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.

A new Board has been appointed at NanoEcho – increased focus on commercialization

A new Board that reflects the Company's development has been appointed. The newly appointed Chairman is Daniel Johnsson, former CEO and founder of, among others, Exertis Nordics, now investor and advisor. A new member of the Company's Board is PhD and Business Coach Ann-Christin Malmborg Hager.

At the Annual General Meeting, NanoEcho elected Daniel Johnsson as Chairman of the Board. Daniel is a serial entrepreneur, former CEO and founder of Exertis Nordics (formerly known as CapTech Distribution), a profitable, fast-growing gazelle company that today is one of the Nordic region's largest distributors of IT, AV and multimedia products. Under the leadership of Daniel, the Company's sales grew from SEK 0 to 3 billion. Daniel currently works as an investor, board professional and advisor.

Also new to the Board is Ann-Christin Malmborg Hager, who has solid experience as CEO of development companies, most recently as CEO of PainDrainer and before that as CEO of SenzaGen for 5 years. Under the leadership of Ann-Christin, SenzaGen developed animal-free allergy testing, from an innovation to the Company entering the commercial stage and being listed on Nasdaq First North. Led by Ann-Christin, the Company's market capitalization increased from MSEK 5 to 500. Today, Ann-Christin works as a consultant and business coach for SmiLe Life Science Incubator.

Furthermore, the board members PhD Johannes Swartling, MBA BG Svensson, and Professor Tomas Jansson were re-elected.

The Company's Board is elected in view of the position shift that the Company has made, from being a research company to being a clear product development company. Today, the Company is fully focused on developing a product for commercialization.

“We are both happy and proud that Daniel has chosen to take on the role of Chairman of the Board of NanoEcho. We really look forward to sharing Daniel's knowledge, network and solid experience of building profitable companies.” – says Linda Persson, CEO of NanoEcho.

“I see great potential in NanoEcho's system and I really believe in the Company. I look forward to supporting them in the work of launching a product in the market that improves the quality of life for people affected by cancer." – says Daniel Johnsson, newly appointed Chairman of the Board of NanoEcho.

For a complete presentation of NanoEcho's Board, see:www.NanoEcho.se

NanoEcho takes the next step and enters a detailed product development phase

NanoEcho has conducted a "Design Input Review" – a systematic review of collected requirements and development plans for the product development phase. The company now enters a detailed design development phase with the objective of developing a prototype prepared for commercialization.

The result of the conducted review is that all requirements; clinical, regulatory, technical and user requirements, have been defined and documented. The conclusion of the review is that plans are now established to manage risks, clinical evaluation, and product development. This ensures that the company has a well-defined plan to develop a commercial product. A key input has been the feedback received from the ongoing clinical development study on surgically removed rectal cancer tissue.

To have passed our "Design Input Review" is an important step in our journey to become a more market-oriented product development company. We have gradually reinforced the organization and we now have a team that knows what it takes to put medical devices on the market. My assessment is that we are well prepared to enter a more detailed development phase of our commercial system, says Linda Persson, CEO for NanoEcho.

We are working systematically according to our newly established quality management system adapted to the medical devices industry. The company is now entering a more detail-oriented product development phase with the aim to develop a prototype prepared for commercialization.

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

NanoEcho has developed 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

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

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.

A historic day – for the first time ever, a magnetomotive ultrasound was applied to human tissue

Yesterday was a historic day for NanoEcho. To our knowledge, this is the first time ever that the magnetomotive ultrasound method has been applied to human tissue. This was carried out on operated cancer tissue using NanoEcho's first generation portable system at Sahlgrenska University Hospital in Gothenburg. Our system is designed to map, with high precision, the spread of cancer to the lymph nodes, an important marker of how far the cancer has progressed, even before surgery. Our clinical study is now underway at Sahlgrenska University Hospital.

It was a very educational day, and we appreciate the professional leadership of Senior Consultant and Professor, Eva Angene, and her team's engaging approach. Everything has gone according to plan, and we have succeeded in identifying nanoparticles in the human tissue. As such, we have achieved our goal with the first patient. We now look forward to continuing the clinical study on operated tissue, and gathering knowledge and receiving guidance in readiness for the design and system development of the next system, adapted for commercialisation, says Linda Persson, CEO of NanoEcho. 

One year ago, we submitted our joint ethics application for this clinical study. Due to the burden on healthcare from Covid, the start was delayed. It is exciting to finally be up and running, and I look forward to following the development of the study, says Professor and Senior Consultant, Eva Angenete, who is leading the study at Sahlgrenska University Hospital. 

This press release was published in Swedish in 18 June 2021.

Basic patent granted in Japan

The basic patent for NanoEcho's method has now been granted in Japan. We have also received positive feedback on the same patent in Europe from the European Patent Office, which has announced that it intends to grant the patent. The same patent is also under review in Canada and the US, where the process is also progressing according to plan.

The patent protects the unique combination of placing an ultrasonic transducer together with one or more magnets on the same device, as such the basic patent protects the performance of a handheld probe. The magnets create an alternating magnetic field which, together with the ultrasonic transducer, is used to locate iron oxide-based nanoparticles. 

We work actively with our patent portfolio and continuously evaluate how we can best strengthen and expand our patent portfolio as our product development progresses. This is to ensure the use of strategically and technically important innovations. The Japanese market accounts for approximately 8.5 per cent of the global rectal cancer market, says Linda Persson, CEO of NanoEcho. 

This press release was published in Swedish in 1 July 2021. 

First patient recruited in clinical trial on surgically removed tissue

NanoEcho has been given the go-ahead to begin clinical trials on surgically removed rectal cancer tissue at Sahlgrenska University Hospital in Gothenburg and at Skåne University Hospital in Malmö. The first patient has now been recruited at Sahlgrenska University Hospital. NanoEcho is developing a new medical imaging technique for the diagnosis of rectal cancer. The ambition is to contribute to a more reliable mapping of cancer spread to nearby lymph nodes, which is an important marker of how far along the cancer is.

The first patient has now been recruited at Sahlgrenska University Hospital. On June 17 the clinical trail, on surgically removed rectal cancer tissue, will start using the company's first-generation portable system, under the condition that nothing unforeseen happens. The recruitment procedure is ongoing at Skåne University Hospital in Malmö as well. The studies will compare results from NanoEcho's diagnostic method with other imaging modalities such as magnetic resonance imaging (MRI) and pathology. Patient recruitment will be ongoing at both university hospitals and the studies will last for one to two years from their respective start dates.

The results of these clinical development studies will be used to evaluate the effectiveness of our existing system and guide the design of our next system for commercialization. Together, these two studies will provide us with a comprehensive analysis of the system's performance, as both patients with different positions of the tumor in the rectum and patients with different stages of cancer are included," says NanoEcho CEO Linda Persson. 

Eva Angenete, Professor of Surgery and Senior Consultant at Sahlgrenska University Hospital, is leading the study in Gothenburg, which will include about 20 patients:

In the study, we will ensure that the system works to easily diagnose lymph node proliferation. This could be a very interesting and good development towards a simpler and cheaper diagnostic tool. 

Henrik Thorlacius, Professor of Surgery at Lund University and Senior Consultant at Skåne University Hospital in Malmö, is leading the study in Malmö, which will involve about 40 patients:

Patients will undergo routine standard surgery. Once the cancer is removed from the patient, we will take the surgically removed specimen and examine it with NanoEcho's instrument and then compare the result with the final microscopic examination by the pathologist.

 

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