PlasmaSure™ Receives FDA Breakthrough Device Designation
Ilan Uchitel, CEO & Co-Founder of CAPS Medical, commented: “Receiving Breakthrough Device Designation is a strong validation of the clinical need for a safer, more accessible solution for NMIBC patients and of the differentiated potential of our PlasmaSure™ platform. This designation provides priority review and interactive communication with the FDA, more flexible clinical study design, and promising potential eligibility for CMS’s Transitional Coverage for Emerging Technologies pathway, supporting earlier and more predictable reimbursement.Our team is committed to turning this innovation into a new standard of care.”
Share:
More News
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.