Medtronic plans to bring next-gen diabetes tech to FDA this fiscal year, no spinoff planned


2021-11-24 03:30:10 Mass Device


The Medtronic MiniMed 780G system. [Image from Medtronic]Medtronic confirmed that it anticipates major regulatory steps for its next-generation insulin pump and sensor during this fiscal year. Medtronic’s fiscal years wrap up at the end of April. Speaking on the company’s second-quarter earnings call, Chair & CEO Geoff Martha said Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 sensor for continuous glucose monitoring (CGM) to drive growth once approved, with the company currently in talks with the FDA. “We’ve got a really strong uptake of 780G and Guardian 4 outside the U.S. and inside the U.S., we’re waiting for that approval to come through,” Medtronic EVP & President of its Diabetes Operating Unit and Cardiovascular Portfolio Sean Salmon said on the call. “We’re making progress with the FDA.” Previous generations of MiniMed insulin pumps have come under scrutiny. Still, Medtronic as recently as last month touted one-year clinical data for the next-generation MiniMed 780G with Guardian 3 in children. Company officials expect Guardian 4 to deliver positive outcomes as well. Additionally, Martha touched on the Simplera disposable CGM sensor (formerly Synergy), which he touted as half the size of the Guardian 4 sensor. The company expects to bring the Simplera sensor to the FDA later this fiscal year. Finally, when asked by an analyst if Medtronic had any plans to spinoff its diabetes business, Martha said there are no current plans, but the executive committee at the medtech giant is spending “a lot more time” looking at portfolios and capital allocation to “make sure we’re the right owner.” “I do see opportunities,” Martha said. “I’m not signaling anything, but I can tell you this is something we’re constantly looking at. I don’t see ourselves as [General Electric] or [Johnson & Johnson] with dramatically different businesses, but I do believe it is an opportunity over time.”
美敦力最小780g系统。[图片来自美敦力]美敦力(纽约证券交易所代码:MDT)证实,预计将在本财年对其下一代胰岛素泵和传感器采取重大监管措施。 美敦力的财政年度将于4月底结束。 在公司第二季度财报电话会议上,董事长兼首席执行官杰夫·玛莎(Geoff Martha)表示,美敦力预计,一旦获得批准,其配有Guardian 4连续葡萄糖监测传感器(CGM)的最小780g胰岛素泵系统将推动增长,该公司目前正在与美国食品和药物管理局进行谈判。 美敦力糖尿病手术部和心血管组合总裁肖恩·萨蒙(Sean Salmon)在电话中说:“我们在美国境外和境内都有780G和Guardian 4的强劲吸收,我们正在等待批准。”“我们正在与美国食品和药物管理局取得进展。” 前几代最小化胰岛素泵已经受到审查。尽管如此,美敦力上个月还吹捧下一代儿童监护人3的一年临床数据最低可达780g。公司官员预计《卫报4》也将带来积极的结果。 此外,玛莎谈到了Simplea一次性CGM传感器(以前的Synergy),他吹捧它是卫报4传感器的一半大小。该公司预计在本财年晚些时候将Simplera传感器提交给FDA。 最后,当一名分析师问及美敦力是否有剥离糖尿病业务的计划时,玛莎表示,目前没有计划,但这家美敦力巨头的执行委员会正在花“更多的时间”研究投资组合和资本分配,以“确保我们是正确的所有者”。 “我确实看到了机会,”玛莎说。“我没有发出任何信号,但我可以告诉你,这是我们一直在关注的事情。我不认为自己是(通用电气公司)或(强生公司)有着截然不同的业务,但我确实相信随着时间的推移,这是一个机会。“