Quality Policy
Envoy Medical Corporation provides superior value to the field of otology through innovative technology, quality products, continuous improvement and customer service.
History
Envoy Medical Corporation was founded – originally as St. Croix Medical – in 1995 to design, manufacture, and bring to market the world’s first, and only, fully implantable hearing restoration device not to use a microphone or speaker. Envoy Medical began its operations in March of 1996 and spent its first several years developing the breakthrough technology that has become Esteem® – The Hearing Implant™.
Envoy Medical successfully completed a feasibility study in 2002. After a few improvements to the product design, pivotal clinical trials were initiated in 2004 in both the European Union and the United States. Envoy Medical received its CE Mark approval to market the Esteem® in the European Union in May of 2006.
In August of 2009, Envoy Medical completed its Esteem® premarket approval (“PMA”) application and submitted it to the Food and Drug Administration. On August 27, 2009, the FDA notified Envoy Medical that they had received the Esteem® PMA application and decided to grant the application expedited processing for the following reason:
“We believe that the Esteem Totally Implantable Hearing System represents a breakthrough technology, which provides an alternative to non-implantable and partially implantable hearing aid technology.”
On March 17, 2010, Envoy Medical received the formal premarket approval letter from the FDA granting approval for commercial distribution of the Esteem®.
Board of Directors
Envoy Medical’s Board of Directors consists of individuals who are experienced in the medical device industry and have been instrumental in successfully advancing the growth of other enterprises. Each Director is a major investor in Envoy Medical.
Kenneth H. Dahlberg was appointed a Director in October 2007. Mr. Dahlberg has served as Chairman of Carefree Capital, Inc. since June 1995, and he served as its Chief Executive Officer from June 1995 to January 2004. He was the founder of Dahlberg, Inc., Miracle Ear, a public company prior to its acquisition by Bausch & Lomb, Inc. in 1993, and served as its Chairman of the Board from 1948 to 1993. Mr. Dahlberg is currently Chairman Emeritus of Buffalo Wild Wings, Inc. (NASDAQ:BWLD).
Allen U. Lenzmeier was appointed a Director in February 2008. Mr. Lenzmeier previously held various positions at Best Buy Co. (NYSE:BBY) including Vice Chairman, President/COO from March 2003 to February 2005, President of Best Buy Retail Stores from March 2002 to February 2003, and CFO from August 1984 to February 2002. Mr. Lenzmeier currently serves on the board of UTStarcom, Inc.
Roger C. Lucas, Ph.D. was appointed a Director in May 1996 and is currently Chairman of the Board of Directors. He is also currently Vice Chairman and Chief Scientific Advisor to the Board of Techne Corp. (NASDAQ:TECH), a biotechnology company that he co-founded in 1985 and developed into one of the world’s largest suppliers of genetically engineered immuno-modulatory molecules. A founding shareholder of Envoy Medical, he holds a BA in Biology from St. Mary’s College in Winona, Minnesota, and a Ph.D. in Physiology/Biochemistry from the Illinois Institute of Technology. He was a recipient of the National Institutes of Health Pre- and Post-doctoral fellowships and also served as Assistant Professor of Biochemistry at the State University of New York, Medical School (Brooklyn). Dr. Lucas is also currently a board member of ChemoCentryx, Inc., and Discovery Genomics, Inc.
Michael Spearman was appointed as a Director in August 2005 and is now Vice Chairman of the Board of Directors. Mr. Spearman was a co-founder, director and corporate vice-president of Porous Media Corporation. He is also co-founder, and a Management Committee Member of Lexion Medical, LLC and Hemerus Medical, LLC. Mr. Spearman’s experiences include responsibility for strategic planning and the development and market introduction of a number of new technologies and products for medical and industrial applications. He is the holder of over 25 patents. He has a Biology degree from the University of St. Thomas in St. Paul, Minnesota.
Patrick Spearman joined Envoy in October 2004 as VP of Marketing and Sales. Mr. Spearman is a Director and currently holds the CEO position. He co-founded Porous Media Corporation, Hemerus Medical LLC, and Hemostasis LLC. He is also a co-founder of Lexion Medical LLC and a co-founder of The Woodlands Preparatory School. He has a B.A. degree in both Business and Hospital Administration from Concordia College.
Glen A. Taylor was appointed a director in May 2006. Mr. Taylor is Chairman of Taylor Corporation and owner of the NBA’s Minnesota Timberwolves and the WNBA’s Minnesota Lynx. The Taylor organization includes more than 85 subsidiaries operating divisions in 19 states, three Canadian provinces, the United Kingdom, Australia, the Netherlands, Sweden and Mexico. More than 10,500 professionals are employed across the Taylor organization.
LocationsWorldwide Corporate Headquarters
Envoy Medical Corporation5000 Township Parkway
Saint Paul, MN 55110 U.S.A.
Customer Toll Free: 866-950-HEAR (4327)
Corporate Tel: +1 651-361-8000
Corporate Fax: +1 651-361-8099
E-Mail: esteem@envoymedical.com
Web: www.envoymedical.com
CAUTION: Federal Law restricts this device to sale by or on the order of a physician.