Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Core Insights - EDAP TMS SA will participate in the UBS Global Healthcare Conference, hosting 1x1 investor meetings on November 10, 2025 [1][2] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced the Focal One® system, a leading prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]

Core Points - EDAP TMS SA will announce its third quarter financial results for 2025 on November 6, 2025, before market opening [1] - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer on the same day at 8:30 am EST [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology for various medical conditions [4] - The company has introduced the Focal One system, which is a leading prostate focal therapy device controlled by urologists, with potential applications beyond prostate cancer [4]

Core Viewpoint - EDAP TMS SA has secured a €36 million credit facility from the European Investment Bank to support the global expansion of its Focal One Robotic HIFU platform and accelerate the development of new clinical indications for its technology [1][2][3] Group 1: Credit Facility Details - The credit facility consists of three tranches: Tranche A for €11 million at an interest rate of 8%, Tranche B for €12 million at 7%, and Tranche C for €13 million at 6% [8] - The maturity date for each tranche is set at 5 years from the date of disbursement [8] - EDAP plans to draw the first tranche of €11 million in the fourth quarter of 2025 [2] Group 2: Strategic Importance - The financing will enable EDAP to expand the reach of its Focal One Robotic HIFU technology, addressing the growing global demand for non-invasive treatment options for cancer and benign conditions [3][4] - The collaboration with the EIB highlights EDAP's commitment to innovation in urological and gynecological care through advanced robotic HIFU technologies [4] Group 3: Company Background - EDAP TMS is recognized as a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [7] - The Focal One platform is positioned as a leading prostate focal therapy, with potential applications extending beyond prostate cancer [7]

Core Insights - EDAP TMS SA's Focal One Robotic HIFU treatment was highlighted during Prostate Cancer Awareness Month, reaching millions through national television exposure [1][2] - The treatment offers a non-invasive option for prostate cancer patients, allowing them to maintain their quality of life while effectively targeting cancer [3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [4] - The Focal One system is positioned as a leading prostate focal therapy, with potential applications beyond prostate cancer [4] Patient Experience - A patient named Peter D. shared his positive experience with Focal One Robotic HIFU, emphasizing minimal disruption to his daily life and a quick return to normal activities [2] - Dr. Eric Giesler, Peter's urologist, noted the importance of non-invasive treatment options in improving patient outcomes and quality of life [3] Awareness Campaign - The national exposure from the television segment is part of a broader campaign to raise awareness about prostate cancer treatment options among patients, caregivers, and healthcare professionals [3]

Core Insights - EDAP TMS SA has been awarded the 2025 Industry Award for Innovations in Endourological Instrumentation by the Endourological Society for its Focal One High-Intensity Focused Ultrasound (HIFU) platform [1][2][3] - Focal One is the first Focal Therapy technology to receive this prestigious award, recognizing its contributions to the field of urology, particularly in robotic HIFU for prostate cancer [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [4] - The Focal One platform is designed for prostate focal therapy and is controlled by urologists, with potential applications beyond prostate cancer [4]

Summary of EDAP TMS FY Conference Call Company Overview - **Company**: EDAP TMS - **Industry**: Medical Devices, specifically focused on HIFU (High-Intensity Focused Ultrasound) technology for treating prostate cancer - **Key Product**: FocalOne platform, with the latest version being FocalOne-i launched in April 2025 [1][3] Strategic Shift - Management has shifted focus entirely to the HIFU business, de-emphasizing lithotripsy and distribution businesses [1][3] - Plans to expand HIFU applications to include endometriosis treatment and benign prostatic hyperplasia (BPH) [1][12] Market Opportunity - Prostate cancer is the most diagnosed cancer in men globally, with nearly 1.5 million cases annually, projected to double by 2040 [4] - The market for prostate cancer treatment is expected to grow significantly, with an increase in mortality rates [4] - FocalOne addresses a gap in treatment options between active surveillance and radical treatments, providing a less invasive alternative [5][6] Product Features and Clinical Data - FocalOne-i features a five-axis robotic positioning system and is compatible with various imaging technologies, including AI [3][4] - HIFU is showing exponential growth, while traditional treatments like cryoablation and surgery are stagnating [8] - The HiFi study, involving 3,328 patients, demonstrated superior functional outcomes for HIFU compared to traditional surgery [10][11] - A randomized controlled trial (FARP) showed that 25% of patients opted for FocalOne HIFU over surgery, indicating strong patient preference [11] Financial Performance - Reported a 77% increase in HIFU revenues year-over-year for Q2 2025 [15] - Increased guidance for HIFU revenue growth, indicating confidence in the strategic shift [17] Reimbursement and Market Access - Anticipated 5.6% increase in facility payment levels from CMS starting January 1, 2026, which is expected to enhance hospital investment in HIFU [18][19] - Hospitals are recognizing the ROI of investing in FocalOne due to its efficacy and quality of life outcomes for patients [18] Future Developments - Clinical studies for BPH are expected to begin in early 2026, with a potential labeling change following [21] - CE Mark received for endometriosis treatment, with limited launch currently underway [22] Financial Strategy - Agreement with the European Investment Bank for a €36 million credit facility to support investments in HIFU [23][24] - Transitioning to a domestic filer on NASDAQ effective January 1, 2026, to enhance market presence [26] Conclusion - EDAP TMS is positioned for significant growth in the HIFU market, with a clear strategy focused on expanding treatment applications and improving patient outcomes through innovative technology and clinical validation [1][12][15]

Core Viewpoint - EDAP TMS SA has secured reimbursement for its Focal One Robotic HIFU procedure for prostate cancer treatment in France, marking a significant commercial milestone that enhances patient access to non-invasive treatment options [1][2][6] Company Developments - The French Ministry of Health's decision to reimburse the Focal One procedure allows eligible patients to receive it as a primary treatment for localized prostate cancer and as a salvage option post-radiotherapy [1][2] - The reimbursement coverage became effective on September 1, 2025, following a favorable opinion from the French National Authority for Health in December 2023 [2] Market Implications - The reimbursement in France is expected to accelerate similar reimbursements in other European countries, potentially increasing the adoption of the Focal One platform among urologists [2] - The positive outcomes from the HIFI Study and Level 1 evidence from the FARP Study are anticipated to further drive demand for the Focal One Robotic HIFU procedure [2] Technology and Product Information - EDAP TMS specializes in robotic energy-based therapies and has developed the Focal One as a leading prostate focal therapy device, which utilizes advanced imaging, robotics, and non-invasive energy delivery technologies [4]

Financial Data and Key Metrics Changes - Global HIFU revenues reached $9.7 million, an increase of 89% year over year, driven by the placement of 12 Focal One systems, representing a 140% growth compared to Q2 2024 [4][5] - Total revenue for Q2 2025 was €16 million, a 1.6% increase from €15.8 million in Q2 2024, with HIFU revenue growing 76.8% year over year [21][22] - Gross profit for Q2 2025 was €6.8 million, with a gross margin of 42.5%, up from 37.5% in the same period last year [24] Business Line Data and Key Metrics Changes - HIFU business revenue for Q2 2025 was €8.5 million, compared to €4.8 million in Q2 2024, driven by nine capital sales versus three in the prior year [22][23] - Non-core distribution and ESWL businesses declined by 31.2% in Q2 2025 compared to Q2 2024 [21] Market Data and Key Metrics Changes - U.S. procedures grew approximately 4.8% year over year, despite challenges with Medicare Advantage plans impacting growth in certain markets [10][11] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [12] Company Strategy and Development Direction - The company is focusing on expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis [14][15] - A strategic financing facility with the European Investment Bank for €36 million is expected to enhance the balance sheet and support the expansion of Focal One robotic HIFU [17][19] - Transitioning to a U.S. domestic filer starting January 1, 2026, to comply with SEC reporting rules and attract new institutional investors [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating growth of Focal One, driven by strong clinical data and increasing awareness among patients and physicians [30] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [29] Other Important Information - Inventory decreased to $15.5 million in Q2 2025 from €18 million at the end of Q1 2025, attributed to efficient inventory management [26] - The company is actively working with market access partners to improve pre-authorizations for Focal One procedures [11] Q&A Session Summary Question: Can you provide details on the payer issues and reimbursement situation? - Management noted improvements in reimbursement efforts, with strong collaboration with market access partners to accelerate pre-authorizations for Focal One procedures [33][34] Question: What factors does CMS consider for higher reimbursement rates? - CMS evaluates average payments, cost of service, volume of procedures, and clinical value when determining reimbursement rates [43][44] Question: Can you provide an update on the endometriosis trial? - The phase three study showed over 80% of sham arm patients opted for Focal One treatment post-unblinding, with a limited European launch currently underway [53][54] Question: How is the €36 million from the EIB intended to be used? - The funds are earmarked for accelerated commercial growth in the HIFU business and investment in clinical indications and new technologies [56][59]

Financial Data and Key Metrics Changes - Global HIFU revenues reached $9.7 million, an increase of 89% year over year, driven by the placement of 12 Focal One systems, representing a 140% growth compared to Q2 2024 [3][4] - Total revenue for Q2 2025 was €16 million, a 1.6% increase from €15.8 million in Q2 2024, with HIFU revenue growing 76.8% year over year to €8.5 million [21][22] - Gross profit for Q2 2025 was €6.8 million, with a gross margin of 42.5%, up from 37.5% in the same period last year [23] Business Line Data and Key Metrics Changes - The HIFU business saw a 76.8% increase in revenue, driven by nine capital sales compared to three in the prior year, and a 16.1% increase in treatment-driven revenue [21][22] - Non-core distribution and ESWL businesses declined by 31.2% in Q2 2025 compared to Q2 2024 [21] Market Data and Key Metrics Changes - U.S. procedures grew approximately 4.8% year over year, despite challenges with Medicare Advantage plans impacting growth in certain markets [9][10] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [11] Company Strategy and Development Direction - The company is expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis, which is expected to drive incremental sales growth [13][15] - A strategic financing facility with the European Investment Bank for €36 million is expected to enhance the balance sheet and support the expansion of Focal One robotic HIFU [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating growth of Focal One, driven by strong clinical data and increasing awareness among patients and physicians [5][29] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [28] Other Important Information - The company will transition to a U.S. domestic filer starting January 1, 2026, which is expected to enhance transparency and attract new institutional investors [18][20] - Inventory decreased to $15.5 million in Q2 2025, reflecting efficient inventory management and higher turnover due to increased demand for Focal One [25][26] Q&A Session Summary Question: Can you provide details on the payer issues and improvements? - Management noted solid growth in the HIFU business despite challenges with Medicare Advantage plans, with early signs of improvement in procedure approvals [32][34] Question: What factors does CMS consider for reimbursement rate increases? - CMS considers service value, clinical value ratios, procedure volume, and costs associated with services when determining reimbursement rates [43][45] Question: How much effort is placed on multi-unit purchases? - Significant effort is placed on every sale, with recent sales indicating strong validation of the technology's value [48][50] Question: Update on the endometriosis trial? - The phase three study is ongoing, with over 80% of sham arm patients opting for Focal One treatment post-unblinding, and a limited European launch is underway [55][56] Question: Status of the €36 million financing? - No funds have been received yet, as the company is finalizing terms with the European Investment Bank [58][59]