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Not sure why this board exists with the wrong ticker symbol, but please post to the other board from now on.
VPTDF: effective Dec. 7,2015 a one for 10 reverse split:
http://otce.finra.org/DLSymbolNameChanges
VPTDF: effective Dec. 7,2015 a one for 10 reverse split:
http://otce.finra.org/DLSymbolNameChanges
VPT halted in US & Canada "At the Request of the Company Pending News"
Read more at http://www.stockhouse.com/news/press-releases/2015/10/21/iiroc-trade-halt-ventripoint-diagnostics-ltd#dAKC53e3ciVIixrE.99
Based on?
Seriously, I'd like to hear why...
Thanks!
VPTDF-VPT: Ventripoint Receives Marketing Clearance from the FDA to Expand the Use of the VMS Heart Analysis System
SEATTLE, WASHINGTON, May 26, 2015 (Marketwired via COMTEX) -- Ventripoint Diagnostics Ltd. ("Ventripoint") (VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS(TM) product which states; "The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired".
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition," stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI."
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS(TM) is the first cost-effective and accurate tool for measuring right ventricle heart function. The Corporation has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts - a multi-billion dollar market potential.
VentriPoint Diagnostics- double digits ahead-FDA clearance will now allow them to dominate and capitalize tremendously!!
VPT on Canadian market- US -VPTDF- May 25, 2015) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS(TM) product which states; "The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired."
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition," stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI."
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
**VPDTF**Ventripoint Diagnostics- FDA Clearance. .10++ ahead of some major licensing and large pharma collaborations
VPDTF- FDA Approval -VPT on Canadian market- US -VPTDF- May 25, 2015) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS(TM) product which states; "The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired."
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition," stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI."
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
VPDTF- FDA Approval -VPT on Canadian market- US -VPTDF- May 25, 2015) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS(TM) product which states; "The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired."
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition," stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI."
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
This is huge news- Up to 20 million people in need
Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS(TM) product which states; "The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired."
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition," stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI."
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
This is huge news- Up to 20 million people in need
VPT- Canada TSX- FDA!!!
SEATTLE, WASHINGTON--(Marketwired - May 25, 2015) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS(TM) product which states; "The VMS system is indicated for use where RV (right ventricle) volumes and ejection fractions are warranted or desired."
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition," stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI."
Previously the VMS was limited in use on adults with known pulmonary arterial hypertension (PAH), which is newly diagnosed in approximately 200,000 individuals each year in the U.S. Now the VMS can be used on the more than 20,000,000 people that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used with cardiac ultrasound to assess RV function is real-time 3D echocardiography, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT scan). Further, both MRI and CT scan may require the injection of contrast media, which can be detrimental in patients with concerns for kidney failure. The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam modality of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
Read more: http://www.benzinga.com/pressreleases/15/05/m5537477/ventripoint-receives-marketing-clearance-from-the-fda-to-expand-the-use#ixzz3b9ZdrLyY
First Patients Examined in China
SEATTLE, WASHINGTON--(Marketwired - Dec. 18, 2014) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has installed its VMS™ heart analysis system at the Shandong Provincial Hospital (SPH) in Jinan, China and has examined a number of patients. The SPH does 300 cardiac ultrasound exams a day and has nine other hospitals in its group.
"The cardiologists in our hospital have been conducting research on the right ventricle for a long time and have achieved significant results in this field of study. The VMS is a convenient and valuable diagnostic tool, which allows our cardiology team to create fast and accurate reconstructions of the right ventricle", said Director Guo Wen Bin, Director of the Ultrasound Centre at SPH and also the Director of the Image and Ultrasound Association in Shandong Province. "I am very impressed that the cardiologists in our ultrasound center were able to master the VMS so quickly and obtain accurate results for the right ventricle. The quantitative medical data is very useful in diagnostics, clinical treatment, and medical research. "
"The scale of echocardiography in China is truly a wonder and their cardiologists enthusiastically embraced the ability to obtain functional information about the right heart in a few minutes using the VMS heart analysis system", said Dr. George Adams, CEO of Ventripoint. "The pioneer VMS machine in China has attracted the attention of cardiologists in hospitals and universities from different cities. The opportunity and marketplace in China is absolutely enormous and the best part is, it's untapped. Our potential revenue forecasts in China alone could easily propel our company to the next level so I am very excited to see where these prospects lead to in 2015. With such positive feedback from doctors, we are one step closer towards distributing the VMS machines throughout the country."
About Shandong Provincial Hospital (SPH)
Founded in 1897, Shandong Provincial Hospital is the largest and highest level hospital in Shandong Province with more than 5,000 doctors and staff and 3,294 beds. SPH treated 3.02 million patients in 2013 and carried out 53,000 operations. In 2014, EENT Hospital, Shandong Medical Image Institute, Shandong Maternity Hospital, Shandong Orthopedics Hospital, Shandong Children's Hospital, Shandong Stomatological Hospital, HeZe City Hospital and Dongying City Hospital were merged to form the SPH Medical Group.
Read more at http://www.stockhouse.com/companies/bullboard/vptdf/ventripoint-diagnostics-ltd#1DWMSV8jUmRFxB2D.99
Best PR release explaining the technology I have seen to date:
http://pulmonaryhypertensionnews.com/2014/07/09/pah-heart-disease-patients-may-benefit-novel-accurate-time-saving-heart-visualization-method/
Announce a marketing partner and this could take off!
No need for miracle here, just patience. I'm adding to my position to close it around 100k shares. They have one more product due to be approved yet. I think that's the one thats going to do it for them. Until then I add a few thousand shares every so often until my final position is reached.
~Abbs~
good question. Wish I knew the answer
Just waiting for a miracle
Who exactly is going to buy them out??
You posted this tripe in March, FDA approval has come and gone. No buyout, what is your opinion on why they have not been bought out?
~Abbs~
wake up people- FDA approved. Next buyout
Resubmission by Ventripoint to get its VMS system approved by the FDA, and 4 million warrants go unexercised:
SEATTLE, WASHINGTON--(Marketwired - Jan. 23, 2014) - Ventripoint Diagnostics Ltd. (TSX VENTURE:VPT) is pleased to announce that it has submitted to the US Federal Drug Administration ("the Agency") a new 510(k) for clearance for the VMS™ heart analysis system for use in Pulmonary Arterial Hypertension (PAH).
"We have included in the submission significant additional information concerning the accuracy, reproducibility and clinical use of various imaging approaches in patients with PAH," according to Jim Bodtke, Vice-President, Clinical Affairs for Ventripoint. "We feel we have appropriately addressed the Agency's concerns as expressed in their letter of November 8, 2013."
The Company affirms that it has maintained an open dialog with the Agency in preparing the submission and as a result changed the submission from a "software-only" application, as previously recommended by the Agency and announced by the Company, to a submission with software and hardware descriptions. The Company continues to expect the review process to be completed by the end of the first quarter of 2014.
"The team did an excellent job re-writing the submission so quickly, which allowed us to re-submit the 510(k) in record time," stated Dr. George Adams, CEO of Ventripoint. "I would like to thank our consultants as well the Agency for all their assistance."
In other news, the Company also announces, subject to all necessary regulatory and TSX Venture Exchange approval, that it intends to issue 2,187,913 Common Shares at a deemed price of $0.05 per Common Share in payment of CDN$109,395.67 of accrued interest owing to the holders of outstanding notes and debentures of the Company. The 2,187,913 Common Shares will have a hold period of four months from the date of issuance in accordance with applicable securities legislation.
The Company would also like to inform its shareholders that 4,953,195 warrants to purchase Common Shares expired unexercised on December 23, 2013, and a further 1,133,650 warrants expired unexercised on January 18, 2014
http://finance.yahoo.com/news/ventripoint-announces-510-k-submission-120000439.html
Abbs
Nice move on Friday with decent volume.
Hopefully someone knows something and the move wasn't due to some people going for a lotto play.
Nov 25, 2013 (ACCESSWIRE via COMTEX) -- ** FDA has Invited the Company to Meet the Review Team **
Seattle, Washington, November 25, 2013 - Ventripoint Diagnostics Ltd. CA:VPT +14.29% is pleased to announce that after careful review of the information received from the U.S. Food and Drug Administration (FDA) regarding market clearance of the Ventripoint Medical System ("VMS(TM)") for use in Pulmonary Arterial Hypertension (PAH), the Company has developed a strategy for addressing the concerns raised by the Agency.
The results of the clinical trial demonstrated that the calculated parameters between right ventricular volumes computed from echocardiograms by VMS and MRI images computed with Simpson's rule were within the pre-specified 10% range for each of the mean difference and 95% confidence interval (4.8+/-1.4% for EDV, 1.8+/-1.5% for ESV, and 2.0+/-0.7% for EF). Nevertheless, the Agency had some concerns about the routine use of the VMS in this patient population.
In advance of filing a formal appeal, Ventripoint has received an invitation to meet with the review team to gain an understanding of the reasoning behind the current decision. This is an important first step in the appeals process and will form the basis of discussions throughout the appeal.
"It is important for us to fully engage the FDA through the available engagement and appeal processes", stated Jim Bodtke, Vice-President of Clinical Affairs. "We currently have other submissions for requesting regulatory approval of various applications for the VMS and we need to better understand the current criteria for acceptance before initiating these submissions."
In addition to the above, Ventripoint has reached distribution agreements for France, Germany, Austria and Switzerland for the VMS with further expansion planned. "We look forward to the upcoming EuroEcho meeting December 11-14, 2013 in Istanbul to meet with the cardiology community and distributors for Western and Eastern Europe as well as the Middle East," said Jerry Gatewood, Vice-President of Global Sales and Marketing. "Many areas in the world have expressed interest in offering VMS in their respective regions for a more comprehensive evaluation of the right ventricle."
The VMS is approved for clinical use for multiple heart conditions in Canada and Europe and continues to be available for investigational use only in the United States.
true. not dead yet.
Down today on this news but still has a chance IMO.
http://www.4-traders.com/VENTRIPOINT-DIAGNOSTICS-L-1412147/news/VentriPoint-Diagnostics-Ltd--Ventripoint-Receives-Response-from-FDA-for-Application-of-VMS-tm-fo-17467181/
Looks like a rising tide here...Im liking what I see and hoping it continues.
~Abbs~
VPTDF Gains Critical Support From Well-Connected Board Of Directors
VentriPoint Diagnostics, Seattle-based imaging technology company, is dedicated to making heart analysis more convenient and less expensive using knowledge-based techniques. The company’s VentriPoint Medical System (VMS), often referred to as the VentriPoint Angelo System or simply “Angelo’s”, is a unique 2D ultrasound imaging system. Through the use of Knowledge Based Reconstruction (KBR) an accurate 3D image of the heart can be generated from standard 2D ultrasound input. This eliminates all the disadvantages of having to go through an elaborate and expensive MRI scan, such as the often long waiting list, the one hour scan time, the claustrophobic environment, the requirement of a general anesthetic for children, a lengthy heart analysis process, and the need for a second trip to the hospital.
Key to the development of the technology, and to the success of the company itself, has been the support of an impressive board of directors, and the many critical contacts that they represent.
• Treuman Katz (Chairman; Chairman of Nominating and Corporate Governance Committee) is currently the President Emeritus of the Seattle Children’s Hospital & Regional Medical Center (“Seattle Children’s”), after serving as its President and Chief Executive Officer from 1979 to 2005.
• George Adams (Director; President and Chief Executive Officer; Member of Nominating and Corporate Governance Committee) is a scientist, a serial entrepreneur, and a financier. His previous position was CEO of Amorfix Life Sciences from 2005-2010, and he continues as Chairman of Sernova Corp.
• Danny Dalla-Longa (Director; Chairman of Audit Committee; Member of Compensation Committee) is former CEO and Chairman of Luca Capital Inc., and has had extensive experience with public companies in a number of different industry sectors.
• Brad Harlow (Director; Chairman of Compensation Committee) is the Managing Partner of B. Harlow & Associates, which advises med-tech companies for financing, Mergers & Acquisitions and buyouts. His group has led over $200 million in financing, asset/division sales, and new technology investments.
• Don Black (Director; Member of Audit Committee; Member of Compensation Committee) has worked in the health care industry for over 25 years and has recently stepped down as the President of the Children’s Health Corporation of America.
• Hugh Cleland, CFA (Director; Member of Audit Committee; Member of Nominating and Corporate Governance Committee) is an Executive VP and Portfolio Manager at Northern Rivers Funds, a BluMont Capital Company.
For more information on VentriPoint’s leading-edge cardiac diagnostic technology, visit www.VentriPoint.com
VPTDF Business Model Designed for Rich Recurring Revenue
The VentriPoint business model parallels that of GE Healthcare, Phillips, Siemens, and Toshiba, with initial technology-based product sales acting as a platform for a range of recurring revenues. VentriPoint’s innovative ultrasound based medical imaging analysis technology provides an easy-to-use and highly cost-effective alternative to MRI and other high-end medical diagnostic tools and procedures. It’s of special value for right heart analysis, where a standard ultrasound approach is ineffective, and for pediatric patients where elaborate MRI scanning may be difficult to tolerate. It’s a technology of widening application, designed to save both time and money, and it’s finding a home in a growing number of hospitals around the world.
The system’s capital purchase list price of $100,000 per unit sets up a base for the following recurring revenues:
• $10,000 per year per unit – Access to databases, software, and hardware maintenance
• $20,000 – $50,000 per year per unit – Software upgrades, access to new databases and additional training
• $5,000 – $10,000 per year per unit – Training services and certification, with recertification required if you have not used the software for 3 months
For smaller clinics, and as applications increase, the move will be to a per-use revenue model.
Sales projections for year-end 2013 total $3 to $5 million, including recurring revenue from earlier installations, for new applications, support, maintenance, and training, with projections for 2014 totaling $10 to $15 million.
The company targets a large market opportunity, representing a well described unmet clinical need, with gross margins of 80%. The technology is patented and proprietary, with excellent clinical validation by respected experts. It already holds Canadian and European regulatory approvals, with FDA processing underway.
For more information on VentriPoint’s leading-edge cardiac diagnostic technology, visit www.VentriPoint.com
VPTDF Heart Analysis System Published in Prestigious Medical Journal by University of Chicago
VentriPoint Diagnostics was pleased to announce today that the cardiology group from the University of Chicago, led by Dr. Roberto Lang, has published a paper entitled “Three-Dimensional Modeling of the Right Ventricle from Two-Dimensional Transthoracic Echocardiographic Images: Utility of Knowledge-Based Reconstruction in Pulmonary Arterial Hypertension” in the Journal of the American Society of Echocardiography (JASE), Volume 26, Issue 8, Pages 860-867, August 2013.
Knowledge-Based Reconstruction (KBR) is the scientific terminology for VentriPoint’s VMS™ product. The VMS™ has been approved for clinical use in Canada and Europe, but is currently for investigational use only in the United States.
The paper concludes: “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.”
Dr. George Adams, CEO of Ventripoint, stated, “We congratulate the Chicago cardiology team on the publication of this first-in-humans, clinical study in the premiere journal in the field of echocardiography.”
JASE is the official publication of the American Society of Echocardiography, which is the largest international organization for cardiac imaging. The journal brings physicians and sonographers the most current clinical, scientific, legal, and economic information regarding the use of cardiac ultrasound. JASE’s original, peer-reviewed articles cover conventional procedures as well as newer clinical techniques.
For more information on VentriPoint’s leading-edge cardiac diagnostic technology, visit www.VentriPoint.com
VPTDF Connects All the Dots
Seattle-based VentriPoint Diagnostics has developed a groundbreaking new approach to imaging analysis, particularly as it relates to what is called the right heart, a portion of the heart that is especially difficult to accurately image. The basis of the VMS system is Knowledge Based Reconstruction (KBR), which is able to take standard 2-dimensional ultrasound data and generate an accurate 3-dimensional image of the heart. Although KBR can also be used in conjunction with MRI images, the use of ultrasound as a data source offers major cost and operational advantages over other image technologies.
The traditional MRI approach requires more expensive equipment and procedures, often requiring costly and time-consuming followup visits. Ultrasound imaging is far simpler and less involved, meaning a major cost break for hospitals and patients. KBR takes ultrasound to a new level, offering superior analytical capabilities. Physicians will now be able to monitor patients at each clinic visit, more easily tracking heart conditions. It is also helpful for pediatric patients that may have problems with other types of imaging or invasive procedures.
With Knowledge Based Reconstruction, the user simply traces a few points on the ultrasound images to mark the position of anatomic landmarks. Advanced software is then able to essentially connect the dots, utilizing programmed knowledge concerning the shape of the human heart, and how it changes in reaction to various disease states, to generate a comprehensive and accurate picture of the heart and heart functioning. In addition to providing easier and accurate right-heart imaging, the VentriPoint VMS system, called Angelo, can also be used for cost effective left heart analysis, as well as for diagnosing pulmonary hypertension, and is being evaluated for other possibilities. The technology’s use is spreading, and can already be found in a number of top level hospitals around the world.
For additional information, visit www.VentriPoint.com
Timely Heart Analysis System Positioned for Pulmonary Arterial Hypertension Application
VentriPoint’s Angelo (VMS™) heart analysis system provides a quick and accurate assessment of the right ventricle heart function. Following several installation in multiple sites in cardiac centers in Europe, Canada, and the United States, the company aims to install the device in more centers and expand its applications beyond congenital heart disease in adults and children.
Angelo’s (VMS™) 2D ultrasound imaging provides the accuracy of an MRI but eliminates several disadvantages of traditional imaging, such as a long procedure time, a claustrophobic environment, general anesthesia often needed for children, lengthy heart analysis process, and the need for a second trip to the hospital.
The procedure boasts a brief process time of between 5-10 minutes, including examination and analysis, which eliminates the need for sedation that lengthy MRIs may require. Angelo (VMS™) uses 2D ultrasound equipment, so the process in its entirety can be done on the first visit.
As previously reported, the FDA has requested additional information from the company concerning its 510(k) submission for Pulmonary Arterial Hypertension (PAH). While PAH is relatively rare (affecting 1 in 100,000 to 1 in 1 million people), the disease is life-threatening, worsening over time – approximately 50 percent of people diagnosed with PAH die within five years, according to the American Lung Association. Early detection of the disease followed by proper treatment improves the quality of life and helps the person perform everyday tasks.
Coordinating with the FDA, VPTDF has crafted a statistical plan to obtain and deliver additional information which is currently re-analyzing clinical studies.
The company’s VMS™ technology has been approved for clinical use in Canada and Europe.
For more information, visit www.ventripoint.com
VPTDF Expands Target Market to Include Pulmonary Hypertension
A unique ultrasound-based system for performing right heart analysis, developed by VentriPoint Diagnostics and now used in various hospitals around the world, is also being developed and introduced as a superior approach to diagnose pulmonary hypertension (PH), an unhealthy increase in blood pressure in the pulmonary artery or pulmonary vein which can lead to a variety of problems, up to and including heart failure.
The VentriPoint VMS system, called Angelo, uses 2-dimensional ultrasound data, together with a patented system called Knowledge-Based Reconstruction (KBR) for analyzing that ultrasound data. The result is an information-rich 3-dimensional model of the heart. For right heart analysis, it has major advantages over the use of MRI, which is far costlier and time consuming for patients, putting increased pressure on limited hospital resources. Similar advantages apply to the system’s use for PH diagnosis. It is already approved in both Europe and Canada and is under review by the FDA. VentriPoint is in discussion with 2D ultrasound OEMs to jointly build a PH-dedicated integrated system,
As with the system’s application to right heart analysis, the ability to use conventional ultrasound equipment, versus more invasive, time consuming and costly procedures, is an underlying advantage to the use of the VentriPoint system for PH diagnosis.
• PH related drugs work best with early detection, which the VentriPoint system can provide.
• PH is currently detected using invasive catheterization, an involved and risky procedure.
• 20 million people are considered at risk for PH, but the number of people actually experiencing the disease is essentially unknown.
Considering PAH and heart analysis, the remaining market for Angelo’s potential use is large. It would take from 2,000 to 5,000 VentriPoint systems to equip all of the hospitals and cardiologist offices in the U.S. The list price of the VentriPoint system is $100,000
For more information, visit www.ventripoint.com
VentriPoint Diagnostics Ltd. (VPTDF) Releases Thick Corporate Update, Closing of $500,000 Private Placement
VentriPoint Diagnostics today provided a corporate update and said that it has completed a first closing of the second of two non-brokered private placements.
As previously reported, the U.S. FDA had requested additional information concerning the company’s 510(k) submission for Pulmonary Arterial Hypertension (“PAH”). In response, VPTDF said it has prepared a detailed statistical plan to obtain the information required in collaboration with the Hospital for Sick Children, Toronto, which will re-analyze the clinical studies.
In accordance with its original plans for the clinical trial, VPTDF has completed the collection of an additional 21 clinical cases, which along with the 54 studies used in the first analysis, yields 75 total cases. The new analysis will use all 75 cases and will take approximately six to eight weeks to complete. The PAH clinical trial has been completed.
The company also announced:
• Tetralogy of Fallot (TOF) clinical trial has finished recruitment with the 75 required clinical cases – the study is now completed and closed. The analysis of the data will begin upon completion of the PAH analysis.
• The development of a clinical trial protocol in collaboration with a major cardiac center interested in evaluating if VMS assessment of right heart function and structure in patients admitted with congestive heart failure can predict hospital readmission within 30 days of discharge (see CEO blog on Web site http://ventripoint.com/index.php?Itemid=511).
• The company last week exhibited at the 11th International Symposium entitled “Echocardiography Today and Tomorrow” in St. Wolfgang, Austria.
• From June 29-July 2, 2013, VPTDF will exhibit at the 24th Scientific Sessions of the American Society of Echocardiology (“ASE”) in Minneapolis, Minnesota. There will be three scientific papers presented by three groups of researchers discussing the clinical use of the VMS.
• A multicentre group from the University of Chicago and Elisabethinen Hospital in Linz, Austria will present a study entitled “Three-dimensional Modeling of the Right Ventricle from Two-Dimensional Transthoracic Echocardiographic Images: Utility of Knowledge-Based Reconstruction in Pulmonary Arterial Hypertension.”
• A group led by Dr. Laser from the Heart and Diabetes Center NRW (HDZ NRW), Bad Oeynhausen, Germany, will report on the first use of the prototype VMS-3DE™ software, which analyses 3D ultrasound cardiac images.
• A group led by Dr. Soriano from the Seattle Children’s Hospital will report on their early experiences with the VMS in a number of children with a broad range of heart.
• VPTDF has been upgrading VMS systems to the new mobile VMS-Angelo™ model and installing new systems for customer evaluation. By the end of this quarter, there will be seven systems in clinical use, four of which are being placed for a 30-day trial period prior to purchase. Additionally, four institution-sponsored clinical research studies have been completed and favorable purchase terms are being negotiated. The company anticipates several sales agreements in the next quarter and has a number of new cardiac centers requesting a VMS-Angelo system for evaluation.
In regards to its private placement, VPTDF has issued an aggregate of 500 units for gross proceeds of $500,000. The company intends to use the proceeds from private placement for product and service commercialization of the VMS machines; clinical validation of VMS functionality, including applications for additional diagnoses and heart diseases; and for general working capital purposes and to repay debt and outstanding payables.
The company also said it has received approval from the Exchange and has issued 694,425 Common Shares at $0.099 per Common Share in payment of $68,748.09 of accrued interest owing to a holder of a debenture of the Company.
For more information, visit www.ventripoint.com
VPTDF VMS™ Technology Notches Favorable Feedback Worldwide
VentriPoint Diagnostics has designed a heart visualization system designed to benefit doctors, patients, and the overall healthcare industry by reducing time and costs of the procedure. The system uses a 2D echo to make a 3D model of the heart to evaluate right heart function and get the same information obtained from an MRI, but in a fraction of the time.
As company CEO George Adams recently stated in an interview, the biggest beneficiary of the system is the patient. While cardiac MRIs can take anywhere between 30-90 minutes and take up to three months to get results, with VentriPoint’s VMS™ system the procedure is done within 10 minutes producing immediate results. This time advantage is especially significant for children and adults who have a hard time lying still or are anxious within confined spaces, as is necessary with traditional MRI procedures.
VentriPoint has already installed the system at multiple sites in the United States and overseas, and has received positive feedback across the board.
“The VMS is non-invasive and repeatable as compared to MRI, and we are confident in the results using routine clinical scanning. At Evelina, all children undergoing MRI must have a general anesthetic. This is not required for the VMS and is a major improvement as we will not have to subject these children to the added complexity and risk of a general anesthetic.” —John Simpson, MD, director of the Echocardiography Laboratory at Evelina Hospital in London, UK.
As of now, the VMS™ is for investigational use only in the United States and has been approved for clinical use in Canada and Europe. VentriPoint in April received from the U.S. FDA a request for additional information as the agency completes the review of Pulmonary Arterial Hypertension (PAH) 510(k). The company must now show the FDA that its technology works as well as MRI, as has already been demonstrated in other parts of the world.
“The VentriPoint system combines the best of both worlds: the ease and availability of 2D echo and the intrinsic 3D information of the MRI acquired shapes of the right ventricle in the database. We anticipate a reduction of the need for (expensive) cardiac Magnetic Resonance Imaging (MRI) for the purpose of assessment of right ventricle volumes.” —Willem Helbing MD, head of Pediatric Cardiology at Erasmus Sophia Children’s Hospital in Rotterdam, Netherlands.
For more information, visit www.ventripoint.com
VPTDF Seeks to Expand AngeloVMS™ Applications, Triple Sales by 2014
Ventripoint Diagnostics is the creator of what company management believes to be the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. The company created the blueprint to achieve its application expansion and goals for continued financial growth, supported by key management.
The first applications of the company’s Angelo (VMS™) analysis system are congenital heart disease and pulmonary arterial hypertension. Ventripoint has been granted Canada and Europe (CE Mark) approval for the sale of VMS and is awaiting the U.S.-FDA marketing clearance as well.
VMS was developed to address several issues associated with current heart diagnostics and holds several advantages over an MRI scan. VMS procedure time is 15 minutes and is much cheaper compared to MRI or CT, in part because of the reduced office visit time. The tool eliminates the requirement of general anesthetic for children, a lengthy heart analysis process, and the need for a second trip to the hospital.
As of March 2013, Ventripoint had installed VMS in numerous research centers (10 in Europe, four in Canada, and 12 in the United States) and forecasts full-year 2013 revenue between $3 million – $5 million. The company’s goal by the year 2014 is to triple revenue to $10 million – $15 million.
Raising awareness and generating sales are obvious keys to achieving these sales goals, and in support of this, the company later this month will travel to Minneapolis, Minn., for the 24th Annual Scientific Sessions (ASE2013) where it will host a booth to present its products to attendees.
Ventripoint in December will also hold a booth at EuroEcho2012 in Istanbul, Turkey, an annual meeting that this year will focus on heart failure and imaging in interventional cardiology. Scientific minds from around the world will convene to discuss the latest research and clinical findings on the broader spectrum of echocardiography as well as other cardiovascular imaging modalities.
CEO George Adams heads the company as a serial entrepreneur and financier. Dr. Adams has 124 scientific publications and is a reviewer for major scientific journals, federal granting agencies, and Centres of Excellence.
The company in March appointed Ellen Briant as its CFO to head the company’s financial strategy as it continues to launch new products, build revenues, and seek out and establish partnerships to further grow the company.
For more information, visit www.ventripoint.com
VPTDF Addresses Unmet Medical Need, Offers Outlook for 2013-2014 Sales
Ventripoint has created a diagnostic ultrasound tool to monitor patients with heart disease. Company management believes that VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. The product has received Canada and Europe approval (CE Mark) for the sale of VMS™ and the company is now pursuing the U.S.-FDA approval.
VMS was developed to address issues with current heart diagnostics. Because of its location between the ribs, the right side of the heart is hard to see with ultrasound and produces “blurry” images of the organ. For this reason, cardiologists order an MRI to view the right side of the heart, a process that can take hours comprised of machine time, analysis, radiology analysis and may require a second or third visit to the cardiologist. VMS, on the other hand, provides diagnosis within an hour, boasting procedure time between 5-10 minutes vs. 90-120 minutes of procedure time with a traditional MRI.
VMS is also more cost-effective, offering a 300% increase in net income per hour compared to MRI. Each unit is priced at $100,000 and has the potential to generate recurring revenue of $10,000 per year per unit for access to databases, software support and hardware maintenance; $20,000-$50,000 per year per unit for software upgrades, access to new databases, and additional training; and $5,000-$10,000 per year per unit for training services and certification, contingent on time of last use.
As of March 2013, Ventripoint had installed VMS in numerous research centers: 10 in Europe, four in Canada, and 12 in the United States.
Ventripoint estimates 2013 sales between $3 million – $5 million with an installed base of 50-75 machines and recurring revenue from 2012 sales of 26 machines.
The company’s goal by the year 2014 is to triple revenue to $10 million – $15 million with an increased base of 200-300 installed machines paired with recurring revenue from 2012-2013 sales. As part of this mission, the company recently appointed Jerry Gatewood as its vice president of Sales and Marketing to assist the company in its goal to expand sales around the world.
VPTDF Appoints New Vice-President of Sales and Marketing
Ventripoint Diagnostics today reported the appointment of Mr. Jerry Gatewood as its Vice-President of Sales and Marketing.
Gatewood brings more than 18 years of introducing new medical products with extensive experience in sales and marketing of imaging equipment. He was Global Market Manager for ATL Ultrasound (now Philips Medical Systems), where he created and executed global marketing and market introduction plans, and Director of U.S. Marketing for SonoSite (now part of FujiFilm) where he managed the U.S. marketing team and identified and developed new markets. He was also Director for Global Sales for Merge CAD, where he established, negotiated, and managed all aspects of original equipment manufacturer (OEM) partnerships, while securing national U.S. account agreements with major group purchasing organizations.
“It is with great pleasure that I welcome Jerry to the team” said Dr. George Adams, CEO of Ventripoint. “Jerry’s ‘been-there-done-that’ wisdom will lead us as we prepare for expanding sales into the U.S. and the rest of the world.”
“I am very excited at the opportunity to be a part of the Ventripoint team. This Company and its technology have a great potential to positively impact patient care and I am proud to be part of that movement” said Jerry Gatewood, VP of Sales and Marketing.
Mr. Amol Karnick will continue to be a consultant to the company and focus on Business Development.
For additional information, visit www.VentriPoint.com
VPTDF Technology Now Used by Hospitals around the World
With much effort, Dr. Florence Sheehan and a team of cardiologists at the University of Washington were able to develop a radically new and more cost effective way of performing critical heart imagery. Through the use of conventional 2-dimensional ultrasound data, easily acquired in a few minutes, together with a patented system known as knowledge-based reconstruction (KBR), the system is able to build a 3D model of the heart and calculate the functional information of heart volumes, cardiac output, and ejection fraction.
It’s a revolutionary approach of particular value for performing right-heart analysis, which has traditionally required time consuming and expensive MRI scans, especially challenging when dealing with small children. VentriPoint’s clinical-grade system, trade named “Angelo (VMS™)”, offers a far quicker, easier, and more affordable way to get the heart data required to save lives, and it is now being picked up by leading cardiac and general hospitals all over the world:
• Alberta Children’s Hospital, Calgary, AB
• Allegheny General Hospital, Pittsburgh, PA
• Baylor’s Medical Center, Houston, TX
• Central Manchester University Hospitals, Manchester, UK
• Children’s Hospital Colorado, Denver, CO
• Children’s Hospital of Philadelphia, Philadelphia, PA
• Cleveland Clinic, Cleveland, OH
• Evelina Hospital, London, UK
• German Heart Institute, Berlin, Germany
• Great Ormond Street, London, UK
• Harvard/Brigham and Women’s Hospital, Boston, MA
• Hospital for Sick Children, Toronto, ON
• Hospital Necker Enfants Malade, Paris, France
• Krankenhaus der Elisabethinen Hospital in Linz, Austria
• Mayo Clinic, Rochester, MN
• Nationwide Children’s Hospital, Columbus, OH
• Omaha Children’s Hospital, Omaha, NB
• Oregon Health Sciences University, Portland, OR
• Rikshospitalet University Hospital, Oslo, Norway
• Seattle Children’s Hospital, Seattle, WA
• Sophia Hospital, Rotterdam, The Netherlands
• St. Paul’s Hospital, Vancouver, BC, Calgary, AB
• Toronto General Hospital, Toronto, ON
• University Children’s Hospital, Zurich, Switzerland
• University Medical Center, Utrecht, The Netherlands
• University of Chicago, Chicago, IL
For additional information, visit www.VentriPoint.com
Top Lineup for VPTDF
VentriPoint Diagnostics has developed a technology, now being used in a growing number of hospitals around the world, which effectively replaces costly and time consuming MRI scans for certain types of heart imaging. It has been a challenging task that is now paying off, thanks to the efforts of a dedicated group of people, including the company’s management team:
• Dr. George Adams (CEO) is a scientist as well as a long-time entrepreneur and expert financier. Prior to VentriPoint, he was CEO of Amorfix Life Sciences, and continues as Chairman of Semova Corp., both publicly owned companies. Earlier, he was President and CEO of the UT Innovations Foundation, and has also held research and executive positions with Boston Scientific, Pfizer, Corvita Canada, the University of Ottawa, and others. He has been instrumental in founding over 30 companies who have raised $100 million, and has been Director of 10 venture capital funds and 10 startup companies. He has 124 scientific publications, and is a reviewer for major scientific journals, federal granting agencies, and others. Dr. Adams has accepted awards for World Economic Foundation Technology Pioneer, 2007, and TBI Company Of The Year, 2009.
• Ellen Briant (CFO) has 20 years of professional finance experience, with a focus on private placement and merger & acquisitions transactions to mid-market and startup companies. She has provided corporate financing advisory services at Spire Sharwood, and was VP & Director of the Private Placement Group for Deloitte & Touche, arranging debt financing and advisory services for various sized clients, including government entities. She was also part of the Corporate Banking Group at Scotiabank, and the Financial Services Audit Group of Ernst & Young.
• Amol Karnick (VP, Sales & Business Development) has over 18 years of medical imaging experience, including 7 years at GE Healthcare where he helped drive $150 million in imaging sales in addition to integrating 4 companies. He was the Chief Operating Officer for Sentinelle Medical, responsible for Engineering, Service, Manufacturing, and Regulatory Affairs, and was General Manager at Ultrasonix Medical where he grew sales through business development. He has experience working with multiple cultures around the world.
• Scott Ashley (VP, Research & Development) has 26 years of core operating system software development and project management, as well as first-line, second-line, and director experience. He was Director of Software Development for HP Integrity NonStop NS 16000 Server, managing over 80 developers, and was a key driving force across the Tandem NonStop Division.
• Eyal Schwartz (Chief Architect) has 16 years of experience leading various software development projects. He was a development leader at Microsoft in the Windows, MSN, and Entertainment divisions, and did lead design and development of a wide array of technologies. He is also the owner of 10 U.S. patents.
For additional information, visit www.VentriPoint.com
VPTDF and Knowledge Based Reconstruction
VentriPoint Diagnostics, a Seattle based imaging technology company, has developed an important proprietary system that provides a uniquely simple and cost effective way of imaging various heart functions, offering the promise of significantly lower diagnostic and support costs for hospitals and patients. Its current focus is on the diagnosis of congenital heart disease in adults and children, due largely to its remarkable ability for imaging of the right ventricle, but other applications are already being developed.
The VentriPont Angelo (VMS™) imaging system is based upon what is called Knowledge Based Reconstruction (KBR), a way of generating an accurate 3-dimensional surface from basic ultrasound 2-dimensional data, by fitting points which the user enters at anatomic landmarks, avoiding all of the operational and economic disadvantages of complex MRI scanning.
KBR is based on the piecewise smooth subdivision surface reconstruction method, the most anatomically accurate 3D surface reconstruction method reported to date and the only reconstruction method proven to provide faithful representation of 3D shape and volume. It’s fast, taking just a few minutes per volume measurement, and requiring the user to provide a very sparse input of points as opposed to whole borders. The user can choose the highest quality images to trace those points, meaning that the user is free to work just on the images where each part of the ventricle is best seen. Tests have shown KBR to have excellent accuracy in the measurement of right ventricular volume at both end diastole (EDV) and end systole (ESV).
The VentriPont system is currently installed in hospitals throughout the U.S., Canada, and Europe, and is now in the process of enabling dozens of additional centers, expanding the applications beyond congenital heart disease in adults and children.
For additional information, visit www.VentriPoint.com
VPTDF Prices Private Placements of Common Stock
VentriPoint Diagnostics, developer of a diagnostic ultrasound tool to monitor patients with heart disease, said it intends to complete a non-brokered private placement of up to 1,000 units of the company for $1,000 per unit for gross proceeds of up to $1 million. Each unit will consist of $1,100 principal amount of non-convertible secured debentures that will mature three years from the date of issuance and 2,000 common shares in the capital of the company.
The company also reported a non-brokered private placement of up to $800,000 of non-convertible secured debentures in a principal amount of $1,000 per non-unit debenture, which will mature July 18, 2014.
Each unit debenture is subject to a 10 percent capital discount premium to the subscriber such that for every $1 unit debenture acquired, upon the maturity date VentriPoint will owe an amount equal to $1.10 to the subscriber minus any payments of principal to date.
The debentures will bear interest at a rate of 12 percent per annum and shall be calculated on the initial debenture amount.
The debenture holders shall receive a pro rata 20 percent first charge on gross revenues at the end of each calendar quarter from sales of VentriPoint Medical System (VMS) machines until the debentures are retired.
VentriPoint plans to use the proceeds from the private placements to commercialize the product and service of its VMS machines; to obtain clinical validation of VMS functionality, including applications for additional diagnoses and heart diseases; and for general working capital purposes as well as to potentially to repay debt and outstanding payables.
For more information, visit www.ventripoint.com
VPTDF and the MRI Alternative
Since its gradual development, from initial concepts in the 1950s to experimental machines in the 1970s and 1980s, MRI based imaging in its various iterations has grown to become a multi-billion global industry, with a market that continues to increase as an aging population feeds the need for heart, cancer, and neurological related diagnostics.
Hospitals all over the world demand the machines, given their ability to reveal the internal structures of the body in significant detail, but it’s a technology that comes at a price. Even small scale systems can cost hundreds of thousands of dollars, with large scale high-power systems going for millions. Add to this the associated facility and operational costs and it’s easy to see why hospital budgets are being pushed through the roof, and why healthcare reforms are putting increased pressure on the purchase and use of MRI technology.
All of this spells a tremendous opportunity for VentriPoint Diagnostics, a Seattle-based imaging technology company capitalizing on an invention already grabbing part of the massive MRI market. Their proprietary system gives inexpensive ultrasound imaging the power to replace capabilities previously limited to MRI. The company’s Angelo’s (VMS™) 2D ultrasound imaging system uses anatomical “dots” to build a 3D model of the heart, calculating the functional information of heart volumes, cardiac output, and ejection fraction that is required by a cardiologist to determine heart function status.
Unlike an MRI, all of this critical information is acquired in 10 minutes using conventional 2D ultrasound, analyzed via a patented system known as knowledge-based reconstruction (KBR). The net result is the elimination of all the disadvantages of an MRI scan: a long wait list, the one-hour scan time, the claustrophobic environment, the requirement of a general anesthetic for children, a lengthy heart analysis process, and the need for a second trip to the hospital. Most of all, it means less use of MRI equipment and supporting processes, with all of the cost savings that represents.
For additional information, visit www.VentriPoint.com
VPTDF Receives Expanded License from Health Canada
Today, VentriPoint Diagnostics reported receiving an expanded license from Health Canada that allows the company to sell the VMS™ heart analysis system for clinical use in Canada. The expansion was for the NRV™ application for the analysis of 2-D ultrasound images for patients with non-specific heart disease. The NRV™ application will enable healthcare providers to rapidly and accurately assess the status of the right ventricle in all patients that do not have significant congenital heart defects or pulmonary hypertension, yet may have a variety of other conditions.
VentriPoint’s VMS-2DE™ heart analysis system will be used in conjunction with the NRV™ database for patients where knowledge of the function of the right heart would be useful in assessing the overall heart function and optimally treat the patient. Heart disease and stroke costs the Canadian economy more than $20.9 billion every year in physician services, hospital costs, lost wages, and decreased productivity (Conference Board of Canada, 2010). It is estimated that there are 1.5 million Canadians living with heart disease and about 10% of them die each year. There are also 300,000 hospitalizations for heart failure each year and this accounts for 17% of all hospitalizations.
The addition of the NRV™ application to the VMS™ heart analysis systems will provide a direct avenue for clinicians to better evaluate and care for these individuals. VentriPoint believes that the NRV™ application can also be used to provide a reference baseline study for patients at risk for developing right heart dysfunction and would benefit from frequent monitoring.
The VMS-2DE™ is approved for clinical use in Europe and Canada and is available for investigational use only in the United States.
VentriPoint today also corrected a press release from last week. In conjunction with the final closing of the offering announced March 1, 2013, VentriPoint paid cash commissions of $10,296 and issued 102,960 agent’s options (“Agent’s Options”). As a result of the two closings, VentriPoint raised gross proceeds of $933,700 and paid total cash commissions of $26,776 and issued 267,760 Agent’s Options.
Each Agent’s Option is exercisable into one Common Share for a period of 18 months from the date of issuance at a price of $0.10 per Common Share. All securities issued pursuant to the Offering are subject to a four-month hold period pursuant to applicable securities legislation. The proceeds made available through the sale of Units will be used for the general working capital needs of the company.
For more information, visit www.ventripoint.com
VPTDF Reports FDA Response to 510 (k) Submission for Pulmonary Arterial Hypertension
VentriPoint Diagnostics, creator of the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function, announced that the U.S. Food and Drug Administration (FDA) responded to its Pulmonary Arterial Hypertension (PAH) 510(k) submission with a short list of suggestions, clarifications and requests for additional information.
“We are very pleased the FDA has reviewed our submission so expeditiously and we now have a small number of modifications to the filing to prepare,” said, Dr. George Adams, CEO of VentriPoint.
Known as the most serious form of the five recognized groups of pulmonary hypertension, PAH is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. The disease affects individuals of all ages, even infants. Although quickly applying treatment helps, most patients with PAH are diagnosed too late for any therapy to be fully effective.
The VMS™ analysis system is currently for investigational use only in the United States and approved for clinical use in Canada and Europe. VentriPoint designed this system to be used for all major heart diseases, including pulmonary hypertension, cardiovascular disease, and heart failure. Offering better efficiency and cost savings, VMS™ offers the healthcare industry a superior method of heart visualization.
For more information on VentriPoint and VMS™, visit www.ventripoint.com
The Case for VPTDF
If you think that you’re safe from heart disease, America’s #1 killer, think again. There’s a good chance that you are at risk, and simply don’t know it. In fact, approximately half of all people, both men and women, who die from heart attack each year had no prior knowledge of their own heart disease. It’s the reason that researchers around the world are anxious to improve diagnostic technologies, with an eye toward saving potentially millions of lives that will otherwise be lost.
One of the newest diagnostic technologies now available for doctors in the fight against heart disease is the VentriPoint Medical System (VMSTM), going by the name “Angelo(VMSTM)”, from VentriPoint Diagnostics. Different than any other heart diagnostic system, it uses sophisticated knowledge-based reconstruction technology applied against 2D ultrasound generated data to create a clear image of the “right heart,” the portion of the heart that pumps blood to the lungs where it picks up oxygen.
It’s important for doctors to have a clear picture of right heart functioning for accurate diagnostics. However, because of the unique position of the right heart, getting a useful image has required an expensive and time-consuming MRI, especially difficult to get if the patient is a child. A standard MRI involves 1-2 hours of machine time, a radiologist, 15-45 minutes of analysis time, and often a second visit to the MRI center and a third visit back to the cardiologist. Prior to this new technology, ultrasound images of the right heart were too blurry to use, but now the VentriPoint system offers full right-heart image clarity together with the ease, speed, and cost advantages of a quick and simple ultrasound scan, usable even with babies.
Leading hospitals around the world have already begun using the VentriPoint right-heart analysis system, and the company is now in talks with 2D ultrasound OEMs to jointly build a system for the early detection of pulmonary hypertension, potentially involving thousands of machines in the U.S. alone. Additional applications of the technology are on the horizon.
For additional information, visit www.VentriPoint.com
CEO George Adams has posted the following blog on the VentriPoint website: http://dtg.fm/4gPM
“I’ve looked at life from both sides now…”*
I was amazed to find out that 26% of heart patients return to hospital within a month of being discharged. This means that current therapies work well on 74% of people, but the other 26% need more aggressive monitoring and therapy. The way the current healthcare system identifies these patients is to re-admit them to hospital and assess them more aggressively. The cost of the average hospital stay in the USA, according to the University of Washington, has doubled in the last decade to $33,079 in 2010. That is an expensive way to diagnose patients who need extra care.
I recently spoke to the Chief Cardiologist at one large American hospital to confirm this information and he told me they discharge 1,200 cardiac patients a month and see 300 of them come back the next month. I pointed out that just eliminating three returns (1%) would pay for the Angelo™ system in the first month. He said, “let’s prove right heart analysis will reduce re-admissions”. We have started the process to do the clinical study.
But how does this work? For decades, some visionary cardiologists have been advocating the application of a functional right heart analysis, in the setting of left heart disease as THE way to properly assess the patient – to see just how damaged the left heart is by looking at the related issues in the right heart. This idea is starting to take hold, as now there are entire conferences dedicated to the right heart.
In June we will be exhibiting at one of these conferences in Austria , entitled, "Everything about the Right Heart". Ventripoint will present two live cases in the workshop to show cardiologists how easy it is to get the correct information using the Angelo™ system.
With the help of Ventripoint’s Angelo™ system it is possible to see the whole picture to attain whole-hearted health. So we can look at both the right and the left sides now!
*Thanks to Joni Mitchell: Both Sides Now (1969), Cardiologists will soon be singing -“I’ve looked at life from both sides now.”
VPTDF Receives CE Mark for NRV™ Application, Vastly Expands Capabilities
Today, VentriPoint Diagnostics, developer of ultrasound tools used on patients with heart disease, announced that the European Notified Body, Intertek Semko AB, has granted a CE Mark for its NRV™ application, which pertains to the analysis of 2-D ultrasound images for patients with non-specific heart disease. The application will allow clinicians to rapidly and accurately assess the status of the right ventricle in patients without significant congenital heart defects or pulmonary hypertension, but who may have a variety of other conditions (such as left-heart failure or valve disease).
The NRV™ database can be used in conjunction with the VMS-2DE™ heart analysis system in instances when knowledge of the function of the right heart is useful in assessing overall heart function. The VMS-2DE™ is approved for clinical use in Europe and Canada. In the United States, the system is currently available for investigational use only.
Adding the NRV™ application to the VMS™ heart analysis systems provides a direct avenue for clinicians to better evaluate and care for individuals currently suffering from some form of heart disease. The application may also be used to provide a reference baseline study for patients at risk for developing right-heart dysfunction, who may benefit greatly from frequent monitoring.
“Leading cardiologists, who have the VMS-2DE™ heart analysis system, have been requesting the NRV™ application so they can examine almost every patient they see,” remarked VentriPoint’s CEO, Dr. George Adams. “This approval will allow our sales force to offer this major expansion of the capability of the VMS-2DE™ to our existing and pending customers in Europe, where heart disease remains the leading cause of death at a financial cost of 196 billion Euros each year.”
VentriPoint also announced that its quality management system has passed the annual surveillance audit and has received renewal compliance certificates for ISO 13485:2003/CMDCAS and MDD 93/42/EEC – Annex II standards. These certificates are required to maintain the company’s licenses to sell medical devices in Europe and Canada.
For more information on VentriPoint and its leading-edge technology, visit www.ventripoint.com
VPTDF Changes the Way Doctors Look at Hearts
VentriPoint Diagnostics, a Seattle-based heart analysis technology company, is in the process of changing the way hearts are analyzed, a significant venture given the size of the market. According to the American Heart Association, there are approximately 80 million U.S. adults experiencing some form of cardiovascular disease, representing an annual total cost of nearly $500 billion. However, in spite of advances in ultrasound, MRI, and other non-invasive diagnostic technologies, there are currently a number of problems with accurate heart diagnosis.
In particular, accurate analysis of what is called the “right heart” has been problematic. The right side of the heart is the part that pumps blood through the lungs where it picks up oxygen. The blood is then returned to the left side of the heart which proceeds to pump the oxygenated blood to the rest of the body. The left heart is thicker, since it has to pump the blood throughout the entire body, and tends to have a more consistent left ventricular shape. The right heart has a more complex ventricular shape, and is positioned in a way that can make proper imaging difficult. And yet the right ventricle is critical to heart function, and is important in evaluating clinical outcomes.
Ultrasound is a convenient and cost effective tool for analysis, but cardiologists do not use ultrasound for right heart analysis because the resulting images are blurry. With ultrasound, it’s hard to see the right heart (front part of the heart) due to the small imaging window through the ribs. As a result, cardiologists use MRI scans, but that requires 1-2 hours of machine time, the use of a radiologist, and greater analysis time. It can also require additional MRI and cardiologist visits. For pediatric patients, the use of MRI equipment poses even more problems.
The VentriPoint Medical System (VMSTM) 2D ultrasound imaging approach eliminates the many disadvantages of expensive and complex MRI scans. VMS uses knowledge-based reconstruction (KBR), essentially a library of disease specific hearts, which can be used with standard ultrasound images. The physician or sonographer identifies anatomical landmarks, using dots on a number of the 2D ultrasound views through the heart. The system also has a positioning sensor on the ultrasound probe to show where the 2D slice (plane) is in 3D space. In this way precise anatomical landmarks are located in 3D space. 25 of these points is all that is required to define the ventricle of the heart and to allow an accurate 3D image to be constructed using KBR.
VMS is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. It is quick, easy, and much less expensive, and the company is now planning to expand the technology’s application.
For additional information, visit www.VentriPoint.com
Revamped and Updated 23-Page Corporate Presentation
http://VPTDF.QualityStocks.net/Presentation/
Busy March Sets the Stage for VPTDF
March was a busy month for VentriPoint Diagnostics, a Canadian based medical device company focused on revolutionary software for 3D heart analysis. The company was successful in completing several important steps in the development and approval of what is viewed as potentially transformative diagnostics technology.
March began with the announcement that the company had received acceptance from the FDA (U.S.) of its submission for right heart analysis in Pulmonary Arterial Hypertension (PAH), meaning that all of the required information is present for the FDA to proceed with a substantive review. PAH is a devastating disease, which can affect individuals from infancy to the elderly, offering an average patient lifespan of less than 3 years after diagnosis if untreated. Although treatment started early after detection appears to be more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective. VentriPoint has created diagnostic tools to monitor patients with heart disease, and has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure, and normal hearts.
Shortly after the positive notice from the FDA, VentriPoint announced intention to complete a private placement of up to $2 million, providing additional funds to continue progress in developing and moving its technologies to market. That was soon followed by the company’s announcement of formal application for European and Canadian approval for its database for non-specific heart disease (NRV), a database that allows clinicians to rapidly and accurately assess the status of the right ventricle (RV) in all patients that do not have significant congenital heart defects or Pulmonary Arterial Hypertension, yet may have a variety of other conditions. The company expects to have a response from the European CE Mark and Health Canada offices in the next 30 days.
For additional information, visit www.VentriPoint.com
VPTDF Offers New Hope for CHD Patients
One of the challenges facing heart doctors is working with people having congenital heart disease (CHD). It’s a growing problem that involves unique issues. Though CHD is usually associated with children, a recent article by Michael O’Riordan in Clinical Cardiology (http://dtg.fm/5AjT) references a report indicating that the frequency of hospitalizations among adults for congenital defects has grown twice as fast as for children, with annual adult admissions now over a third of total CHD admissions. Among other factors, people who used to die young from such problems are now often living well into adulthood. The result is a growing burden on the healthcare system.
Accurate analysis of the heart can be a difficult and expensive process, and involves special issues dealing with the many children afflicted with the disease. Adding to the problem is the fact that people with CHD almost always have right heart defect, which can pose special challenges for accurate analysis. The unconventional shape, position, and size of the right ventricle has made it difficult to obtain reliable data regarding pump volume and cardiac function.
VentriPoint Diagnostics, a Canadian-based medical device company, offers what could be a breakthrough solution to the problems of accurate and comprehensive heart function analysis. The company’s new imaging system, called “Angelo,” is the only software available that offers comprehensive 3D imaging as quickly and cost-effectively, including the right heart. The system uses anatomical “dots” to build a 3D model of the heart, calculating such functional information as heart volumes, cardiac output, and ejection fraction, all within only 10 minutes, using conventional 2D ultrasound input.
The technology is based upon a patented approach known as knowledge-based reconstruction. The software can be added to any 2D ultrasound equipment, providing results that are faster, easier, and less expensive than any other heart assessment techniques. For both patients and doctors dealing with CHD, it offers new hope, and has already been approved for congenital heart disease application in Canada and Europe, with clinical trials currently finishing up in the U.S.
For more information, visit www.ventripoint.com
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VentriPoint Diagnostics Ltd. (VPTDF) leverages knowledge-based techniques to make heart analysis more convenient and less expensive. Having already installed multiple VMS™ analysis systems for heart testing in leading cardiac centers in Europe, Canada and the United States, the company is currently focused on expanding the applications of its technology beyond congenital heart disease in adults and children.
VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. The company designed its analysis system to be used for all major heart diseases, including pulmonary hypertension, cardiovascular disease, and heart failure. Canada and Europe (CE Mark) have granted approval for the sale of the VMS™ diagnostic tool, and VentriPoint is pursuing the US-FDA approval through the 510(k) process.
The company's VMS™ analysis systems eliminate all the disadvantages of an MRI scan, including a long wait list, the one-hour scan time, the claustrophobic environment, the requirement of a general anesthetic for children, the lengthy heart analysis process, and the need for a second trip to the hospital. Offering better efficiency and cost savings, VMS™ offers the healthcare industry a superior method of heart visualization.
The management team executing VentriPoint's business strategy retains extensive experience in both healthcare technology and business development. Many expansion opportunities exist for the company's technology with a total market potential exceeding $1 billion. As a leader in the clinical diagnostics market, the company is well positioned to meet the well-defined clinical need for efficient, accurate, and inexpensive heart analysis.
Ventripoint Diagnostics Ltd.
100 W. Harrison St.
North Tower Unit 410
Seattle, WA 98119, United States
Phone: (206) 283-0221
Email: info@ventripoint.com
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