SoniVie Appoints Charles Carignan, MD, Chief Executive Officer and Announces Upcoming Presentation of TIVUS™ Clinical Trial Data at EuroPCR 2019
Medical device industry veteran will advance clinical and commercial development of SoniVie’s percutaneous ultrasound pulmonary artery denervation treatment for pulmonary arterial hypertension – – Results of TROPHY1, a multi-center, international clinical trial of TIVUS in patients with pulmonary arterial hypertension, will be presented at leading interventional cardiovascular medicine conference –
SoniVie, an Israeli startup company developing a novel system for the treatment of pulmonary arterial hypertension (PAH), today announced the appointment of Charles “Chuck” Carignan, MD, to the position of Chief Executive Officer and the upcoming presentation of data from TROPHY1 (TReatment Of Pulmonary HYpertension 1) at EuroPCR 2019, which is taking place May 21st – 24th in Paris. Data from TROPHY1, a multi-center international clinical trial (NCT02835950) evaluating the safety and efficacy of SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System in PAH patients who are on a stable regimen of dual- oral combination therapy, will be presented in an oral, Late-Breaking Trial session on May 22nd.
SoniVie developed TIVUS, a dedicated therapeutic catheter to enhance the treatment of PAH, based on prior technology developed for renal artery denervation by Cardiosonic. The TIVUS catheter is inserted into the pulmonary artery during a right heart catheterization procedure, and selectively ablates nerves associated with disease activity without damaging the vessel walls or the adjacent tissues. This treatment may significantly slow disease progression. Data from preclinical animal studies providing proof-of-concept of the TIVUS technology in the treatment of PAH were recently published in EuroIntervention.1
“The TIVUS technology has tremendous potential to improve the lives of patients suffering from PAH, and Dr. Carignan’s track record of success in the medical device and healthcare industries will advance SoniVie’s efforts to realize that potential,” said Irit Yaniv, Chairperson of the SoniVie Board of Directors. “We are confident that his vision and strategic capabilities will leverage the momentum of the TROPHY1 data presentation into critical growth opportunities for the company.”
Dr. Carignan brings more than 25 years of experience in the healthcare industry to SoniVie, including more than 20 in the medical device sector. He has a successful track record of developing, funding and growing clinically meaningful and differentiated medical devices. He has expertise in strategy, product and clinical evidence development, achieving regulatory approvals and advantageous reimbursement, and in capital raising, sales, marketing, and operations.
“We are very excited to present the results of the TROPHY1 study at EuroPCR, which represents an important milestone for SoniVie and for the PAH patients who may benefit from this new therapeutic modality,” said Dr. Carignan. “I believe that our EuroPCR data will demonstrate the safety and clinical utility of TIVUS and provide a solid foundation for future studies, building value for all of our stakeholders.”
Prior to joining SoniVie in March 2019, Dr. Carignan was most recently the CEO and Director of Rex Bionics Pty Limited. Previously Dr. Carignan was President and CEO of BionX Medical Technologies, sold to Ottobock. Additional prior experience includes serving as President and CEO of NinePoint Medical, Inc.;
Executive Vice President and Chief Medical Officer of Novasys Medical, Inc.; Chief Medical Officer, Endosurgery and Minimally Invasive Therapies at Boston Scientific Corporation; and Vice President, Clinical Research and Medical Affairs at Conceptus, Inc.
TROPHY1 Data Presentation at EuroPCR 2019 Presentation title
Percutaneous therapeutic intravascular ultrasound pulmonary artery denervation for the treatment of pulmonary arterial hypertension (TROPHY1): a multicenter, international, open-label trial
Alex Rothman, MA, BM BCh, MRes, PhD, MRCP, Wellcome Trust Clinical Research Career Development Fellow in the Department of Infection, Immunity & Cardiovascular Disease at the University of Sheffield Medical School
10:30 – 10:43 a.m., Wednesday, May 22, 2019
Presentation location Palais de Congrès Room 342A/Level 3
1 Rothman A, Jonas M, Castel D et al. Pulmonary Artery Denervation Using Catheter based Ultrasonic Energy. EuroIntervention. 2019; May DOI: 10.4244/EIJ-D-18-01082
SoniVie is a medical device company developing the TIVUS™ Ultrasonic Denervation System as an innovative system for the treatment of pulmonary arterial hypertension (PAH). PAH is an incurable disease that affects millions of people in the United States and Europe. The TIVUS procedure is straightforward, and has shown excellent results in first-in-human clinical trials in Group-I PAH patients. The company is also conducting a clinical trial of TIVUS in Group II PAH patients. The company’s offices are located in Israel.
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