VPTDF - Ventripoint Provides Update on Clinical Studies
(TheNewswire)
Toronto, Ontario – TheNewswire –September 15, 2021 - Ventripoint Diagnostics Ltd. (" Ventripoint " or the " Company "), (TSXV:VPT ) ; ( OTC:VPTDF) has provided anupdate on clinical studies using the VMS+ 3.0.
Ventripoint Overview: A RevolutionaryWay to View and Analyze the Heart
Ventripoint is an industry leader in the application of ultrasound AI(artificial Intelligence) for heart imaging. The company’s VMS+ 3.0technology offers a proven, patented, non-invasive AI solution for 3Dvisualization of all four chambers of the heart, providing a pivotalnew diagnostic tool for aiding cardiologists to combat cardiovasculardisease and sustain heart health in both adults and children. VMS+3.0delivers a faster, more precise and economical way to view and analyzethe heart, providing results equivalent to more expensive andtime-consuming MRI. These advantages also allow for faster, morefrequent monitoring of patients.
The VMS™ Technology
VMS+ (Ventripoint Medical System Plus) 3.0 marries the high-resolutionof cardiac MRI (Magnetic Resonance Imaging) and ease of use ofultrasound with the power of Ventripoint's proprietary KBR(Knowledge-Based Reconstruction) AI technology. KBR enables physiciansto construct a precise 3D model of the heart and calculate volumes andejection fractions for all chambers of the heart with an accuracyequivalent to MRI using standard ultrasound images obtained using anycardiac ultrasound machine such as General Electric, Phillips,Siemens, etc.
Planned and Ongoing ClinicalStudies
The Company has twelve clinical projects underway or being planned. This shows the innovative nature of the VMS+3.0 in enablingclinicians to study a variety of heart problems by analyzing the wholeheart for the first time. All these studies are being funded throughinstitutional sponsorships or grants. The Company is providingtraining for research staff and logistical support for theseground-breaking studies conducted by leading cardiologists. Below isbrief description of the five projects currently underway. A morecomprehensive description of each clinical project will be availableon the Company’s website shortly. The other seven studies willaddress, single-ventricle, hypertension, Duchennemuscular dystrophy , acute COVID-19, long-haul COVID-19,COVID-19 in elite athletes and surgical planning in valvereplacements. The Company will provide details on these studies whenthey have been approved by the host institutions.
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1. Normal andAbnormal Maternal Heart Function during Pregnancy
The Company is supporting a world-first study on maternalcardiovascular changes during pregnancy. A recent review* stated,“Profound haemodynamic changes, such as a 50% increase in cardiacoutput, place an added burden on the maternal cardiovascular systemduring pregnancy and can provoke new-onset or an exacerbation ofexisting cardiovascular disease. Cardiovascular disease complicates1-4% of pregnancies and is more common in women with hypertensivedisorders, which is the leading cause of maternal death”. Thereare 4 million births a year in the United States and 8 million inEurope and maternal hypertensive deliveries has been increasingsteadily for decades.** They are estimated to represent 10% of birthsaccording to the CDC. It is hard to imagine but the changes in amother’s heart during pregnancy have never been studied in detail. A study of the changes in vascular and ventricular function inhealthy pregnant women and those with underlying cardiovasculardisease is beginning at a major heart center. The VMS+3.0 will beused to perform repeated heart assessments in this study and willallow for quick and accurate measurements in this groundbreaking studyof women’s health. The study has been awarded funding by anational granting agency.
*(Ramlakhan et al, Pregnancy and cardiovasculardisease. Nat RevCardiol 17, 718–731 (2020). https://doi.org/10.1038/s41569-020-0390-z )
**https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregnancy-complications-data.htm
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2. CongenitalHeart Defects with Septal Defects
It is estimated 1.35 million babies are born with Congenital HeartDefects (CHD) each year.* The American CDC ( https://www.cdc.gov/ncbddd/heartdefects/data.html )estimates there are 1 million children and young adults and 1.4million adults living with CHD in the United States. In 2013, hospitalcosts for this population of individuals with cardiovascular defectswere about USD$6.1 billion.
Atrial and Ventricular Septal Defects (ASD and VSD) are the mostcommon forms of Congenital Heart Disease (CHD), worldwide*. A septaldefect is a hole in the heart wall (septum) that divides the left andright chambers of the heart. This causes oxygenated blood to leak backinto the right side of the heart from the left side resulting indamage to pulmonary circulation and overworking the heart and lungs.The study will pioneer a novel minimally-invasive procedure to sealthe hole in ASD patients and the VMS+3.0 will be used to monitor theefficacy of the procedure by measuring the remodeling of the atria tonormal anatomy and function.
* van der Linde et al, Birth Prevalence of CongenitalHeart Disease Worldwide: A Systematic Review and Meta-Analysis,Journal of the American College of Cardiology, Volume 58, Issue 21,2011, Pages 2241-2247, ISSN 0735-1097, https://doi.org/10.1016/j.jacc.2011.08.025 .
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3. LAEnlargement as an Earlier Indicator of Heart Failure with DiastolicDysfunction
Heart failure is a global health concern affecting at least 26 millionpeople worldwide and is increasing in prevalence as populations ageand become more affluent.* It is estimated that 30% to 90% of patientswith heart failure have diastolic dysfunction or stiffening of theheart.** Left atrial enlargement (LAE) correlates to diastolicdysfunction** (also known as heart failure with preserved ejectionfraction,” or HFpEF) and is a marker of severity of mitral stenosisand regurgitation as well as a risk factor for atrial arrhythmias***.LAE may be an early indicator of HFpEF. Lung congestion due to HFpEFoften has a rapid onset with difficulty to breathe. This study willdetermine if a simple way to measure LAE would enable earlieridentification of patients at risk for heart failure.
*Savarese et al, Global Public Health Burden of HeartFailure. Card Fail Rev. 2017 Apr;3(1):7-11. doi:10.15420/cfr.2016:25:2. PMID: 28785469; PMCID: PMC5494150.
**Blume et al, Left atrial function: Physiology,assessment, and clinical implications. European Journal ofEchocardiography, 12, 421–430. doi:10.1093/ejechocard/jeq175
***Brucks et al, Contribution of left ventriculardiastolic dysfunction to heart failure regardless of ejectionfraction. Am J Cardiol. 2005 Mar 1;95(5):603-6. doi:10.1016/j.amjcard.2004.11.006. PMID: 15721099.
****Leung et al, Echocardiographic evaluation of leftatrial size and function: Current understanding, pathophysiologiccorrelates, and prognostic implications. American Heart Journal,156(6), 1056–1064. doi:10.1016/j.ahj.2008.07.021
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4. RA and RVEnlargement as an Indicator of Tricuspid Valvular Dysfunction
Right atrial (RA) volume is a marker of right ventricular (RV)diastolic dysfunction and severity of tricuspid regurgitation orstenosis. There is surprisingly little information, and limited toolsvalidated for accurately measuring right atrial and ventriculardimensions and function. The VMS+3.0 is a simple and reliable way ofmeasuring RA and RV volumes and is being used to study children withvalvular disease to better characterize the severity of the valvulardisease.
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5. Benefits ofVMS+3.0 for Determining Optimal Point for Pulmonary Valve Replacement(PVR) in Young Adults with Tetralogy of Fallot
A recent review* in 2020 stated, “The benefits of pulmonary valvereplacement (PVR) for pulmonary insufficiency in patients withrepaired tetralogy of Fallot are still incompletely understood, andoptimal timing remains challenging”. This study will review theexperience of one center, which has used the VMS+ to assess over 500patients before and after PVR. The ease of use of the VMS+ hasenabled more frequent monitoring of the RV and expected to show theoptimal RV volume for PVR to achieve the best outcome.
*( Van den Eyndeet al, Pulmonary Valve Replacement in Tetralogy of Fallot: An UpdatedMeta-Analysis. Ann Thorac Surg. 2020 Dec 27:S0003-4975(20)32173-1.doi: 10.1016/j.athoracsur.2020.11.040. Epub ahead of print. PMID:33378694)
For further information, pleasecontact:
Dr. George Adams
519-803-6937
Neither the TSX Venture Exchange nor its RegulationServices Provider (as that term is defined in the policies of the TSXVenture Exchange) accepts responsibility for the adequacy or accuracyof this news release.
Forward Looking Statements
This news release contains forward-looking statements andforward-looking information within the meaning of applicablesecurities laws. The use of any of the words "expect","anticipate", "continue", "estimate","objective", "ongoing", "may","will", "project", "should","believe", "plans", "intends'' and similarexpressions are intended to identify forward-looking information orstatements. The forward-looking statements and information are basedon certain key expectations and assumptions made by the Company.Although the Company believes that the expectations and assumptions onwhich such forward-looking statements and information are based arereasonable, undue reliance should not be placed on the forward-lookingstatements and information because the Company can give no assurancethat they will prove to be correct.
Since forward-looking statements and information address future eventsand conditions, by their very nature they involve inherent risks anduncertainties. Actual results could differ materially from thosecurrently anticipated due to a number of factors and risks. Factorswhich could materially affect such forward-looking information aredescribed in the risk factors in the Company's most recent annualmanagement's discussion and analysis that is available on theCompany's profile on SEDAR at www.sedar.com. Readers are cautioned that theforegoing list of factors is not exhaustive. The forward-lookingstatements included in this news release are expressly qualified bythis cautionary statement. The forward-looking statements andinformation contained in this news release are made as of the datehereof and the Company undertakes no obligation to update publicly orrevise any forward-looking statements or information, whether as aresult of new information, future events or otherwise, unless sorequired by applicable securities laws.
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