CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

The extended agreement covers any European country. Inspira has signed summary distribution agreements with Innovimed in Poland, Czech Republic, and Slovakia, subject to completion of product development and regulatory approval, potentially generating over $130 million in revenues for the Company over seven years.

“Dravet syndrome is a rare and devastating form of childhood epilepsy in which there is an unmet need for patients whose seizures remain difficult to control and who experience significant side effects with current medications,” said Paolo Baroldi, PhD, MD, Chief Medical Officer of Bloom Science. “BL-001 shows promise as a novel treatment option that can change lives. With these results we plan to proceed into Phase 2 clinical development with doses we expect to be within the therapeutic window in both Dravet syndrome and ALS.”

“The 24-month data from the SENZA-PDN RCT show us high-frequency SCS is a viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time,” said lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. “These results further validate not only the efficacy of high-frequency 10 kHz SCS for pain relief, but also show profound improvements in quality of life, sleep, and neurological function.”

“We very much look forward to the analysis of the primary endpoint of this important trial at six months, as this is the first prospective randomized trial of a sirolimus-coated balloon in AVF patients with angiographic follow-up. Furthermore, we have also measured fistula volume flow rates, which is another key index of failing or maintained fistula function.   I thank MedAlliance for initiating a trial in this difficult patient population” commented Principal Investigator (PI) Dr. Konstantinos Katsanos, MSc, MD, PhD, EBIR, Associate Professor of Interventional Radiology, Patras University Hospital , Patras, Greece.

The Evoke® System is the First SCS System to Demonstrate Cost-Dominance at Two Years Post-Implant