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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Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings - Stephen Industries Inc Oy

Bioretec Ltd Company announcement 20 May 2024 at 7:00 p.m. EEST

Bioretec Ltd has on 20th May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Stephen Industries Inc Oy in Bioretec Ltd have before 19 April 2024 crossed the threshold of 10%. 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 Stephen Industries Inc Oy 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	10.85%	0%	10.85%	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	2,206,370	0	10.85%	0%
SUBTOTAL	2,206,370		10.85%

 

After 19 April 2024, Stephen Industries Inc Oy holds 10.85% 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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Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)

Bioretec Ltd Company announcement 20 May 2024 at 7:00 p.m. EEST

Bioretec Ltd has on 20th May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Stephen Industries Inc Oy in Bioretec Ltd have before 19 April 2024 crossed the threshold of 10%. 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 Stephen Industries Inc Oy 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	10.85%	0%	10.85%	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	2,206,370	0	10.85%	0%
SUBTOTAL	2,206,370		10.85%

 

After 19 April 2024, Stephen Industries Inc Oy holds 10.85% 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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Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)

Bioretec Ltd Company announcement 20 May 2024 at 7:00 p.m. EEST

Bioretec Ltd has on 20th May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Stephen Industries Inc Oy in Bioretec Ltd have before 19 April 2024 crossed the threshold of 10%. 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 Stephen Industries Inc Oy 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	10.85%	0%	10.85%	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	2,206,370	0	10.85%	0%
SUBTOTAL	2,206,370		10.85%

 

After 19 April 2024, Stephen Industries Inc Oy holds 10.85% 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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