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
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
"We are a custom software development, engineering firm. We specialize in cloud applications from helping customers that have on-premise applications migrating to the cloud, to helping customers design brand new apps in the cloud. And we specialize in mobile apps," explained Peter Di Stefano, Vice President of Marketing at Impiger Technologies, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
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, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
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 Soli...
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effici...
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...