# Hypoglycemia Vagal Nerve Stimulation Therapy (HVNS Therapy)

> **NIH NIH R43** · RESHAPE LIFESCIENCES, INC. · 2022 · $300,000

## Abstract

Project Summary/Abstract
30.3 million Americans are diabetic w/ 1.5 million new cases per year. Hypoglycemia negatively affects
diabetics. The average type 1 diabetic experiences 2 symptomatic hypoglycemia episodes/week. Severe
hypoglycemia (need for 3rd party assistance) results in 1.0 – 1.7 episodes per patient per year. Annually, 73%
of insulin dependent type 2 diabetics experience hypoglycemic episodes and 15% have severe episodes.
Hypoglycemia can cause loss of consciousness, stroke, coma or death with repeated episodes linked to
cardiovascular disease. Treatments typically involve consuming 15 grams of fast-acting carbohydrate.
However, this treatment is not ideal for nocturnal hypoglycemia & contraindicated for severe hypoglycemic
episodes. Insulin pumps w/ glucose sensor technology decreases hypoglycemia risk, but it still remains a
meaningful problem. Less than 1% of insulin dependent diabetics use insulin pumps with issues of
maintenance and tolerance required by continuous use of an external device. Thus, there is need for new
treatment modalities for hypoglycemia. ReShape Lifesciences Inc. is developing an innovative approach to
hypoglycemic control involving hypoglycemia vagal nerve stimulation (HVNS) using an implantable pulse
generator interacting with a continuous glucose monitor (CGM). The HVNS System consists of an implantable
pulse generator, stimulation leads attachable to posterior vagal nerve, a CGM and an external
programmer to alter parameters to customize therapeutic effect. This HVNS system has shown efficacy by
increasing plasma glucose (PG) in diabetic rat and diabetic pig models following insulin administration. We
hypothesize that HVNS of PVN cranial to the celiac branch (shown to increase glucagon release) is an
effective method to increase PG to a safe level during hypoglycemia. This NIH-SBIR Phase I study will
successfully demonstrate feasibility of the HVNS system with the following specific aims: Specific Aim 1:
Develop minimally invasive electrodes implantation technique. Specific Aim 2: Determine Effectiveness of
HVNS and Non-Inferiority to Intranasal Glucagon. Specific Aim 3 Determine change in glucagon and insulin
w/HVNS. Specific Aim 4 Determine the safety of stimulation on vagus nerve by demonstration of healthy
nerve, pancreas, brain and liver histopathology ReShape Lifesciences has assembled an experienced team to
complete this project which was previously developed HFAC technology to block sub-diaphragmatic vagus
nerve for commercial use. The successful completion of this NIH SBIR Phase I study will allow an application
for Phase II funding allowing the further development of HVNS hardware, larger scale Good Laboratory
Practices (GLP) safety and efficacy studies in swine and development of regulatory strategies leading to the
initiation of human trials.

## Key facts

- **NIH application ID:** 10599574
- **Project number:** 1R43DK135147-01
- **Recipient organization:** RESHAPE LIFESCIENCES, INC.
- **Principal Investigator:** JON James WAATAJA
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2022-09-20 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10599574

## Citation

> US National Institutes of Health, RePORTER application 10599574, Hypoglycemia Vagal Nerve Stimulation Therapy (HVNS Therapy) (1R43DK135147-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10599574. Licensed CC0.

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