MALVERN, Pa., July 15, 2022 (GLOBE NEWSWIRE) — Waypoint Orthopedics, Inc., a spinal instrumentation firm, introduced the corporate’s current submission of an FDA 510(okay) software for the Waypoint GPS™ – a wise bone axe to be used throughout pedicle screw pilot gap drilling. The system is designed to supply the surgeon visible suggestions that signifies a change in shade on the tip of the probe and will point out contact of the tip with mushy tissues and potential vertebral cortex perforation. The Waypoint GPS™ is indicated to be used in each open and percutaneous (MIS) surgical approaches to the backbone.
The Waypoint GPS is a Good Gear Shift™ that appears, feels, and acts like a normal bone axe, whereas offering the operator with further info through visible suggestions. It makes use of proprietary color-sensing expertise displayed wirelessly to an app-based working system in real-time – probably making vertebral fixation safer and extra environment friendly for everybody within the working room.
“The Waypoint Orthopedics crew has labored tirelessly during the last 18 months to develop and take a look at the Waypoint GPS, in anticipation of this submission. I’m extremely pleased with all of the exhausting work,” stated Jeffrey F. O’Donnell, Jr., President and CEO of Waypoint Orthopedics. “We’re excited to work with the FDA in bringing this much-needed instrument to the working room, enhancing the surgeon’s confidence through the cannulation of every pedicle, whereas probably decreasing the quantity of ionizing radiation throughout a case. We consider in surgeon designed merchandise, and have had large enter and steerage from our world-class Surgeon Advisory Board all through this course of.”
Waypoint Orthopedics, a Runway Healthcare LP portfolio firm, will look to switch its expertise to a industrial entity upon approval from the FDA, which is anticipated later this yr.
About Waypoint Orthopedics:
Waypoint Orthopedics, Inc. was based to make vertebral fixation safer and extra environment friendly for the affected person, surgeon, and assist workers. Waypoint Orthopedics’ controlling stockholder is Runway Healthcare, LP – a MedTech accelerator fund.
Inquiries: Data@WaypointOrthopedics.com | www.WaypointOrthopedics.com
About Runway Healthcare Companions, LLC:
Runway Healthcare is an early-stage MedTech Accelerator. Runway funds and manages the product growth technique of all portfolio firms. After navigating the corporate by way of the regulatory course of, Runway transitions the corporate’s possession to bigger multi-national healthcare firms for commercialization. Runway Healthcare is concentrated on early-stage expertise within the Orthopedic, Cardiovascular, and Neurology sectors.
Inquires: Data@RunwayHC.com | www.RunwayHC.com
This press launch accommodates “forward-looking statements” regarding the growth of Waypoint Orthopedics merchandise, the potential advantages and attributes of these merchandise, and the corporate’s expectations relating to its prospects. Ahead-looking statements are topic to dangers, assumptions, and uncertainties that might trigger precise future occasions or outcomes to vary materially from such statements. These statements are made as of the date of this press launch. Precise outcomes could fluctuate. Waypoint Orthopedics undertakes no obligation to replace any forward-looking statements for any purpose.