Inossia AB announces Enrollment of First Patient in European Multicenter Randomized Clinical Trial

On Friday the 12th of March, 2021 the first patient of the study was enrolled. The study is a
multicenter, prospective, single-blind, randomized, controlled clinical investigation to
document the safety and efficacy of the use of V-Flex, a bone cement with adapted stiffness
containing Inossia® Cement Softener, in patients with vertebral compression fractures
caused by low energy trauma. This trial aims to assess the effectiveness of low-modulus bone
cement containing Inossia® Cement Softener, compared to traditional higher-modulus
cement as measured by the reduction of new fractures in patients with symptomatic onelevel T5 to L5 fracture.

Neurosurgeon Dr. Raquel Gutiérrez-González, and her team at Puerta de Hierro University
Hospital in Madrid, Spain, performed the first vertebroplasty.
V-Flex, is manufactured by G21 S.r.l. and will be the first Radiopaque Bone Cement for
Percutaneous Vertebral Augmentation to include Inossia® Cement Softener. The softener is
a universal solution that can be used with any PMMA bone cement existing in the market to
adapt it to osteoporotic bone in order to prevent unnecessary adjacent fractures, and their
associated pain and high costs. This technology is patented in the EU, US, China, Hong Kong,
India and South Korea.

The clinical trial has been funded by EIT Health SOFTBONE Project 20519.
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