Bottmedical obtains CE certificate for its NaturAligner

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26.11.2020

NaturAligner is a bio-based material medical device for dental alignment, and the flagship product of Bottmedical, a spin-off from the University of Basel. The device is now CE-certified which paves the way for the next steps starting with clinical trials.

Bottmedical applies a polymer thin-film technology for the development of innovative medical products and devices. Its first product, NaturAligner, is a patented transparent teeth aligner made from biocompatible materials that allow for a high level of comfort and provide a gentle fit. The natural saliva storage in the bio-based polymers reduces the risk of dry teeth and caries, and it improves overall oral hygiene. To date, the bio-based coating has shown neither toxicity nor has harmful leachable substances in the body.

The company has received the CE certificate for the NaturAligner. A CE mark demonstrates that a product meets the EU requirements for safety, health and environmental protection. The Basel based startup has also announced the launch of its clinical trial in Switzerland with the support of BaselDent clinics and the University of Basel, DBE, Biomaterials Science Center.

Fighting snoring and sleep apnea
Besides the progress on NaturAligner, Bottmedical’s team is also leveraging its six years of research for the development of an innovative solution for snoring and sleep apnea therapies. Its second product ‘TOFI Trainer’ is based on polymer nano-technology that enables ultra-thin pressure sensors and stretchable electronics as a tactile interface between the tongue and a smartphone app. The device sends data directly to a connected device for monitoring and reviewing. The data is used to steer the therapy session to obtain the best results. With TOFI Trainer, the company has added gamification to empower users to participate in myofunctional exercises, which are proven to increase the strength and subconscious control of the tongue at night. The company is accepting pre-orders.

(RAN)

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