoing COVID-19 pandemic slowed study enrollment considerably, though began to resolve in the third quarter of the year.
+Added: Due to actual dropout rates observed in the study being lower than planned, in September 2020, we completed enrollment of 447 patients, and anticipate this number will allow for sufficient power to make the planned analyses.
+Added: We also amended the protocol to establish an open label extension to the trial and allow patients to receive a second injection of the active treatment at six months, nine months, or 12 months subsequent to their completion of study visits, if their pain has not resolved or responded, regardless of treatment arm.
The study will still be blinded to subjects, sites and MiMedx during this extension.
−Removed: However, we now expect that FDA approval to market AmnioFix Injectable for this indication will take longer than previously expected, and it may take several years.
−Removed: There can be no assurance that we will ultimately receive FDA approval.
−Removed: Approval may be delayed due to a variety of factors, including failure of the studies to achieve their endpoints, the extra effort and cost required to improve our clinical trials as described above, the impact of the COVID-19 pandemic on study enrollment and FDA operations, and the work required to achieve commercial and manufacturing readiness.
−Removed: See discussion below - “ 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.”
+Added: We expect that the blinded primary and secondary efficacy observation visits of this trial will be completed in April 2021, and expect the last patient visit will be completed in the second half of 2021.
+Added: Following the completion of this study, and if the data from the study are favorable, we expect to launch a Phase 3 study in the beginning of 2022 and file a BLA for this indication in the second half 2024 or first half of 2025.
+Added: We are exploring opportunities to accelerate the program where possible, including the anticipated start date of the Phase 3 trial and the submission of a BLA.
+Added: There can be no assurance that the COVID-19 effects on study activities and FDA resources will fully resolve and allow completion of all activities in the anticipated timeframe;
+Added: that the ongoing wave of virus infections will not continue to impact the study;
+Added: that no further disruptions can be expected, or when completed, that the FDA will view the Phase 2B and Phase 3 studies as sufficient to support a BLA filing.
+Added: There can be no assurance that we will receive FDA approval, and approval may be delayed due to a variety of factors, including failure of the studies to achieve their endpoints;
+Added: the extra effort and cost required to improve our clinical trials as described above;
+Added: the impact of the COVID-19 pandemic on study enrollment and FDA operations;
+Added: the potential that the results of the clinical studies do not merit further investment;
+Added: and the work required to achieve commercial and manufacturing readiness.
+Added: See discussion in Item 1A - “ Risk Factors ” under the heading “ Obtaining and
+Added: 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
3 unchanged sentences
This 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.
−Removed: With this in mind, we have concluded 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.
+Added: With this in mind, we concluded 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 has completed and we anticipate that the last patient visit will occur in the first half of 2021.
−Removed: In addition, we intend to file an IND for AmnioFill in the second half of 2020, although we have not yet initiated any clinical trials under an IND in furtherance of any regulatory approvals for AmnioFill.
−Removed: We also intend to file an IND for injectable micronized EpiFix for the treatment of DFUs or other areas of advanced wound care in the second half of 2020.
+Added: We plan to review our options for this program after we have assessed the results of this study, and may explore the efficacy potential of AmnioFix Injectable in a more well-defined subset of patients.
+Added: In addition, we plan to initiate efforts to file appropriate investigational applications for AmnioFill and EpiFix Micronized, prior to the end of enforcement discretion in the first half of 2021.
+Added: We have not yet initiated any clinical trials for AmnioFill or EpiFix Micronized related to these applications.
Clinical study initiation will depend on FDA feedback for both of these programs.
−Removed: Given the timelines of these proposed filings and anticipated delays at FDA in processing applications due to the COVID-19 pandemic, it is likely that studies will not begin enrollment in this calendar year.
If any of the study results support potential product approval and potential for commercialization, we intend to file BLAs as described above.
1 unchanged sentence
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.
−Removed: While there can be no assurance that we will ultimately obtain regulatory approval for our micronized products, we have already completed substantial work towards multiple BLAs, including engineering our manufacturing processes to conform to cGMP guidances.
+Added: While there can be no assurance that we will ultimately obtain regulatory approval for our micronized products, we have already completed substantial work towards multiple BLAs, including engineering our manufacturing processes to conform to CGMP requirements.
FDA Post – Market Regulation
−Removed: Tissue processors regulated solely under Section 361 are still required to register as an establishment with the FDA.
−Removed: As a registered establishment, we are required to comply with regulations regarding labeling, record keeping, donor eligibility, screening and testing.
−Removed: We are also required to process the tissue in accordance with established cGTP, as well as report any adverse reactions caused by a possible transmission of an infectious disease attributed to our tissue.
+Added: Tissue processors regulated solely under Section 361 are still required to register as a tissue establishment with the FDA.
+Added: As a registered tissue establishment, we are required to comply with regulations regarding labeling, record keeping, donor eligibility, screening and testing.
+Added: We are also required to process the tissue in accordance with established CGTP, as well as report any deviations from core CGTP requirements or adverse reactions caused by a possible transmission of an infectious disease attributed to our tissue.
Our facilities are also subject to periodic inspections to assess our compliance with the regulations.
−Removed: Products covered by a BLA, New Drug Application, 510(k) clearance or a pre-market approval are subject to numerous additional regulatory requirements, which include, among others, compliance with cGMP (or, in the case of devices, with FDA’s Quality System Regulation), which imposes certain procedural, substantive and record keeping requirements, and labeling regulations to ensure a product’s identity, strength, quality, and purity.
+Added: Products covered by a BLA, New Drug Application, 510(k) clearance or a pre-market approval are subject to numerous additional regulatory requirements, which include, among others, compliance with CGMP (or, in the case of devices, with FDA’s Quality System Regulation), which imposes certain procedural, substantive and record keeping requirements, and labeling regulations to ensure a product’s identity, potency, quality, and purity.
These products are also subject to the FDA’s general prohibition against promoting products for unapproved or “off-label” uses, and additional adverse reaction reporting.
As part of our BLA development effort, we are updating our manufacturing establishments into compliance with CGMP for production for our injectable and other applicable Section 351 products.
−Removed: We are also pursuing opportunities to partner with a contract manufacturing organization.
−Removed: The transition process includes development and enhancement of production processes, procedures, test and assays, and it requires extensive validation work.
−Removed: It can also involve the procurement and installation of new production or lab equipment.
+Added: The transition process includes development and enhancement of production processes, procedures, tests and assays, and it requires extensive validation work.
+Added: It also involves the procurement and installation of new production and lab equipment.
These efforts require human capital, expertise and resources.
−Removed: We have made significant improvements in this transition over the last year.
+Added: We have made significant improvements in this transition over the last two years.
We have engaged industry experts to assess our state of compliance and to provide guidance on the additional activities needed to meet CGMPs.
−Removed: Our goal is to achieve compliance with cGMP for our injectable and other applicable Section 351 products by the time the FDA’s current period of enforcement discretion is complete in November 2020.
−Removed: See discussion below – “ Risk Factors ” under the heading “ To the extent 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, this could result in removal of the applicable products from the market, would make the introduction of new tissue products more expensive and would significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements,” and “ We may be subject to fines, penalties, injunctions and even criminal sanctions if we are deemed to have made a misstatement of compliance to a federal agency.”
+Added: Our goal is to achieve compliance with CGMP for our injectable and other applicable Section 351 products by the time the FDA’s current period of enforcement discretion is complete in May 2021.
+Added: See discussion in Item 1A – “ Risk Factors ” under the heading “ To the extent 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, this could result in removal of the applicable products from the market, would
+Added: make the introduction of some new tissue products more expensive and could significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.”
Other Regulation Specific to Tissue Products
National Organ Transplant Act
−Removed: 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 reasonable payment associated with the removal, transportation, implantation, processing, preservation, quality control and storage of human tissue and skin.
+Added: 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 productions and is involved with the recovery and storage of donated human amniotic tissue.
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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.
+Added: In April 2020, the Company settled a qui tam action brought by two former employees alleging violations of the FCA relating to the
+Added: Company’s commercial pricing practices with respect to the VA, and as part of the settlement, the Company paid the government $6.5 million.
+Added: 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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Such information will subsequently be made publicly available by CMS on the Open Payments website.
+Added: There is a risk that CMS or another government agency may take the position that our products are not human cell and tissue products regulated solely under Section 361, and thereby assert that we are currently subject to the Sunshine Act, which could subject us to civil penalties and the administrative burden of having to comply with the law.
+Added: see Item IA, 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.”
• Federal conflicts of interest laws, the Standards of Ethical Conduct for Employees of the Executive Branch, and local site policies for each federal institution we call upon govern our interactions with federal employees at our various government accounts ( e.g.
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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.
−Removed: We typically experience seasonality, with lower shipments in the first quarter of each year compared to the immediately preceding fourth quarter.
−Removed: This seasonal shipments pattern relates to U.S.
−Removed: annual insurance deductible resets and unfunded flexible spending accounts.
Research and Development
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As of December 31, 2020, we had 735 employees.
−Removed: We consider our relationships with our employees to be satisfactory.
−Removed: None of our employees are covered by a collective bargaining agreement.
+Added: Generally, we consider our relationships with our employees to be good, and none of our employees are covered by a collective bargaining agreement.
+Added: We conduct an annual survey of employees to monitor engagement levels and act on feedback received through this process.
+Added: We strive to promote diversity, inclusion and equal opportunity across the organization.
+Added: In 2020, we formed a Diversity and Inclusion Council with the goal of supporting strategic initiatives and practices to foster an inclusive & diverse organization in order to better serve our customers and their patients.
+Added: With the appointment of Dr.
+Added: Gardner to our Board effective upon the filing of this report, women and minorities hold a third of the seats on our Board of Directors, including the Chair of the Board.
+Added: 54% of our employees are women, and women comprised 57% and 58% of our new hires in 2020 and 2021 respectively.
+Added: Additionally, approximately 20% of our workforce identifies as Black or African American, 8% as Hispanic or Latino, and 4% as other non-White including American Indian, Alaskan Native, Asian, Native Hawaiian, or Other Pacific.
+Added: We track turnover and retention for all employees.
+Added: We also track time-to-hire and time-to-train for certain departments.
+Added: In the last year, turnover has been elevated relative to historical trends.
+Added: We have adopted specific measures and incentives to improve retention within the most affected organizational areas.
+Added: The health of our workforce is important to us, particularly of our processing employees and other employees who, based on their specific job tasks and requirements, are not able to work remotely.
+Added: We employ approximately 59 highly-trained employees in our processing area.
+Added: 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 required for all areas at MiMedx.
+Added: 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, implementing a number of safety protocols, and partnering with a testing facility to provide test kits and rapid results for employees that have symptoms or have a known risk of exposure, although there can be no assurance that we will continue to be effective.
+Added: 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.”
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.