SOUTH JORDAN, Utah, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today that the U.S. Centers for Medicare & Medicaid Services (“CMS”) has notified Merit that its application for Transitional Pass-Through (“TPT”) incremental payment for WRAPSODY® Cell-Impermeable Endoprosthesis (“CIE”) procedures in the outpatient and ambulatory surgery center (“ASC”) settings requires further consideration prior to CMS making a final decisi ...

Core Insights - Inspira Technologies has completed the regulatory submission of its FDA-cleared INSPIRA™ ART100 system to the UAE Ministry of Health and Prevention, with final approval expected imminently, marking a significant step towards commercial entry into the Gulf region [1][2][3] Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with the INSPIRA™ ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [4] - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and spontaneously breathing, alongside advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [4] Regulatory and Market Strategy - The regulatory milestone follows high-level discussions in the UAE, laying the groundwork for potential nationwide deployment and clinical integration of the ART100 system post-approval [2][3] - The UAE is recognized for its efficient and innovation-driven regulatory framework, which is expected to enhance Inspira's regional partnerships and unlock broad commercialization potential across the UAE's healthcare networks [3]

Core Insights - Anteris Technologies has initiated the global pivotal trial for its DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis, marking a significant step towards commercialization [1][2] - The PARADIGM Trial will provide comparative evidence on the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements (TAVRs) [3][4] Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a strong presence in both Australia and the United States [7] - The DurAVR THV is designed to treat aortic stenosis and is the first biomimetic valve, utilizing Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years [8][9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will enroll approximately 1,000 patients, comparing the DurAVR THV to commercially available TAVRs [4][6] - The primary endpoint of the trial is to assess non-inferiority in terms of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [4]

Core Insights - Anteris Technologies has received regulatory clearance from the Danish Medicines Agency to initiate the global pivotal trial for the DurAVR Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis, known as the PARADIGM Trial, with patient recruitment expected to start in Q4 2025 [1][2][3] Company Overview - Anteris Technologies is a global structural heart company focused on designing, developing, and commercializing advanced medical devices aimed at restoring healthy heart function [12] - The company's lead product, the DurAVR THV, is designed to treat aortic stenosis and is the first biomimetic valve that mimics the performance of a healthy human aortic valve [13] PARADIGM Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [7][8] - The trial aims to enroll approximately 1,000 patients with a 1:1 randomization between the DurAVR THV and TAVR, assessing non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure [8] Regulatory and Market Implications - The successful completion of the PARADIGM Trial could lead to multiple approvals and labels for the DurAVR THV, marking a significant milestone in the company's commercialization planning phase [5] - Anteris is also awaiting an Investigational Device Exemption (IDE) application review by the U.S. FDA, which is expected to facilitate the initiation of study sites in the U.S. [6]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $564,000, down from $901,000 in the same period last year, with a six-month revenue of $1,300,000 compared to $1,600,000 in the prior year [9] - Gross profit was $245,000 or 43% of revenue in Q2 2025, compared to $470,000 or 52% of revenue in the prior year quarter, with a six-month gross profit of $568,000 or 44% of revenue compared to $940,000 or 58% in the previous year's period [10] - Operating expenses totaled $3,100,000 in Q2 2025, down from $4,300,000 in the prior year period, reflecting a 29% reduction driven by lower expenses across various departments [11] - Net loss for Q2 was $2,800,000 or $0.36 per share, compared to a net loss of $3,800,000 or $8.16 per share in 2024, with a six-month net loss of $6,400,000 compared to $7,400,000 in the same year-ago period [12] Business Line Data and Key Metrics Changes - The Catamaran platform is advancing with real-world adoption in complex spine procedures, supported by FDA clearance for uses in thoracolumbar fixation [4] - The Catamaran SE, a second-generation low-profile implant, is on track for full commercial launch in the coming weeks, with positive feedback from alpha reviews [4] - The company is preparing for initial alpha surgeries using the newly developed Symmetry Plus system, expected to begin in Q4 2025 [5] Market Data and Key Metrics Changes - The strategic acquisition of SciVantage enhances the company's commercial organization and market access, providing new pathways through hospital approval processes and distribution networks [3] - The acquisition is expected to increase active case volume and revenue-generating technologies, contributing to the company's growth trajectory [2] Company Strategy and Development Direction - The company is focused on delivering solutions that promote true biologic fusion and structural stability for patients with sacropelvic disorders, with a commitment to driving value for patients, physicians, and shareholders [14] - The integration of SciVantage is expected to create a more diversified product offering, allowing the company to address various clinical needs in the sacropelvic region [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in recovering from the recent decline in revenue, anticipating a quick rebound as the integration with SciVantage progresses [28] - The company is optimistic about the upcoming launches of Catamaran SE and Symmetry Plus, which are expected to drive top-line growth [12][44] Other Important Information - The company ended the quarter with $7,800,000 in cash and no debt, providing flexibility to execute its strategic roadmap [12] - The company hosted 16 physician workshops in Q2 to support long-term adoption strategies and accelerate the learning curve for new users [7] Q&A Session Summary Question: How does the acquisition help achieve scale? - Management confirmed that the acquisition provides a pathway to scale and enhances access to hospital systems and contract groups, allowing for a more diversified product offering [17][20] Question: What is the timeline for filing audited financials for the acquisition? - The company indicated a 75-day post-close period to file the audited financials for SciVantage, expected by mid-October [24][27] Question: How should investors view Catamaran revenues in Q3 and Q4? - Management suggested that Q2 was disrupted by the acquisition process but expects a quick recovery in Catamaran revenues moving forward [28][30] Question: What is the reimbursement landscape for the new products? - The new products will participate in existing CPT codes for SI procedures, similar to the Catamaran system, with a focus on supporting technologies with data [40][41] Question: What is the expected impact of the Symmetry Plus launch? - The Symmetry Plus launch is anticipated to begin with alpha surgeries in October, with a full-scale launch expected early next year [44]

Financial Performance - Revenue for fiscal Q2 2025 was $564,000, down from $901,000 in Q2 2024, attributed to lower procedure volumes and a shift in commercial initiatives [20][21] - Gross margin decreased to 43% in Q2 2025 from 52% in Q2 2024, due to reduced procedure volumes and consistent production costs [3][22] - Operating expenses were $3.1 million in Q2 2025, a 29% decrease from $4.3 million in Q2 2024, driven by reductions in G&A, R&D, and sales and marketing costs [3][23] - Net loss for Q2 2025 was $2.8 million, or $0.36 per share, compared to a net loss of $3.8 million, or $0.816 per share, in Q2 2024 [4][24] - Cash and cash equivalents increased to $7.8 million as of June 30, 2025, up from $6.5 million at the end of 2024, with no outstanding debt [4][25] Strategic Developments - The company completed the acquisition of CyVantage post-quarter, enhancing its product portfolio and commercial capabilities [5][10] - The Catamaran SE implant is on track for full commercial launch, supported by positive early feedback and FDA clearance for use as an adjunct to thoracolumbar fixation [6][15] - Initial alpha surgeries for the Symmetry Plus system are expected to begin in Q4 2025, aimed at enhancing outcomes in SI joint fusion procedures [6][16] Clinical and Market Engagement - Sixteen physician workshops were conducted to support adoption of new solutions and accelerate the learning curve for physicians [7][18] - The company is focused on clinical validation, with the second interim analysis from the main sale post-market study expected to provide additional evidence regarding clinical endpoints [7][17] - The CyVantage acquisition is anticipated to provide immediate revenue and enhance the company's commercial infrastructure, enabling cross-selling opportunities [9][10][41] Future Outlook - The integration of CyVantage is expected to unlock new pathways for market access and strengthen the commercial organization [14][19] - The company is optimistic about recovering revenue levels with the upcoming launches and increased physician engagement [36][38] - The focus remains on delivering solutions that promote biologic fusion and structural stability for patients with sacropelvic disorders [26]

Financial Data and Key Metrics Changes - Total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period [20] - GAAP net loss in 2025 was $19.2 million compared to $11.4 million in the prior year period [21] - Cash and cash equivalents totaled $106.3 million as of June 30, 2025, compared to $26.2 million as of June 30, 2024 [21] Business Line Data and Key Metrics Changes - The NSPFA Percutaneous Electrode System is FDA cleared for the ablation of soft tissue, with over 140 patients treated in the pilot program to date [9][12] - Surgeons are transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR) for better patient and surgeon experience [10] - The company expects to generate initial revenue from the percutaneous electrode in the second half of the year [23] Market Data and Key Metrics Changes - The market potential for the NSPFA device in benign thyroid disease is significant, with hundreds of thousands of patients in the US alone [7] - The prevalence of thyroid nodules is estimated to be 50% or greater in the population, increasing with age [28] - Approximately 250,000 patients are diagnosed with thyroid issues annually, with 150,000 undergoing thyroidectomy [32] Company Strategy and Development Direction - The company is focused on advancing its NSPFA technology and expanding its market presence through pilot programs and clinical studies [5][19] - A strategic partnership in the electrophysiology space is being pursued to enhance market opportunities [19][39] - The company aims to demonstrate that NSPFA may be a better treatment than surgery for many patients suffering from benign thyroid disease [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value proposition of NSPFA technology and its potential to transform treatment options [16] - The company anticipates increased cash usage as it invests in commercial infrastructure and clinical studies [22] - Management highlighted the importance of generating high-quality clinical data to support technology adoption and regulatory filings [17] Other Important Information - The company is engaged in a multicenter prospective clinical study to generate additional clinical data for the NSPFA technology [11] - The FDA awarded Breakthrough Device Designation for the Cardiac Surgical Clamp Ablation Device, which is under review for IDE submission [13][14] Q&A Session Summary Question: Can you share some patient baseline characteristics driving the pull through for NSPFA? - Management noted that symptomatic patients with benign nodules often seek therapy due to discomfort and the risks associated with thyroidectomy [28][30] Question: Is the expectation still for a single-arm study for catheter ablation? - Management confirmed it would be a single-arm study for electrophysiology [35] Question: Is Pulse collaborating with a market leader in cardiac ablation? - Management affirmed ongoing partnership discussions with a market leader in cardiac ablation [38][39] Question: How does the ASC opportunity position the NSPFA platform? - Management highlighted that the NSPFA system is well-suited for ASCs due to rapid procedure times and low neuromuscular stimulation [44][46] Question: Will the data collected overseas play into the PMA application for the clamp? - Management confirmed that human data collected will be included in IDE submissions, which is beneficial for FDA approval [53][55]

Core Viewpoint - NeurAxis, Inc. (NRXS) has demonstrated significant revenue growth in Q1 2025, with a notable stock performance compared to the S&P 500, despite reporting a net loss that widened year over year [1][3]. Revenue and Earnings Performance - In Q1 2025, NeurAxis reported revenues of $0.9 million, a 38.5% increase from $0.6 million in the same quarter of the previous year [2]. - Unit sales increased by 46% year over year, driven by higher patient volumes with full insurance reimbursement and financial assistance [2]. Profitability Metrics - The company reported a net loss of $2.3 million, compared to a $2.1 million loss in Q1 2024, resulting in a per-share loss of $0.33 versus $0.32 a year ago [3]. - Gross margin decreased to 84.4% from 88.4% due to a higher proportion of discounted sales and increased manufacturing and shipping costs [3]. Operating Expenses - Operating expenses rose by 26.9% to $3.1 million in Q1 2025 from $2.4 million in the same quarter last year [4]. - Excluding a one-time legal settlement, operating expenses remained relatively flat, indicating effective cost controls [4]. Cash Position and Financial Health - As of March 31, 2025, NeurAxis had cash and cash equivalents of $2 million, down from $3.7 million as of December 31, 2024, with no long-term debt reported [5]. - Net cash used in operations for Q1 2025 was $1.6 million, compared to $1.3 million a year ago [5]. Management Insights - CEO Brian Carrico noted that Q1 2025 marked the third consecutive quarter of robust revenue growth, attributing this to improved billing practices and expanding insurance coverage [6]. - CFO Tim Henrichs indicated that while operating expenses may rise in the short term due to sales and marketing efforts, they are expected to decrease as a percentage of sales [7]. Market Dynamics - Revenue growth was supported by the adoption of NeurAxis' proprietary technology, but pricing pressure from financial assistance patients constrained gross margin expansion [8]. - A one-time legal settlement of $750,000 impacted operating and net losses, but without this charge, net loss would have improved by 22% year over year [9]. Future Outlook - Management is optimistic about revenue acceleration in upcoming quarters, driven by the publication of academic guidelines and the implementation of a permanent CPT code for IB-Stim [11]. - FDA clearance is pending for expanding IB-Stim's indication, which could double the addressable market [12]. Regulatory Developments - NeurAxis achieved regulatory milestones, including a broadened FDA label for IB-Stim and 510(k) clearance for its rectal expulsion device [13]. - The company settled a legacy lawsuit for $750,000, payable over 12 months starting January 2026 [14].

Core Insights - SINTX Technologies is undergoing a disciplined transformation to focus on high-growth medical applications of silicon nitride, aiming for sustainable value creation [2][3] Operational Progress - The company is transitioning from a diversified industrial-ceramics business to a pure-play medical device innovator, targeting large clinical needs in infection resistance and tissue healing [3] - Recent initiatives include improved financial positioning, operational streamlining, and strengthened governance with a reconstituted Board of Directors [4][5][6] Financial Position - As of March 31, 2025, SINTX reported $6.5 million in cash, nearly doubling from $3.6 million at year-end 2024 [8] - The company reduced operating cash burn from $2.7 million in Q1 2024 to $1.3 million in Q1 2025 due to cost optimization efforts [8] - A recent $5 million private placement in February 2025 supports strategic initiatives, with potential to raise an additional $5 million from warrant exercises [8] Strategic Focus Areas - SINTX is strategically aligned around orthopedic implants, spinal fusion devices, dental products, and medical textiles, including wound care and surgical masks [7] - The company is actively developing new R&D programs targeting implantable and antipathogenic products, with ongoing partnerships and licensing discussions with leading medical OEMs [8]