OrtoWay Creates New Segment in Spinal Field With Next-generation Hydraulically Powered OrtoWell® Distractor

Thursday, May 21, 2020

OrtoWay AB, makers of the OrtoWell® Distractor - the world's first hydraulically powered device for spinal surgery - today announces new tool design improvements extending the clinical usage. It has also formed a new subsidiary and established manufacturing in Tuttlingen, Germany to secure world-class quality - laying a safe and solid foundation for US launch.

For the first time ever, the novel device puts hydraulic power in the hands of spinal surgeons for safer, smoother, gentler and more controlled separation of vertebral bodies - ensuring high accuracy in fixation. Compared with manual alternatives, it offers a new level of holding strength and freedom of movement, with very precise calibrations. This provides a controlled, measured and reproducible solution for opening the space between vertebra, making it easier to remove all of the disc - without excessive force. In other words, less time in the OR without speeding up the procedure.

Despite the COVID-19 situation, pent-up demand for elective spine surgeries means the sector is likely to be among the first to bounce back, according to a report by Moody's Analytics. Here, the OrtoWell® Distractor will provide a safe, well-proven solution, having now been used in more than 50 surgeries worldwide.

Clinical Research program continues
Currently, the company says it is halfway through a clinical research program in Germany, which is continuing successfully without any complications or delays due to Covid-19 or other. This is expec- ted to provide a solid and credible backbone for an eventual US market entry.

Safety - the guiding star
"The guiding star for these latest steps is to offer spinal surgeons a safer, more efficient and fully thought-through professional system to meet their surgical challenges," says Stan Mikulowski, CEO of OrtoWay.

He adds: "To satisfy the stringent demands of German spinal clinics and hospitals, it made sense to open our next subsidiary, OrtoWay GmbH, in Southern Germany close to Tuttlingen, which is regarded as an important global center of excellent for the manufacturing of surgical tools."

New design improvements
The new design improvements cover the entire OrtoWell® Distractor System - a thorough adapta- tion of the instrument to fit the modern needs of different clinical situations, including revisits.

"This is truly the next generation of OrtoWell® and will allow spinal surgeons new surgical options such as use in MIS," says Mikulowski. "It can be used from the anterior and posterior approach - one sided, two sided, or for multilevel surgeries, depending on the clinical condition."

Opening new possibilities
"Naturally, the specific application of the device will depend a lot on the patient situation and sur- geon's preference," he says. "But it puts new choices in their hands, opening time-saving possibility for everything from spinal corpectomies and lumbar disc prosthesis to tumor removal, ALIF cages, minimally invasive surgery and revisits."

Commercialization partners wanted
As the product enters a new phase of development, Mikulowski says OrtoWay is actively seeking partners and investors who can support further commercialization of the OrtoWell® Distractor.

About OrtoWay AB
OrtoWay AB was founded in 2006 by a group of experts in biomaterials, spinal surgery and medical technology who were looking for ways to improve anterior surgery and implantation of spi- nal prosthesis in the lumbar region. The developer behind the OrtoWell® Distractor System, OrtoWay is currently a Swedish privately held medical technology company that is seeking partners for commercialization. The OrtoWell® instrument has CE marking for medical devices in Europe and is approved for usage as a Class 1 Medical Device in the USA. The product will be made availa- ble through OrtoWay LLC, an independent company based near Philadelphia, Pennsylvania, USA.

Patents & registrations
OrtoWay has received patents for this invention in Europe, the USA and in Australia. OrtoWell® is a registered trademark in the USA, Canada, EU and Australia.
Currently OrtoWay is looking for partners to commercialize this invention. US patent number 8,152,811, CE Marked / OrtoWell® Distractor.
Additional US patent pending.

Newly redesigned OrtoWell® Distractor Caddy Equipment

For further information, please contact:
Stan Mikulowski, CEO of OrtoWay AB, and OrtoWay GmbH
Cell Phone: + 46-708-769-991. From the US: 00146-708-769-991.
OrtoWay AB, Svärdvägen 21, SE-182 33 Stockholm, Sweden. info@ortoway.com / www.ortoway.com