US High Intensity Focused Ultrasound

What US High Intensity Focused Ultrasound does

Sonablate Corp. (operating under the legacy name US High Intensity Focused Ultrasound / US HIFU and doing business as Sonablate HIFU) is a privately held medical device company headquartered in Charlotte, North Carolina, founded in 2004. The company develops and commercializes the Sonablate® HIFU system, a high-intensity focused ultrasound platform for minimally-invasive ablation of prostate tissue. The device provides real-time ultrasound imaging feedback to the performing physician and integrates proprietary patient safety features — Tissue Change Monitoring, Total Acoustic Power, and Reflexivity Index Monitoring — that enable customizable focal therapy with robotic precision and no incisions. Sonablate HIFU was the first focused ultrasound device to receive FDA clearance in the United States for the ablation of prostate tissue and is available in more than 50 countries worldwide.

The company generates revenue primarily through hardware sales of the Sonablate system to healthcare institutions, urology practices, and qualified physicians, with distribution handled through a combination of direct enterprise sales and a global distributor network. Its go-to-market motion is enterprise-focused, targeting urologists and prostate cancer specialists through conference presence (notably the American Urological Association annual conference), a physician webinar series for focal therapy program development, and educational content marketing aimed at supporting hospitals in building new focal therapy programs. Primary customer segments are urologists/prostate cancer specialists and healthcare institutions, with prostate cancer patients served as an indirect downstream user.

The business is small in scale (11–50 employees), has completed at least one disclosed financing round of $5 million in 2009 led by MMV Capital Partners, and has no disclosed AI/ML capabilities, no recurring software or consumables revenue stream, and no current visibility into recent revenue, headcount, or funding activity beyond what is stated above. The core competitive positioning rests on regulatory first-mover status, proprietary safety monitoring features, and an established international distribution footprint.

Name

US High Intensity Focused Ultrasound

Legal name

Sonablate Corp.

Website

https://sonacaremedical.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

51–100 employees

Short description

Sonablate Corp., doing business as Sonablate HIFU, is a Charlotte, NC-based medical device company that develops and sells the Sonablate® HIFU system — the first FDA-cleared focused ultrasound device for prostate tissue ablation — to urologists and healthcare institutions across more than 50 countries.

Ownership category

akta.pro rank

Product category

Prostate Ablation Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

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

akta.pro primary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

Keywords

• HIFU medical devices
• Prostate tissue ablation
• Focal therapy systems
• Urology equipment
• Minimally invasive 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

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

Revenue model

1. Medical Device Sales: Sale of Sonablate HIFU medical device system for prostate tissue ablation. Federal (USA) law restricts device to sale by or on the order of a physician. The device is sold directly to healthcare institutions and urology practices for use in treating patients with prostate conditions.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Sonablate Corp. (operating under US High Intensity Focused Ultrasound / SonaCare Medical) manufactures and sells the Sonablate® HIFU medical device, a minimally-invasive system that uses High Intensity Focused Ultrasound for the ablation of prostate tissue. The device provides real-time ultrasound feedback to the performing physician and integrates proprietary safety features including Tissue Change Monitoring, Total Acoustic Power, and Reflexivity Index Monitoring, enabling customizable focal therapy with robotic accuracy. It is the first focused ultrasound device to receive FDA clearance for prostate tissue ablation in the United States and is distributed to healthcare institutions and physicians in more than 50 countries.

Product overview

Sonablate Corp offers the Sonablate® HIFU system, a single unified medical device platform for minimally-invasive prostate tissue ablation. The system provides focal therapy with robotic accuracy, real-time ultrasound imaging feedback, and multiple safety monitoring features. Sonablate® HIFU is FDA-cleared in the United States for ablation of prostate tissue and is available in more than 50 countries worldwide.

Differentiator

Problem solved

Functional benefit

Products and services

• Sonablate® HIFU A minimally-invasive medical device for prostate tissue ablation using High Intensity Focused Ultrasound. The system delivers customizable focal therapy with robotic accuracy, provides real-time ultrasound feedback to the performing physician, and incorporates multiple patient safety features including Tissue Change Monitoring, Total Acoustic Power, and Reflexivity Index Monitoring. It is sold to healthcare institutions and by or on the order of a qualified physician for the treatment of patients with prostate conditions.

Quantifiable outcome

• Good disease control in medium-term for patients treated using Sonablate HIFU

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Global DistributorscoreChannel Partner/ Reseller/ DistributorInternational distribution network spanning over 50 countries where Sonablate HIFU is available. These distributors facilitate local sales and support for the medical device in their respective regions.

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Accuray: Developer of CyberKnife and TomoTherapy radiation therapy systems used in prostate cancer treatment. A broader incumbent offering an alternative standard-of-care modality (radiation) that competes against HIFU for the same urology patient population and hospital capital budgets.
• AngioDynamics: Medical device company with a portfolio spanning vascular access, oncology, and surgical/urology procedures. A broader incumbent with sales reach into the same hospital and urology accounts where Sonablate competes for capital equipment budget.
• Varian (Siemens Healthineers): Major radiation oncology and proton therapy incumbent serving prostate cancer patients. Competes with Sonablate HIFU for the same urology customer base as the dominant radiation therapy alternative, with substantially broader portfolio and resources.
• Intuitive Surgical: Developer of the da Vinci robotic surgical system, widely used for radical prostatectomy. Competes with Sonablate HIFU as the dominant minimally-invasive alternative for prostate cancer treatment and sets the clinical standard against which focal therapy must justify adoption.

Emerging players

• Insightec: Developer of MR-guided focused ultrasound (Exablate Neuro, Exablate Body) for non-invasive tissue ablation. A focused-ultrasound peer with adjacent technology and overlapping clinical ambitions in image-guided therapy, but currently focused on brain and other indications rather than competing directly in prostate.
• Theraclion: French developer of the Echopulse HIFU platform for thyroid, breast, and varicose vein applications. A focused-ultrasound peer using the same core technology modality in different clinical indications, illustrating the broader HIFU competitive landscape.
• HistoSonics: US-based developer of histotripsy (non-thermal focused ultrasound) platforms for liver and kidney tissue ablation. A next-generation focused-ultrasound peer expanding the modality into new organs, with potential future overlap in urology applications.
• Koelis: Developer of MRI/ultrasound fusion-guided prostate biopsy and treatment planning systems. A prostate-focused imaging and guidance peer addressing overlapping urologist workflows and building complementary technology for the same focal therapy ecosystem.

Direct peers

• Profound Medical: Developer of the TULSA-PRO system, a transurethral ultrasound ablation device for prostate tissue. Competes head-to-head with Sonablate HIFU in focal therapy for prostate cancer, addressing the same urologist customer segment with a similar image-guided ablation approach.
• EDAP TMS: French-listed developer of the Focal One and Ablatherm HIFU systems for prostate tissue ablation. Direct competitor to Sonablate in the same FDA-cleared HIFU prostate indication, with overlapping urology customer base and similar capital equipment business model.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xx.com/sonablatecorp
• Facebookfacebook.com/Sonablate
• LinkedInlinkedin.com/company/sonablatecorp
• Instagraminstagram.com/sonablatecorp

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds2 records

Investors2 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 US High Intensity Focused Ultrasound