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SoniVie Presents Clinical Trial Data Supporting the Safety and Efficacy of the TIVUS™ System in the Treatment of Pulmonary Arterial Hypertension

SoniVie, an Israeli company developing a novel system for the treatment of pulmonary arterial hypertension (PAH), today announced the presentation of positive data from a multi-center international clinical trial of its Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with pulmonary arterial hypertension (PAH) who are on a stable regimen of dual-oral combination therapy. Alex Rothman, MD, PhD, a Wellcome Trust Fellow at the University of Sheffield and Sheffield Teaching Hospitals NHS Trust, presented the results of the TROPHY1 (TReatment Of Pulmonary HYpertension 1) trial (NCT02835950 and NCT02516722) yesterday at EuroPCR 2019, which is taking place May 21st – 24th in Paris.

TIVUS is a dedicated therapeutic catheter to enhance the treatment of PAH and is inserted into the pulmonary artery during a right heart catheterization procedure. It is designed to selectively ablate nerves associated with disease activity without damaging the vessel walls or the adjacent tissues to improve quality of life and clinical outcomes. PAH is a disease characterized by narrowing of the small blood vessels of the lungs, which causes an elevated pulmonary-artery pressure leading to deterioration in heart function, with a consequent average survival rate of five years. In the United States alone there are more than 50,000 patients suffering from PAH.

“A growing body of data suggests that the sympathetic nervous system may play an important role in the pathogenesis of PAH. Decreasing sympathetic activity may help to reduce symptoms and slow disease progression,” said Dr. Rothman. “The favorable safety and initial efficacy results observed to date in TROPHY1 suggest that TIVUS improves cardiopulmonary function and daily activity in PAH patients. Additional studies of this innovative approach to PAH therapy are warranted, as many patients continue to have symptoms on current treatment options.”

Dr. Rothman presented the study results in an oral session titled “Percutaneous therapeutic intravascular ultrasound pulmonary artery denervation for the treatment of pulmonary arterial hypertension (TROPHY1): a multicenter, international, open-label trial.”

TROPHY1 was conducted at eight clinical sites in Europe, Israel and the United States. The trial enrolled 23 Functional Class III PAH patients who were on an established regimen of dual-oral medical therapy. Pulmonary artery denervation was performed with TIVUS following a qualifying right heart catheterization. The primary endpoint of the trial was safety of the procedure, and secondary endpoints included changes from baseline in hemodynamic parameters, six-minute walk distance, N-terminal pro b-type natriuretic peptide (NT-pro-BNP, a hormone produced in the heart in response to heart failure and other cardiac dysfunction) and quality of life questionnaire at 5-months follow-up. Key findings from the trial include:

  • There were no serious adverse events related to the device or procedure.
  • At mean follow-up of 5 months, pulmonary vascular resistance decreased by 94 (17.8%, SD 151, P=0.001), six-minute walk distance increased by 42m (SD 63, P=0.02) and daily activity increased by 671 average accelerometer unit (SD 1555, P=0.04) compared with baseline values.
  • A reduction in baseline pulmonary vascular resistance of >10% was observed in 14 (70%) patients, of which 8 (40%) had a reduction of >20%.
  • Improvements in mean pulmonary artery pressure (-5.1 mmHg SD 7.4, P<0.01) and right atrial pressure (-2.4 mmHg, SD 3.5, P=0.01) were also observed.
  • At 5-months follow-up, no significant changes were identified in quality of life or NT-proBNP.
  • Combined hemodynamic and functional improvements were reflected in an increase in the number of European Society of Cardiology (ESC) low-risk indicators achieved at 5-month follow-up compared with baseline assessment (ESC/French invasive risk score 0.4, SD 0.6, P<0.001).

The study authors conclude that the TROPHY1 results support the safety of pulmonary denervation using TIVUS in this patient population and suggest that this procedure may improve hemodynamics and exercise tolerance in patients with PAH.

“These results support the clinical and commercial potential of the SoniVie TIVUS System in addressing unmet need in the treatment of PAH,” said Chuck Carignan, MD, Chief Executive Officer at SoniVie. “The completion of TROPHY1 is an important milestone for the company and the results provide a solid foundation on which to advance the clinical and regulatory development of the TIVUS System. We expect to initiate a pivotal trial in 2020.”

About SoniVie
SoniVie is a medical device company developing the TIVUS™ Ultrasonic Denervation System as an innovative system for the treatment of pulmonary hypertension including pulmonary arterial hypertension (PAH). Pulmonary hypertension is a disease affecting millions of patients in the United States and Europe. The TIVUS procedure is straightforward, and has shown excellent results in first-in-human clinical trials in Group 1 PAH patients. The company is also launching a clinical trial of TIVUS in Group 2 PH patients. The company's offices are located in Israel.

Media Contact – Lazar Partners
Glenn Silver

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