NanoPass from Nes-Ziona, Israel, has signed a strategic agreement with the Korean company Micro2Nano (M2N) to develop a mass production infrastructure for the smallest microneedles. NanoPass tiny needles, less than 1 millimeter of length, are manufactured using MEMS (Micro-electromechanical systems) technology. The companies are being cooperated for several years now in developing the production technology, and the current agreement is part of accelerating NanoPass product trade. Using M2N production infrastructure will allow for the fabrication of million units annually. The complete system is being assembled and produced in Israel by the medical production vendors Elcam Medical (owned by Kibbutz Baram) and TAV Medical Company from Shlomi.
NanoPass developed unique microneedle which enable to inject the medical material – whether it is a vaccine, medicine or aesthetic one – directly into the upper skin layer. This intradermal method has clinical advantages comparing to subcutaneous or intramuscular injections, since the intradermal injection generates better immune response and the substance absorbed faster. Some researches even showed that intradermal injection requires less medical material, but using standard needles for this purpose is a complex process which requires high proficiency.
The length of NanoPass microneedle is about 0.6 millimeter and it can be mounted onto standard syringe. The microneedle simplifies the intradermal injection process and with a higher precision level. It is made of a silicon crystal and shaped as a hollow pyramid. Producing such structure is feasible only when using MEMS, which is a process technology used to create tiny integrated devices or systems that combine mechanical and electrical components.
Till now, NanoPass performed about 60 clinical tests in the United States, Europe and Israel. These tests were aimed to examine both safety and clinical efficiency of the needle. About 7,500 patients took part in these tests, receiving about 30,000 shots. NanoPass says to Techtime that this needle is the smallest needle ever approved by the FDA. Currently, the company destines the new microneedle to three main applications: Vaccines (to include flu and COVID-19), delicate aesthetic treatments such as mesobotox and Platelet-Rich Plasma 9PRM), allergy diagnosis and tuberculosis tests and vaccines.
Additional advantage of such highly flattened intradermal injection is that no pain is accompanies to the process, since no nerve cells are being injured. Minimizing pain might be highly significant for diabetes type 1 patients, for example, which need to inject Insulin several times a day, and inoculating children or people with fear of needles (Trypanophobia). Preliminary test performed by the company showed that injecting insulin into the skin speeds up the body response to the material, which may allows the patient to inject near to the meal.