ReShape Lifesciences has been awarded a US$300,000 Small Business Innovation Research (SBIR) grant for the development of ReShape’s Diabetes Bloc-Stim Neuromodulation (DBSN) device, The DBSN device utilises the compay’s proprietary vagus nerve block (vBloc) technology platform, combined with vagus nerve stimulation, for the treatment of Type 2 diabetes and metabolic disorders. Specifically, the grant will fund development of the device for the treatment of hypoglycaemia. The technology is currently protected by 48 issued and pending patents related to vBloc, glucose control, artificial intelligence and Bluetooth applications.
The ReShape DBSN utilises hypoglycaemia vagal nerve stimulation (HVNS) using an implantable pulse generator (IPG) in a closed loop with a continuous glucose monitor (CGM). The HVNS System consists of an IPG, stimulation electrodes/leads attachable to the posterior vagal nerve, a CGM and a programmer to alter settings for therapeutic customisation.
This dual vagus nerve neuromodulation selectively modulates vagal block and stimulation to the liver and pancreas to manage blood glucose in the treatment of diabetes and individualised glucose control. The technology has demonstrated safety and efficacy through experiments in diabetic swine utilizing a previous Phase I funding from a NIH SBIR grant.
“The award of our second NIH SBIR grant is a testament to the strength of the commercial opportunity of our novel DBSN device to address the significant, global diabetes market,” explained Paul F Hickey, President and Chief Executive Officer of ReShape Lifesciences. “With the assistance of a previous grant from the NIH, our team successfully completed the pre-clinical development of the device, which is able to adjust insulin production and potentially treat Type 2 diabetes. With this latest grant, we will now focus on the development of the DBSN™ to treat the metabolic disorder, hypoglycaemia. Severe hypoglycaemia negatively affects many diabetics, which can require intervention, cause loss of consciousness, stroke, coma or death. We are eager to further the development of the DBSN to bring an important therapeutic device to diabetes patients in need and help reduce their dependence on medications. We are committed to continuing the evaluation of DBSN, backed by a strong intellectual property portfolio, through potential strategic alliance opportunities and a non-dilutive funding strategy.”