For years, Cambridge Heart Inc. has been in an almost missionary mode. Since its founding in 1990, it has spent millions on R&D, conducting myriad large clinical trials to validate the predictive value and clinical relevance of its novel diagnostic for sudden cardiac death, a disease that kills 300,000 to 400,000 in the US each year. With steady losses—most recently, a $2.9 million loss on 2005 revenues of $4.2 million--its stock languished below $1 for two years. Few analysts even covered the microcap. Lately, however, the stock has enjoyed a meteoric rise—to the $2-$3 range--because Cambridge Heart is finally well on the way to answering the two key questions for medical technology developers: clinical relevance and reimbursement.
On March 21, the US Centers for Medicare & Medicaid Services (CMS) issued a national coverage decision for Cambridge Heart's...
