– International study designed to build on positive 12-month data from TROPHY1 demonstrating improvement in multiple clinical endpoints and no serious procedure-related adverse events –

Tel Aviv, Israel – October 13, 2020 – SoniVie, an Israeli company developing a novel system for the treatment of pulmonary arterial hypertension (PAH), today announced that it has received FDA approval for its IDE for a pivotal study of the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with pulmonary arterial hypertension (PAH) (NCT04570228). The study will be the first randomized, controlled, pivotal medical device trial for PAH. The inclusion of a control group is expected to provide more robust safety and efficacy data than previous device trials in this indication.  SoniVie presented positive 12-month safety and efficacy data from the earlier TROPHY1 (TReatment Of Pulmonary HYpertension 1) study (NCT02835950 and NCT02516722) of the TIVUS System earlier this year at the EuroPCR and American Thoracic Society (ATS) virtual meetings. TIVUS is a dedicated therapeutic catheter to treat PAH and it 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.

“Despite the availability of approved pharmacotherapy for PAH, a condition with a five-year mortality rate greater than 40 percent, there is an urgent need for new therapies that can improve outcomes for patients living with this life-threatening, debilitating disease,” said Dr. Lewis Rubin, Emeritus Professor of Medicine, University of California, San Diego School of Medicine and Adjunct Professor of Medicine, Columbia University College of Physicians and Surgeons. “The TIVUS System has the potential to address PAH at a physiologic level by selectively ablating nerves associated with disease activity, specifically targeting the cause of disease without the systemic exposure and attendant side effects associated with pharmacotherapy. This sham-controlled study will provide important information on the safety and efficacy of the TIVUS System in the treatment of PAH.”

The international, randomized, sham-controlled study will be conducted 25 sites in the US, Europe, Israel and Australia and will include 168 evaluable patients with documented PAH, functional class II/III and on at least 2 medications (112 treated/ 56 sham). Patients in the treatment group will undergo nerve ablation with the TIVUS System during a right heart catheterization procedure, while those in the sham group will undergo catheterization without nerve ablation. The primary endpoint of the study is the difference in six-minute walk distance (6MWD) at six months. Sham patients will be allowed to cross over to TIVUS treatment after six months.

Promising 12-Month TROPHY1 Data

12-month data from TROPHY1 were presented at EuroPCR and ATS and showed continued effectiveness of treatment with the TIVUS System at 12 months. No serious procedure related adverse events were reported 12-months post-pulmonary artery denervation, and transplant-free survival was 96%.

• Of 23 patients enrolled, 19 completed 12-month follow-up with 4 patients unavailable (1 death, 1 therapeutic non-adherence, 2 transition to intravenous prostanoid).
• Compared with baseline, mean pulmonary artery pressure was reduced (-3.9 mmHg, p=0.03). Indicators of hemodynamic and functional capacity (six-minute walk distance, daily activity, pulmonary vascular resistance, cardiac output and mean right atrial pressure) were maintained.
• At 12-months following a TIVUS procedure, a combined assessment of hemodynamics, functional capacity and clinical risk score was improved in 58% (11), maintained in 32% (6) and declined in 10% (2) of patients compared to baseline, excluding the 4 patients not available for follow-up at 12 months.

“The 12-month TROPHY1 data are extremely promising and support the potential of the TIVUS System to transform the care and outcomes for patients with PAH,” said Alex Rothman, MD, University of Sheffield and Sheffield Teaching Hospitals NHS Trust, who presented the data at EuroPCR. “Improvements in pulmonary artery pressure while maintaining baseline metrics in multiple indicators of hemodynamic function and functional capacity are especially encouraging given that patients with PAH typically see declines in these endpoints over time. The initiation of the pivotal study for the TIVUS System, the first controlled study of a device in this indication, is an important advance for the PAH patient and physician communities. Based on the TROPHY1 data, I am optimistic that the results of the pivotal study will provide additional validation of this innovative technology.”

About TIVUS

SoniVie’s proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic intra-vascular catheter to treat PAH. It is inserted into the pulmonary artery during a right heart catheterization procedure and 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.

In September 2019, TIVUS received Breakthrough Device Designation from the U.S. Food and Drug Administration because it is the first of any potential therapeutic product for PAH to use high-frequency non-focused ultrasound and can address a significant unmet need in this patient population. The Breakthrough Device Designation is granted to certain medical devices and device-led combination products that may provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. Recently, CMS published a draft OPPS rule that would provide for 4 years of coverage of Breakthrough Devices.

About Pulmonary Arterial Hypertension

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 (Kirson NY, et al. Curr Med Res Opin. 2011 Sep;27(9):1763-8. doi: 10.1185/03007995.2011.604310).

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 performed during a standard right-heart catheterization procedure and has shown encouraging results in first-in-human clinical trials in Group 1 PAH patients. The company has also launched a clinical trial of TIVUS in Group 2 PH patients. The company’s offices are located in Rosh Haayin, Israel and in Boston MA.

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