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
Inside information: Bioretec´s Board of Directors to initiate a new CEO recruitment process
Inside information: Bioretec´s Board of Directors to initiate a new CEO recruitment process
Bioretec Ltd Inside information 16 November 2023 at 1.30 p.m. EEST
Bioretec Ltd, a pioneer of biodegradable orthopedic implants, is initiating a new CEO recruitment process as the company’s current CEO, Mr. Timo Lehtonen, shall transfer into a new role within the company. The Board of Directors and Mr. Lehtonen have reached a mutual consensus in good understanding, based on a shared vision for the company’s future, to begin a recruitment process for a new CEO who will steer Bioretec to its forthcoming growth stages. Mr. Lehtonen will maintain his role as CEO with the Board’s full support until the successor is appointed, ensuring stability and continuity in the leadership of the Company.
During Mr. Lehtonen’s tenure, Bioretec has reached numerous milestones, notably reforming the surgical treatment of bone fractures with biodegradable metal implants through a first-ever FDA market authorization of magnesium-based implants in the U.S., thus significantly improving patient recovery and quality of life. Furthermore, under his leadership, the Company has enhanced its international market reach with sustained double-digit (in percentages) revenue growth and solidified its status as an innovator in biodegradable technologies.
“It has been an honor to lead Bioretec since 2019, overseeing the company’s dynamic growth with unwavering commitment. I deem that this is an appropriate juncture for a new leader to continue to implement the Company’s vision. My deepest appreciation goes out to our executive team, the Board, and our knowledgeable staff, whose collaborative efforts have been integral to our successes in redefining bone fracture treatment and improving patients’ quality of life.”, says Timo Lehtonen, the CEO of Bioretec.
Mr. Tomi Numminen, Chairman of the Board states, “The Board expresses its gratitude to Mr. Timo Lehtonen for his strong leadership and dedication. As we proceed with the selection of a new CEO, our focus remains on securing a leader with profound expertise in driving international business growth in alignment with Bioretec’s strategic ambitions.”
Further enquiries
Tomi Numminen, Chairman of the Board, 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 is expected to be received during the first 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 – Managers’ transactions
Bioretec Ltd – Managers’ transactions
Bioretec Ltd Managers’ transactions 6 November 2023 at 10.00 a.m. EET
Bioretec Oy - Managers' Transactions
____________________________________________
Person subject to the notification requirement
Name: Timo Lehtonen
Position: Chief Executive Officer
Issuer: Bioretec Oy
LEI: 7437008736AG7HY51K13
Notification type: INITIAL NOTIFICATION
Reference number: 42517/5/4
____________________________________________
Transaction date: 2023-11-01
Outside a trading venue
Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT
ISIN: FI4000480454
Nature of transaction: ACCEPTANCE OF A STOCK OPTION
Transaction details
(1): Volume: 100000 Unit price: 0 EUR
Aggregated transactions (1):
Volume: 100000 Volume weighted average price: 0 EUR
Further enquiries
Tomi Numminen, Chairman of the board, tel. +358 40 581 2132
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 6 November 2023 at 10.00 a.m. EET
Bioretec Oy - Managers' Transactions
____________________________________________
Person subject to the notification requirement
Name: Rami Ojala
Position: Other senior manager
Issuer: Bioretec Oy
LEI: 7437008736AG7HY51K13
Notification type: INITIAL NOTIFICATION
Reference number: 42518/5/4
____________________________________________
Transaction date: 2023-11-01
Outside a trading venue
Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT
ISIN: FI4000480454
Nature of transaction: ACCEPTANCE OF A STOCK OPTION
Transaction details
(1): Volume: 67000 Unit price: 0 EUR
Aggregated transactions (1):
Volume: 67000 Volume weighted average price: 0 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