Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received FDA 510(k) Clearance and performed first surgeries with PASS^® TULIP top-loading fixation including world-first patient-specific hybrid constructs.

Top-loading fixation is the global standard for posterior spinal instrumentation. Medicrea’s PASS^® TULIP provides a procedurally-integrated solution for surgeons to benefit from the Company’s UNiD™ ASI technology, a scientific, data-driven model for personalized spine care. The PASS^® TULIP components are fully compatible with Medicrea’s PASS LP^® to provide a unique hybrid approach in complex indications. The first-ever patient-specific hybrid spine surgery was successfully performed by Dr. Frank Schwab, Chief of Spine, at the Hospital for Special Surgery in New York.

“By using two compatible implant designs in a hybrid application, I am able to personalize a patient’s operation in a whole new way. The increased flexibility and precision help me to best achieve the patient’s optimal spinal alignment targeted by Medicrea’s patient-specific implants,” stated Dr. Schwab, who uses UNiD™ ASI technology to strategically plan cases supported by the UNiD™ LAB team. “Having these additional tools to achieve my surgical strategy translates to better alignment post-operatively and that’s clearly been shown to correlate with patient satisfaction and with long-term benefits of surgery.”

Denys Sournac, President and CEO, stated, “We are pleased to extend our distinctive Lifetime Warranty covering UNiD™ Rod constructs to include associated PASS^® TULIP components.” Mr. Sournac continued, “The addition of PASS^® TULIP to our comprehensive implant range will open new doors for Medicrea to gain market share for our UNiD™ ASI technology by lowering the barrier to entry for the large number of surgeons trained on top-loading instrumentation.”

PASS^® TULIP components are differentiated from traditional top-loading implants by a thoughtful proprietary design that allows a single implant to perform multiple clinical functions through a simple one-step maneuver. The anticipated result is increased surgical efficiency in implant placement as well as a reduction in the inventory required for a case and associated processing costs.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France, housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: Medicrea.com.

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Medicrea is listed on
ALTERNEXT Paris
ISIN: FR 0004178572
Ticker: ALMED