#FDA Approval #Switzerland #Geneva #BAGUERA C #Spineart

Spineart's Breakthrough in Cervical Disc Surgery

Spineart, a rapidly growing leader in spine surgery innovation based in Geneva, has recently made a significant advancement by completing an interim analysis for its 2-level BAGUERA® C IDE study. This analysis revealed that BAGUERA® C, a cervical disc prosthesis designed for the treatment of symptomatic cervical diseases, has met the necessary threshold for a non-inferiority claim against the study control.

This promising development follows close on the heels of a similar announcement regarding Spineart's 1-level BAGUERA® C IDE study, which also achieved the threshold for non-inferiority. The results from both studies will be pivotal as Spineart prepares to submit a modular Premarket Approval (PMA) to the U.S. Food and Drug Administration (FDA). The plan is to consolidate the interim results of these two studies into a single PMA submission. This coordination is projected to expedite the approval process and is expected to be submitted by the end of August 2025, which is earlier than initially anticipated.

The BAGUERA® C trials are comprehensive, involving close to 600 patients and taking place across 30 sites within the United States. These trials are randomized, prospective, and multi-centered, comparing the safety and effectiveness of the BAGUERA® C prosthesis against the well-established Mobi-C® cervical disc. By addressing symptomatic cervical disease across one and two contiguous levels, these studies are set to support the FDA submission, which is essential for making this innovative treatment option available to patients.

In a statement, Jerome Trividic, the CEO of Spineart, emphasized the significance of these findings: "The interim analysis data from our 2-level study is a significant milestone for Spineart, coming less than a month after the promising interim results of our 1-level study. These findings bring us closer to providing patients with a highly effective solution for treating symptomatic cervical disease at multiple levels, potentially improving their quality of life. We are committed to advancing spinal health and working with the FDA to bring BAGUERA® C to patients in the United States."

The BAGUERA® C disc prosthesis is at the forefront of spine surgery innovation, with Spineart’s commitment to quality and simplicity in design and functionality. The company’s aim is to facilitate the adoption of groundbreaking technologies that empower both surgeons and patients. With accolades such as the “Prix de l'Economie Genevoise 2022” under its belt, Spineart stands out not only for its technological innovations but also for its commitment to job creation and adherence to environmental, social, and governance (ESG) principles.

As we await the outcomes of the combined PMA submission, it's clear that the advancements brought forth by Spineart in spine surgery offer a glimpse into the future of patient care within this critical medical field. The company's collaboration with the FDA reflects its dedication to bringing innovative treatment options to those in need and enhancing overall quality of life for patients battling spinal issues.

Stay up to date with Spineart's progress by visiting their website and following their journey as they continue to push the boundaries of spinal health and surgery innovation.