The Early Bird^® Bleed Monitoring System Proven to Significantly Lower Bleeding in Protected PCI Patients

March 11, 2024, Houston, TX – Saranas, Inc. announced today the compelling results of SAFE-MCS, a multi-center clinical study 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 (EBBMS). Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS, presented the “The Safe Surveillance of Percutaneous Coronary Intervention Under Mechanical Circulatory Support with the Saranas Early Bird Bleeding Monitoring System (SAFE-MCS) Study” as part of the late-breaking clinical trial sessions at the annual Cardiovascular Research Technologies (CRT) meeting in Washington D.C. 

“I am pleased to announce a significant reduction in BARC (Bleeding Academic Research Consortium) type III or V access site bleeds in patients monitored with the EBBMS was shown compared to the historical control (4.2% vs. 12.5% in PROTECT II) which corresponded to a relative reduction in risk of 66.3%,” noted Dr. Basir. “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results. These findings are clinically significant and endorse the use of EBBMS for high-risk PCI patients who are receiving MCS support.”

The study enrolled 203 patients across multiple centers in the United States. Patients undergoing complex high-risk PCI with MCS via Impella and transfemoral arterial approach were enrolled. The Early Bird Bleed Monitoring System was used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“The SAFE-MCS study highlights the importance of prompt bleed detection and continuous monitoring to prevent severe complications and improve clinical outcomes, especially as the use of MCS increases globally,” stated Dr. Philippe Genereux, interventional cardiologist and Director of the Structural Heart Disease Program at Morristown Medical Center and co-principal investigator of SAFE-MCS. “We now have a deeper understanding of the frequency of bleeding events during such procedures with improved strategies to enhance patient safety during protected PCI.”  

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 MCS. 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 system¹. The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications. 

“We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Mike MacKinnon, CEO and President of Saranas. “This represents an important advancement in our mission to continue building the clinical proof supporting the effectiveness of the Early Bird device. Saranas is dedicated to establishing a new benchmark for bleed detection during and after endovascular procedures, with the goal of improving patient outcomes and decreasing healthcare expenses overall.”

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. 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% sensitivity².

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. 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.
2. 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.

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

September 18, 2023, Houston, TX – Saranas, Inc. announced today that it has completed 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 Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system. It 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.

“With the global rise in utilization of MCS, the SAFE-MCS study aims to provide valuable understanding of the actual frequency of bleeding incidents during these procedures and strategies to enhance the safety of patients undergoing complex and high-risk treatments,” stated Dr. Philippe Genereux, interventional cardiologist and Director of the Structural Heart Disease Program at Morristown Medical Center and co-principal investigator of SAFE-MCS. 

SAFE-MCS enrolled 184 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 mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants. The Early Bird Bleed Monitoring System is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“Prompt detection of bleeding incidents is vital to prevent complications that can severely impact patients. The insights from SAFE-MCS will offer significant insight and guidance on how continuous monitoring can improve clinical outcomes by actively addressing bleeding events,” said Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS.

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 MCS. 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 system¹. The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.

“We are pleased to have completed enrollment of the SAFE-MCS trial,” said Saranas President and CEO Mike MacKinnon. “This marks a significant step in our journey to further establish clinical evidence for the effectiveness of the Early Bird device. Saranas is dedicated to setting a new standard for bleed detection during and after endovascular procedures, aiming to enhance patient outcomes and reduce the overall cost of healthcare.”

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. 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% sensitivity².

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.

Media Contact Information:

Kristen Lomas
[email protected]

310-529-5431

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.
2. 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.

MacKinnon brings a wealth of medical device senior leadership experience to the company as it establishes early bleed detection as standard of care 

February 27, 2023, Houston, TX – Saranas^® Inc., a medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications, today announced the hiring of seasoned medtech executive, Mike MacKinnon as Chief Executive Officer. He joins the company to accelerate commercialization of its Early Bird Bleed Monitoring System – the first and only system FDA-approved bleed detection system for endovascular procedures. It is designed to detect bleeds early, enabling physicians to address and mitigate the risk immediately, reducing costly complications and improving the patient experience. 

“We are delighted to have Mike join and lead Saranas as we continue our mission establishing early bleed detection and monitoring as the standard of care for patients undergoing endovascular procedures,” commented Dan Wolterman, Saranas Board Chairman. “He is an accomplished executive with an impressive record of bringing disruptive technology to market, guiding strategy, and driving significant growth.” 

Mike brings 25 years of executive leadership experience and most recently was a Partner and President of Madison Ventures +, a boutique Private Equity firm located in Greenwood Village, CO. Before joining Madison Ventures +, he was the CEO of Zidan Medical, an early-stage company focused on endobronchial ablation for early-stage lung cancer. Prior to this, he served as the CEO of ROX Medical, a privately held medical device company that pioneered an innovative interventional vascular therapy for uncontrolled hypertension. 

Before his most recent roles, Mike spent 4 years as Vice President, Head of Sales, for Philips North America’s Image Guided Technologies division, where he was instrumental in the development and growth of the company’s interventional devices business. Mike also played a key role with M&A during his time at Philips, where he led the commercial due diligence for the acquisition of Spectranetics for more than $2B in 2017 and ultimately integrated a combined 500-person sales team. He joined Philips after the company’s acquisition of Volcano Corporation, where he served as the General Manager of Phoenix Atherectomy division and Peripheral Sales Leader. He originally joined Volcano as part of the acquisition of AtheroMed in June 2014, which he led as CEO.

“I am excited to join Saranas at this important time as the company continues to build commercial momentum and clinical evidence for the Early Bird,” stated Mike MacKinnon, CEO of Saranas. “Bleeding remains a common issue during and after endovascular procedures and can result in life-threatening complications. The Early Bird alerts physicians to signs of bleeding in real-time so they can take the necessary actions, protecting patient safety and optimizing clinical outcomes.”

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. 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 transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and percutaneous mechanical circulatory support (MCS)². 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.

Media Contact Information:

Kristen Lomas

[email protected]

310-529-5431

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.

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]