Indications for use
Orthopedic surgery
CMF, neuro-, and plastic surgery
Oncology
STEP 2
IMPLANT PRODUCTION
The resulting 3D model of the patient-specific bone implant will be used for its subsequent production using A.D.A.M. proprietary 3D printers. Printing may take place at A.D.A.M. or directly on site, subject to the medical institution's preferences.
Overall production time will take up to 24 hours, which is substantially faster compared to the existing alternatives. At the same time, use of 3D-printing technology and A.D.A.M. material composites results in a lower cost of production than for titanium or PEEK-based implants.
A personalized bone, just like yours.With no toxic, allergic, and teratogenic effects.
STEP 3
IMPLANTATION
A.D.A.M. will help medical professionals through a developed set of Quality Management System procedures, which will ensure safety, efficacy and quality of the implant.
Medical professionals will receive a sterilized 3D-printed bone implant ready for use in surgery.
STEP 3
IMPLANTATION
A.D.A.M. will help medical professionals through a developed set of Quality Management System procedures, which will ensure safety, efficacy and quality of the implant.
Medical professionals will receive a sterilized 3D-printed bone implant ready for use in surgery.
STEP 4
RECOVERY
A.D.A.M. bone implants are biodegradable. They stimulate osteogenesis and are fully replaced by the bone tissue over time. Therefore, there is no need for reoperation to extract metal fixation elements.
Pre-clinical trials data:
Ceramics
• No hematoma, edema, scarring, degenerative changes, tumors, tissue necrosis and other abnormalitiesPre-clinical trials data:PolymersCeramics
• In the 4th week - cell migration and germination of the connective tissue (T) deep into the implant due to the porous structure of the ceramic material; in the 12th week - intensification of the process.
Polymers
• Formation of connective tissue capsule
• Active phagocytic processes, partial destruction of test material and phagocytosis of cell metabolism products
• Local germination of connective tissue strands deep into the implanted material; increased neovascularization and formation of a large number of capillaries
• Pre-clinical trials completed in accordance with ISO standards• Safety, biocompatibility and resorbability tested and confirmed• FDA Q-submission response confirmed 510(k) rule eligibility• No human trials required• 2 PCT patents published (materials)• Mount Sinai Innovation Partners' Elementa Labs startup
• Pre-clinical trials completed in accordance with ISO standards
• Safety, biocompatibility and resorbability tested and confirmed
• FDA Q-submission response confirmed 510(k) rule eligibility
• No human trials required
• 2 PCT patents published (materials)
• Mount Sinai Innovation Partners' Elementa Labs startup
Expected market launch in 2024Bones are just the beginning. In future A.D.A.M. aims to deal with other tissues.