Med-tech approaches to treating obesity-related diseases have gained limited traction beyond bariatric surgery. That's in part because obesity itself is not considered a disease by the U.S. FDA and payers, so the focus is typically on ameliorating each of a series of associated disorders as they arise. Lexington, Mass.-based startup Fractyl Laboratories Inc. is developing a duodenal mucosal resurfacing system known as Revita. It resurfaces this uppermost part of the small intestine in an effort to mimic some of the benefits of bariatric surgery via a minimally invasive, endoscopic ablation procedure.
Silk Road Medical Inc. has raised $120 million in an initial public offering that then proceeded to climb by more than 80% in its first day of trading. The Sunnyvale, Calif.-based company priced 6 million shares at the top of its stated range at $20 each; initial trading on April 4 (NASDAQ:SILK) pushed the stock price above $36.
There are three FDA-approved imaging agents for use in the diagnosis and monitoring Alzheimer's disease (AD), which started off with the 2012 approval for Eli Lilly's Amyvid (florbetapir F 18 injection). But reimbursement for positron emission tomography (PET) amyloid beta imaging has remained limited, due in large part to a 2013 decision from the Centers for Medicare & Medicaid Services (CMS).