A system intended to meet authority and customer requirements is now on site

NanoEcho has now successfully completed the detailed product development phase. The work has resulted in a system that has been developed to meet both the authorities' and customers' requirements. This system consists of parts manufactured by the company's selected partners and key suppliers, Vermon and us4us. The system is now on site at the company's premises in Lund, ready for integration and evaluation.

The detailed product development phase is now complete and the company's product development work is moving into an integration and evaluation phase. In this phase, all the parts of the system, that the company has developed together with its partners, are assembled and the system software will be developed.
Once the integration work is completed, the system will be evaluated with regard to authority and customer requirements. The company's ambition is to replace the prototype system currently used in the ongoing investigator-led clinical development studies with this new system in 2023.

"We have had our sights set on this milestone all year, and today I am extremely proud that we now have our system assembled on site here in Lund. Both our team and our partners have done a very impressive job, developing and producing this system to meet highly set medical technical requirements in such a short time. When we replace the prototype system with this system in the ongoing clinical development studies, the goal is to increase the quality of the data we obtain," says Linda Persson, CEO of NanoEcho.

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.

NanoEcho Strengthens its Regulatory Competence

As part of the company's development, NanoEcho is strengthening the organisation by adding regulatory expertise to the management team. Kristina Hallström will bear responsibility for Quality Assurance and Regulatory Affairs, with a particular focus on market approval for NanoEcho's system.

Kristina Hallström, Head of Marketing and Communication at NanoEcho, now has an expanded remit. She boasts extensive experience in working strategically with clinical issues and regulatory matters. In recent years, she has been active as a medical technology consultant with a clinical and regulatory focus. At NanoEcho, Kristina will work actively together with clinics, product developers and authorities, all with a view to securing market approval for NanoEcho's system.

Kristina has taken on this assignment gradually. During the autumn, the company worked on developing a regulatory strategy, selected a Notified Body to certify the quality management system, and applied for – and was granted – a Vinnova grant for regulatory work.

'I am very happy that Kristina has chosen to expand her corporate responsibility and also taken on this key regulatory work. I feel we are in safe hands with Kristina in the management team, where she is a great asset and contributes on many fronts with the breadth and depth of her experience,' says Linda Persson, CEO at NanoEcho.

'It will be exciting to drive the process of getting market approval for our system – something we do by showing, step by step, that our system is both clinically useful and meets all the authorities' requirements,' says Kristina Hallström.

Since October 17, Kristina has been working full-time at the company with responsibility for Marketing, Communications, Regulatory Affairs and Quality Assurance.

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.

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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