−Removed: and Facilities
−Removed: lease a 14,507 square foot manufacturing facility in Irvine, California under a lease that expires on September 30, 2027.
−Removed: is designed expressly for the manufacture of biologic vascular grafts and is equipped for research and development, prototype fabrication,
−Removed: cGMP manufacturing and shipping for Class III medical devices, including biologic cardiovascular devices.
−Removed: We believe that our facilities
−Removed: are sufficient for the near future as there is present capacity to manufacture up to approximately 24,000 venous valves per year to meet
−Removed: potential market demands.
−Removed: and Safety Disclosure
+Added: of December 31, 2025, we lease a 14,507 square foot manufacturing facility in Irvine, California under a lease that expires on September
+Added: Our facility is designed expressly for the manufacture of biologic vascular grafts and is equipped for research and development,
+Added: prototype fabrication, cGMP manufacturing and shipping for Class III medical devices, including biologic cardiovascular devices.
+Added: that our facilities are sufficient for the near future as there is present capacity to manufacture up to approximately 20,000 venous
+Added: valves per year to meet potential market demands.
+Added: Legal Proceedings
+Added: Mine and Safety Disclosures
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.