BioInterventional Corp.
This article was originally published in Start Up
Executive Summary
The explosion of new interventional cardiology procedures has triggered the growth of a new device niche, arterial puncture closure devices. BioInterventional Corp. has developed a technology that uses small discs deployed at the puncture site to facilitate hemostasis.
You may also be interested in...
An Open Market for Vascular Access Closure Devices
After an initial warm welcome for first-generation femoral artery closure devices--including a few high-profile exits--sales have stalled. Early devices are flawed, indicating the technical challenge is tougher than it looks. A dozen or so start-ups are trying to address the technology problems that have hampered the pioneers. The newcomers face high hurdles as early experience with first generation devices temper clinician and investor enthusiasm. All will have to prove, in large, rigorous clinical trials, that devices are more complication-free and are as easy-to-use as market leader Angio-Seal, and that they're at least as safe, if not safer, than manual compression. But although start-ups face a great of skepticism about particular technologies, they also inherit a $350 million market made up of devices with an average selling price of $200, which is an endorsement of this new device market. At the same time, an enormous opportunity remains in the 75% of the market that remains unpenetrated.
AAA and Vascular Device Start-Ups
The first generation less-invasive devices for abdominal aortic aneurysm (AAA) surgery haven't yet been approved and the next generation is already here.
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.