Profoud Medical Corp. (PROF): Analyse du Pestle [Jan-2025 MISE À JOUR]

Dans le paysage rapide de la technologie médicale en évolution, Defound Medical Corp. (PROF) est à l'intersection de l'innovation et des défis mondiaux complexes. Cette analyse complète du pilon dévoile les forces externes à multiples facettes qui façonnent la trajectoire stratégique de l'entreprise, explorant comment les réglementations politiques, la dynamique économique, les besoins sociétaux, les progrès technologiques, les cadres juridiques et les considérations environnementales interviennent pour définir le potentiel de la croissance et la résilience de la technologie concurrentielle dans le secteur de la technologie médicale concurrentielle sectorie .

Profoud Medical Corp. (Prof) - Analyse du pilon: facteurs politiques

Paysage réglementaire en technologie médicale

Defound Medical Corp. opère dans un environnement réglementaire complexe régi par des processus d'approbation des dispositifs médicaux stricts dans plusieurs juridictions.

Corps réglementaire	Statut d'approbation	Exigences de conformité
FDA (États-Unis)	510 (k) effacé	Règlement sur les dispositifs médicaux de classe II
Santé Canada	Licence de dispositif médical	État de licence active de dispositif médical
Agence européenne des médicaments	Certification CE Mark	Conformité de la directive des dispositifs médicaux

Implications de la politique des soins de santé

Facteurs politiques clés affectant Defound Medical Corp.

• Politiques de remboursement des dispositifs médicaux au Canada et aux États-Unis
• Stratégies d'investissement technologique des soins de santé gouvernementaux
• Règlement sur les crédits de la recherche et du développement
• Accords commerciaux internationaux de la technologie médicale

Paysage du financement du gouvernement

Source de financement	Allocation annuelle	Focus de recherche
Instituts canadiens de recherche en santé	1,2 million de dollars	Innovation en technologie médicale
National Institutes of Health (USA)	2,5 millions de dollars	Technologies de traitement urologique

Conformité réglementaire internationale

Defound Medical Corp. maintient le respect des réglementations internationales des dispositifs médicaux dans plusieurs juridictions, assurant l'adhésion Normes de qualité et de sécurité strictes.

• ISO 13485: Certification du système de gestion de la qualité des dispositifs médicaux 2016
• Surveillance continue des changements réglementaires dans les marchés cibles
• Engagement proactif avec les autorités réglementaires

Profoud Medical Corp. (Prof) - Analyse du pilon: facteurs économiques

Tendances des dépenses de santé et cycles d'investissement en technologie médicale

Les dépenses mondiales de santé ont atteint 9,4 billions de dollars en 2022, avec une croissance prévue à 11,8 billions de dollars d'ici 2026. Les cycles d'investissement de la technologie médicale montrent des investissements annuels en capital-risque dans la technologie médicale à 16,3 milliards de dollars en 2023.

Année	Dépenses de santé mondiales	Investissements en technologie médicale
2022	9,4 billions de dollars	14,7 milliards de dollars
2023	10,1 billions de dollars	16,3 milliards de dollars
2024 (projeté)	10,8 billions de dollars	17,9 milliards de dollars

Fluctuations de taux de change

Tendances du taux de change CAD / USD: Le taux de change moyen en 2023 était de 1 CAD = 0,74 USD, avec une plage de volatilité entre 0,71 et 0,76 USD.

Période	Taux de change	Plage de volatilité
Q1 2023	1 CAD = 0,73 USD	0,71-0,75 USD
Q2 2023	1 CAD = 0,74 USD	0,72-0,76 USD
Q3 2023	1 CAD = 0,75 USD	0,73-0,77 USD

Marché de l'imagerie médicale et de la technologie thérapeutique

La taille du marché mondial de l'imagerie médicale était de 39,7 milliards de dollars en 2022, avec un TCAC projeté de 5,3% de 2023-2030.

Segment de marché	Valeur 2022	2030 valeur projetée	TCAC
Imagerie médicale	39,7 milliards de dollars	62,5 milliards de dollars	5.3%
Technologie thérapeutique	28,4 milliards de dollars	45,2 milliards de dollars	5.7%

Investissements d'infrastructure de soins de santé

L'investissement mondial des infrastructures de soins de santé a atteint 256 milliards de dollars en 2022, avec une croissance attendue à 342 milliards de dollars d'ici 2026.

Région	2022 Investissement	2026 Investissement projeté
Amérique du Nord	98 milliards de dollars	132 milliards de dollars
Europe	76 milliards de dollars	104 milliards de dollars
Asie-Pacifique	82 milliards de dollars	106 milliards de dollars

Profoud Medical Corp. (Prof) - Analyse du pilon: facteurs sociaux

Répondre aux besoins de diagnostic et de traitement médicaux croissants de la population

La population mondiale âgée de 65 ans et plus pour atteindre 1,5 milliard d'ici 2050, représentant 16,7% de la population totale. Les dépenses de santé pour la démographie des personnes âgées devraient atteindre 2,1 billions de dollars par an d'ici 2030.

Groupe d'âge	Projection de population	Dépenses de santé
65-74 ans	686 millions	987 milliards de dollars
75-84 ans	479 millions	672 milliards de dollars
85 ans et plus	335 millions	441 milliards de dollars

Demande croissante d'imagerie médicale non invasive et de technologies thérapeutiques

Un marché mondial d'imagerie médicale non invasive d'une valeur de 39,6 milliards de dollars en 2022, prévu atteinterait 62,3 milliards de dollars d'ici 2030, avec 5,7% de TCAC.

Technologie	Part de marché	Taux de croissance
IRM	28.5%	6.2%
Ultrason	22.3%	5.9%
Tomodensitométrie	19.7%	5.5%

Répondre aux préférences des patients pour des procédures médicales avancées et précises

La préférence des patients pour les procédures mini-invasives a augmenté de 73% entre 2015-2023. Le marché de la médecine de précision devrait atteindre 175 milliards de dollars d'ici 2028.

Type de procédure	Préférence des patients	Taux d'adoption
Peu invasif	68%	5,6% de croissance annuelle
Chirurgie robotique	42%	7,2% de croissance annuelle
Diagnostic de précision	55%	6,8% de croissance annuelle

Expansion potentielle du marché par la télémédecine et les capacités de diagnostic à distance

Le marché mondial de la télémédecine d'une valeur de 79,8 milliards de dollars en 2022, devrait atteindre 258,5 milliards de dollars d'ici 2030, représentant 16,5% de TCAC.

Segment de télémédecine	Valeur marchande 2022	Valeur marchande projetée 2030
Diagnostics à distance	24,3 milliards de dollars	87,6 milliards de dollars
Téléconsultation	35,5 milliards de dollars	112,4 milliards de dollars
Surveillance à distance	19,9 milliards de dollars	58,5 milliards de dollars

Profoud Medical Corp. (PROF) - Analyse du pilon: facteurs technologiques

Imagerie médicale avancée et technologies thérapeutiques

Profoud Medical Corp. a développé le système Tulsa-Pro® (transuréthral échlation par ultrasons), une technologie de thérapie focale de précision pour l'ablation des tissus de la prostate. En 2023, le système a été utilisé dans plus de 1 500 cas cliniques dans plusieurs pays.

Technologie	Caractéristiques	Métriques de performance
Système Tulsa-Pro®	Ablation échographique guidée par la MRI	95,3% Taux de réussite de la procédure
Surveillance de la température en temps réel	Ciblage de précision à moins de 1 mm	Précision de la température ± 1 ° C

Investissement de la recherche et du développement

Au cours de l'exercice 2022, Defound Medical a investi 8,3 millions de dollars dans la R&D, ce qui représente 42,5% du total des dépenses d'exploitation.

Année	Dépenses de R&D	Pourcentage des dépenses d'exploitation
2020	6,1 millions de dollars	38.2%
2021	7,2 millions de dollars	40.7%
2022	8,3 millions de dollars	42.5%

Intelligence artificielle et intégration d'apprentissage automatique

L'entreprise a développé des algorithmes améliorés par l'IA pour la planification du traitement, avec des capacités actuelles, notamment:

• Segmentation automatisée des lésions
• Optimisation de la zone de traitement
• Prédiction de réponse tissulaire en temps réel

Plateformes de traitement médical de précision

Les plates-formes technologiques de Defound Medical démontrent une grande précision dans les interventions médicales:

Plate-forme de traitement	Métriques de précision	Validation clinique
Traitement de la prostate Tulsa-Pro®	± 1 mm Précision de ciblage	FDA 510 (k) Autorisation en 2018
Thérapie focale guidée par la MRI	99,2% de précision d'ablation tissulaire	Validé dans 12 études cliniques

Profoud Medical Corp. (Prof) - Analyse du pilon: facteurs juridiques

Conformité aux exigences réglementaires strictes de dispositifs médicaux

Defound Medical Corp. maintient la conformité à plusieurs cadres réglementaires:

Corps réglementaire	Statut de certification	Détails de la conformité
FDA (États-Unis)	510 (k) Autorisation	Reçu pour l'appareil Tulsa-Pro® en septembre 2019
Santé Canada	Licence de dispositif médical	Autorisation des dispositifs médicaux de classe III
CE Mark (Union européenne)	Approuvé	Conformité pour le marketing de la technologie médicale

Protéger la propriété intellectuelle par le biais de brevets et d'innovations de recherche

Répartition du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Couverture géographique
Technologie Tulsa-Pro®	17 brevets accordés	États-Unis, Canada, Europe, Japon
Dispositifs thérapeutiques guidés par la MRI	9 demandes de brevet en instance	Traité international de coopération en matière de brevets (PCT)

Navigation des processus de certification des dispositifs médicaux internationaux complexes

Mesures internationales de conformité réglementaire:

• Coût de préparation de soumission réglementaire: 425 000 $ par an
• Équipe de gestion de la conformité: 6 professionnels dévoués
• Temps moyen pour la certification des appareils internationaux: 18-24 mois

Gérer les risques juridiques potentiels associés au développement de la technologie médicale

Métriques de gestion des risques juridiques:

Catégorie de risque	Stratégie d'atténuation	Investissement annuel
Responsabilité du produit	Assurance complète des dispositifs médicaux	1,2 million de dollars
Litige d'essai clinique	Conseil de conseiller juridique externe	$650,000
Conformité réglementaire	Systèmes de gestion de la qualité en cours	$475,000

Profoud Medical Corp. (Prof) - Analyse du pilon: facteurs environnementaux

Développer des solutions de technologie médicale soucieuse de l'environnement

Defound Medical Corp. a investi 3,2 millions de dollars dans la recherche sur les technologies vertes pour les dispositifs médicaux en 2023. L'objectif de réduction des émissions de carbone de la société est de 22% d'ici 2026.

Investissement technologique vert	Objectif de réduction du carbone	Budget de durabilité de la R&D
3,2 millions de dollars (2023)	22% d'ici 2026	1,7 million de dollars par an

Réduire l'empreinte carbone dans les processus de fabrication des dispositifs médicaux

La consommation d'énergie de fabrication réduite de 17,5% en 2023 grâce à des améliorations d'efficacité.

Réduction de la consommation d'énergie	Consommation d'énergie renouvelable	Réduction des déchets
17.5% (2023)	36% de l'énergie totale	12,3 tonnes métriques par trimestre

Mise en œuvre de pratiques durables dans la recherche et le développement

Des pratiques de R&D durables ont été mises en œuvre dans 4 installations de recherche, avec 1,1 million de dollars alloués aux technologies de laboratoire Green.

Installations de laboratoire vert	Investissement en R&D durable	Équipement écologique
4 centres de recherche	1,1 million de dollars	67% de l'équipement de laboratoire total

Alignement potentiel sur la technologie verte et les tendances de la durabilité des soins de santé

Defound Medical Corp. a identifié 3 partenariats clés de durabilité dans le secteur des technologies médicales.

Partenariats de durabilité	Initiatives technologiques vertes	Investissements de la conformité environnementale
3 partenariats stratégiques	5 projets technologiques verts en cours	Budget de conformité de 2,4 millions de dollars

Profound Medical Corp. (PROF) - PESTLE Analysis: Social factors

Growing patient demand for minimally invasive, organ-sparing prostate cancer treatments

You are seeing a clear, accelerating shift in patient preference toward treatments that spare vital functions, and this is a massive tailwind for Profound Medical Corp. (PROF). The TULSA-PRO system, which is an incision- and radiation-free procedure, directly addresses this demand by promising to preserve urinary continence and sexual function better than traditional surgical or radiation options.

This patient-driven demand is manifesting in Profound's financials. The company's revenue for the third quarter of 2025 soared 87% year-over-year to a record $5.3 million, largely thanks to this strong demand. More granularly, the utilization of existing TULSA-PRO systems is growing, with 'same store' procedure volumes up 10% sequentially from Q1 2025 to Q2 2025. This indicates that once a system is installed, patient flow is building quickly. Honestly, the demand for a better quality of life post-treatment is a powerful economic force.

Here's a quick look at the patient mix in Q3 2025, which shows the TULSA-PRO system is being used primarily for its core indication:

Patient Intention-to-Treat	Percentage of Procedures (Q3 2025)
Prostate Cancer only	79%
Hybrid (Cancer and Benign Prostatic Hyperplasia - BPH)	14%
Salvage Therapy	4.5%
BPH only	2.5%

Aging global population (especially in the US and Europe) increases the total addressable market for prostate treatments

The demographic reality of an aging population is the single most reliable long-term driver for the prostate cancer market. Prostate cancer is overwhelmingly a disease of older men, with risk increasing sharply after age 50. As life expectancy rises in the US and Europe, the total addressable market (TAM) for all prostate treatments, including TULSA-PRO, expands. The global prostate cancer therapeutics market is projected to be valued at approximately $12.9 billion in 2025, and is expected to grow at a Compound Annual Growth Rate (CAGR) of 8.5% through 2035.

This macro-trend provides a deep, structural foundation for Profound's growth. The North American market, which is a primary focus for TULSA-PRO, is a dominant region, with the overall prostate cancer market in the region anticipated to reach $6.17 billion by 2033. This massive and growing patient pool means that Profound is not fighting for a shrinking slice of the pie; the pie itself is getting bigger every year.

Urologist training and acceptance of new technology, like MRI-guided focused ultrasound, is a key adoption hurdle

While patient demand is strong, adoption of any new medical technology hinges on physician acceptance and workflow integration. For TULSA-PRO, which is a magnetic resonance imaging (MRI)-guided focused ultrasound system, this means urologists and interventional radiologists need to be trained and comfortable with the procedure. This is defintely a hurdle, but the company is showing progress on overcoming it.

The installed base is growing, with Profound aiming to have at least 75 TULSA-PRO units installed by the end of 2025, up from 70 in Q3 2025. The sales pipeline is also robust, with 93 new systems currently in the 'Verify, Negotiate and Contracting' stages. This shows institutions are committing capital, but training and integration still take time.

Key factors mitigating the training hurdle include:

• AI-driven treatment plans reduce planning time to as little as 30 minutes, improving workflow efficiency.
• Approximately 80% of procedures are now performed by a single urologist, indicating increasing specialist comfort.
• Positive initial perioperative data from the Level 1 CAPTAIN trial, presented at the American Urological Association (AUA) 2025, showed TULSA-PRO had statistically significant improvements in blood loss and length of stay compared to radical prostatectomy, which builds clinical confidence.

Public awareness campaigns about prostate health defintely drive early patient interest in TULSA-PRO

The shift from physician-led adoption to patient-led demand is a powerful social factor. Public awareness campaigns, especially those focusing on prostate health and the availability of minimally invasive options, are driving men to ask their doctors specifically about TULSA-PRO. Profound Medical has been proactive here, notably appointing former NFL player Leonard Wheeler as its Global Ambassador in June 2025 to advocate for the system.

The most concrete evidence of this patient-driven demand is the high rate of cash-pay procedures. Over 3,000 patients have been treated with cash payments of approximately $35,000 each for the procedure, demonstrating a willingness to pay out-of-pocket for the quality-of-life benefits. This is a strong signal that the message about TULSA-PRO's function-sparing attributes is resonating directly with the target audience.

Profound Medical Corp. (PROF) - PESTLE Analysis: Technological factors

You are looking at Profound Medical Corp. (PROF) and trying to figure out if their technology advantage is sustainable. The short answer is yes, for now, because their core platform is unique, but the real work is in the continuous, expensive software upgrades and the critical data coming from their head-to-head clinical trials.

TULSA-PRO's core strength is its unique, real-time, MRI-guided focused ultrasound (MRgFUS) technology.

The TULSA-PRO system's technological edge comes from its unique combination of real-time Magnetic Resonance Imaging (MRI) guidance with robotically-driven, directional transurethral ultrasound. This isn't just a gimmick; it's a closed-loop system that gives the physician pixel-by-pixel precision and real-time thermal feedback, actively protecting critical anatomy like the urethra and rectum. This allows for predictable, incision-free ablation of prostate tissue. The technology's versatility is a key selling point, allowing treatment for a broad spectrum of prostate disease. For instance, in the second quarter of 2025, the system was used for prostate cancer in 79% of cases, and for hybrid patients (cancer and BPH) in another 17%.

The company's installed base reached 70 systems as of September 30, 2025, and they expect to hit at least 75 installs by the end of 2025. That's a solid, growing footprint. You can't just drop this system into any clinic; it requires an MRI suite, which acts as a barrier to entry for competitors.

Competition from other focal therapies like high-intensity focused ultrasound (HIFU) and cryotherapy is intense.

While TULSA-PRO competes with other focal therapies like High-Intensity Focused Ultrasound (HIFU) and cryotherapy, the company is increasingly positioning the technology as a direct alternative to the gold-standard, radical treatments like robotic radical prostatectomy. That's a much bigger market. The TACT pivotal trial data already showed a favorable risk-benefit profile against whole-gland HIFU and cryotherapy. Honestly, the biggest competitive advantage in the US market right now is reimbursement.

Here's the quick math on the competitive reimbursement advantage for 2025:

Procedure	2025 Medicare National Average (Hospital)	TULSA-PRO Advantage
TULSA-PRO (CPT 55882)	$12,992	Baseline
Robotic Radical Prostatectomy	~$10,394	TULSA is 25% higher
PROCEPT BioRobotics' Aquablation (BPH)	~$9,214	TULSA is 41% higher

This higher reimbursement rate for TULSA-PRO, established by the U.S. Centers for Medicare and Medicaid Services (CMS) for 2025, makes it a financially more attractive option for hospitals than key competitors.

Continuous software and hardware upgrades are needed to maintain a competitive edge and improve procedure times.

The company must keep accelerating its research and development (R&D) to stay ahead. The platform is software-driven, so continuous innovation is defintely necessary. A great example of this is the launch of the TULSA-AI® Volume Reduction Module in 2025. This was a direct response to a clinical need-reducing procedure duration for Benign Prostatic Hyperplasia (BPH) patients-which expands the addressable market.

The need for this investment is clear in their financials. Operating expenses, which include R&D and sales expansion, totaled $12.8 million in Q3 2025 alone, demonstrating a significant commitment to ongoing technological development and commercialization.

• Launch new AI-powered modules to cut procedure time.
• Expand indications beyond prostate tissue ablation (e.g., uterine fibroids with Sonalleve®).
• Refine the user interface to improve clinical workflow efficiency.

Data from ongoing clinical trials (like the pivotal TACT trial) will be essential to validate long-term efficacy.

The TACT pivotal trial, which supported the FDA 510(k) clearance, already confirmed the technology's safety and efficacy. But the real game-changer is the ongoing CAPTAIN randomized trial, which directly compares TULSA-PRO to robotic radical prostatectomy. Initial perioperative data from CAPTAIN, presented in Q2 2025, showed TULSA provided statistically significant improvements in post-operative experience.

Specifically, the TULSA procedure showed:

• Elimination of blood loss.
• No overnight hospital stays required.
• Reduced post-procedure pain.
• Faster recovery to baseline activities.

Initial clinical outcomes data from this pivotal CAPTAIN trial is expected to be presented in December 2025. Positive, published data from a randomized trial like this could lead to new clinical guidelines, effectively requiring TULSA to be offered as a mainstream option alongside surgery and radiation.

Profound Medical Corp. (PROF) - PESTLE Analysis: Legal factors

Maintaining and Defending the Patent Portfolio

You can't build a disruptive medical device company like Profound Medical Corp. without a formidable intellectual property (IP) moat, but that moat is defintely expensive to maintain. The core asset, the TULSA-PRO technology, is protected by a global patent portfolio that requires constant monitoring, defense, and expansion to ward off competitors like EDAP and Insightec, who also offer prostate ablation systems. Here's the quick math: the cost to maintain this competitive edge is embedded in the company's Research and Development (R&D) expenditure, which includes patent procurement costs.

For the first three quarters of 2025, Profound Medical Corp.'s commitment to this technical and legal defense is clear in their operating expenses. R&D expenses alone were $4.808 million in Q1 2025 and part of the total operating expenses of $15.4 million in Q2 2025. This is a high-cost, non-negotiable legal effort. Losing a key patent could wipe out years of commercialization work, so this cost is effectively an insurance premium for the entire business model.

Strict Adherence to Global Medical Device Regulations

Selling a medical device globally means navigating a labyrinth of regulatory bodies, and there is no cutting corners. Profound Medical Corp. has successfully secured the necessary clearances, but maintaining them is an ongoing legal risk and compliance cost. The TULSA-PRO system is already recognized in key markets, which is a major commercial advantage, but the regulatory landscape is always shifting.

• U.S. Market: TULSA-PRO holds 510(k) clearance from the U.S. Food and Drug Administration (FDA).
• European Market: The system is CE marked, confirming its compliance with European health, safety, and environmental protection standards.
• Canadian Market: TULSA-PRO is also Health Canada approved.

The biggest near-term legal change is the European Union's Medical Device Regulation (MDR). While TULSA-PRO is CE marked, the transition to the new MDR rules is complex. For devices compliant with the older MDD, the CE marks will still be recognized in the UK until the earlier of June 30, 2028, or the certificate's expiration, which forces a compliance timeline for the new, stricter EU MDR.

Potential for Medical Malpractice Litigation

Any company introducing a new surgical procedure, even a minimally invasive one like Transurethral Ultrasound Ablation (TULSA), faces the persistent risk of medical malpractice litigation. This risk doesn't sit with Profound Medical Corp. directly, but with the hospitals and physicians using the TULSA-PRO system. Still, any perceived failure of the device or procedure can lead to product liability claims against the company, which could trigger costly defense and reputational damage.

The company mitigates this risk by designing TULSA-PRO to be highly controlled and predictable, actively protecting critical structures like the urethra and rectum to preserve patient function. Despite these design features, the risk remains and is amplified by the fact that the procedure is still relatively new compared to traditional prostatectomy or radiation. This risk is managed through extensive insurance policies and rigorous physician training, but a single high-profile case could negatively impact adoption rates, which is why the company must monitor clinical outcomes closely.

Data Privacy Laws (HIPAA) Governing Patient Data

The TULSA-PRO system is an AI-enhanced, MRI-guided technology, meaning it collects and processes Protected Health Information (PHI) from patients. This puts the company squarely under the legal umbrella of data privacy regulations, most notably the Health Insurance Portability and Accountability Act (HIPAA) in the U.S.

While Profound Medical Corp. is not a direct healthcare provider, they operate as a Business Associate to their customers-the hospitals and clinics-and must sign a Business Associate Agreement (BAA). The company has taken concrete action to address this legal exposure, completing an independent HIPAA compliance assessment as of November 2025. This compliance effort is critical for sales, especially to large hospital systems.

The security controls are detailed and mandatory:

• Data at rest is secured with AES-256 encryption.
• Data in transit uses TLS 1.2 or higher.
• Access is controlled via multi-factor authentication and role-based access controls.

They are also 'GDPR-Ready' for international compliance, plus they have ongoing security validation through independent SOC 2 Type II audits. This is a necessary, high-overhead compliance function.

Legal/Compliance Factor	2025 Financial/Statistical Data Point	Strategic Impact
Patent Portfolio Defense Cost	R&D Expense (Q1 2025): $4.808 million	High, recurring cost to maintain competitive moat against rivals.
U.S. Regulatory Status	TULSA-PRO is 510(k) cleared by the FDA.	Mandatory for commercial sales in the largest market.
EU Regulatory Status	TULSA-PRO is CE marked.	Requires ongoing compliance with complex, shifting EU MDR standards.
Data Privacy Compliance	Completed HIPAA compliance assessment in November 2025.	Enables BAA execution with U.S. healthcare providers and protects against massive fines.

Finance: Ensure the legal budget for 2026 accounts for the full transition to EU MDR requirements and increased patent defense activity as commercial adoption grows.

Profound Medical Corp. (PROF) - PESTLE Analysis: Environmental factors

Managing the lifecycle and disposal of complex medical equipment, including the MRI-compatible components.

The core environmental challenge for Profound Medical Corp. revolves around the full lifecycle management of its capital equipment, the TULSA-PRO system, and its single-use consumables. The capital equipment itself-the console and robotic components-has a long operational lifespan, which is a positive factor for lifecycle management compared to short-lived devices. As of Q3 2025, the installed base stands at 70 systems, with a projected increase to at least 75 by year-end 2025. This longevity reduces the frequency of major equipment disposal.

However, the system's reliance on a Magnetic Resonance Imaging (MRI) machine introduces a secondary environmental factor. Profound's co-sales agreement with Siemens Healthineers for the Magnetom Free.Max scanner is a strategic advantage here, as this specific MR scanner uses only 0.7 liters of liquid helium, significantly reducing the lifecycle and infrastructure costs associated with conventional superconducting MR scanners. This partnership helps mitigate the high environmental footprint traditionally associated with large imaging systems.

Hospital clients increasingly prioritize vendors with sustainable manufacturing and operational practices.

The market reality is that hospitals are now embedding sustainability into their procurement decisions. Data from 2025 shows that a striking 96% of healthcare organizations are actively integrating environmental criteria into their sourcing process. For Profound Medical Corp., this means the environmental profile of the TULSA-PRO procedure is a direct competitive factor, not just a compliance issue. The procedure's non-invasive, radiation-free nature offers a clear 'green' advantage over procedures like external beam radiation therapy.

Hospital procurement teams are looking for vendors who can demonstrate a lower carbon footprint across the supply chain. The fact that the U.S. healthcare sector contributes nearly 10% of the nation's total carbon emissions means any device that reduces the need for energy-intensive operating rooms (ORs) or minimizes biohazardous waste generation will be prioritized. The TULSA Procedure is an outpatient procedure, often performed in an MR suite, which is generally significantly less expensive to operate than an operating room (OR).

Energy consumption of the TULSA-PRO system and its reliance on MRI machines is a factor in hospital green initiatives.

The TULSA-PRO system's energy profile is dominated by the MRI machine it requires. While the TULSA-PRO console itself uses ultrasound energy, the main power draw comes from the imaging system. The strategic choice of partnering with low-helium MRI technology is a strong point for Profound Medical Corp. in the 2025 market.

Here's the quick math on the MRI component:

MRI Component Type	Liquid Helium Requirement	Environmental Impact
Conventional Superconducting MRI	Hundreds of liters	High lifecycle and operating cost; significant resource use.
Siemens Healthineers Magnetom Free.Max (Partnered)	Only 0.7 liters	Substantially reduced helium consumption, lowering environmental and infrastructure costs.

This low-field MRI strategy allows hospitals to reduce their reliance on a scarce resource (helium) and lower the overall energy and infrastructure burden, which directly aligns with their green initiatives.

Reducing waste from single-use components in the procedure is a minor but growing concern.

The TULSA Procedure, while incision-free, relies on several single-use (disposable) components, which contribute to the recurring revenue stream. In Q3 2025, recurring revenue, which includes these consumables, was $4.1 million.

The single-use components that must be disposed of after each treatment include:

• Transurethral ultrasound applicator
• Endorectal cooling device (ECD)
• Fluid circuit tube sets

While the overall waste volume is small compared to a complex open surgery, these components are classified as regulated medical waste, which is more expensive and complex to dispose of than general waste. This waste stream is a clear area for future product design and a potential risk, as hospitals are increasingly focused on eliminating single-use plastics and devices to reduce their environmental footprint.

If Profound defintely wants to maintain a competitive edge, developing a clear, documented end-of-life program for these consumables-perhaps a take-back or recycling program for the non-biohazardous components-is a necessary next step to satisfy the 96% of clients prioritizing sustainability.