Medtronic announced it has expanded its partnership with Nutrino to integrate an updated FoodPrint App with the iPro2 professional CGM. Below, FENIX provides insight into the potential impact of the new feature and future application.
A Montreal-based research group presented data at ADA on a dual-hormone artificial pancreas using both insulin and pramlintide. The study, presumed to be the clinical trial MAP-1, showed significantly improved glucose levels compared to an insulin-only artificial pancreas. Below, FENIX has provided context and insight regarding this study and its potential implications to the AP development space.
The FIGS-2 trial for GlySens’s implantable CGM, Eclipse, has completed according toCT.gov- two and a half years after the originally scheduled completion date of December 2015. The primary endpoint of the 20-subject study was adverse events. FENIX has conducted a headwinds/tailwinds analysis of the Eclipse system in the context of the larger CGM market.
A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.
J&J announced it has accepted a final offer from Platinum Equity for the acquisition of the LifeScan BGM business. Recall, the offer was made in March 2018, and according to the press release, the transaction is anticipated to close by YE ’18.
Dexcom announced that CMS is updating its mobile device policy to allow for G5 CGM data to be viewed and shared on a mobile device. Previously, Medicare would not reimburse Dexcom G5 if patients paired the CGM to a smartphone. Additionally, Dexcom presented at William Blair in addition to announcing that G6 CGM has received CE Mark.
The CT.gov record for Novo’s pediatric Victoza study (ELLIPSE) has recently been updated to “completed.” Assuming Novo files ELLIPSE by the end of Q2 ’18, approval is projected in H1 ’19 with an 8 to 10-month review. Below, FENIX provides implications and market context for the Victoza pediatric label update.
Zealand has announced positive topline results from its Ph3 dasiglucagon immunogenicity study. Recall, in March 2018, the company reported results stating the trial met primary and secondary endpoints.
Senseonics and Beta Bionics announced a new collaboration to integrate the Eversense implantable CGM with the iLet bionic pancreas. Below, FENIX analyzes the collaboration including statements from the companies that suggest iCGM systems can be switched between closed-loop systems.
In the second installment of our post-AACE 2018 promotional material coverage (see first installment on diabetes drugs), FENIX has conducted an analysis of diabetes device promotional materials covering Dexcom G6, Abbott Freestyle Libre, Medtronic 670G, Insulet Omnipod, and Tandem t:slim X2.