SPINEART COMPLETES ENROLLMENT IN THE BAGUERA®C IDE TRIAL FOR TWO-LEVEL CERVICAL DISC REPLACEMENT
Spineart SA today announced it has completed enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with cervical disc disease at two contiguous levels between C3 to C7 compared to a commercially marketed cervical disc implant.
The multi-center, prospective, randomized controlled trial enrolled over 300 patients at 25 sites across the United States. The primary endpoint of the study is the clinical success rate of BAGUERA®C in two contiguous levels from C3 to C7 compared with two-level cervical disc replacement with a commercially available disc replacement implant. The Company announced the completion of enrollment for its one-level IDE trial at the end of February 2024.
Jerome Trividic, CEO of Spineart, said, “The enrollment completion of our two-level BAGUERA®C IDE study marks a significant milestone in Spineart’s ambition to emerge as a global leader in spine arthroplasty. Coupled with the ongoing one-level BAGUERA®C IDE study, Spineart is spearheading the gathering of crucial long-term clinical evidence from nearly 600 artificial disc recipients across the United States. This unprecedented achievement underscores our commitment to advancing the adoption of cutting-edge technologies in spinal surgery. We extend our sincere gratitude to our esteemed investigators and their teams whose dedicated participation has been instrumental in this endeavor. We eagerly anticipate bringing these two studies to fruition.”
Domagoj Coric, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, NC, and co-lead investigator of the IDE trials, stated, “The outcomes from this study will further build the level I evidence supporting the safety and effectiveness of cervical disc arthroplasty with its head-to-head comparison against another cervical implant with similar design features.”
The BAGUERA®C Cervical Disc prosthesis is evaluated in two separate IDE trials in the U.S. for one- and two-level cervical disc disease. The BAGUERA®C implant has been commercially available in selected European and worldwide markets since 2008. Internationally, early long-term feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.
SPINEART COMPLETES ENROLLMENT IN THE BAGUERA®C IDE TRIAL FOR SINGLE-LEVEL CERVICAL DISC REPLACEMENT
Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant.
“We would like to thank all the investigators, their staff and the patients participating in the BAGUERA®C trial for their dedication and support,” said Jerome Trividic, chief executive officer of Spineart. “We are committed to advancing spine arthroplasty worldwide and establishing BAGUERA®C as a leading motion preserving technology for US surgeons and their patients.”
Hyun W. Bae, MD, with the Spine Institute, Santa Monica, CA and one of the lead investigators for the study, said, “Cervical Disc Arthroplasty is becoming the preferred option in the treatment of degenerative disc disease as it allows to achieve decompression of the nerves, while preserving physiologic segmental motion. I am excited to continue following up my patients in the BAGUERA®C IDE study and confirming the initial positive outcomes we have collected so far.”
The BAGUERA®C Cervical Disc Prosthesis has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.
SOLCO BIOMEDICAL HAS BEEN OFFICIALLY APPOINTED AS OUR NEW EXCLUSIVE DISTRIBUTOR FOR BAGUERA® C IN THE REPUBLIC OF KOREA.
On September 1st, 2023, Spineart SA entered into a distribution agreement with Solco Biomedical of Republic of Korea. Since January 1st, 2024, Solco is the sole distributor of BAGUERA® C, with exclusive commercialization rights in the Republic of Korea.
This partnership combines over 12 years of BAGUERA® C clinical experience with Solco’s extensive distribution network and 50 years of presence in the medical device environment.
About Spineart
Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing, and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients. Spineart markets a complete portfolio, in 60 markets, combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.
About Solco
Established in 1974, Solco Biomedical manufactures and distributes a wide range of medical devices and is listed on the KOSDAQ since 2000.
GROUNDBREAKING CEREMONY OF OUR NEW FACTORY!
We are building a new factory and broke ground on October 26th, 2023.
Built on a 7,000 sqm (70,000 sqft) greenfield development lot, the new Spineart factory is our third production site and our largest so far with more than 4,200 sqm (42,000 sqft) and will eventually regroup all our manufacturing and logistics activities. It will be equipped with state-of-the-art additive manufacturing, CNC machines and a new clean room. This new site will support Spineart continued double-digit growth through a significant manufacturing footprint expansion and the integration of the latest manufacturing innovations as well as sustainability standards.
The new factory is located close to our global headquarters in Geneva, Switzerland, in a region renowned for being a center of excellence for precision manufacturing.
The official opening of the new Spineart factory is scheduled early 2025.
SPINEART HAS REACHED AND SURPASSED THE €100M OF REVENUE.
For the first time in its history, Spineart has reached and surpassed €100m of trailing 12-month revenue.
As the success and expansion of the Ti-LIFE ranges continues, we are rolling out the posterior fixation PERLA® platform and actively invest and develop multiple enabling technologies for spine surgeries, as exemplified by its co-development agreement with eCential robotics.
We are steadily gaining market share in Europe where the MDR certification of our full portfolio is well ahead of our peers and in the US through the addition of state-of-the-art systems to our portfolio. Our 2 US IDE trials for the BAGUERA® C cervical disc prothesis are enrolling at full speed and we are aiming for enrollment completion in the coming months. Meanwhile the 10-year safety and efficacy data for BAGUERA® C collected from Europe have been published in the prestigious European Spine Journal.
Spineart is committed to transform spine surgery for patients, surgeons and hospitals as we aim to create safe solutions and ultimately advance healthcare worldwide.
FIRST WOMEN SPINE NETWORK!
For the first time in its history, Spineart has organized an exclusive event for women in the Spine industry in Luzern, Switzerland last week.
The goal of this program was to offer women spine surgeons a dedicated platform to advance the dialogue on important spine topics, make lasting connections and inspire each other.
Considering the quality of the exchanges between the 22 participants who addressed scientific subjects but also discussed how to strengthen the science ecosystem together, we are delighted to share that the mission was accomplished!
We would like to thank all our special guests Susanne Siegenthaler, Military pilot in the Swiss Air Force, Dr. Med. Nermine Habib, Founder and President of Swiss Female Orthopaedics, Dr. Adéla Wyncoll, Co-Founder and managing partner of Women’s Leadership Academy and Dr. Med. Dominique Kuhlen, Chief Clinical Officer of the Hirslanden Group. A special thanks also goes to our speakers Dr. Caroline Hirsch, Dr. Sara Burguet, Dr. Lima Sprenger, Dr. Sonja Häckel and Dr. Raluca Reitmeier and to all the participants.
We are absolutely certain that this event will be the first of a long list and we can’t wait for the next editions!