BD’s Type 2 Patch Pump Filed with FDA, CE Mark Application in the Works – Still Slated for Limited Launch by End of 2019


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BD Medical Segment President Mr. Alberto Mas confirmed that the type 2 patch pump is on track for a “deliberate, cautious” limited launch by the end of 2019 (calendar year).

In line with expectations from the 3Q18 call, the device has been filed with FDA, and a CE mark application is in the works. Critical for a disposable patch pump, initial manufacturing lines are up and running, and management is comfortable that production will not be an issue. In Q&A, one analyst asked about historical uptake challenges for pumps in type 2 diabetes – how will BD be different? Mr. Mas boiled down his response to components: (i) BD has done a number of clinical trials, gaining insight not only on the product, but also on its use and ecosystem; (ii) The pump will be complemented by the Briight app (AI chat and diabetes education), which will help with “compliance” and other lifestyle aspects (we note that Briight is still early, with 10,000+ total installs on Google Play); (iii) BD has placed an emphasis on access, evidence generation, and value proposition for payers – all components of a successful launch (it’s been promised to be priced on par with pen therapy); and (iv) The limited, sequential launch approach offers the ability for BD to gain insights before taking the next step, “though it’ll take some time.” Mr. Mas concluded that the long-term prospects of this pump are fantastic, and that BD is “very committed” to it. We’re glad to hear this, since diabetes device R&D from BD has been rough over the past few years, including discontinuing the CGM program, discontinuing its work on microneedles, and discontinuing its FlowSmart infusion set (MiniMed Pro-set).