Finnish medical device company Bioretec Ltd has announced an acceleration in the development of its RemeOs™ Spinal Interbody Cage, following the US Food and Drug Administration’s (FDA) decision to grant it Breakthrough Device Designation earlier this year. The decision, made by Bioretec’s board of directors, aims to fast-track the product’s progress towards market entry, with expectations of boosting the company’s long-term sales growth.
The FDA’s designation, granted on 14 March 2024, highlights the innovation and potential impact of the RemeOs™ Spinal Interbody Cage on spinal surgeries, offering a biodegradable alternative to traditional implants. This cutting-edge device is designed to support bone growth and healing without the need for follow-up removal surgeries, a factor that could significantly improve patient outcomes.
Revised Financial Targets
In light of this accelerated product development, Bioretec has also revised its financial targets. The company now aims to achieve net sales of EUR 65 million by the end of 2028, with further growth expected to push sales beyond EUR 100 million by the close of 2030. This represents an upward revision from the previous target of EUR 62 million by the end of 2027.
However, Bioretec’s board also acknowledged a delay in reaching positive cash flow from operations. The company now anticipates achieving this milestone by the end of 2027, a year later than previously forecast. The revised targets are largely a result of delays in securing market authorisation for the RemeOs™ Trauma Screw in Europe. While approval is still in its final stages, no specific timeline has been confirmed by the relevant authorities.
Strategic Shift Due to Regulatory Delays
Bioretec’s CEO, Alan Donze, confirmed that the delays in European market authorisation for the RemeOs™ Trauma Screw prompted the strategic shift towards accelerating the spinal cage development. He also noted that the company expects net sales to grow more rapidly from 2028 onwards, following the expected market launch of the RemeOs™ Spinal Interbody Cage.
“While the delay in Europe is unfortunate, the FDA’s Breakthrough Device Designation for the Spinal Interbody Cage represents a major opportunity,” said Mr Donze. “We are confident that this product will accelerate our growth in the global orthopedic trauma and spine market, with significant sales potential starting in 2028.”
Pioneering Biodegradable Implants
Bioretec is at the forefront of developing biodegradable orthopedic implants, with its RemeOs™ product line based on a magnesium alloy and hybrid composite. These implants are absorbed and replaced by natural bone, potentially rendering traditional titanium implants obsolete. The RemeOs™ implants eliminate the need for secondary removal surgeries, providing both cost savings and improved patient outcomes, a significant step towards value-based healthcare.
The company has already received market authorisation for its first RemeOs™ product in the US in 2023, while the European approval process is ongoing. With its sights set on the USD 9 billion global orthopedic trauma and spine market, Bioretec aims to revolutionise surgical bone fracture treatment. Better healing – Better life. www.bioretec.com
