Renal artery

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".

Otsuka Medical Devices and ReCor Medical Announce Submission of Application for Pre-Market Approval of the Paradise™ Ultrasound Renal Denervation (uRDN) System to the U.S. Food and Drug Administration

Retrieved on: 
Wednesday, November 30, 2022

Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) and ReCor Medical, Inc. (ReCor, subsidiary of Otsuka Medical Devices) announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise uRDN System in the treatment of uncontrolled hypertension.

Key Points: 
  • Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) and ReCor Medical, Inc. (ReCor, subsidiary of Otsuka Medical Devices) announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise uRDN System in the treatment of uncontrolled hypertension.
  • Paradise uRDN uses a combination of ultrasound energy to denervate the renal nerves and a water-filled balloon to protect the renal artery.
  • Since 2009, ReCor has been focused on developing and testing the Paradise uRDN System to treat hypertension safely and effectively.
  • In September of this year, ReCor and Otsuka Medical Devices announced that the trial successfully reached its primary efficacy endpoint.

ReCor Medical and Otsuka Medical Devices Announce Submission of Application for Pre-Market Approval of the Paradise™ Ultrasound Renal Denervation (uRDN) System to the U.S. Food and Drug Administration

Retrieved on: 
Wednesday, November 30, 2022

ReCor Medical, Inc. (ReCor) and its parent company, Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) today announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise uRDN System in the treatment of uncontrolled hypertension.

Key Points: 
  • ReCor Medical, Inc. (ReCor) and its parent company, Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) today announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise uRDN System in the treatment of uncontrolled hypertension.
  • Paradise uRDN uses a combination of ultrasound energy to denervate the renal nerves and a water-filled balloon to protect the renal artery.
  • Since 2009, ReCor has been focused on developing and testing the Paradise uRDN System to treat hypertension safely and effectively.
  • ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension.

Verve Medical Announces Results of Feasibility Trial for Transurethral Renal Pelvic Denervation for Uncontrolled Hypertension

Retrieved on: 
Wednesday, November 16, 2022

The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation.

Key Points: 
  • The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation.
  • We are pleased that we were able to complete this feasibility study of renal denervation for people with uncontrolled hypertension.
  • Verve Medical, headquartered in Phoenix, AZ, is an early-stage medical device company that is committed to developing novel transurethral (natural orifice) renal denervation devices to ameliorate uncontrolled hypertension and associated diseases for the benefit of patients worldwide.
  • Verve Medical and Verve RPD are registered trademarks of Verve Medical, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221116006004/en/

ELEVATE IDE Study highlights the Safety and Effectiveness of the ALTO® Abdominal Stent Graft System in One-year Results; Data to Be Presented at 2022 VEITHsymposium

Retrieved on: 
Thursday, October 20, 2022

The study reports the clinical outcomes of the ALTO Abdominal Stent Graft System and highlights the devices safety and effectiveness at one-year post-procedure.

Key Points: 
  • The study reports the clinical outcomes of the ALTO Abdominal Stent Graft System and highlights the devices safety and effectiveness at one-year post-procedure.
  • The study concluded that the Endologix ALTO stent graft is safe and effective in treating AAA with appropriate anatomy at one year.
  • Featuring a unique, patented, sealing technology, the ALTO Abdominal Stent Graft System is the latest generation of innovative therapies for AAA patients.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.

SoniVie Announces successful procedure with TIVUS system on first patient enrolled for REDUCED1 Pilot study

Retrieved on: 
Wednesday, July 13, 2022

TIVUS's catheter excellent ease of use and its ability to denervate at significant depth of the perivascular space allowed for a short, simple and straightforward procedure.

Key Points: 
  • TIVUS's catheter excellent ease of use and its ability to denervate at significant depth of the perivascular space allowed for a short, simple and straightforward procedure.
  • We will closely follow our patient and look forward to continuing enrolment in this exciting trial."
  • 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.
  • "Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.

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.