RESHAPE LIFESCIENCES INC — Department of Health and Human Services SBIR Phase I: NIDDK

Description

Project Summary Abstractmillion Americans suffer from TypeDiabetes MellitusT DMandmillion pre diabetics risk becoming diabetic There is need for treatments providing improved efficacydurability and that is customized to patient s complianceNeuromodulation of nerves innervating organ systems that regulate plasma glucosePGmay be a method for treating T DMStandalone stimulation or ligation of the vagus nerve has undesirable resultsLittle is knownhoweverof the effect on PG with combined dual neuromodulation consisting of adjustable pacing simulation of fibers innervating the pancreasincreasing insulin secretionwith simultaneous adjustable and reversible electrical blockade of neuronal fibers innervating the liverpreventing glucose releasein a T DM animal modelWe used a proprietary bio electronic device and algorithm developed by Enteromedics Inccomprising a pacing stimulationHzof the celiac branch of the vagus nerveinnervating the pancreaswith a simultaneous reversible high frequency alternating currentHFACinduced blockade of the hepatic branchinnervating the liverThis technology is termed Diabetes Blocking Stimulation NeuromodulationDBSNExperiments were conducted in T DM Zucker rats and a pig model of T DMWe measured PG following an IV or oral glucose toleranceOGTTtest with DBSNIn a T DM pig model chronic study when subjected to DBSN blood glucose was significantly decreased following an OGTT compared to ShamDBSNarea unitsAUvs ShamAUanalyzing the area under the curveIn a T DM rat study a similar and significant result was observed with DBSNAUcompared to ShamAUThere was no significant difference from Sham compared to Vagotomy or Stimulation aloneMuch was learned with these studieshoweverthere is still important information that needs to be gatheredFirst would be to investigate if delivery of DBSN at time points following an OGTT will still be affective at increasing glycemic controlSecond we need to investigate if a multiplex algorithm would be affective at increasing glycemic controlFinally the safety of DBSN needs to be tested by histology of organs that the celiac and hepatic branch innervateProject Narrative Current TypeDiabetes Mellitus treatments include life style managementpharmaceuticals and may include bariatric surgery for the morbidly obeseEnteromedic s Diabetes Block Stimulation Neuromodulation TherapyDBSN Therapyprovides a disruptive therapy in which an implantable neuromodulation device blocks nerve impulse along the hepatic branch of the vagus nerve while concurrently stimulating the celiac branch of the vagus nerve to reduce blood glucose levelsIn so doingnegative side effects of pharmaceutical therapies and bariatric surgeries are avoided and patient compliance with therapy improves