Silver Against Biofilm: The Future of Implant Technology?
Interview with Agnieszka Mierzejewska, COO of aap Implantate AG
Despite the multifold crisis of high energy prices and material shortages, the Berlin-based medical device manufacturer aap Implantate has made significant progress in its principal development project: its innovative, antibacterial surface-treated implants are expected to significantly reduce the risk of infection. The clinical human study is nearing completion – and the company is already considering further applications.
Wirtschaftsforum: Ms. Mierzejewska, as the world began to put the coronavirus pandemic behind it in 2022, the next geopolitical crises followed immediately – with massive overall economic upheavals. How strongly was aap Implantate AG affected?
Agnieszka Mierzejewska: Significantly – because we were just coming out of a restructuring process, and suddenly found ourselves as an energy-intensive metal processing company facing electricity costs that had increased three to fourfold. At the same time, 20% of the globally available titanium was no longer accessible to us, as it came from Russia.
Wirtschaftsforum: Nevertheless, you were able to make significant progress in your large-scale human study on implants with silver surfaces.
Agnieszka Mierzejewska: In the case of the implants in question, we incorporate silver into the titanium oxide layer of the respective plate so that a homogeneous surface is created, which releases silver ions after insertion into the human body, thereby minimizing the risk of biofilm formation as much as possible - because where there is no biofilm, the risk of an infection is drastically reduced. Currently, a double-blind study with just over 200 patients is underway, intended to prove that our medical product is at least as safe as its untreated counterpart. Last August, the final study participant was treated, and after the one-year follow-up period, the final explantation or follow-up will also take place in August. By the end of this year/beginning of next year, the final study report by the CRO should be available - an important milestone on the way to approval.
Wirtschaftsforum: Meanwhile, you have already conducted individual healing trials* with corresponding implants – one of the treated patients was a Ukrainian soldier.
Agnieszka Mierzejewska: He was admitted in June 2022 with severe war injuries - including an open fracture and deep leg wounds with a massive infection that showed no improvement despite multiple antibiotic treatments. The patient was essentially out of treatment options and the next step would have been amputation of the limb. The treating doctor in Hamburg had heard about our antibacterial technology and saw no other way out in this case. The results were very pleasing: Just six weeks after the surgery, bone consolidation was evident, and eight weeks later an infection-free soft tissue area was seen. In two other cases, we were able to achieve similarly impressive results. Of course, the clinical data obtained so far is not yet sufficient for the extensive approval processes - but they do significantly strengthen our confidence in being on the right track with our technology.
Wirtschaftsforum: The fields of application are likely to go far beyond your established core expertise.
Agnieszka Mierzejewska: We are aware that the scope of our technology with our product portfolio is far from over. That is why we are already in discussions with other market participants, to whom we could potentially offer our surface treatment technology as a service - thereby also opening up another revenue stream. Our goal is a platform technology that, as initial tests on products of other market competitors have shown, can cover geometry-independent applications, from prostheses to pacemaker casings.
* Individual healing trials are used in exceptional cases when there is no standard treatment available anymore; the decision is at the discretion of the doctor and patient after careful consideration of all alternatives and a thorough briefing, see for example the following reference: Individuelle_Heilversuche_gemeinsames_Informationsblatt_EK_und_FEK.pdf