AOT successfully completes clinical study

On June 19, 2020, Basel-based Medtech company Advanced Osteotomy Tools (AOT) successfully completed the last surgery required for the first-in-man clinical study of its proprietary CARLO device. The aim of the study was to demonstrate the performance and safety of the system. CARLO was used for the first time in July 2019 at the University Hospital in Basel, Switzerland. Since then, laser osteotomies have been used as part of a clinical study during the surgeries of 28 patients at the University Hospital Basel, the Medical University of Vienna (AKH Wien) and the University Hospital Hamburg-Eppendorf.

Accelerate the healing process

Due to a delay caused by the COVID-19 crisis, the last surgery took place on June 19, 2020. The preliminary findings of the study are impressive already: The freely definable cutting patterns allow for alternative surgical techniques, which protect bone structures and accelerate the healing process.

"For us, as team of the Department of Maxillofacial Surgery at the Medical University of Vienna, it was both very important and an honour to participate in an impressive chapter of innovative intraoperative surgical technology. With success and confidence, we were able to use the CARLO technology on a patient collective with skeletal dysgnathia of varying degrees of severity, with very satisfactory results for us as surgeons as well as for our patients. The future of 'Cold Ablation Robot-guided Laser Osteotomy' will lie in the high precision and the individually designable cutting patterns. The successful first-in-man study has opened the door for this," says Ass. Prof. Dr. Gabriele A. Millesi, President of the International Association of Oral and Maxillofacial Surgery (IAOMS).

CE mark before the end of the year

The full, final report of the findings is currently being compiled. Based on this report, AOT is aiming to achieve a CE marking for CARLO before the end of the year, which enables the company to market and sell its technology in Europe. In early 2021, AOT also plans to submit all relevant documentation to the US Food and Drug Administration (FDA) as part of the so-called De Novo process.

Tests in spinal surgery and neurosurgery

In addition to facial surgery, AOT is also currently testing other areas of application for the CARLO technology, for example in the fields of spinal surgery and neurosurgery, with further areas of indication planned. In addition, the further technical development of the technology is being advanced as well: The three current focus areas of R&D are more powerful lasers, the cutting of skin tissue and the use of artificial intelligence for real-time analysis of diseased and healthy bone tissue during the cutting process.

“The successful completion of the first-in-man study is a big success for us. We were able to show the enormous potential of contactless, robotic surgery based on laser technology and the improvements it offers for patients. This brings us one large step closer to our next milestone – achieving a CE marking”, says Cyrill Bätscher, CEO of AOT AG.

(Press release / SK)

Picture: AOT