SoniVie Overview
SoniVie is a medical device company developing a system for the treatment of pulmonary hypertension (PAH). The companys therapeutic intravascular ultrasound (TIVUS) is a dedicated therapeutic catheter that offers a treatment for PAH. The TIVUS catheter is inserted into the pulmonary artery in a catheterization procedure and selectively damages nerves associated with disease activity without touching the vessel walls or damaging the adjacent tissues. This treatment may significantly slow the disease progression. In March 2016, SoniVie successfully completed the first two procedures in its phase 1 multicenter clinical trial. The TIVUS system is currently approved for sale in markets regulated by the CE mark. In September 2019, the TIVUS system received a breakthrough device designation by the FDA for use in the treatment of pulmonary arterial hypertension, and in December 2020, the system received a breakthrough device designation for use in renal artery denervation for the treatment of resistant hypertension.
Cumulative Funding Raised Over Time ($)
$9.8MJan 2018
$69.8MJan 2023
$73.3MNov 2015
Latest News
Boston Scientific to acquire Israel’s SoniVie for up to $540M in push for hypertension treatment | CTech
growth-positive
SoniVie Ltd., Appoints Veteran Medtech Executive Raymond W. Cohen as Chairman of its Board of Directors
SoniVie Ltd., a medical device company specializing in renal denervation systems for hypertension treatment, has appointed Raymond W. Cohen as its new chairman of the board. Cohen, who has extensive experience in the medical technology sector, recently retired from Axonics following its acquisition by Boston Scientific for $3.7 billion. SoniVie is currently conducting a PMA study for FDA approval of its TIVUS™ system, which uses high-frequency ultrasound to treat hypertension. The study is enrolling patients in the US, Europe, and Israel. Cohens appointment is expected to leverage his expertise in growing Medtech companies and renal denervation to advance SoniVies commercialization efforts.
Management Changes
growth-positive
Israeli medical device co SoniVie raises $60m
Israeli medical device company SoniVie has completed a $60 million series C financing round led by Andera Partners. The company is developing a proprietary solution to treat hypertension using ultrasound-based denervation technology. The financing will be used to reach clinical and regulatory milestones and support the companys renal artery denervation program. SoniVie has also appointed two medtech experts to its board of directors.
Investment
growth-positive
SoniVie Announces successful procedure with TIVUS system on first patient enrolled for REDUCED1 Pilot study
SoniVie, an Israeli company, announced the successful treatment of the first patient with its Renal Artery Denervation TIVUS™ technology. The procedure, which uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery, aims to reduce blood pressure in patients with resistant hypertension. SoniVie is developing the TIVUS™ Ultrasonic Denervation System for multiple therapeutic areas, including pulmonary artery denervation and total lung denervation. The companys offices are located in Rosh Haayin, Israel, and Newark, NJ, USA.
Customers
growth-positive
Israeli company SoniVie receives FDA approval for innovative hypertension treatment
Israeli medical company SoniVie has received an IDE exemption from the US FDA for its Pilot study to treat Resistant Hypertension Patients. SoniVies treatment, called TIVUS, is an innovative Ultrasound system that treats Hypertension patients with Renal Artery Denervation. This milestone marks a major step and priority in the companys history. The new study will expand the companys clinical experience based on previous trials using the earlier generation of TIVUS. SoniVie aims to introduce TIVUS in the US to provide a safe, effective, and easy-to-use device treatment for patients suffering from resistant hypertension.
Investment
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $73.26M |
| Last funding | $60M |
| Stage | C |
| Rounds | 3 |
| Investors | 6 |
Team Members
2
Employees: 1-10
Web & Social Links
| Website | sonivie.com/ |
Locations
Ha-Rav Shalom Shabazi Street 26, Rosh Haayin, Israel
758 Stillwater Rd, St Paul, MN 55115, USA
Photos & Videos
No files yet
SoniVie Business
Business models
B2B
Product stage
Released
Employees
1-10
Sector
Health Tech & Life SciencesMedical DevicesMedical Treatment & TherapeuticsTarget Customer
Healthcare & Life SciencesHealthcareProvidersCore Technology
Simulation & ImagingUltrasoundTags (11)
ultrasoundcatheterspulmonaryblood-pressuremedical-deviceshospitalsdoctorshealthcare-providersclinicsvasculartreatmentsSoniVie Financials
$73.26M
Total funding
Undisclosed
Capital raised
$60M
Last funding
C
Funding stage
3
Total rounds
6
Investors
Cumulative Funding Raised Over Time ($)
$9.8MJan 2018
$69.8MJan 2023
$73.3MNov 2015
Private Equity Funding
C Round
Jan 2023
$60M
Andera Partners (Lead)
,
Supernova Invest, TechWald Holding, Omega Funds
B Round
Jan 2018
$9.75M
Accelmed, Arkin Tech
A Round
Nov 2015
$3.51M
Accelmed
SoniVie Lifecycle
Cumulative Funding Raised Over Time
$9.8MJan 2018
$69.8MJan 2023
$73.3MNov 2015
All Events
C Round
Jan 2023
$60M
Andera Partners (Lead)
,
Supernova Invest, TechWald Holding, Omega Funds
B Round
Jan 2018
$9.75M
Accelmed, Arkin Tech
A Round
Nov 2015
$3.51M
Accelmed
SoniVie News
14 articlesBoston Scientific to acquire Israel’s SoniVie for up to $540M in push for hypertension treatment | CTech
growth-positive
SoniVie Ltd., Appoints Veteran Medtech Executive Raymond W. Cohen as Chairman of its Board of Directors
SoniVie Ltd., a medical device company specializing in renal denervation systems for hypertension treatment, has appointed Raymond W. Cohen as its new chairman of the board. Cohen, who has extensive experience in the medical technology sector, recently retired from Axonics following its acquisition by Boston Scientific for $3.7 billion. SoniVie is currently conducting a PMA study for FDA approval of its TIVUS™ system, which uses high-frequency ultrasound to treat hypertension. The study is enrolling patients in the US, Europe, and Israel. Cohens appointment is expected to leverage his expertise in growing Medtech companies and renal denervation to advance SoniVies commercialization efforts.
Management Changes
growth-positive
Israeli medical device co SoniVie raises $60m
Israeli medical device company SoniVie has completed a $60 million series C financing round led by Andera Partners. The company is developing a proprietary solution to treat hypertension using ultrasound-based denervation technology. The financing will be used to reach clinical and regulatory milestones and support the companys renal artery denervation program. SoniVie has also appointed two medtech experts to its board of directors.
Investment
growth-positive
SoniVie Announces successful procedure with TIVUS system on first patient enrolled for REDUCED1 Pilot study
SoniVie, an Israeli company, announced the successful treatment of the first patient with its Renal Artery Denervation TIVUS™ technology. The procedure, which uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery, aims to reduce blood pressure in patients with resistant hypertension. SoniVie is developing the TIVUS™ Ultrasonic Denervation System for multiple therapeutic areas, including pulmonary artery denervation and total lung denervation. The companys offices are located in Rosh Haayin, Israel, and Newark, NJ, USA.
Customers
growth-positive
Israeli company SoniVie receives FDA approval for innovative hypertension treatment
Israeli medical company SoniVie has received an IDE exemption from the US FDA for its Pilot study to treat Resistant Hypertension Patients. SoniVies treatment, called TIVUS, is an innovative Ultrasound system that treats Hypertension patients with Renal Artery Denervation. This milestone marks a major step and priority in the companys history. The new study will expand the companys clinical experience based on previous trials using the earlier generation of TIVUS. SoniVie aims to introduce TIVUS in the US to provide a safe, effective, and easy-to-use device treatment for patients suffering from resistant hypertension.
Investment
growth-positive
SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System for Renal Artery Denervation
SoniVie, an Israeli company, has acquired new intellectual property and other assets from Cardiosonic, expanding its TIVUS System into new therapeutic areas beyond pulmonary hypertension. The company has also been granted Breakthrough Device Designation from the U.S. FDA for the TIVUS System for renal artery denervation in the treatment of resistant hypertension. This designation provides a special regulatory status for medical devices that provide more effective treatment for life-threatening or irreversibly debilitating diseases. SoniVie believes that its ultrasound-based denervation technology can provide clinical benefit in the treatment of diseases that lack optimal medical management. With control of the intellectual property and assets, SoniVie has a competitive advantage in advancing targeted denervation as a therapeutic approach. The company plans to initiate new clinical trials for its TIVUS System in patients with resistant hypertension in late 2021.
Acquisition
growth-positive
SoniVie Receives IDE Approval for its Pivotal Study for the TIVUS System to Treat Patients with Pulmonary Arterial Hypertension (PAH)
SoniVie, an Israeli company developing a novel system for the treatment of pulmonary arterial hypertension (PAH), has received FDA approval for a pivotal study of its Therapeutic Intra-Vascular Ultrasound (TIVUS) System. The study will be the first randomized, controlled, pivotal medical device trial for PAH. The TIVUS System has the potential to selectively ablate nerves associated with disease activity, targeting the cause of PAH without systemic exposure and side effects. The international study will be conducted at 25 sites and will include 168 evaluable patients. SoniVie presented positive 12-month safety and efficacy data from an earlier study of the TIVUS System. The 12-month data showed continued effectiveness of treatment with the TIVUS System and no serious procedure-related adverse events.
Customers
growth-positive
SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System in the Treatment of Pulmonary Arterial Hypertension (PAH)
SoniVie, an Israeli company, has been granted Breakthrough Device Designation from the FDA for its Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with pulmonary arterial hypertension (PAH). The TIVUS System has shown promise in early clinical studies for stabilizing or improving pulmonary vascular resistance in PAH patients. The Breakthrough Device Designation will provide priority review for regulatory submission and reimbursement benefits under a new Centers for Medicare and Medicaid Services alternative new technology add-on payment. SoniVie expects to initiate a pivotal trial of the TIVUS System in 2020. The Centers for Medicare and Medicaid Services also finalized a proposal to create an alternative new technology add-on pathway for medical devices with Breakthrough Device Designation. SoniVie presented data from the TROPHY1 trial, which demonstrated improvements in PAH patients using the TIVUS System.
Customers
New System Could Hold Promise for Patients Suffering from Pulmonary Arterial Hypertension
growth-positive
SoniVie Presents Clinical Trial Data Supporting the Safety and Efficacy of the TIVUS™ System in the Treatment of Pulmonary Arterial Hypertension - TechWald Holding S.p.A.
SoniVie, an Israeli company, presented positive data from a clinical trial of its Therapeutic Intra-Vascular Ultrasound (TIVUS) System for the treatment of pulmonary arterial hypertension (PAH). The trial showed favorable safety and initial efficacy results, with improvements in cardiopulmonary function and daily activity in PAH patients. The TIVUS System is designed to selectively ablate nerves associated with disease activity without damaging the vessel walls or adjacent tissues. The company plans to initiate a pivotal trial in 2020 and sees potential for the TIVUS System to address the unmet need in the treatment of PAH. SoniVie is a medical device company based in Israel.
Customers
growth-positive
SoniVie Appoints Charles Carignan, MD, Chief Executive Officer and Announces Upcoming Presentation of TIVUS™ Clinical Trial Data at EuroPCR 2019
Israeli startup SoniVie appoints new CEO and announces data presentation from TROPHY1 clinical trial at EuroPCR 2019. The trial evaluates the safety and efficacy of SoniVies Therapeutic Intra-Vascular Ultrasound (TIVUS) System in pulmonary arterial hypertension (PAH) patients. The TIVUS catheter, based on prior technology developed for renal artery denervation, selectively ablates nerves associated with disease activity. The presentation of TROPHY1 data is expected to create growth opportunities for SoniVie. The new CEO, Charles Carignan, brings extensive experience in the medical device sector. SoniVie is a medical device company developing the TIVUS Ultrasonic Denervation System for the treatment of PAH.
Management ChangesCustomers
growth-positive
SoniVie completes first PAH catheter procedures
Israeli startup SoniVie has successfully completed the first two procedures for its First In Human multi-center clinical trial for the treatment of pulmonary arterial hypertension (PAH). SoniVie has developed a therapeutic catheter called TIVUS that offers a unique treatment for PAH, a progressive and fatal illness. The procedures were performed as part of a clinical study that will include 15 patients in Europe and Israel. SoniVie was founded by Accelmed, an Israeli medical device investment fund, and has received $3 million in investment. The market potential for PAH treatment is estimated at $6.5 billion.
Customers
growth-positive
SoniVie, a Portfolio Company of Accelmed Fund, Announces Successful Completion of First-In-Human Procedures Using the TIVUS Catheter
Israeli startup SoniVie has completed the first two procedures in its clinical trial for the treatment of pulmonary arterial hypertension (PAH). The company developed a therapeutic catheter called TIVUS, which offers a unique treatment for PAH, a progressive and fatal illness with no cure. The procedures were performed as part of a clinical study that will include 15 patients in Europe and Israel. SoniVie was founded by Accelmed and has received approximately $3 million in investment from the company. Pulmonary hypertension affects millions of people in the US and Europe, and the market potential for PAH treatment is estimated at $6.5 billion.
Investment
growth-positive
SoniVie Raises $2.5M From Accelmed
SoniVie has raised an additional $2.5 million from Israeli bio-medical fund Accelmed. The funding will be used to fund the first in vivo trials for their system to treat pulmonary arterial hypertension.
Investment
Employee Info
| Employees (range) | 1-10 |
| Exact count | 7 |
| Team members | 2 |
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SoniVie Internal
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Admin Info
| Confidence | 88/100 |
| Missing | video or image, markets, external profiles, not claimed |
| BI Verification | RPA |
| Registrar ID | 515125789 |
| Crunchbase | sonivie |
| Phone | +97237163152 |
| Creator | Sharon Shapira |
| Creator email | shapira.sharon2@gmail.com |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2023-02-23T00:00:00.000Z |
| Created | 2015-11-02T00:00:00.000Z |