POLTX-FiberTM是一种防止感染和促进愈合的非抗生素伤口敷料,获得欧盟批准。
Polaroid Therapeutics gained EU approval for POLTX_Fiber™, a non-antibiotic wound dressing that prevents infection and promotes healing.
波拉罗伊德治疗公司已获得CE标志批准,用于使用其抗菌聚合物技术的POLTX_FiberTM,这是一种IIb类伤口包裹,使其能够防止细菌殖民,而不会释放抗菌剂.
Polaroid Therapeutics has received CE Mark approval for POLTX_Fiber™, a Class IIb wound dressing using its Antimicrobial Polymer Technology, enabling it to prevent bacterial colonization without releasing antimicrobials.
2026年2月23日经TüV Süd批准,根据欧盟第2017/745号MDR 2017/745号指令,在接触伤口液、保持潮湿环境和保护皮肤时,敷料形成凝胶。
Approved by TüV Süd on February 23, 2026, under EU MDR 2017/745, the dressing forms a gel when exposed to wound fluid, maintaining a moist environment and protecting skin.
其目的是在医疗监督下用于腿部、压力、糖尿病、外科和创伤外伤。
It is intended for use in leg, pressure, diabetic, surgical, and traumatic wounds under medical supervision.
该产品是按照ISO 13485标准制造的,标志着PTx的APTTM平台首次商业启动,通过临床和分销伙伴关系在选定的欧洲市场首次推出。
Manufactured under ISO 13485 standards, the product marks the first commercial launch of PTx’s APT™ platform, with initial rollout in select European markets through clinical and distribution partnerships.