In traditional fracture repair, the rigidity of locking screws can lead to discomfort, pain and healing complications. Research has shown that the complications related to delayed unions and non-unions of implants may lead to implant fatigue and failure, and often result in the need for secondary procedures.
When Douglas L. Cerynik, M.D., MBA, was the Director of Orthopaedic Research at Drexel University College of Medicine in 2009, he saw firsthand how complications due to rigid locking screws affected patients. He and three fellow MBA classmates launched StabilizOrtho to focus on the design and manufacture of a novel system. Today, he is CEO and Director of the company.
Introducing Motion Into the Mix
StabilizOrtho has developed the first FDA-cleared plate and hybrid metallic/polymer screw system that adjusts with the body during fracture healing. Their signature product is the Stabiliz Polymer Locking (SPL) screw, which combines a stainless steel screw with a biodegradable and biocompatible polymer (PLGA) locking mechanism.
SPL screws are dynamic, introducing motion into fractures that are being stabilized by plates and screws.
“Micromotion improves bone healing,” Dr. Cerynik said. “Motion is initiated over time utilizing a bioresorbable polymer locking mechanism on our SPL metallic screws. SPL screws function in a manner similar to conventional locking screws at implantation and reduce construct stiffness over time, promoting interfragmentary motion. By introducing motion with time, we naturally stimulate the bone healing process.”
Using common bicortical screw and plating methods, surgeons do not need to learn new techniques to utilize the Stabiliz plating system. No additional procedure steps such as shims or locking caps are necessary, and SPL screws can be used in any plate hole.
“Our technology allows the trauma surgeon to use it in conjunction with their current standard of care,” Dr. Cerynik said. “We allow the surgeon to choose where and when to use our SPL screw versus a standard locking or non-locking screw. They have total flexibility.”
The innovation lies in the polymer locking mechanism. SPL screws function in a manner similar to conventional locking screws at implantation. Over four to six months, the PLGA locking mechanism resorbs, reducing stiffness and creating interfragmentary motion at the injury site while under load. (See Exhibit 1.)
“SPL locking technology is important because mainstay screw systems are limited in function and patients continue to suffer poor outcomes as a result,” Dr. Cerynik said. “Our implants are a revolutionary improvement on an existing – but problematic – treatment method.”
Filling a Need in the Market
The trauma space has been ripe for innovation, particularly in fracture fixation. The challenges associated with long-term positive outcomes have not changed significantly in recent years, inviting the opportunity for StabilizOrtho to create a cutting-edge solution.
In peer-reviewed literature, SPL screws have shown a decrease in axial stiffness of up to 57% after resorption of the locking mechanism. StabilizOrtho’s target applications will expand to include all fractures that can be plated, including both long and small bone fractures.
The market potential is large, with fracture fixation taking up a sizable portion of the $7 billion orthopedic trauma market in the U.S. The plate and screw market is dominated by the industry’s largest players, but hundreds of mid-market and smaller companies also exist.
“The largest subsegment is the $3 billion plate and screw market, where we operate,” Dr. Cerynik said. “Similar to when locking screws were introduced, we expect our SPL technology to increasingly become the standard of care. This means Stabiliz is used in an increasing number of fracture types and patient populations, especially those with complex, hard to heal conditions.”
StabilizOrtho is selling its screws into multiple accounts to key opinion leaders in the trauma space. As they expand their user base, they seek to grow their product offering.
When envisioning the next five years, Dr. Cerynik sees SPL screws becoming the gold standard of care when plates and screws are used in fracture repair.
“A seismic shift will have occurred in clinical practice wherein the things which are now done clinically to enhance motion are done naturally and instinctively by way of Stabiliz SPL technology,” he said.
Heather Tunstall is an ORTHOWORLD Contributing Editor.