Workshop on Hyperthermia in Oncology

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MARACA International and Safe-N-Medtech participate in the workshop on Hyperthermia in cancer treatment, organized by Vall d’Hebron Hospitals, Barcelona, Spain.

Dr. Luc Van Hove presents the European regulation of medical devices and in vitro diagnostics from a rare disease’s perspective.

Pancreatic cancer is a rare disease. It is therefore difficult to include sufficient study subjects for a rare disease clinical investigation. At the European chaired IMDRF congress in Brussels 27 March 2023, real world data collection was discussed as an option for clinical studies of rare diseases. During this Hyperthermia workshop we’ll examine this possibility for pancreatic cancer as a rare disease. Specifications for post-market clinical follow-up studies will be considered. Interaction with notified bodies and the Spanish Competent Authority will be part of this discussion. It is exciting to be in the forefront of this new hyperthermia treatment for rare cancers.

Heirbaan, Rotselaar

Klimaatdag – Rotselaar

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Kom je ook naar de Klimaatdag-Rotselaar, 23 April 2023, in de Sportoase Den Toren?

You are invited to the Climate Day of Rotselaar, 23 April 2023, Sportoase Den Toren.

Organized by the MAR – Milieuadviesraad van Rotselaar

including Dr. Luc Van Hove of MARACA International

Met:

  • Infomarkt met slimme oplossingen voor energiebesparing
  • Lezing van Pieter Bousemaere over de 10 klimaatacties die werken
  • Voorstelling Klimaatplan van Rotselaar met interview door student van het Montfort college

With:

  • Infomart on smart solutions for energy savings
  • Presentation by Pieter Bousemaere on the ten climate actions that work
  • Presentation of the Climate Plan of Rotselaar with an interview by a student at the Montfort college

The ten climate actions that work for you are:

  • Inform yourself
  • Influence your environment
  • Influence your government
  • Select green electricity
  • Use electricity wisely
  • Select the right heating
  • Select the right mobility
  • Limit flying and compensate

De tien klimaatacties die werken zijn:

  • Informeer jezelf
  • Beïnvloed je omgeving
  • Beïnvloed je overheid
  • Kies de juiste elektriciteit
  • Spring verstanding om met elektriciteit
  • Kies de juiste verwarmingsbron
  • Kies de juiste motor
  • Beperk vliegreizen en compenseer

Tijdslijn:

12 u infomarkt met o.a:

  • Workshop veggie zero waste Koken
  • Zonnepanelen, thuisbatterijen en laadpalen
  • Warmtepompen en isoleren
  • Repair café
  • Energieloket en premies
  • Deelwagens en mobiliteit

14 u: ECoOB productie hernieuwbare energie door burgers

14.20 u: Lezing Pieter Bousemaere

16.30 u: Interview Klimaatplan Rotselaar

Time Line

12 hr.: Infomart with

  • Workshop veggie zero waste cooking
  • Solar panels, home batteries, charging stations
  • Heat pumps and isolation
  • Repair Cafe
  • Energy counter and premiums
  • Share cars and mobility

14 hr.: ECoOB production of renewable energy by citizens

14.20 hr.: Lecture by Pieter Bousemaere

16.30 hr.: Interview Climate Plan Rotselaar

We need to reduce Carbon emission by 55% within the next 7 years (2030) per the European Green Deal regulation.

The MARACA International office is already carbon neutral with its solar panels, heat pumps, home batteries and led lights. What are you doing to preserve a livable world for your grandchildren and to become carbon neutral?

Het MARACA bedrijf is reeds koolstofneutraal met zijn zonnepanelen, warmte pompen, thuis batterijen en led verlichting. Wat doe jij om een leefbare wereld na te laten voor je kleinkinderen en om koolstofvrij te zijn tegen 2050?

 

 

Vall d'Hebron Hospital

MARACA at Safe-N-Medtech meeting in Barcelona

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MARACA International participated in the annual Safe-N-Medtech OITB consortium meeting in Barcelona. Dr. Luc Van Hove presented the work package

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IMDEA building, Madrid

NoCanther study moves magnetic nanoparticle device towards the clinic

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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!

Tenoes, Braga, Portugal

MARACA presents regulatory update at Safe-N-Medtech meeting in Braga Portugal

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MARACA International is participating in the Management Committee meeting in Braga, Portugal on 4-5 May of the European Safe-N-MedTech consortium. Dr. Luc Van Hove is presenting the progress report of the regulatory workgroup and presents a customer survey on the support needs of nanotechnology companies. These nanotechnology companies from Europe, the Americas and South East Asia were surveyed during the Business Review Webinar organized by MARACA International in March on the regulatory roadmap for registration of nanotechnology-based medical devices in Europe. The Webinar is still available in 2022 for on-demand review and can be accessed via the following link: BRW:

Nanotechnology-based medical device registration roadmap for Europe

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Nanotechnology-based medical device registration roadmap for Europe presented by MARACA International and Safe-N-Medtech at Business Webinars on 15 March 2022, 3 PM CET.

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.

Biocompatibility testing

MARACA training on nanotechnology-based medical device biocompatibility testing

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“Nanotechnology-based medical devices require special attention to biocompatibility testing.”

Dr. Luc Van Hove of MARACA International will train the Safe-N-MedTech consortium partners on the regulatory requirements in Europe for biological toxicity testing of nanotechnology-based medical devices. This training is an introduction to the Medical Device Regulation 2017/745 and the REACH Regulation 1907/2006, last amended in 2021, which specify how nanotechnology-based medical devices need to be handled. The training will then introduce the EN ISO 10993 series of harmonized standards. It starts with the review of the current version of EN ISO 10993-01:2020. The focus will be on defining the list of the chemical components of the final product and on developing the biological toxicity risk documentation. Depending on the location and duration of the contact with the patient and on the toxicity of the component a set of biocompatibility tests will have to be performed. For nanotechnology-based medical devices these harmonized standards are applicable. However, due to the nature of the nanomaterials the general information of the standards are not sufficient and specific tests might have to be developed. Hence, special attention needs to be paid to biocompatibility testing for nanotechnology-based medical devices.

Happy Holidays

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MARACA International wishes

our clients and community

a Merry Christmas and a Happy and Healthy 2022.

 

Thank you to all the volunteers who are keeping up with the relentless CORONA waves and continue to booster vaccinate our community. MARACA also supports the efforts of De Warmste Week,  Physicians without borders, Mercy ships, UNICEF, Fight against Cancer, Fight against MS and local nature preservation initiatives to build a better world for us all.

vaccinatiecentrum Rotselaar

MARACA International participates in COVID-19 vaccination in Rotselaar

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Dr. Luc Van Hove from MARACA International participates in the local vaccination campaign in Rotselaar.  “I felt compelled to help our local vaccination effort in Rotselaar to protect my community from the COVID-19 pandemic.  It feels great to be part of this excellent core team of volunteers. The vaccination program and vaccination center are well received by our population. We are expecting to reach a vaccination level of 90% of our people. It is a wonderful experience to be part of this local effort. I’m sure that this effort is strengthening our community sense and will prepare us better for the climate change efforts needed in the future. MARACA International supporting this local vaccination campaign in Rotselaar is an effort well spent”.

Regulatory Roadmap for the EU registration of nanotechnology-based medical devices and IVDs is published by MARACA International for the Safenmt consortium

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Dr. Luc Van Hove of MARACA International developed a regulatory roadmap for NT-based MD.

Luc developed a regulatory roadmap for the EU registration of Nanotechnology (NT)-based medical devices (MD) and IVDs. This roadmap was commissioned by the Safenmt consortium. For NT-based MD and IVD, as for conventional MD and IVD, this regulatory roadmap is the same.  However, for the NT-based MD additional analytical performance characterization, risk management and labeling is required. The report is now used for training of Safenmt consortium partners and will be presented externally at nanotechnology scientific meetings.

The objective is to educate the nanotechnology field on the required steps for developing a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations.

Within the next two weeks two Safenmt trainings will be organized.

A first external presentation of the regulatory roadmap for NT-based MD will be at the NanoMedSpain symposium on 20 May 2021, which has the new MDR as symposium topic.

Another session is planned for the ETPN (Nanomedicine European Technology Platform) conference on 7-9 September 2021 in Switzerland.