Bioretec Ltd Inside information 26 October 2025 at 10.00 a.m. EEST

TAMPERE, Finland, Oct. 27, 2025 /PRNewswire/ -- On 12 September 2025, Bioretec Ltd ("Bioretec" or the "Company"), announced that the revised timeline of the planned commercialization of the DrillPin in the U.S. was then not expected to have a material effect on Bioretec's financial targets published on 4 October 2024, and that Bioretec was assessing its overall commercialization strategy and pipeline, including the commercialization of the DrillPin in the U.S., and would provide an update by the end of 2025.

The Company is currently in the process of assessing and updating its overall commercialization strategy and pipeline and will be providing an update by the end of 2025. However, in the course of its assessment, the Board of Directors of Bioretec has now concluded that the financial targets published on 4 October 2024 are unattainable and will likely not be met. In particular, the Board of Directors of Bioretec deems that the target of reaching net sales of EUR 65 million by the end of the year 2028 will need to be postponed given lengthened FDA-approval timelines, the Company's current financing needs and the strategic readjustment initiatives which are currently pending assessment. While the Board of Directors of the Company believes that the addressable market for the Company's products remains the same, the Company now withdraws its financial targets and will provide an updated commercialization strategy and pipeline along with revised financial targets by the end of 2025.

The previous financial targets, which are now withdrawn, were to:

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)

Further enquiries:
Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified Adviser:
Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec:

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. 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's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA polymer. These implants deliver secure fixation through patented innovations and naturally degrade in approximately two years, eliminating the need for costly and invasive removal surgeries while supporting optimal bone regeneration. Activa products are both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

The company's latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable 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 first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit https://bioretec.com.

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