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MiMedx Group, Inc. (MDXG)

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6.47-0.08 (-1.22%)
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Neutralpattern detected
Previous Close6.55
Open6.41
Bid0.00 x 1000
Ask0.00 x 800
Day's Range6.40 - 6.50
52 Week Range2.95 - 7.95
Volume16,885
Avg. Volume159,758
Market Cap718.396M
Beta (5Y Monthly)1.24
PE Ratio (TTM)N/A
EPS (TTM)-0.08
Earnings DateAug 04, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
  • GlobeNewswire

    MiMedx Files Definitive Proxy Materials

    MARIETTA, Ga., Oct. 15, 2020 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (OTC PINK: MDXG) (“MiMedx” or “the Company”), an industry leader in advanced wound care and a therapeutic biologics company, today announced that it has filed a definitive proxy statement with the U.S. Securities and Exchange Commission (“SEC”) in connection with its upcoming 2020 Annual Meeting of Shareholders (“Annual Meeting”). The meeting is scheduled to be held on Friday, November 20, 2020 at 10:00 a.m. Eastern Time at www.virtualshareholdermeeting.com/MDXG2020. Shareholders as of the record date, 5:00 p.m. Eastern Time on Wednesday, October 7, 2020, are entitled to notice of, and to vote at, the Annual Meeting. In light of public health concerns regarding the coronavirus (COVID-19) outbreak, the Annual Meeting will be conducted in a virtual format only to assist in protecting the health and well-being of our shareholders, directors and employees and to provide access to our shareholders regardless of geographic location.The Company is mailing the definitive proxy statement (the “Proxy Statement”) and accompanying proxy card for the 2020 Annual Meeting to its shareholders. A free copy of the Proxy Statement and other relevant documents that the Company files with the SEC may be obtained through the SEC’s website at www.sec.gov or at the Company’s website at https://mimedx.com.About MiMedxMiMedx® is an industry leader in advanced wound care and a therapeutic biologics company developing and distributing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied more than 1.9 million allografts to date. For additional information, please visit www.mimedx.com.Contact:Hilary Dixon Investor Relations & Corporate Communications 770.651.9066 investorrelations@mimedx.com

  • GlobeNewswire

    Novan Strengthens Financial Leadership with Appointments of Chief Financial Officer and Seasoned Industry Executive to Board of Directors

    \- John M. Gay, Vice President, Finance and Corporate Controller with over 20 years of financial and accounting experience appointed as Chief Financial Officer - James L. Bierman, seasoned industry executive with extensive strategic financial expertise and business acumen and former CEO, COO and CFO of Owens & Minor, Inc. appointed to Board of Directors MORRISVILLE, N.C., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced the appointment of John M. Gay to serve as the Company’s Chief Financial Officer and the appointment of James L. Bierman to its Board of Directors.Mr. Gay is an accomplished finance and accounting executive with 20 years of professional experience and a demonstrated track record of strategic financial planning and analysis, accessing capital markets and public company technical and regulatory reporting over the course of his career. Mr. Gay joined Novan in May 2018 and has most recently served as Vice President, Finance and Corporate Controller, in addition to Principal Financial Officer and Corporate Secretary for the Company.“John has established himself as a key member of the team since joining Novan and is now perfectly suited to take on the role of Chief Financial Officer. He has proven himself to be a financial leader and is responsible for executing the Company’s financial strategy, which has provided us with sufficient capital to advance SB206 through the B-SIMPLE4 pivotal Phase 3 study in molluscum, a potentially transformational catalyst for the Company, through to data targeted for Q2 2021,” commented Paula Brown Stafford, Chairman and Chief Executive Officer of Novan. Mr. Bierman is a seasoned executive and brings extensive strategic financial expertise, including financial and operational strategies, mergers and acquisitions, strategic alliances, enterprise risk management and investor relations to Novan’s Board of Directors.“We are thrilled to welcome Mr. Bierman to our Board of Directors. He is a proven industry leader with key executive experience amassed over the course of his career including having served as the CEO, COO and CFO of Owens & Minor, Inc., a FORTUNE 500 company. His strategic expertise will be an integral asset and bring a new perspective to our Board. With these two key appointments, I believe our financial leadership has never been stronger and believe we continue to make tremendous progress towards Novan’s next phase of growth,” continued Ms. Stafford.Mr. Bierman is an experienced independent director who has mentored and assisted in the professional development of both financial executives and senior members of management over the course of his career. In addition to his executive leadership experience, including serving as President and Chief Executive Officer of Owens & Minor, Inc. (NYSE: OMI), as well as Executive Vice President and Chief Financial Officer of Quintiles Transnational Corporation (formerly Nasdaq: QTRN), he has also served on multiple public company boards, including currently serving as a member of the Board of Directors of Tenet Healthcare Corporation (NYSE: THC), a FORTUNE 500 company, and MiMedx Group, Inc. (Nasdaq OTC: MDXG). About NovanNovan, Inc. is a clinical development-stage biotechnology company focused on leveraging its proprietary nitric oxide (NO) based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications in dermatology, men’s and women’s health, infectious diseases and gastroenterology conditions with significant unmet needs. The Company’s lead product candidate, SB206, a topical antiviral gel, for the treatment of molluscum contagiosum, is currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would address an important patient-care need for the treatment of molluscum.Forward-Looking StatementsThis press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates and the timing of reporting findings or results from our programs currently in process. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; our ability to retain key personnel; our ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of our product candidates; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the enrollment in and conduct of the B-SIMPLE4 Phase 3 trial; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. INVESTOR AND MEDIA CONTACT:Jenene Thomas JTC Team, LLC 833-475-8247 NOVN@jtcir.com

  • GlobeNewswire

    MiMedx Concludes Enrollment for Phase 2B Study of Osteoarthritis (OA) of the Knee

    Research Advances Understanding of Amniotic Tissue as Potential Unique Treatment for Painful Chronic Condition that Affects 242 Million People GloballyMARIETTA, Ga., Sept. 21, 2020 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (OTC PINK: MDXG) (“MiMedx” or “the Company”), an industry leader in advanced wound care and a therapeutic biologics company, announced the conclusion of enrollment into its Phase 2B study of its micronized injectable amniotic tissue product in patients with osteoarthritis (OA) of the knee (KOA). “Osteoarthritis is by far the most common joint disease – millions of adults experience pain and decreased quality of life every day because of joint destruction caused by osteoarthritis,” said Alfred Gellhorn, MD, Associate Professor of Clinical Rehabilitation and Director of Sports Medicine, Weill Cornell Medical Center. “Although knee replacement is an option for those with advanced knee arthritis, this should be reserved for end-stage disease; it is extremely expensive and carries significant potential risks. We are in desperate need of better conservative options to treat those with mild-to-moderate knee arthritis. Current treatments, including oral anti-inflammatory medications, cortisone injections, and hyaluronic acid injections, are very limited in the amount of relief they provide. Furthermore, anti-inflammatories have negative cardiovascular effects and injected steroids cause further joint degeneration. In my practice, patients are frustrated with these limited options and very interested in novel approaches that provide safe and long-lasting pain reduction. I believe this Phase 2B clinical trial is critically important to inform the potential for MiMedx’s amniotic membrane-based technology to fill this treatment void.”The OA Clinical Trial is the first randomized clinical study of a micronized dehydrated Human Amnion/Chorion Membrane (mdHACM) Injection in the Treatment of KOA. A previously published retrospective study by Dr. Gellhorn provided initial evidence of pain reduction and functional improvement in a cohort of 40 patients with chronic tendinopathy and arthropathy. The subsequent publication of an observational study by Kris Alden, M.D., Ph.D., Orthopaedic Surgeon, Hinsdale Orthopaedics, of 100 knee injections in 82 KOA patients provided further evidence that mdHACM injections reduced pain and improved function. In both studies, pain and functional improvements continued to improve over the entire observation period, and no significant adverse events were noted.MiMedx Executive Vice President, Research and Development, Robert Stein, M.D., Ph.D., commented, “We have enrolled the planned number of patients needed to assess the statistical significance of response to treatment in this Phase 2B trial, ahead of our enrollment schedule, despite the access restrictions from the COVID-19 pandemic. We are grateful to our dedicated investigators and their staff for making this possible. If our data analyses support product safety and effectiveness, we will approach the FDA and leverage our Regenerative Medicine Advanced Therapy (RMAT) designation to discuss our pivotal study plans and advance the program toward a Biologics License Application (BLA) filing.”“Osteoarthritis is responsible for a staggering public health and economic impact: more than 242 million people worldwide currently suffer from symptomatic OA of the knee and hip; 45% of all people have a lifetime risk of developing OA of the knee; and OA is responsible for $71 billion in lost earnings annually in the U.S.,” said Timothy R. Wright, Chief Executive Officer, MiMedx. “Addressing this significant, unmet patient need is urgent – and MiMedx is committed to applying our unique amniotic tissue platform to better understand and address both the symptomatic pain and underlying loss of function caused by OA of the knee. We look forward to sharing these data.”About MiMedx OA Trial This trial is a Phase 2B, prospective, double-blinded, randomized controlled trial of the micronized dehydrated Human Amnion Chorion Membrane (mdHACM) injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee. Trial enrollment was planned to include 466 patients between the ages of 21 to 80 years, with a diagnosis of osteoarthritis defined as grade 1 to 3 on the Kellgren Lawrence grading scale and a Visual Analog Scale (VAS) for Pain score greater than 45. Due to a lower than expected number of study participant dropouts, and with an adequate number of patients meeting the required time in study to assess the primary endpoint, the final number randomized will be in the range of 430-440.The primary efficacy endpoints include change from baseline in VAS at 90 days, change from baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 days, and incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 365 days. Secondary endpoints include, change from baseline in VAS at 180 days and change from baseline in WOMAC at 180 days. The WOMAC Index has become a standard study metric in KOA studies, and its use has been extensively validated.Important Cautionary Statement This press release may include forward-looking statements. Forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. There can be no assurance that the clinical study will be successful, will be completed on time, or result in an approved Biologics License Application or future products or indications. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.About MiMedxMiMedx® is an industry leader in advanced wound care and a therapeutic biologics company developing and distributing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied more than 1.9 million allografts to date. For additional information, please visit www.mimedx.com.Contact:Hilary Dixon Investor Relations & Corporate Communications 770.651.9066 investorrelations@mimedx.com