Regulatory, Medical & Safety Information

Transparency, Safety, and Responsible Use

GASTER control® is committed to providing clear, responsible, and medically coherent information regarding the regulatory status, intended use, safety principles, and scientific development of its technologies.

1. Regulatory Positioning

Medical Device Framework

GASTER control® develops non-invasive biomechanical technologies designed for integration into external medical devices.

Depending on the device configuration, intended use, and applicable jurisdiction, devices integrating GASTER control® technology may be subject to specific regulatory classifications, registration requirements, conformity assessments, or market-access obligations.

Where applicable, CE marking indicates conformity with relevant European Union safety and performance requirements.

GASTER control® technologies are developed with compatibility in mind for structured medical-device pathways and regulated healthcare environments.

2. Intended Use

Scope of Use

Devices integrating GASTER control® technology are designed to support:

  • controlled external abdominal compression
  • modulation of the perception of satiety signals
  • support for food-intake regulation
  • integration into structured nutritional and clinical follow-up

These technologies are intended to function as complementary tools within broader care pathways.

They are not intended to replace validated pharmacological, nutritional, or surgical approaches.

3. Medical Information Disclaimer

The content provided on this website is for informational and educational purposes only. It does not constitute medical advice and should not replace professional medical evaluation or clinical decision-making.

GASTER control® technologies:

  • are external and non-invasive
  • do not enter the body
  • do not modify internal anatomy
  • do not function as intragastric balloons or implantable systems
  • should be used according to applicable instructions for use and, where appropriate, under healthcare professional supervision

Individual responses may vary.

Any clinical observations or early findings presented on this website are exploratory in nature and should not be interpreted as guaranteed outcomes or established clinical performance.

4. Safety Principles

Design and Usability

Safety is a core design principle of GASTER control® technologies.

Development priorities include:

  • controlled and adjustable compression
  • anatomical compatibility
  • comfort and tolerability
  • reproducibility of use
  • stability of performance
  • use of high-quality, skin-compatible materials

These principles are integrated throughout design, development, and real-world evaluation processes.

5. Scientific and Clinical Transparency

Current Evidence Status

Preliminary observational data in real-life conditions suggest consistent trends with devices integrating GASTER control® technology, including:

  • facilitation of satiety perception during meals
  • reduction in food intake or portion size
  • improvement in eating behavior regulation
  • good overall tolerance and acceptability

These findings are exploratory and remain under further clinical evaluation.

They do not constitute definitive proof of efficacy and require confirmation through controlled studies and broader clinical development programs, including multicentric evaluation.

6. Position Within Care Pathways

GASTER control® technologies are intended to support integration into structured care pathways, including nutritional, behavioral, and medically supervised environments.

Their role is to provide a non-invasive, external, complementary option that may assist patients and healthcare professionals in selected clinical contexts.

GASTER control® is not presented as a standalone treatment for overweight or obesity.

7. Intellectual Property

GASTER control® and related biomechanical designs, including the Extra-Parietal Balloon (BEP™) technology and associated engineering principles, are proprietary.

Patent pending. Unauthorized reproduction, imitation, or use of protected elements is prohibited.

8. Liability and Responsible Use

GASTER control® shall not be held responsible for:

  • use inconsistent with instructions for use
  • misuse or inappropriate adaptation of the technology
  • use outside applicable professional, clinical, or regulatory frameworks where required

Technical specifications, intended use statements, and regulatory information may evolve over time in accordance with product development, jurisdictional requirements, and clinical validation pathways.

9. Summary Statement

GASTER control® develops non-invasive biomechanical technologies designed to support the perception of satiety signals through controlled external abdominal compression.

These technologies are intended for responsible integration into structured medical and therapeutic environments, with safety, transparency, and scientific evaluation as core principles.