MOLLI Surgical Competitors

Lungpacer Medical, Inc., is a privately held medical device company focused on improving respiratory and critical care medicine. Headquartered in Vancouver, Canada, and with US offices in Exton, Pennsylvania, Lungpacer Medical is dedicated to designing non-surgical, minimally invasive technologies to ventilate patients more safely and effectively. The Lungpacer Diaphragm Pacing Therapy System™ is the first, minimally invasive, temporary transvenous diaphragmatic neurostimulation system that has FDA Emergency Use Authorization (EUA) for use during the COVID-19 pandemic. This non-surgical, non-implanted, diaphragm stimulation therapy is delivered via a central venous catheter (Lungpacer IntraVenous Electrode - LIVE Catheter®), similar to catheters currently placed in mechanically ventilated ICU patients. The LIVE Catheter is intended to stimulate the diaphragm in conjunction with an invasive mechanical ventilator. This device is designed to strengthen a weakened diaphragm already atrophied by mechanical ventilation (also known as VIDD) which may help patients wean off the ventilator more rapidly. The Lungpacer DPTS has neither been cleared or approved for the indication to assist in weaning patients off ventilators in healthcare settings during the COVID-19 pandemic. The Lungpacer DPTS has been authorized for the above emergency use by FDA under an EUA. The Lungpacer DPTS has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. For more information on Emergency Use Authorization visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices.

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

Izotropic is a a medical device company commercializing imaging-based products utilizing innovative and emerging technologies for the more accurate screening, diagnoses, and treatment of breast cancers.