The commercialization of Bioretec’s RemeOs™ Trauma Screw in the U.S. proceeds with the signing of new logistics agreement

Bioretec Ltd                   Press release             20 November 2024 at 3:30 p.m. EET

Bioretec Ltd, a pioneering company dedicated to advancing biodegradable orthopedic implants, is moving ahead with the next phase of commercializing its innovative RemeOs™ Trauma Products in the U.S. market. Bioretec strengthens its operational efforts by entering into a new logistics agreement with a partner providing customer support services for U.S. operations. This agreement with GlobalMed Logistix (GMLx), a leader in healthcare logistics, will enable the smooth import and distribution of implants and instrument sets to hospitals throughout the country, which secures high service levels for customers in the U.S. market. GMLx has its own logistics center on the east coast of the United States, which serves the distribution of Bioretec’s products through its nationwide network.

 

“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. This agreement evidences our commitment to the RemeOs™ Trauma Product line, its commercialization, and the strengthening of distribution channels in the U.S.”, says Alan Donze, CEO of Bioretec Ltd.

 

Further enquiries

Alan Donze, CEO, tel. +358 40 663 5011

Johanna Salko, CFO, tel. +358 40 754 8172

 

Bioretec in brief

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

 

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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

Bioretec Ltd  Company announcement 14 November 2024 at 8:45 a.m.

This announcement summarizes Bioretec Ltd’s business review for January–September 2024. The complete business review is attached to this release as a PDF file and available on the company’s website at https://bioretec.com/investors/investors-in-english/releases.

 

July – September 2024 in brief

• Net sales amounted to EUR 685 thousand (7–9/2023: EUR 483 thousand).
• The sales margin (excl. other income) was EUR 499 (397) thousand, or 72.9% (82.2%). The main reasons for the lower sales margin percentage were related to the foreign currency exchange rate impacts, China’s volume-based procurement policy effect, and the opening of the direct sales channel in Germany.
• The result for the reporting period amounted to EUR -1,367 (-1,013) thousand.

 

January–September 2024 in brief

• Net sales amounted to EUR 2,746 thousand (1–9/2023: EUR 2,373 thousand).
• The sales margin (excl. other income) was EUR 1,951 (1,724) thousand, or 71.0% (72.6%). The main reasons for the lower sales margin percentage were related to the foreign currency exchange rate impacts, China’s volume-based procurement policy effect, and the opening of the direct sales channel in Germany.
• EBITDA was EUR -3,217 (-2,108) thousand. EBITDA was burdened by increased personnel costs due to headcount growth and additional fixed costs relating to U.S. commercialization and R&D projects.
• The result for the reporting period amounted to EUR -3,251 (-3,088) thousand. The result for the comparison period included the cost of financing arrangement amounting to EUR 795 thousand.

 

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

 

EUR 1,000 unless otherwise noted	7–9/2024	7–9/2023	Change	1–9/2024	1–9/2023	Change	1–12/2023
Net sales	685	483	41.9%	2,746	2,373	15.7%	3,906
Sales margin	562	415	35.3%	2,084	1,742	19.6%	2,810
Sales margin (excl. other income)	499	397	25.8%	1,951	1,724	13.2%	2,728
Sales margin, % of net sales	82.0%	86.0%		75.9%	73.4%		71.9%
Sales margin, % (excl. other income)	72,9%	82.2%		71.0%	72.6%		69.8%
EBITDA	-1,353	-978	38.2%	-3,217	-2,108	52.6%	-2,833
EBIT	-1,395	-1,029	35.5%	-3,316	-2,262	46.6%	-3,034
Profit/-loss for the period (+/-)	-1,367	-1,013	35.0%	-3,251	-3,088	5.3%	-3,789
R&D spend on total costs, %	23.1%	24.2%		24.2%	27.4%		25.6%
Equity ratio, %	73.1%	82.2%		73.1%	82.2%		77.3%
Cash and cash equivalents at the end of the period	2,377	8,483	-72.0%	2,377	8,483	-72.0%	6,910
Number of personnel at end of the period	44	32	37.5%	44	32	37.5%	37

 

Key events during July – September 2024

 

• In September 2024, the following persons were appointed to Bioretec’s Shareholders' Nomination Board: Kustaa Poutiainen, Chair and Founder of Stephen Industries Inc Oy as Chair and Karoliina Lindroos, Head of Responsible Investment of Ilmarinen Mutual Pension Insurance Company and Marko Berg, Deputy Investment Officer of University of Helsinki, as members. The Chairman of the Board of Bioretec acts as an expert to the Nomination Board.

 

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:

• RemeOs™ Trauma Screw received Breakthrough Device Designation -status in the U.S. from the FDA in September 2021.
• RemeOs™ Trauma Screw application for the CE mark and market authorization in Europe was submitted to the European Notified Body in December 2021.
• RemeOs™ Trauma Screw application for marketing authorization in the U.S. was submitted to the FDA in May 2022.
• FDA granted market authorization to start the sales of RemeOs™ Trauma Screw in the U.S. in March 2023. This approval was the first market authorization granted by the FDA for a magnesium-based resorbable bone fixation implant in the U.S.
• Bioretec entered into a distribution agreement in the U.S. with Spartan Medical in September 2023. Spartan Medical is specialized in supplying medical devices for the U.S. government (military and veteran hospitals), and the distribution agreement allowed Bioretec to initiate the controlled launch phase of the commercialization of the RemeOs™ trauma screw in the U.S.
• Bioretec strengthened the marketing and sales experience and know-how especially in U.S. markets:
  • In May 2024 the company appointed Mr. Alan Donze as the CEO. Alan has a long experience in commercialization of medical devices in U.S.
  • In June 2024 the company appointed Mr. Frank Sarcone as Vice President of Sales for the USA. Frank has an extensive background in sales operations of medical devices in U.S.
• In preparation for the RemeOs™ Trauma Screw product launch in Europe, the company appointed Ms. Michaela Knigge to lead the direct sales activities in Central Europe.
• Bioretec announced 100% healing rate with the patients treated during the controlled product launch phase of RemeOs™ Trauma Screw in the U.S. in June 2024.
• In the U.S., Bioretec submitted a 510(k)-registration application for the FDA to widen the product range of the RemeOs™ Trauma Screw to increase market penetration.

 

Next steps:

• Bioretec shall further strengthen the operational efforts in the U.S. by entering into a new logistics agreement with a partner providing customer support service for the U.S. operations. This will enable smooth importation and distribution of implants and instrument sets to hospitals throughout the country.
• Bioretec shall also further strengthen the commercialization efforts in the U.S. by entering into new local distribution agreements to serve private hospitals as part of the next phase of the RemeOs™ Trauma Screw commercialization.
• In Europe, the company is waiting for the final approval of the Notified Body to enter the product launch phase. The company has not been given any specific timeline for the receival of the CE-mark, however, all documentation required by the Notified Body has been delivered to the authorities, and final stages of the process are ongoing.
  • The approval process in Europe has been long due to an extensive regulatory transition from MDD to MDR. All companies within the industry are suffering from the consequences of these changes in terms of prolonged handling times of new product approvals and the re-registration of old products.

 

 

Significant events after the review period

• Bioretec's Board of Directors updated on 4 October 2024 the company's product development strategy by accelerating the product development of the RemeOs™ Spinal Interbody Cage. In order to move into the next stages of RemeOs™ Trauma Screw commercialization processes in U:S. and in Europe and to support the acceleration of RemeOs™ Spinal Interbody Cage development, Bioretec is reviewing different financing alternatives and has engaged Danske Bank A/S, Finland Branch as a financial advisor.
• Bioretec's Board of Directors updated on 4 October 2024 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 2027 (previous target: by the end of 2026).

 

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    Johanna Salko

CEO     CFO

+358 40 663 5011   +358 40 754 8172

alan.donze@bioretec.com  johanna.salko@bioretec.com

 

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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Inside information: Bioretec updates its financial targets

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

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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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, 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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Bioretec’s Shareholders' Nomination Board appointed

Bioretec Ltd   Company announcement      20 September 2024 at 9:00 a.m. (EET)

The following persons have been appointed to Bioretec's Shareholders' Nomination Board: Kustaa Poutiainen, Chair and Founder of Stephen Industries Inc Oy as Chair and Karoliina Lindroos, Head of Responsible Investment of Ilmarinen Mutual Pension Insurance Company and Marko Berg, Deputy Investment Officer of University of Helsinki, as members. The Chairman of the Board of Bioretec acts as an expert to the Nomination Board.

In accordance with the decision taken by the Annual General Meeting (AGM) held on 26 April 2024, the Shareholders' Nomination Board consists of three members. Each of the three largest shareholders as of the last working day in August has the right to nominate a member.

 

The Shareholders’ Nomination Board is responsible for preparing and presenting to the AGM a proposal on the members of the Board of Directors as well as proposals on the remuneration and number of members of the Board of Directors. The Shareholders’ Nomination Board will submit its proposals for the 2025 AGM to the Board of Directors by 31 January 2025.              

 

Further inquiries

Johanna Salko, CFO, Bioretec Ltd., tel. +358 40 754 8172

Tomi Numminen, Chair of the Board of Directors, Bioretec Ltd., tel. +358 40 581 2132

 

Certified advisor

 

Nordic Certified Adviser AB, +46 70 551 67 29

 

Bioretec in brief

 

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 USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

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Bioretec Ltd’s half-year report January–June 2024: RemeOs™ trauma screw controlled launch in the U.S. yielded expected positive clinical results

Bioretec Ltd  Company announcement 15 August 2024 at 8:00 a.m.

This announcement is a summary of Bioretec Ltd’s half-year report January–June 2024. The complete half-year report with tables is attached to this release as a pdf file and available at the company’s web pages at https://bioretec.com/investors/investors-in-english/releases.

 

April–June 2024 in brief

• Net sales increased by 68% and amounted to EUR 1,379 thousand (4–6/2023: EUR 820 thousand).
• Sales margin (excl. other income) was EUR 1,033 (609) thousand, or 74.9% (74.3%) of net sales.
• Profit (loss) for the reporting period was EUR -787 (-1,518) thousand. The comparison period included the cost of financing arrangement amounting to EUR 795 thousand.

 

January–June 2024 in brief

• Net sales amounted to EUR 2,061 thousand (1–6/2023: EUR 1,891 thousand).
• Sales margin (excl. other income) was EUR 1,451 (1,327) thousand or 70.4% (70.2%) of net sales. The sales margin in January–June 2024 includes other income of EUR 72 (0) thousand accrued relating to a Business Finland grant.
• Profit (loss) for the reporting period was EUR -1,884 (-2,075) thousand.
• Earnings per share (undiluted) were EUR -0.09 (-0.11).

 

Key figures

 

EUR 1,000	4–6/2024	4–6/2023	Change, %	1–6/2024	1–6/2023	Change, %	1–12/2023
Net sales	1,379	820	68.3%	2,061	1,891	9.0%	3,906
Sales margin	1,045	609	71.6%	1,523	1,327	14.8%	2,810
Sales margin (excl. other income)	1,033	609	69.8%	1,451	1,327	9.4%	2,728
Sales margin, % of net sales	75.7	74.3		73.9%	70.2%		71.9%
Sales margin% (excl. other income)	74.9	74.3		70.4%	70.2%		69.8%
EBITDA	-752	-639	17.8%	-1,864	-1,130	65.0%	-2,833
EBIT	-782	-690	13.4%	-1,921	-1,233	55.8%	-3,034
Profit/-loss for the period (+/-)	-787	-1,518	-48.2%	-1,884	-2,075	-9.2%	-3,789
R&D spend on total costs, %	23.9%	33.5%		24.8%	29.2%		25.6%
Equity ratio, %	77.9%	85.6%		77.9%	85.6%		77.3%
Cash and cash equivalents at the end of the period	3,947	9,196	-57.1%	3,947	9,196	-57.1%	6,910
Earnings per share (undiluted)	-0.04	-0.07		-0.09	-0.11		-0.19
Earnings per share (diluted)	-0.04	-0.06		-0.08	-0.09		-0.15
Shares at end of period (undiluted)	20,336, 858	19,136, 858		20,336, 858	19,136, 858		19,536, 858
Shares at end of period (diluted)	24,908, 133	23,908, 133		24,908, 133	23,908, 133		24,908, 133
Personnel at end of period	43	30	43.3%	43	30	43.3%	37

 

Key events in April–June 2024

 

• In May, Alan Donze was appointed Bioretec’s CEO.
• In June, Frank Sarcone was appointed as Vice President of Sales for the US and a member of the Management team.
• Also in June, Bioretec communicated positive clinical outcomes from the controlled launch of RemeOs™ trauma screw.
• European market authorization application for the RemeOsTM trauma screw returned from expert panel evaluation in June and the market authorization is expected later compared to earlier estimate (Q2/2024).

 

Alan Donze, CEO of Bioretec Ltd:

 

”Bioretec’s controlled launch plan was designed to systematically gather surgeon feedback and clinical evidence from selected hospitals. In the first half of the year, we received invaluable positive feedback from surgeons regarding the user experience. More importantly, all treated patients experienced the expected healing outcomes, which will facilitate expansion outside the controlled launch plan centers. Our research and development efforts have been focused on expanding the RemeOs™ product portfolio in the U.S. Notably, the FDA granted another Breakthrough Device designation to Bioretec for the RemeOs™ Spinal Cage, an osteopromotive and absorbable cervical spine interbody device made from patented hybrid composite. After my first weeks as the CEO of Bioretec, I am very excited about the opportunities presented by the RemeOs™ product line, which we are actively expanding.

 

The controlled launch of the RemeOs™ trauma screw has proceeded as expected. All surgical procedures using RemeOs™ technology in the U.S. have been successful, with all cases achieving fracture healing and no adverse events or complications during the follow-up period. With these expected positive outcomes and feedback from surgeons, we are preparing to enter the next phase of the launch in the U.S. This phase will involve expanding the distribution of the trauma screw from a selected group of hospitals to a broader network. With the recent appointment of a new VP of Sales in the U.S., we have bolstered our management team, positioning us to enhance our commercialization efforts in this market.

 

The strong global performance of the Activa product line marked Bioretec’s second quarter of 2024. Net sales grew by 68% from the first quarter due in part to a planned shutdown for new machinery investments resulting in an expected backlog. Sales in the United States saw significant growth, while in Europe, the increase was primarily driven by robust demand from new distributors. However, net sales in the rest of the world declined due to a slight decrease in demand in China, where governmental volume-based procurement initiatives and other changes affected orders. Our sales margin remained consistent with the previous year, ending at 70.4% (70.2%). As part of our strategic implementation and increased recruitment efforts, operating expenses rose. We hired a sales leader in Germany and Austria in the first half of the year and will initiate direct sales in these markets during the second half of the year.

 

European CE market authorization application for the RemeOs™ trauma screw is progressing, although the process has been extended beyond the prior estimate. The Expert panel review was completed during the second quarter and our application has now returned to the Notified Body for the final steps of the market approval process. The anticipated European market authorization will provide substantial ability to gather real-world evidence of a variety of indications, which will support indication expansions also in the U.S. In other respects, we saw good development with our R&D efforts. I am especially excited about the unprecedented RemeOs™ Spinal Interbody Cage implant, which recently received the FDA Breakthrough Device Designation in the U.S. market. We will be evaluating our resource needs required for bringing it to the market, together with the other RemeOs™ products in the pipeline.

 

As we focused on ramping up our production capacity in the first half of the year, we anticipate that our net sales will be more robust in the second half. Expanding production capacity and investing in U.S. market development are crucial components of building our growth platform. We continue with our efforts to introduce more RemeOs™ products to the market incrementally through the US FDA process.”

 

Financial reporting in 2024

 

In 2024, Bioretec will publish the following financial reports:

 

• business review for January–September 2024 on Thursday 14 November 2024

 

The releases will be available online at Bioretec Ltd’s website at

https://bioretec.com/investors/investors-in-english/reports-and-presentations.

 

 

Tampere, 15 August 2024

 

Board of Directors

Bioretec Ltd

 

Further inquiries:

 

Alan Donze    Johanna Salko

CEO     CFO

+358 40 663 5011   +358 40 754 8172

alan.donze@bioretec.com  johanna.salko@bioretec.com

 

Certified advisor:

Nordic Certified Adviser AB, p. +46 70 551 6729

 

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 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.

 

Better healing – Better life. www.bioretec.com

 

Appendix

Bioretec Ltd’s half year report January–June 2024 (pdf)

 

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Inside Information: Update for Bioretec's RemeOs™ Trauma Screw European Marketing Authorization

Bioretec Ltd     Inside information        27 June 2024 at 10:30 p.m. EET

Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, announces that according to the information received from the Notified Body (Dekra), its European CE mark market authorization application for the RemeOs™ trauma screw has returned from the expert panel evaluation. Although the previously estimated timeline projected that the CE mark would be obtained by the end of Q2 2024, we now anticipate that it will be issued later beyond this timeline. 

The duration of the expert panel evaluation was a maximum of 60 days, and with this step now completed, Bioretec continues to work diligently towards finalizing the authorization process with the Notified Body.

Further enquiries

Alan Donze, CEO, tel. +358 40 663 5011

Johanna Salko, CFO, tel. +358 40 754 8172 

Certified advisor

Nordic Certified Adviser AB, +46 70 551 67 29

Bioretec in brief

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 USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.

 Better healing – Better life. www.bioretec.com

 

 

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Bioretec reports successful clinical outcomes from U.S. controlled launch of RemeOs™ trauma screw: fracture healing confirmed in 100% of surgical procedures

Bioretec Ltd                    Press release                   19 June 2024 at 9:00 p.m. EEST

Bioretec Ltd., a pioneer in biodegradable orthopedic implants, is pleased to announce that a number of cases have been performed around the U.S. utilizing the RemeOs™ technology. The follow-up results confirmed successful implantation and fracture healing were achieved in all cases. Surgeons reported very positive feedback in that there is no change to existing surgical technique while operating with an absorbable metal implant for their patients. The added benefit of osteopromotion and bioactivity on the fracture healing site was also reported to be a factor in the surgeon’s choice to use RemeOs™ screws in these procedures.

 “The controlled launch of the RemeOs™ trauma screw in the United States has progressed very much in line with our expectations. In my short tenure with Bioretec, these excellent results and surgeon feedback have given me confidence in our plans to increase our commercialization efforts in the U.S.", says Alan Donze, CEO of Bioretec.

 

Further enquiries

Alan Donze, CEO, tel. +358 40 663 5011

Johanna Salko, CFO, tel. +358 40 754 8172

 

Bioretec in brief

 

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 is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.

 

Better healing – Better life. www.bioretec.com

 

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Bioretec Appoints Frank Sarcone as Vice President of Sales for the US and a member of the Management Team

Bioretec Ltd  Press release 18 June 2024 at 9:00 a.m. EEST

Bioretec Ltd, a pioneer in biodegradable orthopedic implants, has, as of June 17, 2024, appointed Frank Sarcone as Vice President of Sales for the United States and a member of Bioretec’s Management Team. In his role, Sarcone reports to the company’s CEO. This strategic addition to Bioretec’s leadership team comes as part of the ongoing commitment to driving growth and innovation in the medical device technology industry.

Frank Sarcone brings with him a wealth of experience and a remarkable track record in the medical device sector. With over 25 years of experience, Sarcone is recognized for his exceptional leadership, strategic acumen, and ability to build and mentor high-performing teams. His extensive background includes founding and leading successful orthopedic companies and developing national distribution channels that have significantly boosted sales and market presence.

Sarcone’s career highlights include:

• Founding and self-funding two successful orthopedic companies.
• Establishing long-lasting partnerships and developing extensive networks within the medical device industry.
• Serving in several key leadership roles such as CEO of Promotus LLC and IMS Consulting LLC, where he drove significant revenue growth and spearheaded major sales initiatives.
• His tenure at Stryker Inc., where he managed large teams and achieved substantial increases in regional market share and revenue.

Alan Donze, Bioretec’s newly appointed CEO, expressed his confidence in Sarcone’s abilities: "Frank's profound expertise and dynamic leadership style make him an invaluable addition to our team. His ability to drive strategic initiatives and his deep understanding of the medical device market will be pivotal as we continue to expand our footprint and enhance our product offerings."

Further enquiries

Tomi Numminen, Chairman of the Board, tel. +358 40 581 2132

Alan Donze, CEO, tel. +358 40 663 5011

Certified advisor

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 is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

 

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Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings - Ilmarinen Mutual Pension Insurance Company

Bioretec Ltd Company announcement 21 May 2024 at 2:30 p.m. EEST

Bioretec Ltd has on 21 May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Ilmarinen Mutual Pension Insurance Company in Bioretec Ltd have before 19 April 2024 crossed the threshold of 5%. The reason for the flagging notification is the amendment to the Securities Market Act, which expanded the flagging obligation to companies listed on the Nasdaq First North Growth Market Finland.

Total position of Ilmarinen Mutual Pension Insurance Company according to the notification:

 

	% of shares and voting rights	% of shares and voting rights through financial instruments	Total of both in %	Total number of shares and voting rights of the issuer
Resulting situation on the date on which threshold was crossed or reached	6.64%	0%	6.64%	20,336,858
Position of previous notification (if applicable)

 

Notified details of the resulting situation on the date on which the threshold was crossed:

 

	Number of shares and voting rights		% of shares and voting rights
Class/type of shares ISIN code	Direct (SMA 9:5)	Indirect (SMA 9:6 and 9:7)	Direct (SMA 9:5)	Indirect (SMA 9:6 and 9:7)
FI4000480454	1,350,000	0	6.64%	0%
SUBTOTAL	1,350,000		6.64%

 

After 19 April 2024, Ilmarinen Mutual Pension Insurance Company holds 6.64% of the shares and votes.

 

Further enquiries

Johanna Salko, CFO, +358 40 754 8172

 

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

 

Bioretec in brief

 

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, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.

 

Better healing – Better life. www.bioretec.com

 

 

 

 

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