9.3亿融资！创新械企完成B轮

Core Viewpoint - Apreo Health's Breathe™ airway stent represents a significant advancement in the treatment of severe emphysema, providing a minimally invasive solution that improves patient outcomes without the need for tissue removal [2][3][5]. Group 1: Product Overview - The Breathe stent is designed to relieve trapped air in the lungs by supporting collapsed bronchi and facilitating airflow, thus alleviating lung hyperinflation [5]. - It is a self-expanding airway stent system made from a nitinol coil, with a maximum diameter of 10mm and various lengths available (55, 70, 85, 100mm) [6]. - The stent's deployment success rate is reported at 98%, with manageable adverse events such as pneumonia (10%) and acute exacerbation of COPD (5%) [6][7]. Group 2: Clinical Trials and Data - Apreo Health has completed the BREATHE-1 and BREATHE-2 trials, which included 60 patients, and presented six-month data at the 2025 ATS annual meeting [6]. - The FDA granted the Breathe stent "breakthrough device" designation in May 2024, facilitating expedited review for subsequent clinical trials [7]. Group 3: Financing and Commercialization - Apreo Health raised $130 million in a Series B financing round, led by Bain Capital Life Sciences and Norwest, to support the BREATHE-3 registration trial and early commercialization efforts [8][9]. - The BREATHE-3 trial aims to enroll 250 patients across 25 centers in the U.S. and Europe, focusing on further validating the stent's efficacy [10]. Group 4: Market Strategy - Apreo Health is developing its manufacturing system, market access strategies, and reimbursement models concurrently with clinical trials to accelerate product availability [11]. - The company emphasizes a clinical and commercial preparation approach to enhance product uptake in the market [11]. Group 5: Broader Implications - The Breathe stent addresses a significant unmet need in the treatment of emphysema, where less than 1% of patients currently receive surgical interventions [3]. - Its design allows for a broader patient population due to its non-reliance on collateral ventilation and simpler bronchoscopic implantation process [15].