MEDICREA Secures FDA Approval For TULIP GENESIS Solution

MEDICREA has received FDA Clearance for its TULIP GENESIS which completes its UNiD Adaptive Spine Intelligence (ASI) platform technology.

MEDICREA aims at digital transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD ASI software platform, services and technologies.

The FDA clearance of TULIP GENESIS marks the completion of UNiD ASI platform by providing a top loading screw solution designed to integrate seamlessly with UNiD ASI.

In addition, it is an advanced comprehensive top loading screw system that offers solutions for both degen and complex deformity cases.

MEDICREA president and CEO Denys Sournac said: “To date, we have performed more than 4,000 cases using the UNiD ASI technology, with a strong and continuous adoption rate in the US of +47% since the beginning of the year.

“With the adoption of the UNiD ASI technology accelerating, MEDICREA created a unique opportunity for a pull-through effect by offering surgeons a complete solution of implants. TULIP GENESIS completes MEDICREA’s portfolio to achieve full pull-through and incremental revenue”.

TULIP GENESIS is the only FDA-cleared top loading screw system that can be used with the unique UNiD ROD

MEDICREA said that its implant database integrated within the UNiD HUB includes IB3D, the 3D-printed patient-specific interbody cages, UNiD ROD, a patient-specific rod for optimal individual surgical simulation, PASS LP, a modular screw system, and TULIP GENESIS, a top-loading screw system.

In addition, its proprietary UNiD ASI technology is a comprehensive collection of solutions that comprise of services and products designed to help surgeons improve the patient’s outcomes.

The platform   enables the surgeon to plan cases preoperatively by leveraging artificial intelligence and the latest clinical research. The Artificial Intelligence embedded platform facilitates surgeons to envisage the compensatory mechanisms above and below the instrumented spine.

UCSF Medical Centre spinal tumor and spinal deformity surgery director Chris Ames said: “The combination of big data and patient-specific care is the new frontier. MEDICREA’s technologies are specifically developed to that effect.

“They help surgeons better manage the entire clinical workflow, providing them with targeted relevant data, to help them better analyze and plan, leading to improved clinical results. Through the power of data collection and machine learning, a unique capability is created, allowing for a continuous cycle of improvement.” – NS Medical Devices