ImThera Medical Apnea Implant Demonstrates Benefits of Treating Patients Suffering from Obstructive Sleep Apnea With aura6000™ System

Results to be published in the European Respiratory Journal report significant and sustained improvements in OSA measures

Underlying Science of Targeted Hypoglossal Neurostimulation to be published in the journal Neuromodulation: Technology at the Neural Interface

SAN DIEGO--(BUSINESS WIRE)--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.

“Today’s announcement represents a tremendous milestone for patients with moderate to severe OSA—patients who have few therapeutic options”

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.

About OSA:

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of respiratory arrest despite continuing breathing efforts. More than 800,000 patients in the U.S. are diagnosed with OSA annually. As many as 38 million Americans may suffer from OSA and approximately 20 percent of this population is receiving treatment today.

OSA is readily treated with continuous positive airway pressure therapy. CPAP is an effective but cumbersome treatment for OSA. While CPAP remains the established therapy, studies show that between 20-80% percent of patients cannot or will not comply with CPAP.

About the aura6000™ THN Sleep Therapy System:

The aura6000™ system is based on ImThera’s proprietary Targeted Hypoglossal Neurostimulation (THN) technology. The system consists of two implantable components, a rechargeable pulse generator placed under the skin near the collarbone, and a multi-electrode lead placed in the upper neck. The electrodes deliver mild electrical pulses to the hypoglossal nerve, stimulating multiple tongue muscles and thereby restoring muscle tone to the upper airway.

CAUTION: The aura6000™ is not for sale in the U.S.A.

About ImThera Medical, Inc.:

Based in San Diego, ImThera Medical is a privately-held company that has developed a neurostimulation device for the treatment of Obstructive Sleep Apnea (OSA).

ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy delivers neurostimulation to the hypoglossal nerve to control certain muscles of the tongue. Using a multi-contact electrode and a programmable implantable pulse generator (IPG), the system delivers muscle tone to key tongue muscles to prevent the tongue from collapsing into the upper airway during sleep. This innovative technology is designed to increase nighttime upper airway flow, permitting normal and restful sleep for OSA patients. For more information, visit www.ImTheraMedical.com.