SONIVIE


Associated tags: Chronic obstructive pulmonary disease, Denervation, Clinical trial, Patient, Pulmonary artery, Bronchitis, Pulmonary hypertension, Hypertension, Blood pressure, Stroke, Kidney failure, TEL, Renal artery, Physician, Pharmaceutical industry, The Company, Wiśniewski, Axon Sports, Therapy, Medtech, Respiratory disease, FDA, Ultrasound, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IDE

Locations: GERMANY, ITALY, ISRAEL, UNITED STATES OF AMERICA, MINNESOTA, UNITED STATES

SoniVie announces enrollment completion in the REDUCED-1 pilot study with TIVUS™ Ultra-Sound Renal Denervation

Retrieved on: 
Wednesday, January 31, 2024

TEL AVIV, Israel, Jan. 31, 2024 /PRNewswire/ -- SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUSTM) System to treat a variety of hypertensive disorders, announced that on January 8th 2024, the last patient was treated with its Renal Artery Denervation TIVUS™ technology, as part of its FDA IDE-approved pilot study to treat hypertension (The REDUCED-1 Study).

Key Points: 
  • The REDUCED-1 Study had two enrollment cohorts that were conducted under an identical protocol in the United States and in Israel.
  • Twenty-five patients were enrolled in the U.S. and 15 patients were enrolled in Israel.
  • Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal arteries.
  • This causes a reduction in the nerve activity, which may decrease blood pressure.

SoniVie announces enrollment completion in the REDUCED-1 pilot study with TIVUS™ Ultra-Sound Renal Denervation

Retrieved on: 
Wednesday, January 31, 2024

TEL AVIV, Israel, Jan. 31, 2024 /PRNewswire/ -- SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUSTM) System to treat a variety of hypertensive disorders, announced that on January 8th 2024, the last patient was treated with its Renal Artery Denervation TIVUS™ technology, as part of its FDA IDE-approved pilot study to treat hypertension (The REDUCED-1 Study).

Key Points: 
  • The REDUCED-1 Study had two enrollment cohorts that were conducted under an identical protocol in the United States and in Israel.
  • Twenty-five patients were enrolled in the U.S. and 15 patients were enrolled in Israel.
  • Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal arteries.
  • This causes a reduction in the nerve activity, which may decrease blood pressure.

SoniVie Raises $60m in Round C Financing, and Appoints New Board Members

Retrieved on: 
Monday, January 9, 2023

TEL AVIV, Israel, Jan. 9, 2023 /PRNewswire/ -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • In conjunction with the financing, the Company appointed two renowned medtech experts to its Board of Directors, Raymond W. Cohen and Zeev Zehavi, as independent directors.
  • The proceeds from SoniVie financing are envisioned to be used to reach clinical and regulatory milestones and to support TIVUS™ renal artery denervation program.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

SoniVie Raises $60m in Round C Financing, and Appoints New Board Members

Retrieved on: 
Monday, January 9, 2023

TEL AVIV, Israel, Jan. 9, 2023 /PRNewswire/ -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • In conjunction with the financing, the Company appointed two renowned medtech experts to its Board of Directors, Raymond W. Cohen and Zeev Zehavi, as independent directors.
  • The proceeds from SoniVie financing are envisioned to be used to reach clinical and regulatory milestones and to support TIVUS™ renal artery denervation program.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

EQS-News: Andera Partners invests in SoniVie, a medtech company developing a promising device for the treatment of hypertension

Retrieved on: 
Sunday, January 22, 2023

TEL AVIV, ISRAEL, AND PARIS, FRANCE, JANUARY 10, 2023 -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • Andera Partners invests in SoniVie, a medtech company developing a promising device for the treatment of hypertension
    The issuer is solely responsible for the content of this announcement.
  • The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

SoniVie receives IDE approval from FDA for its Pilot study to treat Hypertension with its Renal Artery Denervation TIVUS™ technology

Retrieved on: 
Monday, June 20, 2022

Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.

Key Points: 
  • Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.
  • The REDUCED1 study will further expand the Company's clinical experience based on two clinical trials in Renal Denervation performed using the earlier generation of the TIVUS.
  • Renal Denervation with TIVUS is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery.
  • SoniVie is a medical device company developing the TIVUS, the only Ultra-Sound Denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and lung denervation for chronic obstructive pulmonary disease with chronic bronchitis.

SoniVie receives IDE approval from FDA for its Pilot study to treat Hypertension with its Renal Artery Denervation TIVUS™ technology

Retrieved on: 
Monday, June 20, 2022

Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.

Key Points: 
  • Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.
  • The REDUCED1 study will further expand the Company's clinical experience based on two clinical trials in Renal Denervation performed using the earlier generation of the TIVUS.
  • Renal Denervation with TIVUS is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery.
  • SoniVie is a medical device company developing the TIVUS, the only Ultra-Sound Denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and lung denervation for chronic obstructive pulmonary disease with chronic bronchitis.

SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System for Renal Artery Denervation

Retrieved on: 
Wednesday, December 9, 2020

Breakthrough Device Designation is a special regulatory status granted to medical devices that provide a more effective treatment for life-threatening or irreversibly debilitating diseases.

Key Points: 
  • Breakthrough Device Designation is a special regulatory status granted to medical devices that provide a more effective treatment for life-threatening or irreversibly debilitating diseases.
  • The Company previously received Breakthrough Device Designation for the TIVUS System in the treatment of pulmonary arterial hypertension (PAH) in September 2019.
  • Renal denervation with the TIVUS System is a minimally invasive procedure that uses high-frequency non-focused ultrasound to ablate nerves in the renal artery.
  • SoniVie is a medical device company developing the TIVUS Ultrasonic Denervation System, the only platform denervation technology with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and total lung denervation for chronic obstructive pulmonary disease with chronic bronchitis.

SoniVie Receives IDE Approval for its Pivotal Study for the TIVUS System to Treat Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Tuesday, October 13, 2020

TEL AVIV, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- 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).

Key Points: 
  • TEL AVIV, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- 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).
  • TIVUS is a dedicated therapeutic catheter to treat PAH and it is inserted into the pulmonary artery during a right heart catheterization procedure.
  • This sham-controlled study will provide important information on the safety and efficacy of the TIVUS System in the treatment of PAH.
  • 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).

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

Retrieved on: 
Thursday, May 23, 2019

"A growing body of data suggests that the sympathetic nervous system may play an important role in the pathogenesis of PAH.

Key Points: 
  • "A growing body of data suggests that the sympathetic nervous system may play an important role in the pathogenesis of PAH.
  • "The favorable safety and initial efficacy results observed to date in TROPHY1 suggest that TIVUS improves cardiopulmonary function and daily activity in PAH patients.
  • 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).
  • The company is also launching a clinical trial of TIVUS in Group 2 PH patients.