FUNDING FOR CONTINUED DEVELOPMENT OF NEUROSTIMULATION DEVICE TO TREAT OBSTRUCTIVE SLEEP APNEA (OSA)
HOUSTON, Texas, October 5, 2011 — Cyberonics, Inc. (NASDAQ:CYBX), a global leader in medical devices for the treatment and management of epilepsy, today announced an initial investment of $4 million in ImThera Medical, Inc. (“ImThera”). Based in San Diego, California, ImThera is an early-stage company developing a novel, implantable neurostimulation device for the treatment of obstructive sleep apnea (“OSA”).
The investment in ImThera can total $12 million subject to the achievement of certain regulatory and clinical milestones. Cyberonics is a minority shareholder with certain rights, including representation on ImThera’s board of directors. In addition, ImThera will raise up to $4 million from its private investors, for a total Series C placement of up to $16 million.
OSA is a serious, potentially life-threatening condition associated with significant long-term health problems and accompanying costs. ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy combines a multi-contact electrode specifically designed to control certain muscles of the tongue with an implantable pulse generator and an external programmer. The company is currently pursuing CE Mark regulatory approval in the European Union and expects to initiate a pivotal clinical trial in the U.S. in the near future.
“OSA affects millions of people in the U.S. and around the world,” said Dan Moore, Cyberonics’ President and Chief Executive Officer. “We are excited about the opportunity to invest in a promising new therapeutic neurostimulation technology outside our core business.”
“ImThera is pleased to have Cyberonics as an investor and partner. Cyberonics brings outstanding experience to our board, providing significant expertise to ImThera as we continue to execute our plan,” stated Marcelo Lima, ImThera’s Chairman, President and Chief Executive Officer.
About Cyberonics, Inc. and the VNS Therapy® System
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses an implanted medical device that delivers electrical pulsed signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
Additional information on Cyberonics and the VNS Therapy System is available at www.cyberonics.com.
ImThera Medical is an early-stage company that has developed a novel, neurostimulation medical device for the treatment of Obstructive Sleep Apnea (OSA). Through targeted tongue-muscle stimulation, ImThera’s open-loop hypoglossal nerve multi-contact device delivers muscle tone to key tongue muscles during sleep, opening the upper airway and substantially reducing or eliminating OSA events.
ImThera’s mission is to help patients live longer and enjoy better lives while substantially reducing health care costs related to serious complications associated with Obstructive Sleep Apnea. Additional information on ImThera and the THN Sleep System is available at www.imtheramedical.com.
Safe harbor statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including “may,” “believe,” “will,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “forecast,” or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning investing up to $12 million in ImThera while ImThera receives up to $4 million from other investors, developing ImThera’s implantable neurostimulation device as a therapy for OSA and obtaining CE Mark approval, initiating and completing a pivotal clinical study in the U.S., and obtaining U.S. marketing approval for ImThera’s implantable neurostimulation device. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS TherapyTM and sales of our product; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of VNS Therapy for the treatment of other indications; satisfactory completion of post-market studies required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new indications; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management’s estimates of future expenses and sales; the results of the previously disclosed governmental inquiries; the potential identification of material weaknesses in our internal controls over financial reporting; risks and costs associated with such governmental inquiries and any litigation relating thereto or to our stock option grants, procedures, and practices and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10- K for the fiscal year ended April 29, 2011.
Greg Browne, CFO Cyberonics, Inc.
100 Cyberonics Blvd. Houston, TX 77058 Phone: (281) 228-7262 Fax: (281) 218-9332 firstname.lastname@example.org
Fran Bosecker, Account Director
Vantage Communications for ImThera Medical Phone: (845) 536-1416 email@example.com
For Release Wednesday, October 5, 2011; 4:00 PM ET