|By PR Newswire||
|February 10, 2014 09:03 AM EST||
MARIETTA, Ga., Feb. 10, 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 that Medicare contractor, Noridian Healthcare Solutions, LLC, has confirmed that the Company's wound care allograft, EpiFix®, has been approved to receive reimbursement coverage.
The coverage from Noridian becomes effective March 1, 2014, and brings the total Medicare Administrative Contractors (MACs) covering EpiFix to seven of the eight. The Noridian jurisdictions include Washington, Oregon, Idaho, Alaska, North Dakota, South Dakota, Montana, Wyoming, Utah, Arizona, California, Nevada and Hawaii. The only remaining MAC needed to approve EpiFix coverage is First Coast Service Options (FCSO), whose jurisdiction is the State of Florida. Thus, EpiFix, now has coverage in 49 of the 50 states.
"Noridian has approved EpiFix for both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that fail to respond to standard of care treatments. Two of the largest categories of chronic wounds are DFUs and VLUs", commented Parker H "Pete" Petit, Chairman & CEO. In the U.S., approximately 1 million patients per year are reported to be suffering from DFUs and nearly 900,000 patients each year are reported to suffer from VLUs.
"The success of EpiFix in attaining coverage from the MACs and many of the commercial health plans and state Medicaid programs is based on our clinical study data presented to those health plans. Also included in this clinical data are the results from another recently completed Randomized Control Trial (RCT) that is expected to be published shortly," commented Bill Taylor, President & COO. "In this study, patients were enrolled following a 2-week run-in period, after having been treated with 4 weeks of conventional therapy. Those patients exhibiting rapid healing (wound reduction of more than 50%) at the conclusion of 'run-in period' were excluded. EpiFix was either utilized weekly or bi-weekly on 40 patients. In both groups, EpiFix achieved wound closure in 70% of patients in 4 weeks. Furthermore, 92.5% of the overall population exhibited healing at 12 weeks with EpiFix. The mean time to closure for the weekly applications was 17 days, and 25 days for bi-weekly applications. Pooling this data with the previously published EpiFix data, on patients who did not heal with conventional therapy after four weeks of conventional therapy and a subsequent two week 'run-in period', EpiFix healed 52 of 64 (81%) of patients in 6 weeks, 58 of 64 (91%) of patients in 9 weeks, and 59 of 64 (92%) of patients in 12 weeks. The median time to closure of the 58 healed patients was 14 days," added Taylor.
A clinical study published July 24, 2013 in JAMA Dermatology, a peer reviewed journal published by the American Medical Association, reports that the median size of a DFU is 1.35 square centimeters and the median size of a VLU is 2.32 square centimeters. Taylor stated, "The legacy skin substitute products most widely approved by commercial health plans are only offered in fixed sheet sizes of approximately 40 square centimeters. This leads to a tremendous amount of wastage in treating both DFUs and VLUs. The MiMedx EpiFix allograft comes in sizes ranging from 1.5 square centimeters on up, allowing for size-appropriate grafts, particularly for these wound types."
"Coupling the robust clinical results with the cost effectiveness of EpiFix, we expect a continuing rapid rate of health plan and state Medicaid reimbursement coverage in the months ahead," concluded Petit.
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 clinical and cost effectiveness of EpiFix®, the prospect of additional reimbursement approvals from the remaining Medicare Administrative Contractor and other commercial health care plans and state Medicaid programs, and the opportunities presented by the Noridian coverage determination. 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 remaining Medicare Administrative Contractor will not approve EpiFix® for reimbursement, that other commercial plans and state Medicaid programs will not approve EpiFix for reimbursement coverage, that we will be unable to capitalize on the opportunity for expanded sales of our EpiFix® allografts, that EpiFix® will not perform as expected or will not gain acceptance in the medical community, 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, 2012, and the Company's Forms 10-Q filed in 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.
Between 2005 and 2020, data volumes will grow by a factor of 300 – enough data to stack CDs from the earth to the moon 162 times. This has come to be known as the ‘big data’ phenomenon. Unfortunately, traditional approaches to handling, storing and analyzing data aren’t adequate at this scale: they’re too costly, slow and physically cumbersome to keep up. Fortunately, in response a new breed of technology has emerged that is cheaper, faster and more scalable. Yet, in meeting these new needs they...
Dec. 4, 2016 12:30 AM EST Reads: 1,776
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, provided an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data professionals...
Dec. 3, 2016 11:00 PM EST Reads: 4,138
"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.
Dec. 3, 2016 11:00 PM EST Reads: 949
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Dec. 3, 2016 09:30 PM EST Reads: 1,765
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Dec. 3, 2016 09:30 PM EST Reads: 1,601
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
Dec. 3, 2016 08:00 PM EST Reads: 1,746
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...
Dec. 3, 2016 08:00 PM EST Reads: 3,955
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
Dec. 3, 2016 06:15 PM EST Reads: 1,514
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 3, 2016 05:30 PM EST Reads: 4,046
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Dec. 3, 2016 05:15 PM EST Reads: 2,139
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Dec. 3, 2016 05:15 PM EST Reads: 2,002
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.
Dec. 3, 2016 04:30 PM EST Reads: 1,476
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, discussed using predictive analytics to mon...
Dec. 3, 2016 04:00 PM EST Reads: 4,863
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...
Dec. 3, 2016 03:30 PM EST Reads: 1,592
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Dec. 3, 2016 03:15 PM EST Reads: 3,226