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.--------------...
aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German Stock Exchanges -
