BBS-Bioactive Bone Substitutes – Inside information: The first audit completed by the Notified Body, CE marking process may continue as planned
BBS-Bioactive Bone Substitutes Oyj, Company release, Inside Information, 18 November 2022 at 2.30 p.m. EET
The Notified Body has completed its first audit (15-18 November 2022) and has delivered its audit report to the company. The audit was focused on the quality system of BBS-Bioactive Bone Substitutes Oyj (BBS), and it was a part of the CE marking process of the company’s first product (ARTEBONE® Paste bone filler).
During the authorities’ first audit, the Notified Body inspected documentation related to the quality system. No critical non-conformities related to the quality system were reported during the audit and the CE marking approval process may thus proceed as planned.
“We are very pleased with the results of the audit. We have been successful in developing our quality system further, as the audit revealed only minor non-conformities, while no critical ones were observed”, says BBS’s CEO Ilkka Kangasniemi.
The Notified body shall continue to review the documentation provided by the company and the second audit is currently scheduled for February 2023.
For more information:
Ilkka Kangasniemi, CEO,
tel. +358 40 708 0307, e-mail: firstname.lastname@example.org
Nordic Certified Adviser AB, tel. +46 70 551 67 29, email@example.com
This is information that BBS-Bioactive Bone Substitutes Plc is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on 18 November 2022 at 2:30 pm EET.
BBS in brief
BBS-Bioactive Bone Substitutes is a health technology company that started operations in 2003. We have developed a new product for the treatment of severe bone fractures and lumber problems. Our goal is to provide a new generation of medical products for the treatment of bone damage in orthopaedic surgery. In the pharmaceutical sector, development and research requires perseverance and courage to develop new things. We have evidence of this for over 20 years. Our activities are characterised by top expertise, innovation and employees who are enthusiastic and committed to their work. The ARTEBONE ® in the final stages of product development, and we are looking for a CE marking that enables commercialisation in the EU. We are a company in Oulu with a pharmaceutical factory permit in Reisjärvi.
BBS-Bioactive Bone Substitutes Oyj:n shares are listed in Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.
More information: www.bbs-artebone.fiTo view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
CNH Industrial: Periodic Report on $1 Billion Buyback Program6.12.2023 22:30:00 CET | Press release
CNH Industrial: Periodic Report on $1 Billion Buyback Program Basildon, December 6, 2023 CNH Industrial N.V. (NYSE: CNHI / MI: CNHI) announces that under the €400 million component (the “First Component”) of its $1 billion share buyback program the Company completed transactions in the period November 27, 2023 through November 28, 2023, reported in aggregate, as set forth in the table below. After the purchases announced today and considering those previously executed under the First Component, the total invested amount in the First Component is approximately €187,597,638.20 ($203,388,077.50) or a total amount of 20,060,075 common shares purchased. DateNumber of common shares purchasedAverage price per share excluding feesConsideration excluding fees Consideration (*) excluding fees(€)(€)($) November 27,2023 1,500,000 9.3947 14,092,050.00 15,432,203.96 November 28,2023 1,000,000 9.5264 9,526,400.00 10,430,455.36 2,500,000 - 23,618,450.0025,862,659.32 (*) All translations determined fro
Study results of psilocybin treatment in bipolar II depression published in JAMA Psychiatry6.12.2023 22:00:09 CET | Press release
Believed to be first ever psilocybin clinical trial for treatment of bipolar II depression LONDON, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the publication of a paper in JAMA Psychiatry that demonstrates the potential for investigational COMP360 psilocybin treatment in treatment-resistant bipolar type II disorder (bipolar II). Results from the investigator-initiated open-label study were first presented at the Annual Meeting of the American College of Neuropsychopharmacology in 2022. The study, which was conducted by Dr Scott Aaronson at Sheppard Pratt, Baltimore, and funded by Compass, investigated the safety and efficacy of a single 25mg dose of COMP360 psilocybin treatment in participants with treatment-resistant bipolar II. The primary endpoint was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total s
SustainableIT.org Announces Commitment to Elevate Technology Leadership in Global Sustainability Efforts at COP286.12.2023 20:25:50 CET | Press release
REDWOOD CITY, California, Dec. 06, 2023 (GLOBE NEWSWIRE) -- SustainableIT.org, a leading nonprofit organization championed by technology executives, today affirmed its commitment to advancing global sustainability through information technology innovation and leadership. This announcement comes as a strategic response to the ongoing COP28 United Nations Climate Change Conference, emphasizing the need for a stronger technology presence in sustainability dialogues and decision-making processes. The COP28 event underscores the urgent need for a global conversation on sustainability strategy. However, it also highlights a significant gap: the limited involvement of digital, data, and information technology leaders in these critical discussions. Floor Bleeker, Group Chief Technology Officer of Accor and member of SustainableIT.org’s European Advisory Board, is one of the technology executives participating in this year's conference. Bleeker will be speaking on a panel with ServiceNow on Dec
Final results of the Offer for Beter Bed Holding: 98.44% of the Shares obtained6.12.2023 20:00:00 CET | Press release
JOINT PRESS RELEASE This is a joint press release by Beter Bed Holding N.V. ("Beter Bed Holding" or the "Company") and 959 B.V. (the "Offeror"), a company controlled by Torqx Capital Partners ("Torqx"). This joint press release is issued pursuant to the Article 16, paragraphs 1 and 2, Article 17 paragraph 1 and Article 4, paragraph 3 of the Netherlands Decree in Public Takeover Bids (Besluit openbare biedingen Wft, the "Decree") in connection with the recommended public offer by the Offeror for all the issued and outstanding shares in the capital of the Company (the "Offer"). This press release does not constitute an offer, or any solicitation of any offer, to buy or subscribe for any securities in the Company. Any offer is only made by means of the offer memorandum (the "Offer Memorandum"), dated 4 October 2023, approved by the Dutch Authority for the Financial Markets (Autoriteit Financiële Markten, the "AFM"). Terms not defined in this press release will have the meaning as set fort
Kvika banki hf.: Change of Managing Director at Kvika Securities Ltd.6.12.2023 19:26:26 CET | Press release
Gunnar Sigurðsson has requested to resign as Managing Director of Kvika Securities Ltd. in London ("KSL" or the "Company"), a subsidiary of Kvika banki hf. ("Kvika" or the "Bank"). Alongside his resignation Gunnar will leave the Executive Committee of Kvika group and the number of positions in the Executive Committee will also be reduced by one. The Board of KSL has appointed Richard Beenstock as the new Managing Director of Kvika Securities Ltd. Gunnar has led the development of Kvika's UK operations since its establishment in 2017. He will continue to carry out certain tasks for KSL and support the Company during the management change. Richard Beenstock, who graduated from the University of Birmingham and is a Chartered Accountant, has over 20 years of experience in the UK financial markets in lending and investment activities. In 2013, Richard co-founded among others Ortus Secured Finance, an alternative credit provider specialising in property backed lending, that was later acquire