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.