Saranas develops the Early Bird Bleed Monitoring System, a device designed to detect and track bleeding complications during endovascular procedures. The Early Bird received FDA approval in 2019 and Saranas began clinical trials thereafter. The company says the Early Bird is the first and only device of its kind and notes that roughly 20% of patients suffer bleeding complications during endovascular procedures. Saranas plans to expand its clinical evidence through prospective clinical trials and to commercialize the product. It also intends to launch next-generation products, including Bird on a Wire, to address a broader range of endovascular procedures. The company will use the new funding to continue clinical trials and accelerate commercialization. Saranas is a privately held Houston-based medical device company focused on early detection and monitoring of internal bleeding during endovascular procedures. Its core product, the Early Bird Bleed Monitoring System, is a vascular access sheath with embedded sensors designed to detect bleeding from injured blood vessels during procedures such as TAVR and large-bore hemodynamic support device placement. The technology was invented at the Texas Heart Institute and the company reports a growing intellectual property portfolio. Since the last financing, Saranas has completed design verification and validation activities and submitted a De Novo application to the U.S. FDA for the Early Bird system. The company plans to use the new proceeds to conduct a multicenter clinical pilot in the U.S. and to support its U.S. commercialization plan. Saranas positions the device as a way to reduce bleeding complications, improve patient outcomes, and lower related healthcare costs. Saranas develops the Early Bird system, a standard vascular access introducer sheath embedded with sensors that detect bleeding from vessels ruptured during procedures such as transcatheter aortic valve replacements (TAVRs). The technology was invented at the Texas Heart Institute and is intended to allow physicians to detect and address “blind” bleeds earlier, improving patient outcomes and lowering healthcare costs. The company says more than 20 million people in the U.S. undergo vascular access procedures annually, and about 5% experience severe bleeding complications, highlighting the clinical need. Saranas is privately held and based in Houston, Texas. Management plans to use the recent financing to complete product development, pursue regulatory clearance in the United States and Europe, and initiate a clinical pilot with physicians. CEO Zaffer Syed, who joined Saranas in 2017, emphasized bringing the technology through final testing and regulatory submission. Saranas develops a sensor-enabled cardiac sheath that detects internal bleeding during vascular access by measuring electrical resistance across the vessel with surrounding electrodes. The sensors create a baseline tissue signature for each patient and detect changes when blood is introduced, enabling immediate identification of a ruptured vessel. The sheath is typically placed in the thigh and connects by a chord to an external monitor that displays analytics for clinicians. Saranas cites that 5% of U.S. vascular access procedures result in internal bleeding, estimating about a million cases per year with ninefold higher mortality and roughly doubled care costs to about $25,000. The company has yet to earn any revenues, aims to file a 510(k) for FDA clearance soon, and targets beginning sales in 2016 with a sheath price of $250. It also highlights economic incentives under the Affordable Care Act, noting hospitals with high adverse-event rates could face a 1% Medicare reimbursement penalty.

Total raised

$24M

Funding rounds

4

Latest round

Series B

Latest activity

Jul 2021