Diversified 3D Technologies, Inc. — Department of Defense SBIR Phase I: J201-CSO1

Description

Exiom (formerly known as Diversified 3d Technologies) provides a comfortable alternative to treating broken bones that maximizes healing while minimizing the inconvenience and pain of traditional plaster and fiberglass casting. Utilizing the Xkelet scanning and modeling software, providers can create a cast through non-contact scanning of the extremity with a simple iPad app and occipital structure scanner. The app models the custom orthosis, which is created rapidly and on-site by a proprietary 3D printer.  3D printing represents a significant advance in fracture immobilization technology. Unlike traditional casts that cover the entire affected area with a heavy, inflexible, non-breathable material, this injury immobilization product features an open lattice design that is lightweight and exposes the skin to the air, allowing it to breathe and enhancing healing. It is designed to treat over 80% of orthopedic injuries in hard and soft tissues, including fractures, muscle injuries, articular injuries (such as sprains and dislocations), chronic pathologies (including arthritis and arthrosis), and decompression of the median nerve in carpal tunnel syndrome, with minimal disruption and discomfort during the healing process. The immobilization is tailored to each patient and each limb, maximizing ergonomics, comfort, and fixation of the injured limb. Each device is waterproof, cleanable and hygienic, and easy to apply and remove.  The technological innovation behind this invention conforms to the FDA standards for biocompatibility of the final finished device. Exiom has evaluated the Xkelet cast to ensure it is pursuant with the guidance section of the “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.’ “[10] No chemical additives with known toxicities are to be used. The catalyst materials and curing agents are FDA approved materials with no known harmful interaction when combined, heated, printed, or worn on the skin, which is a proprietary high strength casting and splinting resin which IS biocompatible. The labeling of the device is in accordance with FDA regulations for devices of this type. The device is classified under “Orthosis, Limb Brace” in the Regulation Medical Specialty “Physical Medicine” with the Product Code IQI. The device has been evaluated by the Division of Neurological and Physical Medicine Devices (DNPMD) Physical Medicine and Rehabilitation Devices Branch (PMDB). This device has a registered device regulation number of 890.3475.  The Smart Materials 3D printing materials SMARFIL® PETG NATURAL has been manufactured with PETG pellets and complies with medical regulations ISO 11607-1:2006. SMARFIL® PETG is in subjective compliance to ISO 11607-1:20 / EN ISO 11607-1: 2009, as it applies to raw materials and not the finished device.