Memorandum
PROMISE 180-day study enrolls ~180 US participants; No update on PMA supplement for calibration reduction
Senseonics announced on Thursday that it has submitted a PMA supplement to the FDA for a non-adjunctive (insulin dosing) label claim for the 90-day implantable Eversense CGM. This timing is in line with the November call, when a PMA supplement for non-adjunctive dosing was slated for submission “in the coming weeks.”
In the same press release, Senseonics announced that the first US participant received the 180-day Eversense XL CGM as part of Senseonics’ pivotal clinical trial to support FDA submission. (The great Dr. Mark Christiansen performed the first 180-day US insertion.) This timing is also in line with the November call, which expected the first 180-day study insertions within “the next couple of months.” The multi-site, PROMISE clinical study will evaluate the safety and efficacy of Eversense XL in ~180 people with diabetes – an increase from the previously expected 125 participants. We were unable to locate the study on clinicaltrials.gov. Eversense XL received CE Mark approval in 2017 and as of the 2Q18 call in August was available in all OUS markets. Kelly, major supporter of all CGM for all people taking insulin or SFUs, got an Eversense in December and is absolutely loving it – she is very impressed with the accuracy, the ease of use, and she loves that there is another option for patients. What a strong market in a very competitive and exciting field. She’ll have an upcoming longer review in diaTribe.
It’s great to see Senseonics forging ahead on its US pipeline and hitting its milestones, and we’ll be listening in the 4Q18 call for an update on a PMA supplement for calibration reduction; as of November this was the other main US pipeline priority. The press release also mentioned that a PMA supplement for removal of Eversense’s MRI contraindication was submitted – more good news, the leadership team is really getting so much done.
--by Maeve Serino, Adam Brown, and Kelly Close