Moroxite AB reports positive outcome on Xerafuse™ rhBMP-2 and Xerafuse™ Tobramycin study

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Nov 7
2 min read

Moroxite AB, a Swedish company specialized in innovative implants for spinal fusion, reports on positive outcome with complete spinal fusion for Xerafuse™ rhBMP-2 to replace autologous bone harvested from the patient’s iliac crest, and for Xerafuse™ Tobramycin as a bone graft extender to minimize post-operative infections.

The study was conducted by researchers at Lund University, Sweden, based on Moroxite AB´s bone mineral platform using Xerafuse™ bi-phasic ceramic beads impregnated perioperatively with either E. coli derived rhBMP-2 or with the aminoglycoside antibiotic Tobramycin. A rabbit posterolateral spine model following FDA guidelines was used, including mechanical testing, X-ray and Micro CT, 12 weeks following surgery. Study aims were:

To investigate spinal fusion outcome for Xerafuse™-BMP alone, compared to autologous bone at 12 weeks. The study showed non-inferiority for Xerafuse™-BMP
To investigate spinal fusion outcome for Xerafuse™ Tobramycin as an autologous bone graft extender, compared to autologous bone alone. The study demonstrated Xerafuse™ Tobramycin bone graft extender to be non-inferior to autologous bone at 12 weeks.

Spinal fusion surgery is burdened with two major complications; at least 10 % of the fusions fail and up to 5 % get infected, conditions that often require costly and difficult re-operations. The increased risk and the shortage of autologous bone has made an ageing population especially vulnerable.

A US nationwide longitudinal database from 2014 to 2018 has been used to calculate incidence and payments associated with postoperative infection following spinal fusion surgery. Incremental payments/costs for a patient with deep infection were $74,875 at 12 months, and $93,741 at 24 months. “The authors concluded that the implementation of robust evidence-based surgical-care bundles to mitigate postoperative infection in Spinal Fusion Surgery is warranted” (https://pubmed.ncbi.nlm.nih.gov/35322778/)

To prevent infection and simultaneously build bone, a next-generation orthobiologics product has been developed by Moroxite AB, to enable spinal fusion without autologous bone harvesting; A combined approach using the combination of Xerafuse™ Tobramycin beads and Xerafuse™-BMP beads.

Professor Magnus Tägil, Lund University said

“Moroxite AB has recently got FDA breakthrough designation for Xerafuse™-BMP as a medical device combination. The recent in-vivo study confirmed previous results and added outcome data supporting safety and efficacy for Xerafuse™ Tobramycin, which is another unique leap forward for the company.”

“This ambitious project offers a potential solution to the two most challenging complications in spinal fusion surgery. A combination product capable of preventing infections and at the same time building bone without the need of harvesting autologous bone could be a game changer in spine surgery” says professor Benny Dahl, Rigshospitalet, Copenhagen, Denmark.

For additional information contact CEO fredrik.lindberg@moroxiteab.com and to know more about us, please visit www.moroxiteab.com

Download the press release here: