Spineart has revealed that the 100th surgery has been performed in their combined single-level and two-level US investigational device exemption (IDE) clinical trials of the BAGUERA® C cervical disc prosthesis. In addition, the company has also reached an exclusive agreement with LMT Surgical to distribute Spineart products in Australia from 1 January 2022.
Armen Khachatryan at The Disc Replacement Centre (Salt Lake City, USA), is currently the leading enroller for the single-level trial, and Hyun Bae at the Foundation for Spinal Restoration (Santa Monica, USA) is the leading enroller for the two-level trial. The BAGUERA C implant is an investigational device designed to reconstruct the cervical disc following discectomy for symptomatic cervical disc disease.
The two prospective, multicentre, randomised clinical studies, will evaluate the safety and efficacy of BAGUERA C compared to the Mobi-C cervical disc (Zimmer Biomet) in the treatment of symptomatic cervical disc disease at a single- or two contiguous levels in the cervical spine. Each study will enrol approximately 300 subjects at up to 30 study sites in the USA. Results of the trials will act as the basis of a premarket approval submission to the US Food and Drug Administration (FDA).
“As part of the FDA IDE study, we implanted one single-level and two two-level patients with BAGUERA discs in an outpatient setting last week. Similar to most anterior cervical procedures, all three patients reported positive relief of symptoms in the recovery room and were discharged within a few hours”, said Khachatryan.
Spineart has also entered into an exclusive partnership with LMT Surgical to distribute the former’s products in Australia from the beginning of next year.
LMT Surgical is a fully owned entity of the EBOS Group and is already present in over 300 hospitals and a partner with more than 1,400 surgeons, according to a company press release.
Edouard Goetgheluck, senior vice president of sales OUS at Spineart, said: “We are thrilled with the opportunity of establishing a strong partnership with LMT, an experienced healthcare distributor based in Australia. We look forward to working together to reinforce our go-to-market reach and to expand sales of our latest innovative technologies such as Ti-LIFE interbody devices, BAGUERA total disc replacements and the Perla thoracolumbar portfolio.”
Scott Davis, business manager of spine and neuro at LMT Surgical, added: “This new partnership further strengthens the LMT brand and portfolio, by building on our tradition of surgeon customer relationships, through education, training and product innovation, while aligning with our core values and goals; engagement, integrity, trust, accountability and collaboration.”