Medicrea issued the following announcement on Aug. 2.
The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED ; OTCQX Best Market – MRNTF), pioneering the digital transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that it has received FDA-Clearance for TULIP GENESIS™ which completes its UNiD™ ASI platform technology.
With the FDA clearance of the TULIP GENESIS™, MEDICREA® completes its UNiD™ ASI platform by providing a top loading screw solution designed to integrate seamlessly with UNiD™ ASI. TULIP GENESIS™ is a state-of-the-art comprehensive top loading screw system that competes with any screw system on the market offering solutions for both degen and complex deformity cases. It is the only FDA-cleared top loading screw system that can be used with the unique UNiD™ ROD.
MEDICREA® ’s implant database integrated within the UNiD™ HUB now includes: IB3D™, a selection of 3D-printed patient-specific interbody cages ; UNiD™ ROD, a patient-specific rod industrially pre-bent to precisely match the optimal individual surgical simulation ; PASS LP™, a modular screw system; and TULIP GENESIS™, a top-loading screw system.
MEDICREA® ’s proprietary UNiD™ ASI technology is a comprehensive suite of solutions comprising services and products designed to help surgeons improve their patient’s outcomes. By leveraging artificial intelligence and the latest clinical research, the platform enables the surgeon to plan cases preoperatively. The Artificial Intelligence embedded within the platform allows a surgeon to visualize the compensatory mechanisms above and below the instrumented spine that will most likely occur based on their surgical plan.
This unique technology offers solutions designed both for complex deformity and degenerative applications. The combination of A.I. with this product offering makes MEDICREA® the only manufacturer able to streamline inventory required to operate as well as provide patient-specific devices, through intelligent pre-operative surgical planning.
“The combination of big data and patient-specific care is the new frontier,” says Dr Chris Ames, MD, Director of spinal tumor and spinal deformity surgery at UCSF Medical Center, CA . “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.”
The MEDICREA® ’s UNiD™ LAB team of biomedical engineers can more efficiently generate comprehensive surgical plans, using outcome-centered predictive modeling algorithms to optimize surgical strategy. These documented UNID™ surgical plans also allow the operating room staff to clearly anticipate when each implant will be needed by the surgeon. This is a critical combination as it streamlines the OR workflow with precise pre-selected implants and alignment of staff to the patient specific surgical plan and as it makes the surgery safer for the patient by reducing the chances for errors.
Denys Sournac, President and CEO, to conclude “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”.
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 200 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.
Original source can be found here.