News

BIOBank, a French leader in bone allografts, and Spineart are proud to announce a strategic partnership aimed at improving access to high-quality allogenic bone substitutes for spine surgeons in France and Switzerland.

A Synergistic Approach to Spinal Fusion

Under the agreement, Spineart will promote BIOBank’s portfolio, with a focus on BIOBank Synergy® – a moldable natural putty designed for bone fusion – leveraging its well-established commercial spine network, ensuring a wide market coverage in both countries.

Spineart’s fusion products and BIOBank’s biologic solutions complement each other by offering spine surgeons a complete, integrated approach to spinal fusion combining advanced implants with high-quality allografts that support effective bone healing.

Strengthening European Leadership

Already distributing BIOBank products in Spain, Spineart is now expanding its biologics offering to France and Switzerland. As a major player in the French spine market, Spineart is the ideal partner to deliver surgeons the BioBank products.

Alexandre Tepas, CEO, BIOBank said: “We are thrilled to join forces with Spineart. Their proven expertise and extensive network make them the ideal partner to accelerate the adoption of our bone allografts in spine surgery. Together, we will not only expand into key markets, but also support surgeons in their practice and, most importantly, improve outcomes for patients.”

Jerome Trividic, CEO, Spineart added: “We are expanding our European leadership by integrating BIOBank’s allografts, sourced from living donors, into Spineart’s procedural spine surgery offering. This partnership strengthens our ability to provide surgeons with a complete solution for each intervention, combining cutting-edge implants and biologics to support reproducible workflows and deliver optimized patient outcomes.”

About BIOBank

Founded in 1999, BIOBank is a leading French human tissue bank specializing in production allogenic bone grafts for orthopedic, spinal, dental and maxillofacial applications. BIOBank masters its value chain: from the collection from living donors, to the preparation of BIOBank allografts using Supercrit® technology, and their distribution on multiple European markets (Switzerland via its affiliate NEUTROMEDICS, Spain, Poland and the United Kingdom via its partners). BIOBank’s product portfolio includes geometrical shapes, powder, and granules as well as BIOBank Synergy® to address a broad range of surgical needs.

26 September 2025

Plan-Les-Ouates & Zurich (CH) – Antwerp (BE)

Spineart (www.spineart.com), a global medtech innovator in advanced spine surgery solutions, today announces a CHF 25 million capital increase backed by its long-standing investors Gimv and EGS Beteiligungen (EGSB). This new funding will fuel Spineart’s next phase of profitable growth, enabling the company to advance its innovation pipeline and strengthen its global footprint in delivering better outcomes for spine surgery patients.

Spineart’s profitable growth strategy is anchored in a comprehensive portfolio of cutting-edge technologies designed to make spine surgery safer, more efficient and more effective. With a strong focus on clinical outcomes, the company is expanding across Europe and the United States with ongoing regulatory submissions to the U.S. FDA for its BAGUERA® C cervical disc prosthesis. Strategic partnerships and investments in digital navigation and robotics are also enhancing Spineart’s innovation capabilities, adding a transformative dimension to its future growth.

Spineart currently employs over 360 professionals worldwide and is projected to reach revenues of approximately EUR 140 million in 2025, reflecting five consecutive years of growth at an average annual rate of +16%. With a recently opened modern production facility in Reignier, France, the company is well-positioned to meet the rising global demand for its advanced spine surgery solutions.

“This investment represents a major milestone in Spineart’s profitable growth journey,” said Jerome Trividic, CEO of Spineart. “Over the past years, we’ve made targeted strategic investments in product innovation, robotics, regulatory expansion in Europe and the United States and manufacturing, that are now coming to fruition. With the continued support of Gimv and EGSB, we are well-positioned to scale globally, deliver innovative, differentiated technologies and reinforce our commitment to surgical excellence and improved patient outcomes.”

“Our sustained commitment to Spineart reflects our strong belief in the company’s innovation capabilities in the field of spine surgery and its international growth potential,” said Bart Diels and Gautier Lefebvre, respectively Managing Partner and Partner Healthcare of Gimv. “This investment fits perfectly with the ambition of our Healthcare platform to support pioneering companies shaping the future of healthcare and demonstrates our ability to successfully do it on the long run. This additional investment underlines Gimv’s accelerated growth ambitions. The total cumulative investment in the company makes it one of Gimv’s five largest investments.”

“As an investor in Spineart since 2020, we are very pleased with its strong development and remain fully committed to supporting this outstanding company,” said Dominik Sauter, former Managing Director and current Senior Advisor, and Christian Pfab, Member of the Executive Committee of EGSB. “Our additional investment underscores our dedication to fostering entrepreneurship and helping innovative businesses scale and thrive internationally.”

Spineart announces the full-market launch of its SCARLET® AC-Ti secured anterior cervical cage in the United States.

Following 510(k) clearance in May 2024, SCARLET® AC-Ti has been extensively evaluated by clinical experts and this launch signifies the Company’s continued commitment to US product expansion.

After implanting more than 50 SCARLET® AC-Ti, Zakhria Belasher, MD* from Insight Surgical Hospital shared, “With SCARLET® AC-Ti, I have observed consistent performance, reliable standalone stability—with no instances of postoperative dysphagia. Its intuitive design, porous titanium structure, and optimized screw angulation promotes early fusion while enhancing patient recovery and surgical efficiency, making it a seamless and trusted component of my anterior cervical fusion practice!”

Alessia Erlingher, Chief Commercial Officer at Spineart said, “With SCARLET® AC-Ti, we’re bringing an exciting new advancement to the ACDF segment in the US, reinforcing our ongoing commitment to innovation. Following the highly promising results from the initial release phase, we are thrilled to now make this latest technology available to more surgeons.”

SCARLET® AC-Ti builds on a decade of experience with the SCARLET® system and utilizes our Ti-LIFE technology, a proprietary additive manufacturing process, providing a porous structure that closely mimics the trabecular bone structure. Our secured anterior cervical cage is known for its redefined anatomical shape, integrated screw guides and anti-backout mechanism.

To learn more about SCARLET® AC-Ti, contact your local sales representative or complete the form: https://www.spineart.com/us/contact/

*Dr. Belasher is a paid consultant of Spineart. His statements represent his own opinions based on personal experience and are not necessarily those of Spineart. Individual results may vary.

Spineart today announces that it has completed a planned interim analysis for its 2-level BAGUERA® C IDE study, which showed that BAGUERA® C, its innovative cervical disc prosthesis, met the threshold for a non-inferiority claim against the study control.

Last month, Spineart announced that its interim analysis for its 1-level BAGUERA®C IDE study had also showed that BAGUERA® C had met the threshold for a non-inferiority claim against the study control and that it had agreed on a timeline with the U.S. FDA for the submission of a modular Premarket Approval (PMA) for BAGUERA® C.

Spineart has agreed with the U.S. FDA to submit the interim results from both IDE studies under the same PMA. Completion of this combined PMA submission remains scheduled for the end of August 2025, potentially enabling an earlier approval than had originally been anticipated.

The BAGUERA®C 1-level and 2-level IDE trials are prospective, multi-center, randomized clinical studies evaluating the safety and efficacy of BAGUERA®C compared with the Mobi-C® cervical disc in the treatment of symptomatic cervical disease at one level and two contiguous levels in the cervical spine. The studies enrolled close to 600 patients at 30 sites in the U.S. Results of these clinical trials are intended to be the basis of a PMA submission to the U.S. FDA.

Jerome Trividic, Chief Executive Officer at Spineart, commented: “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.”

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Spineart and eCential Robotics proudly announce the 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Spineart PERLA® TL application (PERLA® App) for use with the new eCential Robotics Op.n^TM robotic navigation platform.

This clearance marks a significant milestone in advancing robotic-assisted spine surgery and demonstrating new ways to innovate by combining Spineart’s and eCential Robotics’ expertise. The newly approved PERLA® App, which further integrates the Spineart PERLA® TL Open and MIS screw systems with the eCential Op.n^TM platform, offers a Spineart navigation-specific interface and dedicated Spineart navigated instruments, aiming to enhance surgical precision and procedural workflow. Additionally, by expanding the range of 3D C-arms compatible with the system, Spineart and eCential underscore their ability to provide cutting-edge solutions while optimizing available resources at medical facilities through modular solutions.

“We are excited to announce the 510(k) clearance for our first PERLA® App on the eCential Op.n^TM platform. This underscores our commitment to delivering advanced procedural solutions to spine surgeons, ultimately benefiting their patients. Our partnership with eCential Robotics in surgical and robotic navigation has empowered us to pursue an innovative approach that enhances precision and workflow efficiency in the operating room while utilizing our implants and instruments for spine surgery.” said Jerome Trividic, CEO of Spineart.

“This 510(k) clearance shows our dedication to innovation and increasing the capabilities and modularity of our Op.n^TM platform for surgical and robotic navigation,” said Clement Vidal, CEO of eCential Robotics. “By combining our partner Spineart’s spine systems with our expertise in advanced robotic navigation, we are bringing a transformative solution to the operating room, benefiting both surgeons and patients while optimizing cost for medical facilities.”

Building on this successful collaboration, Spineart and eCential Robotics will continue to join forces to drive further innovation on the Op.n^TM platform.

Spineart today announces that it has completed a planned interim analysis for its 1-level BAGUERA®C IDE study, which showed that      BAGUERA® C, its innovative cervical disc prosthesis, met the threshold for a non-inferiority claim against the study control.

Spineart has now agreed on a timeline with the U.S. FDA for the submission of Premarket Approval (PMA) for BAGUERA® C in three components (modules) which will be submitted and reviewed separately. Completion of the PMA submission is now scheduled for the end of August 2025, potentially enabling an earlier approval than had originally been anticipated.

The BAGUERA® C 1-level IDE trial is a prospective, multi-center, randomized clinical study evaluating the safety and efficacy of BAGUERA® C compared with the Mobi-C® cervical disc in the treatment of symptomatic cervical disease at a single level in the cervical spine. The study enrolled 285 patients at 25 sites in the U.S. Results of this clinical trial are intended to be the basis of a PMA submission to the U.S. FDA.

Jerome Trividic, Chief Executive Officer at Spineart, commented: “This interim analysis data is extremely promising. We look forward to working with the FDA as we prepare to submit our PMA modules later this year, bringing us closer to making our innovative cervical disc prosthesis available to patients in the United States.”

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

About the BAGUERA® C Cervical Disc Prosthesis

The BAGUERA® C cervical disc prosthesis, developed by Spineart, is an investigational device in the U.S., designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease. The BAGUERA® C is designed to maintain the natural behavior of a functional spinal unit. This design enables the BAGUERA®C nucleus to move in all six degrees of freedom, with independent angular rotations (flexion-extension, lateral bending, and axial rotation) along with independent translational motions (anterior-posterior and lateral translations).