Fresh from winning regulatory approval for its Esteem hearing device, Envoy Medical Corp. is seeking $16.5 million from the sale of equity, according to documents filed with the Securities and Exchange Commission. The company, based in White Bear Township, Minn., has so far raised $330,000. In March, the Food and Drug Administration approved Envoy’s Esteem […]
In an interview, Roger Lucas, a former senior vice president and chief scientific officer for Techne, says he believes Envoy will go public in two years and reach a $3 billion to $5 billion market cap.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
CEO Patrick Spearman said he expects the FDA to grant Envoy's Premarket Approval (PMA) application by next February. Although FDA advisory panel recommendations are not binding, the agency almost always follows them.