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 
Investor.relations@saranas.com

SAFE-MCS Will Examine the Impact of the Early Bird® Bleed Monitoring System on Reducing Bleeding Complications in Patients Undergoing High Risk PCI with Mechanical Circulatory Support

Houston, TX – December 6, 2021 – Saranas, Inc., has announced initiation and first patient enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird Bleed Monitoring System. The first patient was enrolled at Atlantic Health System’s Morristown Medical Center in Morristown, NJ, by Dr. Philippe Généreux, Co-Director of the Structural Heart Program, and Dr. Dimitrios Karmpaliotis, Medical Director of the Cardiovascular Rescue and Recovery Program and the Advanced Coronary Therapeutics and Chronic Total Occlusions Program, at Morristown Medical Center.

“We are excited to participate in SAFE-MCS as this trial aims to build the clinical evidence and key learnings on integrating early bleed detection as a viable solution to enhance safety for patients undergoing complex high-risk PCI with MCS,” said Dr. Généreux, co-principal investigator of SAFE-MCS. 

SAFE-MCS will enroll up to 265 patients across multiple centers in the United States. The primary endpoint of the study is incidence of access-site related BARC (Bleeding Academic Research Consortium) type III or V bleeding. Patients undergoing complex high-risk PCI with MCS via Impella and transfemoral arterial approach will be enrolled as study participants. The Early Bird Bleed Monitoring System will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“As the field of minimally-invasive, catheter-based procedures continues to advance, patient safety is paramount,” said Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS. “This study will collect comprehensive procedural data in patients undergoing PCI with MCS. The data will undergo independent adjudication of clinical events to provide meaningful guidance on how real-time bleed monitoring can improve clinical outcomes.”

Approximately one in every five patients will experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and percutaneous MCS1. 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. The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications. 

Saranas is partnering with the Cardiovascular Research Foundation (CRF) Clinical Trials Center to assess cost savings associated with the Early Bird in the SAFE-MCS trial. “As health systems are highly sensitive to the burden of incremental costs from procedural complications, it is more important than ever to quantify the economic value of innovative technologies like early bleed detection,” said Dr. David Cohen, Director of Clinical and Outcomes Research at CRF.  

“SAFE-MCS is the first prospective trial focused exclusively on the impact of integrating  bleed monitoring in large-bore access for high-risk protected PCI patients,” said Saranas President and CEO James Reinstein. “Saranas is committed to building objective evidence to support the clinical utility of the Early Bird device. We are pleased to support the SAFE-MCS study, and we wish to thank the investigators for their efforts to commence the trial.”

To learn more about SAFE-MCS, please visit the study record on clinicaltrials.gov.

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.

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Contact Information

Investor Relations

Saranas, Inc.

713-357-1049

Investor.relations@saranas.com

  1. 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.

SAFE-MCS Will Examine the Impact of the Early Bird® Bleed Monitoring System on Reducing Bleeding Complications in Patients Undergoing High Risk PCI with Mechanical Circulatory Support

Abdel-Wahab, Mohamed et al. https://doi.org/10.1161/CIRCULATIONAHA.121.057856 Circ. 5 Nov 2021

Philippe Généreux, MD – Morristown Medical Center

Background

  • Patients undergoing TAVR procedures may be candidates for early or same-day discharge if certain criteria are met including no intraprocedural bleeding complications1.
  • COVID-19 has resulted in a surge of ICU admissions that has stressed ICU resources within hospital systems, limiting bed capacity.
  • Providers seek objective metrics to confirm safety of patient disposition for early discharge.
  • The Early Bird® Bleed Monitoring System provides assurance to clinicians that no intra and post- procedural bleeding events occur for a patient vulnerable to bleeding complications.
  • The Zio® (iRhythm® Technologies, Inc.) is a wearable heart monitor that attaches to the patient’s chest for a period of up to 14 days.

Case

  • 69-year-old male
  • TAVR procedure incorporating the Zio patch and the Early Bird
  • Patient is a candidate for same-day discharge given that there is no detection of bleeding by the Early Bird

Results

  • Following successful TAVR procedure, the Early Bird remained activated for post-procedure monitoring.
  • With no identified procedural complications and no bleed notifications from the Early Bird, the patient was safely discharged on the same day.
  • The Zio patch remained on the patient for 2 weeks to monitor conduction disturbances.
  • The patient was out on the golf course 2 days following the procedure.

Discussion Points

Integration of adjunctive technologies, such as the Early Bird and Zio, may make early or same-day discharge following a TAVR procedure feasible.

Incorporation of a risk-stratified same-day discharge TAVR algorithm has the potential to ease patient disposition and satisfaction, while reducing hospital resource utilization and ICU burden.

1 Généreux P et al. Catheterization and Cardiovascular Interventions 87:980-982, 2016.