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
[email protected]

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
[email protected]

HOUSTON–(BUSINESS WIRE)–Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, has been invited to present at the Transcatheter Valve Therapies (TVT) Structural Heart Disease Summit, which will take place June 20-23 at the Sheraton Grand Chicago. Scheduled presentations of interest include a moderated poster session by Philippe Généreux, MD, Saranas Chief Medical Officer and Co-Director of the Structural Heart Disease Program at Morristown Medical Center, Morristown, New Jersey, on Thursday, June 21 at 11:30 AM. Dr. Généreux will present results from the FDA-mandated validation study designed to assess the performance and safety of the Early Bird™ Bleed Monitoring System.

“Data from this robust animal study demonstrates the Early Bird’s efficacy in positively detecting the onset and progression of internal bleeds. As designed, the Early Bird System may 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 to take appropriate steps to address the bleed before detrimental, irreversible, and life-threatening consequences occur,” stated Dr. Généreux.

An innovation presentation as part of the TVT Main Arena Day II on Friday, June 22 at 2 PM, will review the science of bioimpedance monitoring and the potential application of the Early Bird Bleed Monitoring System during endovascular procedures. Also, on Friday, June 22 at 12 PM, Saranas, Inc. is supporting the Lunch Satellite Program: Optimization of Vessel Access and Closure in Large Bore Catheter Procedure Tips and Tricks Case-Based Review.

President and CEO Zaffer Syed said, “We are excited to showcase the Early Bird System and to report the latest study data at TVT. We believe the Early Bird System may significantly reduce bleeding complications and improve clinical outcomes in patients undergoing endovascular procedures.”

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 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. The technology was invented at the Texas Heart Institute.

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
[email protected]

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 the completion of a $2.8 million Series C funding round. The financing follows the company’s recent De Novo application to the U.S. Food and Drug Administration (FDA) for the Early Bird™ Bleed Monitoring System. The proceeds will be used to conduct a multicenter clinical pilot in the U.S. and to support the company’s U.S. commercialization plan.

“We are pleased to bring additional investment and appreciate the confidence shown by so many returning investors. We continue our work to deliver a product to market that has the potential to significantly reduce bleeding complications while reducing related costs to providers and the healthcare system,” said President and CEO Zaffer Syed. “Since our last round of financing, we have completed design verification and validation activities, continued to build our growing intellectual property portfolio, and submitted a De Novo application to the FDA. With this investment, we are well positioned to initiate a multicenter clinical pilot and extend access to this innovative device to patients in the U.S.”

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 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. The technology was invented at the Texas Heart Institute.

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
[email protected]

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 submitted to the U.S. Food and Drug Administration (FDA) an application requesting Agency review and de novo classification of the Early Bird Bleed Monitoring System.

“This is an important milestone for Saranas as it illustrates the ability of our team to execute on our development and regulatory strategies,” said President and CEO Zaffer Syed. “This submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, design verification testing, and preclinical animal studies. We look forward to continuing our preparation to bring this innovative technology to the market upon FDA clearance.”

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 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. The technology was invented at the Texas Heart Institute.

“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. “With this FDA submission, we are one step closer to providing a solution that has the potential to significantly reduce bleeding complications and improve 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 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
[email protected]