A Three-phase Study That Will Compare the ECG Data Recorded Using the Test Device With the Data Recorded by a Reference Device, Evaluate the ECG Signal Quality of the Test Device Over a 10-day Simulated Use Period, and Assess the Effects of Variable ECG Electrode Placement for the Test Device

ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects.  Detailed Description  At least 150 subjects will participate in this study over a 24-hour test period. The subjects must have been diagnosed with a known condition such as Atrial Fibrillation (AF), Tachycardia, Bradycardia, Premature Ventricular Contractions (PVC/VEB), and/or Premature Atrial Contractions (PAC), etc.  A Testing Facility analyst will conduct an initial visual evaluation of the level of skin adhesion for the Test Device. The Testing Facility analyst will apply the Test device adhesive on the subject and initiate ECG data collection. Subjects will observe a 5-minute stabilization period to ensure the device is connected appropriately and has a stable input signal. Subjects will be allowed to leave the Testing Facility for the next 24 hours. During this period, subjects will follow the instructions for use provided by the Sponsor and engage in normal routine activities. After the 24-hour recording, subjects will return to the Testing Facility, and an analyst will then remove the Test Device.  Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis according to the Sponsor's statistical analysis plan. The cardiologist's assessment will be compared with the analysis by the ZywieAI algorithm. A summary of the ECG statistical analysis comparing the agreement of the cardiologists will be included as an appendix to the final report for the study.  Official Title  Assessing Compatibility of the ZywieAI Algorithm to Analyze ECG Data Collected From the Zywiez3 Sensor and Adhesive Over a 24-hour Period  Conditions  Atrial Fibrillation (AF)  Tachycardia  Bradycardia  PVC - Premature Ventricular Contraction  Premature Atrial Contraction  Atrial Fibrillation (AF)  Tachycardia  Bradycardia  PVC - Premature Ventricular Contraction  Premature Atrial Contraction  Atrial Fibrillation (AF)  Tachycardia  Bradycardia  PVC - Premature Ventricular Contraction  Premature Atrial Contraction  Atrial Fibrillation (AF)  Tachycardia  Bradycardia  PVC - Premature Ventricular Contraction  Premature Atrial Contraction  Intervention / Treatment  Device Test Algorithm and Test Device  Other Study ID Numbers  Study Start Actual  Primary Completion Actual  Study Completion Actual  Enrollment Actual  Study Type  Interventional  Phase  Not Applicable  Resource links provided by the National Library of Medicine  MedlinePlus  (https://medlineplus.gov/) related topics: Atrial Fibrillation  (https://medlineplus.gov/atrialfibrillation.html)  FDA Drug and Device Resources  (https://clinicaltrials.gov/fda-links)  Contacts and Locations  This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.  To learn more, please see the Contacts and Locations section in How to Read a Study Record (https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations)  This study has 1 location  United States  Montana Locations  Bozeman, Montana, United States, 59715  Bioscience of Bozeman, LLC  Click to view interactive map  Participation Criteria  Researchers look for people who fit a certain description, called eligibility criteria . Some examples of these criteria are a person's general health condition or prior treatments.  For general information about clinical research, read Learn About Studies (https://clinicaltrials.gov/study-basics/learn-about-studies)  Eligibility Criteria  Description  Inclusion Criteria:  Of the 150 subjects who complete the study, at least 60 (i.e., ≥ 40%) subjects must be male, and at least 60 (i.e., ≥ 40%) subjects must be female.  Subjects must be more than 18 years of age.  Subjects' body mass index (BMI) will be calculated based on their weight and height at the time of consent. BMI will be calculated using the CDC's online Adult BMI Calculator (https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html). This calculator will also automatically categorize the calculated BMI as underweight to healthy (< 18.5 to 24.9), overweight (25.0 to 29.9), or obese (≥ 30.0). Of the 150 subjects who complete the study, no more than 70 subjects can be from a given BMI category.  Subjects must be able to read, write, and understand English.  Subjects must be in good general health (i.e., no current or recent severe illness).  Subjects must have a known condition of Atrial Fibrillation (AF), Tachycardia, Bradycardia, Premature Ventricular Contractions (PVC/VEB), and/or Premature Atrial Contractions (PAC) diagnosed by a medical professional.  Subjects with body hair on their upper-left chest must be willing to have the body hair clipped by a Testing Facility analyst before applying the Test Device.  Subjects must be willing to have their upper-left chest cleaned with 70% isopropanol preparation pads before applying the Test Device.  Exclusion Criteria:  Subjects cannot be currently participating in another clinical study.  Subjects cannot have active skin rashes, dermatoses, or breaks in the skin on the upper left chest region.  Subjects cannot have undergone any surgeries during the last 3 months involving incisions along their upper-left chest.  Subjects cannot have any tattoos on their upper-left chest.  Subjects cannot have currently active inflammatory skin conditions (e.g., atopic dermatitis/eczema, contact dermatitis, or psoriasis) anywhere on the body within 2 days of the start of the test period and during the 24-hour test period.  Subjects cannot have a medical diagnosis of an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.  Subjects cannot have a pacemaker.  Subjects cannot have any type of port, shunt, or Peripherally Inserted Central Catheter (PICC).  Subjects cannot receive any vaccinations within 7 days of the start of the test period and while participating in the 24-hour test period.  Subjects cannot have known allergies or sensitivities to latex (natural rubber), adhesives, inks, sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, to topical application of fragrances (e.g., perfumes or colognes), acrylic, hydrogel, isopropyl alcohol, C11-12 isoparaffin, isopropyl palmitate, isopropyl myristate, or isopropyl stearate.  Subjects cannot be pregnant, plan to become pregnant, or cause a partner to become pregnant during the study.  Subjects cannot be nursing a child during the 24-hour test period.  Subjects cannot have any medical condition or use any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation or might impact data.  Ages Eligible for Study  18 Years and older  Adult Older Adult  Sexes Eligible for Study  All  Accepts Healthy Volunteers  No  Study Plan  This section provides details of the study plan, including how the study is designed and what the study is measuring.  Expand all Collapse all  How is the study designed?  Design Details  Primary Purpose  Diagnostic  Allocation  N/A  Interventional Model  Single Group Assignment  Masking  None (Open Label)  Arms and Interventions  Participant Group/Arm  Intervention/Treatment  Participant Group/Arm  Other  Evaluation of 24-hour ECG Data from Test Device by a Test Analysis Algorithm  ECG data will be collected from subjects with previously diagnosed heart arrhythmias by a test algorithm. ECG data collected using a Test Device with non-traditional lead placement worn for a 24-hour period. The Test Algorithm analysis will be compared to assessments of the ECG data by 2 cardiologists with a 3rd cardiologist employed when there is no agreement by the 2 cardiologists.  Intervention/Treatment  Device Test Algorithm and Test Device  Test Algorithm analysis of 24-hour ECG Data collected with a Test Device  What is the study measuring?  Primary Outcome Measures  Outcome Measure  Measure Description  Time Frame  Demonstration that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects  Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis by ZywieAI algorithm identifying cardiac anomalies. The cardiologist's assessment will be compared with the analysis by the ZywieAI.  24 Hours after Application of Test Device  Collaborators and Investigators  This is where you will find people and organizations involved with this study.  Sponsor  Zywie, Inc.  Investigators  Principal Investigator  Christopher M Beausoleil, B.S.  Bioscience of Bozeman LLC  Study Record Dates  These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.  Study Registration Dates  First Submitted  First Submitted that Met QC Criteria  First Posted  Study Record Updates  Last Update Submitted that met QC Criteria  Last Update Posted  Last Verified  More Information

Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period

Collaboration aims to enhance cardiovascular care. Michael Barbella, Managing Editor09.04.24

“We are proud to welcome Zywie to the MedAxiom community,” said Joe Sasson, Ph.D., MedAxiom chief commercial officer and executive vice president of ventures. “Remote rhythm monitoring is a crucial tool for diagnosing cardiac arrhythmias. Zywie’s adaptable solutions offer an opportunity to bring more innovations to our members, provide education on the options and strategies available to them, and advance our goal of transforming cardiovascular care together.”

Zywie offers multiple types of monitors to fit most patients' and physicians' needs, including the ZywieNano patch, a compact band-aid-like patch that continuously monitors the heart’s electrical activity for up to 30 consecutive days. The data collected by the ZywieNano patch is sent to Zywie’s cloud-based platform, where it is analyzed by algorithms to provide insights into a patient’s heart rhythm and potential cardiac conditions. Zywie's ability to analyze patients' electrocardiograms in real time allows clinicians to proactively address abnormal heart rhythms before they worsen or become lethal. “Zywie is excited to announce our partnership with MedAxiom, the leader in cardiovascular organizational performance solutions,” Zywie CEO Latha Ganeshan stated. “Zywie reaffirms its dedication to advancing patient care through innovative cardiac diagnostics, and this partnership enables us to collaborate closely on that mission with MedAxiom's extensive network and expertise. Together with MedAxiom, we are committed to delivering enhanced value to patients, healthcare providers and the broader cardiovascular community.”

Zywie’s platform has been shown to increase diagnostic yields and actionable data for providers over standard 14-day monitors by capturing the rhythms previously missed between days 15 to 30. The higher diagnostic yield, or arrhythmia detection rate, increases providers’ ability to accurately identify and diagnose heart-related conditions. Zywie is a full-suite, remote cardiac monitoring company specializing in wearable biosensor devices and cloud-based data analytic solutions. Zywie’s flagship product is the ZywieNano patch, a small band-aid-like patch that patients wear on their chest to continuously monitor their heart’s electrical activity for up to 30 days. The data collected by the ZywieNano patch is sent to Zywie’s cloud-based platform, where it is analyzed by algorithms to provide insights into a patient’s heart rhythm and potential cardiac conditions. MedAxiom, an ACC company, is the cardiovascular community’s premier source for organizational performance solutions. MedAxiom is transforming cardiovascular care by combining the knowledge and power of hundreds of cardiovascular organization members, thousands of administrators, clinicians and revenue cycle experts, and dozens of industry partners. Through the delivery of proprietary tools, smart data and proven strategies, MedAxiom helps cardiovascular organizations achieve the Quadruple Aim of better outcomes, lower costs, improved patient experience and improved clinician experience.

Zywie Forges Industry Partnership With MedAxiom

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— Andrew Carlton, Vice President of Sales at Zywie
PENSACOLA, FL, UNITED STATES, November 21, 2023 / EINPresswire.com / -- Lovell® Government Services is pleased to announce a partnership with Zywie Healthcare, an innovator in wearable cardiac monitoring solutions. Lovell will represent Zywie as their Service-Disabled Veteran-Owned Small Business (SDVOSB) Vendor in the federal space. “As a growing company committed to improving patient care through continual advancements in heart monitoring technology, we look forward to the impact this partnership can have for our Veterans nationwide,” said Andrew Carlton, Vice President of Sales at Zywie. “By partnering with Lovell, we are thrilled to gain access to VA and DoD organizations allowing us to expand our mission to help more people.”
Zywie's system uniquely provides lightweight, easy-to-use devices that increase patient compliance without sacrificing clinical outcomes. Zywie offers the world's smallest wearable heart monitor, which is not only water-resistant but can also live-transmit every heartbeat to the cloud for analysis. Combining a low-profile easy-to-wear patch with the ability to analyze a patient's EKGs in near real-time, enhances patient compliance and enables healthcare professionals to make actionable clinical decisions on their patients' health within minutes, revolutionizing the efficiency of care delivery. “This is a significant partnership for us. Cardiac monitoring saves lives, and we are grateful to be able to provide these solutions to the federal government. We appreciate Zywie for making Veterans a point of focus for their technology,” Chris Lovell, USMC Major (Ret. ), Chief Executive Officer, Lovell Government Services. This partnership announcement comes with the news that Zywie’s ZywieNano™ patch and Zywie Clarus devices have been approved on major government contract vehicles overseen by the General Services Administration (GSA), Department of Veterans Affairs (VA), and Defense Logistics Agency (DLA). Government customers can now find the ZywieNano™ patch and Zywie Clarus device on the Federal Supply Schedule (FSS) and the DLA’s ECAT system. Listing products on these contracts through Lovell gives government customers the dual benefit of a streamlined acquisition process while working towards their SDVOSB procurement goal. ABOUT ZYWIE
Zywie is a full-suite, remote cardiac monitoring company specializing in wearable biosensor devices and cloud-based data analytic solutions. Zywie’s flagship device is the ZywieNano™ patch, a small band-aid-like patch that patients wear on their chest to continuously monitor their heart's electrical activity for up to 30 days. The data collected by the ZywieNano™ patch is sent to Zywie’s cloud-based platform, where it is analyzed by algorithms to provide insights into a patient's heart rhythm and potential cardiac conditions. Learn more at https://zywie.healthcare. ABOUT LOVELL® GOVERNMENT SERVICES:
Lovell Government Services Inc. was founded by Chris Lovell, Major USMC Retired, in 2013 out of a desire to continue to serve by providing specialty Medical and Surgical Resources to the Veterans Administration Hospital System and the U.S. Military Medical Networks. Lovell partners with medical, dental, and pharmaceutical companies looking to better serve Veteran and Military patient populations, increase their federal revenue stream, and win government contracts. Learn more at www.lovellgov.com
Mia McCann

Zywie Awarded a Spot on ECAT and FSS Contract Vehicles Through SDVOSB Partner, Lovell Government Services

MedAxiom is a cardiovascular performance community that provides consulting, networking, and membership services including data analytics, program excellence tools, and educational events to improve business and patient care outcomes.

MedAxiom

`` Zywie is excited to announce our partnership with MedAxiom , the leader in cardiovascular organizational performance solutions , '' Zywie CEO Latha Ganeshan stated .

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ZYWIE is a medtech company focused on the early detection and remote monitoring of cardiovascular disease. The company offers a range of wearable cardiac monitors that provide live-streaming electrocardiogram (ECG) analysis to identify abnormal heart rhythms. ZYWIE's technology aims to assist healthcare providers in optimizing treatment plans. It was founded in 2014 and is based in Duluth, Georgia.

Date	Round	Amount	Investors	Valuation Valuations are submitted by companies, mined from state filings or news, provided by VentureSource, or based on a comparables valuation model.	Revenue	Sources
5/3/2020	Loan	$0.68M	Paycheck Protection Program	$XXM	0 FY undefined
11/2/2015	Unattributed	$XXM	Subscribe to see more	$XXM	0 FY undefined	10

Date	5/3/2020	11/2/2015
Round	Loan	Unattributed
Amount	$0.68M	$XXM
Investors	Paycheck Protection Program	Subscribe to see more
Valuation	$XXM	$XXM
Revenue	0 FY undefined	0 FY undefined
Sources		10

First funding	5/3/2020
Last Funding	5/3/2020
Investor	Paycheck Protection Program
Rounds	1 Loan
Board Seats
Type	Government
Location	DC

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