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  • Morten Henneveld

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    OssDsign reaches commercial milestone of 750 implants sold in Germany

    Uppsala, April 27, 2023. OssDsign AB (publ.) today announces that the company has reached the commercial milestone of 750 implants sold in Germany since market entry, with a significant acceleration in sales during the last two years.Germany is one of the most important markets in Europe and, in recent years, OssDsign has considerably increased its sales efforts in Germany, resulting in a significant acceleration in sales. In addition to this, the company has successfully delivered on its strategic priority to increase operational efficiency and reduce lead time for OssDsign Cranial PSI.

    OssDsign reaches commercial milestone of 200 implants in France

    Uppsala, March 14 2023. OssDsign AB (publ.) today announces that the company has reached the commercial milestone of 200 implants in France. Since entering the market in late 2019, OssDsign has signed several important tenders in France leading to significantly accelerated sales during the last year.In 2019, the French health authorities decided OssDsign Cranial PSI provided high therapeutic value to patients and granted the product reimbursement on the French market. During the following years, OssDsign established an initial sales presence, secured first sales, and later gained broader

    Post-market surveillance shows continued low complication rates with OssDsign Cranial PSI

    Uppsala, December 2, 2021. OssDsign AB (publ.) today announces updated clinical data from a long-term follow-up of the company's innovative product OssDsign Cranial PSI, which is used in the treatment of cranial bone defects. The data, based on 1,480 surgeries, shows that the frequency of infections leading to implant removal was 1.6% after a median follow-up time of 22 months. This positive outcome exceeds what has been observed in previous follow-ups, thus highlighting the exceptional performance of OssDsign Cranial PSI.OssDsign Cranial PSI is a patient-specific cranial implant made from

    OssDsign awarded 3D Medical Printing Products agreement with Premier Inc.

    Uppsala, Sweden, 08:00 CET, 5 July 2021 – OssDsign, a global provider of reconstructive orthopaedic solutions for treatment of patients who have suffered from cranial or spinal bone defects, has been awarded a group purchasing agreement for 3D Medical Printing Products and Accessories with Premier Inc. The new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for OssDsign’s cranial reconstructive solutions.“We are pleased to have been awarded an agreement with Premier, which opens up a valuable distribution

    New scientific paper further confirms osteointegration of OssDsign Cranial PSI implants

    OssDsign AB (publ) (“OssDsign” or the “Company”) today announced that independent researchers from Uppsala University Hospital, Sweden, have published a scientific paper in Journal of Neurosurgery describing bone integration in patients implanted with OssDsign Cranial PSI. Samples from four studied patients consistently show vascularized bone, integrating the OssDsign implant with surrounding native bone. This reaffirms the positive findings presented in previously published papers and further strengthens the benefits of OssDsign’s custom-made calcium phosphate implants.Patients undergoing

    New clinical data from 1,055 cranioplasty procedures with OssDsign Cranial PSI continue to show low complication rates

    OssDsign AB (publ) (“OssDsign” or the “Company”) today announced that updated outcome data on the use of OssDsignCranial PSI in 1,055 cases of cranioplasty and cranial reconstructions have been made public via the company’s website. After a median follow-up time of 21 months, rate of infections leading to implant removal was 2.1%, which is consistent with the low levels previously presented. All data were collected as part of post-market surveillance of product performance in Europe, US and selected Asian markets in compliance with MEDDEV 2.7/1 rev.4 and MDR 2017/745.Reconstruction of

    OssDsign – strong sales in third quarter 2020

    OssDsign AB (publ) (“OssDsign”) publishes prelimary results for the third quarter 2020 ahead of plan in connection to the announcement of OssDsign’s acquisition of Sirakoss and the intention to carry out a directed share issue. OssDsign recorded strong sales growth in major territories. Total sales in the third quarter amounted to TSEK 6 481, an increase of 39% compared to the same period last year and the profit for the period amounted to TSEK -18 740.As communicated in separate press releases, OssDsign has signed an agreement to acquire the Scottish company Sirakoss and intends to carry

    OssDsign acquires Sirakoss, enters USD 4 billion bone graft market

    OssDsign AB (publ) (“OssDsign”), a leading bone-regeneration company with headquarters in Uppsala, Sweden, today announces the signing of an agreement to acquire the privately held, Scottish bone graft specialist company Sirakoss Ltd (“Sirakoss”). The acquisition broadens OssDsign’s product portfolio with the 510(k) cleared Osteo[3] ZP Putty, a next-generation synthetic bone graft substitute for use in orthopaedic surgery. OssDsign acquires all outstanding Sirakoss shares in an all-cash transaction, which is subject to customary closing conditions. The purchase price of USD 11 million, not

    New publication in high-impact scientific journal PNAS confirms the bone regenerative potential of OssDsign’s technology.

    A scientific article titled “In situ bone regeneration of large cranial defects using synthetic ceramic implants with a tailored composition and design” was recently published in the scientific journal PNAS (Proceedings of the National Academy of Sciences of the United States of America). The research article describes how OssDsign’s unique implant concept and proprietary material composition promote bone regeneration and osseointegration.OssDsign AB (publ) (“OssDsign”) today announced that a scientific article with the title “In situ bone regeneration of large cranial defects using

    New investment analysis of OssDsign and upcoming presentation

    Swedish investment bank Redeye has initiated coverage of OssDsign and today published an initial analysis report. OssDsign has also been included on Redeye’s “Conviction Buy List”. On Monday 7 September, OssDsign’s new CEO Morten Henneveld will present the company during the ABG Sundal Collier Investor Day. The presentation starts 14.30 CET and will stream live here: https://www.introduce.se/artiklar/2020/9/abgsc-investor-day-livestreamed-seminar-7-September/ The Redeye analysis can be found here: https://www.redeye.se/research/792865/ossdsign-growth-set-to-accelerate   For

    OssDsign AB (publ) publishes Q2 2020 interim report

    Sales growth during a quarter impacted by Covid-19.The second quarter in figures · Net sales amounted to TSEK 3 905 (3 454). · Loss after taxes amounted to TSEK 22 586 (18 330). · Loss per share was SEK 1,3 (1,3). · Cash flow from current operations was TSEK -15 829 (-13 917).  The first half year in figures ·Net sales amounted to TSEK 11 631 (6 968). · Loss after taxes amounted to TSEK 40 898 (35 670). · Loss per share was SEK 2,3 (2,7). · Cash flow from current operations was TSEK -37 962 (-36 464).  Important events during the second quarter

    OssDsign AB signs business partner agreement with Muranaka Medical Instruments Co., Ltd., in Japan

    OssDsign AB (Publ) (”OssDsign”) today announced that the company has signed a business partner agreement with Muranaka Medical Instruments Co., Ltd., (“Muranaka”), a pre-eminent medical product distributor in Japan. Muranaka will represent OssDsign commercially in Japan, driving adoption and sales of OssDsign’s regenerative implants for cranial reconstruction.Launching OssDsign Cranial in Japan with a national business partner is a key priority for OssDsign in 2020. The distribution agreement with Muranaka means that the company has reached a major milestone, and mutual launch preparations

    Annual general meeting held in OssDsign AB (publ)

    Today, the annual general meeting of 2020 was held in OssDsign AB (publ) (the “Company” or “OssDsign”). Below follows a summary of the resolutions passed at the annual general meeting (all in accordance with the proposals presented in the notice to attend the meeting kept available at the Company’s website www.ossdsign.com).The annual general meeting resolved:  · to adopt the profit and loss statement and the balance sheet and the group profit and loss statement and the group balance sheet for the financial year 2019; · that the Company’s accumulated profits shall be carried

    OssDsign AB (publ) publishes Q1 2020 interim report

    The positive trend from the end of 2019 continues as OssDsign kicks off 2020 with continued  consecutive sales growth of 52% in Q1 vs Q4 2019.The first quarter in figures · Net sales amounted to TSEK 7 726 (3,514). · Loss after taxes amounted to TSEK 18 312 (17 340). · Loss per share was SEK 1,0 (1,5). · Cash flow from current operations was TSEK -21 898  (-22 547).  Important events during the first quarter ·The company has signed a new lease for the head office and  state of the art manufacturing facility in Uppsala, Sweden. · Completed transfer of the

    OssDsign appoints VP of Sales for OssDsign USA, Inc to drive continued growth in the company’s largest market

    OssDsign announces the appointment of Eric Patermo as VP of Sales for OssDsign USA, Inc, a wholly owned subsidiary of OssDsign AB. Eric will be responsible for further strengthening the company’s sales organisation in the United States with the aim to deliver continued strong growth.This appointment follows a period of very positive development for OssDsign in the United States since the IPO in May 2019. During this period, OssDsign resumed control of all commercial operations and strengthened the US organisation. The company has since reported strong consecutive quarterly growth and an

    OssDsign AB (publ) publishes year-end report 2019

    OssDsign CEO Anders Lundqvist: “OssDsign AB finished an exciting and eventful year on a very strong note. Our strategy for, and investments in the US market, as presented in the IPO process generated the expected good results.”The fourth quarter in figures · Net sales amounted to TSEK 5 069 (4 220).  · Loss after taxes amounted to TSEK 28 641 (15 755). · Loss per share was SEK 1,6 (2,8). · Cash flow from current operations was TSEK -24 023 (-26 887).  The full year in figures · Net sales amounted to TSEK 16 873 (13 264). · Loss after taxes amounted to TSEK 84 245 (

    OssDsign AB (publ) publishes Q3 2019 interim report

    OssDsign CEO Anders Lundqvist: “To conclude it has been a busy and rewarding quarter which has seen the positive effects of the important investments in the US organization and transition of the business to OssDsign USA Inc.”The third quarter in figures · Net sales amounted to TSEK 4 836 (3 420). · Loss after taxes amounted to TSEK 19 709 (13 626). · Loss per share was SEK 1,1 (2,8). · Cash flow from current operations was TSEK -22 640 (-11 790). The first 9-months in figures · Net sales amounted to TSEK 11 804 (9 044). · Loss after taxes amounted to TSEK 55 379 (39

    New data show positive outcome when using OSSDSIGN Cranial PSI for cranial reconstruction

    OssDsign AB (publ) (“OssDsign” or the “Company”) today announced that updated outcome data on the use of OSSDSIGN Cranial PSI in 670 cases of cranioplasty and cranial reconstructions have been made public via the company’s website. All data were collected as part of post-market surveillance of product performance in Europe, US and selected Asian markets in compliance with MEDDEV 2.7/1 rev.4 and MDR 2017/745. After a median follow-up time of 17 months, rate of infections leading to implant removal remained low at 2.4%.Reconstruction of cranial defects can be a complex surgical procedure

    OssDsign is granted a new European patent related to the company’s ceramic material technology

    The European Patent Office (EPO) has issued that it has granted OssDsign AB (publ) (“OssDsign” or the “Company”) a new European patent related to the company’s ceramic material technology. This further strengthens OssDsign’s extensive patent protection in the field of ceramic material formulations and their applications for medical use.OssDsign’s material protected technology provides OssDsign’s implants with unique biological properties, which has been reported in scientific publications. The protection of this technology is further strengthened by the grant of this patent. The patent

    OssDsign receives US FDA clearance for Cranial PSI Accessories – strengthening business position in the US

    OssDsign AB (publ) (“OssDsign” or the “Company”) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US. The cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of OssDsign’s patient specific cranioplasty implant already cleared by the FDA. The accessories are designed to make cranial reconstructions safer and easier and to enable new solutions for patients in need of complex cranial reconstructions.OssDsign is a provider of

    OssDsign AB (publ) initiates commercial preparations for launch in Japan following regulatory filing for OssDsign Cranial

    OssDsign AB (publ) (”OssDsign” or the ”Company”), the Swedish designer and manufacturer of innovative implants for bone regeneration has filed for a Japanese regulatory approval of OssDsign Cranial. Subsequent to the filing, OssDsign initiates commercial planning for a market entry in Japan.OssDsign has, as previously communicated, spent a significant amount of time and resources in order to compile a regulatory submission for Japan. This work has required further pre-clinical testing in order to comply with the stringent Japanese requirements. The complete file was submitted on June

    Announcement on stabilization measures in OssDsign AB (publ) during the period from June 17 to June 20, 2019 and termination of the stabilization period

    NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR TO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, OR OTHER COUNTRIES WHERE THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE PERMITTED OR REQUIRE REGISTRATION OR OTHER MEASURES Erik Penser Bank AB (”EPB”) announces that stabilization measures have been undertaken in OssDsign AB’s (publ) (”OssDsign” or the ”Company”) shares on Nasdaq First North. EPB also announces that the stabilization period, which started on May 24, 2019, today has ended and no further stabilization transactions will be undertaken. During the

    Announcement on stabilization measures in OssDsign AB (publ) during the period from June 10 to June 14, 2019

    NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR TO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, OR OTHER COUNTRIES WHERE THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE PERMITTED OR REQUIRE REGISTRATION OR OTHER MEASURES Erik Penser Bank AB (”EPB”) announces that stabilization measures have been undertaken in OssDsign AB’s (publ) (”OssDsign” or the ”Company”) shares on Nasdaq First North.As announced in connection with the offer to acquire newly issued shares in the Company and the listing of the Company's shares on Nasdaq First North (the "Offer"), EPB has

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