Welcome!

News Feed Item

MiMedx Schedules Shareholder Call To Update Progress Of FDA Discussions, Reimbursement Successes And Recent Short-Selling Initiatives

COMPANY ALSO RAISES LOWER END OF 2014 REVENUE GUIDANCE

MARIETTA, Ga., March 24, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it will host a shareholder call tomorrow, Tuesday, March 25, 2014 at 11:00 AM Eastern Time to update shareholders on the positive progress of its discussions with the Food and Drug Administration ("FDA") regarding the Company's micronized allograft. During the call, the Company also plans to provide updates on its progress with wound care reimbursement, its sales force expansion, as well as its reaction to the misinformation in certain recent short-selling related blogs.

Parker H. "Pete" Petit, Chairman and CEO, said, "We had our first Pre-Investigational New Drug ("IND") meeting at the FDA on March 13, 2014. During the meeting, we presented a series of questions focused on our detailed plans for our first targeted Biologics License Application ("BLA") for our micronized tissue and reviewed some of our data. The FDA was extremely helpful in answering our questions and providing additional information related to this complex process. In the near future, we anticipate a second meeting to finalize our study protocols and review additional information."

"Because of the significant changes in the Hospital Outpatient Prospective Payment System ("OPPS") Final Rule issued by CMS effective January 1, 2014, and particularly because the changes were announced in late November 2013, almost a month later than usual, we expected the wound care clinics and physicians to be somewhat confused about their reimbursement processes during the first couple of months of this year. To address this expected confusion, we have focused on providing them with detailed education regarding the changes. Revenue in March has grown significantly and we expect March will be a record revenue month. The March revenue trend is an indicator that most of the wound care centers have absorbed the changes and are comfortable with the new reimbursement process," stated Bill Taylor, President and COO. 

"With the reimbursement confusion settling down in the Medicare market, additional Medicare Administrative Contractor ("MAC") coverage, and continued growth in the number of commercial health plans and state Medicaid plans approving coverage for EpiFix®, we expect our quarter-over-quarter growth to continue to accelerate. We are continuing the expansion of our sales force to facilitate these opportunities. In our February shareholder call, I announced that our sales force expanded from 76 at the end of last year to 110.  By the end of this month, we will have 120 sales professionals in our direct sales force, and we still expect that number to be between 130 and 150 by the end of the year," added Taylor.

"Our reimbursement successes are attributed to the data we have collected in our peer-reviewed published clinical trials," stated Petit.  "We have four different publications in Level One Journals on EpiFix®, our wound care allograft.  We also have several other supporting scientific and clinical publications. Shortly, we will announce the publication of a 90-patient study on venous leg ulcers ("VLUs").  This is a multi-center, randomized, controlled trial involving seven centers.  This should clear any questions on the effectiveness of EpiFix® on the larger VLU wounds. Shortly after this publication, we expect to announce another publication of a study of 60 patients with diabetic foot ulcers.  This will bring our total study population to well over 200 patients, which we believe should be more than sufficient to obtain coverage from most health plans."

Last Thursday and Friday, March 20th and 21st, a blog organization, that admits to having shorted the Company's stock, published two articles.  The first article is related to the pending civil suit by the Securities and Exchange Commission ("SEC") against Pete Petit, the Company's Chairman & CEO. The second article is related to the Company's relationships with its Medical Advisory Board ("MAB") members and other physician consultants.

When the SEC suit was announced in January of 2012, the Company's Board of Directors issued a press release announcing its support for Mr. Petit. Because the Company is not a party to the litigation, the Company does not deem it appropriate to comment further.  However, Mr. Petit intends to respond to the article by posting several case-related documents on his personal website. To review this information, go to www.petepetit.com and click on "Personal" in the upper left corner. Then click on "SEC Case" under "Blog Posts." This information should be on the site by 10:00 AM today. Following the conclusion of tomorrow's investor call, Mr. Petit will address this personal matter.

"The second blog article misrepresented the participation and compensation of our MAB members," said Taylor.  "First, the agreements to which links are provided in the article were entered into more than 6 years ago at a time when MiMedx was a development stage company with no revenues and prior to Pete or me joining the Company.  The then-physician advisory board was actively involved in the Company's efforts to develop its HydroFix® and CollaFix™ technologies. Their levels of compensation were commensurate with their development activities.  Additionally, the two early members of the MAB referenced in the article were also founders of the Company, and as such, received founder's shares.  Both of those individuals are no longer members of our MAB.  To our knowledge, none of those early advisory board members mentioned in the article has ever used or referred the Company's products. 

"As a more mature company with substantial operating revenues, we have invested in internal resources to further our product development efforts and have reduced our reliance on outside consultants. More than 70% of MAB stock options were granted over six years ago and approximately 65% of total MAB options expired without being exercised.   All of our relationships with health care professionals are structured so as to comply with applicable law and regulatory guidance, as well as ethical principles and best practices.  Currently, the physicians who provide consulting services to the Company, conduct clinical trials of our products or speak on our behalf are generally paid an hourly rate that meets AdvaMed guidelines and is documented as fair market value compensation."

"We are still refining our second quarter revenue guidance range, and will announce that in April," said Petit.  "At this stage, we feel comfortable increasing the lower end of our full year revenue range from $90 million to $95 million.  Therefore, our updated revenue goal for 2014 is $95 million to $110 million." 

A listen-only simulcast of the MiMedx March 25, 2014 conference call will be available online at 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.

About MiMedx
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 200,000 allografts to date for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the timing and outcome of the Company's next meeting with the FDA, expected March, first quarter and full year 2014 revenues, the expected acceleration of quarter-of-quarter revenue growth, anticipated expansion of the Company's direct sales force, the prospect of additional publications of the results of clinical studies of the Company's products and the expected effect on third party reimbursement coverage. These statements are based on current information and belief, and are not guarantees of future performance.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company's next meeting with the FDA might be delayed, that the Company may not meet its revenue goals or show accelerated quarter-over-quarter revenue growth as a result of expansion of third party reimbursement coverage or otherwise, that the Company may not be able to expand its direct sales force as anticipated or that the expansion may not have the anticipated effect on revenue growth, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2013. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said “No to LUNs.” With Tintri they mana...
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of So...
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, showed how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningful f...
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. Big Data at Cloud Expo - to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is...
SYS-CON Events announced today that China Unicom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
SYS-CON Events announced today the Enterprise IoT Bootcamp, being held November 1-2, 2016, in conjunction with 19th Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA. Combined with real-world scenarios and use cases, the Enterprise IoT Bootcamp is not just based on presentations but with hands-on demos and detailed walkthroughs. We will introduce you to a variety of real world use cases prototyped using Arduino, Raspberry Pi, BeagleBone, Spark, and Intel Edison. Y...
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
I’m going to cry tonight, long and hard. I’ll do so as I remember and mourn Jeremy Geelan. I knew Jeremy for almost 20 years, from the time he showed up one day at Cloud Expo’s headquarters in Bergen County, New Jersey, and went to work. The show wasn’t called Cloud Expo then, of course – it was still known as Java Edge, a pioneering event that grabbed developers, architects, and enterprise IT users alike for twice-yearly confabs. Jeremy didn’t have a job there, or even a job offer. He was s...
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, will discuss how VPaaS enables you to move fast, creating scalable video experiences that reach your...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...