Following the registration of its patents for the SomnoDent MAS for the treatment of obstructive sleep apnea (OSA) in January in Japan, SomnoMed Limited (ASX:SOM) has announced its plans to proceed with the launch and development of its business in Japan.
SomnoMed Japan, a wholly owned
subsidiary of SomnoMed Limited, is in the process of being formed with agreements being reached with two leading Japanese dental laboratories - ASO Orthodontics and KYOYUKAI CO - to manufacture the SomnoDent MAS and provide warranty and repair services. Technicians from both Tokyo-based laboratories were trained by SomnoMed Global Technical Support in March.
To assist with the roll out and distribution, SomnoMed Japan will work in close association with Pentron Japan, a distributor of dental products to several thousand dentists and wholesale organisations across Japan.
"Japan will become an important market for SomnoMed in the medium term," said Ralf Barschow, CEO of SomnoMed Limited. "The use of a dental device to treat OSA is already quite well accepted in Japan. All other available products on the market there are made locally and are so-called mono-blocks. They are often less effective and less patient friendly than our SomnoDent device. The registration of our patents in Japan this year now allows us to manufacture our product in country and introduce it to Japanese practitioners."
The SomnoDent device will initially be offered to private patients as the cost of the appliance is above the reimbursement allowance offered by the general public health insurance system. "We believe that the superiority of our device will justify a higher price than that currently charged for simple mono-block MAS devices. The SomnoDent device not only offers far greater comfort to patients but is also more durable and can be fitted by the dentist in a much shorter time. Over the past 6 months, clinical tests have shown very favourable results and a higher acceptance level among Universities and Key Opinion Leaders," Mr Barschow said.
"Japan is potentially one of the biggest markets for the treatment of OSA with oral appliances and SomnoDent will be launched and positioned as the leading MAS in the world today."
The SomnoDent Mandibular Advancement Splint (MAS) consists of two acrylic plates fitted over the upper and lower teeth. A patented fin coupling mechanism on the lower arch accurately positions the mandible slightly forward of its natural position. This positioning tightens the soft tissue at the back of the throat to stop it from collapsing during sleep, which results in snoring (partial collapse) or sleep apnea (full collapse). The SomnoDent MAS allows the normal opening and closing of the mouth, allowing the wearer to yawn, speak and drink. The device will last for at least 5 years and comes with a warranty.
The SomnoDent MAS is provided to patients through an integrated clinical protocol, involving dentists, primary care practitioners and sleep physicians. This pathway ensures that all patients are appropriately diagnosed and that only suitable patients are fitted with the device.