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.

Board member resigns at his own request due to medical reasons

At his own request, BG (Bengt-Göran) Svensson has chosen to leave NanoEcho's board for medical reasons. At the same time, he announces that he is leaving all of his board assignments.

BG Svensson has been an elected board member on NanoEcho's board since 2020.

"This was sad news, I have appreciated working together with BG and I am grateful for the work he has put into NanoEcho's board," says Linda Persson CEO of NanoEcho.

NanoEcho announces collaboration partner for the nanoparticle

NanoEcho and SPL medical have signed a Letter of Intent and initiated a cooperation on regulatory partnership and supply for the iron-oxide based nanoparticle. The aim of the collaboration is to achieve market approval for the NanoEcho indication, diagnostics of rectal cancer lymph node metastases.

NanoEcho and SPL medical have signed a Letter of Intent to explore the possibilities to expand the medical indication and intended purpose of SPL’s particles to also cover NanoEcho’s application.

In NanoEcho's method for diagnostics of rectal cancer lymph node metastases, modern ultrasound technology is used together with iron-oxide based nanoparticles. For the clinical effectiveness of the system, the choice of nanoparticle is essential.

The Letter of Intent also includes discussions regarding collaborations around potential additional indications for NanoEcho's method.

The lymphotropic nanoparticle from SPL medical, Ferumoxtran, has been developed for the detection of lymph node metastases. It is available today to patients in Europe, within an ongoing registration clinical trial. The particle is intended to be used as a contrast agent for MRI (Magnetic Resonance Imaging) in diagnostics of various cancers. In total the nanoparticle from SPL medical has so far been used with more than 700 patients in the Netherlands and Switzerland in special approvals.

Together with SPL medical, NanoEcho aims to compile necessary data to obtain regulatory approval to start a clinical registration study on the diagnosis of rectal cancer lymph node metastases with NanoEchos patented magnetomotive ultrasound technology. The aim of the upcoming clinical registration study is to obtain market approval for the combined NanoEcho device and nanoparticle in Europe.

“We are very pleased to have established this collaboration with SPL medical. This is an important step in our journey. Based on our initial evaluation, the particle provided by SPL medical looks very promising for our application. Their expertise in the development and commercialisation of nanoparticles is impressive and will be very beneficial for us at NanoEcho“, says Dr. Linda Persson CEO for NanoEcho.

“The extension of the scope of applicability of Ferumoxtran, our proprietary iron-oxide nanoparticle, also to modern ultrasound technology demonstrates the wide power of this platform technology beyond the broad field of nano-MRI”, says Dr. Jürgen Feuerstein CEO for SPL Medical.

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.

NanoEcho has chosen supplier of ultrasound transducer

NanoEcho has chosen the supplier Vermon SA, and started cooperation for the development and future manufacturing of the ultrasound transducer.

As an important step in NanoEchos work, to design and produce a product for commercial use, NanoEcho will collaborate with Vermon in the development of the ultrasound transducer.

NanoEcho and Vermon have signed a Letter of intent, regarding collaboration of an ultrasound transducer integrated in a rectal probe, which utilizes NanoEcho’s patented magnetomotive ultrasound technology. The probe is aimed to be used at hospitals, as support in rectal cancer diagnostics and will be CE-marked according to the EU Medical Device Regulation.

In NanoEcho’s next step, development of a commercial product, Vermon will be one of the key suppliers. Together with Vermon, NanoEcho will develop an ultrasound transducer optimized to fulfill both market, manufacturing and regulatory requirements of a commercial medical device.

Vermon, an International OEM Leading Manufacturer provides ultrasound technologies and solutions for the medical device industry. Vermon Headquarters are in Tours, France, and are certified under ISO 13485 and ISO 14001 Quality Management Systems. Vermon has a long-term market experience in development of applications of ultrasound probes at a global scale.

We are very pleased to have Vermon on board as a supplier in the next step of our journey. Their expertise of both development and manufacturing of innovative ultrasound probes will bring a solid foundation to our design of a commercial product. The team is very eager to get started and we have planned several joint activities within the near future, says Linda Persson, CEO for NanoEcho.

If you have any questions, please contact
Kristina Hallström, CMO & CCO
e-mail: ir@nanoecho.se

NanoEcho develops a new technology for clearer diagnostics of, as the first phase, rectal cancer. The imaging technology is based on a new medical approach where nanotechnology is used in combination with modern ultrasound technology. The images that are generated are intended to facilitate differentiation between healthy and diseased tissue and at the same time determine the location of the cancer tissue more precisely. The aim is to provide more precise, simpler, and less costly diagnosis of cancers and other diseases. With clearer diagnostics, the company wants to assist treating physicians with better guidance for more personalized treatment. Both the quality of life of the patients and their chance of survival can improve after treatment, with reduced treatment costs. www.nanoecho.se

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