Core Viewpoint - BioStem Technologies' products, VENDAJE® and VENDAJE AC®, have been granted a 12-month status quo period for reimbursement eligibility under the CMS CY 2026 Final Medicare Reimbursement Rule, ensuring continued access for patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU) [3][4]. Group 1: Reimbursement Status - The 12-month status quo designation allows BioStem's products to remain eligible for reimbursement in 2026, provided their use meets the "reasonable and necessary" standard [4]. - The Medicare Administrative Contractors (MACs) will review additional evidence by December 31, 2026, with updated determinations expected in early 2027 [4]. Group 2: Impact on Other Products - The final policy from CMS specifically applies to DFU and VLU indications, leaving reimbursement for other wound types, such as pressure ulcers, unaffected [5]. - Pressure ulcers represent the largest segment of the chronic wound market at 41%, which is crucial for BioStem's sales volume and Medicare-related revenue [5]. Group 3: Company Statements and Future Plans - The CEO of BioStem expressed appreciation for CMS's evidence-driven approach and anticipates uninterrupted payment for their products in DFU and VLU applications throughout 2026 [6]. - BioStem plans to engage with CMS and MACs to discuss clinical trial findings and aims to achieve reclassification of their products from Status Quo to Covered status during the 2027 reconsideration cycle [6].

Status Quo designation preserves DFU/VLU reimbursement eligibility for 2026, ensuring continued patient access to BioStem technology Coverage for the majority of BioStem’s non-acute revenue, treatment for pressure ulcers, also remains unaffected by CMS LCD updates POMPANO BEACH, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today ...

Both the CADD-Solisâ"¢ infusion pump and the Sapphireâ"¢ Infusion pump received a unique, brand-specific Healthcare Common Procedure Coding System (HCPCS) code eligible for separate payment in the HOPD and ASC settings. This decision by CMS is a pivotal step towards enhancing access to clinically proven non-opioid treatments for Medicare beneficiaries in HOPD and ASC settings. ROCHESTER HILLS, Mich.--(BUSINESS WIRE)--InfuSystem Holdings, Inc. (NYSE American: INFU) ("InfuSystem†or the "Company†), a leading ...

Financial Data and Key Metrics Changes - The operating revenue for FY 2025 was USD 21.8 million, reflecting a 6% year-on-year increase [10] - Total laboratory throughput decreased by 11.5% year-on-year to 28,894 tests, but remained stable in the second half of the year [10] - The average U.S. sales price increased to USD 5.94 from USD 5.84 the previous year [11] Business Line Data and Key Metrics Changes - The company achieved significant milestones, including the inclusion of CX-beta Triage in the AUA's MicroHematuria guidelines with a Grade A evidence rating [6][7] - The draft pricing from Medicare for TriagePlus was set at USD 10.18 per test, a substantial increase from the previous USD 760 [8] - The transition from CX Bladder Detect to Triage was noted, with volumes remaining relatively stable despite the loss of one salesperson [12] Market Data and Key Metrics Changes - Medicare coverage loss accounted for approximately 56% of FY 2025 revenues, leading to a strategic shift towards commercial payers [9][27] - Non-Medicare volumes represented 47% of U.S. commercial volumes in FY 2025, up from 40% in the prior half [40] - The company is experiencing a shift in payer mix towards more commercial insurance, reducing reliance on Medicare [41][48] Company Strategy and Development Direction - The company aims to leverage the AUA guidelines to enhance sales, marketing, and reimbursement activities [68] - Plans include raising capital to support the commercialization of Triage and TriagePlus, and to maintain investment in clinical research [14] - The strategy focuses on increasing throughput and sales efficiency while adapting to the changing reimbursement landscape [69] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the loss of Medicare coverage but highlighted resilience in financial performance [10] - The inclusion of AUA guidelines is expected to drive test adoption and deepen clinician engagement [12] - Future plans include seeking reimbursement through the Medicare appeals process and expanding access to TriagePlus [30][48] Other Important Information - The company raised USD 16.1 million through institutional placements and USD 4.7 million through a share purchase plan [14] - The CEO emphasized the importance of evidence generation in changing clinical practice and securing reimbursement [25] - The company is working towards developing an in vitro diagnostic (IVD) product for international markets [66] Q&A Session Summary Question: How do auditors ensure the management's claims are valid in a scientific company? - The audit procedures remain consistent regardless of the industry, focusing on financial reporting and validation processes [82][84] Question: What is the significance of the AUA guidelines for the company? - The AUA guidelines enable the use of urine-based biomarkers for intermediate risk patients, enhancing market opportunities and reducing unnecessary procedures [20][22]

Core Viewpoint - NeuroPace, Inc. has responded positively to the Centers for Medicare & Medicaid Services (CMS) decision not to finalize the proposed reassignment of epilepsy neurostimulator cases in the FY 2026 Inpatient Prospective Payment System (IPPS) rule, maintaining the current reimbursement structure for its RNS System procedures [1][2]. Company Overview - NeuroPace, Inc. is a medical technology company based in Mountain View, California, focused on improving the lives of individuals with epilepsy by reducing or eliminating seizures through its innovative RNS System [3]. - The RNS System is the first and only commercially available brain-responsive platform that provides personalized, real-time treatment at the source of seizures, aiming to enhance care for patients with drug-resistant epilepsy and potentially benefiting those with other brain disorders [3]. Regulatory Engagement - The company appreciates CMS's willingness to consider public comments and its decision to retain the existing MS-DRG assignment for RNS System procedures, which supports hospitals serving Medicare beneficiaries with epilepsy [2]. - NeuroPace plans to continue collaborating with CMS on improvements related to MS-DRG and reimbursement policies to ensure access to the RNS System for all eligible patients [2].

Core Viewpoint - Proposed bipartisan legislation, the Health Tech Investment Act, aims to expand Medicare reimbursement pathways for AI-enabled medical devices, supporting Nexalin's Gen-3 HALO Clarity™ neurostimulation device integrated with AI [1][2] Group 1: Legislation Overview - The Health Tech Investment Act (S. 1399) is sponsored by Senators Mike Rounds and Martin Heinrich, proposing a transitional reimbursement mechanism under Medicare for FDA-cleared or approved AI-enabled technologies [2] - The legislation would assign New Technology Ambulatory Payment Classification (APC) codes for up to five years to AI-enabled devices, allowing CMS to collect clinical data for long-term reimbursement decisions [2] Group 2: Nexalin's Gen-3 HALO Clarity™ Device - Nexalin's Gen-3 HALO Clarity™ device is a next-generation neurostimulation system that integrates advanced AI capabilities for treatment delivery and patient monitoring, targeting mental health conditions such as anxiety and depression [3][5] - The device is designed to work with a proprietary virtual clinic ecosystem that utilizes AI for remote treatment and real-time clinical feedback, enhancing mental health care through technology [4][5] Group 3: Strategic Importance of Legislation - The Health Tech Investment Act is viewed as a legislative milestone that prioritizes innovation and accessibility in mental health care, addressing the limitations of traditional care options [6] - The legislation provides a reimbursement framework that aligns with Nexalin's strategy to enhance care coordination and monitoring through intelligent, patient-centered innovations [5][6] Group 4: Company Developments - Nexalin has completed Phase 1 of its AI-powered virtual clinic infrastructure, allowing patients to initiate therapy at home via a secure mobile app while providing clinicians with automated insights [4] - The company is preparing for FDA submission of the Gen-3 device following planned clinical trials, indicating a focus on regulatory and clinical milestones [7]