Building a commercially scalable bionic pancreas for automated diabetes management

Through ayear collaboration between Boston UniversityBUand the Massachusetts General HospitalMGHwe have built insulin only and bihormonalconfigurations of our bionic pancreasBPand extensively tested them in inpatientoutpatientand real world home use studies in people with typediabetesT DWe have also conducted preliminary clinical studies testing the insulin only configuration of our BP in people with typediabetesT Dand the glucagon only configuration of our BP in people with chronic hypoglycemiaOver the pastyearswe have built and tested progressive generations of a stand alonefully integratedBP devicewhich we call the iLetthat integrates our micro precision dual infusion pump with a continuous glucose monitorchoice of either the Dexcom or Senseonicsand our clinically tested suite of mathematical control algorithms that autonomously determine and command insulin and glucagon doses based on continuous sensor glucose dataThe development effort of the iLet platform began in the Co PIandapos s lab at BU inand was then translated to Beta Bionics in JanuaryDevelopment of the third generation iLetthe GeniLettook place at Beta Bionics throughoutand into earlyOur clinical partners at MGH and Stanford University will begin clinical trials testing the GeniLet in a home use setting in adults with T D in MayThe objective of this Fast Track application is to integrate all of the cumulative experiencetechnologyand innovation that we have assembled in the GeniLetinto the design and development of a highly reliableeasily serviceableand commercially scalableGeniLetwhich is intended for broad distribution in the US and other worldwide marketsThe objective of Phase I of this project is to leverage what we learn from the preclinical and clinical studies of the GeniLet to informdefineand implement the final design and use requirements of our commercially scalable GeniLet and iLet disposables and to build the first clinical ready devices suitable for the final pivotal trial required for a premarket approvalPMAapplication to the FDAThe objective of Phase II is to progressively improve automation and scalability in the manufacturing and distribution processes that will make the GeniLet commercially viable and widely accessible to meet the largest possible demand it will need to serveThese objectives will be achieved with the following specific aimsto implement the final design and use requirements of our commercially scalable GeniLetand its associated disposableswhich will be informed by data obtained from clinical studies of our GeniLet systemand then to build the first clinical ready prototypes of the GeniLet system and submit the investigational device exemptionIDEapplication to the US FDA for the GeniLet systemandto acquireinstalland validate manufacturing machinery that will transition several of our manual assembly processes to fully or partially automated processesthus optimizing the efficiency of our manufacturing operations by continuously improving and advancing the process and technology used in the production of the GeniLet and iLet administration set Goodconsistent management of blood sugar levels in people with typediabetes is essential to preventing and minimizing health complicationsWe have developed a new fully integrated and wearable bionic pancreas medical devicereferred to as the iLetthat will automatically manage blood sugar levels in people with typediabetes and thus reduce the burden of diabetes careThe aims of this project areto leverage the clinical data gathered using our investigational iLet system to implement the final design and use requirements for our commercial iLet systemand then to build the first clinical ready prototypes of our commercial iLet system and submit the investigational device exemptionIDEapplication to the US FDA for the commercial systemandto acquireinstalland validate manufacturing machinery that will automate and optimize manufacturing operations used in the production of the iLet and iLet accessories