V-Wave News
16 articles
Johnson & Johnson buys Israeli co V-Wave for up to $1.1b
Johnson & Johnson has announced plans to acquire Israeli company V-Wave, a developer of heart failure treatments. The deal, worth an upfront payment of $600 million with potential for additional payments that could increase the total to $1.1 billion, is expected to close by the end of 2024. V-Waves product, the Ventura Interatrial Shunt, has already received marketing approval in Europe and is in the process of applying for FDA approval in the US. The company, which was founded in 2010, has previously raised funding from investors including Johnson & Johnson and Edwards.
AcquisitionInvestment
V-Wave Completes Enrollment in the RELIEVE-HF Randomized Double-Blind Controlled Trial of Interatrial Shunting for Heart Failure
V-Wave has completed enrollment in the RELIEVE-HF trial, a clinical trial assessing the safety and effectiveness of the V-Wave Ventura Interatrial Shunt for the treatment of heart failure. The trial enrolled 508 advanced heart failure patients and will analyze the results after 12 months of follow-up. The Ventura Shunt is an investigational device that aims to reduce hospitalizations and improve symptoms and quality of life for heart failure patients. The company has not reported any major adverse events related to the device. V-Wave is a privately held medical device company based in Israel and the U.S.
Customers
V-Wave's Ventura® Interatrial Shunt: One Year Follow-up from RELIEVE-HF Roll-in Arm Shows Improved Left and Right Ventricular Function in Patients with Advanced Heart Failure
V-Wave Ltd, the manufacturer of the V-Wave Ventura investigational interatrial shunt device, announced positive 12-month echocardiographic results from the RELIEVE-HF clinical trial. The trial showed improvement in cardiac function for patients with advanced heart failure. The patients who received the shunt during a minimally invasive procedure experienced no major adverse events. The findings suggest that the shunt device unloads high diastolic pressures in the left ventricle without overloading the right side of the heart. V-Wave plans to continue the trial and expects to complete enrollment by Fall 2022. The company aims to provide a definitive answer on the safety and effectiveness of interatrial shunting for heart failure.
CustomersInvestment
V-Wave Completes Financing of $98M from Syndicate of Leading Global Healthcare Investors
V-Wave Ltd., a cardiovascular device company, has successfully closed the remaining tranches of its Series C extension, raising a total of $98M. The funding will support the completion of the clinical trial for the Ventura Interatrial Shunt for the treatment of advanced heart failure and the submission of a PMA for Agency review. It will also fund the continued development of V-Waves product pipeline. The financing was led by Deerfield Management and included participation from various other investors. The Ventura Shunt is currently being evaluated in an international, multicenter RELIEVE-HF randomized trial. V-Waves technology has been designated as a Breakthrough device by the FDA. The company aims to address the unmet clinical and economic need for new therapies for heart failure.
Investment
V-Wave Completes Financing of Up to $98M from Syndicate of Leading Global Healthcare Investors
V-Wave Ltd., a cardiovascular device company, has closed a Series C extension of up to $98M. The financing will support the completion of clinical trials for their Ventura Interatrial Shunt for the treatment of advanced heart failure and obtaining FDA clearance. The shunt is being evaluated in the RELIEVE-HF trial and the RELIEVE-PAH trial. The financing was led by Deerfield Management and included participation from various other investors. The company aims to develop a disruptive technology that can modify the physiology of heart failure by reducing left atrial and pulmonary artery pressures. The Ventura shunt has received positive feedback from physicians in terms of ease of use and reliability. V-Wave is addressing the unmet clinical and economic need for simple and cost-effective therapies for heart failure.
Investment
V-Wave secures CE Mark for Ventura Interatrial Shunt System
V-Wave has received CE Mark approval for its Ventura Interatrial Shunt System in the European Union. The shunt system is a minimally invasive implant designed to reduce excessive pressure in the left side of the heart and prevent fluid accumulation in the lungs, which can lead to severe heart failure symptoms. V-Wave is currently conducting a clinical trial called RELIEVE-HF to evaluate the safety and effectiveness of the shunt therapy. The CE Mark approval, along with the FDA Breakthrough Device Designations received last year, will help accelerate the introduction of the treatment to heart failure patients.
PartnersInvestment
V-Wave receives second FDA breakthrough device designation - NS Medical Devices
V-Wave has received a second Breakthrough Device Designation from the FDA for its implantable interatrial shunt device for Pulmonary Arterial Hypertension (PAH). The company is testing the device in a global approved IDE Early Feasibility Study. PAH is a severely debilitating disease that affects approximately 20,000 patients in the USA. The device aims to create a well-controlled, durable shunt that will yield more reliable results and prolong the benefits found with current treatment options. V-Wave is dedicated to innovation and improving outcomes for HF and PAH. The Breakthrough Device Designation may provide expedited access to this novel therapeutic approach for highly symptomatic and compromised PAH patients.
Investment
https://www.mpnnow.com/news/20190712/clinical-trial-in-rochester-could-change-26m-lives
V-Wave Announces Enrollment of First Patients in RELIEVE-HF Pivotal Trial of its Heart Failure Therapy
V-Wave Ltd. has enrolled the first patients in its global pivotal study of its interatrial shunt device for treating heart failure. The RELIEVE-HF study will evaluate the safety and effectiveness of the device therapy in severe heart failure patients. The study is funded by V-Waves $70M C-Round financing. The first two patients have been successfully implanted and discharged. The study is expected to involve approximately 50 major North American hospitals and up to 25 centers in the EU and Israel. V-Wave CEO, Dr. Neal Eigler, stated that the interatrial shunt provides a novel therapeutic approach for patients with chronic heart failure. Heart failure affects millions of people globally and is a leading cause of hospitalizations.
Investment
V-Wave Closes $70M Financing to Support Pivotal Study of its Heart Failure Therapy
V-Wave Ltd., a medical device company, has closed a Series C financing round of $70 million led by Deerfield Management. The company has developed an interatrial shunt device for treating patients with severe symptomatic heart failure. V-Wave also announced the upcoming launch of its global clinical trial to evaluate the safety and effectiveness of its device therapy. Heart failure is a leading cause of hospitalizations globally, and V-Waves technology has the potential to significantly improve outcomes for patients and reduce the cost burden of heart failure. The funding will help bring the device closer to commercial release and provide relief for hundreds of thousands of suffering patients.
InvestmentPartnersExpand
First Human Results with V-Wave's Interatrial Shunt Published in The Lancet
J&J leads $28m round in Israel's V-Wave
Israeli medical device company V-Wave has raised $28 million in a funding round led by Johnson & Johnson Innovation - JJDC Inc. The funds will be used to support clinical evaluation and development, expand senior management, and scale up manufacturing of V-Waves proprietary minimally invasive device for treating chronic symptomatic heart failure. The device has already been successfully implanted in 30 patients. The company was founded by Yaacov Nitzan, Dr. Gad Keren, and Dr. Ascher Shmulewitz.
InvestmentManagement ChangesExpand
V-Wave Ltd. Announces $28M Series B Financing
V-Wave Ltd., a medical device company, has completed a Series B financing of $28M. The funds will support clinical evaluation and development, addition of senior management, and manufacturing scale-up of V-Waves proprietary minimally invasive device for the treatment of heart failure. New investors in the round include Johnson & Johnson Innovation - JJDC Inc., TriVentures, Pura Vida Investments, and BioStar Ventures. Existing investors BRM Group, Pontifax, and Edwards Lifesciences also participated in the financing.
Investment
V Wave heart device implanted in first patient
V Wave Ltd. has successfully implanted its first shunt for the treatment of congestive heart failure. The company, founded in 2009, has developed a miniature shunt that reduces pressure on the heart muscle. The implantation of the shunt is a significant milestone for the company, as it is a complex regulatory process. The patient who received the implant reported improvement in their condition. V Wave has raised $6.5 million from investors including BRM Capital, Pontifax, and Dr. Ascher Shmulewitz. The companys solution aims to greatly improve the quality of life and extend the lifespan of patients with congestive heart failure.
InvestmentPartners
Heart implant co V Wave raises $2m
V Wave Ltd., a medical device company, has raised $2 million in funding led by Pontifax fund. The company has developed an implant for the treatment of congestive heart failure, which is implanted by catheterization into the left ventricle. The funding will be used to finance the first human clinical trial of the product. V Wave aims to reduce hospitalizations and improve patients quality of life. Two other Israeli companies, BioControl Medical Ltd. and EnoPace Biomedical Ltd., are also developing similar products. The article was published on July 3, 2013.
Investment
V-Wave הישראלית מגייסת 2 מיליון דולר
Israeli medical device company V-Wave has announced the completion of a $2 million funding round to advance its first product, a device for blood pressure regulation in heart failure patients. The device is implanted in the heart and helps reduce blood pressure by diverting blood flow between the hearts chambers. V-Wave recently completed a successful animal trial and plans to begin human testing later this year. The funding round was led by Pontifax and included participation from BRM, as well as existing shareholders. V-Wave aims to become a major player in the cardiology device market, which is estimated to be worth billions of dollars.
Investment