Positive Clinical Data Presented at US Dental Sleep Meeting
- Significant interest in encouraging results of pilot study presented at the American Academy of Dental Sleep Medicine in Boston.
- This was the first detailed physiological pilot study into the effect of the O2Vent TTM on pharyngeal pressure swings which cause the airway to collapse in Obstructive Sleep Apnoea and as a continuous positive air pressure (CPAP) interface.
- Encouraging data (n=4) supports the benefit of the Oventus Airway Technology by demonstrating clinical results comparable to traditional CPAP and when used in combination with a CPAP interface, significantly decreased the mask and pressure related complications - often the causal factor of CPAP failure or non-adherence.
- Trial has now progressed to an expanded study with recruitment of first patients as part of the CRC-P for sleep apnoea which received $2.95 million in non-dilutive government funding earlier this year - Oventus is the lead participant.
CPAP is the first line of treatment for sleep apnoeic patients and involves a pressure pump attached to a mask blowing air into the patient's airway. While not well tolerated, it is a multibillion dollar industry with massive unmet needs due to issues associated with current treatment options. In a potential paradigm shift in the treatment of this debilitating illness, the early data supports the use of the O2Vent TTM as a CPAP alternative either as a standalone appliance, or in combination with CPAP, using it as a strapless CPAP interface (no longer requiring high pressures or a mask).
Oventus founder and clinical director Dr Chris Hart said: "This was a major advancement in the ever-expanding range of sleep apnoea solutions using Oventus Airway Technology. A high percentage of complications and non-compliance with traditional CPAP are due to mask and pressure related issues - both minimised with the Oventus solution."
Sleep disorder device manufacturer and developer Oventus Medical is developing a treatment solution, addressing the treatment needs of the full spectrum of obstructive sleep apnoea disease severity - potentially changing the paradigm of care.
Dr Hart added: "The process to optimise the CPAP interface will be completed in the expanded trial. It's expected to be finished by the end of the year. Another trial is now under way in Perth, focussing on specific pressure and flow measurements in the patient's airway and how the Oventus Airway Technology influences this."
The clinical trial results from these two studies will also enable the development of a wearable micro PAP.
Notes: Continuous Positive Airway Pressure (CPAP)
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About Oventus Medical Ltd
Oventus Medical Ltd (ASX:OVN) is a Brisbane based medical device company that is commercialising a suite of oral appliances for the treatment of sleep apnoea and snoring. Unlike other oral appliances, the Oventus devices have a unique and patented airway within the device that delivers air to the back of the mouth bypassing multiple obstructions from the nose, soft palate and tongue. They are particularly designed for the many people that have nasal obstructions and consequently tend to mainly breathe through their mouth. While it may seem counterintuitive, the device actually prevents oral breathing. The O2Vent is designed to allow nasal breathing when the nose is unobstructed, but when obstruction is present, breathing is supplemented via the airways in the appliance.
A clinical study completed earlier this year showed the company's first generation product the O2Vent Mono(TM) is successful in treating OSA and that snoring was either eliminated or significantly reduced to 100 per cent of patients. The positive results included those people who had nasal obstructions and mainly breathed through their mouths, including when they were asleep. It also improves oxygen levels for patients.
According to a report published by the Sleep Health Foundation Australia, an estimated 1.5 million Australians suffer with sleep disorders and more than half of these suffer with obstructive sleep apnoea.
Continuous positive airway pressure (CPAP) is the most definitive medical therapy for obstructive sleep apnoea, OSA, however many patients have difficulty tolerating CPAP. Oral appliances have emerged as an alternative to CPAP for obstructive sleep apnoea treatment.
Oventus Medical Ltd