ImThera Medical announces results from targeted hypoglossal neurostimulation study on OSA

ImThera Medical, Inc.Sep 3 2012

ImThera Medical, Inc. today announced that results from the first single-center study of targeted hypoglossal neurostimulation (THN) for obstructive sleep apnea (OSA) will appear in an upcoming print edition of the European Respiratory Journal. The study, conducted at Université catholique de Louvain (UCL) in Belgium and sponsored by ImThera, followed thirteen patients with moderate to severe OSA who were implanted with the ImThera aura6000™ System for at least one year. It was found that the aura6000™ improved the conditions of patients with obstructive sleep apnea and it was neither painful nor did it awaken patients.   

The primary objective of the study was 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. Thirteen out of 14 operated patients were successfully implanted with a six electrode cuff around the main trunk of the hypoglossal nerve, and a pulse generator (IPG) in a subcutaneous pocket in the upper chest. The mean surgical time was 100 minutes. Surgical complications were generally mild, and all fully resolved without sequelae. Stimulation was initiated three to four weeks after surgery.

76% of patients (10 of 13) responded to therapy, defined as realizing at least a 50% reduction in AHI or 50% improvement in ODI. The study had very broad inclusion criteria, allowing patients usually not considered for this type of treatment to be included. If these patients (one with many central apneas and the other with a very large and long uvula) are excluded from analysis, then 91% of patients responded to therapy. Among responders, 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; and 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.

"These results exceeded my expectations," said Dr. Daniel Rodenstein, principal investigator of the study, "as they clearly demonstrate that THN therapy has the potential to be viable therapy for a broad range of patients with OSA."

OSA is a very prevalent condition. The World Health Organization estimates that over six percent of the adult population suffers from OSA and only approximately twenty percent of OSA patients in the first world have the benefit of some type of treatment.

"Today's announcement represents a tremendous milestone for patients with moderate to severe OSA—patients who have few therapeutic options," said Marcelo G. Lima, president and CEO of ImThera. "We are so happy for the patients in the study, and honored to have these historic results accepted for publication in the highly-respected European Respiratory Journal."

In a related announcement, ImThera also announced today that a paper titled, "Tongue Anatomy and Physiology, the Scientific Basis for a Novel Targeted Neurostimulation System Designed for the Treatment of Obstructive Sleep Apnea" is now available online in the Volume 15, Issue 4 edition of Neuromodulation: Technology at the Neural Interface. The paper describes the anatomy, physiology and mechanisms of actions of hypoglossal nerve stimulation. The result of this ImThera Medical-sponsored basic research guided the specification, design and development of the aura6000 THN Sleep Therapy System.