|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.
SYS-CON Events announced today that Infranics will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Since 2000, Infranics has developed SysMaster Suite, which is required for the stable and efficient management of ICT infrastructure. The ICT management solution developed and provided by Infranics continues to add intelligence to the ICT infrastructure through the IMC (Infra Management Cycle) based on mathemat...
Mar. 23, 2017 09:30 AM EDT Reads: 2,379
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in ...
Mar. 23, 2017 08:59 AM EDT Reads: 227
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Mar. 23, 2017 08:30 AM EDT Reads: 2,562
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Mar. 23, 2017 08:00 AM EDT Reads: 834
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
Mar. 23, 2017 08:00 AM EDT Reads: 1,968
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Mar. 23, 2017 08:00 AM EDT Reads: 3,640
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Mar. 23, 2017 08:00 AM EDT Reads: 3,200
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...
Mar. 23, 2017 07:45 AM EDT Reads: 964
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Mar. 23, 2017 06:45 AM EDT Reads: 1,488
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
Mar. 23, 2017 05:30 AM EDT Reads: 1,264
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
Mar. 23, 2017 05:30 AM EDT Reads: 3,054
"Peak 10 is a national cloud data center solutions managed services provider, and part of that is disaster recovery. We see a growing trend in the industry where companies are coming to us looking for assistance in their DR strategy," stated Andrew Cole, Director of Solutions Engineering at Peak 10, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Mar. 23, 2017 05:15 AM EDT Reads: 8,108
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership abi...
Mar. 23, 2017 05:00 AM EDT Reads: 10,516
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to transi...
Mar. 23, 2017 05:00 AM EDT Reads: 5,724
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...
Mar. 23, 2017 04:30 AM EDT Reads: 4,741