Profound Medical
Profound Medical is a Canadian commercial-stage medical device company that develops MRI-guided, incision-free thermal ultrasound ablation systems (TULSA-PRO for prostate disease and Sonalleve for uterine fibroids and bone metastases) sold to hospitals and urology practices globally under a capital-plus-consumables model.
- Company typePublic
- Founded2008
- HeadquartersMississauga, Canada
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Profound Medical does
Profound Medical Corp. is a commercial-stage Canadian medical device company that develops and markets MRI-guided, incision-free thermal ultrasound ablation systems for tissue treatment. Founded in 2008 and headquartered in Mississauga, Ontario, the company is publicly listed on NASDAQ (PROF) and TSX (PRN) and operates offices in Canada, the United States, Germany, and Finland, serving hospitals and urology practices across North America, Europe, the Middle East, and Oceania.
The company's two core platforms are TULSA-PRO, a robotically-driven transurethral ultrasound ablation system that combines real-time MR imaging, directional ultrasound, and proprietary closed-loop temperature feedback control for radiation-free treatment of prostate cancer and benign prostatic hyperplasia, and Sonalleve, an MR-HIFU (high-intensity focused ultrasound) platform acquired from Philips in 2017 for incision-free treatment of uterine fibroids, bone metastases pain palliation, osteoid osteoma, and desmoid tumors. Both platforms leverage the company's patented closed-loop thermal feedback algorithm, invented by COO Mathieu Burtnyk, with regulatory clearances spanning FDA 510(k), CE marking, China FDA, and FDA HDE.
The business operates a capital equipment razor-and-razorblade model: hospitals purchase TULSA-PRO systems (78 installed globally as of end-2025) and generate recurring high-margin consumables and procedure revenue (70%+ gross margins on consumables). The company markets directly through North American sales teams and via distribution partnerships in Canada (regained from Knight Therapeutics in November 2025), Saudi Arabia, and Australia/New Zealand, alongside strategic co-sales alliances with Siemens Healthineers, Philips, and GE Healthcare that bundle TULSA-PRO with the dominant MRI installed bases. CPT Category 1 reimbursement codes became effective in January 2025, and the CAPTAIN randomized controlled trial reported statistical superiority of TULSA over robotic radical prostatectomy in functional preservation outcomes in March 2026, materially strengthening the clinical and commercial case for adoption.
Profound Medical firmographics
Firmographics- Name
- Profound Medical
- Legal name
- Profound Medical Corp.
- Website
- http://www.profoundmedical.com
- Company type
- Public
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Profound Medical is a Canadian commercial-stage medical device company that develops MRI-guided, incision-free thermal ultrasound ablation systems (TULSA-PRO for prostate disease and Sonalleve for uterine fibroids and bone metastases) sold to hospitals and urology practices globally under a capital-plus-consumables model.
- Ownership category
- akta.pro rank
Profound Medical industry classification
Industry- Product category
- MRI-Guided Medical Devices for Therapeutic Ablation
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- 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
- Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN), Ultrasound & Echography Systems (HLAHABAD)
Keywords
Where Profound Medical is headquartered
LocationHeadquarters
- HQ city
- Mississauga
- HQ country
- Canada
- HQ region
- North America
Offices4 records
Markets served
Profound Medical business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Supply Chain
Revenue model
- TULSA-PRO Capital Equipment Sales: Sale of TULSA-PRO systems to hospitals and medical facilities with MRI suites. Q4 2025 capital sales reached US$3.7M driving installed base to 78 systems globally.
- Procedure/Consumable Revenue: Razor-and-razorblade model with procedure revenue from disposables and consumables used in TULSA procedures. Gross margins exceeding 70% on consumables.
- Sonalleve Platform Sales: Sales of Sonalleve MR-HIFU systems for women's health (uterine fibroids) and oncology (bone metastases pain palliation) applications in markets where regulatory approved
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | TULSA-PRO System with 70%+ gross margin razor-and-razorblade model |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels7 records
Profound Medical product offering
Product offeringCore offering
Profound Medical develops and commercializes MRI-guided, incision-free tissue ablation systems. Its flagship TULSA-PRO® system uses real-time MR imaging combined with robotically-driven transurethral thermal ultrasound and closed-loop temperature feedback control to perform customizable, radiation-free ablation of prostate tissue for treating prostate cancer and BPH while preserving erectile function and urinary continence. The Sonalleve® MR-HIFU platform extends the same MRI-guided HIFU technology to incision-free treatment of uterine fibroids, adenomyotic tissue, osteoid osteoma, benign desmoid tumors, and palliative pain treatment of bone metastases. The company also offers AI-powered FDA-validated contouring software and operates a razor-and-razorblade business model with capital equipment sales complemented by high-margin (70%+) procedure consumables.
Product overview
Profound Medical develops and commercializes two core therapeutic platforms: TULSA-PRO® for men's health (prostate cancer and BPH treatment) and Sonalleve® for women's health and oncology (uterine fibroids and bone metastases pain palliation). Both platforms combine real-time MRI imaging, thermal ultrasound, and closed-loop temperature feedback control for radiation-free, incision-free tissue ablation. The TULSA-PRO system uses a transurethral (inside-out) approach while Sonalleve uses an external (outside-in) HIFU approach. The company also offers AI-powered contouring software tools for enhanced treatment planning and operates clinical evidence programs including the CAPTAIN randomized trial.
Differentiator
Problem solved
Functional benefit
Brands
- TULSA-PRO: MRI-guided, robotically-driven transurethral thermal ultrasound system for customizable and predictable radiation-free ablation of prostate tissue while protecting urethra and rectum to preserve natural functional abilities.
- Sonalleve
- TULSA Procedure
- PRO-Talk Academy
Products and services
- TULSA-PRO® MRI-guided, robotically-driven transurethral thermal ultrasound system for customizable, radiation-free ablation of prostate tissue. Combines real-time MR imaging, directional ultrasound, and closed-loop temperature feedback control for precise prostate cancer and BPH treatment while preserving natural functional abilities (erectile function and urinary continence). Treats prostates up to 250cc and supports up to 4 procedures per day. Sold to hospitals with MRI suites and urology practices, with high-margin consumables driving a razor-and-razorblade revenue model.
- Sonalleve® MR-HIFU Platform MR-HIFU (Magnetic Resonance-guided High Intensity Focused Ultrasound) platform for incision-free ablation of uterine fibroids, adenomyotic tissue, and palliative treatment of bone metastases pain. Uses external ultrasound delivery through intact skin with real-time MRI temperature monitoring and control. Also indicated for treatment of osteoid osteoma (U.S. FDA HDE) and management of benign desmoid tumors (EU CE marked). Sold to women's health centers, oncology centers, and hospitals with MRI suites.
- AI-Powered Contouring Tools FDA-validated AI software tools for automated treatment planning and contouring in TULSA procedures, enabling more efficient and consistent physician workflow as a software add-on to TULSA-PRO.
Quantifiable outcome
- 50% of patients preserved both erectile function and urinary continence at 6 months vs 24% for robotic radical prostatectomy (CAPTAIN trial, 211 patients)
- +5 more outcomes
Companies that use Profound Medical
Customer profileNamed customers3 records
Segments2 records
Ideal customer profiles2 records
Profound Medical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature5 records
Profound Medical partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered minor and core.
- Telix PharmaceuticalsminorLetters of intent to pursue collaboration on use of PSMA-PET imaging agents (Gozellix and Illuccix) with MRI-guided TULSA procedures. Focus on patient selection, treatment planning, and post-treatment monitoring. Initiative aims to accelerate adoption of novel therapeutic workflows and generate clinical evidence for personalized prostate cancer care.
- Knight Therapeutics Inc.minorFormer exclusive Canadian distributor agreement (April 2015 - November 2025) ended as Knight refocused on pharmaceuticals. Profound paid CDN$90,000 (US$64,000) one-time payment plus 5% royalty on Canadian Net Sales for 15 years. Profound regained exclusive distribution rights effective November 2025.
- Siemens HealthineerscoreDefinitive co-sales and co-marketing agreement to commercialize combined MRI-guided prostate therapy solution pairing Profound's TULSA-PRO system with Siemens Healthineers' Magnetom Free.Max MR scanner. Companies expect to initiate sales of 'total prostate solution' in 2025 pending compatibility testing. CMS placement at Urology APC Level 7 supports economic case for adoption.
- GE HealthcareminorStrategic agreement to expand provider access to TULSA-PRO (December 2020). Partnership for market access with GE's diagnostic imaging installed base.
- Royal PhilipscoreDefinitive agreement to expand collaboration and acquire Sonalleve MR-HIFU business (June 2017). Philips previously partnered on sales/marketing (2016) and joint development (2015). Sonalleve table designed compatible with Philips MRI systems.
- Siemens (Strategic Agreement)coreStrategic agreement with Siemens to further development of prostate cancer care (February 2016). Forms foundation for ongoing collaboration leading to 2024 co-sales agreement.
Scale indicators11 records
Recent moves6 records
Expansion highlights6 records
Profound Medical competitors and assessment
Company assessmentDirect peers
- EDAP TMS: EDAP TMS offers Focal One, a robotic HIFU platform for prostate tissue ablation, making it the most direct competitor to Profound's TULSA-PRO. Both companies target localized prostate cancer with non-invasive/incision-free ablation workflows and compete on similar clinical outcomes and reimbursement positioning.
- InSightec: InSightec markets ExAblate, an MR-guided focused ultrasound system for uterine fibroids, bone metastases pain palliation, and other indications — directly comparable to Profound's Sonalleve MR-HIFU platform. Both companies are the two principal players in clinical MR-guided HIFU worldwide.
Broad incumbents
- Intuitive Surgical: Intuitive Surgical's da Vinci robotic platform is the dominant treatment for radical prostatectomy — the comparator arm in Profound's CAPTAIN trial. While not a direct ablation competitor, it is the incumbent modality TULSA-PRO must displace in urology purchasing decisions and clinical guidelines.
- Stryker Corporation: Stryker acquired Profound CEO Arun Menawat's previous company (Novadaq Technologies) for ~$701M, giving it fluoroscopic imaging and surgical visualization. Stryker is a broad interventional/surgical device incumbent whose urology, ENT, and surgical visualization portfolios overlap with Profound's hospital call points.
- Boston Scientific: Boston Scientific has a large urology and pelvic health franchise (formerly Endo Pharmaceuticals/AMS) competing for the same hospital budgets and urology practice mindshare as TULSA-PRO. As a broad medtech incumbent, it offers alternative BPH and prostate treatment options and adjacent capital equipment.
- Hologic: Hologic is a leader in women's health, including fibroid treatment (Acessa / Sonata radiofrequency ablation) and gynecologic surgical offerings. It overlaps directly with Sonalleve's uterine fibroid indication and competes for the same gynecology purchasing channels.
- Medtronic: Medtronic is a broad medtech incumbent with significant urology, surgical, and ablation portfolios (e.g., Emprint, Cool-tip RF ablation, InterStim). It competes for hospital capital equipment budgets and ablation procedure share across overlapping indications.
Emerging players
- AngioDynamics: AngioDynamics offers NanoKnife irreversible electroporation and other ablation technologies used in urology and oncology. It competes for the same focal/partial ablation procedures as TULSA-PRO in prostate and other soft-tissue indications, though with a different energy modality.
- CONMED: CONMED offers electrosurgical, ablation, and general surgery instruments used in urology and other specialties. While smaller in scale than the broad incumbents, it provides alternative energy-based tissue ablation devices that compete for the same hospital capital and procedure budgets.
- Merit Medical Systems: Merit Medical provides interventional radiology and oncology products, including ablation and image-guided therapy accessories. It is a relevant adjacent peer selling into the same interventional radiology and oncology hospital call points as TULSA-PRO and Sonalleve.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Profound Medical social profiles
Digital presenceProfound Medical compliance and trust
Trust signalCompliance5 records
Profound Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
Profound Medical leadership team
Management profileNumber of profiles
Profiles9 records
Profound Medical funding detail
Funding detailFunding overview
Funding rounds15 records
Investors14 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Profound Medical M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Profound Medical
What does Profound Medical do?
Profound Medical develops and commercializes MRI-guided, incision-free tissue ablation systems. Its flagship TULSA-PRO® system uses real-time MR imaging combined with robotically-driven transurethral thermal ultrasound and closed-loop temperature feedback control to perform customizable, radiation-free ablation of prostate tissue for treating prostate cancer and BPH while preserving erectile function and urinary continence. The Sonalleve® MR-HIFU platform extends the same MRI-guided HIFU technology to incision-free treatment of uterine fibroids, adenomyotic tissue, osteoid osteoma, benign desmoid tumors, and palliative pain treatment of bone metastases. The company also offers AI-powered FDA-validated contouring software and operates a razor-and-razorblade business model with capital equipment sales complemented by high-margin (70%+) procedure consumables.
Is Profound Medical a public or private company?
Profound Medical is a public company. It is classified as public and is currently operating.
When was Profound Medical founded?
Profound Medical was founded in 2008. It employs 101 to 250 people.
Where is Profound Medical based?
Profound Medical is headquartered in Mississauga, Canada, in the North America region.
How does Profound Medical make money?
Three revenue lines are on record. TULSA-PRO Capital Equipment Sales are the primary driver. The others are procedure/Consumable Revenue and sonalleve Platform Sales.
Who are Profound Medical's main competitors?
Direct peers on record are EDAP TMS and InSightec. Broad incumbents are Intuitive Surgical, Stryker Corporation, Boston Scientific, Hologic and Medtronic. Emerging players are AngioDynamics, CONMED and Merit Medical Systems.
Does Profound Medical have an API?
No public API is recorded for Profound Medical.
What industry is Profound Medical in?
Profound Medical's product category is MRI-Guided Medical Devices for Therapeutic Ablation. Its primary akta.pro industry code is HLAHABAG, Interventional Radiology & Image-Guided Therapy Systems, with a secondary code of HLAHADAN, Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools). Its NAICS code is 334510 and its SIC code is 3841.