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    OssDsign Partners with Red One Medical to Provide Reconstructive Cranial Solutions and Synthetic Bone Grafts to US Veterans and Military Members

    Savannah, Ga., Aug. 10, 2021 – OssDsign, a global provider of reconstructive implant solutions, has recently entered into an agreement with Red One Medical, a private sector scout of medical innovation for the Department of Veterans Affairs (VA) and Department of Defense (DoD). Through the Distribution and Pricing Agreement (DAPA), American veterans and warfighters will have access to OssDsign’s innovative products for the treatment of patients who have suffered from cranial or spinal bone defects."We're proud to have entered into a partnership with Red One Medical, one of the most

    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

    Announcement on stabilization measures in OssDsign AB (publ) during the period from May 31 to June 7, 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

    OssDsign AB (publ) further strengthens its patent portfolio

    The European Patent Office (EPO) has issued that it intends to grant OssDsign AB two new European patents related to the company’s material technology and implant design. This further strengthens OssDsign’s extensive patent protection in the field of ceramic material formulations and their applications for medical use.The first patent covers the implant, its support structure, as well as the method of making a custom implant through additive manufacturing. The additive manufacturing process provides a number of advantages, including rapid fabrication of customized implants for each patient,

    OssDsign AB (publ) receives initial positive notice regarding reimbursement for OSSDSIGN Cranial PSI in France

    OssDsign today announced that the Haute Autorité de Santé (HAS), the French health technology assessment institute, has given an initial positive opinion regarding use of OSSDSIGN Cranial PSI in cranioplasty to be covered by the French national reimbursement system. France is the only remaining European key market where OssDsign to date lacks reimbursement.Following the notice from the HAS, OssDsign’s application can proceed to the next stage of the application process where a specific reimbursement level for OSSDSIGN Cranial PSI can be determined. As a result of the positive notice from

    OssDsign AB (publ) has received approval for listing of the company’s shares on Nasdaq First North

    Nasdaq has approved OssDsign AB (publ) (”OssDsign” or the ”Company”) for listing on Nasdaq First North. First day of trading in the Company’s shares is Friday, May 24, 2019.OssDsign has recently completed a new share issue prior to listing on Nasdaq First North. The share issue was oversubscribed and raised SEK 151.3M before issue costs. Provided that the over-allotment option of up to an additional 825,000 shares is fully exercised, the Company will receive a total of SEK 174M before issue costs. The subscription price in the share issue was SEK 27.50 per share. Following the share issue,

    The share issue in OssDsign AB (publ) before listing on Nasdaq First North oversubscribed

    On May 2, 2019, the Board of Directors of OssDsign AB (publ) (“OssDsign” or the “Company”) resolved, with the support of the authorization from the Annual General Meeting on April 24, 2019, on a share issue of up to 5,500,000 shares (the “Offer”) and to apply for admission to trading of the Company’s shares on Nasdaq First North. Expected first day of trading is May 24, 2019. There has been a strong interest for participating in the Offer and the Offer was subscribed to approximately 117 percent. Through the Offer, the Company will raise approximately SEK 151.3m before transaction costs.

    OssDsign applies for listing on Nasdaq First North and publishes a prospectus in connection with share issue of SEK 151,3M

    The Board of Directors of OssDsign AB (publ) (“OssDsign” or the “Company”) has resolved on a new share issue of up to 5,500,000 shares and has decided to apply for admission to trading of the Company’s shares on Nasdaq First North. The subscription price is 27.50 SEK per share, corresponding to an issue amount of up to SEK 151.3M (the “Offer”). Based on the subscription price and the existing number of shares, the Company is valued at SEK 336M before the Offer. In the Offer, a number of institutional and private investors, including Lancelot Asset Management, Consensus Asset Management,

    OssDsign AB raises 64 MSEK (6 MEUR) through private placement and initiates preparations for stock exchange listing

    OssDsign AB, the Swedish designer, manufacturer and distributor of regenerative implants for improved healing of bone defects, today announced the closing of a private placement of 64 MSEK (6 MEUR). The financing was achieved through a combination of Swedish private investors and the French investment management company Alto Invest. OssDsign will now also initiate the process towards a stock exchange listing during 2019.Erik Penser Bank acted as financial advisor for the private placement and will continue to work with OssDsign also in the next phase as the company begins the process

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