At the request of aap Implantate, the German Federal Ministry of Education and Research (BMBF) increased the overall funding framework to conduct the human clinical trial of aap’s silver coating technology by approximately €0.4 million. In addition to the funding of up to ¢2.7 million already committed by the BMBF in 2019, this now results in a funding framework of up to €3.1 million over the entire duration of the study. The BMBF funding underscores the strategic nature of aap’s silver coating technology and its potential to 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.
Depending on the human clinical trial and the regulatory authorities, aap expects the first market launch of the new technology in three years.
Source: aap Implantate
At the request of aap Implantate, the German Federal Ministry of Education and Research (BMBF) increased the overall funding framework to conduct the human clinical trial of aap's silver coating technology by approximately €0.4 million. In addition to the funding of up to ¢2.7 million already committed by the BMBF in 2019, this now results in...
At the request of aap Implantate, the German Federal Ministry of Education and Research (BMBF) increased the overall funding framework to conduct the human clinical trial of aap’s silver coating technology by approximately €0.4 million. In addition to the funding of up to ¢2.7 million already committed by the BMBF in 2019, this now results in a funding framework of up to €3.1 million over the entire duration of the study. The BMBF funding underscores the strategic nature of aap’s silver coating technology and its potential to 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.
Depending on the human clinical trial and the regulatory authorities, aap expects the first market launch of the new technology in three years.
Source: aap Implantate
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.