Exciting news for medtech startup IPD: the company has officially received the prestigious FDA Breakthrough Device Designation and is preparing to launch clinical trials in the Netherlands and, subsequently, the United States. With this breakthrough designation, the Leiden-based company is significantly accelerating its efforts to bring its patented induction technology to the U.S. market. The innovation is designed to tackle implant-related infections at the source without the need for major revision surgery.
“The idea was clear: use induction heating to heat the implant locally and briefly in order to immediately destroy the harmful bacterial biofilm. It is applied during the first re-intervention without damaging the surrounding tissue while the implant is still in the patient. In addition, this approach eliminates the need for major revision surgery, ” says Richard van de Wateringen, CEO of IPD. At PLNT, the startup evolved from the initial concept and prototype phase with manufacturers into a professional organization.
The Power of Contactless Induction Heating
What makes IPD Health’s technology unique is its use of a patented induction heating technique. By briefly heating an implant locally and very precisely for 90 seconds, a harmful bacterial biofilm is destroyed without damaging the surrounding tissue.
This breakthrough eliminates the need for major, invasive recovery procedures for patients and serves as the direct basis for obtaining FDA Breakthrough Device Designation. ““Our primary focus is on the U.S. market and obtaining FDA approval,” says Van de Wateringen. “With the FDA Breakthrough Device Designation, we receive valuable support to bring our technology to market quickly.” In September, IPD was also admitted to the FDA’s “Total Product Life Cycle Advisory Program,” or TAP.
Building a New Standard of Care
Although not many people experience complications related to implants, they pose enormous medical challenges every year. IPD Health aims to change that with a revamped care pathway, which helps treat serious postoperative complications and infections.
“We want to establish a new international standard of care for the treatment of infections associated with orthopedic and other metal implants,” Van de Wateringen explains. “Our goal is to create a comprehensive care pathway that will drastically reduce serious complications and significantly improve clinical outcomes for patients.” Clinical trials will begin in the Netherlands and, in 2027, in the United States to demonstrate this effectiveness in practice.
A Strong American Network
Anyone looking to conquer the U.S. market cannot do so from Europe alone. That is why IPD is building strong bridges across the ocean by working closely with leading partners and networks. For example, starting October 1, 2026, IPD will participate in the renowned Texas Medical Center Biobridge program, among others. In addition, IPD participated in programs such as the Cedars-Sinai Accelerator Program in Los Angeles, the Zimmer Biomet Ambassador Program, and the Plug and Play MedTech Batch 4 program. These programs helped them expand their network in the United States. Communication channels remain short thanks to IPD’s development team in the Netherlands.
Moving on to the next phase
In addition to its regulatory successes and clinical progress, the company itself is also moving forward. Management has recently secured bridge financing to further expand its efforts toward the U.S. market, continue clinical trials, and ensure upscaling.
“PLNT’s entrepreneurial environment has supported us in our development,” Van de Wateringen concludes. “Together with our engineering team in the Netherlands, our American partners, and the bridge financing, we are working to further scale up IPD Health.” From a smart idea in Leiden to a medical revolution on the other side of the ocean.
