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  • Timo Lehtonen

    CEO


    Yrittäjänkulma 5, FI-33710 Tampere, FINLAND
    +358 50 433 8493
    https://bioretec.com/
  • Johanna Salko

    CFO


    Yrittäjänkulma 5, FI-33710 Tampere, Finland
    +358 40 754 8172
    https://bioretec.com/

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    It is an honor to announce this SAB and integrate these merited leaders of the orthopedic industry with our new RemeOs™ Screw products and material technology development. We are thrilled to have decades of the expertise and impactful accomplishments of SAB members behind us. Their combined resume includes significant professional and academic contributions and influential positions in the global orthopedic community. We are looking forward to this cooperation with our SAB and interesting future activities.
    Timo Lehtonen, CEO of Bioretec
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    The commercialization of Bioretec’s RemeOs™ Trauma Screw in the U.S. proceeds with the signing of new logistics agreement

    Bioretec Ltd                   Press release             20 November 2024 at 3:30 p.m. EETBioretec Ltd, a pioneering company dedicated to advancing biodegradable orthopedic implants, is moving ahead with the next phase of commercializing its innovative RemeOs™ Trauma Products in the U.S. market. Bioretec strengthens its operational efforts by entering into a new logistics agreement with a partner providing customer support services for U.S. operations. This agreement with GlobalMed Logistix (GMLx), a leader in healthcare logistics, will enable the smooth import and distribution of implants

    Bioretec Ltd’s business review January–September 2024: Launch of the RemeOs™ Trauma Screw in the U.S. is proceeding to the next phase, EU authorization in the final stage

    Bioretec Ltd  Company announcement 14 November 2024 at 8:45 a.m.This announcement summarizes Bioretec Ltd’s business review for January–September 2024. The complete business review is attached to this release as a PDF file and available on the company’s website at https://bioretec.com/investors/investors-in-english/releases.   July – September 2024 in brief · Net sales amounted to EUR 685 thousand (7–9/2023: EUR 483 thousand). · The sales margin (excl. other income) was EUR 499 (397) thousand, or 72.9% (82.2%). The main reasons for the lower sales margin percentage were

    Inside information: Bioretec updates its financial targets

    Bioretec Ltd  Company announcement 4 October 2024 at 2:31 p.m. EESTBioretec Ltd announced today, 4 October 2024, that Bioretec's board of directors had decided to update the company's product development strategy by accelerating the product development of the RemeOs™ Spinal Interbody Cage following the granting of Breakthrough Device Designation status by the US Food and Drug Administration on 14 March 2024. Due to the acceleration of the product development of the RemeOs™ Spinal Interbody Cage, Bioretec's Board of Directors has today updated Bioretec's financial targets as follows:

    Inside information: Bioretec updates its product development strategy by accelerating the product development of RemeOs™ Spinal Interbody Cage

    Bioretec Ltd Company announcement 4 October 2024 at 2:30 p.m. EESTBioretec updates its product development strategy by accelerating the product development of the RemeOs™ Spinal Interbody Cage, an innovative medical device engineered from a multifunctional, MRI-compatible, absorbable hybrid composite based on the company's proprietary magnesium alloy. The decision to accelerate the product development of the RemeOs™ Spinal Interbody Cage is based on an evaluation by the company following the granting of Breakthrough Device designation by the US Food and Drug Administration on March 2024.

    Bioretec’s Shareholders' Nomination Board appointed

    Bioretec Ltd   Company announcement      20 September 2024 at 9:00 a.m. (EET)The following persons have been appointed to Bioretec's Shareholders' Nomination Board: Kustaa Poutiainen, Chair and Founder of Stephen Industries Inc Oy as Chair and Karoliina Lindroos, Head of Responsible Investment of Ilmarinen Mutual Pension Insurance Company and Marko Berg, Deputy Investment Officer of University of Helsinki, as members. The Chairman of the Board of Bioretec acts as an expert to the Nomination Board. In accordance with the decision taken by the Annual General Meeting (AGM) held on 26 April

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

    Bioretec Ltd  Company announcement 15 August 2024 at 8:00 a.m.This announcement is a summary of Bioretec Ltd’s half-year report January–June 2024. The complete half-year report with tables is attached to this release as a pdf file and available at the company’s web pages at https://bioretec.com/investors/investors-in-english/releases.   April–June 2024 in brief · Net sales increased by 68% and amounted to EUR 1,379 thousand (4–6/2023: EUR 820 thousand). · Sales margin (excl. other income) was EUR 1,033 (609) thousand, or 74.9% (74.3%) of net sales. · Profit (loss) for the

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

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

    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. EESTBioretec 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

    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. EESTBioretec 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

    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. EESTBioretec 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

    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. EESTBioretec 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:

    Inside information: Alan Donze has been appointed as Bioretec's new CEO

    Bioretec Ltd    Inside information  20 May 2024 at 6:00 p.m. EESTBioretec 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

    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

    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. EESTThe 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

    Notice of Annual General Meeting (AGM) of Bioretec Ltd

    Bioretec Ltd                         Company announcement    5 April 2024 at 3:00 p.m. EETThe shareholders of Bioretec Ltd are hereby invited to the Annual General Meeting to be held on 26 April 2024 at 10:00 a.m. (Finnish time) at Bioretec premises in the auditorium of Tampark, at the address Yrittäjänkulma 5, FI-33710 Tampere, Finland.   A shareholder may participate in the Annual General Meeting and exercise their rights at the meeting by way of proxy representation. A proxy representative shall present a dated power of attorney or, in another reliable manner, demonstrate their

    Inside information: Bioretec’s RemeOs™ biodegradable magnesium alloy composition has been allowed a patent by the U.S. Patent office

    Bioretec Ltd    Inside information       21 March 2024 at 7:00 p.m. EETBioretec Ltd., a pioneer in biodegradable orthopedic implants, has been allowed a patent by the U.S. patent office for its RemeOs™ magnesium alloy composition. The U.S. patent office will grant and publish the patent after the Company´s confirmation. Allowed patent concerns RemeOs™ magnesium-calcium-zinc alloy composition for orthopedic implants[1]. The patent also includes the usage of the RemeOs™ magnesium alloy in the manufacturing of orthopedic implants or a part of such implants for all patient populations. The

    Bioretec Ltd’s Annual Report and Financial Statements 2023 published

    Bioretec Ltd    Company announcement      15 March 2024 at 5:30 p.m. EETBioretec Ltd has today published its 2023 Annual Report, Financial Statements and Report by the Board of Directors. The publications are attached to this release and also available in Finnish and English on the company’s website at www.bioretec.com/investors/investors-in-english/reports-and-presentations.   Further enquiries Timo Lehtonen, CEO, +358 50 433 8493Johanna Salko, CFO, +358 40 754 8172  Certified adviser Nordic Certified Adviser AB, +46 70 551 67 29   Bioretec in brief Bioretec is

    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. EETBioretec 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

    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. EETBioretec 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

    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

    Bioretec and Stephen Industries donate medical devices to Ukraine

    Bioretec Ltd  Press release 8 February 2024 at 5:00 p.m. EETBioretec 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

    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. EESTAn 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

    Bioretec Ltd – Managers’ transactions

    Bioretec Ltd      Managers’ transactions 9 January 2024 at 17.00 p.m. EETBioretec 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

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