Medical device commercialization
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NeurAxis Stock Gains Following Strong Q1 Earnings and FDA Milestones
ZACKS· 2025-05-15 17:11
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].
SINTX Technologies Provides Business Update Highlighting Strategic Focus to Medical Device Commercialization
GlobeNewswire News Room· 2025-05-15 11:05
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]