Core Insights - Inspire Medical Systems, Inc. reported financial results for Q4 and full year 2025, highlighting a revenue increase of 12% to $269 million for Q4 and a 14% increase to $912 million for the full year, driven by growth at existing centers and new center additions [18][19] - The company is facing challenges related to reimbursement coding for the Inspire 5 system, specifically the transition to CPT code 64582 with a -52 modifier, which could lead to a professional fee reduction of 10% to 50% [6][21] - Inspire 5 has shown superior performance compared to Inspire 4, with a 79.5% responder rate in the Singapore study, indicating strong patient outcomes [11] Financial Performance - Q4 revenue increased to $269 million, while full year revenue reached $912 million, primarily due to growth at existing centers and new center additions [18] - Q4 net income per diluted share rose to $4.66, an increase of $3.51, while full year net income per diluted share increased to $4.89, up by $3.09 [19] - The company ended the year with $405 million in cash and investments, allowing for continued investment in growth initiatives [20] Reimbursement Challenges - The transition to CPT code 64582 with a -52 modifier is expected to significantly impact physician willingness to perform the Inspire 5 procedure, potentially limiting the number of cases [6][7] - The company is actively engaging with government agencies and physician societies to address reimbursement issues and minimize the impact of the -52 modifier [5][30] - The WISER program, requiring prior authorization for Medicare cases in six pilot states, has introduced additional challenges, affecting procedures in those states [14][33] Product Development and Market Strategy - Inspire Medical Systems is focused on developing a new CPT code for the Inspire 5 procedure, with a long-term goal of establishing a Category I code by January 2028 [10][61] - The company has made significant progress in the U.S. launch of Inspire 5, with over 90% of centers now implanting the system and physician training completed [12] - The Inspire 5 system has demonstrated improved surgical efficiency and patient outcomes, reinforcing the company's commitment to enhancing patient access to Inspire therapy [11][16] 2026 Outlook - The company has revised its full year revenue guidance for 2026 to a range of $950 million to $1,000 million, reflecting the potential impact of coding uncertainty and reimbursement changes [20][21] - Adjusted operating margin is expected to be in the range of 6% to 8%, with net income per diluted share projected between $1.23 and $1.81 [22] - The company anticipates sequential improvement in revenue and net income throughout 2026, with the fourth quarter expected to yield the highest levels of revenue and profit [25]

Core Insights - Lifeward Ltd. has received approval from a major U.S. health insurance company for the ReWalk 7 Personal Exoskeleton, marking a significant step in expanding access for individuals with spinal cord injuries (SCI) [1][2] - The approval follows the Centers for Medicare & Medicaid Services (CMS) establishing a reimbursement pathway for personal exoskeletons in 2024, which is expected to enhance access for Medicare beneficiaries, who represent about one-third of individuals living with SCI [2][3] Company Overview - Lifeward is a leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities, with a mission to drive innovation in rehabilitation and recovery [4] - The company has launched the ReWalk 7, a device designed to assist paralyzed individuals in standing, walking, and navigating everyday environments [3][4] Market Context - The decision by a major commercial health insurer to cover the ReWalk 7 is seen as a pivotal moment that could encourage other insurers to follow suit, thereby solidifying Lifeward's growth trajectory [2][3] - The ReWalk 7 received FDA clearance in March 2025 and was launched for sales in the U.S. on April 15, 2025, indicating a timely entry into the market [1][3]