Myomo Obtains CE Mark Approval For Myopro
Published: Jul 31, 2017
Enables Company to Start Providing Devices in Europe
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Myomo, Inc. (NYSE MKT:MYO) (“Myomo” or the “Company”), a commercial stage medical robotics company, today announced that it has obtained CE Mark approval for commercial sale of its next-generation MyoPro myoelectric arm orthosis across the European Economic Area (EEA). The CE Mark indicates MyoPro complies with the essential requirements of relevant EU legislation and has achieved quality system certification. MyoPro is the only lightweight wearable device that can restore function in the paralyzed or weakened arms and hands of individuals who have suffered a stroke, spinal cord or nerve injury, or other neuromuscular disability.
“The MyoPro powered brace allows individuals suffering from paralysis or stroke to perform routine daily activities,” said Paul R. Gudonis, Chairman and CEO of Myomo. “Gaining CE Mark approval is an important milestone for our Company and for the many people in Europe who will now be able to experience the benefits of MyoPro as they struggle with upper limb paralysis.”
Gudonis continues, “We are currently working with our partner Ottobock to plan our European launch beginning in Germany. Myomo recently conducted sales and clinical training for Ottobock staff, which has begun evaluating patients for the MyoPro device. With revenue of over a billion Euros and operations in 50 countries, Ottobock is a global market leader in technical orthopedics and prosthetics.”
Myomo launched its next-generation MyoPro orthosis in June 2017, extending the capabilities of the previous device. With the powered orthosis, a paralyzed individual can perform activities of daily living including feeding themselves, carrying objects and doing household tasks, and many are able to return to work. MyoPro is available in three models to match patient-specific needs.
Myomo, Inc. is a commercial stage medical robotics Company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Based on patented technology developed at MIT and the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuromuscular disability such as amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). It is provided through clinical relationships with VA medical centers, leading rehabilitation hospitals, and Orthotics and Prosthetics (“O&P”) practices. Several hundred have been successfully used by patients. It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com.
Forward Looking Statements
This press release contains forward-looking statements regarding the Company's future business expectations, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Other risks and uncertainties include, among others, risks related to new products, services, and technologies, government regulation and taxation, and fraud. More information about factors that potentially could affect Myomo's financial results is included in Myomo's filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.