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.

Endotoxic septic shock is a life-threatening form of septic shock associated with elevated endotoxin activity, organ failure and a high risk of death. Spectral Medical is focused on this urgent clinical challenge through a targeted approach that pairs the EAA™ Endotoxin Activity Assay with Toraymyxin™ (PMX), a hemoadsorption device designed to remove endotoxin from the bloodstream. The EAA is an FDA-cleared rapid in vitro diagnostic test that measures endotoxin activity in whole blood. PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada and has been used in more than 360,000 treatments worldwide. In July 2022, PMX received FDA Breakthrough Device Designation for the treatment of endotoxic septic shock. Results from Spectral’s U.S. Phase 3 TIGRIS trial, published in The Lancet Respiratory Medicine (DOI: 10.1016/S2213-2600(26)00047-0), demonstrated a high posterior probability of mortality benefit with PMX at 28 and 90 days. 12-month follow-up subsequently showed that the mortality difference favouring PMX was maintained through one year (https://spectraldx.com/newsroom/) PMX is not approved for clinical use in the United States. Its Premarket Approval application is currently under FDA review. Follow Spectral for updates on the PMX FDA review and TIGRIS trial, along with new research, clinical insights and educational content on endotoxin activity, endotoxic septic shock, and precision approaches to blood purification.

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.