AAP IMPLANTATE

EQS-News: Progress in the MDR process - important MDR initial certification audit carried out

EQS-News: aap Implantate AG / Key word(s): Regulatory Admission/Miscellaneous
Progress in the MDR process - important MDR initial certification audit carried out

07.10.2024 / 07:30 CET/CEST
The issuer is solely responsible for the content of this announcement.



aap Implantate AG ("aap" or "Company") has reached another important milestone in the transition from MDD (Medical Device Directive 93/42/EEC) to MDR (Medical Device Regulation EU 2017/745). In the week from 9 September 2024 to 13 September 2024, the Notified Body mdc medical device certification GmbH audited aap's quality system according to MDR. The audit was successfully completed. With this important milestone and the first positively audited technical documentation for its Class IIa products in accordance with the MDR, the company is continuing to work with its notified body to ensure a smooth and rapid transition to MDR certification.





 

----------------------------------------------------------------

aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German stock exchanges -

 

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily utilises a broad network of distributors in around 25 countries. In the USA, the company utilises a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both via distribution agents and through partnerships with global orthopaedic companies. The aap Implantate AG share is listed in the General Standard segment of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at

 

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

 

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore only apply on the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.



 

Contact:
If you have any questions, please contact:
aap Implantate AG; R. Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; D-12099 Berlin
Phone: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; e-mail:


07.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at -news.com


Language: English
Company: aap Implantate AG
Lorenzweg 5
12099 Berlin
Germany
Phone: +49 (0) 30 75 019-0
Fax: +49 (0) 30 75 019-111
E-mail:
Internet:
ISIN: DE000A3H2101
WKN: A3H210
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2002633

 
End of News EQS News Service

2002633  07.10.2024 CET/CEST

fncls.ssp?fn=show_t_gif&application_id=2002633&application_name=news&site_id=research_pool~~~9efe1c65-8ece-4ff7-9608-f21c8e0a38a3
EN
07/10/2024

Reports on AAP IMPLANTATE

 PRESS RELEASE

EQS-News: aap informs about the actual status of the mandatory convert...

EQS-News: aap Implantate AG / Key word(s): Bond aap informs about the actual status of the mandatory convertible bond 2023-2028 06.11.2024 / 23:39 CET/CEST The issuer is solely responsible for the content of this announcement. aap Implantate AG ("aap" or "Company") informs that as of October 31, 2024, conversion rights in the amount of 97.4% of the mandatory convertible bond issued in October 2023 were exercised in the context of elective conversions. This means that only 2.6% of the conversion rights have not yet been exercised, which corresponds to an amount of around E...

 PRESS RELEASE

EQS-News: aap informiert über den aktuellen Stand der Pflichtwandelsch...

EQS-News: aap Implantate AG / Schlagwort(e): Anleihe aap informiert über den aktuellen Stand der Pflichtwandelschuldverschreibung 2023-2028 06.11.2024 / 23:39 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Die aap Implantate AG („aap“ oder „Gesellschaft“) informiert, dass zum Stichtag 31. Oktober 2024 Wandlungsrechte im Umfang von 97,4 % der im Oktober 2023 begebenen Pflichtwandelschuldverschreibung im Rahmen von Wahlwandlungen ausgeübt wurden. Dies bedeutet, dass lediglich 2,6 % der Wandlungsrechte noch nicht ausgeübt wurden, was ei...

 PRESS RELEASE

EQS-News: Fortschritte im MDR-Prozess - wichtiges MDR Erstzertifizieru...

EQS-News: aap Implantate AG / Schlagwort(e): Zulassungsantrag/Sonstiges Fortschritte im MDR-Prozess - wichtiges MDR Erstzertifizierungsaudit durchgeführt 07.10.2024 / 07:30 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Die aap Implantate AG („aap“ oder „Gesellschaft“) konnte einen weiteren wichtigen Meilenstein in Richtung Übergang von MDD (Medical Device Directive 93/42/EWG) hin zur MDR (Medical Device Regulation EU 2017/745) erreichen. In der Woche vom 09. September 2024 bis 13. September 2024 wurde von der Benannten Stelle mdc me...

 PRESS RELEASE

EQS-News: Progress in the MDR process - important MDR initial certific...

EQS-News: aap Implantate AG / Key word(s): Regulatory Admission/Miscellaneous Progress in the MDR process - important MDR initial certification audit carried out 07.10.2024 / 07:30 CET/CEST The issuer is solely responsible for the content of this announcement. aap Implantate AG ("aap" or "Company") has reached another important milestone in the transition from MDD (Medical Device Directive 93/42/EEC) to MDR (Medical Device Regulation EU 2017/745). In the week from 9 September 2024 to 13 September 2024, the Notified Body mdc medical device certification GmbH audited aap's ...

 PRESS RELEASE

EQS-News: Very successful human clinical trial with the innovative ant...

EQS-News: aap Implantate AG / Key word(s): Study/Study results Very successful human clinical trial with the innovative antibacterial surface-treated implants receives approval for quick end of recruitment. 24.09.2024 / 22:15 CET/CEST The issuer is solely responsible for the content of this announcement. BfArM and lead ethics committee approve early end of recruitment Last patient included on 6 August 2024; A total of 202 patients were included in the study; Start of the MDR registration phase aap Implantate AG ("aap" or "Company") informs that due to the ongoing good ...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch