TheraCell announces the first use of TheraFuzeDBF®Fiber Anchor™ surgery for pedicle screw augmentation


TheraCell completed the first three surgical cases with TheraFuzeDBF®Fiber Anchor™, providing surgeons with improved screw fixation and bone protection
Los Angeles, November 3, 2020-PR Newswire/-The leading bone technology company TheraCell Inc. today announced that it has completed the first three spinal surgery cases using the world’s first desalted bone fiber screw anchor Surgery cases. This unique product acts much like a drywall anchor and can immediately improve screw fixation in major situations and renovation situations.
“The improved fixation is obvious when the screw is inserted. The fiber anchor can change the rules of the game.” Dr. Neel Anand, MD
One of these cases was done by Dr. Neel Anand, MD. Orth. (Liverpool), FAAOS, Professor of Orthopedic Surgery and Director of Spinal Trauma, Cedar Sinai Medical Center, Minimally Invasive Spine Surgery, DOCS Surgery Hospital, Beverly Hills. This case was a revision of adult MIS deformity of T-11 to I bone, and bilateral fracture at the level of pseudoarthritis. Dr. Anand used fiber anchors to fix the screws at three levels. In addition, he combined two TheraFuzeDBF®Fiber Wraps™ with 10cc TheraFuze DBF FiberForm™+ in two stages.
“In this case, I am very interested in using fiber anchors because of the huge potential for improved fixation at the proximal and distal ends of the structure. The improved fixation is tactilely obvious when the screw is inserted, and the whole process is very simple and It is suitable to easily complete the routine process of pedicle preparation and screw placement. The fiber wrap film also left a deep impression on me: we wrapped the fiber wrap with some autologous bone grafts and TheraFuze DBF containing mineralized cortical fragments Made four “burrito”. The position is very easy and easy to control. The fiber anchor and fiber winder have changed the rules of the game. I plan to arrange other operations and will continue to use these products.
The second case was completed by Dr. Anis Mekhail, an orthopedic spine surgeon, assistant clinical professor of orthopedics at the University of Illinois at Chicago. Dr. Mekhail confirmed the concept of pedicle screw enhancement using fiber anchors. He plans to actively use the technology on appropriate patients in the future instead of PMMA.
The third case was completed by Dr. Frank Phillips, Ronald DeWald, Distinguished Professor of Spinal Deformities, Director of Spine Surgery Division, and Head of Minimally Invasive Spine Surgery at Rush University Medical Center . Dr. Phillips used fiber anchors in revision deformity surgery to add S2AI (sa bone) screws to the tail end of the deformed multi-stage instrument fusion cage. Dr. Phillips said: “During the operation, it is easy to find that S2AI screws with fiber anchors have been added, and excellent screw fixation has been obtained. This technology adds tremendous value to longer deformed structures. The consequences of the loss of hardware fixation and failure of integration are very serious. A major concern.”
Curt Cooper, Chief Business Development Officer of TheraCell, said: “The TheraFuze DBF fiber anchor provides a cost-effective solution for revision cases or situations where the surgeon “feels” bone quality is compromised because it significantly improves the initial internal fixation effect. Clinical studies have shown that Fiber Anchor can promote the formation of new bones juxtaposed with screws, in which the reshaped bones interlace into threads surrounded by natural bone. Therefore, we are proud to develop highly differentiated clinical solutions. I believe that Fiber Anchor provides surgeons with novel solutions and is a safe alternative to polymethyl methacrylate (PMMA).”
The TheraFuze DBF fiber anchor is made of the company’s proprietary demineralized cortical bone fiber. Tests have shown that, compared with screws without fiber anchors, the pull-out force is more than twice that of screws. The TheraFuze DBF fiber anchor size can be used with 5.5-6.0mm, 6.5-7.0mm, 7.5-8.0mm and 8.5-9.0mm screws. The TheraFuze DBF fiber wrap contains demineralized bone fibers formed into 1mm thick flakes by TheraCell’s FiberLok™ technology. The lyophilized sheet can be rehydrated with saline, and the patient’s blood or bone marrow is aspirated out of a flexible sheet that can be manipulated by the surgeon. It can be rolled up with an autologous graft to accommodate the graft and placed in the posterolateral sulcus to accommodate PLF. The FiberLok process maintains morphological integrity after hydration. TheraFuze DBF FiberForm+ is a plastic, demineralized, excipient-free putty, designed for plastic surgery and spinal surgery, including mineralized cortical fragments. The cortical chip provides additional compressive strength and radiation density for visualization. All TheraFuze DBF products are 100% cortical bone fiber products, with osteoconductivity, have the potential to induce bone formation, and can stimulate long-term bone formation.
TheraCell’s TheraFuze DBF fiber anchor, Fiber Wrap and FiberForm+ are part of the comprehensive portfolio of TheraFuze DBF grafting solutions that TheraCell now offers.
About TheraCell Company TheraCell is committed to the development of advanced technology for bone and soft tissue repair, and the inventor of the next generation TheraFuze DBF desalting bone fiber technology. It is also bringing its novel O2ssify oxidation technology to the market, which has been shown to enhance bone formation. The company was founded in 2008 and is headquartered in Los Angeles, with offices and laboratories in Littleton, Massachusetts. www.theracellinc.com. TheraFuzeDBF®, Fiber Anchor™, Fiber Wrap™ and FiberForm™+ are trademarks of TheraCell, Inc.