MALVERN, Pa., Could 16, 2023 (Newswire.com) – Waypoint Orthopedics, Inc., a spinal medical system firm, broadcasts that the corporate’s Waypoint GPS™ – a sensible bone axe to be used throughout pedicle screw pilot gap drilling – has obtained 510k clearance from the U.S. Food and Drug Administration (FDA).
The Waypoint GPS is a Good Gear Shift™ that appears, feels, and acts like an ordinary bone axe whereas offering the operator with extra data by way of visible suggestions. It makes use of proprietary color-sensing know-how displayed wirelessly to an app-based working system in real-time. The Waypoint GPS confirmed 100% operator interpretation cancellous, cortical, and breach throughout an in-vivo research. The system has the potential to extend surgeon confidence in pilot gap drilling whereas additionally doubtlessly obviating the necessity for dangerous ionizing radiation for all events within the working room. The system is indicated to be used in each open and percutaneous (MIS) surgical approaches to the spine.
Dr. Andrew Cappuccino, an orthopedic spine surgeon, stated: “The Waypoint GPS is an easy instrument that may guarantee security throughout the pedicle for the location of pedicle screws. I imagine that the combination of the Waypoint GPS helps to decrease radiation publicity and save time within the correct placement of pedicle screws.”
Jeffrey F. O’Donnell, Jr., President and CEO of Waypoint Orthopedics, stated: “We’re proud to announce the FDAs clearance of the Waypoint GPS. We firmly imagine this product will turn out to be an on a regular basis instrument for spine surgeons saving time, growing confidence in screw placement, and including layers of security to each case no matter strategy. The Waypoint GPS has been designed to combine simply into any workflow, all whereas offering the surgical staff with data clearly and intuitively. As a Runway Healthcare portfolio firm, we are going to look to switch Waypoint Orthopedics to an present industrial entity for wide-scale commercialization.”
Dr. Stephen Banco, an orthopedic spine surgeon and co-founder of Waypoint Orthopedics, stated: “The Waypoint GPS offers surgeons real-time suggestions and confidence as they cannulate pedicles with extremely easy and easy-to-use know-how. I stay up for using the Waypoint GPS in all of my instrumented fusions shifting ahead as an extra layer of security and reliability.”
Waypoint Orthopedics is the primary portfolio firm of Runway Healthcare, LP, a MedTech accelerator fund. Runway Healthcare builds commercially prepared alternatives for the medical system trade to amass following regulatory approval.
About Waypoint Orthopedics:
Waypoint Orthopedics, Inc. was based to make vertebral fixation safer and extra environment friendly for the affected person, surgeon, and help workers. Waypoint Orthopedics’ product, the Waypoint GPS, makes use of proprietary color-sensing know-how to tell the operator of the bone/tissue sort change on the slicing fringe of the axe. Waypoint Orthopedics’ controlling stockholder is Runway Healthcare, LP – a MedTech accelerator fund.
About Runway Healthcare, LP:
Runway Healthcare, LP is an early-stage MedTech accelerator. Runway Healthcare funds and manages the product improvement means of its portfolio corporations. After navigating a portfolio firm by means of the regulatory course of, Runway Healthcare transitions the corporate’s possession to a bigger multi-national healthcare firm for commercialization. Runway Healthcare is targeted on early-stage know-how within the Orthopedic, Cardiovascular, and Neurology sectors.
This press launch comprises “forward-looking statements” in regards to the improvement 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 would 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 might fluctuate. Waypoint Orthopedics undertakes no obligation to replace any forward-looking statements for any cause.
Supply: Waypoint Orthopedics, Inc.