Profile: RTI Surgical Inc (RTIX.O)
1 May 2015
RTI Surgical Inc., incorporated on April 25, 2000, produces orthopedic and other surgical implants that repair and promote the natural healing of human bone and other human tissues and improve surgical outcomes. The Company process donated human musculoskeletal and other tissue, including bone, cartilage, tendon, ligament, fascia lata, pericardium, sclera and dermal tissue, and bovine and porcine animal tissue in producing allograft and xenograft implants utilizing proprietary BIOCLEANSE, TUTOPLAST and CANCELLE SP sterilization processes and manufacture metal and synthetic implants for distribution to hospitals and surgeons. The Company distributes human tissue, bovine and porcine animal tissue, metal and synthetic implants through various distribution channels. The Company’s business has six categories: spine, sports medicine, surgical specialties, bone graft substitutes and general orthopedic (BGS and general orthopedic), dental and ortho fixation. The Company processes tissue at two facilities in Alachua, Florida and one facility in Neunkirchen, Germany, and manufacture metal and synthetic implants in Marquette, Michigan and Greenville, North Carolina and distribute its implants and services in all 50 states and in over 45 countries worldwide.
The Company designs, manufactures, and distributes surgical implants and instruments used in the treatment of conditions affecting the spine and musculoskeletal system caused by degenerative conditions, deformities or traumatic injury of the spine. Its surgical implants include allograft and synthetic interbodies, bone graft substitutes, rods, pedicle screws and plates. The Company’s spine allografts are marketed domestically through its non-exclusive relationships with Aesculap Implant Systems, Inc. (Aesculap), Alphatec Spine, Inc. (Alphatec), Integra Life Sciences Corporation (Integra), Medtronic, Inc. (Medtronic), Orthofix International NV (Orthofix), Stryker Spine a division of Stryker Corporation (Stryker), and Zimmer, Inc. (Zimmer).
The Company’s sports medicine allografts are tendons for ligament reconstruction and meniscal allografts for transplantation. Many of its sports medicine allografts utilize the Company’s pre-shape technology and are shaped to fit surgeon’s requirements. The Company’s sports medicine implants such as BioCleanse Meniscus, Bone-Tendon-Bone Select, BioCleanse Peroneus Longus, fresh-stored osteochondral (OC) allograft for cartilage repair, Matrix HD dermis implants for wound repair and its Fresh OC Talus are marketed domestically through its direct biologics representatives and through network of independent distributors and internationally through a network of independent distributors.
The Company processes and distributes implants for surgical specialties which include hernia repair, breast reconstruction, ophthalmology and urology. Th Company distributes through Integra for its bovine pericardium and dural repair applications, Davol, Inc., a subsidiary of C. R. Bard, Inc. (Davol) for hernia repair and breast reconstruction, IOP, Inc. (IOP) for ophthalmology and Coloplast A/S of Denmark (Coloplast) for urology.
Bone Graft Substitutes and General Orthopedics
Allograft Paste, surgeons use its allograft paste implants, which are composed of demineralized bone matrix (DBM) and in some cases a biologic gel carrier, in fracture treatment, bone and joint reconstruction and periodontal applications, such as ridge augmentation for dental implants. The Company’s allograft paste implants are marketed under Osteofil by Medtronic, Puros DBM by Zimmer and the Optefil, Opteform, Regenafil and Regenaform brands with Exactech, Inc. (Exactech) and it distributes directly the BioSet, BioReady and BioAdapt families of paste implants through its direct distributor force. The Company’s DBM Boat implants are marketed under BIO DBM by Stryker; Milled Allograft and Xenograft, the Company’s bone graft substitutes business also includes types of blended and milled bone allografts and xenografts, such as demineralized bone matrix, cortical cancellous chips and ground cancellous chips, used in total hip and knee replacements and for various injuries, and Conventional Allografts, includes a variety of allograft categories including its intercalary grafts, such as its frozen femoral heads which are used for cancer treatment procedures and hip and knee reconstruction. It also produces various types of fashioned bone, such as strips and shafts used for various orthopedic procedures.
The Company provides various implants including cancellous and cortical bone and human and bovine membranes primarily for dental procedures related to augmenting ridge restoration. It distributes its dental implants exclusively through Zimmer.
The ortho fixation includes instruments and implants for trauma and cardio thoracic markets. The Company’s trauma implants include devices used to stabilize damaged or broken bones and cardio thoracic implants include cable and plating systems used to close median sternotomies. The Company’s trauma implants are distributed through Zimmer and DePuy Synthes (Synthes), a Johnson & Johnson Inc. subsidiary and cardio thoracic implants are distributed through a direct distribution organization and a network of independent distributors.
The Company has developed and utilized in the United States BioCleanse tissue sterilization process, which is an automated, pharmaceutical grade chemical sterilization process for musculoskeletal bone and certain soft tissue. This process is fully validated to kill or inactivate all classes of conventional pathogens, viruses, microbes, bacteria and fungi. The Company BioCleanse process is able to remove greater than 99% of the blood, fats, lipids and other unwanted materials from the tissue it process. The Company’s BioCleanse process is used on most of its bone allografts and most of its musculoskeletal soft tissue implants. The Company applies the TUTOPLAST process to two types of preserved allografts: soft tissue, consisting of fascia lata, fascia temporalis, pericardium, dermis and sclera; and bone tissue, consisting of various configurations of cancellous and cortical bone material.
The Company competes with the Musculoskeletal Transplant Foundation (MTF), AlloSource, Kinetic Concepts Inc., LifeNet, Medtronic, Integra, Wright, Synovis, LifeCell, Cook Surgical, Alphatec, Globus Medical, Inc., NuVasive, Inc. and Orthofix.
RTI Surgical Inc
11621 Research Circle
ALACHUA FL 32615