MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone. "Innovations in Regenerative Biomaterials" is the framework behind their mission to give physicians products and tissues to help the body heal itself. Their biomaterial platform technologies are AmnioFix®, EpiFix®, OrthoFlo, Physio™, AlloBurn™, and CollaFix™. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Elected in advance of delivery through our donor program, a mother delivering a healthy baby via scheduled full-term Caesarean section birth may donate the placenta in lieu of having it discarded as medical waste. MiMedx processes the human amniotic membrane utilizing their proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. MiMedx recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section. Through the recent acquisition of Stability Biologics, MiMedx's newest proprietary platforms include Physio™, a unique bone grafting material consisting of 100% bone tissue with no added carrier, thus maximizing bone forming potential, a demineralized bone matrix (DBM) to complement their product portfolio offerings within the Orthopedic market and AlloBurn, a skin product for burns. CollaFix, their next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. CollaFix is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness. The company's wholly owned subsidiary, Stability Biologics, LLC, is accredited by the American Association of Tissue Banks (AATB) and registered with the FDA.

History

MiMedx was founded by serial entrepreneur Steve Gorlin in 2008, with HydroFix and CollaFix technology platforms as its initial assets.

In early 2011, the company bought Surgical Biologics, LLC, which had been developing amnion tissue processing technology and creating body implants for almost two decades. When MiMedx bought it, Surgical Biologics was distributing tissue in several membrane sub-segments, such as ocular, dental, and spine.

During the same year, MiMedx launched AmnioFix and EpiFix, products from Surgical Biologics, across the United States.

From 2012 to 2013, the company's shares surged from $1 to more than $7. It formed a distribution agreement with Medtronic, the world's largest standalone medical device company. In February 2013, it moved into its current headquarters, a 80,000 square foot building in Marietta, Georgia. In September, however, the Food and Drug Administration posted a letter notifying the company that some of its injectable therapies may violate regulations for human tissue products. Despite the setback, MiMedx, having grown to 200 employees, managed to raise $34 million in December in a follow-on offering of public shareholders.

In 2014, MiMedx formed a distribution partnership with another major medical device firm, Zimmer Biomet, to sell its regenerative biomaterial products.

In 2015, MiMedx's revenue grew 108% to $40.8 million. The company currently has roughly 500 employees. It has registered several dozens of patents.

Methods and products

MiMedx acquires placenta for its products through donations from mothers delivering via caesarean section. Mothers decide in advance whether they will donate the placenta instead of having it discarded as medical waste. The amniotic material from the placenta is then ground up through micronization so that it can be used as skin grafts or injections.

MiMedx's PURION cleansing process removes all impurities that could cause rejection, resulting in tissue technologies that can be repopulated by the patient’s own cells to heal hard-to-heal wounds. They can be stored at room temperature with a 5-year shelf life.

These technologies are sold as AmnioFix and EpiFix. AmnioFix is used for spinal procedures as a barrier membrane that reduces scar tissue formation between the dura mater and soft tissue. EpiFix is an allograft specifically processed for acute and chronic wounds. AmnioFix Wrap is used for nerve and tendon protection applications.

The company has been developing CollaFix, a collagen fiber technology developed with their patented cross-linking polymers mimicking the natural composition, structure and mechanical properties of musculoskeletal tissues to augment their repair, acting as a scaffold.

MiMedx has supplied more than 450,000 allografts for application in the wound care, surgical, orthopedic, spine, sports medicine, ophthalmic and dental sectors of healthcare.

External links

• Official website