Saranas Announces Over 1,200 Patients Treated with the Early Bird® Bleed Monitoring System

HOUSTON – Saranas, Inc. announced today that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. The Early Bird was launched in 2019 following a De Novo classification by the U.S. Food and Drug Administration. The device monitors and detects endovascular bleed complications through a novel application of bioimpedance sensors.

“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,” stated Dr. Philippe Genereux, interventional cardiologist and Director of the Structural Heart Disease Program at Morristown Medical Center, Morristown, NJ. “We have been using it in our clinical practice for over two years, and its design of incorporating a fully functional introducer sheath with bleed detection allows for seamless integration into high-risk, interventional cardiovascular procedures.”

“We have established a new standard of care for bleed monitoring during endovascular procedures, which not only helps to reduce intra- and post-procedural complications, but improve the patient experience,” said Saranas Interim CEO Kim Rodriguez. “The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”

“We implemented the Early Bird as part of our post-procedure protocol and have seen a significant reduction in bleeding in our TAVR patients,” stated Dr. Hursh Naik, Chief of Cardiology and Director of Structural Heart Disease at St. Joseph’s Medical Center in Phoenix, AZ. “Our staff embraced the Early Bird as it has become a critical component in the continuity of care for our patients, enabling our bleed management team to quickly identify and manage a bleeding complication. We have not only improved our TAVR outcomes but enhanced the patient experience as well.”

The Early Bird Bleed Monitoring System includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. It 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), mechanical circulatory support (MCS) 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. In the FIH clinical study, bleed detection with the Early Bird was compared with a CT scan, the gold standard, and level of agreement was nearly perfect with 100% sensitivity1.

Approximately one in every five patients will experience a bleeding complication during large-bore endovascular procedures including TAVR, endovascular aneurysm repair (EVAR), and percutaneous MCS2. The average cost of a single bleeding complication incident across these large-bore procedures is approximately $18,000 with an estimated $729 million cost on the healthcare system.

About Saranas, Inc.

Saranas, Inc. 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.

  1. Genereux P et al. First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events. J Invasive Cardiol. 2020 Jul;32(7):255-261. Epub 2020 Jun 8.
  2. Redfors B et al. Mortality, length of stay, and cost implications of procedural bleeding after percutaneous interventions using large-bore catheters. JAMA Cardiol. 2017 Jul 1;2(7):798-802.

Contacts

Kristen Lomas
[email protected]
310-529-5431

 

Saranas® Receives Innovative Technology Contract From Vizient

Contract awarded for Saranas’ novel Early Bird® Bleed Monitoring System

Houston, TX, April 7, 2022– Saranas announced its Early Bird Bleed Monitoring System has received an Innovative Technology contract from Vizient, Inc., the nation’s largest member-driven health care performance improvement company. This contract was awarded based on the recommendation of Early Bird by hospital experts who serve on one of Vizient’s member-led councils, and it signifies to Vizient members unique qualities that potentially bring improvement to the health care industry.

The Early Bird is the first and only FDA-approved device for real-time detection and monitoring of endovascular bleed complications, where 1 in 5 of these procedures has been shown to have a high risk for bleeding. The Early Bird detects a bleed the moment it happens, helping to reduce both intra-procedural and post-procedure complications, length of hospital stay, and overall healthcare costs. 

“We are excited for this opportunity to work with Vizient members through this contract, expanding access to the Early Bird for more clinicians across the country,” said Saranas Vice President of Sales, Frank Natale. “Bleeding complications are a problem, and the Early Bird has been shown to greatly improve patient, clinician, and hospital experience during endovascular procedures.” 

Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program. Vizient member-led councils identify technologies that have the potential to enhance clinical care, patient safety, or improve business operations of healthcare organizations.

“Congratulations to Saranas for being awarded an Innovative Technology contract,” said Kelly Flaharty, director of contract process for Vizient. “Our member council recommended the Early Bird Bleed Monitoring System for this contract based on the efficiencies it offers and its potential to make an incremental difference in health care.”

Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks, and non-acute healthcare providers and represents more than $130 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to evaluate products for their potential to bring real innovation to healthcare. 

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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.

Contact Information

James Reinstein

Saranas, Inc.

713-357-1049

[email protected]

Saranas® Expands Intellectual Property with Key Patent Integrating Bleed Monitoring and Vascular Access Closure Device

HOUSTON, TX, February 23, 2022 – Saranas, a company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications, announced today that the U.S. Department of Commerce’s United States Patent and Trademark Office (USPTO) has issued them Patent No. 11,224,414. Titled “Access Closure with Bleed Monitoring,” this key patent allows for embedding a vascular access closure device with the company’s proprietary bleed monitoring technology. Saranas’ Early Bird Bleed Monitoring System® is the first and only FDA-approved device for real-time detection and monitoring of endovascular bleed complications.

“As we continue to grow our commercial presence with the Early Bird, we are pleased to secure this important patent that is designed to further expand the implementation of our differentiated bleed monitoring technology,” said Saranas CEO James Reinstein. “This patent award demonstrates Saranas’ commitment to innovation and further strengthens our intellectual property portfolio.”

“From vessel injury to failure of obtaining hemostasis with access closure devices, bleeding complications in interventional procedures continue to pose challenges for clinicians,” said Dr. Timothy Henry, Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital. “Technologies to better manage access site complications are paramount as the continued emergence of percutaneous interventions often require large-bore vascular access.”

Dr. Philippe Généreux, interventional cardiologist, commented, “We have been using the Early Bird in our clinical practice for the past two years, and the current design of incorporating a fully functional introducer sheath with bleed detection allows for seamless integration into high- risk interventional cardiovascular procedures. Embedding bleed detection directly onto a vascular closure device is the eventual next step and has the potential to become the standard of care across all types of vascular access procedures.”

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.

Contact Information

James Reinstein
Saranas, Inc.
713-357-1049

[email protected]

Saranas® Awarded Multiple Purchasing Contracts with Large Healthcare Systems

January 05, 2022 08:00 AM Eastern Standard Time

HOUSTON–(BUSINESS WIRE)–Saranas announces today the closing of the company’s two largest Integrated Delivery Network (IDN) contracts and agreements signed to date: CommonSpirit Health and the Department of Defense.

CommonSpirit Health, encompassing all Catholic Health Initiative (CHI) and Dignity Health hospitals, has awarded Saranas a multi-year contract for the use of the Early Bird® Bleed Monitoring System through Premier’s Supply Chain Advisor platform. CommonSpirit Health represents 199 hospitals spread across 21 states nationwide. They are the country’s third largest IDN with approximately $30B in net patient revenue.

In addition, Saranas has been approved for a Distribution and Pricing Agreement (DAPA) by the Department of Defense (DoD) for the use of the Early Bird. This agreement opens up access to the military hospital system which provides care to more than 10 million service members, military retirees, and their families. It encompasses 162 VA’s and 36 DoD hospitals, representing more than $60M in medical device spending per year.

Saranas’ Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time detection and monitoring of endovascular bleed complications. CommonSpirit Health hospitals and the military hospital system will now have access to this new, one-of-a-kind technology for bleed monitoring, replacing the current paradigm of waiting for symptoms to appear.

“The Early Bird’s ability to detect bleeds well ahead of complications is significant in helping to reduce intra-procedural and post-procedure complication risks, length of hospital stays, and overall healthcare costs, while greatly improving the patient experience,” said Saranas Vice President of Sales Frank Natale. “We are excited to work with the clinicians and administrators at CommonSpirit Health and the DoD following their decision to partner with Saranas, and we look forward to providing access to the Early Bird at many more hospitals.”

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.

Contacts

James Reinstein 
Saranas, Inc. 
713-357-1049 
[email protected]