Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Hospira’s Symbiq 3.13 infusion pump and Organogenesis’ Gintuit oral soft tissue regeneration product are new on the market.

Which kinds of innovations make for incremental enhancements in the hands of large companies and which are meaningful enough to sustain a venture-backed start-up company? In a mature market for coronary stents dominated by large companies, start-ups developing new stents need to find the answers. Areas of innovation fall into four basic categories: improving stent safety and biocompatibility, avoiding the need for dual antiplatelet therapy, enhancing deliverability, and introducing specialty stents for complex vessels. Three companies profiled here have a plan for taking sufficient market share, reducing risk, and rewarding investors.