The most oversold stocks in the health care sector presents an opportunity to buy into undervalued companies.Here's the latest list of major oversold players in this sector, having an RSI near or below 30.Inspire Medical Systems Inc (NYSE:INSP)Profound Medical Corp (NASDAQ:PROF)         Biomarin Pharmaceutical Inc (NASDAQ:BMRN)Learn more about BZ Edge Rankings—click to see scores for other stocks in the sector and see how they compare.Photo via Shutterstock ...

The most oversold stocks in the health care sector presents an opportunity to buy into undervalued companies.Here's the latest list of major oversold players in this sector, having an RSI near or below 30.Inspire Medical Systems Inc (NYSE:INSP)Profound Medical Corp (NASDAQ:PROF)         Biomarin Pharmaceutical Inc (NASDAQ:BMRN)Learn more about BZ Edge Rankings—click to see scores for other stocks in the sector and see how they compare.Photo via Shutterstock ...

Core Insights - Profound Medical Corp. announced the superiority of the TULSA Procedure over robotic radical prostatectomy (RP) in terms of primary safety endpoints in the CAPTAIN trial for men with intermediate-risk prostate cancer [1][5] Group 1: CAPTAIN Trial Overview - The CAPTAIN trial exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aimed to compare the safety and efficacy of the TULSA Procedure with RP, focusing on preserving erectile function and urinary continence [8] Group 2: Clinical Outcomes - At 6 months post-treatment, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, indicating a statistically significant improvement (p<0.05, risk ratio 2.1) [5] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [5] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [5] Group 3: Perioperative Measures - TULSA demonstrated zero blood loss during the procedure, while RP had an average blood loss of 150 mL (p<0.001) [5] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP (p<0.05) [5] - There were significantly fewer serious complications requiring hospitalization after TULSA (0.7%) compared to RP (6.3%) within 90 days (p<0.05) [5] Group 4: Future Implications - The CAPTAIN trial is positioned to potentially establish the TULSA Procedure as a standard of care for prostate cancer treatment, with secondary oncologic outcomes expected later this year [6][8] - The trial's design allows for a rigorous comparison of safety, quality of life, and oncological control between the two treatment modalities [6]

Core Insights - The CAPTAIN trial demonstrates that the TULSA Procedure shows significant improvement over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence at 6 months post-treatment [1][3][5] Group 1: Trial Overview - CAPTAIN trial successfully exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aims to compare the safety and efficacy of the TULSA Procedure with RP in men with localized, intermediate-risk prostate cancer [7] Group 2: Clinical Outcomes - At 6 months, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, with a statistically significant p-value of <0.05 [3] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [3] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [3] Group 3: Perioperative Measures - TULSA showed zero blood loss compared to 150 mL after RP, with a significant p-value of <0.001 [3] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP [3] Group 4: Complications and Safety - The rate of serious complications within 90 days was significantly lower for TULSA at 0.7% compared to 6.3% for RP [3] - No patients required ICU admission after TULSA, while 1.6% did after RP [3] Group 5: Future Outlook - Secondary oncologic outcomes from the TULSA Procedure are expected to be reported later this year, which will provide further insights into its efficacy [4][5] - The trial positions the TULSA Procedure as a potential standard of care in prostate cancer treatment, pending further results [5][6]

Core Insights - Profound Medical Corp. is set to present the first clinical outcomes from the Level 1 post-market CAPTAIN trial, comparing the TULSA Procedure™ with robotic radical prostatectomy for localized prostate cancer at the EAU 2026 Congress on March 13, 2026 [1][2] Company Overview - Profound Medical Corp. is a commercial-stage medical device company specializing in AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [1][5] - The company's flagship platform, TULSA-PRO, allows for precise, incision-free prostate therapy, enabling real-time treatment confirmation and personalized strategies for prostate care [6] - Profound also offers Sonalleve, an MRI-guided therapy for non-surgical treatment of various conditions, including pain palliation for bone metastases and gynecologic issues [7] Upcoming Events - A press release summarizing the CAPTAIN presentation will be issued after the event, followed by an investor webinar at 11:30 a.m. EDT on March 13, 2026, where Dr. Klotz will discuss the clinical relevance of the data [3][4] - Profound management will participate in one-on-one investor meetings at the 38th Annual Roth Conference from March 22-24, 2026 [4] Market Approval - Profound's technologies, including TULSA-PRO and Sonalleve, are approved in major global markets, including the United States, Europe, Canada, and several other countries [8][9]

Core Insights - Profound Medical is set to present the first clinical outcomes from the CAPTAIN trial ahead of schedule at the EAU meeting, which could influence reimbursement decisions for their technology [1][5][8] - The company reported a 43% year-over-year increase in Q4 2025 revenue, totaling $6.0 million, but experienced a decline in gross margin to 67% [2][3][6] - Profound Medical aims to achieve over 70% recurring revenue and profitability in the $80–85 million revenue range, supported by a growing number of TULSA-PRO sites and a new BPH software module [4][16][18] Clinical Developments - The CAPTAIN trial, a multicenter randomized controlled trial, has completed recruitment and treatments, with imminent data on primary safety and quality-of-life endpoints to be presented [1][5][7] - Key endpoints include urinary incontinence rates, 90-day hospital readmissions, and time to return to work, which are critical for assessing the technology's efficacy [9][12] Financial Performance - In Q4 2025, Profound Medical reported a net loss of CAD 8.2 million, compared to a loss of CAD 4.9 million in the previous year, with cash on hand amounting to CAD 59.7 million [2][6] - Operating expenses remained stable at approximately CAD 11.4 million, indicating controlled spending despite the net loss [2] Commercial Strategy - The company ended 2025 with 78 TULSA-PRO sites and a pipeline of 110 systems, indicating strong commercial traction [4][10] - Profound Medical has confirmed Category I CPT reimbursement for 2026, enhancing its reimbursement pathway and engaging private insurers for broader coverage [11][12] Market Expansion - The introduction of a new AI software module for benign prostatic hyperplasia (BPH) is expected to significantly expand the addressable market, potentially tripling it by adding 400,000 patients annually [18][19] - International distribution agreements have been signed in Saudi Arabia and Australia, with a cautious approach to market entry through distributors rather than direct sales [19][20]

Financial Data and Key Metrics Changes - For Q4 2025, the company recorded revenue of $6 million, a 43% increase from CAD 4.2 million in Q4 2024, with $2.3 million from recurring revenue and $3.7 million from one-time capital equipment sales [4][5] - Gross margin in Q4 2025 was 67%, down from 71% in Q4 2024, primarily due to product mix and introductory pricing in new markets [5] - The net loss for Q4 2025 was CAD 8.2 million or CAD 0.27 per share, compared to a net loss of approximately CAD 4.9 million or CAD 0.20 per share in Q4 2024 [5][6] Business Line Data and Key Metrics Changes - The company had 78 TULSA-PRO sites as of December 31, 2025, with a growing sales pipeline of 110 new systems in various stages of the sales process [21] - The TULSA-PRO system is seeing broader adoption across both academic and community hospitals, driven by increased awareness of its clinical benefits and established reimbursement pathways [22] Market Data and Key Metrics Changes - TULSA reimbursement was confirmed for 2026 at Urology level seven, with expectations for private insurance coverage decisions in the second half of 2026 [22][24] - The company is experiencing significant interest in image-guided interventions, which is expected to drive growth [24] Company Strategy and Development Direction - The company aims to establish TULSA as a third distinct category in prostate cancer treatment, capable of treating the whole gland or specific regions while minimizing side effects [27][28] - Strategic partnerships are being developed globally, with recent agreements in Saudi Arabia and Australia already yielding sales [25][26] - The introduction of the TULSA-AI Volume Reduction module is expected to enhance BPH treatment efficiency and expand the total addressable market significantly [35][44] Management's Comments on Operating Environment and Future Outlook - Management believes the company is on a path to profitable growth, with expectations of declining cash burn and eventual cash flow positivity as revenues grow [6][24] - The company anticipates high double-digit to low triple-digit revenue growth in 2026, supported by the expansion of TULSA-PRO sites and increased procedure volumes [24][46] Other Important Information - The CAPTAIN trial, a significant clinical study, is expected to provide important data that could accelerate reimbursement timelines and enhance the credibility of TULSA [9][76] - The company is also exploring opportunities with its Sonalleve technology, which is being used for various treatments, including for uterine fibroids and pancreatic cancer [42][43] Q&A Session Summary Question: Update on private payers and reimbursement - Management reported that the number of patients going through private payers is increasing, with typical payments between 1.5 to 2.5 times Medicare rates, and over 90% of rejections are being tracked for potential reversals [48][49] Question: Dynamics of non-capital revenue decline - Management noted that while there was a sequential decline in non-capital revenue, overall usage is increasing, and the mix is expected to shift towards recurring revenue as the install base grows [54][60] Question: Expectations for 2026 revenue growth - Management did not provide specific guidance but indicated confidence in achieving high double-digit to low triple-digit growth, with an expected increase in the number of sites [66][70] Question: Progress on TULSA installations - Management confirmed that installations are progressing well, with expectations for increased installations throughout the year [84] Question: BPH module usage - At least 10 sites are currently using the BPH module, with expectations for rapid growth in usage by mid-year [91] Question: International expansion progress - Management highlighted increased attention in international markets and the signing of distributor agreements to facilitate growth [92]

Financial Data and Key Metrics Changes - For Q4 2025, the company recorded revenue of $6 million, a 43% increase from CAD 4.2 million in the same period last year [4][5] - Gross margin in Q4 2025 was 67%, down from 71% in Q4 2024, primarily due to product mix and introductory pricing in new markets [5][6] - The net loss for Q4 2025 was CAD 8.2 million or CAD 0.27 per share, compared to a net loss of CAD 4.9 million or CAD 0.20 per share in Q4 2024 [6] Business Line Data and Key Metrics Changes - Recurring revenue for Q4 2025 was $2.3 million, while one-time sales of capital equipment accounted for $3.7 million [4] - The company had 78 TULSA-PRO sites as of December 31, 2025, with a growing sales pipeline of 110 new systems in various stages of the sales process [22] Market Data and Key Metrics Changes - The company is seeing broader adoption of TULSA-PRO across both academic and community hospitals, driven by increased awareness of clinical benefits and established reimbursement pathways [22][24] - TULSA reimbursement was confirmed for 2026 at Urology level 7, with expectations for private insurance coverage decisions in the second half of 2026 [24] Company Strategy and Development Direction - The company aims to establish TULSA as a third distinct category in prostate cancer treatment, capable of treating the whole gland or specific regions while minimizing side effects [28][29] - Strategic partnerships with distributors in Saudi Arabia and Australia are expected to enhance market presence and sales [26][27] - The introduction of the TULSA-AI Volume Reduction module is anticipated to streamline BPH treatment and expand the total addressable market significantly [36][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitable growth, projecting a path to cash flow positivity as revenues grow and margins remain high [7][25] - The company expects to reach high double-digit to low triple-digit revenue growth in 2026, supported by new clinical data and product offerings [25][47] Other Important Information - The CAPTAIN trial, a significant clinical study, is set to present its first outcomes at the European Association of Urology meeting, which may influence reimbursement timelines [15][76] - The company is also exploring opportunities with its Sonalleve technology for treating conditions like adenomyosis and pancreatic cancer [43][44] Q&A Session Summary Question: Update on private payers and reimbursement - Management reported that the number of patients going through private payers is increasing, with typical payments between 1.5 to 2.5 times Medicare rates, and over 90% of rejections are being tracked for potential reversals [49][50] Question: Dynamics of non-capital revenue decline - Management noted that while there was a sequential decline in non-capital revenue, overall usage is increasing, and the mix is expected to shift towards recurring revenue as the install base grows [55][56] Question: Expectations for 2026 revenue growth - Management did not provide specific guidance but indicated confidence in achieving a range of 90% to 110% growth based on the number of new sites and product offerings [66][71] Question: Progress on TULSA installations - Management confirmed that installations are progressing well, with expectations for increased installations in the first quarter and throughout the year [85] Question: Use of the BPH module - At least 10 sites are currently using the BPH module, with expectations to increase to 30-40 sites by mid-year [92] Question: International expansion progress - Management highlighted growing interest in international markets and recent distributor agreements, with introductory pricing aimed at facilitating market entry [93]

Financial Data and Key Metrics Changes - For Q4 2025, the company recorded revenue of $6 million, a 43% increase from CAD 4.2 million in Q4 2024 [4][5] - Gross margin in Q4 2025 was 67%, down from 71% in Q4 2024, primarily due to product mix and introductory pricing in new markets [5] - The net loss for Q4 2025 was CAD 8.2 million or CAD 0.27 per share, compared to a net loss of CAD 4.9 million or CAD 0.20 per share in Q4 2024 [5][6] - As of December 31, 2025, the company had cash of $59.7 million, with expectations of declining cash burn and eventual cash flow positivity [6] Business Line Data and Key Metrics Changes - Recurring revenue for Q4 2025 was $2.3 million, while one-time sales of capital equipment accounted for $3.7 million [4] - The company had 78 TULSA-PRO sites as of December 31, 2025, with a growing sales pipeline of 110 new systems [20] Market Data and Key Metrics Changes - The company is seeing broader adoption of TULSA-PRO across both academic and community hospitals, driven by increased awareness of clinical benefits and established reimbursement pathways [20] - TULSA reimbursement was confirmed for 2026 at Urology level 7, with expectations of coverage decisions from private insurance carriers in the second half of 2026 [21] Company Strategy and Development Direction - The company aims to establish TULSA as a third distinct category in prostate cancer treatment, offering both whole-gland and focal treatment options [25][26] - The strategy includes focusing on existing MR installations and achieving an install base of 200 TULSA-PRO sites, with plans for compatibility with new Siemens interventional MR technology [37] - The introduction of the TULSA-AI Volume Reduction module is expected to enhance BPH treatment efficiency and expand the total addressable market [33][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving high double-digit to low triple-digit revenue growth, supported by upcoming catalysts and a strong sales pipeline [22][43] - The company is on a path to profitable growth, with projections indicating that revenues of $80 million to $85 million could lead to profitability [76] Other Important Information - The CAPTAIN trial, a significant clinical study, is expected to provide important data that could influence reimbursement timelines and treatment paradigms [72][74] - The company is also exploring opportunities with its Sonalleve technology, which is being used for various treatments, including for adenomyosis and pancreatic cancer [40][41] Q&A Session Summary Question: Update on private payers and reimbursement - Management noted that the number of patients going through private payers is increasing, with typical payments between 1.5 to 2.5 times Medicare rates, and over 90% of rejections are being tracked for potential reversal [44][46] Question: Dynamics of non-capital revenue decline - Management clarified that the 20% growth mentioned was year-over-year, not quarter-over-quarter, and that the mix of capital versus recurring revenue is expected to shift as the install base grows [49][50] Question: Expectations for 2026 revenue growth - Management did not provide specific guidance but indicated confidence in achieving a range of 90% to 110% growth based on site additions and overall market dynamics [62][63] Question: Progress on CAPTAIN trial data release - Management expects that early dissemination of CAPTAIN trial data will enhance confidence in reimbursement decisions and emphasized the integrity of the trial data [72][74] Question: Cash flow positivity timeline - Management indicated a trend of decreasing cash burn, projecting that reaching revenues of $80 million to $85 million would lead to cash flow positivity [76] Question: Installation pacing for TULSA systems - Management suggested that installations would increase throughout the year, with a standardized approach to announcing numbers expected [82][83] Question: Usage of the BPH module - At least 10 sites have started using the BPH module, with expectations for rapid growth in adoption [89] Question: International expansion progress - Management confirmed ongoing interest in international markets, with distributor agreements in place and a careful strategy for growth outside the U.S. [91][92]

Regulatory Approvals - The TULSA-PRO system received FDA clearance in August 2019 for transurethral ultrasound ablation of prostate tissue, based on the TACT pivotal clinical trial results[19]. - The Sonalleve system is CE Marked in the EU for multiple applications, including the treatment of uterine fibroids and has received HDE approval from the FDA for osteoid osteoma treatment[20]. - The TULSA-PRO system has received 510(k) clearance for commercial sale in the United States and regulatory approvals in multiple countries, including Canada and China[110]. - TULSA-PRO received approval as a class III device from Health Canada on November 20, 2019, which is crucial for the company's global expansion strategy[149]. - Sonalleve system received FDA authorization for commercial distribution in the U.S. on November 27, 2020, for the treatment of osteoid osteoma[153]. - Sonalleve applications for ablation of uterine fibroids and adenomyotic tissue are CE marked and available in the EU, Canada, and South Korea[154]. Clinical Trial Results - The TACT trial demonstrated a 96% reduction in prostate-specific antigen (PSA) levels to a median nadir of 0.34 ng/ml at 12 months, with a median decrease in perfused prostate volume of 91%[35]. - By five years, the median PSA nadir further reduced to 0.26 ng/ml, with 96% of men returning to baseline urinary continence and 87% recovering erectile function[39]. - In a clinical study, TULSA-PRO demonstrated a significant IPSS improvement of 58% from 16.1 to 6.3 at 12 months, with all patients achieving full urinary continence[43]. - In the sTULSA study, median PSA decreased from 3.3 ng/ml at baseline to 0.05 ng/ml at three months, with 89% of subjects cancer-free in the treated zone at 12 months[45]. - The CAPTAIN trial enrolled 211 subjects, comparing TULSA to robotic prostatectomy, aiming to show non-inferiority in efficacy and superior quality of life outcomes[48][50]. - The CAPTAIN trial demonstrated that TULSA is statistically superior to robotic prostatectomy in terms of blood loss, length of stay, and recovery to baseline activities[53]. - In a prospective Phase II study, prostate volume decreased from a median of 52 to 32 mL, and PSA levels decreased from 3.1 to 1.5 μg/L after TULSA treatment[43]. - The randomized controlled Phase III study showed a significant pain reduction of 64.3% in patients receiving MR-HIFU compared to 20.0% in the sham treatment group (p<0.001) after three months[65]. - The average NRS pain score reduction was 3.6 ± 3.1 in the MR-HIFU group versus 0.7 ± 2.4 in the control group, with an initial median NRS score of 7.0 for both groups[65]. Market Opportunity - The annual incidence of newly diagnosed prostate cancer cases in the U.S. is estimated to reach 333,830 in 2026, highlighting a significant market opportunity for the TULSA-PRO system[24]. - The company aims to increase commercial adoption of its products and is pursuing additional regulatory approvals in international markets[21]. - The company may consider strategic acquisitions to expand the applications of its platform technology and enhance its commercial footprint[21]. Business Model and Financials - The company’s business model includes sales of capital equipment and recurring non-capital equipment, with a focus on raising funds through securities offerings and bank financings[22]. - The company anticipates the need for additional financing as commercialization efforts and program development costs increase[17]. - For the year ended December 31, 2025, approximately 76% of revenues were generated in the United States, 5% in the EU, and 19% in Asia, compared to 78%, 8%, and 14% respectively for the year ended December 31, 2024[74]. - The company plans to pursue coverage and reimbursement for its products in key markets where marketing authorization is obtained, as reimbursement is critical for revenue generation[156]. - On July 11, 2024, CMS proposed rules establishing a Category 1 CPT code for the TULSA procedure, effective January 1, 2025[157]. - The TULSA procedure has been established with a Medicare National Average payment of $13,479 for CPT 55882 in 2026, which is higher than mainstream prostate cancer treatments[159]. - For ASCs, the facility payment for CPT 55882 will be $10,874, indicating a competitive pricing structure in the market[159]. - The Relative Value Units (RVU) for CPT 55882 is set at 288.50 when performed by one physician, reflecting the complexity and resource allocation for the procedure[161]. - The TULSA procedure features a 0-day Global Period, allowing separate billing for all post-operative visits, unlike other treatments with a 90-day Global Period[162]. Technology and Innovation - The TULSA-PRO system is designed to provide customizable, incision-free ablative therapies with real-time MRI visualization and thermometry[29]. - The TULSA-PRO system is designed to minimize side effects associated with overheating during ablation procedures, ensuring precision in temperature control[100]. - The TULSA-PRO system is designed to ablate prostate tissue with millimeter accuracy, allowing for the treatment of prostates up to 120 cubic centimeters or larger[100]. - The TULSA-PRO system aims to provide customizable, incision-free therapies for MRI-guided ablation, reducing invasiveness and improving clinical outcomes compared to traditional surgical methods[76]. - The Sonalleve MR-HIFU system has shown impressive performance in ablation efficiency and symptom reduction for uterine fibroids and adenomyosis[62]. - MR-HIFU has shown good clinical success in treating desmoid tumors with low adverse events, offering a non-invasive alternative to traditional management methods[70]. - The ability to re-treat with MR-HIFU without an upper dose limit is advantageous for managing conditions with a high recurrence rate, such as desmoid tumors[72]. Corporate Governance and Operations - The company holds approximately 40 patent families, with around 169 granted or allowed patents and 29 patent applications in various stages of review globally[103]. - The company has invested in expanding its intellectual property portfolio, particularly the technology acquired from Philips in 2017, to support sales and marketing efforts[105]. - The company has established direct sales and marketing teams for TULSA-PRO and Sonalleve systems, focusing on increasing utilization and generating recurring revenues from clinical support and service maintenance[77]. - The company collaborates with strategic partners like Philips, GE, and Siemens for lead generation and distribution of capital equipment, enhancing market reach[78]. - The company has established exclusive licenses, including a significant agreement with Sunnybrook, which includes a milestone payment of C$250,000 related to FDA clearance[109]. - As of December 31, 2025, the company had 162 full-time employees, with a focus on employee development and retention strategies[166]. - The company emphasizes competitive compensation and benefits packages to attract and retain top talent, including health insurance and paid time off[167]. - Profound Medical Corp. transitioned from a capital pool company to a publicly traded entity on the TSX and Nasdaq, enhancing its market presence[168]. - The company’s registered office is located in Mississauga, Ontario, indicating its operational base in Canada[169]. - Additional corporate information and reports are available on the company’s website and through regulatory filings, ensuring transparency and compliance[170]. - The company maintains a code of ethics and corporate governance policies accessible to stakeholders, reinforcing its commitment to ethical practices[171]. FDA Regulations - The FDA typically issues a decision on a De Novo classification request within 150 days of receipt, allowing manufacturers to classify devices into class I or II based on low or moderate risk evidence[117]. - Manufacturers must register their establishments annually and pay an annual registration fee, adhering to the Quality System Regulation (QSR) which includes design control and good manufacturing practice (cGMP) requirements[119]. - The effective date for the Quality Management System Regulation (QMSR) is February 2, 2026, which will harmonize FDA's cGMP regulations with ISO 13485:2016 standards[120]. - Manufacturers must report any device-related death or serious injury to the FDA within 10 days, and device user facilities must also report such incidents[121]. - The FDA has the authority to require recalls of medical devices if there is a reasonable probability that the device could cause serious adverse health consequences or death[122]. - Any modification to a legally marketed device that significantly affects safety or effectiveness requires a new 510(k) submission or PMA application[123]. - The FDA conducts routine inspections of device manufacturers to ensure compliance with clinical trial and regulatory requirements, with enforcement actions including civil penalties and product seizures[124]. - Clinical studies are required to support PMA applications, and significant risk devices must submit an Investigational Device Exemption (IDE) application to the FDA[125]. - The FDA requires sponsors of pivotal clinical trials to develop a diversity action plan for enrollment, which must be submitted if an IDE application is required[129]. - The EU's new Medical Devices Regulation (EU) 2017/745 became effective on May 26, 2021, replacing the previous directive and establishing new compliance requirements for medical devices[131].