Thursday, April 29, 2021
Orthofix Medical Inc., a global medical device company with a spine and extremities focus, today announced they have entered into an exclusive license agreement to commercialize the innovative portfolio of Italy-based IGEA S.p.A’s bone, cartilage and soft tissue stimulation products in the U.S and Canada.
Under terms of this agreement, Orthofix has the rights to pursue U.S Food and Drug Administration approvals and commercialization of IGEA’s platform of orthopedic products, which are not currently available in the U.S. These products, which will be marketed under the Orthofix brand, will expand Orthofix’s bone growth therapies portfolio of Pulsed Electromagnetic Field (PEMF) products with additional treatment modalities and indications such as Low-Intensity Pulsed Ultrasound (LIPUS) and Capacitive Coupling (CC) for fracture management. The license also includes innovative, new technology applications designed to address joint inflammation, pain, and cartilage protection.
“Orthofix is the U.S. market leader with our PEMF technology bone growth stimulation systems indicated for post-operative spinal fusions and treating bone fractures that have not healed after surgery, and IGEA is the European market and technology leader for bone and joint stimulation,” said Orthofix President and Chief Executive Officer Jon Serbousek. “Combined, these portfolios will enable us to offer physicians and patients additional treatment solutions for fracture management and complement our pursuit of new indications for managing soft tissue and joint health such as our ongoing rotator cuff repair IDE clinical study.”
Founded 40 years ago at the University of Modena, Italy, IGEA is a leader in the manufacturing and distribution of bone and joint cartilage stimulation systems which include stimulation modalities of LIPUS, PEMF and capacitive coupling. Outside of the U.S. more than 20,000 patients are treated every year with their products.
“As a company with a long history of treating patients in Europe, we are excited to enter into this agreement that will expand the availability of our bone and joint cartilage systems to patients in the U.S.,” said IGEA President, and founder Dr. Ruggero Cadossi. “Aligning with Orthofix’s expertise and distribution in the stimulation market enables us to provide even more physicians access to our innovative products to improve patient outcomes.”