How it all started

Origin Story

Serendipity. It was the chance meeting between a cardiac surgeon and a PhD bioengineer on the first day of class at the UCLA Anderson EMBA program. One had the idea (from his dissertation) to take the most commonly used tool in healthcare, a blood pressure cuff, and repurpose it into a linear sensor to measure the earliest warning sign of heart disease. The other understood the power and application of such a tool because she battled heart disease from inside an OR every day. 

They teamed up on a class project that tasked them to create a business plan for a fictional product and pitch it to real VC’s. Instead, they pitched the non-fictional SmartCuff and the presentation was so successful that a company was born.

Mission Statement

Beat cardiovascular disease by empowering everyone to check their vascular health anytime, anywhere.

Cordex Systems Inc is a privately held C corporation incorporated in the state of Maryland. It has been funded by state and federal grant support as well as two successful oversubscribed rounds of private funding. 

 Cordex Systems has designed, patented, prototyped and tested, in over 700 patients, a novel cardiovascular diagnostic device known as the “SmartCuffTM”. It is a quick, simple, non-invasive device that takes the direct measurement of vascular health out of a surgical cardiac catheterization lab and makes it accessible to both a consumer at home and a clinician in the office setting. Known as the “vital vital sign”, the vascular compliance measurement taken by the SmartCuff may be used to track direct changes in vascular health as people engage in healthy lifestyle choices such as weight loss, diet, exercise, stress reduction and smoking cessation or take prescribed medications to treat diabetes, hypertension, or abnormal lipids. Doctors and consumers are flying blind when it comes to knowing which of these cardiac risk treatments are actually changing vascular health because we have no practical way of measuring it…until now. 

Medical Technology Development and Testing

FDA Submission Roadmap

Hospitals and Partners

Organizations that we work with

 

Intellectual IP

Patented Proprietary Technology

34 patents in 17 countries 

IP attorneys: Katten, Muchin, Rosenman LLP

In addition, multiple trademarks have been registered and a portion of the  algorithm has been kept as a trade secret

Clinical

Accomplishments

  • Tested over 700 patients and performed over 1200 tests
  • Primary test site is Johns Hopkins Medical center, ranked #1 for 21 consecutive years 
  • Additional collaborations with the Mayo Clinic
  • Clinical studies done outside the US at Fundacion Cardioinfantil Medical Center (Bogota, Columbia)
  • Completed Proof of Concept Studies in 34 subjects
  • Completed performance testing in 331 subjects
  • Completed  observational studies in 311 patients assessing how 98 different cardiovascular metrics correlate with our compliance measurement
  • Published our data in peer-reviewed medical journals
  • Presented our work at American College of Surgeons meeting and the American College of Sports Medicine meeting

Product Development

Accomplishments

  • Passed ISO 81060: Blood Pressure Validation: Systolic / Diastolic- completed during last capital raise
  • Passed ISO 81060: Blood Pressure Validation: MAP (mean arterial pressure)
  • Validated repeatability: Coefficient of Variabiity of 15.3% (goal of <20%) 
  • Successful invasive physiologic testing to assess beat-to-beat variability of measurement 
  • ISO 13485 certified with multiple successful QMS audits as required for medical a device company
  • Created a data assurance plan which encrypts all algorithm code and provides a safe repository with built in redundancies for added security
  • Invested in software tool kits to enable development by in-house software coding and quality control expert
  • Successful assessment of Clinical Usability performed at 17 clinical sites with AstraZeneca collaboration. 62 individual operators (site clinical coordinators) were trained on the SmartCuff device. 57 subjects were enrolled and tested 3 times each (total test count = 171) over the course of 28 weeks

Business Development

Accomplishments

  • Applied, accepted and completed a 6-month UCLA Strategic Management Research (SMR) study focused on strategic marketing plan and product launch strategy included 300+ hours of primary research, 150+ in person interviews with health care professionals, 225+ online surveys, 55+ in person surveys of doctors and med tech professionals
  • Completed 57 patient Phase II multisite study collaboration with AstraZeneca for drug development 
    • Deployed SmartCuffs to 17 US test sites
    • Served as a validation of clinical user utility outside of Johns Hopkins
  • Invited to present to Department of Defense at US Amy Institute of Surgical Research Campus  (San Antonio, TX) 
  • Embarking on Johns Hopkins Biomedical Engineering study incorporating fitness monitoring with FitBit (owned by Google)
  • Applied and selected to present at Life Science Intelligence Medtech Conference USA ’24 in Dana Point, CA

Why now?

3 tailwinds

New anti-inflammatory approach to treating cardiovascular disease

  • New studies presented at the most recent American College of Cardiology meeting show that vascular inflammation is a stronger predictor of residual risk than LDL (bad) cholesterol levels
  • These studies incorporated data from 31,245 patients and was highly significant statistically
  • This led the FDA to recently approve the anti-inflammatory drug, colchicine, to treat heart disease by decreasing inflammation in the arteries
  • Inflammation causes endothelial dysfunction – the functional metric we measure

Read more on The Lancet

Diagnostic Excellence – new trends that are shaping the future of diagnostics

  • The SmartCuff is fully align with the 5 biggest changes in diagnostics by continuously monitoring data patterns in CV disease progression/regression to preserve wellness

Read more on JAMA Network

GLP – 1 receptor agonist (AKA semaglutide) weight loss drugs

  • These drugs, like Ozempic, are known to improve endothelial function – the metric we measure. GLP-1’s 
  • In a recent study of 17,604 subjects showed a 20% reduction in Major Adverse Cardiac Events (MACE) and this was seen BEFORE people lost weight which indicates that these drugs may have a positive cardiac effect that is not related to losing weight
  • We hypothesize that the SmartCuff may be used to track improvement in vascular health independent of weight loss as a companion diagnostic and may be used to  support a cardiovascular indication-for-use for pharmaceutical companies developing pipeline GLP-1/GIP drugs

Read more on the American College of Cardiology

© Copyright - Cordex Systems - This device is not yet FDA approved.