OrtoWay-US Inc., inventors and developers of the world’s first hydraulically-powered OrtoWell® Distractor for spinal surgery, announced the receipt of a new patent from the U.S. Patent Office for its OrtoWell® Distractor system. The patent, numbered US 12,023017 B1, entitled “Apparatus, Methods and Systems for Spine Surgery,” was issued on July 2, 2024. It covers the innovative application of the company’s hydraulically powered distractor for use in corpectomy procedures.
“We are thrilled to receive this newly issued U.S. patent,” says Stan Mikulowski, CEO of OrtoWay-US Inc. “While we have already obtained FDA approval, securing our intellectual property is a crucial step for future investors and our continued commercial success.”
New possibilities for spinal surgeons
The award-winning OrtoWell® Distractor System, originally invented in Sweden and now manufactured in Tüttlingen, Germany (with U.S. production planned), opens new possibilities for spinal surgeons seeking to separate vertebrae for disc implant insertion. Traditional handheld wedge distractors, clamps and retractors often struggle to maintain structural integrity during longer operations. In contrast, the uniquely designed OrtoWell® system addresses and overcomes these challenges.
“Spinal surgeons today face immense pressure to work efficiently, safely, and avoid complications while achieving high efficacy,” says Stan Mikulowski. “During anterior surgeries, it’s not uncommon to encounter up to 100 kg (220 lbs) of axial pressure in the spine, which increases the risk of vertebral damage when using hammers or conventional clamps that may collapse under the strain.”
Safer, smoother, gentler
The novel OrtoWell® device leverages hydraulic power, enabling spinal surgeons to carry out safer, smoother, gentler and more controlled separation of vertebral bodies. This is achieved through a controlled, measured and reproducible solution for opening the space between vertebra, making it easier to remove a disc – without excessive force.
To date, the distractor system has been utilized in more than 50 surgeries worldwide. It includes several permanent parts that must be autoclaved on site (distractor unit, spanner tools, retractors, frame, tools, tray) as well as refurbishable parts (tube unit, gauge, hooks, bone screws), which are returned to us for inspection, cleaning and sterilization. The revenue model is based on repeatable use of refurbished parts.
Used by leading spinal clinics
The OrtoWell® Distractor has been utilized by prominent spinal clinics, with published case reports and ongoing clinical research in Germany. For instance, a leading German spinal surgeon at Sana Dreifaltigkeits-Krankenhaus Köln Clinic (https://www.sana.de/koeln) in Cologne, Germany, successfully employed the hydraulic device in a case involving spine inflammation that required a 2-level corpectomy, vertebral body replacement and fusion. *
In 2020, OrtoWell® was recognized for its design and excellence, winning its category at the MedTech Awards from Global Health and Pharma Magazine (GHP), which was established to honor “innovators and leaders reshaping their sectors.”
To meet the rigorous demands of German and U.S. spinal clinics and hospitals, OrtoWay-US Inc. has recently established a subsidiary, OrtoWay GmbH, in Southern Germany near Tüttlingen – a globally renowned center for surgical tool manufacturing. The company also operates out of Horsham, PA, USA, near Philadelphia, with plans to initiate manufacturing operations in Pennsylvania.
About OrtoWay
