Victrex PLC - Lancashire, England-based polymer solutions provider for automotive, aerospace, energy & industrial, electronics, and medical markets - Says US Food & Drug Administration has granted investigational device exemption approval for a staged study, in partnership with Maxx Orthopedics Inc, for Maxx’s Freedom Total Knee System with Victrex’s Invibio Peek-Optima Femoral Component. Study will be conducted in the US and compare the Peek-Optima component to a control group using traditional metal femoral components. Company notes that this study will build on the existing criminal trial in Belgium, Italy and India, ‘which has been progressing strongly since the first implant in 2021’. It also expects a regulatory submission in India ‘imminently’.
Victrex Chief Executive Jakob Sigurdsson says: ‘We look forward to the study’s progression and remain optimistic about the transformative impact this pioneering device could have on the future of joint replacement...In relation to the regulatory submission in India, following a tenacious focus on innovation, development and investment to scale this significant opportunity, we now look forward to the potential for a Peek Knee being in the market during 2025 and commercial revenues.
‘We also continue to see growing interest in Peek Knee from across the medical device industry, beyond our existing collaborations.’
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12-month change: down 33%
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