FDA-approved system enables safe, smooth and accurate fixation
Differentiated hydraulic design gives spinal surgeons greater freedom
Used in more than 50 surgeries worldwide; now seeking U.S. investors and partner
HORSHAM, PA / ACCESSWIRE / September 23, 2024 / OrtoWay-US Inc., inventors and developers of the world's first hydraulically-powered OrtoWell® Distractor for spinal surgery, announced today 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.
Seeking commercialization partners
With the recent granting of its U.S. patent and the company's product entering a new phase of development, Mikulowski states that OrtoWay-US Inc. is actively seeking partners and investors to support the further commercialization of the OrtoWell® Distractor.
* Clinical Case published as abstract in 2018 by ISASS, Toronto, Canada.
For further information, please contact:
Stan Mikulowski, CEO of OrtoWay-US Inc.
Two Walnut Grove Drive, Suite 100
Horsham, PA 190 44 USA
stan.mikulowski@ortoway-usa.com
Phone (Sweden): 01146 708 769 991
www.ortoway-usa.com
About OrtoWay
OrtoWay was founded in 2006 by a group of Swedish experts in biomaterials, spinal surgery and medical technology aiming to enhance anterior surgical techniques and the implantation of spinal prosthesis in the lumbar region. OrtoWay-US Inc., the current developer and IP holder of the OrtoWell® Distractor System is a privately held medical technology company actively seeking commercialization partners. The OrtoWell® instrument recently received a U.S. patent for corpectomy use and is FDA approved for use as a Class 1 Medical Device. The product will be made available 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.
U.S. patent numbered US 12,023,017 B1 / OrtoWay-US Inc.
U.S. patent number 8,152,811 / OrtoWay-US Inc.
Additional U.S. patent pending.
Attachments & photos:
- Newly redesigned OrtoWell® Distractor Caddy Equipment
- Case Report (with images) involving spine inflammation that required a 2-level corpectomy, vertebral body replacement and fusion, by Dr. Biren Desai, head of the Department of Spinal Surgery at Dreifaltigkeits Clinic, Cologne, Germany.
- U.S. Patent 12,023017 B1, issued July 2, 2024: "Apparatus, Methods and Systems for Spine Surgery."
Contact Information
Stan Mikulowski
CEO
stan.mikulowski@ortoway-usa.com
01146708769991
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SOURCE: OrtoWay-US Inc.
View the original press release on newswire.com.
