MiMedx Group, Inc. develops, manufactures, and markets patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. The company’s biomaterial platform technologies include AmnioFix and EpiFix, its tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through its donor program, mothers delivering full-term Cesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. The company processes the human amniotic membrane utilizing its proprietary Purion Process, to produce a safe and effective implant, which is referred to as an ‘allograft.’ Technology and Products AmnioFix, EpiFix and other Tissue -Based Allografts The company is the supplier of allografts processed from amniotic tissue, having supplied approximately 200,000 allografts for application in the wound care, surgical, sports medicine, ophthalmic, and dental sectors of healthcare. The company’s tissue-based products include its own brands, AmnioFix and EpiFix, as well as products that the company supplies on a private label or ‘OEM’ basis. Tissue Processing and Recovery The company operates a licensed tissue bank that is registered as an establishment with the United States Food and Drug Administration (FDA). The company partners with physicians and hospitals to recover donated placental tissue. The company’s unique processing technique specifically focuses on maintaining the delicate structure and collagen matrix of the tissue. The Purion Process helps maintain graft structure, provides optimal performance and allows the allograft to be stored at room temperature and have a five-year shelf life. Additionally, each allograft incorporates specialized visual embossments that assist the surgeon with proper graft placement and orientation. EpiFix The company’s EpiFix allograft is configured for external use. It is designed to enhance healing of wounds, as well as to reduce inflammation and scarring. EpiFix and EpiFix Micronized are being used to treat chronic wounds, including diabetic foot ulcers, venous stasis ulcers, arterial ulcers and pressure ulcers, burns and surgical wounds (such as wounds following plastic surgery). The company offers EpiFix in a sheet form as well as a micronized powder form. AmnioFix The company’s AmnioFix allografts are configured for internal use. Its AmnioFix product line consists of three configurations, AmnioFix, AmnioFix Wrap and AmnioFix Injectable: AmnioFix is provided in a sheet form. It is configured to reduce inflammation, enhance non-structural soft tissue healing and to minimize scar tissue formation after primary surgical repair. It is being used in spine, general and urology surgeries. AmnioFix Wrap also is supplied in a sheet form and is configured for the same purposes as AmnioFix, but is optimized for use as a ‘wrap’ for nerves, tendons or ligaments. AmnioFix Injectable is supplied in micronized powder form used for injection into soft tissue areas. AmnioFix is used to reduce inflammation while enhancing healing of soft tissue micro tears. AmnioFix is used to treat conditions such as tendonitis, including plantar fasciitis, lateral epicondylitis, and medial epicondylitis; bursitis; strains and sprains. Other Tissue Products Allografts for ophthalmic surgery and dental and oral maxilla facial applications are sold on an OEM basis pursuant to agreements whereby the company has granted third parties exclusive licenses to some of its technology for use in those fields in specified markets. Medical Device Technologies- CollaFix and HydroFix CollaFix The company’s CollaFix technology combines a means of creating fibers from soluble collagen and a specialized cross-linking process. The technology is licensed from Shriners Hospitals for Children and University of South Florida Research Foundation, Inc. pursuant to a world-wide license to practice and use the technology and to manufacture, market, offer for sale and sell products incorporating the technology. HydroFix The company’s HydroFix products are based on licenses to certain patents and patent application rights to a PVA- based hydrogel, which is a water-based biomaterial that can be manufactured with a range of mechanical properties, including those that appear to mimic closely the mechanical and physical properties of natural, healthy human tissue. Patents 53 additional patent applications covering aspects of the company’s technology are pending at the United States Patent and Trademark Office and with various international patenting agencies. Worldwide, its CollaFix and HydroFix technologies are protected with 13 and 14 issued patents, respectively. Additionally, in the U.S. and internationally, there are 49 patent applications pending covering its CollaFix technology and 2 pending applications covering its HydroFix technology. Sales and Marketing In October 2013, the company entered into a non-exclusive distribution agreement with Medtronic, Inc. and its wholly-owned subsidiary, SpinalGraft Technologies, LLC (SGT). Customers The company provides products to Government accounts, including the Veteran’s Administration, through a distributor relationship with AvKARE, Inc., which is a veteran-owned General Services Administration Federal Supply Schedule Contractor. Competition In 2013, the company’s main competitors were Shire, the manufacturer of Dermagraft, and Organogenesis, the manufacturer of Apligraf.
mimedx group inc (MXE:Berlin)
1775 West Oak Commons Court, NE
Marietta, GA 30062
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