Core Insights - Limaca Medical Ltd.'s Precision-GI™ motorized endoscopic biopsy device has received transitional pass-through (TPT) payment approval from the Centers for Medicare & Medicaid Services (CMS), enhancing patient access to this innovative technology starting January 1, 2025 [1][2] - The Precision-GI™ device aims to improve biopsy results for patients with suspected gastrointestinal cancers, including pancreatic and liver cancers, and has previously received FDA Breakthrough Device Designation and clearance [1][2] Company Overview - Limaca Medical is an Israel-based company focused on enhancing endoscopic biopsy results for patients with potentially life-threatening cancers, supported by various investors including the Israeli Innovation Authority and The Trendlines Group [5] - The company is also pursuing market entry in Japan in collaboration with HekaBio [4][5] Product Details - The Precision-GI™ device features a motorized, automated, rotating cutting mechanism that allows for superior tissue acquisition quality, reducing blood content and procedure time compared to traditional endoscopic biopsy devices [3] - The device has begun its U.S. market entry after performing its first cases in September 2024, addressing the significant global incidence of pancreatic cancer, which recorded 510,992 new cases in 2022 [4]

Group 1 - The article expresses a beneficial long position in the shares of STXS and DCTH, indicating a positive outlook on these companies [1] - The author mentions potential interest in investing in AVITA Medical or Myomo in the coming months, but not within the next two weeks, suggesting a cautious approach to these investments [1] Group 2 - The article does not provide specific performance metrics or financial data related to the companies mentioned [2] - There is no recommendation or advice given regarding the suitability of investments for particular investors, emphasizing the need for individual assessment [2]

Core Viewpoint - The U.S. Centers for Medicare and Medicaid Services (CMS) has established a Category 1 CPT® code for the Transurethral Ultrasound Ablation (TULSA) procedure, effective January 1, 2025, which positions TULSA as a leading treatment modality for prostate disease [1][4]. Group 1: CPT Codes and Reimbursement - TULSA will have three CPT codes based on the number of physicians involved: CPT 51721 for Device Management, CPT 55881 for Treatment with two physicians, and CPT 55882 for the Complete Procedure with one physician [2]. - All TULSA codes will have a 0-day global period, meaning that only the work performed on the day of the procedure is covered, allowing separate billing for pre- and post-procedure visits [2][8]. - The final rule has set the payment for TULSA CPT 55882 at $12,992 for Hospital Outpatient and $10,728 for Ambulatory Surgical Centers, representing increases of approximately 41% and 49% respectively compared to previous proposals [4]. Group 2: Clinical and Operational Aspects - TULSA codes are applicable across various treatment settings, including hospitals, ambulatory surgical centers, and private offices, enhancing accessibility for patients [3][5]. - The TULSA procedure is designed to be incision-free, with no blood loss and no hospital stay required, allowing for quick recovery and preservation of vital functions [5][11]. - The TULSA-PRO® system utilizes real-time MRI guidance and precise temperature control to effectively treat a range of prostate conditions while minimizing side effects [11]. Group 3: Relative Value Units (RVUs) - The total Facility RVUs for TULSA are set at 6.47 for CPT 51721, 14.56 for CPT 55881, and 17.91 for CPT 55882 when performed by one physician [6]. - For Non-Facility settings, RVUs are significantly higher, with 16.25 for CPT 51721, 263.05 for CPT 55881, and 272.21 for CPT 55882 [7]. - The TULSA procedure's 0-day global period contrasts with other prostate treatments that typically have a 90-day global period, which includes bundled payments for post-operative visits [8].

Core Insights - The U.S. Centers for Medicare & Medicaid Services (CMS) has announced a new payment structure for specialized diagnostic radiopharmaceuticals, allowing separate payments for these agents in the hospital outpatient setting, which will enhance patient access to advanced imaging technologies [1][3][6] Group 1: Payment Structure Changes - Starting in 2025, the Hospital Outpatient Prospective Payment System (OPPS) will reimburse specialized diagnostic radiopharmaceuticals based on Mean Unit Cost (MUC) for those exceeding a daily cost threshold of US$630 [2] - This new rule will ensure consistent reimbursement for Medicare Fee for Service patients after the expiration of pass-through status, allowing purchasing decisions to be based on clinical utility rather than reimbursement structures [3] Group 2: Impact on Telix Pharmaceuticals - The new payment rule will apply to Telix's lead product, Illuccix®, after its pass-through status expires on July 1, 2025, and will also extend to other investigational agents in its pipeline if approved [4] - If TLX007-CDx is approved, Telix will be the only company with two PSMA-PET imaging agents available, potentially increasing its market reach and providing more options for patients [5] Group 3: Industry Implications - The decision by CMS is expected to promote further investment in the development of new imaging agents, providing a clearer commercial pathway for companies like Telix to recover their innovation costs [6] - The change in reimbursement policy is anticipated to enhance access to advanced imaging agents, which are crucial for informed treatment decisions in oncology [6]

Core Points - The Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for the Medtronic Symplicity Spyral renal denervation (RDN) catheter, effective January 1, 2025, for up to three years [1][2][3] - The TPT program aims to enhance patient access to innovative healthcare technologies by reducing cost barriers for healthcare systems [3] - The Medtronic Symplicity Spyral RDN System, approved by the FDA in November 2023, is a minimally invasive procedure that targets overactive nerves near the kidneys to help lower blood pressure [4][5] Company Overview - Medtronic plc is a leading global healthcare technology company headquartered in Galway, Ireland, with a mission to alleviate pain, restore health, and extend life [6] - The company employs over 95,000 people across more than 150 countries and offers technologies that treat 70 health conditions, including cardiac devices and surgical tools [6] - The Symplicity Spyral RDN System is part of a comprehensive clinical program studying renal denervation in various patient populations, with over 25,000 patients treated globally [5]

Core Insights - HeartCore Enterprises, Inc. corrected its projected sales growth from 115% to 15% for its software business due to a misstatement in a previous press release [1] Company Overview - HeartCore Enterprises is headquartered in Tokyo, Japan, and specializes in enterprise software and consulting services [2] - The company offers Software as a Service (SaaS) solutions and data analytics services to enhance customer experiences for enterprise clients [2] - HeartCore's customer experience management platform includes various systems for marketing, sales, service, and content management [2] - The company also provides digital transformation services, including robotics process automation and process mining [2] - HeartCore assists Japanese companies in going public in the U.S. through its GO IPOSM consulting services [2]

Core Insights - CMS Energy reported $1.74 billion in revenue for Q3 2024, a year-over-year increase of 4.2%, with an EPS of $0.84 compared to $0.61 a year ago [1] - The revenue fell short of the Zacks Consensus Estimate of $1.83 billion, resulting in a surprise of -4.86%, while the EPS exceeded expectations by +7.69% against a consensus estimate of $0.78 [1] Financial Performance Metrics - NorthStar Clean Energy's operating revenue was $82 million, below the four-analyst average estimate of $107.54 million, reflecting a year-over-year change of +5.1% [3] - Consumers Energy (Electric+Gas) reported operating revenue of $1.66 billion, slightly below the four-analyst average estimate of $1.73 billion, with a year-over-year change of -0.7% [3] - NorthStar Clean Energy reported a net loss of $11 million, significantly lower than the average estimate of $18.63 million from two analysts [3] Stock Performance - CMS Energy's shares have returned -1.6% over the past month, contrasting with the Zacks S&P 500 composite's +1% change [4] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [4]

Financial Data and Key Metrics Changes - For the first nine months of 2024, the company reported adjusted earnings per share (EPS) of $2.47, an increase of $0.41 compared to the same period in 2023, primarily driven by favorable outcomes in electric and gas rate cases [20][24]. - The company reaffirmed its full-year guidance range for 2024 at $3.29 to $3.35 per share, with a bias towards the high end, and initiated guidance for 2025 at $3.52 to $3.58 per share, reflecting 6% to 8% growth off the midpoint of the 2024 range [21][35]. Business Line Data and Key Metrics Changes - The company experienced a favorable variance of $0.10 per share due to better weather conditions in Q3 2024 compared to the previous year, which positively impacted the electric business [25]. - Rate relief net of investment costs contributed $0.18 per share to the positive variance, stemming from constructive outcomes in the electric rate order and benefits from the previous gas rate case settlement [26]. Market Data and Key Metrics Changes - The company noted a significant economic development tailwind in Michigan, with over 6 gigawatts of load looking to either move to or expand in the state, 60% of which is manufacturing [15]. - The company highlighted a manufacturing renaissance in Michigan, driven by onshoring and state attributes, which is expected to bring jobs and commercial activity [13]. Company Strategy and Development Direction - The company is focused on a $7 billion electric reliability roadmap aimed at improving reliability performance and resilience through targeted investments in the electric grid [10]. - The upcoming renewable energy plan (REP) will detail clean energy investments and plans to meet targets set by Michigan's clean energy law, which is expected to provide a strong tailwind for the company [9]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver 6% to 8% EPS growth, supported by favorable regulatory outcomes and a strong economic development pipeline [62][67]. - The management team emphasized the importance of proactive investments in reliability and service improvements, which are expected to lower costs for customers [52][106]. Other Important Information - The company has completed all planned financings for the year ahead of schedule, ensuring ample liquidity for future needs [38]. - The company is working collaboratively with the commission to potentially establish a new tariff structure for data centers to ensure residential customers are not subsidizing these operations [48]. Q&A Session Summary Question: Data center demand and grid capacity - Management confirmed that Michigan has the electric infrastructure to support data centers and is working closely with them to meet their load ramp-up timelines [44][46]. Question: Storm and resiliency audits - Management indicated that the findings from the Liberty audit will be incorporated into the five-year reliability plan, enhancing capital investments for better service [51][97]. Question: NorthStar and capacity auctions - Management noted that the NorthStar business continues to perform well, with strength in capacity and energy markets, securing contracts above expectations [56]. Question: Renewable Energy Plan (REP) and sales growth - Management confirmed that the REP will reflect visibility in sales growth from data centers and manufacturing, driving additional renewable assets [91][93]. Question: Cost increases in insurance and IT - Management explained that higher costs in insurance and IT were trending ahead of budget, necessitating adjustments in funding for the year [84][86].

Core Viewpoint - CMS Energy Corporation reported strong third-quarter 2024 earnings, with EPS of 84 cents, exceeding estimates and showing significant year-over-year growth [1] Revenue Performance - Operating revenues reached $1.74 billion, falling short of the Zacks Consensus Estimate of $1.83 billion by 4.9%, but increased by 4.2% year-over-year [2] Operational Performance - Operating expenses were $1.38 billion, a decrease of 1.9% from the previous year [3] - Net income for the quarter was $253 million, up from $176 million year-over-year, surpassing the projected $232 million [3] - Interest charges amounted to $178 million, reflecting an 8.5% increase from the prior year [3] Financial Condition - Cash and cash equivalents stood at $412 million as of September 30, 2024, compared to $227 million at the end of 2023 [4] - Total debt and financial leases were $15.45 billion, up from $14.86 billion at the end of 2023 [4] - Cash generated from operating activities in the first nine months of 2024 was $1.97 billion, compared to $1.90 billion in the same period last year [4] 2024 Guidance - The company reaffirmed its 2024 adjusted EPS guidance of $3.29-$3.35, with the Zacks Consensus Estimate at $3.33, aligning closely with the midpoint of the guidance [5] 2025 Guidance - CMS Energy introduced its adjusted earnings guidance for 2025, expecting EPS in the range of $3.52-$3.58, while the Zacks Consensus Estimate is at $3.60, above the company's range [6] Zacks Rank - CMS Energy currently holds a Zacks Rank 4 (Sell) [7]

Financial Performance & Outlook - CMS Energy's adjusted EPS for YTD 2024 is $247[36], showing an increase compared to 2023, with confidence in achieving the full-year outlook - The company projects an adjusted EPS guidance of $329 to $335 for full-year 2024[36], aiming towards the higher end of the range - For 2025, the adjusted EPS guidance is set at $352 to $358[37], also targeting the higher end - The long-term adjusted EPS growth is projected at +6% to +8%[6,37], with a dividend per share growth also around +6% to +8%[6,37], targeting a ~60% payout ratio over time[37] Capital Investments & Financings - The utility capital plan is estimated at $17 billion[37], which is planned to be updated on the Q4 call - Consumers Energy completed first mortgage bond financings of approximately $13 billion[45], slightly exceeding the planned $1275 billion[45] - CMS Energy completed contracted equity issuances of approximately $266 million[46], aligning with the planned amount of ~$266 million[46] Regulatory & Operational Highlights - A new Michigan Energy Law is in effect from June 1, 2024[7,57], including a Renewable Portfolio Standard targeting 60% by 2035[11] and a Clean Energy Standard aiming for 100% by 2040[14] - The company is undertaking an Electric Reliability Roadmap with ~$4 billion in prior 5-year capital investments and a current filing of ~$7 billion + $3 billion[29], focusing on proactive grid enhancements - CMS Energy has secured 1350 MW of cumulative contracted load since 2015[32] through expansive economic development efforts, including investments from companies like Hemlock Semiconductor (~$375 million)[32], Ford Blue Oval Battery Park (~$26 billion)[32], and Corning Inc ($900 million)[32]