CorVista Health Announces AHA Presentation of Machine Learning to Detect Pulmonary Hypertension at Point-of-Care

Washington DC—November 12, 2023—CorVista Health, Inc, a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the presentation of Machine Learning to Detect Pulmonary Hypertension data at AHA.

“We are pleased to present this important data at this year’s AHA meeting.” said Don Crawford, President and CEO of CorVista Health. “Pulmonary hypertension is a challenging condition to diagnose, especially early in the disease progression. This presentation follows the FDA’s Breakthrough Designation for the CorVista System Add-On to detect pulmonary hypertension and the recent FDA clearance of the coronary artery disease platform.”

Pulmonary hypertension (PH), a life-threatening condition with significant morbidity and mortality, affects an estimated 1% of the world population. It is present in 10% of people over age 65 and 50% of patients with heart failure. Further, the subgroup of pulmonary arterial hypertension (PAH) is frequently diagnosed years after symptom onset, at a point when the pathophysiologic changes have become irreversible.

Existing diagnostics for PH are insufficient; for instance, the sensitivity and specificity of Transthoracic Echocardiography (TTE) varies over a wide range. Moreover, TTE requires specialized equipment and technical support that is often unavailable. Herein we present the results of a machine-learned model addressing the need for an improved point-of-care test for PH in newly symptomatic subjects.

The presentation demonstrates the ability to develop a point of care method to detect PH, based on cardiac orthogonal voltage gradient (OVG) signals and photoplethysmographic (PPG) signals. A machine learned (ML) algorithm was developed to discriminate subjects with no evidence of diastolic dysfunction nor PH on TTE vs. those with mPAP≥25 mmHg from right heart catheterization.

The AUC of the algorithm was 0.93, the sensitivity 87%, and the specificity 83%. Further, the performance is preserved in all subgroups, including pre-capillary PH. This supervised machine-learned model therefore provides strong preliminary evidence that an algorithm can be developed to assess the likelihood of PH in patients with new onset symptoms of cardiovascular disease... CorVista Health's Press Release -

VentriPoint : Clinical Studies of Pulmonary Arterial Hypertension Application of Right Heart Analysis System

Nov. 1, 2011 - The University of Chicago Completes First Patient -

VentriPoint Diagnostics (TSX VENTURE:VPT)(PINK SHEETS:VPTDF) announces the University of Chicago has secured a VentriPoint Medical System (VMS™) and has begun the clinical evaluation of the database for patients with Pulmonary Arterial Hypertension (PAH).

The study will be led by four highly regarded cardiac specialists from the University of Chicago; Dr. Roberto Lang, former President of the American Society of Echocardiography and Director of the Echo Lab; Dr. Mardi Gomberg, expert clinician and researcher in the field of pulmonary hypertension; Dr. Amit Patel, Director of Cardiac MRI; and Dr. Benjamin Freed, Lead Cardiologist.

"I expect that an assessment of RV volume and function using the VMS™ will become part of the routine clinical ultrasound evaluation for patients at risk for PAH," stated Dr. Roberto Lang. "A simple way to detect and monitor PAH is gravely needed and this methodology will be extremely useful to quantify interventions (therapeutic and surgical) performed on the right ventricle," Dr. Lang added.

It is anticipated this first clinical study will take four to six weeks and will verify the accuracy of the system in patients known to have PAH. If successful, a multicenter clinical trial will be initiated to compare VMS™ with MRI as part of a submission to the FDA as part of a 510K submission.

Dr. George Adams, VentriPoint President and CEO stated, "The Company will leverage the success of the VentriPoint technology with congenital heart disease to address the needs of a significantly larger population of patients at risk for pulmonary hypertension."

The VMS™ is for investigational use only in the United States and approved for clinical use in Canada and Europe... [PDF] VentriPoint Diagnostics' Press Release -

Tarix Pharmaceuticals : TXA127 Granted Orphan Drug Status for Treatment of Pulmonary Arterial Hypertension

September 27, 2011 – Tarix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted TXA127, the Company’s lead peptide drug candidate, orphan drug status for the treatment of pulmonary arterial hypertension (PAH). Emerging science has demonstrated that the naturally occurring peptide angiotensin (1-7), the pharmaceutical ingredient in TXA127, exhibits a protective effect in animal models of PAH, suggesting a potentially beneficial role for TXA127 against this disease.

 Rick Franklin, M.D., Ph.D., Chief Executive Officer of Tarix, commented, “We are extremely pleased that TXA127 has been granted orphan drug status for this indication by the FDA. This is an important development for Tarix and is part of our strategy to build a portfolio of products using TXA127 and our synthetic peptide PanCyte to treat a variety of serious pulmonary diseases.”

 Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation and acute respiratory distress syndrome (ARDS). In 2010, TXA127 was granted Orphan Drug designation as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS)... Tarix Pharmaceuticals' Press Release -

Pfizer : The European Commission Approves Pfizer’s Revatio® (sildenafil) for the Treatment of Pulmonary Arterial Hypertension in Children

May 05, 2011 - New Indication Specifically for use in Pediatric Patients Based on Largest Placebo-Controlled Study Conducted in this Population - Pfizer Inc. announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

“Pulmonary arterial hypertension is a rare, devastating disease that can affect children," said Dr. Cara Cassino, vice president, Pfizer Medicines Development Group. “With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition. This approval is another example of our ongoing commitment to rare diseases.”

The approval was based on results of a dose-ranging phase 3 study that evaluated the efficacy and safety of Revatio versus placebo in 234 pediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) following 16 weeks of treatment. In children who were deemed developmentally unable to perform the test due to young age or the presence of other conditions, efficacy was assessed using secondary endpoints, including hemodynamics and change in WHO functional class... Pfizer's Press Release -

GeNO LLC : Investigational New Drug Application for Nitric Oxide Delivery System

March 9, 2010 – GeNO LLC a privately held, advanced development-stage technology company, announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its stand-alone gas cylinder Nitrosyl TM Delivery Platform (NDP). The initial indication to be studied for nitric oxide delivered via the GeNO Nitrosyl delivery system is as a diagnostic agent for administration as an adjunct to right heart catheterization in patients with Pulmonary Arterial Hypertension (WHO Group 1) to add information to improve clinical decision making. No agents are currently approved for this indication... [PDF] GeNO's Press Release -

Invida Group : Actelion Extends Partnership with Invida to Market Tracleer in Key Asian Markets

March 26, 2010 – Invida Group, the leading provider of healthcare brands and services to the Asia Pacific region, today announced that its contract with Swiss biotechnology company, Actelion, has been extended through 2015 to continue commercialization of Tracleer® for the treatment of pulmonary arterial hypertension (PAH) in crucial markets throughout Asia. Actelion signed with Invida initially in 2005, and has extended the contract to market the company’s lead product, Tracleer, in Thailand, Malaysia, Philippines, Vietnam, and Hong Kong.



By extending the contract, Invida will continue to leverage its experience in regulatory and medical affairs, specialized marketing, and its well-established network of key opinion leaders throughout the region. This partnership will allow Invida to continue working with a market-leading biotech firm and leverage its capabilities to commercialize an orphan drug that has proven ability to positively impact disease progression, as well as reduce severity and symptoms in,patients with PAH... [PDF] Invida' Press Release -

Syncrosome : Models for Therapeutic Research

nov 23, 2009 - Syncrosome will participate in the next Animal Models for Therapeutic Research in Basel from December 2nd to 3rd, 2009.
Animal Models for Therapeutic Research is a major international preclinical exhibition in Switzerland.
During this congress Mrs Sandra Robelet will present a conference on the HTAP (Pulmonary Artery Hypertension PAH – Models in rat)... Syncrosome's Press Release -

Aires Pharmaceuticals : Key Technology License Agreement with the National Institutes of Health

October 21, 2008 - Aires Pharmaceuticals Inc., a drug development company focused on developing therapies for pulmonary conditions, announced the signing of an exclusive license agreement with the U.S. National Institutes of Health for the patented use of a nitric oxide prodrug to treat cardiopulmonary conditions.

The technology, identified at the NIH’s National Heart, Blood and Lung Institute, shows that nitrite, which is converted by the body into nitric oxide, can be delivered as an effective treatment for pulmonary hypertension, myocardial infarction, transplantation and cerebral vasospasm. Aires Pharmaceuticals is developing Aironite™, a proprietary, inhalable formulation of nitrite, to treat pulmonary arterial hypertension (PAH). The company has Orphan Drug Status from the U.S. Food and Drug Administration and has completed its first Phase I clinical trial for this indication... Aires Pharmaceuticals' Press Release -

Bayer Schering Pharma : Progress in Clinical Program for Riociguat

October 6, 2008 – Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension. Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008... Bayer Schering Pharma's Press Release -

Novartis : Early data show potential for imatinib to treat life-threatening form of pulmonary artery disease

October 8, 2008 - An early proof-of-concept study presented shows promising results for imatinib in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.

Preliminary findings from a 59-patient, multi-center Phase II clinical trial suggest imatinib provides a treatment benefit, as demonstrated by a significant improvement in pulmonary vascular resistance and a numerical increase in cardiac output, key hemodynamic measures used to monitor the progression of the disease. Improvements in the six-minute walk test, the primary endpoint of the study, approached, but did not reach, statistical significance... Novartis' Press Release -

Pulmo BioTech : Details of the Methodology for its Phase I Human Trials

May 16 2008 - Pulmo BioTech Inc has announced details of the methodology and purpose of its Phase I Human Trials with its PulmoBind Molecular Imaging technology for the diagnosis of Pulmonary Embolism and Pulmonary Hypertension.

The work will be carried out by Pulmo BioTech subsidiary PulmoScience Inc and the title of the work is: “Phase I Study of the Use of PulmoBind for Molecular Imaging of the Pulmonary Circulation”.

The study will be a single center, Phase 1 safety and efficacy study of a single intravenous injection of PulmoBind in human subjects with no history of lung disease... Pulmo BioTech's Press Release -

Gilead : Letairis (ambrisentan) Phase IV Program

May 1, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced the initiation of ATHENA-1, a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis(R) (ambrisentan 5 mg and 10 mg tablets) in patients with pulmonary arterial hypertension (PAH) demonstrating a sub-optimal response to sildenafil monotherapy. ATHENA-1 is the first of several Phase IV Letairis studies Gilead plans to initiate in 2008 and 2009. Letairis is currently approved as a once-daily treatment for PAH (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening... Gilead Sciences' Press Release -

United Therapeutics : Treprostinil Data Presented at Annual Meeting of the American Thoracic Society

May 6, 2008 - United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary Lung Rx, Inc. announced that data related to the four different routes of administration of the drug, treprostinil, for the treatment of pulmonary arterial hypertension will be presented at the annual meeting of the American Thoracic Society (ATS), to be held in Toronto, Ontario, beginning May 16th and ending May 21, 2008,
including the first public presentation of the full data set from the TRIUMPH-1 study of inhaled treprostinil... United Therapeutics Corporation's Press Release -

Actelion and Nippon Shinyaku : pulmonary arterial hypertension (PAH) compound collaboration

February 29, 2008 - Nippon Shinyaku Co., Ltd. and Actelion Ltd announced today that the two companies have signed a binding letter of intent regarding Nippon Shinyaku's novel PGI 2 receptor agonist NS-304 for the treatment of pulmonary arterial hypertension (PAH) *1).NS-304, originally discovered and synthesized by Nippon Shinyaku, is an orally available long acting prostaglandin I 2 receptor agonist *2) , w hich stim ulates PGI 2 receptor in blood vessels and exerts vasodilating effects. NS-304 has major potential as a novel treatment of PAH. Nippon Shinyaku has recently completed phase I evaluation in the United Kingdom. A phase II program in PAH patients was initiated in Europe at the end of 2007... Nippon Shinyaku's Press Release - Actelion's Press Release -

GSK's Volibris (ambrisentan), EMEA positive opinion for approval to treat class II and II pulmonary arterial hypertension (PAH)

Thursday 21st February 2008 - GlaxoSmithKline (GSK) announced that Volibris^® (ambrisentan) has received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of Pulmonary Arterial Hypertension (PAH) in patients classified as World Health Organisation (WHO) Functional Class II and III, to improve exercise capacity¹. Approval by the European Commission and Marketing Authorisation is expected to be granted by the end of April 2008.
Ambrisentan, a non-sulphonamide class endothelin receptor antagonist (ERA), is the first PAH medicine indicated for WHO Functional Class II patients in Europe...GSK's Press Release-

Encysive Pharmaceuticals, Phase III Study With Thelin (Sitaxsentan Sodium) in Pulmonary Arterial Hypertension

Sep 24, 2007 - Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) will move forward with plans to conduct an additional Phase III study evaluating Thelin(tm) (sitaxsentan sodium) in patients with Pulmonary Arterial Hypertension (PAH)... Encysive Pharmaceuticals's Press Release -