#USA #Geneva #Spineart #BAGUERA® C #cervical disc

Introduction

Spineart, an innovative company in the realm of spinal surgery, has successfully completed a planned interim analysis for its two-level BAGUERA® C Investigational Device Exemption (IDE) study. The analysis has revealed that the BAGUERA® C cervical disc prosthesis meets the critical threshold for a non-inferiority claim when evaluated against its study control. This pivotal finding indicates promising potential for BAGUERA® C in treating symptomatic cervical diseases.

Background

The recent development is a continuation of Spineart’s advancements in spinal therapeutics. Just a month prior, positive interim results from the one-level BAGUERA® C IDE study had been disclosed, further affirming the device's viability. These studies reflect Spineart's commitment to innovating spinal health solutions that enhance patients' quality of life. Currently, nearly 600 patients across 30 sites in the United States are participating in these clinical trials, which are designed as prospective, multi-center, randomized investigations to assess the safety and efficacy of BAGUERA® C compared to the well-established Mobi-C® cervical disc.

FDA Submission

In collaboration with the U.S. Food and Drug Administration (FDA), Spineart has laid out a pathway for a comprehensive submission of the interim results from both the one-level and two-level IDE studies under a single Premarket Approval (PMA) application. The completion of this combined PMA submission is anticipated to occur by the end of August 2025. Early approval could offer a crucial timeline acceleration compared to earlier projections, facilitating access to innovative treatment options for affected patients sooner than expected.

Milestones and Future Directions

Jerome Trividic, CEO of Spineart, remarked on the significance of the interim analysis data as a substantial milestone for the company. This achievement underscores the journey towards providing effective solutions for managing symptomatic cervical disorders across multiple levels. The initiative aligns with Spineart's goal of advancing spinal health through collaboration with regulatory bodies, including the FDA.

The results of these trials could potentially lay the groundwork for the development of advanced therapeutic strategies in spinal surgery, offering patients improved treatment outcomes. As the product navigates through the regulatory landscape, Spineart remains focused on its mission to deliver innovative surgical solutions that prioritize patient health and satisfaction.

Innovation in Spinal Surgery

Spineart’s portfolio is characterized by its emphasis on quality, innovation, and simplicity, aiming to streamline surgical practices in thoracolumbar surgery. The company has previously received accolades, such as the 'Prix de l'Economie Genevoise 2022', recognizing its contributions to technological advancements and commitment to environmental, social, and governance (ESG) principles.

With the ongoing clinical trials, Spineart continues to explore paths that enable the integration of cutting-edge technologies into everyday surgical practice, providing healthcare professionals with the necessary tools to elevate patient care standards globally.

Conclusion

The successful interim analysis of the two-level BAGUERA® C IDE study heralds a promising future for Spineart and its commitment to revolutionizing spinal surgery. As the company prepares for the upcoming PMA submission, the clinical community is eagerly anticipating the outcomes that could enhance the quality of life for patients suffering from cervical spine disorders. Through their unwavering dedication to innovation, Spineart stands at the forefront of spinal health advancements, positioning itself as a key player in the evolving landscape of spinal surgery solutions.

For more insights and updates on Spineart, visit www.spineart.com.