Lumendo rebrands to Odne and obtains FDA approval

OdneFill, the first light-curing endodontic filler - developed, patented, and produced by Odne - was successfully cleared by the U.S. Food & Drug Administration (FDA) in July 2023. Today, Odne announced that it has received clearance for its laser-based dental curing light (OdneCure) from the FDA, too. Based on this clearance, Odne can now legally market its endodontic obturation system, consisting of both products. OdneCure is used to irradiate the OdneFill after its application into the root canal. This converts the liquid OdneFill into a solid obturation material within seconds.

Odne’s COO, Mark Bispinghoff, who was leading the development, testing, and FDA-clearance process of OdneCure comments: “The clearance of OdneCure is the result of efficient teamwork and collaboration with our partners and suppliers. It paves the way on our mission to flip the way root canal treatments are done.”

Root canal treatments have long posed challenges for dentists, with traditionally low success rates ranging from 46% to 91%. With over 60 million annual treatments worldwide, these failures result in significant healthcare costs. Odne's technology platform addresses these issues by offering new treatment options.

The FDA clearance of OdneCure is a key milestone towards Odne’s commercial launch, planned for April 2024 in the U.S.A. By launching the world’s first injectable, instant light-curable, hydrophilic endodontic filler and the required curing light, Odne enables dentists and endodontists to obturate root canals with ease and confidence.

Last week Odne also announced the incorporation of Odne Inc. Andreas Schmocker, CEO, commented: “We are thrilled that we achieved FDA approval, which is the basis to establish our US subsidiary and expand our business. Now we can pursue our US launch as planned. After many years of research and development, we are looking forward to improving patients' lives and providing this innovative and smart endodontic solution to the dental market.” The USA is the first commercial market for the company.

(Press release / SK)