The elements which follow were the subject of a research protocol draft and presentation submitted to the Biomedical Research People Protection Committee in Nîmes (CCPPRB).

The CCPPRB committee, whose members are university professors, ensures the law is applied to protect in-patients or out-patients who accept to have new innovative products tested on them.

The CCPPRB authorized the tests of BMN prototypes and classified them in the category: tests with direct individual benefit for the patient.

The study was managed in the department of the ‘functional Explorations of the nervous system and Acupuncture, multidisciplinary Consultations of pain’, Head of Department D PRAT, in the Hospital complex and University of Nimes-Montpellier.

The tests have, therefore, mainly checked the therapeutic benefit to human beings of an innovative device, the BMN, in conformity with French and European pharmacopoeia criteria and respecting international standards, that is to say:

Q To exclude intradermal, intramuscular or sub-cutaneous needles in mésopuncture.

Q To have an easy-to-handle, miniaturized device causing less pain due to the smaller diameter of the needle, the material the reservoir is made of and the capacity adapted to the small diameter of this needle making it possible to eliminate the painful excess pressure phenomena upon injection.

Q To combine, in a single act, treatment by acupuncture and the contribution of micro doses of selected active product according to the pathology.

Q To notably reduce the quantity of remedies for the same affection thanks to a better active product quantity/effectiveness ratio: each depression of the reservoir injecting

in loco only 2 or 3 drops (sucked into the reservoir prior to use).

Q To equitably distribute the total volume of the drug ampule into micro amounts of equal volume.

Q To locally inject micro doses of drug allowing a more precise saturation of the membranous receptors, thereby avoiding the hepatic path. Q To test the reliability of the BMN in mesopuncture, in other words, to check that it allows to suck up, store, and restore 2 or 3 drops of drug due to its intrinsic and functional qualities, and in a totally harmlessness way.