Dr. Luc Van Hove from MARACA International participated in the IMDEA meeting in Madrid on Magnetic nanoparticle-based medical devices towards the clinic. This scientific and clinical meeting transitioned the NoCanther clinical study from REFINE to the Safe-N-Medtech consortium for further development. At the meeting the status of the development of paramagnetic iron nanoparticles was reviewed. Details were presented on how to produce stable iron nanoparticles of the right size and the right properties. The establishment and validation of the clean room manufacturing of the iron nanoparticles was discussed. The status of the preclinical testing in vitro and in vivo in different animal models was reviewed. The first in-human pancreatic adenocarcinoma patients of the NoCanther clinical study which are treated with the Resonant Circuits Limited (RCL) hyperthermia therapy were reviewed. The treatment was found to be safe and possible. The NoCanther clinical investigation is transitioning from REFINE, which comes to an end, to Safenmt for further study progression. MARACA presented at the meeting the regulatory and clinical investigation requirements for a Pre-CE conformity study to establish the safety and performance of the RCL NTT hyperthermia device. Moving this new treatment from the development phase to the clinic is an exciting achievement. Everyone involved deserves congratulations for their hard work!
This regulatory roadmap for nanotechnology-based medical devices and IVDs is the same as for conventional medical devices and IVDs. However, for the nanotechnology-based devices additional analytical performance characterization, biocompatibility testing, risk management and labelling are required. The different regulatory steps are highlighted, as well as the current challenges, such as incomplete intended purpose statements, what biocompatibility testing is needed and what is sufficient clinical evidence. Many small medical device and IVD companies are not well prepared for the transition to the new regulatory requirements.
The key steps of the regulatory roadmap are reviewed: Manufacturer’s role, scientific validity, analytical performance, clinical performance, clinical evidence, clinical performance report, post-market clinical follow-up, conformity assessment, GSPRs, certificates and EUDAMED registration.
Participants will learn what the required regulatory steps are for the development of a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations. The impact of the REACH and CLP regulations on labeling will also be highlighted.
When you are developing nanotechnology-based devices this webinar “Nanotechnology-based medical device registration roadmap for Europe” is a must for you to stay compliant with the current European regulations.
Safe-N-Medtech Consortium kick-off meeting in Bilbao.
The Safe-N-Medtech Consortium initiative kicked off 2-3 May in Bilbao, in a meeting hosted by Osteba, the HTA Unit of the Health Ministry of the Basque Country (Spain) in collaboration with BIOPRAXIS-BIOKERALTY. The project is coordinated by TECNAN (an SME from Navarra, with great experience in Nano products), together with BIOPRAXIS-BIOKERALTY (the research branch of the global health companies Keralty and Praxis).
Safe-N-Medtech is an Open Innovation Test Bed (OITB) initiative from the European Commission, a new and challenging approach towards upscaling the use of nanotechnologies in Europe and abroad. It represents a European investment of 18M€ over 4 years.
More than 50 founding Consortium members, including MARACA International, gathered in Bilbao, coming from 28 entities and from 13 countries to refine the basis of the collaboration, and set the scene for the first years of the Project.
Ambition and strategy
Society and clinical practice pose a growing demand on novel biomaterials, ICT, micro and nanotechnologies for innovative medical devices and in vitro diagnostics (Medical Technologies-MTs). In addition to the challenge of time, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide. In the most recent years it is obvious that nano-enabled MTs can be applied in nearly every medical area, with a major presence and increased importance in cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry.
SAFE-N-MEDTECH with MARACA International will build an innovative open access platform to offer to companies and reference laboratories, the capabilities, knowhow, networks and regulatory and clinical services required for the development, testing, assessment, upscaling and market exploitation of nanotechnology-based Medical and Diagnosis Devices.
SAFE-N-MEDTECH will offer a multidisciplinary and market oriented innovation approach to SME´s, Healthcare providers and Industries for the translation to the market of MTs, based on a deep understanding and knowledge of the material nanoproperties, their advanced use and applications in MTs and other aspects involved in MTs safety (electric compatibility, electromagnetic properties, etc).
Who s in?
There are 28 partners in Safe-N-Medtech, including MARACA International, a great challenge for management, but a huge opportunity to address all the key challenges to come ahead. Research Institutes, Small and larger companies, Associations, Health Technology Assessment experts, Hospitals and Care centres are amongst the partners, and ensure the project can cover all the relevant aspects of the translation of nano-enabled medical technologies.
What s next?
SAFE-N-MEDTECH starts its journey by ensuring its validity with four test cases. During the first years of the initiative, the partners will develop their services and test them, so that in four years from now, it becomes a self-sustainable and competitive services platform for companies to test and ensure their nano enabled medtechs are safe to use!
For more info on the project:
Coordinator: Tamara Oroz, TECNAN (firstname.lastname@example.org)
Scientific Lead: Angel del Pozo, Biopraxis –Keralty (email@example.com)
Communication: Anaïs Le Corvec, Aura Costa (firstname.lastname@example.org)
MARACA International, Partner for Regulatory and Clinical services, (www.maracainternational.com; email@example.com)