Medicrea Receives World’s First and Only FDA-Clearance to Market Patient-Specific Cages

Medicrea Expands its Range of Patient-Specific Implants for Spine

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), 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 Chief Executive Officer, 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.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 185 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Contacts:

Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com

Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87

About Peter Coffaro 516 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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