Dutch medical innovations are rarely granted the Breakthrough Designation by the FDA. Startup ATRO Medical from Nijmegen is the new kid on the block in orthopedics. This week their Trammpolin meniscus prosthesis, designed to treat chronic knee pain, received the Breakthrough Device Designation from the FDA. The designation demonstrates the innovation potential of this implant and expedites US market access by receiving a priority treatment at the FDA.
The US Food & Drug Administration identifies the Trammpolin meniscus prosthesis as a unique and potentially more effective treatment for knee osteoarthritis patients with a deficient meniscus. At the moment there is no effective treatment available for a large group of these patients.
CEO Jan Hunik is excited to receive the Breakthrough Device Designation: “We still have quite some work to do before we can access the US market and obtain the CE mark for the European market. This designation endorses our conviction that the Trammpolin meniscus prosthesis can make an important impact on the lives of patients suffering from chronic knee pain. We look forward to the more intense collaboration with the FDA and are confident that this will expedite our US timelines.”
The goal of the Breakthrough Device Designation program is to provide patients and their health care providers with timely access to effective medical innovations. The designation ensures a predictable and timely assessment by the FDA. The Trammpolin meniscus prosthesis will have priority in upcoming FDA reviews. The FDA will also give more transparency with respect to the required data for market access of ATRO Medical’s meniscus implant.
Knee Osteoarthritis (KOA) is an irreversibly debilitating disease and is one of the leading causes of disability in Europe and the US. The Trammpolin meniscus prosthesis is a durable anatomically shaped implant that aims to reduce knee pain and restore mobility. Trammpolin is currently being assessed in a first clinical study in the Netherlands. A next study will most likely include clinics in other European countries as well as the United States. ATRO Medical is largely financed by venture capital and is expected to organize a next investment round (Series B) in 2021 to further accelerate its path to the EU and US market.
source: Atro Medical