London-based LivaNova PLC has entered into an agreement to acquire the remaining outstanding interests in ImThera Medical, Inc. Headquartered in San Diego, Calif, ImThera is a privately held company focused on neurostimulation for the treatment of obstructive sleep apnea (OSA). ImThera manufactures an implantable device (not yet FDA approved) that stimulates multiple tongue muscles via the hypoglossal nerve, which opens the airway while a patient is sleeping.
“The ImThera device is highly aligned with our existing neuromodulation business, and we are extremely excited about the opportunity to optimize the technology and fold it into our universal platform. In the near term, we will focus on expanding ImThera’s current commercial presence in the European market, while advancing enrollment in a US Food and Drug Administration (FDA) pivotal trial,” says Damien McDonald, LivaNova’s CEO, in a release. “The OSA market is large and growing, with many unmet needs. With our strong commercial capabilities and robust manufacturing, we look forward to bringing this innovative technology to the large patient population that has been unsuccessful with other treatments, allowing them to improve their quality of life.”
ImThera’s implantable device received CE Mark in 2012 and is indicated for patients with moderate to severe OSA who are unable or unwilling to use continuous positive airway pressure (CPAP) therapy. For these patients, the device is designed to reduce or eliminate sleep apnea, as demonstrated through clinical studies and its initial commercial use in Europe. Enrollment in a pivotal study is currently under way with the FDA to obtain premarket approval for the OSA implant.
“Adding ImThera and its obstructive sleep apnea device to our portfolio will strengthen our position as a leader in the field of neuromodulation,” says Jason Richey, LivaNova’s president of North America and general manager of the neuromodulation business.
LivaNova has been an investor in ImThera since 2011 and has agreed to pay up to approximately $225 million to acquire the remaining outstanding interests of ImThera. Up-front costs are approximately $78 million with the balance paid on a schedule driven by regulatory and sales milestones. The deal is projected to be near-term accretive and is expected to close in early 2018 (subject to approvals and other customary closing conditions).
Marcelo Lima, ImThera’s founder, president, and CEO, says, “ImThera Medical shares LivaNova’s mission to help patients live longer, better lives. We are proud of the accomplishments we have made in developing an effective CPAP alternative for individuals suffering from OSA. This acquisition will benefit healthcare providers, shareholders and most of all, the patients who are at the heart of everything we do. This is the culmination of several years of hard work by our team of dedicated professionals. We welcome the opportunity to become part of the LivaNova family and look forward to the continued evolution of our product.”