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 device design and manufacturing with UNiD ASI™ technology, announced today the successful completion of a 360-degree spinal surgery using a bespoke combination of patient-specific implants generated by Medicrea’s proprietary UNiD ASI™ system technology.

The complex two-stage operation took place in London at the Wellington Hospital and was performed by Orthopaedic Surgeon, Dr. Benjamin Taylor, MB, BS, MCh(ortho), FRCS, FRCS(Ed). Dr. Taylor partnered with Medicrea’s UNiD LAB™ team of specialized biomedical engineers to strategically plan the operation and design four custom implants to be precisely manufactured in titanium at the company’s new ultra-modern facilities, all within a tight deadline before surgery. The successful outcome was the result of patient-specific spinal instrumentation being implanted from the front and back to create the first-ever 360-degree personalized spinal surgery.

“The ability to strategically plan and manufacture personalized implants in a controlled iterative process generated by Medicrea’s proprietary UNiD ASI™ system technology was a key element in the success of this operation, helping me to simplify and expedite the procedure. Because the implants are scientifically designed using clinical data, I am confident that this patient will continue to see improvements in their quality of life due to the sophisticated outcome-based technology that UNiD ASI™ injects throughout the process,” stated Dr. Taylor following the operation.

Medicrea’s UNiD ASI™ systems technology was used to create a fully personalized solution for the operation that was adapted to both surgeon and patient requirements. The process began with the Company’s UNiD LAB™ engineers using proprietary planning software to turn Dr. Taylor’s surgical plan into a fully digital simulation using patient imaging. The optimal surgical strategy was then identified by Dr. Taylor who was able to draw on the technology’s Adaptive Spine Intelligence™ to directly answer to his and his patient’s needs. Medicrea’s engineering team took this strategy and translated the digital plans into patient-specific implants, using its proprietary manufacturing techniques to create bespoke spinal rods and interbody devices for the operation.

On the day of the surgery, the implants were already at the hospital, prepared to be placed in two stages. First, Dr. Taylor addressed the patient’s spine through an anterior approach where three custom UNiD™ Cages were inserted between the patient’s lumbar vertebrae to restore the exact height to the spine according to the patient’s unique anatomy. The implants were also perfectly sized to form an exact fit between the patient’s vertebrae, leading to a marked reduction in the operation time required to size and place standard off-the-shelf implants.

In the second stage of the operation, the patient’s spine was approached posteriorly. Here, Dr. Taylor inserted two patient-specific UNiD™ Rods to stabilize the patient’s spine in a predetermined patient-specific alignment. Sagittal alignment of the spine is well known to be directly correlated with the long-term success of a spinal surgery, and as such, matching the rod’s shape with the patient’s unique spinal curvature is a critical component of the surgery and was previously only achieved by manually bending the rod during the operation.

Denys Sournac, President and CEO of Medicrea, stated, “Our partnership with Dr. Taylor in this case demonstrates the power of UNiD ASI™’s system-based approach. We offer true collaboration with surgeons to deliver outcome-based data science that is adapted to surgeon and patient in each spine surgery. The result has been to drive improved outcomes and efficiencies in more than 1,500 UNiD ASI™ cases to date. ”

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea 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 175 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.

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Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that Serrato™ Pedicle Screws have been implanted by more than 100 surgeons across the U.S. during the first 30 days since release, prior to full commercialization.

The Serrato Pedicle Screw is the first dual-thread screw with enhanced cutting flutes (serrations) that are designed to reduce work by lowering the insertion torque, and True-tip geometry, which allows for precise insertion and immediate bone engagement. Stryker’s design innovations elevate one of the most basic spinal surgery tools, with the goal of reducing work, increasing speed, and enhancing surgeon efficiency.

“We are very excited by the initial response to Serrato from our early users,” said Bradley Paddock, President of Stryker’s Spine division. “The feedback from surgeons is exceeding expectations.”

“Game-changing screw,” said Roderick Sanden, M.D., an orthopedic surgeon with Advanced Neurospinal Care and Sutter Roseville Medical Center in Northern California. “I never thought a pedicle screw made that much of a difference until I put in a Serrato screw.”

“The Serrato screw insertion was exactly what I was hoping for,” said Scott Luhmann, M.D., Head of Surgery, Pediatric Orthopaedics at Shriners Hospital for Children in St. Louis. “It allowed for easy initiation of the screw, good tactile feedback, and excellent purchase!”

The Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia^® 3 Spinal System, received 510(k) clearance from the U.S. Food and Drug Administration in May 2017. Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purpose of stabilization. The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

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Dr. Luhmann is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.