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
In his session at 21st Cloud Expo, James Henry, Co-CEO/CTO of Calgary Scientific Inc., introduced you to the challenges, solutions and benefits of training AI systems to solve visual problems with an emphasis on improving AIs with continuous training in the field. He explored applications in several industries and discussed technologies that allow the deployment of advanced visualization solutions to the cloud.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"NetApp is known as a data management leader but we do a lot more than just data management on-prem with the data centers of our customers. We're also big in the hybrid cloud," explained Wes Talbert, Principal Architect at NetApp, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
"Infoblox does DNS, DHCP and IP address management for not only enterprise networks but cloud networks as well. Customers are looking for a single platform that can extend not only in their private enterprise environment but private cloud, public cloud, tracking all the IP space and everything that is going on in that environment," explained Steve Salo, Principal Systems Engineer at Infoblox, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventio...
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"We're focused on how to get some of the attributes that you would expect from an Amazon, Azure, Google, and doing that on-prem. We believe today that you can actually get those types of things done with certain architectures available in the market today," explained Steve Conner, VP of Sales at Cloudistics, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Codigm is based on the cloud and we are here to explore marketing opportunities in America. Our mission is to make an ecosystem of the SW environment that anyone can understand, learn, teach, and develop the SW on the cloud," explained Sung Tae Ryu, CEO of Codigm, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.