About our project
The problem we solve: Our children are unnecessarily dying! The NHLBI calls it a “critical public health issue.”
• 1 in every 10 children are born with a silent congenital heart condition, of which 30% will have moderate to severe lifelong heart risk
• SCD is the #1 killer of student athletes and #2 medical cause of death among youth under age 25
The incidence of SCD has not declined over past 30 years because “sick care” is woefully ineffective at detecting early SCD risks:
• Risk questions meant to raise suspicion of abnormalities have limited effectiveness; only 20% to 50% of SCA survivors describe previous symptoms and only 16% to 43% have positive family history
• The AHA, ACC and NCAA no longer recommend ECG’s as a screening test (>10% false results)
• Echo exam costs (>$1,000) disqualify them as a viable mass screening test
Dental & eye exams are staples of preventive care, yet there is no equivalent test to prevent youth SCD. It's time for a fundamentally new PREVENTIVE approach!
About our solution:
PraeVeni’s novel Cardiologist-designed screening test uses the authority and accuracy of Echo at a reduced non-medical cost structure.
Most young heart problems are present at birth, show now outward symptoms, and become unstable over time. Over 95% of these silent heart conditions have risk features that are detectable by an Echo test, which is uniquely capable of identifying early anatomic, physiologic, and hemodynamic abnormalities.
Where standard screening methods use costly diagnostic tests to search for signs of rare heart abnormalities in asymptomatic youth, our registered Sonographers invert the standard objective and unequivocally affirm the anatomic, physiologic, and hemodynamic features are NORMAL. When a feature cannot be affirmed as normal, THEN a Cardiologist reviews the test to diagnose the ABNORMALITY.
By initially affirming the NORMAL state of key heart features, PraeVeni’s test improves accuracy, reduces costs, and rules-out >95% of known SCD risk associations.
Progress to
date:PraeVeni opened a state-of-the-art screening center in November 2016 with over 230,000 K12 age children living within 15-miles. The business model from appointment registration through final report has been digitized and automated. Our measured launch plan led us to partner with select community organizations, schools, and clubs from 15 local communities. PraeVeni has screened over 1,800 youth and has ruled out abnormalities for all but 2 percent of participants, a ratio consistent with that of the general population. With a successful launch phase completed, PraeVeni is looking grow its scope to 4 Echo machines, to intensify sales efforts and to realize an annualize screening rate of 20,000 young participants during 2018.
About Our Team
Creator: Tim Webert
Location: Minnesota
Bio: I am a father of three who witnessed the tragic sudden cardiac death (SCD) of a young ice hockey player. As a 20 year Marketing Executive and business builder, I've rededicated my professional life to saving and enriching young lives by helping detect early risk features that are associated with SCD. Nothing else has worked, as evidenced by the limited impact of medicine on the incident rate of SCD over the past 30 years. PraeVeni's Cardiologist-designed screening test is proven to unequivocally affirm normal heart and blood vessel features and rule-out abnormal features.
I invite you to join me in preventing young SCD in our communities.
Title: President
Advanced Degree(s): MBA
About Our Company
How We Help Patients
PraeVeni's Focused Echo Screening Test helps screening participants in one of two ways:
98% of participants will be affirmed as having NORMAL anatomic, physiologic, and hemodynamic heart features. This group (and their families) will benefit from "PEACE OF MIND" that they are heart healthy.
2% of participants (consistent with the general population) will have an early abnormal risk feature that will be diagnosed by an Cardiologist at no additional cost. This group will have an opportunity to get a head start on managing/correcting the abnormality BEFORE it becomes dangerous (and not experience an unexpected cardiac event)
How We Help Physicians
PraeVeni's sole focus is on preventing young sudden cardiac death and helping to save and enrich youth lives. Dispite this focus, we do help Cardiologists by identifying the 2% of the young population with abnormal risk features, which leads them to seeking expert Cardiologists for management and treatment. This is lucrative incremental business that Cardiologists may not have otherwise seen.
Innovation Details
Intellectual Property Summary
Company Trademarks applied for. Echo Rule-out test trade secrets
Clinical Information
Clinical Assessment Rule Out-Screening
To demonstrate the use of a specialized rule-out Echo screening exam we examined 1,000 consecutive asymptomatic young athletes and nonathletes (age 4 through 25 years; mean age 15). Each subject completed an American Heart Association (AHA) preparticipation questionnaire and the specialized rule out-echo screening exam. The Echo exams were performed by registered sonographers who documented a sequence of unequivocal binary functional, anatomic, and hemodynamic data features. The average exam time was ≈10 minutes.
Exam Results: 1,000 healthy young athletes and nonathletes
- Function: LR was zero in 100% of the subjects (unequivocal normal diastolic and systolic function) effectively ruled-out cardiomyopathies;
- Anatomy: there were 21 subjects with ‘rule out’ abnormal anatomic findings: 2 subjects with benign persistent left superior vena cava to coronary sinus communication; 18 subjects with bicuspid and 1 unicuspid aortic valve (5 were siblings; 9 had mild and 2 moderate aortic dilation; 7 mild aortic valve regurgitation; and no coarctation); 470 (47%) had an enlarged left atrial volume index (range 28 to 56 mL/m2; median 34 mL/m2) consistent with athletic heart with normal diastolic function (LR-zero functional risk); 100% subjects had normal internal cardiac crux; 100% normal coronary artery origins;
- Hemodynamics: 100% had normal left ventricular function (LR-zero risk); 210 (21%) had resting systolic blood pressure above 120 mmHg (18 subjects above 140 mmHg) all were deemed functional with normal a LR; 100% had normal mean pulmonary systolic pressure. All subjects had normal abdominal aorta Doppler velocity profile, which ruled-out coarctation;
- Channelopathy rule-out: Two subjects with normal cardiac function (functional LR-zero) had an abnormal AHA questionnaire: 1 subject with a family history of ARVD/C and parent with an implanted CV defibrillator (ICD); 1 subject with unexplained syncopal spells. Both subjects had a normal LR-zero and normal right ventricular outflow diameter (i.e., ruled-out major feature for arrhythmogenic cardiomyopathy). Both were undergoing expert electrophysiologic evaluation.
Based on published literature Echo would be expected to rule-out more than 90 % of CV conditions associated with SCD and identify >2% incidence of potentially serious CV risk anomalies in the young. These findings would be infrequently detected by physical exam, ECG or limited exercise testing. A normal rule-out exam omitted the need for further risk assessment. Any individual with a positive questionnaire (2 subjects) or abnormal rule-out Echo screening exam (19 subjects) were referred for cardiovascular rule-in evaluation and management. The principal goal is to assure safe exercise and athletics and identify any CV risk as early as possible.
Full manuscript currently under review
Regulatory Status
FDA approval not applicable
How we will use the funds raised
Your contributions will save and enrich young lives.
No existing diagnostic test works to detect early risk features of sudden cardiac death... PraeVeni's screening test is proven to detect early risk features and all funds raised will be used to broaden our ability to screen more children. Plans include: additional echocardiography machines (increase capacity), professional branding and promotion campaigns, enhance our MVP registration/workflow system to facilitate mulitple integrated screening sites, and initiating development of location #2.
Thank You
Three years ago I witness the sudden cardiac death of a young player during my son's ice hockey game. It affected me, my family, and our community deeply. Afterwards, I learned there are no tests available to detect heart abnormalities in symptom-free kids. It is unexceptable and unethical to allow kids to unnecessary die or to unsuspectingly live with a silent timebomb when the required technology and knowhow to prevent such tragedy has gone unheeded for 50 years. PraeVeni has a proven solution that unequivically works. The test is simple, acurate, and affordable... and has a positive lifelong impact on familes and communities alike!
Thank you for your financial contributions and helping ensure no familiy again experiences the loss of a seemingly healthy child!
