Businessweek

MiMedx Group, Inc. operates as an integrated developer, manufacturer, and marketer of patent protected regenerative biomaterial products and allografts processed from human amniotic membrane. The company’s biomaterial platform technologies include the device technologies, such as HydroFix and CollaFix, and its tissue technologies, AmnioFix and EpiFix. Technology and Products AmnioFix and EpiFix The company supplies allografts processed from amniotic tissue, having supplied approximately 70,000 allografts for application in the ophthalmic, orthopedic, dental, spinal, and wound care segments of healthcare. The company’s amnion products, AmnioFix and EpiFix, are processed from human tissue according to the American Association of Tissue Banks (AATB) regulations. The company has launched AmnioFix Wrap for both nerve and tendon repair applications; and AmnioFix Injectable, which is an allograft consisting of micronized amniotic tissue. The AmnioFix and EpiFix allografts can be used for a range of procedures, including ocular surface repair, gingival recession repair, wound care, burns, and various other types of procedures for the repair of a patient’s integumental (native) tissue. CollaFix The company’s CollaFix technology combines a means of creating fibers from soluble collagen and a specialized cross-linking process. It utilizes two separate cross-linking technologies for various applications. In 2012, the company received the CE certification for its proprietary CollaFix Surgical Mesh CD, which is a Class III product in Europe. HydroFix The company licenses the rights to a poly-vinyl alcohol (PVA) polymer, which is a water-based biomaterial that can be manufactured with a range of mechanical properties, including those that appear to mimic the mechanical and physical properties of natural, healthy human tissue. The company has received the Food and Drug Administration (FDA) clearance via a 510(k), for its HydroFix Vaso Shield (the Vaso Shield), which is a vessel guard made of its hydrogel material to protect the major vessels from the anterior spinal column during an anterior spinal procedure. During 2011, the company received two additional 510(k) clearances for its HydroFix Vaso Shield device: one for an expanded range of sizes and for a higher temperature exposure limit, and the second for additional information to be included in the marketing materials. Outside the United States, HydroFix Spine Shield is CE marked for use for the anterior and posterior spine to provide a barrier for scar tissue attachment (adhesions). This permanent sheet is a physical barrier between two tissue types and could help with the re-access to the surgical site on a revision. During 2011, the company received 510(k) clearance for its HydroFix OrthoShield device, which is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The OrthoShield device is a permanent, protective sheet that minimizes soft tissue attachments to the device providing a protective environment for the repaired tendon to heal. Marketing and Sales The company has a network of independent sales representatives and stocking distributors to sell its MiMedx-labeled products domestically. It also has various private label and OEM relationships, where its tissue is packaged and branded in accordance with the customer’s specifications. Intellectual Property Worldwide, the company's platform technologies are protected with 10 patents and approximately 50 patent applications, as well as proprietary manufacturing processes and trade secrets. The company owns trademark and trade name registration of the mark Paradís Vaso Shield and licenses the SaluMedica and Salubria trademarks. The company also owns the trade name registration of the trademarks of MiMedx, EpiFix, AmnioFix, HydroFix, and Purion. Government Regulation Human Amniotic Tissue: The company's AmnioFix and EpiFix platforms are human tissue, and qualify under Section 361 of the Public Health Service Act as products that do not require premarket review under a drug, device or biological product market application. Medical Devices: The company’s HydroFix and CollaFix product platforms are medical devices subject to regulation by the FDA, under the Federal Food, Drug, and Cosmetic Act and they are also regulated in the European Economic Area by the Medical Device Directive 93/42/EEC. Environmental Matters The company is compliant with applicable laws and regulations promulgated by the Resource Conservation and Recovery Act, the U. S. Environmental Protection agency, and the Georgia Department of Natural Resources, Environmental Protection /division.