MALVERN, Pa., May 15, 2023 (Newswire.com) - Waypoint Orthopedics, Inc., a spinal medical device company, announces that the company's Waypoint GPS™ - a smart bone awl for use during pedicle screw pilot hole drilling - has received 510k clearance from the U.S. Food and Drug Administration (FDA).
The Waypoint GPS is a Smart Gear Shift™ that looks, feels, and acts like a standard bone awl while providing the operator with additional information via visual feedback. It utilizes proprietary color-sensing technology displayed wirelessly to an app-based operating system in real-time. The Waypoint GPS showed 100% operator interpretation cancellous, cortical, and breach during an in-vivo study. The device has the potential to increase surgeon confidence in pilot hole drilling while also potentially obviating the need for harmful ionizing radiation for all parties in the operating room. The system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine.
Dr. Andrew Cappuccino, an orthopedic spine surgeon, said: "The Waypoint GPS is a simple instrument that can ensure safety within the pedicle for the placement of pedicle screws. I believe that the integration of the Waypoint GPS helps to lower radiation exposure and save time in the accurate placement of pedicle screws."
Jeffrey F. O'Donnell, Jr., President and CEO of Waypoint Orthopedics, said: "We are proud to announce the FDAs clearance of the Waypoint GPS. We firmly believe this product will become an everyday instrument for spine surgeons saving time, increasing confidence in screw placement, and adding layers of safety to every case regardless of approach. The Waypoint GPS has been designed to integrate easily into any workflow, all while providing the surgical team with information clearly and intuitively. As a Runway Healthcare portfolio company, we will look to transfer Waypoint Orthopedics to an existing commercial entity for wide-scale commercialization."
Dr. Stephen Banco, an orthopedic spine surgeon and co-founder of Waypoint Orthopedics, said: "The Waypoint GPS provides surgeons real-time feedback and confidence as they cannulate pedicles with incredibly simple and easy-to-use technology. I look forward to utilizing the Waypoint GPS in all of my instrumented fusions moving forward as an additional layer of safety and reliability."
Waypoint Orthopedics is the first portfolio company of Runway Healthcare, LP, a MedTech accelerator fund. Runway Healthcare builds commercially ready opportunities for the medical device industry to acquire following regulatory approval.
About Waypoint Orthopedics:
Waypoint Orthopedics, Inc. was founded to make vertebral fixation safer and more efficient for the patient, surgeon, and support staff. Waypoint Orthopedics' product, the Waypoint GPS, uses proprietary color-sensing technology to inform the operator of the bone/tissue type change at the cutting edge of the awl. Waypoint Orthopedics' controlling stockholder is Runway Healthcare, LP - a MedTech accelerator fund.
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About Runway Healthcare, LP:
Runway Healthcare, LP is an early-stage MedTech accelerator. Runway Healthcare finances and manages the product development process of its portfolio companies. After navigating a portfolio company through the regulatory process, Runway Healthcare transitions the company's ownership to a larger multi-national healthcare company for commercialization. Runway Healthcare is focused on early-stage technology in the Orthopedic, Cardiovascular, and Neurology sectors.
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Forward-Looking Statements:
This press release contains "forward-looking statements" concerning the development of Waypoint Orthopedics products, the potential benefits and attributes of those products, and the company's expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions, and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Waypoint Orthopedics undertakes no obligation to update any forward-looking statements for any reason.
Contact Information:Jeff O'Donnell
President & CEO
[email protected]
Original Source: Waypoint Orthopedics Announces FDA Clearance of the Waypoint GPS
