ImThera Medical has reported positive results from a clinical study of its aura6000 targeted hypoglossal neurostimulation (THN) sleep therapy system, designed for the treatment of obstructive sleep apnea (OSA).
The device includes two implantable components, a rechargeable pulse generator placed under the skin near the collarbone, as well as a multi-electrode lead placed in the upper neck to deliver mild electrical pulses to the hypoglossal nerve and stimulate multiple tongue muscles to prevent the tongue from collapsing into the upper airway during sleep.
The study, which followed 13 moderate-to-severe OSA patients implanted with the aura6000 system for at least one year, is designed to demonstrate a statistically significant improvement in the polysomnographically measured apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) at three months, and to maintain that improvement at 12 months.
76% of patients (10 of 13) responded to therapy, which is defined as realising at least a 50% reduction in AHI or 50% improvement in ODI, according to the company.
The mean AHI improved from 41.5 ± 13.1 to 14.3 ± 8.8 (66% improvement) at 3 months and 13.2 ± 5.5 (68%) at 12 months, while ODI improved from 23.1 ± 10.2 to 7.6 ± 4.1 (67%) at 3 months and 7.8 ± 5.3 (66%) at 12 months.
Study principal investigator Dr Daniel Rodenstein said the therapy has the potential to be viable for a broad range of patients with OSA.
ImThera president and CEO Marcelo Lima said the positive results demonstrate a milestone for patients with moderate-to-severe OSA, who have little in the way of therapeutic options.
"We are so happy for the patients in the study, and honoured to have these historic results accepted for publication in the highly-respected European Respiratory Journal," Lima said.