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

Investor.relations@saranas.com

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

Investor.relations@saranas.com

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 
Investor.relations@saranas.com

Saranas® Announces Initial Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

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.

Saranas Awarded Technology Breakthroughs Contract with Premier

Houston, TX – Saranas, Inc., developer of the Early Bird® Bleed Monitoring System designed for early detection of internal bleed complications during endovascular procedures, has been awarded a group purchasing agreement with Premier Inc., as part of Premier’s Technology Breakthroughs program.  This new agreement, effective November 1, 2020, will allow Premier’s network of over 4,100 U.S. hospitals and health systems to receive special pricing and access to the Early Bird – the first and only device on the market that provides accurate and actionable bleed detection, enabling effective intervention before the patient shows symptoms or recovery is impacted.

“The Early Bird has the potential to significantly reduce the severity of bleeding complications, which can occur during and after endovascular procedures.  These complications are dangerous for patients and costly to the healthcare system,” said Saranas President and CEO James Reinstein. “We are honored to be recognized by Premier’s Technology Breakthroughs program and are excited to make the Early Bird available to their physicians for the benefit of patients undergoing endovascular procedures.”

Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,100 U.S. hospitals and 200,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost.

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

Investor Relations
Saranas, Inc.
713-357-1049
investor.relations@saranas.com

Saranas Announces Peer-Reviewed Publications Highlighting Accuracy and Clinical Utility of Early Bird® Bleed Monitoring System

Houston, TX — Saranas, Inc., developer of the Early Bird® Bleed Monitoring System for the monitoring and early detection of internal bleed complications during endovascular procedures, announced the online publication of two peer-reviewed articles highlighting the system’s accuracy and performance.  The publications provide evidence of the  Early Bird’s reliability to detect the early onset and progression of bleeding events during endovascular procedures. 

One paper, entitled “Safety and Accuracy of a Novel Bioimpedance System for Real-Time Detection and Monitoring of Endovascular Procedure-Related Bleeding in a Porcine Model,” was published online in the Journal of Invasive Cardiology (https://bit.ly/2XK0qj8). The paper contains results from the study, which evaluated the performance of the Early Bird to detect endovascular bleeding through a validated animal bleed model.  The study concluded that the Early Bird could detect the onset and progression of bleeds with 100% sensitivity as well as 100% specificity. 

A second paper, entitled “First-in-Human Study of the Saranas Early Bird® Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events,” was published online in the Journal of Invasive Cardiology (https://bit.ly/2AdKEEh). The Early Bird was used during and after endovascular procedures in 60 patients across 5 centers in the United States. The primary endpoint was the level of agreement in bleeding detection between the Saranas Early Bird and post-procedural computed tomography (CT).  The clinical study results validate the effectiveness of the Early Bird with a high level of agreement (Cohen’s kappa=0.84) when compared to independently reviewed post-procedural CT scans. 

“Among a population of all-comer patients undergoing a broad variety of endovascular procedures, the Early Bird was safe, easily incorporated into our standard workflow, and demonstrated the capacity to detect bleeding before the progression to a more severe or symptomatic phase,” said Philippe Généreux, MD (Morristown Medical Center, NJ), the study’s primary author.

“These two published studies underscore our commitment to conducting rigorous scientific and clinical studies that demonstrates the value and utility of the Early Bird Bleed Monitoring System,” said Saranas President and CEO James Reinstein.  “As the first and only device on the market for early bleed detection, the Early Bird has the potential to significantly reduce the severity of bleeding complications and resulting costs, while improving clinical outcomes in patients undergoing endovascular 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

Investor Relations
Saranas, Inc.
713-357-1049
investor.relations@saranas.com

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

HOUSTON–(BUSINESS WIRE)–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.

Contacts

Zaffer Syed
Saranas, Inc.
713-357-1049
zaffer@saranas.com

Saranas Recognized as One of Houston’s Most Innovative Companies

Houston, TX — Saranas Inc., a medical device company pioneering technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been named one of Houston’s most innovative companies. Saranas is the only medical device company to be honored at the inaugural Innovation Awards presentation sponsored by the Houston Business Journal on September 26, 2019.

Innovation honorees were selected by a panel of judges based upon their demonstrated success in innovation in the past 16 to 18 months. During this time, Saranas was granted de novo classification by the U.S. Food and Drug Administration (FDA) for their Early Bird®Bleed Monitoring System. Additionally, the company presented ‘first in human’ results at the Society for Cardiovascular Angiography Interventions (SCAI) Scientific Sessions, demonstrating that the Early Bird device is effective in early detection of internal bleeding.

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 mechanical circulatory support. The Early Bird is the first and only device for real-time detection and monitoring of these types of complications.

“We are honored to be recognized as a leader in Houston’s rapidly expanding innovation ecosystem,” said Saranas President and CEO, Zaffer Syed. “We believe that the Early Bird is an important technology advancement that will significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”

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.

FDA Grants Saranas DeNovo Designation for the Early Bird® Bleed Monitoring System

HOUSTON–(BUSINESS WIRE)–Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System.

According to a recent study of over 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database, one in five patients experienced a bleed complication. A 2017 report in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters.

“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said Saranas President and CEO Zaffer Syed. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”

The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded bioimpedance sensors that are designed to detect and monitor bleeding from vessel injury which may occur during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access. In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100% sensitivity and 100% specificity.1

“Bleeding remains an Achilles’ heel of advancing minimally-invasive, catheter-based procedures,” said Dr. Dimitrios Karmpaliotis, Director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”

“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” stated Saranas Chief Medical Officer Dr. Philippe Généreux. “I firmly believe the Early Bird Bleed Monitoring System will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”

The Early Bird Bleed Monitoring System is currently being piloted in multiple centers to assess the versatility of the Early Bird to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans to commercially launch the device in select centers of excellence across the U.S.

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.

1. Data on file, included in device’s Instructions for Use (IFU).

Contacts

Zaffer Syed
Saranas, Inc.
713-357-1049
zaffer@saranas.com

Saranas™ Announces Initial Clinical Cases with the Early Bird™ Bleed Monitoring System

HOUSTON–(BUSINESS WIRE)–Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, announced that the first clinical cases with Early Bird Bleed Monitoring System were performed at Atlantic Health System’s Morristown Medical Center (Morristown, NJ). The cases varied across multiple interventions including transcatheter aortic valve replacement (TAVR), hemodynamic support and standard percutaneous coronary interventions, demonstrating the versatility of the Early Bird to potentially improve patient safety with improved bleed status monitoring during and after endovascular access procedures.

“The Early Bird Bleed Monitoring System is designed to protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible, and life-threatening consequences occur,” said Saranas Chief Medical Officer Dr. Philippe Généreux. “The initial clinical cases have successfully demonstrated the versatility and potential benefit of the Early Bird across a wide variety of case types.”

“Our goal in the development of the Early Bird Bleed Monitoring System is to provide doctors with a groundbreaking tool to reduce bleeding complications and to improve clinical outcomes in patients undergoing endovascular procedures,” said Zaffer Syed, President and CEO of Saranas. “As we expand our clinical pilot to multiple US centers in the coming weeks, we look forward to gaining more insight and experience on the utility of bleed monitoring.”

The first in human experience with the Early Bird will be showcased in the following presentations at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held September 21-25, 2018 in San Diego, CA:

  • Friday, September 21, 2018, @ 2:25pm during Innovation Sessions:
    • “Real-Time Bleed Detection and Monitoring: Initial Clinical Experience with the Early Bird™ Bleed Monitoring System” by Dr. Philippe Généreux
  • Sunday, September 23, 2018, @7:32am during Breakfast Satellite Program:
    • “Real Time Bleed Detection: Novel Saranas Early Bird Bleed Monitoring” by Dr. Philippe Généreux

The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR, large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute.

The Early Bird Bleed Monitoring System is not yet approved by the U.S. Food and Drug Administration and is currently available for investigational use only.

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 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, visit www.saranas.com.

Contacts

Saranas, Inc.
Zaffer Syed, 713-357-1049
zaffer@saranas.com