List of Medical Device Companies in South Carolina - 2

CeQur®, a medical device company dedicated to simplifying mealtime insulin delivery for individuals on multiple daily injections, manufactures CeQur Simplicity, a simple-to-use wearable insulin delivery device enabling discreet, convenient and injection-free bolus dosing. In June 2024, the company announced the FDA's recent 510(k) clearance of CeQur Simplicity for an extended wear duration from 3 to 4 days. One CeQur Simplicity 4-day wearable patch holds up to 200 units of rapid-acting insulin administered in two-unit increments and replaces, on average, twelve daily mealtime injections over four days. CeQur is headquartered in Horw, Switzerland. Please visit myceqursimplicity.com for more information.

Spectral Medical is a Phase 3 company advancing the fight against endotoxic septic shock through an innovative theranostic approach. This unique strategy combines the EAA™ Endotoxin Activity Assay, the only FDA-cleared diagnostic for the risk of developing sepsis, with targeted rapid therapy using Toraymyxin™ (PMX). PMX is a Polymyxin B extracorporeal direct hemoadsorption column which is highly effective in removing endotoxin in the bloodstream. Already approved in Japan and Europe (1994 and 2002 respectively), PMX has been safely used on over 340,000 patients. Spectral holds exclusive U.S. development and commercialization rights for PMX since 2009, with a distribution agreement for Canada since 2010. In July 2022, the FDA granted Breakthrough Device Designation to PMX for treating endotoxic septic shock, a condition that affects around 330,000 people in North America annually. Spectral is currently conducting the Tigris Trial, a confirmatory study evaluating PMX combined with standard care vs. standard care alone in a 2:1 randomized trial of 150 patients, utilizing Bayesian statistics to assess its effectiveness. The trial methods are detailed in the Critical Care publication “Bayesian methods: a potential path forward for sepsis trials." https://doi.org/10.1186/s13054-023-04717-x