Bioretec has announced an acceleration in the development of the RemeOs Spinal Interbody Cage, a medical device that is set to innovate spinal surgery with its MRI-compatible, absorbable hybrid composite technology.
This strategic decision follows the device's receipt of the breakthrough device designation from the US Food and Drug Administration in March 2024.
This approval has led the company to re-evaluate its product development timeline and financial strategy, considering the device's potential impact on spinal surgery technology.
The RemeOs Spinal Interbody Cage is designed to restore intervertebral height and facilitate fusion in the cervical spine. It stands out for its use of a magnesium alloy, which has earned patents in both the US (US11969519B1) and Europe (EP3782657B1).
It aims to overcome the limitations of traditional implants by reducing complications and improving patient outcomes.
The results from initial simulations and technological proofs of concept have established a strong commercial rationale for the acceleration of the RemeOs Spinal Interbody Cage's development.
The feedback from medical experts has been positive, highlighting the device's potential applications and benefits.
With an estimated market potential of approximately €2.3bn ($2.5bn) by 2028 for the RemeOs Spinal Interbody Cage and €8.1bn for related hybrid composite applications, Bioretec is positioning itself for a significant commercial opportunity.
The device's properties are expected to enhance bone growth and reduce stress shielding complications.
To align with the revised product development strategy, Bioretec's board of directors has updated the company's financial targets.
Bioretec is exploring various financing options and has appointed Danske Bank, Finland Branch, as its financial advisor to support these efforts.
