Saranas Launches Early Bird® Bleed Monitoring System in the U.S.

Saranas, Inc. today announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors. Saranas will demonstrate the device in Booth 1755 at the Transcatheter Cardiovascular Therapeutics (TCT) Conference being held September 25 ? 29, 2019, at the Moscone Center in San Fransicso, CA.

One in five patients experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR) and percutaneous hemodynamic support. This complication is associated with a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs, according to a 2017 report in the Journal of the America Medical Association.

"As the first and only early bleed detection system on the market, the Early Bird is ideally positioned to play a key role in making the rapidly expanding, minimally-invasive catheter-based procedures safer by providing physicians with bleed monitoring in real-time," said Saranas President and CEO Zaffer Syed. "With the launch of the Early Bird, physicians will now have a standard of care to monitor the bleed status of the patient during and post procedure, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures."

Saranas was granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird in March of this year. The company presented first-in-human results in May 2019 at the Society for Cardiovascular Angiography Interventions (SCAI), demonstrating that the Early Bird Bleed Monitoring System is safe, easily incorporated into standard workflows and able to detect bleeding before progression to a more severe or symptomatic phase.

"Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure," stated Saranas Chief Medical Officer Dr. Philippe Généreux. "Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient."

Concurrent with the launch, industry veteran Tom Lucas joins Saranas as Vice President, Sales and Marketing. He brings 28 years medical sales experience and leadership, including strategic market development roles with Cook Medical and Circadiance. Lucas will direct and oversee all aspects of commercial sales, business development, marketing, strategic alliances and distributor relationship management.

"Tom is a critical strategic hire for Saranas as we launch our first product in the U.S.," said Saranas President and CEO Zaffer Syed. "His expertise will be invaluable as we expand distribution of the Early Bird into additional centers of excellence."

Initial clinical experience with the Early Bird and its potential role in protecting outcomes with real-time bleed monitoring will be reviewed at the following TCT presentation:

• Friday, September 27, 2019, @ 6:45am during Breakfast Satellite Program:
  • "Optimization of Vessel Access and Closure in Large Bore Catheter Procedures: Tips and Tricks Case-Based Review"

About the Early Bird Bleed Monitoring System

The Early Bird Bleed Monitoring System includes a Bleed Detection Array with integrated electrodes in a fully functional vascular access sheath. The Early Bird is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events.

About Saranas

Saranas is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company's patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs. For more information, please visit www.saranas.com.