FDA approves BioStage’s esophageal device investigational new drug application

FDA 批准 BioStage 公司的食管装置研究新药申请

2020-03-26 11:00:23 Mass Device


Biostage  this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was implanted in a 75-year old male patient who had a life-threatening cancerous mass in his chest. “FDA’s approval of Biostage’s first IND is an extremely important milestone for Biostage as it will transition Biostage into a clinical-stage company. In addition, establishing a safety profile for the CEI in adults will facilitate and support the use of the CEI in Esophageal Atresia patients,” chairman Jason Jing Chen said in a news release. “Esophageal Atresia (EA) is a congenital condition in infants who are born with an incomplete esophagus and are unable to receive oral nutrition. We believe the CEI will be a significant advancement for EA and will provide a treatment option that will hopefully change the standard of care for these infants.” The approval will allow the company to investigate the safety and feasibility of the implant in adult patients. “The use of the CEI is an organ saving approach that reserves the esophagus while treating conditions that would otherwise require the use of other organs to repair the diseased tissue,” chief scientific officer William Fodor said. “Our next goal is focused on ‘clinical readiness’ and to build upon our expertise in the clinical application of tissue-engineered and cell-based products,” Fodor said. “This is an exciting time for Biostage to establish itself as a leader in the clinical application of the regenerative medicinal products, such as the CEI, where the product provides the stimulus and the foundation for the body to heal itself.”
BioStage本周宣布,其细胞跨度食管植入剂研究的新药申请获得 FDA 批准。 细胞跨度食管植入物被设计用于治疗终末期食道病患者,需要手术切除以修复病变组织。 Biostage 公司于2017年8月宣布首例患者接受食管植入治疗。这个装置被植入一个75岁的男性病人,他的胸部有致命的癌肿。 “ FDA 批准 Biostage 的第一个 IND 是 Biostage 的一个极其重要的里程碑,因为它将把 Biostage 转变为临床阶段的公司。此外,在成人患者中建立 CEI 安全档案将有助于和支持 CEI 在食管癌患者中的应用,”主席 Jason Jing Chen 在新闻稿中说。“食管反流症( EA )是婴儿的先天性疾病,婴儿出生时食管不全,无法接受口腔营养。我们相信 CEI 将是 EA 的一个重大进步,并将提供一种治疗选择,有望改变这些婴儿的护理标准。” 该批准将允许公司调查成人患者植入的安全性和可行性。 “使用 CEI 是一种保存食道的器官方法,它可以保留食道,同时治疗其他需要使用其他器官修复病变组织的条件,”首席科学官威廉·佛多( William Fodor )说。Fodor 说:“我们的下一个目标是专注于‘临床准备工作’,并在组织工程和基于细胞的产品的临床应用方面积累我们的专业知识。”“对于 Biostage 来说,这是一个令人兴奋的时刻,它将自己确立为再生医学产品(如 CEI )临床应用的领导者,在 CEI 中,该产品为身体自我疗愈提供了刺激和基础。”