Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage
Bioretec Ltd Inside information 14 March 2024 at 3.45 p.m. EET
Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery. RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
Obtaining the Breakthrough Device Designation status is an important milestone in getting the product launched into the U.S. markets, and therefore, Bioretec will evaluate the potential acceleration of RemeOs Spinal Cage product development as well as resource allocation requirements, which might impact the future capital needs of the Company.
Bioretec's biodegradable RemeOs™ Spinal Interbody Cage met the strict criteria set for entering the FDA’s Breakthrough Device Designation program. FDA requires a breakthrough technology to provide more effective treatment for life-threatening or irreversibly debilitating conditions or diseases. In addition, breakthrough technology must either represent a completely new form of treatment or offer significant advantages over existing approved or cleared alternatives, including the potential to reduce the need for hospitalization, improve patient’s quality of life, and create long-term clinical benefits, or alternatively represent a form of treatment that is in the best interest of patients. Under the Breakthrough Devices Program, the FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Spinal Interbody Cage implant in the U.S. market.
“This designation gives us another validation of our expertise in creating innovative products for the unmet clinical needs in the orthopedic field. I am enthusiastic about the future prospects and the market opportunities of this product, which is based on the patented hybrid technology”, states Timo Lehtonen, the CEO of Bioretec.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
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: Bioretec's European market authorization for RemeOs trauma screw has proceeded to expert panel evaluation, the approval is estimated during the Q2 2024
Inside information: Bioretec's European market authorization for RemeOs trauma screw has proceeded to expert panel evaluation, the approval is estimated during the Q2 2024
Bioretec Ltd Inside information 8 March 2024 at 9:15 p.m. EET
Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, European market authorization application of the RemeOs™ trauma screw has, according to the information received from the Notified Body, progressed to the expert panel stage. The duration of the evaluation is a maximum of 60 days. After this step, the process returns to the Notified Body. Based on the information, the company estimates that the CE mark will be obtained during the second quarter of 2024 instead of the previous estimate of the first quarter of 2024.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
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
Bioretec Ltd’s financial statements bulletin 2023: Another successful year in the growth trajectory
Bioretec Ltd’s financial statements bulletin 2023: Another successful year in the growth trajectory
Bioretec Ltd Company announcement 16 February 2024 at 8:00 a.m.
This announcement is a summary of Bioretec Ltd’s financial statements bulletin for January–December 2023. The complete financial statements bulletin 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.
July–December 2023 in brief
- Net sales increased by 33% and amounted to EUR 2,016 thousand (7-12/2022: EUR 1,520 thousand).
- Sales margin was EUR 1,483 (1,121) thousand or 73.6% (73.8%) of net sales, with year-on-year growth of 32%.
- Net loss for the period amounted to EUR -1,714 (-1,049) thousand.
- Earnings per share (undiluted) were EUR -0.09 (-0.07).
January–December 2023 in brief
- Net sales grew 33% and amounted to EUR 3,906 thousand (1-12/2022: EUR 2,942 thousand).
- Sales margin was EUR 2,810 (2,139) thousand or 71.9% (72.7%) of net sales, with year-on-year growth of 31%.
- Net loss for the period amounted to EUR -3,789 (-2,416) thousand.
- Earnings per share (undiluted) were EUR -0.19 (-0.17).
- The Board of Directors proposes that no dividend be distributed for the financial period 1 January–31 December 2023.
Key events in 2023
- In March 2023, Bioretec was granted a De Novo market authorization for its biodegradable RemeOs™ magnesium screw in the U.S.
- In April 2023, Bioretec announced that it will update and refocus its product portfolio and refine its U.S. go-to-market strategy, and consequently update its financial targets.
- In April 2023, Bioretec successfully completed a private placement and raised EUR 10 million.
- In May 2023, Bioretec appointed Dr. Jeremy Dublon as a Regulatory Advisor to support the company’s U.S. go-to-market strategy.
- In June 2023, Bioretec invested in a CNC machining center to increase the RemeOs™ production capacity.
- In August 2023, Bioretec announced its revised Scientific Advisory Board, whose members are the world's leading orthopedic experts in their own specialty.
- In September 2023, Bioretec entered into a distribution agreement with Spartan Medical for the RemeOs™ screws launch in the U.S.
- In October 2023, Bioretec changed its estimate for the granting of the European market authorization for its biodegradable RemeOs™ trauma screw and estimated that the approval will move to the first quarter of 2024.
- In November 2023, Bioretec´s Board of Directors initiated a recruitment process for a new CEO.
This financial statements bulletin is unaudited. The full-year 2022 figures are audited.
Key figures
|
EUR 1,000 |
H2 2023 |
H2 2022 |
Change, % |
FY 2023 |
FY 2022 |
Change, % |
|
Net sales |
2,016 |
1,520 |
32.6% |
3,906 |
2,942 |
32.8% |
|
Sales margin |
1,483 |
1,121 |
32.3% |
2,810 |
2,139 |
31.4% |
|
Sales margin, % |
73.6% |
73.8% |
|
71.9% |
72.7% |
|
|
EBITDA |
-1,703 |
-916 |
85.9% |
-2,833 |
-2,112 |
34.1% |
|
EBIT |
-1,801 |
-1,006 |
78.9% |
-3,034 |
-2,292 |
32.4% |
|
Net profit (loss) |
-1,714 |
-1,049 |
63.3% |
-3,789 |
-2,416 |
56.8% |
|
R&D spend on total costs, % |
22.7% |
25.3% |
|
25.6% |
28.1% |
|
|
Equity ratio, % |
77.3% |
55.2% |
|
77.3% |
55.2% |
|
|
Cash and cash equivalents |
6,910 |
1,223 |
465.1% |
6,910 |
1,223 |
465.1% |
|
Earnings per share (undiluted) |
-0.09 |
-0.07 |
18.0% |
-0.19 |
-0.17 |
13.3% |
|
Earnings per share (diluted) |
-0.07 |
-0.05 |
28.6% |
-0.15 |
-0.12 |
23.4% |
|
Number of shares at the end of the period (undiluted) |
19,536,858 |
14,111,858 |
|
19,536,858 |
14,111,858 |
|
|
Number of shares (diluted) |
24,908,133 |
19,608,126 |
|
24,908,133 |
19,608,126 |
|
|
Number of personnel at the end of the period |
37 |
28 |
32.1% |
37 |
28 |
32.1% |
Timo Lehtonen, CEO of Bioretec Ltd:
”In 2023, Bioretec achieved a historic milestone by becoming the first player to receive an FDA market authorization in the U.S. for a biodegradable metal product with our RemeOs™ magnesium alloy screw. This landmark achievement not only signifies our entry into the world's largest orthopedic market but also sets a strong foundation for the future commercialization of our innovative RemeOs™ product line. Our continuous efforts in developing advanced, bioabsorbable orthopedic solutions also resulted in the year ending with the highest net sales in Bioretec's history.
Following the FDA market authorization, we conducted a diligent evaluation process for various distribution channels, which resulted in a partnership with Spartan Medical. This collaboration is particularly strategic, given Spartan's network and experience in both civilian and Department of Defense and Veterans healthcare (DOD & VA) markets. After signing the distribution agreement, we initiated the hospital approvals processes and the roll-out of our RemeOs™ products in chosen top-tier U.S. academic centers and hospitals. As these processes are time-consuming, we are currently awaiting approvals from these selected academic centers and hospitals. The shipments of the RemeOs™ magnesium screws to Spartan started in the fourth quarter of 2023, and the first surgery using the RemeOs™ screws has been performed.
Last spring, we took in a significant stride in fortifying our financial position through a successful funding round. Despite the challenges presented by the financial market conditions, we managed to secure EUR 10 million in gross proceeds through a directed share issue targeting institutional and other experienced investors. This capital infusion is vital for our company, as it will catalyze the acceleration of commercialization and distribution efforts for our RemeOs™ product line. Additionally, the funds will be instrumental in furthering our product development initiatives and expanding our production capacity, positioning us well for future growth. Therefore, after the funding round, we marked an anticipated decision in Bioretec’s growth trajectory by investing in a new CNC machining center currently dedicated only to our RemeOs™ screws, and the commissioning was completed in January 2024. To further support our growing operations, we've embarked on expanding our production facility space. Additionally, we are investing in a new ERP system scheduled for implementation in 2024. This system is designed to streamline our operations and enhance efficiency, enabling us to surpass our 2023 achievement of delivering products for more than 35 thousand surgical operations. Parallel to these measures, we are also accelerating our product development by expanding our organization and continuing to innovate to meet the evolving demands of the market.
In 2023, we experienced robust growth, with net sales increasing by 33 percent from the previous year, reaching EUR 3.9 million. A significant contributor to this growth was the introduction of our new RemeOs™ screw in the U.S. market, amounting to EUR 374 thousand in its first half year. Meanwhile, China remained a key market for the Activa product group, representing over 50% of our Activa product sales totaling EUR 3.5 million. The sales of RemeOs™ and Activa products in the U.S. showed convincing growth, resulting in nearly 22% of total net sales. In Europe, we faced several market challenges. The discontinuation of deliveries to Russia significantly impacted our operations in Europe. Additionally, this region is still grappling with the aftereffects of the pandemic and acute shortage of hospital staffing, further straining our sales in this market.
As we progress into the first quarter of 2024, we anticipate that we will finally obtain the market authorization for our RemeOs™ trauma screw in Europe. The delay is due to prolonged Notified Body approval processes. Obtaining the CE mark will pave the way for the product's commercialization in the European market. Concurrently, we are set to continue the roll-out of the RemeOs™ screws in the U.S. market and are dedicating substantial resources towards the development of new products in the RemeOs™ series. As part of the expansion plans, we are preparing the next U.S. market authorization application for the RemeOs™ screws, and we have entered into an agreement to conduct a clinical trial of the RemeOs™ DrillPin at the Medical University Hospital in Graz, Austria. This trial is an essential step towards our objective of commercializing the DrillPin in 2025.
As the first half of the year 2024 will partly be burdened by production interruptions (e.g., validation and the ramp-up of our new CNC machining center), we expect our net sales to be generated to a greater extent during the second half of the year. Also, as our RemeOs™ product pipeline is mainly in the development and commercialization phase, we will continue to invest heavily both in S&M and R&D in the forthcoming year. The recruitment process for Bioretec's new CEO is currently underway, and I am transitioning into another leadership position within the organization. I am thrilled to focus my efforts on the future for supporting the RemeOs™ product pipeline's forthcoming endeavors. I am confident that together with the new CEO, we will strengthen our growth to transform bone fracture care and significantly enhance patients’ quality of life.”
Financial reporting and Annual General Meeting in 2024
In 2024, Bioretec will publish the following financial reports:
- annual report for 2023 during week 11/2024 at the latest (week commencing on 11 March 2024)
- business review for January–March 2024 on Thursday 16 May 2024
- 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.
Bioretec Ltd’s Annual General Meeting is planned to be held on Friday, 26 April 2024. The company's Board of Directors will convene the Annual General Meeting separately later.
Tampere, 16 February 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, CE mark is expected to be received during the first 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 financial statements bulletin January–December 2023 (pdf)
Bioretec and Stephen Industries donate medical devices to Ukraine
Bioretec and Stephen Industries donate medical devices to Ukraine
Bioretec Ltd Press release 8 February 2024 at 5:00 p.m. EET
Bioretec Oy and its largest shareholder, Stephen Industries Inc Oy, are donating biodegradable implants and instruments used in orthopedic surgeries to Ukraine for use in approximately 900 surgeries. The aid is based on a request from the Orthopedic Trauma Hospital in Kyiv, and the delivery is coordinated by the Finnish and Ukrainian authorities.
"The war, which has been going on for almost two years, has caused a huge amount of human suffering in Ukraine. With the donation, we want to show our support for Ukrainians and the independence of Ukraine", says Kustaa Poutiainen, chairman of the board of Stephen Industries Inc Oy.
The Finnish company Bioretec Oy is a pioneer in the development of biodegradable implants. One advantage of the usage of the product is, that the implants do not have to be removed, which reduces the overall need for surgery.
"Ukraine is in need of many kinds of assistance and its healthcare is working at its limits. As a manufacturer of biodegradable orthopedic implants, we can support Ukraine by donating our products, which eliminate the need for implant removal surgeries, increasingly allocating the resources of the medical staff to acute treatment," says Timo Lehtonen, CEO of Bioretec Oy.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
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, CE mark is expected to be received during the first 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
Bioretec Ltd´s manufacturer's declaration on the legal extension of the validity of Activa product certifications
Bioretec Ltd´s manufacturer's declaration on the legal extension of the validity of Activa product certifications
Bioretec Ltd Press release 26 January 2024 at 7.50 p.m. EET
In relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in particular with respect to
- the validity of certificates issued under Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MOD) (Directive Certificates) andlor1
- the compliance of the devices and us as their manufacturer with the conditions for the continued placing on the market and putting into service
We, as the manufacturer, declare the validity of legal extension for the following Activa Products groups; ActivaPin™, ActivaScrew™, ActivaScrew™ Interference TCP, Activa IM-Nail, and Instruments Product Groups, and in separate attachment ActivaScrew™ Interference Product Groups
See the attachments:
- Mfr Declaration_Extension of MDR Transitional Period_AP, AS, ASI TCP, IM-Nail, Instruments_with logo.pdf
- Mfr Declaration_Extension of MDR Transitional Period_ASI_with logo.pdf
Further enquiries
Mari Ruotsalainen, Director, QA&RA, +358 40 766 5691
New shares in Bioretec Ltd subscribed with option rights have been registered into the Trade Register
New shares in Bioretec Ltd subscribed with option rights have been registered into the Trade Register
Bioretec Ltd Company announcement 18 January 2024 at 8:00 a.m. EEST
An aggregate number of 800,000 new shares of Bioretec Ltd have been subscribed for with option rights under the company’s option program 2019–1. The new shares have been registered into the Trade Register maintained by the Finnish Patent and Registration Office on 18 January 2024. The total subscription price of EUR 120,000.00 will be recorded in Bioretec's reserve of invested unrestricted equity, and the company's share capital will remain unchanged.
Following the registration of the new shares, the total number of shares in Bioretec is 20,336,858.
The new shares will be issued in the book-entry system on or about 19 January 2024. The new shares will confer shareholder rights in the company as of their registration on the investors' book-entry accounts. Trading in the new shares is expected to commence on the Nasdaq First North Growth Market Finland marketplace on or about 22 January 2024.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
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 was received in the U.S. in March 2023, and in Europe, the CE mark is expected to be received during the first 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
Bioretec Ltd – Managers’ transactions
Bioretec Ltd – Managers’ transactions
Bioretec Ltd Managers’ transactions 9 January 2024 at 17.00 p.m. EET
Bioretec Oy - Managers' Transactions
____________________________________________
Person subject to the notification requirement
Name: Michael Piccirillo
Position: Member of the Board/Deputy member
Issuer: Bioretec Oy
LEI: 7437008736AG7HY51K13
Notification type: INITIAL NOTIFICATION
Reference number: 48928/4/4
____________________________________________
Transaction date: 2023-01-12
Venue: FIRST NORTH GROWTH MARKET FINLAND (FSME)
Instrument type: SHARE
ISIN: FI4000480454
Nature of transaction: ACQUISITION
Transaction details
(1): Volume: 2447 Unit price: 1.95 EUR
Aggregated transactions (1):
Volume: 2447 Volume weighted average price: 1.95 EUR
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
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 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 first 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
Bioretec Ltd – Managers’ transactions
Bioretec Ltd – Managers’ transactions
Bioretec Ltd Managers’ transactions 8 January 2024 at 17.00 p.m. EET
Bioretec Oy - Managers' Transactions
____________________________________________
Person subject to the notification requirement
Name: Michael Piccirillo
Position: Member of the Board/Deputy member
Issuer: Bioretec Oy
LEI: 7437008736AG7HY51K13
Notification type: INITIAL NOTIFICATION
Reference number: 48797/7/6
____________________________________________
Transaction date: 2023-01-13
Venue: FIRST NORTH GROWTH MARKET FINLAND (FSME)
Instrument type: SHARE
ISIN: FI4000480454
Nature of transaction: ACQUISITION
Transaction details
(1): Volume: 7553 Unit price: 2.05 EUR
Aggregated transactions (1):
Volume: 7553 Volume weighted average price: 2.05 EUR
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
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 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 first 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
Bioretec Ltd – Managers’ transactions
Bioretec Ltd – Managers’ transactions
Bioretec Ltd Managers’ transactions 5 January 2024 at 11.00 a.m. EET
Bioretec Oy - Managers' Transactions
__________________________________________
Person subject to the notification requirement
Name: Stephen Industries Inc Oy
Position: Closely associated person
(X) Legal person (1):Person Discharging Managerial Responsibilities In Issuer
Name: Kustaa Poutiainen
Position: Member of the Board
Issuer: Bioretec Oy
LEI: 7437008736AG7HY51K13
Notification type: INITIAL NOTIFICATION
Reference number: 48652/4/6
____________________________________________
Transaction date: 2024-01-03
Outside a trading venue
Instrument type: SHARE
ISIN: FI4000480454
Nature of transaction: ACQUISITION
Transaction details
(1): Volume: 606370 Unit price: 2.1 EUR
Aggregated transactions (1):
Volume: 606370 Volume weighted average price: 2.1 EUR
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
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 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 first 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
Bioretec Ltd's schedule for financial reporting in 2024 and updates in the disclosure policy
Bioretec Ltd's schedule for financial reporting in 2024 and updates in the disclosure policy
Bioretec Ltd Company announcement 11 December 2023 at 5:15 p.m. EET
In the future, in addition to the financial statements bulletin and half-year report, Bioretec will also publish business reviews for January–March and January–September. As a result, Bioretec Ltd has updated its disclosure policy describing the general principles and procedures that the company adheres to in its communication with capital markets and financial media.
The updated disclosure policy is available on the company’s web pages at https://bioretec.com/investors/investors-in-english/investor-relations/disclosure-policy
Bioretec Ltd’s schedule for financial reporting in 2024
In 2024, Bioretec will publish the following financial reports:
- financial statements bulletin for January–December 2023 on Friday 16 February 2024
- Annual Report for 2023 during week 11/2024 at the latest (week commencing on 11 March 2024)
- business review for January–March 2024 on Thursday 16 May 2024
- half-year report for January–June 2024 on Thursday 15 August 2024
- business review for January–September 2024 on Thursday 14 November 2024
The Annual Report includes the report of the Board of Directors, the consolidated financial statements, the parent company financial statements, and the auditor’s report for the financial period 1 January–31 December 2023.
The releases will be available online at Bioretec Ltd’s website at https://bioretec.com/investors/investors-in-english/reports-and-presentations.
Bioretec Ltd’s Annual General Meeting is planned to be held on Friday, 26 April 2024. The company's Board of Directors will convene the Annual General Meeting separately later.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
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, CE mark is expected to be received during the first 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