• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FineHeart Successfully Tests Wireless TET System

    Apria Healthcare Settles Whistleblower Lawsuit

    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment

    Remote Patient Monitoring Market Set to Surpass $645 Million by 2025

    4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Spectrum Plastics Group

    maxon

    K-Tube Technologies

    Creganna Medical, part of TE Connectivity

    Medicoil
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Unicep

    Concise Engineering

    Spectrum Plastics Group

    maxon

    K-Tube Technologies
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Wrighting the MiMedx Ship: An Exclusive Interview

    In this interview with the firm’s new CEO, MPO discovers what’s been done to turn the page on the company’s troubled past.

    Wrighting the MiMedx Ship: An Exclusive Interview
    Tim Wright, CEO of MiMedx
    Related CONTENT
    • Greenlight Guru and Nelson Labs Partner
    • Olympus Releases ScopeLocker Endoscope Storage Cabinet
    • Preparing Your Design Controls for FDA Approval
    • Survey Finds On-Site Inspections Plummeted by 93 Percent
    • Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
    Sean Fenske, Editor-in-Chief11.13.20
    Wound care can be a difficult condition to address, especially for diabetic patients. Treating the wounds of a company that has been through controversies and lost trust within the industry can be just as challenging. Taking on both tasks as the new CEO of MiMedx, Tim Wright has most certainly had his work cut out for him.

    Senior executives of MiMedx were accused of various acts of accounting fraud from 2013 through 2017. As such, the company’s name was brought down by their actions. Joining the firm in May of 2019, Wright’s major focus was to restore trust and regain the confidence of the market in the organization’s product portfolio.

    At the time of his hiring, Wright said, “I am honored and excited to join MiMedx and lead the Company forward into the next stage of its evolution. I have diligently reviewed the strength of the scientific foundation of the MiMedx business, the clinical and economic efficacy of the Company's products, the soundness of the Company's strategic plans, and the current and future market opportunities available to MiMedx. I believe strongly in the Company's potential to positively impact the lives of patients, and look forward to working with the Board and management team to guide MiMedx so that it can reach its full potential while creating long-term shareholder value."

    Now, approximately 18 months in, Wright spoke with MPO to share what he’s done to improve the company’s standing and reputation. In this exclusive interview, he discusses the actions taken to remedy the problems created by the firm’s past leadership, what new innovations the organization is currently working on, and where MiMedx is headed.

    Sean Fenske: Could you please explain what MiMedx does and explain the products?

    Tim Wright: MiMedx is an industry leader in advanced wound care and a therapeutic biologics company. We pioneered the processing and use of amniotic tissue, and currently develop and distribute human placental tissue allografts for multiple sectors of healthcare, including wound care, burn, and various surgical applications. In support of the company’s mission to improve patient lives and elevate the standard of care for the amniotic tissue category, MiMedx is also leading multiple clinical trials to explore applications in osteoarthritis, plantar fasciitis, and other degenerative musculoskeletal conditions.

    As a company, we are driven to bring healing and hope to people with chronic, hard-to-heal wounds, using our innovative, patent-protected, proprietary PURION process methodology, among other processes, to produce allografts. I believe that patients suffering from chronic, hard-to-heal wounds are one of the most underdiagnosed, undertreated, underserved populations I’ve seen in my career. More than 30 million Americans have diabetes; close to three million of these people suffer from chronic wounds. Many will face serious complications—including repeated, unhealed wounds—that may lead to limb amputation. Our essential purpose is to provide advanced treatment options for these patients and the health professionals that serve them.

    Fenske: The former management team of MiMedx brought quite a controversy to the company, from cooked books to spying on employees to unethical behavior. Where does the new team start to restore confidence in the company?

    Wright: In business and in life, trust is earned through actions—and actions are motivated by purpose. For MiMedx, that begins with a renewed focus on patients, operational excellence, and a commitment to do what’s right and follow through. The drive to address a pressing, unmet patient need anchors our decisions and inspires our work. I knew that by establishing a purpose-driven culture, focused on attitudes and behavior, and restoring the company’s financial integrity, MiMedx could realize its potential as a business, and on behalf of people in need of healing.

    I joined MiMedx because I believe in the company's values and its potential beyond the past troubles. The fundamentals are there in our wound care business with a great and versatile product portfolio, and we can build on this as a platform to advance our musculoskeletal pipeline. I was compelled by the early, innovative work to develop foundational clinical and scientific evidence that enabled amniotic tissue to reach the market in a safe, commercially viable, and logistically feasible way.

    With that in mind, we set to work restoring our financial integrity for future growth, and achieved four key milestones since June of this year. First, we announced the concurrent closings of $150 million in private equity, led by EW Healthcare Partners, and debt financing, provided by Hayfin Capital Management. As part of these transactions, we welcomed two highly regarded, accomplished new members—Bill Hawkins and Marty Sutter—to the Board of Directors. Second, we became current in our financial filings, with our 2019 Form 10-K, 1Q 2020 and 2Q 2020 Form 10-Qs. Third, we held our 2019 Annual Meeting of Shareholders and scheduled the 2020 Annual Meeting of Shareholders—important not only to enhance communications with our shareholders, but because it provides an opportunity to refresh our Board with members who have the key experience and strategic expertise we need to advance the company to the next phase of its growth. Fourth, as of November 4th, our common stock is once again being traded on Nasdaq. This is a critically important step, as trading on the public market improves liquidity and visibility for MiMedx within the financial community.

    Lastly, and importantly, we have an entirely new and experienced management team focused on instilling a culture of transparency, accuracy, collaboration, and everyday pursuit of operational excellence.

    Each of these marks a significant step forward for the company, for our employees, for us as a community, and for the patient-care mission that we all share. We are action-oriented and working to earn stakeholder confidence.

    Fenske: Speaking of the new management team, who has been brought in to replace the previous leadership, and what roles will they play?

    Wright: One of my first priorities was to build a cohesive leadership team with a shared view—that when patient care comes first, great things will follow. We now have the right people in place—a team with industry-centered experience, people known for integrity and dedication creating performance-based culture and instilling operational excellence at companies.

    Pete Carlson, chief financial officer, is a recognized leader in accounting, reporting, tax, and internal controls. He joined MiMedx in December 2019 and brings more than thirty years of comprehensive financial expertise as well as extensive corporate governance and financial strategy experience. Pete was instrumental in assisting in the company’s transition, completing our restatement and the timely filing of our most recent quarterly report.

    Butch Hulse, general counsel and secretary, joined MiMedx in December 2019, and brings more than twenty years’ experience in large law firms and life sciences organizations, with significant legal, risk management, compliance, and operational expertise.

    Rohit Kashyap, Ph.D. is executive vice president and chief commercial officer. Dr. Kashyap is an accomplished strategic leader with experience in building successful global businesses, and an impressive track record of transforming business portfolios, building high-impact teams, and delivering growth. He brings to MiMedx more than twenty years of medical device experience, with a proven history of performance in developing commercial models that deliver value to health professionals, patients, and healthcare systems.

    Bob Stein, M.D., Ph.D., is the executive vice president of research and development. Noted for significant contributions and accomplishments in medical research and development, Dr. Stein brings to MiMedx more than forty years of drug discovery and development experience with multiple pharmaceutical and biotechnology companies. He has served as a lead contributor in the discovery and registration of eight marketed drugs, and is experienced in product development, including in the areas of molecular and cellular biology, biochemistry, animal pharmacology, drug metabolism, and safety assessment, among others.

    Stan Micek, senior vice president, business development and portfolio management, brings to MiMedx significant life sciences experience, including leadership roles within multiple aspects of the branded and generic pharmaceutical product value chain, new business ventures, and negotiation of several large corporate transactions.

    Fenske: What steps are you taking to ensure transparency going forward?

    Wright: One of our greatest priorities has been strengthening the company’s internal controls and culture. With oversight from the Board, the company’s new management has designed and begun implementing a number of changes in processes and controls. Some of these changes include the creation of an Ethics and Compliance Committee; the adoption of a revised Code of Business Conduct; and enhanced training that emphasizes the importance of compliance and avenues to report potential compliance violations. Our new chief financial officer and new chief accounting officer have strengthened and formalized accounting policies that encompass numerous levels of review. We also improved processes and controls to monitor sales practices and recognize revenue, and tightened policies, procedures, and governance of customer credit and product returns. Our actions are focused on operational excellence in all parts of the organization.

    Fenske: What is the status of the medical products the company produces? Did they ever come under question by customers or regulatory agencies?

    Wright: We continue to partner with and welcome the guidance of the FDA to ensure our products can safely reach patients in need of advanced treatment options. Following the December 2019 FDA inspections at both of our processing facilities that measured the company’s compliance with Current Good Manufacturing Processes (CGMP), the FDA issued a Form 483 for both facilities. We provided responses to all of the observations and commitments to take corrective actions. All of these remediation actions are now complete.

    During the past year, we undertook significant efforts to characterize and assess the company’s true state of readiness to file Biologics License Applications (BLAs) for our innovative regenerative tissue platform technologies. The regulation of human amniotic tissue as a biologic is not only novel for our category and our company, but also a novel pathway for the FDA. We conducted a thorough analysis of our existing investigational new drug programs to better understand our current state, including the expected timing and resources needed to improve the probability of technical and regulatory success moving forward.

    We recently announced the completion of enrollment for our clinical trials, but that is just one step in the process. We have also taken measures to advance our purity, potency, and identity tests to demonstrate consistency and reliability of our manufacturing process through a rigorous focus on basic chemistry, manufacturing, and controls. We are communicating proactively with the FDA to refine the necessary next steps for our trials, and we are preparing to schedule End of Phase review meetings.

    Fenske: What’s the market’s impression of the technologies you offer? How have they been received by physicians?

    Wright: Our commitment to patient care drives everything we do. Our employees believe in our products, and so do our customers. They see results for their patients, and that we are investing in our science, people, and pipeline because people living with chronic, hard-to-heal wounds need us to act with urgency. They understand that, ultimately, we have to work together to help the patient living with pressing health concerns, and we need to further invest in real partnerships with customers in approaching this work.

    The market understands this, too, and recognizes our return to focus on the meaningful work of making a difference for patients.

    Fenske: Now that the ship is being fully righted, where are the opportunities for growth?

    Wright: There are four key drivers to achieve significant growth: sustaining the success of our core business, expanding the current market, business development beyond our existing portfolio, and international expansion.

    MiMedx has significant opportunity to help the millions of Americans with diabetes who suffer from chronic wounds, many of whom will face serious complications that may lead to limb amputation. Our EpiFix brand remains the brand of choice for an amniotic tissue advanced skin substitute, as reported by third party estimates. And, with the launch on September 14th of our placental allograft EpiCord Expandable, we are giving the physicians who treat chronic wounds the technology to cover wounds with twice the surface area once the graft is expanded. This new placental tissue allograft provides healthcare professionals an additional option to support the advanced wound care needs of their patients with larger, chronic, and hard-to-heal wounds.

    Within the advanced wound care market alone, there is significant unmet patient need, and we have a strong leadership team in place to help us move forward. Our essential purpose is to provide advanced treatment options for these patients and the health professionals that serve them.

    Fenske: Where is the firm headed? Where do you see the business a couple years from now or even five/ten years from now?

    Wright: We are at a pivotal point for MiMedx. Our ability to advance wound-healing science that informs the pathology of healing will further differentiate the value of our business and set the foundation for our platform portfolio to address other areas of unmet need.

    In the near-term, we are also focused on important clinical trials in the musculoskeletal application of placental science. In September, we announced that we completed enrollment for a Phase 3 plantar fasciitis trial, as well as a Phase 2B trial of osteoarthritis (OA) of the knee.

    There are two million patients treated for plantar fasciitis annually in the U.S. and, as recovery time is lengthy and recurrence of the condition is very common, the projected national economic burden is $284 million per year. For OA, the unmet need is also immense and the market is significant: more than 242 million patients worldwide suffer symptomatic OA of the knee and the hip.

    Concluding enrollment for these trials are major milestones for this company, as we continue to advance the science of patient care for musculoskeletal conditions like these and explore the expanded application of placental science and the potential benefits of our injectable products to new groups of patients.

    All of these efforts center on a key focus in our company philosophy: we are constantly improving our knowledge of placental science. The placenta is a unique biological system designed to protect the fetus, which has an unusual healing capability—and our products are able to retain that characteristic. The establishment of a Scientific Advisory Board under the leadership of Dr. Bob Stein will investigate the advancement and possible applications of placental-tissue science, which will help bolster our pipeline for years to come. That’s where we see our future: returning to pioneering innovation, doing what we do better than anyone else, and continuing to advance the field in terms of research, advocacy, and product leadership.

    Fenske: Do you have any additional comments or thoughts you’d like to share?

    Wright: MiMedx has reset and we are moving forward. While having more than its fair share of challenges in the past several years due to the actions of the previous management, the company has a new executive team composed of seasoned leaders who joined recognizing they would be tackling business challenges for an important healthcare company and returning it to its patient care mission. Moreover, our employees—from research and development to processing to our field-based representatives—believe in the power of working together to make a difference in people’s lives. I believe the company has great people who are smart, hardworking, and passionate about our products. There is a big market opportunity with significant patient needs. We have a strong leadership team in place to continue to help us move forward.
    Related Searches
    • Chronic Disease
    Related Knowledge Center
    • Chronic Disease
    Suggested For You
    Greenlight Guru and Nelson Labs Partner Greenlight Guru and Nelson Labs Partner
    Olympus Releases ScopeLocker Endoscope Storage Cabinet Olympus Releases ScopeLocker Endoscope Storage Cabinet
    Preparing Your Design Controls for FDA Approval Preparing Your Design Controls for FDA Approval
    Survey Finds On-Site Inspections Plummeted by 93 Percent Survey Finds On-Site Inspections Plummeted by 93 Percent
    Expert Roundup: Achieving Success in the 2021 Medical Device Landscape Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
    Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon
    Nissha Medical Technologies Nissha Medical Technologies
    Foxx Life Sciences Foxx Life Sciences
    Simbex Simbex
    VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution
    Sommetrics Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation
    FDA Agrees to Participate in MDIC FDA Agrees to Participate in MDIC's Collaborative Community Initiative
    How Design Controls Can Prevent Medical Device Recalls How Design Controls Can Prevent Medical Device Recalls
    Beaumont Technologies Beaumont Technologies
    Indago Appoints President and General Counsel Indago Appoints President and General Counsel

    Related Online Exclusives

    • Chronic Disease
      Increasing Comfort for Chemotherapy Patients

      Increasing Comfort for Chemotherapy Patients

      Leveraging a freelance researcher in bringing the Chemo Mouthpiece to market—A case study.
      Ramya Sriram, Digital Content Manager, Kolabtree 11.24.20

    • Chronic Disease | Digital Health
      An Analysis of the Smart Inhalers Market

      An Analysis of the Smart Inhalers Market

      Pharmaceutical companies are showing increasing keenness in leveraging digital health solutions.
      Saloni Walimbe, Research Content Developer, Global Market Insights (GMI) 06.09.20


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • FineHeart Successfully Tests Wireless TET System
    • Apria Healthcare Settles Whistleblower Lawsuit
    • OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    • Remote Patient Monitoring Market Set to Surpass $645 Million by 2025
    • 4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Cistanche Tubulosa Botanical Shown to Attenuate Locomotive Syndrome
    Maternal Dietary Intake of Fish, Omega-3s, and Omega-6s Linked to Child Neurodevelopment
    Short Term Low-Carb Diet Linked to Remission of Type 2 Diabetes
    Coatings World

    Latest Breaking News From Coatings World

    Huntsman Finalizes Acquisition of Gabriel Performance Products
    PPG Completes COLORFUL COMMUNITIES Project at School in A. Bangsaothong Samutprakarn, Thailand
    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FineHeart Successfully Tests Wireless TET System
    Apria Healthcare Settles Whistleblower Lawsuit
    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Valeo Pharma Appoints President, COO
    Metrion, LifeArc Extend Neuroscience Alliance
    Grifols Begins COVID-19 Plasma Treatment Trial
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    JLo Beauty Launches at Sephora & Amazon
    Unilever and Alibaba Group Join Forces
    Redken Unveils Acidic Bonding Concentrate Range
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    Manscaped Expands Further in Europe
    Color Street Gives Back
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Super Strong Inks Survive Tough Environments
    Ontex Honored for Mask Production
    TFP Acquires PV3 Technologies
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OrthoPediatrics Expands Agent Network in Three European Countries
    Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes
    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login