New Clinical Study Confirms Safety and Effectiveness of the OrtoWell® Hydraulic Distractor System

"A key step toward establishing a new future standard in spinal surgery"

HORSHAM, Pa., Nov. 10, 2025 /PRNewswire/ -- OrtoWay-US Inc, the US-German MedTech innovator focused on spinal surgery tools for orthopedic vertebral separation, today announced the publication of the first prospective, multi-center clinical study evaluating its OrtoWell® Distractor System – the world's first hydraulically powered vertebral distractor.

Unique and safe tool for surgeons
Unlike conventional instruments such as mallets or torque-based retractors, the OrtoWell® system uses a hydraulic mechanism that allows surgeons to open the vertebrae smoothly and safely, with finely controlled incremental pressure. This precise, stable control helps reduce the risk of over-distraction, complications or neural damage, leading to safer, more predictable surgical outcomes.

The study, published in Medical Devices: Evidence and Research (Dove Medical Press, October 2025) and available in abstract on PubMed, confirms the safety, usability, and intraoperative performance of the device across 30 patients treated in Germany. Results showed no device-related complications and consistent positive surgeon feedback on precision, stability and control.

Gentler, more controllable approach
"The data confirms what surgeons have long reported – that hydraulic distraction offers a gentler, more controllable approach to vertebral separation than mechanical systems," said Stan Mikulowski, CEO of OrtoWay-US Inc. "The OrtoWell® Distractor gives surgeons a new level of tactile precision, helping reduce procedural risk while improving predictability in spinal reconstruction. This is a key step to establishing a new future standard in spinal surgery."

Evidence-based advancement
Conducted between 2018 and 2023 at three German independent spine centers (Bonn, Essen, and Tutzing) and led by Professor Robert Pflugmacher at the Clinic and Polyclinic for Orthopedics and Trauma Surgery, University of Bonn, the study demonstrated that controlled hydraulic distraction can significantly improve the surgeon's ability to achieve precise alignment and fixation.

Avoiding complications 
Across all 30 cases, the OrtoWell® Distractor simplified complex spinal procedures and helped maintain stable patient parameters throughout surgery. Investigators noted that the system provided safer, more predictable control compared with traditional mechanical tools – reducing the risk of the slippage of retractors or destruction of cortical walls. Such complications can make motion preservation impossible and, as a last resort, require spinal fusion surgery.

Precision engineering meets clinical reality
The OrtoWell® Distractor System provides controlled, incremental hydraulic separation and fixation of vertebral bodies, enabling precise placement of prostheses or cages, while maintaining soft-tissue protection and optimal visibility. It supports multiple access approaches (anterior, lateral, oblique) and is suitable for use in degenerative, traumatic, and tumor-related pathologies.

Manufactured in Tuttlingen, Germany under ISO 13485:2016 certification, the systems is approved for use in the US for all prosthesis types. The underlying technology is protected by U.S. Patent No. 12,023017 B1 – Apparatus, Methods and Systems for Spine Surgery.

Earlier documented applications
The study builds on earlier work led by Dr. Biren Desai at Dreifaltigkeits-Krankenhaus Clinic in Cologne, which first documented successful multi-level corpectomy using the OrtoWell® system.

"Hydraulic control not only reduces the risk of vertebral damage — it transforms the surgical workflow," added Mikulowski. "We see this as the start of a broader shift toward more ergonomic, precision-based surgical tools."
                                                                           

About OrtoWay-US Inc.

OrtoWay-US Inc. is a privately held German-American medical technology company developing hydraulic solutions that improve safety and precision in spinal surgery. Founded by experts in biomaterials, spinal surgery, and MedTech engineering, OrtoWay is the developer of the OrtoWell® Distractor System, the first hydraulic device designed for controlled vertebral separation and fixation.

Headquartered in Horsham, Pennsylvania, with operations in Tuttlingen, Germany, the company holds FDA clearance (Class I) and a portfolio of US patents. OrtoWay-US Inc. is advancing the field of minimally invasive spine technology and actively pursuing strategic partnerships to support clinical adoption and global commercialization.

Learn more: www.ortoway-usa.com

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SOURCE OrtoWay-US Inc