SonaCare Medical

What SonaCare Medical does

SonaCare Medical (legal entity Sonablate Corp.) is a privately-held medical device company headquartered in Charlotte, North Carolina, founded in 2004 and operating with 51–100 employees. The company develops and commercializes Sonablate® HIFU, a High Intensity Focused Ultrasound system for minimally-invasive ablation of prostate tissue, positioning it as an alternative to the extremes of active surveillance, surgery, or radiation for localized prostate disease.

The Sonablate platform integrates real-time ultrasound imaging for intra-procedural visualization with proprietary safety monitoring features — Tissue Change Monitoring, Total Acoustic Power, and Reflexivity Index Monitoring — that provide automated real-time feedback to the performing physician. The device received FDA clearance for prostate tissue ablation and was the first focused ultrasound device to obtain this indication in the United States; it is also available in more than 50 countries worldwide.

SonaCare generates revenue through one-time hardware sales of the capital equipment to urologists, prostate cancer specialists, hospital urology departments, and ambulatory surgery centers. Pricing is quote-based and not publicly disclosed, with multi-year contract terms. Distribution is hybrid: direct enterprise field sales in the United States, supplemented by an international network of authorized distributors across 50+ countries. Marketing and demand-generation rely on a consultative model — including the "Build Your Program" initiative, a physician-led webinar series, presence at the AUA Annual Meeting, and multi-channel digital content — targeting healthcare institutions seeking to establish focal therapy programs.

Name

SonaCare Medical

Legal name

Sonablate Corp.

Website

https://sonacaremedical.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

51–100 employees

Short description

SonaCare Medical (Sonablate Corp.) is a Charlotte, NC-based medical device company that develops and sells Sonablate HIFU, an FDA-cleared high-intensity focused ultrasound system for minimally-invasive prostate tissue ablation, sold to urologists and healthcare institutions in 50+ countries.

Ownership category

akta.pro rank

Product category

Urology Medical Devices (HIFU / Focused Ultrasound)

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

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

akta.pro primary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

akta.pro secondary industries

Urologic Oncology (HLAKAOAB), Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH)

Keywords

• HIFU medical devices
• Prostate tissue ablation
• Focal therapy systems
• Urology medical equipment
• Focused ultrasound treatment

Headquarters

HQ city

Charlotte

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations, Others

Revenue model

1. Medical Device Sales: Sale of Sonablate HIFU device system to healthcare providers and urology practices. FDA-cleared medical device sold to hospitals, clinics, and specialized urology centers. Revenue is generated through one-time hardware sales with potential for service contracts and support.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

SonaCare Medical develops, manufactures, and commercializes the Sonablate HIFU system, an FDA-cleared High Intensity Focused Ultrasound medical device that ablates prostate tissue as a minimally-invasive alternative to surgery, radiation, or active surveillance. The system provides customizable focal therapy with robotic accuracy, real-time ultrasound imaging feedback, and multiple proprietary patient safety monitoring features, sold to hospitals, urology clinics, and ambulatory surgery centers.

Product overview

Sonablate® HIFU is a single unified medical device platform for prostate care. It provides a minimally-invasive alternative to active surveillance, surgery, or radiation through customizable focal therapy using high-intensity focused ultrasound technology. The system incorporates real-time ultrasound imaging for procedure guidance and multiple automated patient safety monitoring features (Tissue Change Monitoring, Total Acoustic Power, Reflexivity Index Monitoring). FDA-cleared in the United States for ablation of prostate tissue and available in more than 50 countries worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• Sonablate® HIFU: Minimally-invasive High Intensity Focused Ultrasound device for prostate tissue ablation. FDA-cleared for ablation of prostate tissue in the United States and available in more than 50 countries worldwide.

Products and services

• Sonablate HIFU FDA-cleared, minimally-invasive High Intensity Focused Ultrasound (HIFU) medical device for the ablation of prostate tissue, offering customizable focal therapy with robotic accuracy and real-time ultrasound feedback for urologists, prostate cancer specialists, hospitals, and ambulatory surgery centers.

Quantifiable outcome

• Patients treated using Sonablate HIFU showed good disease control in medium-term clinical studies

Named customers1 record

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• EDAP TMS S.A. French-listed medical device company that markets Focal One, a robotic HIFU platform for prostate tissue ablation. EDAP is Sonablate's most direct global competitor, offering a very similar product, indication, and physician customer base (urologists performing focal therapy).
• Profound Medical Corp. Toronto-based medical device company developing TULSA-PRO, a transurethral HIFU system for prostate tissue ablation. Profound competes head-to-head with Sonablate in the urology HIFU prostate ablation market using an MRI-guided approach.
• Insightec Ltd. Israel-based focused ultrasound company (Exablate platform) treating multiple indications including uterine fibroids and essential tremor. While not focused on prostate today, Insightec uses the same core MR-guided focused ultrasound technology and represents the closest technology peer in image-guided HIFU.
• Chongqing Haifu Medical Technology: Chinese medical device company specializing in HIFU systems for treating solid tumors and other conditions. Haifu is one of the pioneers of clinical HIFU and competes with Sonablate in the broader image-guided focused ultrasound ablation market, including urological applications.

Emerging players

• Theraclion S.A. French company developing HIFU systems (Echopulse) primarily for thyroid nodules and breast fibroadenomas. Theraclion shares Sonablate's core HIFU technology platform but targets different indications, making it an emerging adjacent peer.
• HistoSonics, Inc. U.S.-based company developing histotripsy, a non-invasive, non-thermal focused ultrasound platform for tissue destruction. While mechanistically different from thermal HIFU, HistoSonics targets the same physician and patient demand for non-invasive tissue ablation, including potential urological applications.
• Verathon Inc. (BK Medical): Specialty urology and airway imaging company (BK Medical) producing ultrasound systems used during urological procedures including prostate interventions. Verathon competes with Sonablate in the procedure-room imaging and urology visualization segment.

Broad incumbents

• AngioDynamics, Inc. U.S. medical device company with urology and oncology portfolios offering ablation and vascular access products. AngioDynamics competes in the broader urology treatment device market and overlaps with Sonablate in physician call points for prostate and oncology interventions.
• Boston Scientific Corporation: Large diversified medical device company with a significant urology and pelvic health franchise. Boston Scientific serves the same urologist customers with adjacent treatment modalities and represents a broad incumbent competitor in prostate cancer management.
• Siemens Healthineers AG: Global medical imaging OEM whose ultrasound systems are used to guide image-guided procedures including prostate interventions. Siemens competes broadly in the diagnostic imaging infrastructure used by urology departments alongside Sonablate's HIFU platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/sonacaremedical
• Facebookfacebook.com/sonacaremedical
• LinkedInlinkedin.com/company/sonacare-medical-llc-formerly-us-hifu-
• Instagraminstagram.com/sonablatecorp

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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 SonaCare Medical