Medicrea Gains First and Only FDA Nod for Patient-Specific Spinal Cages

The Medicrea Group, pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design with UNiD ASI (Adaptive Spine Intelligence) technology, announced today that it has obtained the first and only 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market patient-specific spinal cages through the extension of its UNiD technology to select from its IB3D range of 3D-printed titanium interbody devices.
 
With this world-first clearance, Medicrea is able to digitally plan, manufacture in-house and supply a 3D-printed device in the United States that has been optimized to follow each patient’s unique spinal anatomy using the Company’s proprietary AI-driven UNiD technology.
 
The current treatment method involves a time-consuming process where surgeons implant a cage from a limited range of standard dimensions during the surgery. This traditional technique represents a significant share of the operating time where the surgeon must test between the available sizes to find the implant that is most suitable for the patient but remains a compromise as it will not be optimized for that patient’s anatomy or that surgeon’s plan.
 
With UNiD IB3D, the implant-selection stage disappears, reducing the operating time, and the patient benefits from an implant that is perfectly adapted to their anatomy and to the parameters defined during preoperative planning.
 
The approval marks further evidence that Medicrea has established its expertise as a leader in patient-specific technology for the Spine as the first company to develop and receive FDA clearance for a patient-specific spinal implant in November of 2014 with the UNiD Rod.
 
Subsequently, the Company has expanded its UNiD ASI (Adaptive Spine Intelligence) platform into a robust outcome-centered process by developing its own FDA-cleared surgical planning software (UNiD HUB).
 
The UNiD ASI platform is powered by data, which it transforms with machine learning and predictive modelling, and is accompanied by a suite of patient-specific implants and engineering services able to transform the way spinal surgeons operate today.
 
Medicrea has successfully completed more than 2,400 surgeries with patient-specific implants.
 
By harnessing the power of an exclusive and growing clinical and radiographic data set, the Company is uniquely able to deliver further immediate and short-term cost-savings to healthcare stakeholders.
 
Denys Sournac, president and CEO, stated, “We are proud to achieve another world-first with this most recent FDA-clearance of UNiD IB3D. It will enable Medicrea to significantly extend our reach in the U.S. market. By expanding our groundbreaking UNiD technology to cages, we are continuing to revolutionize spinal surgery. Patients have an implant that is optimized for their anatomy and pathology, surgeons are able to operate more efficiently, and hospitals are able to significantly reduce the processing cost and simplify supply chain logistics. Additionally, we are now able to increase the share of revenue generated by Medicrea implants in each patient-specific UNiD surgery in both degenerative and complex spinal indications where cages are frequently used—market segments that represent an estimated annual value of over $5 billion in the United States alone.”
 
The algorithmic generation of patient-specific cages within the UNiD HUB’s Analyzer tool is achieved using proprietary methods based on measurements around X-ray or MRI patient imaging. These methods are supported and protected by three unique patents acquired from Dr. Paul McAfee, of University of Maryland St. Joseph’s Medical Center, around a novel technique for physiologically identifying the optimized implant based on anatomical parameters.