Bioneedles are biodegradable, needle shaped mini-implants that can be pre-filled with vaccines or other high potency medicines. Pain free delivery takes place through the skin at high speed using a handheld Bioneedle delivery device. After subcutaneous or intramuscular delivery, the Bioneedle dissolves within minutes and releases the vaccine. Vaccines formulated in Bioneedles become thermostable, eliminating the need for cold chain transport and storage.
Vaccine pre-filled Bioneedles have been tested for thermostability and efficacy for 4 commonly used vaccines: Tetanus toxoid, Hepatitis B, Influenza and IPV (Inactivated Polio Vaccine). In addition, an experimental Tuberculosis vaccine has been tested for efficacy. Empty Bioneedles have passed safety and tolerability evaluations in a clinical trial setting in healthy volunteers in Germany. All trials have been published in peer reviewed scientific journals.
Currently, Bioneedle Drug Delivery is preparing for running preclinical and clinical trials with COVID-19 vaccine pre-filled Bioneedles.
The current COVID-19 pandemic and the global roll out of vaccines clearly brings to light the flaws and hurdles in the traditional Syringe-Needle-Vaccine-Refrigerator (SNVR) system: cooled or even deep-frozen transport and storage requirements (cold chain), large storage and transportation volumes, complex and time-consuming vaccination process, shortage of glass vials, shortage of needles, shortage of freezers. In addition, there are hidden disadvantages, such as needle stick injuries, reuse of syringes and needles (cross contamination), and biohazardous waste disposal.
Bioneedle affects all the links in this vaccination chain -from manufacturing and packaging, through transport, storage and distribution, to vaccinating people, and finally to waste disposal- and brings significant advantages thanks to its unique features:
These unique features combined make vaccinations with Bioneedle easier, faster, safer, less prone to mistakes, more sustainable and environment friendly, and cheaper.