Percutaneous stellate ganglion stimulation in septic shock to improve hemodynamics and vasopressor requirements during transport

The National Heart, Lung, and Blood Institute awarded $293,759 to Coridea, LLC on August 15, 2026, under the Cardiovascular Diseases Research SBIR program (CFDA 93.837) to develop a closed-loop percutaneous stellate ganglion nerve stimulation (SGNS) system for hemodynamic support in septic shock.

Coridea will engineer a custom percutaneous neurostimulation lead with imaging-visible electrodes and fixation features to enable stable, reproducible access to the left stellate ganglion during patient transport. The Phase I effort addresses technical barriers to clinical deployment of SGNS, which modulates sympathetic output to increase arterial pressure through enhanced cardiac contractility and vascular tone without raising heart rate. Preclinical data demonstrates SGNS can raise mean arterial pressure by over 15 millimeters of mercury in septic and non-septic animal models with rapid onset and titratable response. By reducing or eliminating the need for high-dose vasopressor support, the system aims to decrease vasopressor-associated complications—digital ischemia, splanchnic injury, kidney failure, and multi-organ dysfunction—particularly in rural and underserved communities where access to critical care is delayed or unavailable.

Performance occurs in New York, New York, with a period of performance from August 15, 2026, through August 14, 2027. Coridea is a self-certified small disadvantaged business focused on minimally invasive medical device development.

Abstract

Septic shock is a leading cause of death in non-cardiac intensive care units, with over 1.7 million U.S. Cases annually and mortality exceeding 250,000. Characterized by loss of vascular tone and hemodynamic collapse, IT often requires high-dose vasopressor support to maintain perfusion. However, pressors have narrow therapeutic margins and carry significant risks, including digital ischemia, splanchnic injury, kidney failure, and multi-organ dysfunction, particularly at the high doses required for septic shock. These side effects disproportionately impact patients in rural and underserved communities, where access to critical care and timely vasopressor titration may be delayed or unavailable. We are developing a novel neuromodulation system for on-demand hemodynamic support via left stellate ganglion nerve stimulation (SGNS), with the goal of reducing or eliminating the need for high-dose vasopressors. SGNS modulates sympathetic output, increasing arterial pressure by enhancing cardiac contractility and vascular tone without elevating heart rate. Preclinical data from our group and others confirms that SGNS can raise mean arterial pressure by over 15 mmhg in septic and non-septic swine models, with rapid onset and offset and titratable response. While prior work has demonstrated physiologic feasibility, clinical deployment of SGNS has been limited by technical barriers: lack of portable stimulators, inability to precisely and reproducibly access the stellate ganglion percutaneously, and the need for continuous specialist oversight. This phase I sbir will focus on development of complete closed-loop SGNS system composed of 1. Custom percutaneous neurostimulation lead with imaging-visible electrodes and fixation features for secure placement that will provide stable access to the stellate ganglion during transport. Lead under development consists of four platinum-iridium electrodes (1.3 X 2 MM) spaced at 2 MM intervals, dual elastomeric retention tines, and a flexible, radiopaque shaft. Early prototypes confirm feasibility of the design using FDA-cleared materials. 2. Portable, battery-powered stimulator with real-time sensing and autonomous stimulation control. This microcontroller-based stimulator is based on a ESP32 platform capable of real-time ECG and arterial pressure acquisition, stimulation gating, and current modulation. IT communicates with a python-based GUI for real-time parameter control and visualization. By the end of phase I, we will deliver a fully functional prototype system ready for preclinical safety and efficacy studies under a future phase II grant. Our platform holds promise for transforming the management of septic shock, enabling rapid, pressure support in rural and pre-hospital environments where time and safety are paramount.