Healthcare Industry News: Treatment-Resistant Depression
News Release - April 28, 2014
Cyberonics Names Rohan Hoare, Ph.D. Chief Operating Officer And O'Neill D'Cruz, M.D. Chief Medical OfficerHOUSTON, April 28, 2014 -- (Healthcare Sales & Marketing Network) -- Cyberonics, Inc. (CYBX) today announced the promotion of Rohan Hoare, Ph.D., to the newly created role of Chief Operating Officer. As COO, Rohan will be responsible for the development, manufacturing, quality and commercial activities for the Epilepsy franchise. The company also announced that O'Neill F. D'Cruz, M.D. recently joined the company as Chief Medical Officer.
"We have made significant, multi-year investments in our sales force capabilities and our technology pipeline," said Dan Moore, Cyberonics' President and Chief Executive Officer. "The AspireSR™ pulse generator, with seizure detection and response technology, recently received CE-mark approval in Europe, and the Centro™ and ProGuardian™ products are nearing regulatory submissions. With Rohan as COO for the Epilepsy business and Neil as CMO, we have restructured the team and added new personnel to better focus our efforts on epilepsy market-development activities."
"Cyberonics' market position in the treatment of refractory epilepsy has never been stronger; yet, refractory epilepsy is still underserved," commented Rohan Hoare, COO. "I am committed to increasing awareness of VNS Therapy® as a foundational therapeutic option and achieving maximum returns from our investments in sales, marketing and new technology in the form of revenue, profitability and increased market penetration."
Since joining Cyberonics in September 2013, Dr. Hoare has served as Senior Vice President, Strategic Planning, leading the company's business strategy development and execution. Formerly, he served as President of St. Jude Medical's Neuromodulation Division, which designs, manufactures and sells neuromodulation devices for the treatment of chronic pain, movement disorders and chronic migraine headache. He began his career with McKinsey & Co., a premiere strategy consulting firm, where he served clients in high tech, med tech and healthcare payor and providers for nearly a decade. Dr. Hoare received a Bachelor of Science in Physics and was awarded Faculty of Science Scholar honors at Monash University, Melbourne, Australia. He continued his studies at Harvard University as a Fulbright Scholar where he received a Master of Arts and a Ph.D. in Physics.
Dr. D'Cruz was most recently Medical Director, Neurology at UCB, S.A., and previously Professor of Neurology and Pediatrics at University of North Carolina-Chapel Hill. He also earned a Master of Business Administration at the Kenan-Flagler Business School, UNC-Chapel Hill. In addition to industry experience in clinical development, pharmacovigilance, regulatory interactions, public-private partnerships and business development, Dr. D'Cruz has worked in the field of epilepsy for over two decades, as a board-certified neurologist and epileptologist, health policy and patient advocate, clinical investigator and consultant to leading pharmaceutical companies. Dr. D'Cruz was an investigator in Cyberonics' E-05 study, the pivotal study used to obtain the company's original PMA approval for the VNS Therapy® System in 1997, as well as in clinical studies of most of the currently-marketed second-generation anti-epileptic drugs.
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 pulsed electrical 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.
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 enhancing our epilepsy market-development activities and achieving maximum returns from our investments in sales, marketing and new technology in the form of revenue, profitability and increased market penetration. 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 Therapy® and sales of our products; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of new products, including VNS Therapy® for the treatment of other indications; satisfactory completion of the post-market registry 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 products and 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 potential identification of material weaknesses in our internal controls over financial reporting; 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 26, 2013 and our Quarterly Report on Form 10-Q for fiscal quarters ended July 26, 2013, October 25, 2013 and January 24, 2014.
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