MBBP client Pluromed, Inc. has received FDA approval for BackStop™, a medical device used in ureteroscopic kidney stone management procedures. BackStop was approved as a Class II device under the pre-market notification 510(k) process. It is based on Pluromed’s proprietary Rapid Transition Polymers (RTP™) that are liquid at low temperature and transition to gel at body temperature; the transition is reversible via cooling and the gel is completely dissolvable. BackStop is used in the treatment of kidney stones, a disease estimated to affect 5 million people worldwide annually.
It is Woburn, MA-based Pluromed’s first FDA approval. Pluromed’s CEO Jean-Marie Vogel said, “We are pleased to be executing the plan we presented to the Massachusetts Life Sciences Center that resulted in the Accelerator Loan, funding that has contributed to our substantial progress in a very short period of time.”