Bioretec Ltd  Company announcement 4 October 2024 at 2:31 p.m. EEST

TAMPERE, Finland, Oct. 4, 2024 /PRNewswire/ -- Bioretec Ltd announced today, 4 October 2024, that Bioretec's board of directors had decided to update the company's product development strategy by accelerating the product development of the RemeOs™ Spinal Interbody Cage following the granting of Breakthrough Device Designation status by the US Food and Drug Administration on 14 March 2024.

Due to the acceleration of the product development of the RemeOs™ Spinal Interbody Cage, Bioretec's Board of Directors has today updated Bioretec's financial targets as follows:

• reach net sales of EUR 65 million by the end of the year 2028 and to reach net sales in excess of EUR 100 million by the end of the year 2030 (previous target: EUR 62 million by the end of the year 2027); and
• reach positive cash flow from operating activities by the end of the year 2027 (previous target: by the end of the year 2026).

The previously communicated EUR 62 million net sales target and the timing of reaching cash flow positive stage from operating activities have been changed due to the delay in receiving market authorization of RemeOs™ Trauma Screw in Europe. The market authorization is in its final stages in Europe, but there is no exact information available from the notified body on the exact timeline at this stage. Due to acceleration of the product development of the RemeOs™ Spinal Interbody Cage the increase in net sales is expected to be faster from year 2028 onwards.

Further enquiries
Alan Donze, CEO, tel. +1 619 977 5285, alan.donze@bioretec.com
Johanna Salko, CFO, tel. +358 40 754 8172, johanna.salko@bioretec.com 

Certified Adviser:

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries. 

Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval process is currently on-going. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better healing - Better life. www.bioretec.com 

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