Bioretec Ltd's business review January-September 2024: Launch of the RemeOs™ Trauma Screw in the U.S. is proceeding to the next phase, EU authorization in the final stage
Comunicato Precedente
Comunicato Successivo
July - September 2024 in brief
January-September 2024 in brief
This business review is unaudited. This is Bioretec's first business review for the third quarter, and comparison period figures have not been published earlier.
Key figures
Key events during July - September 2024
Alan Donze, CEO of Bioretec Ltd:
" As I reflect on my first 100 days as CEO, I am both proud of the strides we have made and energized by the opportunities ahead for Bioretec. Our commitment to innovation and growth remains unwavering, and our transition into the second phase of the RemeOs™ Trauma Screw launch in the U.S. marks a pivotal moment in our strategy. Our preparations to expand the distribution of the RemeOs™ Trauma Screw from a select group of hospitals to a broader network in the U.S. are progressing alongside the necessary timelines for the U.S. 510(k) approval process for the RemeOs™ cannulated screw and other configurations. In recent months, we have developed plans to expand our U.S. distribution channels, identified key distributor partnerships, and laid the groundwork for our growth platform.
Bioretec achieved a 42% increase in net sales compared to Q3 of the previous year, primarily due to heightened demand in Asia. Although the delay of regulatory approvals for RemeOs™ has affected our H2 revenue, we are optimistic about our pent-up sales growth after receiving these approvals. In the third quarter, despite a slight dip in our sales margin influenced by China's volume-based procurement policies, we remain confident in the positive development of our U.S. and EU business profit margins.
In October, we refined our product development strategy by accelerating the advancement of the RemeOs™ Spinal Interbody Cage. The positive results from simulations and technological proofs of concept for this device have reinforced our belief in its potential to transform spinal treatment options. The market opportunity is substantial, with projections indicating that the market for the Spinal Interbody Cage could reach around EUR 2.3 billion by 2028, and the total addressable market for our proprietary magnesium alloy and hybrid composite-based applications could be approximately EUR 8.1 billion in the same timeframe.
This acceleration of product development does not signify a departure from our core strategy. We remain fully committed to the RemeOs™ trauma product line and its commercialization in the U.S. and worldwide. We anticipate strong revenue growth from the second phase of the RemeOs™ Trauma Screw U.S. product launch from 2025 onwards.
The initial controlled launch of RemeOs™ Trauma Screws in the U.S. yielded excellent patient results, with a notable number of surgeries and successful post-healing follow-ups. This success lays the groundwork for entering the second phase of commercialization for RemeOs™ products in the U.S. and driving strong demand within the surgeon community.
While we wait for the first CE approval and the next U.S. market approvals, our focus will be on readiness for market demand by supporting our logistics partners, distributors, hospitals, and surgeons to immediately be prepared to incorporate RemeOs™ products in their patient procedures.
In summary, I am excited about our progress and the unique opportunities that lie ahead. Together, we are poised to solidify Bioretec's position as a leader in innovative medical solutions, and I look forward to sharing our journey with all stakeholders."
Progress in the commercialization of RemeOs™ trauma screw
Completed steps:
Next steps:
Significant events after the review period
Financial reporting in 2025
Bioretec will publish its financial calendar for 2025 in
December 2024.
Tampere, 14 November 2024
Board of Directors
Bioretec Ltd
Further inquiries:
Alan Donze
CEO
+358 40 663 5011
[email protected]
Johanna Salko
CFO
+358 40 754 8172
[email protected]
Certified advisor:
Nordic Certified Adviser AB, p. +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 resorbed 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 ongoing. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and become a game changer in surgical bone fracture treatment.
Better healing - Better life. www.bioretec.com
Appendix
Bioretec Ltd's business review January-September 2024 (pdf)
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