Daily Newsletter

14 August 2023

Daily Newsletter

14 August 2023

FDA approves smaller height of Mobi-C artificial discs for cervical replacement

The newly approved 4.5mm artificial discs will give surgeons more flexibility in choosing the implant of best fit for patients.

Robert Barrie August 11 2023

Millimetres can make the difference in the world of artificial cervical discs, and the US Food and Drug Administration (FDA) agrees as it has approved a smaller height of ZimVie’s Mobi-C implant.

The new height which is available in seven footprints adds to the Mobi-C lineup which has been in use in the US since 2013 when the artificial discs became approved for one and two levels between C3 and C7 vertebrae.

Taller artificial discs can result in reduced motion, and the latest FDA approval for the device means surgeons will have greater flexibility in choosing the best fitting implant for the patient.

“The 4.5mm height implants are an important addition to the Mobi-C lineup,” said Jad G. Khalil, M.D., orthopaedic spine surgeon at Michigan Orthopaedic Solutions, PLLC.

“Surgeons will be able to use the prostheses in more significantly collapsed discs and avoid over-distraction of the facet joints. This will expand the indications for cervical disc arthroplasty and therefore more patients can benefit from the clinically compelling Mobi-C Cervical disc.

A market report by GlobalData indicates that ZimVie is one of the market leaders in vertebral body replacement systems. ZimVie, which spun off from Zimmer Biomet in 2022, occupies a 7.2% share in the global market. The market, which was worth $356m in 2022, is forecast to reach $519m by 2033.

In a 2023 Q2 earnings call this month, the Colorado, US-based company raised its 2023 outlook, adjusting its net sales target of $835m - $860m to a range of $850m - $870m. However, net sales in the second quarter of 2023 were down on those in the same period from 2022. The company also announced in a Q4 earnings call in May 2023 that it was planning on cutting 5% of its global workforce.

Digital transformation of the healthcare industry is driving the demand and development for precision and personalized medicine

Per GlobalData estimates, the precision and personalized medicine market is expected to achieve a CAGR of more than 43% between 2022 and 2029. The digital transformation of the healthcare industry is driving the market demand. For example, advances in biomarker testing with NGS are improving patient selection, use of AI in identifying trends in big datasets is accelerating the time from drug discovery to commercialization, and the use of Industry 4.0 technologies is improving the quality and efficiency of manufacturing complex drugs such as cell and gene therapies.

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