Lewisville, Texas-based Orthofix Medical Inc. and Villanova, Italy-based LimaCorporate S.p.A. have announced a licensing partnership to provide a solution to the U.S. market for patients suffering from chronic high dislocation of the hip.
The companies are bringing together the “limb-lengthening technology of Orthofix’s patented Fitbone™ intramedullary nail system with LimaCorporate’s proprietary, patient specific, 3D-printed pelvic fixation device.” According to the press release, after the solution is surgically implanted, “the devices work together with the aim of allowing surgeons to distract the femur to an anatomically-correct position thereby correcting the leg-length discrepancy, reducing strain on the spine, and allowing for a total hip replacement to follow.”
The solution does not currently have U.S. Food and Drug Administration (FDA) clearance. It is only available to patients through an FDA Compassionate Use Exemption.
Last year, LimaCorporate opened its ProMade Point of Care Center (PoC Center), its first U.S. based manufacturing facility based in New York City. LimaCorporate’s ProMade 3D-printed custom service is based at its PoC Center.
For OTW’s coverage of the opening of the PoC Center, see “HSS, LimaCorporate Create In-Hospital 3D Printing Facility!”
Professor Rainer Baumgart, M.D. is the surgeon-inventor of the Fitbone limb-lengthening system. The system includes an intramedullary nail that is implanted, a subcutaneously implanted receiver, and an external control set. The external control allows the patient to control the distraction phase.
Dr. Baumgart commented, “This new treatment method has shown compelling results demonstrating improved patient outcomes in this challenging cohort, and I am pleased to see this procedure now being made available to surgeons in the U.S.”
In a note to investors regarding the partnership, Ladenburg Thalmann & Co. Inc. analysts gave a BUY rating to Orthofix Medical. The analysts stated in part “We believe Orthofix Medical Inc. should be valued in comparison with other established technologically advanced orthopedic, skeletal, and biologic medical device companies within the healthcare equipment sector.”
The analysts added “We have determined that the company’s valuation should be an average of three metrics; enterprise value/revenues, price/earnings, and EBITDA which yields a price target of $51.50.”
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