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EQS-News: aap Implantate AG
/ Key word(s): Study
Visible acceleration in clinical trial with already more than 60 patients; increase in funding of around EUR 0.4 million underscores innovative strength of silver coating technology
30.10.2023 / 11:44 CET/CEST
The issuer is solely responsible for the content of this announcement.
- Clinical trial: Visible acceleration with already more than 60 patients recruited since clinical trial resumption in April; completion of patient recruitment planned in 2024
- BMBF funding: increase in total funding by around EUR 0.4 million to up to EUR 3.1 million underscores the strategic innovative character of aap's antibacterial silver coating technology
aap Implantate AG ("aap" or the "Company") announces that, at aap's request, the German Federal Ministry of Education and Research (BMBF) has increased the overall funding framework for the conduct of the human clinical trial for the intended market approval of its silver coating technology by approximately EUR 0.4 million. In addition to the funding of up to EUR 2.7 million already committed by the BMBF in 2019, this now results in a funding framework of up to EUR 3.1 million over the entire duration of the study. The BMBF funding underscores the innovative and strategic nature of aap's silver coating technology and its potential to significantly relieve healthcare systems at the cost level.
In the human clinical trial, which was able to enroll the first patient according to the adapted study protocol in May, a visible acceleration in patient recruitment was achieved. By mid-October, more than 60 patients were enrolled in the study as planned. Overall, the study has been very successful to date. This is reflected, among other things, in the significantly lower number of incidents of predefined, product-dependent adverse events than originally assumed in the study planning. If this trend continues, the necessary number of patients to be included would be reduced in order to make the statistical statements. Depending on patient volume and possible events as mentioned above, aap expects to complete patient recruitment in the course of 2024.
With its groundbreaking surface modification technology, in which elemental silver is incorporated into the titanium surface in an extremely low but highly effective concentration, aap is aiming for a unique selling proposition that effectively counters increasing antibiotic resistance in medicine and has the potential to become the gold standard in traumatology. Depending on the human clinical trial and the regulatory authorities, aap expects the first market launch of the new technology in 3 years.
The execution of the clinical study is funded by the German Federal Ministry of Education and Research ("BMBF"). The grant awarded to the company (grant numbers 13GW0313A+B, 13GW0449A+B) is part of the BMBF's (= grantor) field of action "Healthcare Industry in the Health Research Framework Program". According to the BMBF, projects on the topic of "Transferring medical technology solutions into patient care - proving clinical evidence without delay" are being funded. For further information, please refer to the corresponding guideline on the BMBF website: https://www.bmbf.de/foerderungen/bekanntmachung-1376.html.
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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 headquartered in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, 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 at international level it primarily uses a broad network of distributors in around 25 countries. In the USA, the company relies on a hybrid sales strategy through its subsidiary aap Implants Inc. This involves sales both via distribution agents and as part of partnerships with global orthopedic companies. The aap Implantate AG share is listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.
The figures presented in this press release may be subject to technical rounding differences which do not affect the overall presentation.
Forward-looking statements
This release may contain forward-looking statements based on current expectations, beliefs and projections of the Management Board and currently available information. The forward-looking statements are not guarantees of future performance or results. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date they are made. We assume no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.
Contact:
Marek Hahn; Member of the Management Board/ CFO; Lorenzweg 5; 12099 Berlin
Phone: +49 (0)30 75019 - 134; Fax: +49 (0)30 75019 - 290; Email: m.hahn@aap.de
30.10.2023 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.
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