Client story: Koite Health

Koite Health is known for Lumoral, an oral care device that removes residual plaque from teeth with a light-activated method. Plaque remains on the teeth even after careful brushing: the best toothbrush removes only about 65 per cent of it.

The idea for Lumoral was born when Tommi Pätilä, a paediatric cardiac and transplant surgeon, operated on a severe heart infection that had started in the mouth, and kept asking himself why. Pätilä later met Sakari Nikinmaa, an engineer in medical technology, and the two began to develop a new device together with researchers. That is how Koite Health started, with Nikinmaa as its CEO.

“Pätilä had experience of the antibacterial method, and we set out to find how it could be applied. Oral diseases are common, and from a dental infection bacteria also get into the bloodstream,” says Nikinmaa of their first thoughts.

A photosensitiser makes targeted removal of bacteria possible

Lumoral works with two intense wavelengths of light.

“The light has an antibacterial effect because a photosensitiser is used, a special Lumorinse tablet. The tablet is dissolved in water and the liquid is swished around the mouth before the device is used,” says project manager Mikko Kylmänen, explaining how the device works.

The indocyanine green in the tablet attaches to the surface of the plaque, so that the light from the device reaches the protein structures of the bacteria and destroys them. One treatment takes 10 minutes, and two treatments a week are recommended, or more often if needed.

“If there are problems with oral health, it is important that a dentist or dental hygienist draws up the treatment plan,” Kylmänen says.

The healthy bacterial balance of the mouth stays protected from Lumoral’s antibacterial effect.

Since the launch in 2020 more than 40,000 Lumoral devices have been sold, and Koite Health has doubled its turnover every year. The technology is patented.

“The plan covers every detail”

The efficacy and safety of the device are still being studied in several clinical studies, four of which are monitored by RecQ Clinical. In autumn 2024 the cooperation had lasted two years, and Koite Health’s experience has been excellent.

“The cooperation has been excellent: the people at RecQ Clinical are competent, professional, friendly and calm,” says Mikko Kylmänen.

The work has also been made easier by RecQ Clinical’s mentoring system. It means that the project always has a contact person who is up to date, also during sick leave.

RecQ Clinical’s CRAs make sure that the clinical studies are carried out according to international standards. These include ISO 14155 (clinical investigation of medical devices for human subjects, good clinical practice) and the European Union’s Medical Device Regulation, MDR (EU) 2017/745.

“The plan we made with RecQ covers every detail the monitor has to take care of. That is how we have made sure the data is correct and complete once it has been collected.”

Four joint studies under way

Lumoral studies sponsored by Koite Health are currently running with RecQ Clinical’s support at Metropolia University of Applied Sciences in Helsinki, in the Pirkanmaa wellbeing services county, in Sweden and in northern Finland, where the Lapland wellbeing services county is among those taking part. RecQ Clinical’s CRAs also visit the study sites to check that the facilities and the storage of documents are in order.

“On top of the on-site monitoring, the data is monitored before it goes into the software for analysis,” Kylmänen says.

One important benefit of the cooperation has to do with communication with the study teams.

“I can delegate taking study matters forward, finding out where more training is needed and bringing it to the teams. I don’t have to do absolutely everything myself, and that makes my work a great deal easier,” says Kylmänen.

Periodontal status shows how the situation changes

For everyone taking part in the studies the periodontal status is recorded. It reflects inflammation and includes, for example, the amount of gum bleeding, plaque and deep gum pockets.

“Following the status gives us research data on the efficacy and function of Lumoral. A dentist or dental hygienist measures six surfaces of every tooth of the study participant, so a single visit already produces plenty of data,” Kylmänen says.

Most of the studies also examine bacterial samples and a mouth-rinse sample that measures an enzyme value indicating inflammation, and follow the participants’ own records.

The aim of the clinical studies is to gather broad evidence of the efficacy and safety of the Lumoral device. No adverse events caused by the device have occurred in the studies.

In the future Lumoral may be used in a targeted way in the oral care of specific groups, such as people with cancer or diabetes and people suffering from different oral infections.

Text: Taitoteksti Saga Wiklund. Photos: Markus Pentikäinen. Translated from the Finnish original, first published on RecQ Clinical’s LinkedIn page on 21 October 2024. More about the device: lumoral.fi.

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