Saranas has raised $2.8 million in new financing to support commercialization and a multicenter clinical pilot of its internal bleeding monitoring system, which it recently submitted to the FDA for de novo classification.
The company’s Early Bird medical device includes a vascular access sheath embedded with sensors that can detect bleeding from a blood vessel accidentally injured during endovascular procedures, such as transcatheter aortic valve replacements, large-bore hemodynamic support placements or other complex interventions where the femoral artery or vein is used for access.
Since its last financing round, Saranas has completed design verification and validation work, said President and CEO Zaffer Syed in a statement following the series C funding closure. The Early Bird technology was invented at the Texas Heart Institute.
In addition, the company’s submission to the FDA incorporated agency recommendations in the presubmission process, following biocompatibility and preclinical animal studies, Syed said.
“We continue our work to deliver a product to market that has the potential to significantly reduce bleeding complications while reducing related costs to providers and the healthcare system,” he said. According to the Houston-based company, over 20 million U.S. patients require vascular access procedures, with 1 million experiencing life-threatening bleeding complications.
In 2015, Saranas raised $4.5 million in equity to develop the sheath, which detects injuries in real-time by measuring differences in electrical resistance across the blood vessel following a rupture.