Inside information: Bioretec updates its product development strategy by accelerating the product development of RemeOs™ Spinal Interbody Cage

Bioretec Ltd Company announcement 4 October 2024 at 2:30 p.m. EEST

Bioretec updates its product development strategy by accelerating the product development of the RemeOs™ Spinal Interbody Cage, an innovative medical device engineered from a multifunctional, MRI-compatible, absorbable hybrid composite based on the company's proprietary magnesium alloy.

The decision to accelerate the product development of the RemeOs™ Spinal Interbody Cage is based on an evaluation by the company following the granting of Breakthrough Device designation by the US Food and Drug Administration on March 2024.

The acceleration of product development of the RemeOs™ Spinal Interbody Cage will have an effect on the company's overall product development strategy, and Bioretec's board of directors has updated the company's financial targets in line with the revised overall product development strategy. Information on the updated financial targets will be published in a separate company announcement.

Bioretec is reviewing different financing alternatives and has engaged Danske Bank A/S, Finland Branch as the company's financial advisor.

Bioretec Ltd's board of directors has today decided to update the company's product development strategy by accelerating the product development of the RemeOs™ Spinal Interbody Cage.

On 14 March 2024, Bioretec announced that the US Food and Drug Administration's (the FDA) Breakthrough Device designation had been granted for the RemeOs™ Spinal Interbody Cage. At the same time, Bioretec announced that it will evaluate the potential acceleration of the RemeOs™ Spinal Interbody Cage product development as well as resource allocation requirements, which might impact the future capital needs of the company. Based on this evaluation, Bioretec's board of directors has decided to accelerate the product development of RemeOs™ Spinal Interbody Cage.

Bioretec's RemeOs™ Spinal Interbody Cage is an innovative medical device engineered from a multifunctional, MRI-compatible, absorbable hybrid composite based on the company's proprietary magnesium alloy (patent: US11969519B1). The device is intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine and aims to address the limitations of traditional non-degradable implants by minimizing complications and enhancing patient quality of life. The RemeOs™ Spinal Interbody Cage has met the strict criteria set for entering the FDA's Breakthrough Device Designation program, confirming that the device represents a breakthrough technology in spinal surgery, which is an important milestone for the company in getting the product registered into the U.S. and other markets worldwide. The potential of the RemeOs™ Spinal Interbody Cage has been further validated by Bioretec receiving a patent (patent: EP3782657B1) for its hybrid composite technology used for the production of the RemeOs™ Spinal Interbody Cage.

The RemeOs™ Spinal Interbody Cage has produced highly promising results in simulations and technological proof of concept of the device, fulfilling a key validation point and prerequisite for progressing into preclinical trials in large animal spine, and thereby creating a strong commercial rationale for Bioretec to accelerate the product development of the device. Interest in the potential of the RemeOs™ Spinal Interbody Cage has been broad among medical experts and Bioretec has received positive feedback in discussions regarding the applications and benefits of the RemeOs™ Spinal Interbody Cage as well as other RemeOs™ hybrid composite based applications in spine within the medical field.

Bioretec expects the RemeOs™ Spinal Interbody Cage to revolutionize the field of spinal surgery by addressing the limitations of existing alternatives for treatment of spinal conditions. The RemeOs™ Spinal Interbody Cage offers significant benefits compared to existing products on the market due to its ability to enhance bone growth and limit stress shielding causing complications. The addressable market for treatment through RemeOs™ Spinal Interbody Cage is significant and estimated to reach EUR c. 2.3 billion in 2028 and furthermore the total addressable market for RemeOs™ hybrid composite based applications in spinal indications is estimated to be EUR c. 8.1 billion in 2028, offering an attractive commercial opportunity for Bioretec to pursue accelerated commercialisation of the RemeOs™ Spinal Interbody devices.[1]

The acceleration of the product development of the RemeOs™ Spinal Interbody Cage will have an effect on the company's overall product development strategy, and Bioretec's board of directors has today, 4 October 2024, updated the company's financial targets in line with the revised overall product development strategy. Information on the updated financial targets will be published in a separate company announcement. In order to reach the updated financial targets and to accelerate the product development of the RemeOs™ Spinal Interbody Cage, Bioretec is reviewing different financing alternatives and has engaged Danske Bank A/S, Finland Branch as the company's financial advisor.

Analyst and investor briefing

Bioretec invites media representatives, analysts, and shareholders to attend a live webcast briefing regarding its updated product development strategy on Monday 7 October 2024 at 2:30 p.m. EEST. The presentation will be held in English.

Link to webcast: https://bioretec.com/webcast

Link to investor presentation: https://bioretec.com/investors/investors-in-english/reports-and-presentations

Further enquiries

Alan Donze, CEO, tel. +1 619 977 5285, [email protected]

Johanna Salko, CFO, tel. +358 40 754 8172, [email protected]

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