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.

New shareholders after previous main owner has sold its holdings

NanoEcho welcomes new shareholders when one of the company's previous main owners, Cardeon AB, has sold its holdings in the company. NanoEcho's CEO Linda Persson has actively participated in the process through several national and international presentations to potential investors and has also been available for discussions and questions. The sales process has been handled entirely by Cardeon. The shares have mainly been acquired by long-term investors and foundations. A small share has also been sold through an ongoing distribution to Cardeon's shareholders.

“The investors I have presented the company to have shown great interest in NanoEcho and the strength of the technology and the future product, which has been very inspiring and bodes well for our planned market listing. I would also like to warmly welcome our new shareholders”, comments Linda Persson.

As the company has recently begun clinical studies, on surgically removed rectal cancer tissue, and the market climate has become more favorable for a listing, the Board has together with the financial adviser, G&W Fondkommission, assessed it convenient to take the next step towards a listing. Further information about a market listing will be communicated in a press release as soon as the board has determined the terms and schedule.

Basic patent granted in Europe and South Korea

NanoEcho’s innovative method aims to address an urgent global need for more reliable rectal cancer staging. The method is intended to enable the mapping of lymphatic cancer spread prior to surgery – an important marker for the cancer's progression. This mapping would make it possible to avoid surgery with high risk of complications. The basic patent for the method, previously granted in Japan, has now also been granted in Europe and South Korea.

The granted basic patent protects the design of a hand-held probe, that is, the unique combination of an ultrasonic transducer placed together with one or several magnets in the same unit. 
 
The method uses iron-oxide-based nanoparticles as the contrast agent. A magnetic field is applied to set the particles in motion, which then are detected by ultrasound. This way, a differentiation between healthy and diseased tissue in lymph nodes located in proximity to the tumor is mapped out. 

The fact that the basic patent for NanoEcho’s method, which was previously granted in Japan, has now also been granted in the European and South Korean markets is very positive. This entails that our basic patent is now approved in countries that account for almost 40 percent of the global rectal cancer market, says Linda Persson, CEO of NanoEcho.

The above patents are also being examined in Canada and the United States, where the process is proceeding according to plan.

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