What Gradient Denervation Technologies does

Gradient Denervation Technologies is a privately held, Paris-based medical device company founded in February 2020 that is developing the Gradient™ Denervation System, a minimally invasive, ultrasound-based catheter for pulmonary artery denervation (PADN). The device is designed to ablate nerves around the pulmonary artery using therapeutic ultrasound energy in a percutaneous procedure, with the goal of down-regulating sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. The catheter platform was purpose-built specifically for pulmonary artery anatomy and is built on intellectual property developed at Stanford University by clinicians Dr. Swami Gnanashanmugam and Dr. Jeffrey Feinstein through the Stanford Biodesign Program.

The company targets WHO Group 2 Pulmonary Hypertension — patients with elevated pulmonary vascular resistance due to left-sided heart disease — an indication in which an estimated two-thirds of heart failure patients globally are affected and for which there are currently no approved drug or device therapies in the United States. Gradient has progressed through first-in-human clinical work at Helsicore in Georgia (June 2023), FDA approval of its PreVail-PH2 Early Feasibility Study, first US patient enrollment at Duke University Hospital (March 2024), FDA approval to expand the study (October 2024), FDA Breakthrough Device Designation (May 2025), and FDA TAP Pilot acceptance (June 2025).

The business model is currently pre-revenue: the device is for investigational use only and is not approved for commercial use anywhere in the world. Upon regulatory approval, revenue is expected to be generated through hardware sales of the catheter system to hospitals and academic medical centers via a direct enterprise field-sales motion targeting heart failure specialists. The company operates from Suresnes, France (headquarters) and Maple Grove, Minnesota (US subsidiary Gradient Therapeutics, Inc.), has 11-50 employees, and has raised approximately €17.5M to date across a €3.5M seed (September 2020, Sofinnova MD Start III) and a €14M Series A (September 2023, led by Asabys Partners with Thuja Capital and Sofinnova Partners).

Name

Gradient Denervation Technologies

Legal name

Gradient Denervation Technologies

Website

https://gradientdenervation.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Gradient Denervation Technologies is a Paris-based medical device company developing an ultrasound-based catheter system for pulmonary artery denervation to treat WHO Group 2 pulmonary hypertension in heart failure patients. The device is investigational-only and pre-revenue.

Ownership category

akta.pro rank

Product category

Interventional Cardiology Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

• Pulmonary artery denervation
• Ultrasound catheter system
• Pulmonary hypertension treatment
• Percutaneous medical device
• Cardiovascular interventional device

Headquarters

HQ city

Paris

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales: Pre-revenue company. The Gradient Denervation System is for investigational use only and is not approved for commercial use anywhere in the world. Revenue will be generated through medical device sales upon regulatory approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Gradient Denervation Technologies is developing the Gradient Denervation System, a novel ultrasound-based catheter device that performs pulmonary artery denervation (PADN) to treat pulmonary hypertension, particularly in heart failure patients with WHO Group 2 PH. The minimally invasive, percutaneous device ablates nerves around the pulmonary artery using therapeutic ultrasound energy to reduce vascular resistance and lower pulmonary pressures. The device is for investigational use only and is not yet approved for commercial sale anywhere in the world.

Product overview

Gradient Denervation Technologies offers a single unified product: the Gradient™ Denervation System, an ultrasound-based catheter device designed for pulmonary artery denervation (PADN) to treat pulmonary hypertension, particularly in heart failure patients with WHO Group 2 Pulmonary Hypertension. The device uses therapeutic ultrasound energy to ablate nerves around the pulmonary artery in a minimally invasive procedure, targeting the sympathetic nervous system's input into the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. The company is currently conducting clinical trials (PreVail-PH2 Early Feasibility Study) and the device is for investigational use only, not approved for commercial use.

Differentiator

Problem solved

Functional benefit

Products and services

• Gradient Denervation System

Quantifiable outcome

• Two-thirds of heart failure patients have pulmonary hypertension leading to increased mortality and hospitalization risk
• +1 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Duke University HospitalcoreStrategic or Co-development Partner · 22 October 2024First US patient enrolled in the PreVail-PH2 Early Feasibility Study at Duke University Hospital in Durham, NC. Dr. Marat Fudim and Dr. Richard Krasuski are leading investigators in the FDA-approved study.
• Helsicore (Israeli-Georgian Medical Center)coreStrategic or Co-development Partner · 1 June 2023First-in-human clinical study conducted at Helsicore in Tbilisi, Georgia. Dr. Irakli Gogogorishvili performed the initial procedure. The center was selected for bringing the pulmonary artery denervation therapy to patients for the first time.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• SoniVie: SoniVie is an Israeli medical device company developing the TIVUS ultrasound-based system for pulmonary artery denervation (PADN) to treat pulmonary hypertension. It is Gradient's most direct competitor, employing a similar ultrasound-based minimally invasive catheter approach in the same clinical indication.
• Aria CV: Aria CV is developing an implantable device to treat pulmonary hypertension by restoring elastic recoil in the pulmonary artery. It targets the same WHO Group 1 and 2 PH patient population as Gradient, with a complementary but directly competing interventional approach.
• Pulnovo Medical: Pulnovo Medical is a Chinese medtech company developing a radiofrequency-based pulmonary artery denervation (PADN) system for pulmonary hypertension. It directly competes with Gradient in the PADN category, though it uses RF rather than ultrasound energy.

Broad incumbents

• United Therapeutics: United Therapeutics is an established biopharmaceutical company with a broad pulmonary hypertension drug franchise (Tyvaso, Remodulin, Orenitram). It represents the dominant incumbent treating PH pharmacologically, against which any device therapy like Gradient's must compete.
• Johnson & Johnson (Actelion): Johnson & Johnson, through its Janssen/Actelion franchise, markets leading pulmonary arterial hypertension therapies (Opsumit, Tracleer, Uptravi). As a broad incumbent in PH, J&J is a potential strategic acquirer of device-based PH therapies like Gradient's PADN system.
• Bayer (PH Franchise): Bayer markets Adempas (riociguat), the only FDA-approved drug for chronic thromboembolic pulmonary hypertension (WHO Group 4) and PAH. As a major cardiovascular pharma, Bayer is both a competitor for PH treatment share and a potential strategic acquirer.
• Medtronic: Medtronic markets the Symplicity renal denervation system and is the dominant incumbent in catheter-based denervation. With its strong interventional cardiology, heart failure, and pulmonary vascular portfolio, Medtronic is a potential strategic acquirer or competitor in the PADN space.
• Edwards Lifesciences: Edwards Lifesciences is a leading structural heart and critical care medical device company. Stanton Rowe (Gradient board member) was Edwards' former CSO and co-founded Percutaneous Valve Technologies (acquired by Edwards). Edwards is a logical strategic acquirer for catheter-based cardiovascular innovations like PADN.

Emerging players

• Recor Medical: Recor Medical is developing the Paradise ultrasound renal denervation system for hypertension, with pivotal data in progress. Recor shares Gradient's ultrasound denervation modality and could plausibly pivot its catheter platform to PADN if its renal indication succeeds.
• Shockwave Medical: Shockwave Medical developed intravascular lithotripsy for calcified coronary and peripheral artery disease, and was acquired by Johnson & Johnson. Shockwave shares the catheter-based intravascular energy delivery model and potential cardiovascular acquirer/strategic partner profile relevant to Gradient's commercialization path.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/gradient-denervation-technologies

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds3 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Gradient Denervation Technologies