Phase 2 grant will advance development of Sintact’s surgical film, to include seeking regulatory approval.
[Bloomington] – May 10, 2017 – Sintact Medical Systems, a startup developing an implantable film that prevents internal scar formation following cardiothoracic and neurological surgery, announced today it was awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase 2 grant worth approximately $750,000. Previously, Sintact Medical was awarded SBIR Phase 1 and 1B grants in July and December 2015. The collective funds will significantly advance testing and development of the non-resorbable film, culminating in a 510(k) regulatory submission.
“With the Phase 1/1B grant, we were able to conduct animal studies and prove the concept of our product,” said Sintact Medical CEO Erik Robinson. “We saw tremendous success with the first studies and are eager to continue developing and fine-tuning the film for commercialization. We appreciate the support from the National Science Foundation with this second grant and without them we would not be able to bringing our technology to market so quickly and ultimately improve patients’ lives.”
Phase 2 of the NSF SBIR grant program is designed as a “commercialization acceleration” grant, which can be matched by outside investment through the Phase 2B program. Sintact Medical will conduct pre-clinical testing and development, which align with feedback obtained through a Pre-Submission interaction from the FDA.
Sintact Medical’s technology was developed through Robinson’s doctoral work at Northwestern University in collaboration with Ann & Robert H. Lurie Children’s Hospital of Chicago, which demonstrated a reduction in scar formation in a pilot cardiothoracic animal study. Follow-on studies completed during Phase 1/1B validated the technology through expanded studies.
Phase 2 of the NSF SBIR grant ends March 31, 2019. Upon completion of Phase 2, Sintact Medical will report results to the agency and will rely on external private investment to continue commercialization efforts.
Sintact Medical has received support from organizations such as Health Wildcatters, VentureWell and iBIO Institute’s PROPEL Center, all of which have assisted and invested in the company’s success. For more information on Sintact Medical and its surgical film technology, visit sintactmed.com.
About Sintact Medical Systems
Sintact Medical Systems, Inc. develops non-resorbable films that separate adjacent organs from adhering to each other after surgery. The Sintact Film™ acts as a scar preventative barrier separating organ and tissue surfaces to significantly reduce the likelihood of scar formation and the associated post-operative complications. Sintact Medical was founded by Erik Robinson, PhD and Gali Baler, PhD in 2013 as a result of the founders’ doctoral research at Northwestern University. For more information visit sintactmed.com.