Fintech start-up Walletmor has confirmed the safety of its payment implant with further scientific research. The latest tests carried out by Konmex BioLabs confirmed the implant does not exhibit cytotoxic properties and can be perminantly implanted e.g. in subdermal fascia tissue (under the skin). Tests were conducted in accordance with bio-compatibility standards ISO 10993-5:2009E (cytotoxicity) and 10993-12:2021E. Walletmor plans further testing and international certification of its implant.
Let's recall: Polish-British startup Walletmor has created the first globally accepted payment implant. The device, which is installed in any part of the body under the skin, typically in the hand, allows you to replace your bulky wallet, and is a convenient alternative to credit cards or any payment device, including smartphones. The implant is the size of a small safety pin and only half a millimeter thick. It consists of a microprocessor and a silicon envelope acting as an antenna, which are all enclosed in a hermetic bio-housing. Although the implant itself does not qualify as a medical device, its creators have spent almost 10 years on the development and subsequent confirmation of its safety for users.
Most of the scientific, legislative, and testing work has been done in the United States at the laboratory of VivoKey Technologies Inc. in Seattle. This is where the safe and non-adverse reaction biopolymer was born, which is a type of medical plastic used in the production of medical devices. The polymer's components have a Class VI safety rating from the U.S. Pharmacopeia (USP) , which means that the implant can be placed under the skin without health concerns.
"The implant has also passed a number of tests such as high temperature tests, liquid nitrogen test, high and low pressure tests. The implant is not a contraindication to X-rays. American studies have confirmed that this implant does not cause any disease and can be installed in the body without the slightest risk. In 3 years of testing the biopolymer, VivoKey has not recorded any allergies, disturbing reactions, reactions or other side effects in people with the implant installed" – says Amal Graafstra, chief executive of VivoKey Technologies Inc. and Walletmor's chief technology officer.
In parallel to the tests in the United States, the Walletmor start-up commissioned testing of the implant in Poland, in accordance with EU and international ISO standards. The aim of the tests commissioned in 2021 to Konmex BioLabs was to confirm whether the analyzed product after implantation will not deviate from the standard and will not lead to adverse reactions, such as cytotoxicity, i.e. whether the product in contact with living cells will not destroy them.
"As part of biocompatibility testing of the implant at Konmex BioLabs , we evaluated the level of cytotoxic properties of the product using the MEM elution method. It evaluates and tests the release of various substances by the product in the human body, then applying these substances to cells grown under laboratory conditions and direct microscopic observation of the state of the cells after such contact. In our study, the product proved to have no negative effect on the tested cells" – says Kamila Gołaszewska, In-vitro Study Director at Konmex BioLabs. "For us, this project is very exciting. It’s straight out of a sci-fi movie. Working on this research makes the future seem closer than we previously thought. We are happy to be involved in such a revolutionary project" - she adds.
"The trust of our clients all over the world is our absolute priority" - says Wojciech Paprota, the creator of Walletmor implant. "Meticulous examinations carried out in accordance with ISO procedures by such a renowned testing company confirm that the implant can be placed safely and that it can be used for one's own benefit and comfort" - adds the founder of Walletmor.
Wojciech Paprota is optimistic about the future in terms of possible future international certifications for the implant. This is also confirmed by the Konmex laboratory itself. "The cytotoxicity test is a very sensitive test, which is why it is used as the "front line" when testing medical devices. With such a result as the one achieved by Walletmor, we can foresee, with a high probability, that it will pass further biocompatibility tests" - adds Kamila Gołaszewska from Konmex BioLabs.
Photo copyrights: Piotr Jaczewski
Konmex BioLabs specializes in preclinical tests for the registration of medical devices in accordance with ISO 10993. The company provides a comprehensive range of services from the early stages of R&D, through prototyping, up to and including biocompatibility testing. Qualified research staff and equipment meeting high standards that Konmex has at its disposal make it possible to conduct tests with precision, quality and short lead time. Konmex is GLP-certified (Good Laboratory Practice) and ISO 17025 accredited. At each stage of testing, the company uses methods compliant with ISO, ASTM, AAMI, and FDA standards and guidelines, thanks to which it cooperates with manufacturers worldwide. As an independent research unit, the company ensures reliability and objectivity of tests, allowing for the registration and certification of medical products under the CE mark in the EU, but also in other countries such as the USA, Brazil, Japan or South Korea.