Start of an investigator-led clinical development study at Skåne University Hospital

An investigator-led clinical development study has started at Skåne University Hospital in Malmö. In this context, the first examination of resected rectal cancer tissue has been performed with the NanoEcho diagnostic system.

NanoEcho is developing a system that intends to improve the diagnosis of rectal cancer spread to nearby lymph nodes, an important marker of cancer progression. Since 2021, there has been an ongoing investigator-led clinical development study on resected rectal cancer tissue at Sahlgrenska University Hospital in Gothenburg. Now an investigator-led study has also started at Skåne University Hospital (SUS) in Malmö. Using NanoEcho's system, these developmental studies aim to examine rectal cancer at different stages and located anywhere in the rectum.

The first patient at SUS in Malmö has been recruited and the first examination was carried out with the company's diagnostic prototype system on 3rd November. The study, which will include approximately 40 rectal cancer patients, is lead by Henrik Thorlacius, surgery professor at Lund University and Chief Physician in surgery at Scania University Hospital in Malmö. Patients will undergo usual routine standard surgery and the tissue removed during surgery will be examined with NanoEcho's system before being submitted for pathological analysis.

“We hope that NanoEcho´s instrument can identify lymph nodes containing cancer cells, which could improve the diagnosis of rectal cancer. If we can, we will proceed with further clinical studies whereby NanoEcho's instrument will be evaluated on patients before surgery”, says Henrik Thorlacius.

“Starting now these two investigator-led clinical development studies represents a major milestone. The goal is that together they will provide a comprehensive analysis of the system's performance and contribute important information to the product development of our commercial system”, says Linda Persson CEO of NanoEcho.

Link to a film where Henrik Thorlacius explains more about the investigator-led clinical development study.

Go ahead to start clinical development study at Skåne University Hospital in Malmö

NanoEcho has been cleared to start a clinical development study at Skåne University Hospital in Malmö. The ethics committee has already approved the study and recruitment of patients is planned to commence during the fall.

NanoEcho develops a method intended to facilitate differentiation between healthy and diseased tissue and at the same time determine the location of the cancer spread more precisely. The proprietary diagnostic system aims to fill a current void in rectal cancer care. Since June 2021, NanoEcho is conducting a clinical development study at Sahlgrenska University Hospital. The Company has now also been cleared to start a clinical development study at Skåne University Hospital in Malmö.

The trial will be led by Henrik Thorlacius, Professor of Surgery at Lund University and Chief Physician at Skåne University Hospital in Malmö. Recruitment of patients is planned to commence during the fall, and approximately 40 patients will be included overall. The duration of the study will be one to two years from the commencement date. The patients participating in the study will undergo the usual routine surgery. Once the cancer is removed from the patient, the surgical preparate will be examined with NanoEcho’s instrument. The result will then be compared with the pathologist’s final microscopic examination.

The Company is currently in a detailed stage of development of the next-generation system, with a clear commercial focus on market authorization. One of the objectives of the clinical development studies is to gain a comprehensive picture of the system's performance and get direct feedback. On completion of the two clinical development studies, the ambition is to have examined rectal cancer locations in every part of the rectum and in different stages with NanoEcho's system.

We look forward to starting the clinical development study also at Skåne University Hospital in Malmö this autumn. It is an important piece for us, to get a comprehensive picture of the system's performance and to get direct feedback to the ongoing detailed product development phase.”, says Linda Persson, CEO of NanoEcho.

NanoEcho and us4us have signed a letter of intent

NanoEcho has chosen the supplier us4us and started collaboration around the development and future manufacturing of the imaging device.

NanoEcho and us4us have signed a letter of intent and agreed to collaborate regarding the development of NanoEcho's imaging device, specifically the ultrasound scanner unit. The imaging device is aimed to be used at medical hospitals, as support in rectal cancer diagnostics, and will be CE-marked, according to the EU Medical Device Regulation.

us4us will be one of NanoEcho's key suppliers together with Vermon SA, who is the collaboration partner of the ultrasound probe. Both suppliers will, together with NanoEcho, develop the commercial system with the goal to fulfill market, manufacturing, and regulatory requirements of a commercial medical device.

us4us specializes in research and development, within the scope of medical and industrial applications of ultrasound, as well as the professional design of advanced electronic systems. The company supports its clients in the complete product development cycle: from basic research, through feasibility studies and product concept, to product development and its certification.

I am confident that us4us, with their strong expertise in medical ultrasound scanners and high flexibility, is the right collaboration partner in the development of our imaging device. I am very pleased to announce that we have signed this letter of intent, which outlines our collaboration towards a market approval of our imaging device. These two key suppliers, Vermon SA and us4us, build a solid foundation for the continued development of our diagnostic imaging device.”, says Linda Persson, CEO of NanoEcho.

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