Healthcare Industry News: EpiFix
News Release - June 7, 2018
MiMedx Announces Executive to Lead its International Operations and Provides Update on Company's International ProgressMARIETTA, Ga., June 7, 2018 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that John D. Harris has joined the Company as its Senior Vice President of International, and also provided an update on the status of the Company's international operations and the infrastructure progress the Company has made in specific regions of the globe.
"John Harris brings a significant amount of international operations experience to MiMedx, particularly in Asia and Europe," said Chris Cashman, Executive Vice President and Chief Commercialization Officer. "He has a proven track record of creating and deploying product commercialization strategies, and brings significant general management skills to lead the Company's operations outside the United States (OUS). John has served on two long-term expatriate assignments, is fluent in Japanese, has extensive experience running global operations and has been successful in driving international results in both large and small organizations. I am very pleased to have John on our team."
Prior to Joining MiMedx, Mr. Harris served as Vice President and General Manager of Cytori Therapeutics where he had P&L responsibility for their global product portfolio. Before Cytori, Mr. Harris served with Becton Dickinson (BD) as the President and Representative Director of BD Japan, where he led this $350 million division of BD and served on the Global BD Leadership Team. Mr. Harris' experience prior to BD includes executive positions with TE Connectivity, Delphi Medical Systems, and Kimberly Clark Corporation / Ballard Medical.
"MiMedx has been quietly building our OUS infrastructure. Over the next several years, we expect our OUS business will show meaningful operational progress which will result in expanded revenue contribution for the Company," said Parker H. "Pete" Petit, Chairman and CEO. "Under the leadership of Mike Carlton, Senior Vice President of Global Sales, we have now assembled sales and managerial talent focused on specific global markets. We have one executive focused on Eastern Europe, one focused on Western Europe and the UK, one focused on Canada and the Middle East, and another focused on the Asia-Pacific countries. Mike will be a member of the team reporting to John Harris, and Mike will continue to add his expertise to the growth of these regions. John Harris will report directly to Chris Cashman."
Bill Taylor, President and COO, added, "With regard to Europe, our products are now marketed in Austria, Ireland, Slovenia, Switzerland, and the United Kingdom; pending regulatory approval in Italy; and will soon be filed for regulatory approval in Germany. We are in the last stages of approvals for Italy, and we expect to apply for regulatory approval in Germany in the second quarter of this year. German review and regulatory approval could take 6 to 12 months. In the Middle East, our products are marketed in Saudi Arabia and are in process in multiple countries in the region. Regarding North American countries other than the U.S., our products are also marketed in Canada. We have contracted with commercial partners in each country to focus on wound care and surgical, orthopedics and sports medicine opportunities."
The Company also announced that the placental allografts category have been added to the European Wound Management Association (EWMA) document: Advanced Therapies in Wound Management which will include its dehydrated Human Amnion/Chorion Membrane (dHACM). The EWMA published its updated document prior to the recent EWMA 2018 Conference held from May 9 to 11, 2018 in Krakow, Poland. This initiative investigates the barriers and possibilities of advanced therapies in next generation wound management, including cellular therapies, tissue engineering and tissue substitutes associated with the clinical discipline of regenerative medicine. The 2018 EWMA Conference was EWMA's 28th annual conference offering high-level scientific presentations, knowledge and best practices exchange, and presentation of the most recent advances in wound management research and treatment. With up to 5,000 attendees, the EWMA is one of the largest and most prestigious wound management conferences in the world.
Chris Cashman, noted, "We are pleased to have our dHACM allografts highlighted at the influential EWMA annual conference. In addition to the EWMA, we have been very active in attending major conferences held in the European Union as well as numerous local specialty meetings and conferences highlighting our EpiFix® and AmnioFix® product lines, as well as our clinical and science compendium."
In the Asia-Pacific region, MiMedx products are now registered and permitted for marketing in New Zealand and South Korea, and the Company's products have been submitted for TGA regulatory approval for Australia. The product lines submitted in Australia will include the Company's EpiFix, AmnioFix and injectable product lines for commercialization. The Company has already contracted with a leading in-country commercial distribution partner with plans for a full launch this fall.
In Japan, MiMedx has been preparing regulatory submissions for its EpiFix product with the Pharmaceutical and Medical Devices Agency, the affiliate of the Japanese Ministry of Health, Labor and Welfare that governs the approval of pharmaceuticals and medical devices. Additionally, we are preparing for reimbursement filings to support established payment once approved for market commercialization.
Cashman concluded, "We believe that the Japanese market has a significant unmet need for chronic non-healing wounds associated with a lower limb and foot. Furthermore, the Japanese medical community has embraced and is emphasizing regenerative medicine and therapies as a critical area of medicine to heal damaged tissues and organs that today are considered beyond repair. We expect to establish a MiMedx infrastructure in Japan and hire local direct employees to manage the commercialization in Japan. The commercialization activities could culminate as early as summer 2019."
Shareholder Conference Call
MiMedx will host a conference call on Thursday, June 7, 2018 at 8:30 a.m. eastern time to provide a business update. A listen-only simulcast of the MiMedx conference call will be available in the Investor Relations section of the Company's website at www.mimedx.com. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company's website at www.mimedx.com.
MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind the Company's mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.
Safe Harbor Statement
This press release includes forward-looking statements. Statements regarding the amount and timing of OUS revenues; the timing of regulatory submissions and applications, and regulatory approvals; and the timing of hires, commercialization, and establishment of local country infrastructure, are forward-looking statements. Additional 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. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company's most recent annual report or quarterly report 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.
Source: MiMedx Group
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