The EDG Ortho 65mm is the first and only single-use electronic depth gauge. It is designed to more accurately measure length for orthopedic surgical screws, and also mitigate bioburden contamination, a leading cause of surgical site infections. EDGe Surgical’s device provides healthcare professionals, hospitals, and outpatient medical facilities with a digital alternative to analog depth gauges for greater accuracy at a decreased cost, all while mitigating infection risk.
The company’s EDG Ortho 65mm device has 510(k) clearance and is expanding beyond initial facilities into wider availability.
“The positive reception we’ve received from surgeons to our pilot launch, which started earlier this year, illustrates that our device fills a major market need for a depth gauge that enables more accurate screw selection without the worry of bioburden contamination risk,” said Christopher Wilson, president and CEO of EDGe Surgical. “We appreciate the continued support of our sophisticated angel investors, who bring surgical and medical device C-suite expertise, to help us quickly move the needle. Closing our Series A round will allow us to expand availability of our EDG Ortho 65mm and develop additional new products to serve customers seeking cost-effective and highly advanced solutions.”
Until now, the most common approach for orthopedic surgical measurement has been using a traditional analog depth gauge with a sliding metal scale to determine drill depths and screw lengths. The EDG Ortho 65mm can overcome the drawbacks of these traditional depth gauges, invented almost a century ago, by eliminating many of the inefficiencies and financial costs, such as:
- Up to 20 percent of measurements using the traditional analog depth gauge are inaccurate. Mismeasurement is a leading cause for wasted screws/implants, which is estimated at a $200 million a year cost to the healthcare system.
- Traditional analog depth gauges are reusable by design and are difficult if not impossible to clean properly, and sterilization is not effective on insufficiently cleaned surgical instruments based on a recent study at a university hospital Level 1 trauma center.
- Per case costs associated with using a traditional depth gauge are estimated to be greater than $400, with traditional device downsides including bone non-unions, implant-related complications, infection risk, and unnecessary radiation exposure.
The EDG Ortho 65mm can significantly reduce costs as a result of greater accuracy (i.e., less wasted screws), reduced infection risk, and greater measurement consistency. For example, the EDG Ortho 65mm reduced measurement error by up to 90 percent in recent cadaver and sawbones accuracy labs, and a study presented at the 2018 Annual Meeting of the American Society for Surgery of the Hand (ASSH) found a significant reduction in the rate of major measurement error in sawbones models compared to the traditional analog depth gauge.