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The update today says they are finessing the motion sensors so FDA can't happen before that is complete. It is patented though, so will be worth the wait.
FDA application will be in the next week.
Taken from the MD&A.
Meeting with MD Anderson pg. 17
"The Company announced on June 4, 2018, only a few weeks after obtaining FDA clearance, thatMD Anderson Hospital had ordered a 4C-VMS+ to use for routine clinical assessment of oncology patients to determine cardiac changes during and after treatments. The machine is operational, and the staff trained. It has been used on a number of patients and the Company is meeting with the principal cardiologist in May, 2019 to assess their experience to date. MD Anderson has been one of the top two cancer centers in the USA for decades."
Maz in May - Page 18, end of first paragraph.
The reduction in the number of contrast-enhanced 2D echo studies would represent a significant savings in time and costs for echocardiology departments. It would also reduce the need to inject the patient with contrast media. The use of contrast-enhanced ultrasound is increasing in the western world with the burgeoning population of heavier peoplemaking it more difficult to obtain clear images using ultrasound.On July 17, 2018, the Company announced the study had begun and the research team reports a publication will be coming out in May.
VMS 3.0 Technical Glitch/Delayed Q2/Q3 - Top of page 29.
During 2018 the Company beganramping up sales and marketing efforts, however, with the announcement of the next generation VMS+3.0 System in development(see NR August 8, 2018), which eliminates the need for patients to remain motionless during image acquisition,improves the workflow of the VMS+ through a more intuitive user interface, and has a much smaller footprintwith an innovative new tracking sensor technology, many potential purchasers opted to wait for the launch of the new system once regulatory approval is received. Aside from two sales of the current VMS+2.0 systems in early 2019, expected sales ramp up has been delayed until after regulatory approval has been received.
Given the average 12-18 month sales cycle to hospitals, we do not expect to see revenues from the VMS+ 3.0 to be recognized for accounting purposes until Q4 2019 (i.e. after delivery and clinical acceptance).
The Company had expected to be able to submit the 3.0 for approval in Q4 of 2018, however, a technical issue with the new technology, now resolved, held up the submissions to Health Canada, European CE Mark and the FDA. Applications for approval are expected to be submitted in early May, 2019.
Dear friend
1. This is the sixth sale of the VMS+ heart analysis system since we obtained FDA approval in late May last year. While selling 6 system in 10 months does not sound very fantastic, it is! The normal sell-cycle for a capital purchase by a hospital is 12 -18 months. Thus, these early sales to renown cardiologists are ahead of the curve.
2. We obviously are targeting the KOLs (Key Opinion Leaders) as these are the people who give the keynote talks at major conferences and influence thousands of other cardiologists. The recent ACC conference allowed us to meet up with more KOLs and so we are pushing ahead with the process both in USA, Canada and Europe. Our Chinese partners are also putting together a KOL conference in China to drive awareness and sales.
3. You will read Ottawa Heart will be focused on valvular disease, which is becoming more and more common as the population ages, . The timing of when to intervene is critical as the replacement valve has a limited lifespan and so you do not want to put one in too early. On the other hand, the right heart does not “recover” easily like the left heart and so waiting too long means permanent heart damage and dysfunction even after a new valve is implanted. Monitoring the valves performance in the first year is also critical to determine if the valve was implanted correctly. If not it can malfunction and cause permanent heart problems.
4. I know you will join me and wishing the Ottawa Heart group, directed by Dr, Chan, the best in their efforts to better define when to replace a valve and how to be sure it is working properly.
Dear Friend;
Children and adults in China can now receive an accurate heart exam.
1. We ventured into China in 2013 with a false start with a large corporation as a distributor and they immediately underwent a restructuring and refused to move forward.
2. In 2014, we got involved with Yutian and then assigned them the rights to establish a JV to manufacture, market, distribute and sell the existing VMS in China, which at the time was for right ventricle only.
3. Fast forward 5 years and Yutian has finally gotten through the Chinese FDA for this first device. It is actually a bit of a hybrid as it uses the RV software and the newer VMS+ hardware. It does not do 4 chambers and still uses the old tracking system.
4. Obviously, they will go forward to get the full VMS+ (4 chambers and new hardware) approved but first they will establish the market with the RV-only system.
5. Yutian has built a 40,000 sq. ft manufacturing facility Ma’amshan and produced 10 VMS+ machines. The facility has GMP certification so the VMS+ are built to western standards. The machines have also been verified to meet ISO60601 specifications (Chinese version of the international standard) for use in hospitals. The factory is ready to produce hundreds of VMS+ machines per year.
6. The market in China is huge and the group is well connected to distribution channels that will rapidly roll out the VMS in the 2,500 tier 1 hospitals in China and then the other 30,000+ hospitals. They have sales targets to maintain their rights and I know they will be working hard to meet them as they have spent so much time and money getting this far. I am glad Ventripoint did not try to do this alone as we would have never had the patience and money to do it.
7. Heart disease is a much bigger problem in China then in North America and the Chinese government is trying to get a handle on it as 23% of hospital admissions are for cardiac dysfunction and this is the major reason they keep building more hospitals and expanding the healthcare service. Like the rest of the world, their population is aging and so the number of elderly people with heart problems is increasing quickly.
8. They actually use cardiac ultrasound as a screening tool to find people with heart problems early. I saw this first hand when I visited a major provincial hospital. People were lined up out the door and down the street to have an echocardiogram done.
9. This was a major milestone in our original agreement to assign the rights for China to Yutian in exchange for investments in Ventripoint, service fees and equity in Yutian. There are still some steps left to make this all happen and we will get them done as soon as possible. The Chinese do not like to tell much about financial arrangements due to competitive concerns, so we will give out what we can. I can say that if only a fraction of what can happen in China happens we will do very well from it and it might even outshine the business in the western world given the overwhelming need.
Thanks for your continued support,
Regards,
George Adams, PhD, ICD.D
I just talked to George and it’s game changing news and they are just finishing up the news release and it will be released at close today.
Talked with George today. The bureaucratic problem was a hospital signing off on the purchase order. Now fixed and will be announced with other news beginning of next week. He’s also expecting Chinese fda any day so hopefully next week will be a big week for us finally.
As always, treat China FDA as gravy, because it may never come.
FDA application will be done as soon as the 2 trials are completed. Approval is guaranteed since the device just has to be equivalent to MRI and that was already proven with the last submission a few years ago.
Sarcoidosis market in Canada: At least 13 sites minimum
Timing couldn't be better for VPT.
That's also an important market, by taking a look just at the canadian sites that could buy our technology.
At the bottom of this clinical trial record (below), you'll find all the canadian multi-sites (13) that participate in this related Sarcoidosis trial lead by the Ottawa Heart Institute.
The the Ottawa Heart Institute seems to be clearly THE expert in Canada and by looking at this trial, VPT's technology clearly comes answer a need:
Cardiac Sarcoidosis Multi-Center Prospective Cohort - Full Text View - ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT01477359
Recruitment Status : Recruiting
First Posted : November 22, 2011
Last Update Posted : September 19, 2018
Study Design:
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Sarcoidosis Multi-Center Prospective Cohort Study
Study Start Date : August 2012
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Study Description
Brief Summary:
Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon.
A Canadian physician survey found that most physicians do not investigate for CS as a possibility in these situations. Thus many patients with clinically important CS are going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients' leads to significant mortality and morbidity.
There are no published clinical consensus guidelines on treatment of CS. Corticosteroid therapy is advocated by most experts. This is based on very modest data from small retrospective observational studies using variable definitions of clinical response. The effect of corticosteroid treatment on the clinical course of CS has not been studied in prospective studies and will be one of the aims of this project. Recent physician surveys regarding CS, in Canada and the US, found that current clinical practice varies widely. The 2008 American College of Cardiology/American Heart Association/Heart Rhythm society guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS.
A multi-center collaborative approach to study CS is greatly needed." The investigators propose exactly that i.e. a multi-center prospective cohort to start to answer clinical questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists, cardiac imaging specialists with extensive experience in imaging of sarcoidosis and biostatisticians. The research will be in two phases; a registry of current diagnostic approaches, treatment and prognosis, and a randomized clinical trial of the effect of corticosteroid treatment on the clinical course of cardiac sarcoidosis.
Detailed Description:
Baseline assessment of Clinically Manifest CS patients consists of: history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers within 2 months of the PET scan, cardiac MRI and possibly a signal average ECG and biopsy (encouraged-either endomyocardial or extra-cardiac).
Follow-up and clinical management of clinically manifest patients diagnosed with CS will occur at 3-6 months with a repeat FDG-PET scan and blood biomarkers. Follow-up will then be annually with an echo and ECG. Treatment with steroids/immunosuppressants and device therapy will be at the discretion of the treating physician.
Baseline assessment of patients diagnosed with extra-cardiac sarcoidosis and being screened for CS consists of: history, echocardiogram, ECG, holter, chest CT scan, biopsy, and cardiac MRI (CMR). If the CMR is suggestive of CS the patient will be have a FDG-PET scan done and be followed as a Clinically Silent patient. They will be contacted every 2 years. If the CMR is negative the patient will be followed as a extra-cardiac sarcoidosis patient with no evidence of CS and be in the control group. They will be contacted at 5 years and at the time of study completion.
All patients will be followed until the last patient recruited has been followed for 4 years.
The occurrence of the primary and secondary outcomes will be assessed in treated and untreated patients.
There will be 2 imaging core labs. The PET core lab will be located at UOHI under the direction of Dr. Robert Beanlands. The CMR core lab will be under the direction of Dr. Mathias Friedrich (McGill University). All scans will be read in the core labs by physicians who are blinded to the clinical details of the patients.
The Biomarker core lab will be at The University of Ottawa Heart Institute under the leadership of Dr P Liu.
Sarcoidosis Pulmonary Hypertension News
With that latest indication (Sarcoidosis), they clearly now have 2 solid selling arguments in our favors to have cardiology sites buy their technology:
- MRI equivalent accuracy for the whole heart
- ability to diagnose Sarcoidosis
That should sells like hotcakes.
This 2014 paper showed that back then, they had to rely on MRI for patients with Sacroidosis condition. Knowing that we have MRI-equivalent accuracy and that are operational costs are much lower ... investing in VPT technology sounds like a no-brainer.
Magnetic Resonance Imaging for Identifying Patients With Cardiac Sarcoidosis and Preserved or Mildly Reduced Left Ventricular Function at Risk of Ventricular Arrhythmias
2014
Background—The purpose of this study was to assess whether delayed enhancement (DE) on MRI is associated with ventricular tachycardia (VT)/ventricular fibrillation or death in patients with cardiac sarcoidosis and left ventricular ejection fraction >35%.
Methods and Results—Fifty-one patients with cardiac sarcoidosis and left ventricular ejection fraction >35% underwent DE-MRI. DE was assessed by visual scoring and quantified with the full-width at half-maximum method. The patients were followed for 48.0±20.2 months. Twenty-two of 51 patients (63%) had DE. Forty patients had no prior history of VT (primary prevention cohort). Among those, 3 patients developed VT and 2 patients died. DE was associated with risk of VT/ventricular fibrillation or death (P=0.0032 for any DE and P<0.0001 for right ventricular DE). The positive predictive values of the presence of any DE, multifocal DE, and right ventricular DE for death or VT/ventricular fibrillation at mean follow-up of 48 months were 22%, 48%, and 100%, respectively. Among the 11 patients with a history of VT before the MRI, 10 patients had subsequent VTs, 1 of whom died.
Conclusions—RV DE in patients with cardiac sarcoidosis is associated with a risk of adverse events in patients with cardiac sarcoidosis and preserved ejection fraction in the absence of a prior history of VT. Patients with DE and a prior history of VT have a high VT recurrence rate. Patients without DE on MRI have a low risk of VT. (Circ Arrhythm Electrophysiol. 2014;7:1109-1115.)
MRI and Outcomes in Cardiac Sarcoidosis
...
Methods:
Multicenter Registry for Cardiac Sarcoidosis:
A multicenter registry for the purpose of research collaboration of this rare disease was established, with the University of Michigan serving as the coordinating center for this study
Cardiac MRI:
All patients underwent cardiac MRI ...
Data Analysis:
All DE-MRI images were analyzed off-line
sarcoidosis CLINICAL PERSPECTIVE
Patients with cardiac sarcoidosis are at risk of ventricular arrhythmias and death, leading to a class IIa indication for implantable cardioverter defibrillator implantation according to expert consensus in the ACC/AHA/HRS guidelines for prevention of sudden cardiac death. However, implantable cardioverter defibrillators are associated with life-long device-related morbidity and may not be beneficial in many patients, especially those with relatively preserved left ventricular function. The relation of scar burden assessed from delayed gadolinium enhancement (DE) on cardiac MRI to ventricular tachycardia (VT) and mortality was studied in 51 patients with cardiac sarcoidosis and left ventricular ejection fraction of >35%. Among 40 patients with no prior history of VT, 3 developed VT and 2 died; all but 1 had DE, and the extent and right ventricular DE appeared to be associated with greatest risk. All patients with a history of VT had DE and 10 of 11 had recurrent VT. The presence of a low scar burden determined by DE was not associated with adverse outcomes. These findings suggest that DE-MRI may be useful for risk stratification in patients with cardiac sarcoidosis.
___________________
With that latest indication (Sarcoidosis), they clearly now have 2 solid selling arguments in our favors to have cardiology sites buy their technology:
- MRI equivalent accuracy for the whole heart
- ability to diagnose Sarcoidosis
That should sells like hotcakes.
This 2014 paper showed that back then, they had to rely on MRI for patients with Sacroidosis condition. Knowing that we have MRI-equivalent accuracy and that are operational costs are much lower ... investing in VPT technology sounds like a no-brainer.
Magnetic Resonance Imaging for Identifying Patients With Cardiac Sarcoidosis and Preserved or Mildly Reduced Left Ventricular Function at Risk of Ventricular Arrhythmias
2014
Background—The purpose of this study was to assess whether delayed enhancement (DE) on MRI is associated with ventricular tachycardia (VT)/ventricular fibrillation or death in patients with cardiac sarcoidosis and left ventricular ejection fraction >35%.
Methods and Results—Fifty-one patients with cardiac sarcoidosis and left ventricular ejection fraction >35% underwent DE-MRI. DE was assessed by visual scoring and quantified with the full-width at half-maximum method. The patients were followed for 48.0±20.2 months. Twenty-two of 51 patients (63%) had DE. Forty patients had no prior history of VT (primary prevention cohort). Among those, 3 patients developed VT and 2 patients died. DE was associated with risk of VT/ventricular fibrillation or death (P=0.0032 for any DE and P<0.0001 for right ventricular DE). The positive predictive values of the presence of any DE, multifocal DE, and right ventricular DE for death or VT/ventricular fibrillation at mean follow-up of 48 months were 22%, 48%, and 100%, respectively. Among the 11 patients with a history of VT before the MRI, 10 patients had subsequent VTs, 1 of whom died.
Conclusions—RV DE in patients with cardiac sarcoidosis is associated with a risk of adverse events in patients with cardiac sarcoidosis and preserved ejection fraction in the absence of a prior history of VT. Patients with DE and a prior history of VT have a high VT recurrence rate. Patients without DE on MRI have a low risk of VT. (Circ Arrhythm Electrophysiol. 2014;7:1109-1115.)
MRI and Outcomes in Cardiac Sarcoidosis
...
Methods:
Multicenter Registry for Cardiac Sarcoidosis:
A multicenter registry for the purpose of research collaboration of this rare disease was established, with the University of Michigan serving as the coordinating center for this study
Cardiac MRI:
All patients underwent cardiac MRI ...
Data Analysis:
All DE-MRI images were analyzed off-line
sarcoidosis
Right ventricular involvement in cardiac sarcoidosis ...
Definitively, we'll be in a very solid position to displace MRI for that condition.
One more study that showed that until today, MRI was THE technology.
Not anymore. ...
Note this special passage:
Until recently, limited attention has been given to right ventricular involvement in cardiac sarcoidosis, its prevalence, relevance, and prognostic value. Cardiac magnetic resonance imaging is the preferred imaging tool to evaluate the healthy and diseased right ventricle.
Right ventricular involvement in cardiac sarcoidosis demonstrated with cardiac magnetic resonance (MRI)
First published: 06 June 2017
Smedema JP1, van Geuns RJ2, Ainslie G3, Ector J4, Heidbuchel H5, Crijns HJGM1.
Author information
1
Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands.
2
Department of Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands.
3
Respiratory Clinic, Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa.
4
Department of Cardiology, University Hospitals Gasthuisberg, Leuven, Belgium.
5
University of Hasselt Heart Centre, Virga Jessa Hospital, Hasselt, Belgium.
Abstract
Aims
Cardiac involvement in sarcoidosis is reported in up to 30% of patients. Left ventricular involvement demonstrated by contrastenhanced cardiac magnetic resonance has been well validated. We sought to determine the prevalence and distribution of right ventricular late gadolinium enhancement in patients diagnosed with pulmonary sarcoidosis.
Methods and results
We prospectively evaluated 87 patients diagnosed with pulmonary sarcoidosis with contrastenhanced cardiac magnetic resonance for right ventricular involvement. Pulmonary artery pressures were noninvasively evaluated with Doppler echocardiography. Patient characteristics were compared between the groups with and without right ventricular involvement, and right ventricular enhancement was correlated with pulmonary hypertension, ventricular mass, volume, and systolic function. Left ventricular late gadolinium enhancement was demonstrated in 30 patients (34%). Fourteen patients (16%) had right ventricular late gadolinium enhancement, with sole right ventricular enhancement in only two patients. The pattern of right ventricular enhancement consisted of right ventricular outflow tract enhancement in 1 patient, free wall enhancement in 8 patients, ventricular insertion point enhancement in 10 patients, and enhancement of the right side of the interventricular septum in 11 patients. Pulmonary arterial hypertension correlated with the presence of right ventricular enhancement (P < 0.001). Right ventricular enhancement correlated with systolic ventricular dysfunction (P < 0.001), hypertrophy (P = 0.001), and dilation (P < 0.001).
Conclusions
Right ventricular enhancement was present in 16% of patients diagnosed with pulmonary sarcoidosis and in 48% of patients with left ventricular enhancement. The presence of right ventricular enhancement correlated with pulmonary arterial hypertension, right ventricular systolic dysfunction, hypertrophy, and dilation.
Introduction
Sarcoidosis is a rare, inflammatory condition, resulting from an uncontrolled cellular inflammatory response in genetically predisposed individuals, which affects the heart in approximately a third of patients.1 Left ventricular involvement demonstrated by contrastenhanced cardiac magnetic resonance has been well validated.2 Until recently, limited attention has been given to right ventricular involvement in cardiac sarcoidosis, its prevalence, relevance, and prognostic value.3 Cardiac magnetic resonance imaging is the preferred imaging tool to evaluate the healthy and diseased right ventricle.4, 5 Right ventricular volumes, mass, and function can be quantified without geometric assumptions and excellent intraobserver and interobserver agreement and interstudy reproducibility.4-6 Delayed contrastenhanced magnetic resonance allows for the detection and quantification of focal scar and interstitial fibrosis. Although there are numerous reports on delayed contrastenhanced cardiac magnetic resonance delineating left ventricular sarcoidosis, relatively few studies have reported on right ventricular involvement.3, 7-10 We sought to determine the prevalence and distribution of right ventricular late gadolinium enhancement in patients diagnosed with pulmonary sarcoidosis and determine the relationship with pulmonary hypertension, ventricular volume, mass, and systolic function.
Methods
Patient selection
Between July 2001 and March 2014, we enrolled 87 consecutive patients with histologically proven pulmonary sarcoidosis. Cardiac evaluation was performed because of symptoms or routine screening to exclude cardiac involvement. Patients were excluded when the standard contraindications for contrastenhanced cardiac magnetic resonance existed. Institutional Review Board approval was obtained for this study.
Baseline investigations
Baseline investigations included 12lead electrocardiography, Doppler echocardiography, and contrastenhanced cardiac magnetic resonance.
Cardiac magnetic resonance protocol and analysis
Studies were performed using a commercial 1.5 T scanner with a cardiacdedicated phasedarray coil. The cardiac magnetic resonance studies were electrocardiographically triggered by standard software.
Sarcoidosis Recognition of Early Cardiac Involvement in Systemic Sarcoid
Another recent study (2017) that was using cardiac MRI to detect Sarcoidosis.
So it sounds VPT will offer a very interesting alternative to MRI in terms of technology, cost and accuracy.
Original Research
Cardiac Imaging
T1 and T2 Mapping in Recognition of Early Cardiac Involvement in Systemic Sarcoidosis
Valentina O. Puntmann , Alexander Isted, Rocio Hinojar, Lucy Foote, Gerald Carr-White, Eike Nagel
Author Affiliations
From the Department of Cardiology, Guy’s and St Thomas’ NHS Trust, London, England (V.O.P., A.I., R.H., L.F., G.C., E.N.); Institute of Experimental and Translational Cardiovascular Imaging, DZHK Centre for Cardiovascular Imaging, Goethe University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt am Main 60590, Germany (V.O.P., E.N.); Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany (V.O.P.); Department of Cardiovascular Imaging, King’s College London, St. Thomas’ Hospital, London, England (V.O.P.); Ramn y Cajal University Hospital, University of Alcal, Madrid, Spain (R.H.); and King’s College Hospital NHS Trust, Denmark Hill, London, England (G.C.).
Address correspondence to V.O.P. (email: vppapers@icloud.com).
Published Online: Apr 27, 2017
https://doi.org/10.1148/radiol.2017162732
Abstract
Purpose
To determine whether quantitative tissue characterization with T1 and T2 mapping supports recognition of myocardial involvement in patients with systemic sarcoidosis.
Materials and Methods
Fifty-three consecutive patients with a biopsy-proven extracardiac diagnosis of systemic sarcoidosis (21 men; median age, 45 years; interquartile range, 22 years) and 36 normotensive previously healthy control subjects (14 men; median age, 43 years; interquartile range, 18 years) underwent cardiovascular magnetic resonance imaging, which was performed to assess cardiac function and late gadolinium enhancement, and T1 and T2 mapping. A follow-up substudy was performed in 40 patients (mean follow-up interval, 144 days ± 35 [standard deviation]); of these 40 patients, 18 underwent anti-inflammatory treatment for systemic symptoms. Binary logistic regression and receiver operating characteristic curve analyses were used to assess discrimination between health and disease; Wilcoxon signed rank test was used to assess the effect of treatment.
Results
When compared with control subjects, patients had higher ventricular volume, higher myocardial native T1 and T2, and lower longitudinal strain and ejection fraction (P < .05 for all). Myocardial native T1 and T2 had higher discriminatory accuracy (area under the receiver operating characteristic curve [AUC]: 0.96 and 0.89, respectively) for separation between control subjects and patients when compared with the standard diagnostic criteria (AUC < 0.67). Native T1 was the independent discriminator between health and disease (specificity, 90%; sensitivity, 96%; accuracy, 94%). There was a significant reduction of native T1 and T2 in the patients who underwent treatment (z score: -3.72 and -2.88; P < .01) but not in the patients who did not (z score, -1.42 and -1.38; P > .15).
Conclusion
Quantitative myocardial tissue characterization with T1 and T2 mapping may enable noninvasive recognition of cardiac involvement and activity of myocardial inflammation in patients with systemic sarcoidosis. Future studies will be performed to confirm their role in risk stratification and guidance of clinical management.
Introduction
Systemic sarcoidosis is a chronic systemic inflammatory condition that is histologically characterized by noncaseating granulomatous tissue infiltration (1,2). Most patients present with systemic symptoms and signs of disease due to involvement of the pulmonary system or skin. Clinical symptoms due to cardiac involvement are rare and manifest in only those patients with advanced disease in the form of heart failure and arrhythmia (3,4). The predominantly subclinical inflammatory myocardial involvement poses an overall challenge to disease recognition and treatment (5,6).
Two sets of diagnostic criteria have evolved to provide a pathway for recognition of cardiac involvement in the presence of known systemic disease (7). The 1993 Japanese Ministry of Health and Welfare (JMHW) guidelines (summarized in Appendix E1 [online]) (7–9) integrated findings of multiple cardiac diagnostic tests, including electrocardiography and a dedicated cardiac imaging study (echocardiography, radionuclide scintigraphy, or cardiac catheterization). These later evolved into 2014 Heart Rhythm Society (HRS) expert consensus criteria by including cardiovascular magnetic resonance (MR) imaging based on the visualization of regional myocardial scarring at late gadolinium enhancement (LGE) (Figs 1,2) (8,10–12). These cardiac diagnostic tests rely on detection of gross and advanced abnormalities of structure and function. As such, they are insensitive to the myocardial inflammatory tissue process, precluding early recognition of disease and disease activity. Quantitative tissue characterization imaging with T1 and T2 mapping enables detection of myocardial inflammation by directly relating to the altered magnetization properties (reviewed by Puntmann et al [13]). We and others have shown that T1 and T2 mapping values correlate with histologic evidence of myocardial inflammation, severity of left ventricular (LV) remodeling and longitudinal strain, and activity of myocardial inflammation in patients with other systemic inflammatory conditions (14–18). Quantitative tissue characterization with T1 and T2 mapping may support recognition of myocardial involvement in patients with systemic sarcoidosis.
A total of 13 patients underwent endomyocardial biopsy independently of the cardiovascular MR imaging findings by using the right ventricular approach; 11 subjects showed nonspecific chronic inflammatory infiltrate, and eight had evidence of chronic inflammation with noncaseating granulomas (4). All 13 patients with endomyocardial biopsy had abnormal native T1 (22) and evidence of LGE.
Management of sudden cardiac death in cardiac sarcoidosis
Additional cardiologists that could be targeted by the marketing team to create awareness of our technology ...
Management of sudden cardiac death in cardiac sarcoidosis using the wearable cardioverter defibrillator
Dirk Skowasch (Email: Dirk.Skowasch@ukb.uni-bonn.de)
Georg Nickenig,
Ren Andri
Department of Internal Medicine II, Division of Cardiology and Pneumology, University of Bonn, Bonn, Germany
Published: March 22, 2018
Abstract
Background
Patients with cardiac sarcoidosis are at increased risk of ventricular achycardia/fibrillation.
Objective
We tested the hypothesis that the wearable cardioverter defibrillator can be used to mitigate the risk of sudden cardiac death among cardiac sarcoidosis patients.
Methods
A retrospective review of the commercial database identified cardiac sarcoidosis patients who wore the wearable cardioverter defibrillator. Evidence for cardiac sarcoidosis diagnosis as well as demographic, co-morbidity and left ventricular ejection fraction were provided by patient clinical records. Clinical data also included daily wearable cardioverter defibrillator wear, shock treatment and survival information.
Results
The wearable cardioverter defibrillator was worn by 46 cardiac sarcoidosis patients, 24 (52%) male. The median age was 48 years and median left ventricular ejection fraction was 30%. The wearable cardioverter defibrillator was worn a median of 23.6 hours each day. There were 11 ventricular tachycardia/fibrillation episodes occurring in 10 (22%) patients. Ventricular tachycardia/fibrillation occurred over a range of 1 to 79 days, median 24 days. First-shock success for conversion of ventricular tachycardia/fibrillation was 100%. Patient survival 24 hours after shock treatment was 100%. Follow up to determine the reason for discontinuing wearable cardioverter defibrillator use indicated that among shocked patients 7 received an implantable cardioverter defibrillator, 1 patient was admitted to the hospital ending in death 2 weeks after discontinuing wearable cardioverter defibrillator use, and 2 patients were lost to follow up. Among the not shocked patients, there were 16 who received an implantable cardioverter defibrillator while 7 achieved improved left ventricular ejection fraction.
Conclusion
Management of sudden cardiac death among cardiac sarcoidosis patients was aided by the wearable cardioverter defibrillator resulting in successful termination of ventricular tachycardia/fibrillation upon delivery of shock.
Sarcoidosis: Current Concepts, Research Imperative
Additional sarcoidosis experts from 4 major institutions that could be targeted by VPT's sales/marketing team as they're all using MRI for the moment.
High-Risk Sarcoidosis. Current Concepts and Research Imperatives (2017)
William H. Sauer1, Barney J. Stern 2*, Robert P. Baughman 3, Daniel A. Culver 4, and Walter Royal 2
-Author Affiliations:
Corresponding Author: William H. Sauer
1University of Colorado School of Medicine, Denver, Colorado
2University of Maryland School of Medicine, Baltimore, Maryland
3University of Cincinnati School of Medicine, Cincinnati, Ohio; and
4Cleveland Clinic Foundation, Cleveland, Ohio
Dec 01, 2017
https://doi.org/10.1513/AnnalsATS.201707-566OT PubMed: 29073361
Pulmonary Hypertension
Sarcoidosis-associated pulmonary hypertension has a reported prevalence of 5 to 10% among all patients with sarcoidosis (21), but the prevalence exceeds 50% in patients with persistent dyspnea (22, 23) and in cases severe enough to warrant lung transplantation (24). The detection of pulmonary hypertension in sarcoidosis is often elusive because of the nonspecific presenting symptoms (e.g., exertional dyspnea). Although transthoracic echocardiography may be a useful screening tool, it is inaccurate in many patients with sarcoidosis-associated pulmonary hypertension (25, 26), and other factors, including exertional hypoxemia, may be used to screen for this entity (21). Table 2 lists some of the features that have been associated with the presence of pulmonary hypertension in patients with pulmonary sarcoidosis, but it requires further validation. Some of the features, such as persistent dyspnea, reduced DlCO, and reduced 6-minute-walk distance, may be due to underlying lung disease. However, it has been found that the presence of these features is more common in patients with sarcoidosis with pulmonary hypertension and should warrant further consideration. The definitive test is the right heart catheterization, which should be considered in patients with sarcoidosis with one or more of the features listed in the table. Other objective methods to detect sarcoidosis-associated pulmonary hypertension include determining the ratio of the diameter of the main pulmonary artery to aorta (27). Cardiac magnetic resonance imaging (MRI) may also provide insight into right ventricular function. Although these noninvasive approaches are effective for screening, it is often necessary to perform invasive hemodynamic monitoring to accurately characterize pulmonary hypertension associated with sarcoidosis to guide therapeutic interventions. Future studies may obviate the need for invasive monitoring by better establishing the correlations between noninvasive techniques (e.g., transthoracic echocardiography and cardiac MRI) and through the further development of emerging imaging technology (e.g., myocardial strain detection) (28).
More GA email.
Lots of news coming next week.
Marketing campaign to sarcoidosis doctors going well with 170 reading the promotional materials and requesting additional information.
PH News helped as well.
> Here’s an email from George
>
> Dear Friend;
>
> Pulmonary Hypertension News put out an article on Friday entitled “Dutch Hospital Uses Non-invasive Tool to Diagnose PH in Sarcoidosis Patients Early” based on our recent press release on Dr. Huitema’s evaluation of 500 sarcoidosis patients. Here is the link and I have also attached the PDF in case you would like to forward it on:
>
> https://pulmonaryhypertensionnews.com/2019/01/17/dutch-hospital-uses-non-invasive-diagnostic-tool/
>
> The article states:
>
> “To date, magnetic resonance imaging (MRI) is the gold standard when examining the right ventricle of a patient’s heart. However, the approach is expensive and unavailable for many patients.
> In contrast, the VMS Heart Analysis System is a fast, inexpensive, and non-invasive alternative to the MRI, and other current approaches.”
>
> This is great news!
>
> Regards,
> George
This is what George said about the Chinese FDA situation:
Two steps after audit:
1. Final review of submission
2. Application for Certificate of Production (CoP).
They have received final review (approved) and have filed application for CoP.
There could be more requests for information so not sure when this pops out but will be this month along with sales from China and North America
Thanks for your support
GA interview with Proactive investors claims FDA in the next month or so, but I don't know if trump shutdown will affect the timeline.
Here’s what George had to say in his follow up email today
> Attached is a news release about a group of doctors in The Netherlands, who have been using the VMS to study patients with Sarcoidosis - a disease that mostly affects the lungs and puts people at risk for pulmonary hypertension.
>
> The study will be published in a top peer-reviewed medical journal later this year, but the investigators have given us permission to release these top-line results.
>
> 1. 20 of the 500 patients had abnormal RV shapes and pulmonary hypertension, which as you know is a very serious condition and needs to be detected early for any hope of treatment.
> 2. This is the first study showing the VMS can be used to “screen" people at risk for pulmonary hypertension and find those people who have already developed the condition.
> 3. There are lots of conditions that give rise to pulmonary hypertension (lung cancer, sickle-cell anemia, COPD, etc.) and so this is an exciting study.
> 4. Our marketing group has identified the doctors in Europe and North America who specialize in Sarcoidosis and will now begin a campaign to make them aware of the VMS’s ability to screen their patients.
> 5. The guidelines suggest that patients should be screened every three months for signs of pulmonary hypertension, but this has been impossible as the only way to diagnose pulmonary hypertension is by cardiac catheterization, which is invasive and dangerous.
> 6. We applaud this group in the The Netherlands for such an innovative clinical study and await even more information on the ability of the VMS to monitor the progression for he disease in these patients.
From GA
Attached is a news release announcing the Company’s recent exhibition in Milan, Italy at EuroEcho. Here is some background:
1. EuroEcho is one of the two major medical conferences each year which focus solely on echocardiography. This year 4,200 medical experts attend the event.
2. Ventripoint had an exhibit booth where we featured live scanning along with the reconstruction process to measure volumes and ejection fractions for all 4 chambers of the heart using our new VMS3.0 machine (see attached picture).
3. The response was excellent with over 80 cardiologists viewing the demonstrations and indicating they wanted to be sent additional information. Our sales team is doing that now and we expect to be able to start filling orders for the VMS 3.0 in February once we receive safety certificates and regulatory approvals.
4. It was especially nice to have Dr. Kutty, who has been along-time supporter of the Company present a new paper showing the VMS was accurate and easy to use for 3D scans for the right ventricle (RV) and left ventricle (LV) in normals and patients with congenital heart disease. This is the first data on LV published and it was well received but the attendees at EuroEcho. Dr. Kutty is a leader in the field of pediatric cardiology and is now at Duke University.
5. Having paper at the conference always increases interest and we continue the effort to make people aware of the VMS and its advanced capabilities. People were especially pleased to see the new tracking system which allows for patient repositioning during the image acquisition process. This was a persistent irritation with the VMS+ which while some sonographers were able to make it work, others struggled.
6. The manufacturing cost of the VMS 3.0 is a fraction of the VMS+, so this will improve margins and also allow us to offer a leasing option to customers who do not have the capital budget to acquire the VMS.
7. We also took the opportunity at the show to meet with most the other ultrasound companies (GE, Siemens, Phillips, Hitachi, Whale, etc.) to show them the VMS 3.0 and discuss how we could work together in the future. We identified a number of opportunities and will be following up with the potential partners over the next few months.
From GA, regarding the AI and newly patented probe that are listed in today's nr.
By Feb we will have all the certificates and approvals in place in order to start taking orders.
60M shares plus 22M out of the money warrants make this a sweet deal for those investors who have located this company. there is also There is no way this company will be below $3/share if Anderson or any other hospitals start buying the product in decent quantities.
The biggest mistake novice biotech investors make is falling in love with a novel product that will be hard to sell and/or is going to be difficult for the FDA to approve it, so it burns huge money for years while the company fights with the hospital buyers after a prolonged fight with the ivory tower theorists at the FDA.
VMS is not novel at all and selling will be relatively easy because it is somewhat of a plug and play addition to hospitals existing ultrasound.
https://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issuerNo=00022463
From GA regarding today's nr. They are on the last stage of testing then will be applying for all the approvals.
Great that this is finally moving ahead because it breaks down the capital cost barrier. Here is the explanation that it isn't quite ready yet, and is not hard to figure from reading because if all this was completed there would have been a nr at the time.
"
The next-generation VMS+ System is designed to use Artificial Intelligence (AI) to provide a streamlined approach for volumetric measurements and ejection fractions for all 4 chambers of the heart from standard 2D echo images. Artificial Intelligence (AI) is the future of cardiac imaging and is transforming clinical outcomes. After clinician feedback, we re-designed the system to incorporate an improved user interface and smaller footprint, thereby allowing for superior integration into the clinical echography workflow and environment. The 3D guidance tracking system has also been replaced with an innovative tracking sensor technology to enable patient repositioning during the examination."
Just a note from Ellen this morning
No this isn’t the last news release – there are more coming in the near future
We have a lot of interest in North America and the EU, but we can’t announce anything until we get a purchase order, which took 5 months with our last sale. Let’s hope other hospitals are a little quicker with the paperwork.
Today, we released follow-on news about our new VMS+ software (only) solution for the whole-heart analysis of 3D echocardiograms.
Here is some background:
1. We are now approved in Europe, Canada and USA for the VMS+ software (only) solution for the whole-heart analysis of 3D echocardiograms. We announced this yesterday. Today, we announce the first sale in Europe of this product.
2. Dr. Laser and his group have already published an excellent paper on using the VMS for analysis of RV in children. He expects to do the same for LV, which he tells us is not well measured using existing software packages from the major vendors (GE, Phillips, Toshiba) for 3D echocardiograms. It is wonderful have someone who uses everyone’s software and trusts ours and not the others.
3. He already has the 3D scans and the MRI scans for the same patients so he can complete this study quickly.
4. We do not expect to sell thousands of this product in the next few years as only 2% of heart exams are done with 3D echo. You only get an image you can analyze 40-50% of the time and the scanning is much more difficult - so only used for research or in a few selected clinical settings such as CHD in children with suspected valve problems or pulmonary hypertension. There are over 400 paediatric centres in Europe so depending on how quickly 3D is adopted in these sites, the sales could ramp nicely. Dr. Laser is advocating for the use 3D in children more often.
5. 98% of all echocardiograms are done with 2D, which is our primary product, the VMS+ system. As you know we have been improving this system and will soon showcase this smaller, menu-driven product that allows for patient movement during the scanning exam.
6. Our business today is still focused on selling VMS+ systems (hardware and software) for 2D use, but eventually we expect the major vendors (GE, Siemens, Phillips, Mindray, Samsung, Hitachi, Toshiba) to improve the 3D hardware to obtain 70-80% readable images and then our business will switch to selling software only most of the time, but there will still be a need for the VMS+ hardware 20-30% of the time, so we will be selling both products to cardiac hospitals.
7. In the meantime, we can sell the software only to researchers and some paediatric clinical centres who have really invested in 3D equipment and training and get some clinical experience on how to do the analysis of 3D images better, faster, easier and maybe automated. We see the future (a decade or more from now) as automated 3D analysis 70% of the time and automated 2D analysis 30% of the time and we want to be the software package everyone uses for both imaging modalities.
Dear Friend;
Attached is a news release announcing a grant and technical support from NRC-IRAP. Here some background:
1. Our VMS+ product works using 2D views of the heart to create a 3D image of the whole heart and then analyzes it for volumetric function. It only creates this 3D image at the beginning and ending of the heart beat as this is all that is required for volumetric analysis.
2. If you image the heart using a 3D probe you get a holographic image of the heart and if you get a good enough image, you can create 4D image of the beating heart. This is not done routinely as the images are generally poor quality and it is difficult to get even these poor images. For the left ventricle a decent image might be obtained 60% of time on people with mild heart conditions. For the right side of the heart it about 40% of patients and lower for people with significant heart disease, so the technique is not used. Eventually the hardware will improve and better 3D images will be more reliable, but this will likely take another decade or more to achieve. Research has show wall motion and heart mass are useful parameters to measure to monitor the condition of the heart.
3. We have obtained a grant (IRAP) and technical support from the Canadian Government’s National Research Council to develop the VMS 2D system to create a beating heart by analyzing all the video frames in a convention 2D scan and not just the two we currently use. Depending on the heart rate, there are 16 to 20 frames in a heart beat so lots more information is available from 2D echocardiography without needing to go to 3D scanning and deal with the poor quality images. 2D scanning works 90% of the time (we are working on showing the VMS+ can analyze the other 10% as well).
4. If successful, this would be a new way to measure wall velocity and mass for all 4 chambers of the heart and would be a world’s first. More importantly, these measurements are known to be useful in characterizing heart disease and its progression (they can be measured using MRI, but it is costly and time consuming, so also not done routinely). Cardiologists need a rapid, reliable and easy way to get this information and we believe the VMS can be expanded to do this.
Our focus is still on sales, but with the grant from NRC-IRAP and their technical help, we can also push ahead with innovations like 4D imaging to build our position as a world leader in heart analysis.
Dear Friend,
I have attached todays news release. Here is some background:
1. Dr. Howard Leong-Poi and Dr. Chi-Ming Chow are very keen to use the VMS+ everyday on all patients. They know the American, European and Canadian Guidelines for echocardiography call for a volumetric assessments of the heart at every visit and for the first time, they can actually follow the guidelines for standard of care.
2. More importantly, they will go forward and validate that this information is necessary to achieve the best outcome for their patients and will be publishing their results to make other cardiologists aware of the power of the information in diagnoses and monitoring heart diseases of all kinds.
3. Since St. Michael’s Hospital is "just around the corner”, we will have the VMS+ installed and examining patients very quickly.
4. This is now the fourth top-tier cardiac centre which will be using the VMS+. We have other’s who are also close to buying the VMS+ and we will be announcing them as we receive the orders.
Just talked with Ellen there will be a news release on Monday And another one near the end of the week.
Attached is the news release we issued today. Here is some background:
1. Dr. Roberto Lang is the past President of the American Society of Echocardiogrpahy (ASE) and the recognized leader in adopting new echo techniques.
2. His group was part of the original clinical trial in RV analysis using the VMS in Pulmonary Hypertension (PAH). He published an excellent article in the Journal of the American Society of Echocardiography, Volume 26, Issue 8 , Pages 860-867. The paper concluded: “Three-dimensional reconstruction of the RV endocardium from 2D transthoracic echocardiographic images obtained in patients with Pulmonary Arterial Hypertension (PAH), as accomplished by Knowledge-Based Reconstruction (KBR), is feasible, accurate, and reproducible”. (note: KBR is a scientific term for VMS).
3. Roberto was one of the leading doctors who encouraged us to expand the VMS to include all 4 chambers of the heart and not just the RV to address the unmet need in many heart conditions.
4. He remains very supportive of the VMS+ and will now go forward to verify the system is feasible, accurate, and reproducible for all 4 chambers of the heart in a wide range of patients (not just PAH). We have proven to the FDA that the VMS+ is accurate and reliable, but we did this ourselves, and it needs independent verification, which the University of Chicago will provide.
5. His target is to get this done to submit it to the Annual Scientific Congress of the ASE by February.
6. Having the endorsement of the leading cardiologists will facilitate the widespread adoption of the VMS+.
6. We will be announcing other leading centres with the same target to present the VMS+ results in selected patient types at the ASE meeting, which is the largest annual gathering of echocardiographers.
There is a nr coming on Monday about new purchase orders ,Chinese fda and the positive results out of the Mazankowski heart institutes studies.
Supposed to be a few more nr next week.
The Company has secured two new orders for its VMS+ heart analysis products at leading hospitals in Germany and the United States (more details will follow). That is an odd comment but I havent been able to find any GA update emails after this news on Oct 17. There is also supposed to be a China update since one of the recent pp investors was following China progress.
Dear Stakeholder;
Attached is a New Release outlining the closing of the private placement we announced on August 15th.
Here is some highlights:
1. Total of $1,011,500 raised in two tranches with no finders fees paid so all funds can go to continuing to improve heart diagnostics for all.
2. Insiders did about 1/3 of the round, which shows we believe the future is bright for the Company.
3. There was one new shareholder who did 50% of the round and he is very supportive of our Chinese initiative, which I hope to update you about in the near future. They have made steady (if slow) progress and are coming to a major milestone - more later.
4. On other news, we continue our marketing efforts and are pleased with the reception by the cardiologists. Apart from having now 16 quotes out, we have an additional 15 sites which have indicated they would like a sales call and a demonstration of the VMS. We will schedule these as soon as possible. You may remember that the new VMS3.0 will be portable and so doing demonstrations will be much easier.
5. The funds just raised along with sales will allow us to move forward and build awareness for the VMS. It will especially allow thought leaders in cardiology to present their experience with the VMS this fall at major cardiology conferences around the world in preparation for the launch of the VMS3.0 early in 2019.
Thanks for the continued support,
Regards,
George Adams, PhD, ICD.D
Sept 5 update
Attached is a news release announcing the closing of the first tranche $500,000 tranche of the $1,000,000 private placement we announced on August 15th. Here is some background.
1. While summer is not an ideal time to raise funds, we had a significant investor who wanted to take a position in the company at this time so we elected to go ahead with the private placement.
2. We will be filling out the private placement in the next few weeks to allow us to continue to develop the VMS3.0 with all its added features to improve work flow and much lower cost.
3. Our sales force is making good progress connecting to leading cardiology groups and we now have 12 groups (up from 5 announced a few weeks ago) working to order a VMS+, which is certified for sale in USA, Canada and Europe. The capital purchase process within a hospital continues to be time consuming with all the levels of sign-off. We expect to migrate to a per-use model with the VMS3.0 early next year and shorten the sales cycle significantly. Meanwhile we await the purchase orders and are ready to supply the VMS+ as soon as they arrive.
4. Surprisingly, we are also seeing a desire to use the 4D software-only product for research purposes.
5. A number of groups have also indicated they would like do clinical studies to show the value of the 4-chamber system (VMS+, 4D and VMS3.0) in routine echocardiography exams, as they believe the current approach is inadequate.
Thanks for your continued support as we make heart diagnostics and care selection better for children and adults worldwide.
Regards,
George Adams, PhD, ICD.D
53M shares plus 17M out of the money warrants make this a sweet deal for those investors who have located this company. There is no way this company will be below $3/share if Anderson or any other hospitals start buying the product in decent quantities.
The biggest mistake novice biotech investors make is falling in love with a novel product that will be hard to sell and/or is going to be difficult for the FDA to approve it, so it burns huge money for years while the company fights with the hospital buyers after a prolonged fight with the ivory tower theorists at the FDA.
VMS is not novel at all and selling will be relatively easy because it is somewhat of a plug and play addition to hospitals existing ultrasound.
https://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issuerNo=00022463
Letter from GA after nr Aug 8
Attached is a new release outlining our progress in developing the next generation of cardiac ultrasound products which will be more user friendly and immediate, as well as smaller and less costly. Here is some background:
1. The VMS+ uses a very expensive tracking system based upon magnetic location technology developed for the military to monitor head position of fighter pilots to determine when they blackout and activate the autopilot. This technology is decades old and has the added disadvantage that it cannot be used with patients with pacemakers or defibrillators, which as the population ages is approaching 20% of patients.
2. We set out to build a better tracking system based upon modern technologies and filed a patent on the design last year. This has advanced quickly and we now have a working prototype showing excellent accuracy and it can be used in patients with implantable cardiac devices.
3. Additionally, we have change the reference point so that we no longer need the patient to be motionless while images are collected. This is a major upgrade in the everyday use of the VMS+ - something called workflow. Also, we have reduced the size and cost drastically so we will be able to offer the new VMS3.0 as a rental or a subscription basis to clinics which do not have access to capital to purchase a VMS.
4. We have already had inquiries from other non-cardiac ultrasound OEMs, asking about the tracking system as they need it for needle tracking and many other application outside or cardiology. We see a significant business opportunity to license others to use the tracking system.
5. Lastly, we have filed a new patent on using this new tracking system in small handheld ultrasound systems which are starting to be used in ERs, doctor’s offices and elsewhere instead of stethoscopes. The issue with these smaller devices is the images are poor quality and they are being viewed on small screens making analysis almost impossible. As you know we excel at obtaining accurate analysis from low-quality images, so we are discussing with the makers of these handheld devices adding the new tracking system and then offering a service to do analysis from these handheld devices. In discussions with leading cardiologists, they are concerned that non-cardiologosts will soon be using these devices for screening and trying to interpret the images, which they will not do correctly. They want a solution like ours to allow the front-line doctors to get it right and refer patients to the cardiologists when appropriate.
Item 5 means news next week.
letter from GA today
Hello;
Have had a lot of people asking about sales and when they will be announced and so we have put out the attached news release to address this important subject.
Background on today’s news release:
1. I am encouraged by the contacts with leading cardiologists that see many special situations where the information the VMS+ provides would greatly enhance the ability to properly diagnose, treat and monitor patients. This is great because making cardiac care better is our mission.
2. In June MD Anderson sent us the first purchase order and we have been working with them to set an installation date, which has now been set for the week of August 13th. This a big deal as this is the number one cancer center in the world. They will need 1,000 machines to address their 1.7 million patients each year, so this is just the first one of many more.
3. We have 5 other leading centres in US, Europe and Canada who have made the decision to buy the VMS+ and are going through their process to issue a purchase order. It is a slow business as hospitals have complex procedures to be sure they only buy what they need. While it is nice to know they absolutely need the VMS+, it is still frustrating. We have the machines ready to be installed so just waiting on the PO.
4. These new centres will also need many VMS+ machines to address their patient population so these are the first of many.
4. We are working hard to adapt the VMS+ so we can offer a subscription model for hospitals so they can get started quickly and we can move away from the capital purchase model. This is the trend in medical imaging - to outsource analysis - to allow cardiologists to focus on patient care and treatment. This will be the topic of the next update news release next week.
Thanks for the support in the public market.
Please call me if you haven questions.
Regards,
George Adams, PhD, ICD.D
CEO
Ventripoint Diagnostics Ltd..
Cell: 519-803-6937
TSXV: VPT
Ventripoint Provides Corporate Update on Sales and Marketing
https://web.tmxmoney.com/article.php?newsid=8919099639627388&qm_symbol=VPT
Sharing the letter from February 21st again. If anyone got a new letter today please post here so we can have some clarity on the number of studies at Maz. As I read this letter again it appears that it was always a plan for this comparison to contrast-enhanced 2D Echo study to happen. So I don't think this is the third study.
Since this study was just started they must have been busy with the other study for the past five months which I think has to do with children. Starting a new study probably means they are done with the other study. They now need to just use all the data, write a paper, and publish it.
Dear Stakeholder;
Attached is a new release announcing our first installation of a VMS+ system at “The Maz" in Edmonton. Here is some background information.
1. The Maz had an original VMS for RV only and now has upgraded to the VMS+ for all 4 chambers of the heart.
2. As usual, they want to try it out on a select group of patients until they adopt it for everyone. Accordingly, they are going to study “technically-difficult” patients first and then cancer patients.
3. "Technically-difficult” is jargon for patients (30-40% of people), who give poor quality images, but as you know the VMS+ excels at analyzing studies where only a small area in each of the 16 normal views can be discerned. It is by aggregating all these little bits of information and using an AI approach we can get the correct result.
4. We have been encourage by our expert users, who have been surprised to be able to analyze what they would have previously said were “unreadable” echocardiograms.
5. Normally, such patients would have gone on to have contrast media injected and have the study redone. This is dangerous (allergic reaction to contrast media), expensive, traumatic and time-consuming, as it requires an IV nurse to be summoned and waited for and numerous people, especially children do not like needles.
6. We continue our quest to improve cardiac diagnosis for all, especially for children. While we originally wanted to avoid MRI, we now see the potential to eliminate needles and contrast media.
7. The study will not take long as the Maz is a busy cardiac centre and so we should have something to report Soon.
Article about VMS. http://www.biotuesdays.com/features/2018/5/20/ventripoint-vms-device-offers-mri-quality-4-chamber-analysis-of-the-heart
FDA approval last week of Ventripoint Diagnostics’ (TSXV:VPT) VMS+ medical device with a four-chamber heart analysis system Is expected to change the paradigm of diagnosing and managing heart patients through a five-minute procedure that can be read in a cardiologist’s office in 10 minutes.
“VMS+ is the first simple echocardiography system to be approved by the FDA for the 3D volumetric analysis of all four chambers of the heart using 2D ultrasound,” CEO, Dr. George Adams, says in an interview with BioTuesdays.
“We can now offer VMS+ to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment,” he adds.
Dr. Adams explains that measurements of heart function, expressed as ejection fraction or the volumes of any of the four chambers of the heart, are increasingly recognized as critically important in monitoring the heart and predicting outcomes of patients.
“This applies to patients with heart failure, abnormal heart rhythms, congenital heart disease, pulmonary hypertension and hypertension,” he points out. “With the VMS+, it is now possible to obtain this valuable information quickly, easily and cost effectively.”
Ventripoint-1.jpg
Ventripoint’s first generation VMS system is the only 2D echocardiography approach certified equivalent to MRI for right ventricle analysis. It has been approved by the FDA, Health Canada, and has CE Mark in Europe for all patients.
“There is no fundamental difference in how our VMS and VMS+ work other than VMS measures changes in the right ventricle only, while VMS+ measures all four chambers of the heart,” he adds.
“When the heart gets sicker, it gets bigger. Our device measures size, with MRI-grade results in an overall process that takes about 15 minutes, and can be read in a cardiologist’s office on the first visit.”
The company’s right ventricle VMS device currently has an installed base of more than 20 major hospitals in North America, Europe and China, some of which have participated in Ventripoint’s clinical trials.
Dr. Adams says the company’s marketing plan will involve targeting key opinion leaders in the cardiovascular sector as well as centers of excellence such as the Mayo Clinic, MD Anderson Cancer Center, Cleveland Clinic and major hospitals in regional clusters, including Chicago, New York, Houston and California. “We’re hoping to announce a couple of orders before the end of the month.”
Key opinion leaders have validated the VMS technology in numerous peer-reviewed articles, including in the Journal of the American Society of Echocardiography.
Among other things, researchers have concluded that VMS gives accurate results even with complex and unpredictable shape variations in adult congenital heard disease patients with right ventricle-to-pulmonary conduits.
In addition, VMS has been shown to have excellent reproducibility even with complete retesting by different examiners in patients with pulmonary hypertension and is superior to conventional 2D echo analysis.
According to Dr. Adams, cardiologists need volumetric information on all four chambers of the heart because the left atrium is involved in heart attacks and blood pressure control; the left ventricle in chronic heart failure; the right atrium in electrophysiology and pacemakers; and the right ventricle in pediatric conditions, pulmonary hypertension and cancer therapeutics.
“Cardiologists now will have a convenient, easy-to-use method of determining whether patients need more therapy, less therapy or no therapy at all,” he contends. “They will be able to sort patients that need a simple medicine or a more complex medicine and whether patients need dual therapy or triple therapy. Cardiologists are not going to order a MRI every time they want to change your medication because there aren’t enough MRI machines and the cost would drown the system.”
New VMS-PLUS model being developed for 4-Chamber analysis (RA, RV, LA, LV)
New VMS-PLUS model being developed for 4-Chamber analysis (RA, RV, LA, LV)
The VMS+ system received Health Canada approval in 2017 and CE Mark at the beginning of 2018. Ventripoint also has established a joint venture in China to manufacture and distribute VMS+, following regulatory approval in China expected by mid-2018.
Dr. Adams points out that the number of people with hypertension is increasing, and an estimated 44% of the 64 million U.S. adults with hypertension did not have this condition controlled in 2014. “As a result, there is an enormous potential for improving population health by expanding treatment and improving outcomes.”
Controlling hypertension could prevent some 56,000 cardiovascular events and 13,000 deaths a year and also would result in significant cost savings for the healthcare system, he adds.
“For example, accurate and reliable repeat measurements of left atrium volume would inform the cardiologist which patients need to have their therapy changed to obtain greater stability of blood pressure,” he contends.
Even during pregnancy, Dr. Adams says it is difficult to determine how the mother’s heart is coping with the 40% increased load in the third trimester. “Normal volumetric index curves would enable cardiologists to determine if the heart is unusually large to determine whether a high-risk pregnancy has developed.”
The economic benefit of VMS technology also extends to cancer patients because most chemotherapies impact the heart. According to a study published in 2016 in the peer-reviewed journal, Echo Research and Practice, right heart function deteriorates in breast cancer patients undergoing anthracycline-based chemotherapy.
“We’re hoping to further study how our device can determine the impact of these adverse effects on right and left heart function,” he adds.
Ventripoint also is studying how VMS can read cardiac ultrasounds without the use of contrast media infusions. Currently, 30% to 40% of cardiac ultrasounds are unreadable and blurry, which requires the use of contrast media to get readable outcomes, Dr. Adams points out.
But upping the use of contrast media infusions is expensive, dangerous and time consuming, and requires an IV technologist to attend the ultrasound. “In the 10% of cases, even when contrast media is used, study is still unreadable, VMS should be able to analyze the study and get results,” he adds.
53M shares plus 17M out of the money warrants make this a sweet deal for those investors who have located this company. I have about 1M shares FD including my warrants, and there is no way this company will be below $3/share if Anderson or any other hospitals start buying the product in decent quantities.
The biggest mistake novice biotech investors make is falling in love with a novel product that will be hard to sell and/or is going to be difficult for the FDA to approve it, so it burns huge money for years while the company fights with the hospital buyers after a prolonged fight with the ivory tower theorists at the FDA.
VMS is not novel at all and selling will be relatively easy because it is somewhat of a plug and play addition to hospitals existing ultrasound.
https://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issuerNo=00022463
Anyone remember the link to comments about dealing with blurry images?
It was in a 2018 George Adams video or else a nr where he said cardiologists were amazed that VMS could produce clear images from a former blurr or else it was always clear. Or something like that.
From a Proactive Investors June 6 article
A huge potential opportunity.. Dr George Adams, the chief executive at VentriPoint, says the MD Anderson Cancer Center order represents a huge opportunity. "Since all chemotherapy agents hurt the heart, the American Heart Association (AHA) has put out a statement saying cancer patients should ask to have their heart examined before, during and after therapy as they are more likely to die from heart problems than cancer after they have the therapy," he noted. He reckons the hospital's network would need 750 VMS+ devices to treat their patients according to the AHA (American Heart Association) guidelines (3 three scans per patient) at "full utilisation". There are 1,500 cancer centers in the USA, which deal with 23mln patients, who come back twice a year to check to see if the cancer has regrown and the AHA is saying they really should be more worried about heart conditions then cancer, suggests Adams. He says that to follow AHA guidelines in the USA with the normal use rates would require 20,000 VMS+ machines. At US$75,000 each this would be US$1.5bn of sales, he says, and that is just for the USA. The European market is 1.5 times' the USA. In March this year, the firm said it would advance the AI (artificial intelligence) capabilities of the system, via a government grant. VentriPoint will partner with Ryerson University on a project to further advance the Al already imbedded in the VMS+ products as it is taking part in a Natural Sciences and Engineering Research Council (NSERC) Engage grant. The same month, it established an business advisory committee (BAC) and named Samuel Schwartz as its inaugural chairman. Significantly, in January, its VMSplus device received a European CE mark less than a month after the firm made the application. It means it can now be sold to aid in heart treatment throughout the European Union and the medtech group said it aims to meet with distributors with a focus on Germany, the UK and France. According to the European Heart Network, cardiovascular disease (CVD) causes 3.9mln deaths in Europe annually and accounts for 45% of all deaths in Europe, so the opportunity is vast here. Expansion plans Last November, the group revealed it was putting expansion plans in the Middle East in place. It struck a partnership with the SEED Group, which is a group of firms owned The Private Office of Sheikh Saeed Bin Ahmed Al Maktoum of Dubai, United Arab Emirates. "The SEED Group has already introduced us to leading cardiologists and hospitals in the region, who have expressed their interest in acquiring the VMS-PLUS and demonstrating its application within the healthcare environment," Adams had said. "We see Dubai as an excellent starting place for our expansion plans into the Middle East." In September, the firm said that interest in VentriPoint products is strong from Iran, Singapore, Thailand, UAE and Saudi Arabia, and that regional distributors were verifying the local pathway to regulatory approval
Details from Mr. Adams
1. The sales team is focused on closing sales in Europe and North America. We have put the middle east on hold as not enough people to do everywhere.
2. China is coming along nicely and we expect them to order 10-50 machines from Canada in next 6 months.
3. We will be announcing sales to leading hospitals throughout the summer. We have estimated MD Anderson hospital network will need 500 machines to deal with the 1.5M patients per year. So the first one is just for them to get comfortable with our novel approach and they will start using it clinically as soon as they are trained.
4. We also are working on next generation VMS3.0 for the service business where we would do the reconstructions for a fee. This is the trend in imaging so we want to offer it as well. Target is end of the year to have VMS3.0 ready to deploy with a service provider which we have selected already and already offers analysis services for MRI and CT.
5. We believe that eventually 4D imaging will get good enough to be used clinically (5 years from now?) and then we can stop selling machines and just be an an analysis service with fully-automated reconstructions. Our AI approach to analysis is the only way I know which could be used to do automated analysis so we need to take advantage of this headstart.
6. AI project with Ryerson is beginning to prove this out and should be well advanced by year end. We do not need automation to start the service business but to help it grow with less and less human intervention. So lots going on.
The biggest market would be China, but I place zero value on that because you have to put a server in China and how would you be able to protect that from all the criminals there, including the C army who likes to confiscate? There are few MRI in China but many ultrasounds so it would be a natural for VPT and the poor C who get zero heart care there now.
Standard of care in C for people needing an MRI which is not available is to give aspirin and tell you to come back if the pain doesn't go away. They have a JV with a C manufacturer and C medical sales company who is building an ultrasound machine that would have the VPT system in it, with a royalty to VPT from C sales and the ROW VPT has 100% of the rights to the ultrasound machine - if it ever gets developed.
5. is 4 times the $3.75 in 4.
so it is $15B
4. is $3.75B
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