Oventus Medical Ltd presented positive interim data in a lecture at Australia’s Macquarie University on a group of hard-to-treat obstructive sleep apnea (OSA) patients who were studied in a subgroup as part of the ongoing “NueRA Syndey study.”
Researchers studied 13 patients who had failed previous treatment with oral appliances and/or CPAP. This group of patients was treated using Oventus Airway Technology with the O2Vent oral appliance in combination with Oventus’ ExVent oral EPAP [expiratory positive airway pressure] valve with or without the addition of a nasal EPAP valve (in late-stage development).
Addition of Oventus’ ExVent PEEP [peak end expiratory pressure] valve technology resulted in a statistically and clinically significant improvement in OSA severity from baseline of 49%. Seven of 13 patients who’d failed previous treatment with oral appliances and/or CPAP were treated successfully with a 50% reduction in the number of obstructive events, moving their apnea-hypopnea index (AHI) score to below 10 obstructive events per hour, without CPAP.
Oventus’ founder and clinical director, Chris Hart, M.Phil, BSc, BDSc, says in a release. “Previous results from Oventus-led clinical trials have shown that the existing O2Vent device successfully treats at least 53% of patients. If we combine our trial results, we can see that across our whole Oventus Sleep Treatment Platform of O2Vent devices and add on accessories, 78% of patients across the full spectrum from mild to severe OSA, may able to be treated using our devices without the need for CPAP. Since we know that there are such problems with patients adhering to CPAP, we’ve been driven to offer an alternative, and these results point to the fact that our technology really can be game-changing for the treatment of sleep apnea. We plan to build upon these results with further clinical studies.”
These findings are from an Australian government funded CRC-P project titled: “Targeted therapy for sleep apnoea: A novel personalised approach,” of which Oventus and NeuRA are key participants.
In the process of developing an Oventus O2Vent Connect-CPAP interface, the peak end expiratory pressure (PEEP) valve was developed to manage exhalation through the device while delivering nasal CPAP (nCPAP).
The Oventus ExVent valve is expected to be in market by the fourth quarter in North America and Australia.