US based medical device company, Spinal Stabilization Technologies is scheduled to take part in a business combination agreement with publicly traded special purpose acquisition company, BlueRiver Acquisition Corp.
Spinal Stabilization Technologies develops and markets lumbar implants for nucleus pulposus replacements and tackles various types of lower back pain. The company’s lead product, PerQdisc, which has not yet received FDA approval mimics the function of the nucleus pulposus to provide a motion-preserving surgical solution.
The agreement which is expected to close in the fourth quarter of 2023, or early 2024 depending on regulatory and shareholder approvals, will see the companies operate as Spinal Stabilization Technologies and list on an approved stock exchange.
Following the completion of the agreement, the combined companies would have an estimated value of $302 million. Any proceeds earned from the transaction will be put towards commercial expansion and fund an FDA pivotal trial which is set to begin in Q2 2024.
In November 2022, Spinal announced the start of their LOPAIN2 clinical trial of the PerQdisc nucleus replacement device which was studied in 72 patients with degenerative disc disease.
In May 2021 the company also earned the CE Mark and the FDA's breakthrough designation classification for its PerQdisc replacement system which at the time was the only available commercial lumbar nucleus replacement system.
According to the company, the augmented discectomy market, valued at $4.8 billion and the degenerative disc disease market, valued at $4.6 billion are two opportunities they plan to break into with their PerQdisc system.
