Saranas

High-Level Overview

Saranas is a Houston-based medical technology company that develops the Early Bird Bleed Monitoring System (EBBMS), the first FDA-approved device for real-time detection and monitoring of internal bleeding during endovascular procedures.[1][2][3] It serves interventional cardiologists, vascular surgeons, and hospitals performing high-risk interventions like transcatheter aortic valve replacement (TAVR) or mechanical circulatory support (MCS) device placements, addressing the critical problem of undetected bleeding complications that lead to poor patient outcomes and high healthcare costs.[1][3][4] The company has raised $26.28M in funding, achieved Series B stage, and treated over 1,200 patients since its 2019 launch, demonstrating steady clinical adoption.[1][4]

Origin Story

Founded in 2013 in Houston, Texas, Saranas emerged from technology invented at the Texas Heart Institute, focusing on bleed detection for vascular access procedures.[1][3] Key leadership includes President and CEO Zaffer Syed (as of 2019) and more recently Mike MacKinnon, a seasoned medtech executive appointed to drive commercialization.[2][4] Early traction came with FDA de novo classification in 2019 for the EBBMS, followed by 'first-in-human' results presented at the Society for Cardiovascular Angiography Interventions (SCAI), validating its effectiveness in detecting bleeding early.[2] This milestone earned Saranas recognition as one of Houston's most innovative companies that year.[2]

Core Differentiators

• Novel Bioimpedance Technology: The EBBMS integrates sensors into a vascular access sheath to measure electrical resistance changes, enabling real-time bleed detection before symptoms appear—unlike traditional monitoring that relies on waiting for visible signs.[1][3][4]
• FDA De Novo Classification: First and only approved system for peri- and post-procedural monitoring in endovascular procedures, with 9 patents in catheters, hematology, and surgery.[1][2]
• Proven Clinical Impact: Over 1,200 patients treated, reducing complications in complex interventions like TAVR and MCS, improving outcomes and lowering costs.[4]
• Ease of Integration: Fully functional sheath design fits seamlessly into existing workflows for femoral artery/vein access, enhancing developer and clinician experience without major changes.[1][3]

Role in the Broader Tech Landscape

Saranas rides the wave of advancing endovascular interventions, where minimally invasive procedures like TAVR and large-bore device placements are surging due to aging populations and rising cardiovascular disease—yet bleeding remains a top complication (affecting up to 10-20% of cases).[1][3] Timing is ideal post-2019 FDA approval amid growing adoption of structural heart therapies, with market forces like value-based care favoring tools that cut readmissions and costs.[2][4] By enabling immediate intervention, Saranas influences the ecosystem, setting a standard for bleed monitoring and potentially expanding to other high-risk vascular procedures, bolstering Houston's medtech hub status.[2]

Quick Take & Future Outlook

Saranas is poised for accelerated commercialization under new CEO Mike MacKinnon, building on 1,200+ patient treatments and Series B funding to scale U.S. adoption and pursue international approvals.[1][4] Trends like AI-enhanced monitoring and expanded structural heart markets will shape its path, potentially driving partnerships with device giants or larger trials for broader indications. Its influence could evolve from niche innovator to standard-of-care provider, directly enhancing endovascular safety and tying back to its core mission of transforming bleed detection in high-stakes procedures.[1][4]