The next step for the research team will be to secure funding to develop a prototype for their implantable device. Image Credit: RomarioIen / Shutterstock.

Xstim has received premarket approval from the US Food and Drug Administration (FDA) for its Xstim spine fusion stimulator.

Xstim’s spinal fusion device is a wearable non-invasive bone growth stimulation device that emits a low-energy signal that promotes bone healing in patients following spinal fusion surgery. The US-based company plans to commercially launch the device in the second quarter of this year.

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The use of electrical stimulation after spinal fusion surgery has been shown to improve healing in multiple studies. The global market for orthobiologics, including bone growth stimulation devices, is expected to be worth over $7.8bn by 2025, as per GlobalData market analysis.

Besides finding success in orthopaedics, neurostimulation devices are being investigated as a treatment for multiple neurological conditions. One of the indications that neurostimulation devices have found success is insomnia. Neurovalens’ Modius Sleep device for treating chronic insomnia was approved by the FDA in October 2023.

Last month, Nyxoah’s hypoglossal nerve stimulation system, Genio, met primary endpoints in a pivotal trial for obstructive sleep apnoea. The data from the open-label DREAM trial (NCT03868618) is expected to inform the US marketing authorisation for the device.

In January, the FDA approved NeuroSigma’s second-generation Monarch external trigeminal nerve stimulation (eTNS) system to treat paediatric attention deficit hyperactivity disorder (ADHD). The device delivers mild electrical impulses to the trigeminal nerve, a major cranial nerve involved in various sensory functions.

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Other advances in treatment for spinal injuries include an investigative neurostimulator device by Onward Medical. The Netherlands-based company’s ARC-IM neurostimulator device is designed to improve haemodynamic instability in spinal cord injury (SCI) patients. The device is currently being evaluated in multiple feasibility studies.

In October 2023, Xenix Medical’s nanobody interbody fusion implants received clearance from the FDA. The nanotechnology implants have a 3D-printed lattice that is designed to improve fixation to the adjacent bone. The company says its micro and nano-roughened surface has demonstrated the ability to elicit an endogenous cellular and biochemical response.