Inside Information: Update for Bioretec's RemeOs™ Trauma Screw European Marketing Authorization
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
Bioretec reports successful clinical outcomes from U.S. controlled launch of RemeOs™ trauma screw: fracture healing confirmed in 100% of surgical procedures
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
Bioretec Appoints Frank Sarcone as Vice President of Sales for the US and a member of the Management Team
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
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings - Ilmarinen Mutual Pension Insurance Company
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 |
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
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings - Stephen Industries Inc Oy
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 |
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
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)
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 |
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
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)
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 |
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
Inside information: Alan Donze has been appointed as Bioretec's new CEO
Inside information: Alan Donze has been appointed as Bioretec's new CEO
Bioretec Ltd Inside information 20 May 2024 at 6:00 p.m. EEST
Bioretec Ltd is pleased to announce that Mr. Alan Donze has been appointed CEO of Bioretec as of today, 20 May 2024. He will start in this position immediately. With a distinguished career spanning the banking and medical device industries, Mr. Donze brings a wealth of experience and expertise to the Bioretec organization.
Mr. Donze began his career journey in the banking industry, serving as the Vice President of Commercial Lending and Leveraged Finance for a regional predecessor to Chase bank. He left banking to begin his medical device career as a Regional Sales Representative for Stryker Endoscopy in 1991. Over his 13 years at Stryker, Mr. Donze’s responsibilities increased to various senior management positions, including Vice President General Manager of Stryker Endoscopic Service and Vice President General Manager of Stryker Communications, a division he was given the tremendous opportunity to create and build from the ground up. Mr. Donze has also held senior leadership positions for a number of other medical device and technology companies including Smith+Nephew, Bioventus, and Lima Corporate and venture-led startups such as Isotis Orthobiologics, Aerobiotix and Rx.Health. Mr. Donze received his Bachelor of Science in Finance from Louisiana State University.
"We are excited to announce the appointment of Alan Donze as our new Chief Executive Officer. With his proven track record of leadership and vision, we are confident that Alan will lead our company to new heights of commercial success. Alan brings with him 30 years of sales and marketing leadership experience in medical devices, where he has demonstrated a deep understanding of market dynamics and a relentless drive for excellence. His strategic insights and passion for Bioretec's mission make him the ideal leader to guide us into the future," says Tomi Numminen, Bioretec's Chairman of the Board.
"I am honored to be given the opportunity to lead Bioretec to the next level and deeply appreciate the confidence placed in me by the Board of Directors. Bioretec’s groundbreaking work in developing alternatives to traditional metal implants represents a significant advancement in the medical field. Our products have the potential to reduce the need for invasive surgeries and improve patient outcomes, aligning with a critical need within the healthcare community. I am eager to contribute to Bioretec’s mission by expanding our efforts to introduce these transformative solutions to the benefit of many more patients. I look forward to the journey ahead and to our continued growth and success,” says Alan Donze.
Timo Lehtonen, Bioretec's CEO since 2019, will transfer to the position of Chief Technology Officer (CTO) and continue to lead the development of Bioretec’s future product pipeline.
"It has been a privilege to lead Bioretec since 2019 and support its remarkable growth through interesting, challenging times. I am excited to focus my efforts on advancing the RemeOs™product pipeline. Together with Alan, I am confident we will continue to strengthen our growth and transform bone fracture care. In my forthcoming role as CTO, I will leverage my extensive experience in innovation, product development, and regulatory expertise to support the management team and our skilled personnel. Our goal is to achieve the best possible outcomes in redefining bone fracture treatment and improving patients' quality of life," says Timo Lehtonen.
"I would like to thank Timo Lehtonen for his passionate and dedicated leadership as our CEO over the past five years. Under his guidance, Bioretec has grown strongly and strengthened its position as a leading innovator in biodegradable technologies. With its biodegradable metal implants, the company has significantly modernized the surgical treatment of bone fractures, which significantly increases the quality of the lives of the patients. Our mutual and succesful path with Timo continues while he assumes the role of CTO in which role he continues to provide important support for the future development of our product pipeline," says Chairman of the Board Tomi Numminen.
Further enquiries
Tomi Numminen, Chairman of the Board, tel. +358 40 581 2132
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
Bioretec Ltd’s business review January–March 2024: Controlled launch in the U.S. progresses
Bioretec Ltd’s business review January–March 2024: Controlled launch in the U.S. progresses
Bioretec Ltd Company announcement 16 May 2024 at 8:30 a.m.
This announcement summarizes Bioretec Ltd’s business review for January–March 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.
January–March 2024 in brief
- Net sales amounted to EUR 682 thousand (1–3/2023: EUR 1,071 thousand).
- The sales margin was EUR 478 (718) thousand, or 70.1% (67.0%) of net sales. The sales margin of 2024 includes other income of EUR 60 thousand accrued relating to the Business Finland grant. When excluding the grant effect, the sales margin for the current reporting period is EUR 418 thousand, or 61.3%. The main reason for the lower sales margin percentage has been the planned production shutdown due to the ramp-up of new production capacity.
- EBITDA was EUR -1,112 (-491) thousand. EBITDA was EUR -1,112 (- 491) thousand. It 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 -1,097 (-557) thousand.
This business review is unaudited. This is Bioretec’s first business review for the first quarter, and comparison period figures have not been published earlier.
Key figures
|
EUR 1,000 unless otherwise noted |
1–3/2024 |
1–3/2023 |
Change |
1–12/2023 |
|
Net sales |
682 |
1,071 |
-36.4% |
3,906 |
|
Sales margin |
478 |
718 |
-33.4% |
2,810 |
|
Sales margin, % of net sales |
70.1% |
67.0% |
|
71.9% |
|
EBITDA |
-1,112 |
-491 |
126.6% |
-2,833 |
|
EBIT |
-1,139 |
-543 |
109.6% |
-3,034 |
|
Profit/-loss for the period (+/-) |
-1,097 |
-557 |
97.0% |
-3,789 |
|
R&D spend on total costs, % |
25.9% |
24.8% |
|
25.6% |
|
Equity ratio, % |
74.3% |
44.3% |
|
77.3% |
|
Cash and cash equivalents at end of period |
5,981 |
587 |
919.3% |
6,910 |
|
Number of personnel at end of period |
39 |
28 |
39.3% |
37 |
Key events during the reporting period
- European market authorization application for the RemeOsTM trauma screw proceeded to expert panel evaluation. The approval is estimated to be granted during the second quarter of 2024.
- Bioretec was granted an FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage.
- Bioretec’s RemeOs™ biodegradable magnesium alloy composition was granted a patent by the U.S. Patent Office.
Timo Lehtonen, CEO of Bioretec Ltd:
” In the first quarter of 2024, our focus was on the production and distribution of our Activa product line as the U.S. market continued to utilize inventories of the RemeOs™ trauma screw from Q4 2023. Net sales this quarter were distinctly marked by contributions from different regions: Europe accounted for 27% of net sales (19% in the comparison period), the U.S. increased from 16% to 24%, while the rest of the world decreased from 65% to 49%.
The controlled launch of RemeOs™ trauma screw continued, with an evolving number of surgeries performed utilizing this innovative product. We are actively collecting and analyzing follow-up data from the surgeries to assess the efficacy of the fracture healing treated with our screws.
In preparation for continued US sales growth, the need to enhance our production capabilities resulted in a planned production shutdown In January, which is reflected in our profitability numbers for this period. This operational enhancement included the commissioning, qualification, and ramp-up of the new CNC machine dedicated to our trauma screw line and increasing our resource allocation to operational personnel and projects, setting the stage for increased output in subsequent quarters.
Looking ahead, we are waiting to receive market authorization for the RemeOs™ trauma screws in Europe during the second quarter of 2024. Our development efforts are ongoing for the next RemeOs™ pipeline products, supported by the new RemeOs™ magnesium alloy patent and the new FDA Breakthrough Device Designation received for the Spinal Interbody Cage. Additionally, we are advancing our plans for the next U.S. market authorization and initiating the RemeOs™ DrillPin clinical study in Austria, waiting for the ethical committee and other regulatory approvals to start the First-in-Human study.
As we have concentrated on enhancing our production capabilities in the first quarter, we project that our net sales will be more heavily concentrated in the second half of the year. This strategic growth platform building has been required to expand production capabilities to serve the future anticipated market demand and product portfolio expansions.
We are grateful to our investors, customers, and personnel for their continued confidence and support. Your trust encourages our commitment to innovation and excellence as we navigate these exciting opportunities and challenges.”
Financial reporting in 2024
In 2024, Bioretec will publish the following financial reports:
- half-year report for January–June 2024 on Thursday 15 August 2024
- 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, 16 May 2024
Board of Directors
Bioretec Ltd
Further inquiries:
Timo Lehtonen Johanna Salko
CEO CFO
+358 50 433 8493 +358 40 754 8172
timo.lehtonen@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 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 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 business review January–March 2024 (pdf)
Resolutions of Bioretec Ltd´s Annual General Meeting and the constitutive meeting of the Board of Directors
Resolutions of Bioretec Ltd´s Annual General Meeting and the constitutive meeting of the Board of Directors
Bioretec Ltd Company announcement 26 April 2024 at 12:15 p.m. EEST
The Annual General Meeting of Bioretec Ltd was held on 26 April 2024 in Tampere, Finland.
The Annual General Meeting approved the financial statements for the financial year 1 January–31 December 2023 and resolved to discharge the members of the Board of Directors and the CEO from liability for the financial period 1 January–31 December 2023.
The Annual General Meeting resolved in accordance with the proposal of the Board of Directors that the loss of EUR 3,721,314.67 for the financial period 1 January–31 December 2023 will be booked in the balance sheet as equity under profit/loss for previous financial periods and that no dividend will be distributed.
Number of members of the Board of Directors, election of members of the Board and their remuneration
The Annual General Meeting resolved that the number of members of the Board of Directors will be five (5). Tomi Numminen, Michael Piccirillo, Sarah van Hellenberg Hubar-Fisher, Päivi Malinen and Kustaa Poutiainen were re-elected as members of the Board. The term of the Board of Directors will end at the closing of the Annual General Meeting 2025.
The Annual General Meeting resolved that the Chairman of the Board will be paid EUR 10,000 per month. The Chairman will participate in the operative management of the company in the upcoming term. Members of the Board will be paid EUR 1,500 per month. Reasonable travel expenses of the members of the Board of Directors shall be reimbursed in accordance with the maximum amount of the respective travel allowance base approved by the Tax Administration.
The Annual General Meeting resolved that the company may enter into a consultancy agreement with Valugen GmbH for the services of Michael Piccirillo in connection with establishing the company’s Scientific Advisory Board, to create key opinion leader connections. The consulting fee payable pursuant to such agreement shall not exceed EUR 3,000 per month.
Election and remuneration of auditor
The Annual General Meeting elected audit firm PricewaterhouseCoopers Oy as the auditor of the company until the closing of the 2025 Annual General Meeting. Audit firm PricewaterhouseCoopers Oy has notified the company that it will appoint Kalle Laaksonen, Authorized Public Accountant, as the responsible auditor. The auditor will be compensated as reasonably invoiced.
Authorization of the Board of Directors to resolve on the issuance of shares and special rights entitling to shares
The Annual General Meeting authorized the Board of Directors to resolve on the issuance of shares, as well as the issuance of option rights and other special rights entitling to shares pursuant to Chapter 10 of the Finnish Companies Act, as follows:
Pursuant to the authorization, up to 3,000,000 shares (including the new shares to be issued based on the special rights) can be issued, which on the date
of the notice to the Annual General Meeting corresponded approximately to 15 per cent of all the shares in the company.
Shares or special rights entitling to shares may be issued in one or more tranches, either with or without payment. The shares issued pursuant to the authorization may be new shares or shares in the company's possession. The authorization may be used for financing or execution of acquisitions or other business arrangements, to strengthen the balance sheet and financial position of the company, for implementing the company's share-based incentive plans, or for other purposes determined by the Board of Directors.
Pursuant to the authorization, the Board of Directors may resolve upon issuing new shares, without consideration, to the company itself.
The Board of Directors was authorized to resolve on all terms for share issues and granting of special rights entitling to shares in the company. The Board of Directors was authorized to resolve on a directed share issue and issuance of special rights entitling to shares according to the shareholders’ pre-emptive rights and/or in deviation from the shareholders' pre-emptive right, provided that there is a weighty financial reason for the company to do so.
The authorization is valid until the end of the next Annual General Meeting, however, no longer than until 30 June 2025. The authorization cancels the previous unused share issue authorizations.
Establishment of a Shareholders’ Nomination Board and Approval of the Charter
The Annual General Meeting resolved to establish a Shareholders’ Nomination Board, responsible for annually preparing and presenting to the Annual General Meeting and, if necessary, to an Extraordinary General Meeting, proposals on the composition (number of the members of the Board of Directors and the nominees) and remuneration of the Board of Directors. In addition, the Nomination Board is responsible for identifying candidates to succeed members of the Board of Directors and preparing principles for diversity for the Board of Directors.
The Annual General Meeting resolved to approve the Charter of the Shareholders’ Nomination Board, which had been attached to the notice to the Annual General Meeting and is available on the company’s website at https://bioretec.com/agm2024.
The Nomination Board consists of three (3) members. The company's three (3) largest shareholders are each entitled to nominate one member. The Chair of the Board of Directors of the company serves as an expert in the Nomination Board and will not have a voting right nor be counted in the quorum of the Nomination Board.
The members of the Nomination Board, the shareholders appointing them and any changes to the composition of the Nomination Board are published by a company release.
The Nomination Board is established for the time being until the General Meeting decides otherwise. The members of the Nomination Board are appointed annually and the term of office of the members ends when new members have been appointed to the Nomination Board.
Minutes of the Annual General Meeting
The minutes of the Annual General Meeting will be available no later than 10 May 2024 on the company's website at https://bioretec.com/investors/investors-in-english/governance/general-meetings/annual-general-meeting-2024.
Resolutions of the constitutive meeting of the Board of Directors
At its constitutive meeting held after the Annual General Meeting, the Board of Directors of Bioretec Ltd elected Tomi Numminen as the chairperson of the Board.
The Board resolved to establish an [Audit Committee and a Nomination /Remuneration Committee]. The members of the Committees were elected as follows:
- Audit Committee: Tomi Numminen (chairperson), Päivi Malinen and Sarah van Hellenberg Hubar-Fisher
- Nomination / Remuneration Committee: Päivi Malinen (chairperson), Michael Piccirillo and Kustaa Poutiainen
The Board assessed the independence of its members in accordance with the Finnish Corporate Governance Code for listed companies. The Board concluded that of its members Kustaa Poutiainen is not independent of the company’s significant shareholders and Tomi Numminen and Michael Piccirillo are not independent of the company. Valugen GmbH, a company owned by Michael Piccirillo, receives remuneration from the company for consulting assignments and Tomi Numminen has received compensation for consulting assignments during the past year. In addition, the Board concluded that based on an overall assessment, the other Board members are independent of both the company and its significant shareholders.
Further enquiries
Tomi Numminen, Chairman of the Board of Directors, tel. +358 40 581 2132
Timo Lehtonen, CEO, tel. +358 50 433 8493
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable 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 bioresorbable 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, CE-mark is expected to receive 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