Press release
Orthofix Receives 510(k) Clearance and CE Mark for TrueLok Elevate Transverse Bone Transport System
LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced it has received U.S.
About this update from Orthofix Medical Inc.
[{"type":"text","content":" LEWISVILLE, Texas--(BUSINESS WIRE)--\nOrthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250319068728/en/TrueLok™ Elevate Transverse Bone Transport (TBT) System\nTrueLok Elevate provides a limb preservation treatment option for addressing bony or soft tissue deformities and defects such as diabetic foot ulcers and nonhealing or deep tissue wounds. While the TBT procedure has previously been reported,1 TrueLok Elevate is the first dedicated system for TBT to receive FDA clearance. The product is currently available in a limited market release in the U.S. and select international markets.\n\n“Transverse bone transport with TrueLok Elevate now enables surgeons to effectively address challenging conditions in a patient’s extremity by allowing for an efficient and reproducible method to create a bone segment in the tibia that can then be gradually distracted over a period of several days,” said Dr. Emmy Oji, a podiatric foot and ankle surgeon at Valley Foot and Ankle Specialty Providers, who was among the first surgeons to apply the TrueLok Elevate system to a patient. “Clinical publications have shown this approach improves blood circulation to the affected limb and promotes wound healing in diabetic foot, potentially reducing the need for amputation.” Additionally, first patient cases in Europe were performed in the UK and Germany.\n\nAccording to the American Diabetes Association, over 160,000 amputations occur per year in the U.S. as a result of diabetic-related complications, representing a sizable market opportunity of approximately $1.2 billion. In addition, published studies have shown that patients with diabetic foot ulcers who receive an amputation have a five-year mortality rate of 57% and are burdened with lifetime healthcare costs of just over $640,000 for care directly related to their amputation.2,3 Therefore, TrueLok Elevate offers the potential to not only be a limb and cost-saving device, but most importantly, a life-saving solution to a challenging patient population.\n\n“The introduction of the True...