Periodic Reporting for period 1 - BoldJet (Skin micro-injector)
Reporting period: 2022-06-01 to 2023-11-30
Needle-based injections are very common in modern medicine, notably in vaccination efforts worldwide. However, needle phobia and infection risks affect patient compliance with medical treatments, while millions of used needles contaminate the environment. Lastly, the effectiveness of certain drugs increases when injected intradermally, but targeting the dermis is challenging. Thus, new minimal-invasive procedures are needed. Jet injectors are needle-free medical devices that pressurize thin liquid filaments to penetrate the skin. Jet injections have been effective in subcutaneous and intramuscular delivery, ex vivo, and in vivo. However, the expected needle-free revolution for medical treatments has neither been fulfilled, nor widely commercialized due to factors such as: a) Bruising, a painful consequence of delivering large volumes in a single location. b) When using wrong energy settings, or misalignment with respect to the skin, the injected liquid can perfuse other layers. c) The rejected liquid splashes back, leading to an incorrect dose delivery, risks of cross contamination of the injector parts, or splash-back on the care giver. d) Commercial jet injection methods, such as springs or compressed gas, are noisy which can distress the patient. Hence, there is a need to develop a new way to deliver smaller doses with maximum accuracy in targeting specific skin layers. Bold-Jet is aimed at revolutionizing the experience of people who receive or perform frequent injections by developing for the first time a needle-free device using microjets that is safer, minimally invasive, and eco-friendly. By avoiding the use of needles, we can increase adherence to treatments by patients with fear to sharps and expand clinical routes for existing drugs and treatment.
The objectives of this project were:
1. Product Development towards Minimum Viable Product: an easy-to-use handheld injector, integrating lasers and microfluidics with commercial liquids to be injected (e.g. vaccines and inks).
2. Validation in real world settings: The ease-of-use of the technology will be validated in realistic settings. Specific versions of the injector will be tested with partners in hospitals and cosmetic/tattooing scenarios.
3. Commercialization: The intended commercialization path will be two-folded: first, we will focus on selling the injector to first adopters in the markets with lowest entry barriers. Second, we will finalise the documentation to fulfil the regulations for entry to the medical market.
The objectives of this project were:
1. Product Development towards Minimum Viable Product: an easy-to-use handheld injector, integrating lasers and microfluidics with commercial liquids to be injected (e.g. vaccines and inks).
2. Validation in real world settings: The ease-of-use of the technology will be validated in realistic settings. Specific versions of the injector will be tested with partners in hospitals and cosmetic/tattooing scenarios.
3. Commercialization: The intended commercialization path will be two-folded: first, we will focus on selling the injector to first adopters in the markets with lowest entry barriers. Second, we will finalise the documentation to fulfil the regulations for entry to the medical market.
This project has strengthen the incorporation of a startup academic company, FlowBeams (www.flowbeams.com)
FlowBeams proposes a revolutionary needle-free technology based on microjets, enabling repeated delivery of small, controlled volumes below 0.5 mL into the dermis with a
penetration depth of approximately 0.5 to 1.5 mm. To generate the microjet, a laser beam is focused on and absorbed by the liquid. By means of thermal cavitation, the liquid is then
ejected through a well-defined nozzle towards the skin at a speed of approx. 100 m/s. The typical distance between nozzle output and the skin surface is around 10 mm. So far, the
technology has been developed until experimental proof of concept and successfully tested in a lab environment (TRL3: experimental proof-of-concept).
We focused mainly on work related to design, build and assemble a prototype that is handheld and can be used for demonstrations about the potential to inject without needles.
The device is able to generate jetting characteristics as required by different potential future users. The Testing of the prototype is still ongoing. We have a system for Quality Management being developed in preparation for (pre-clinical) tests with healthy volunteers.
FlowBeams proposes a revolutionary needle-free technology based on microjets, enabling repeated delivery of small, controlled volumes below 0.5 mL into the dermis with a
penetration depth of approximately 0.5 to 1.5 mm. To generate the microjet, a laser beam is focused on and absorbed by the liquid. By means of thermal cavitation, the liquid is then
ejected through a well-defined nozzle towards the skin at a speed of approx. 100 m/s. The typical distance between nozzle output and the skin surface is around 10 mm. So far, the
technology has been developed until experimental proof of concept and successfully tested in a lab environment (TRL3: experimental proof-of-concept).
We focused mainly on work related to design, build and assemble a prototype that is handheld and can be used for demonstrations about the potential to inject without needles.
The device is able to generate jetting characteristics as required by different potential future users. The Testing of the prototype is still ongoing. We have a system for Quality Management being developed in preparation for (pre-clinical) tests with healthy volunteers.
A startup academic company was incorporated in October 1st 2021: FlowBeams https://flowbeams.com(opens in new window) is busy with the commercialisation efforts coming out of this PoC.
FlowBeams is a spin-off from the University of Twente and aims at developing and commercializing a novel, needle-free jet injector technology. Currently available needle-free devices can be painful, noisy, and lack precision in perfusion and dosing.
FlowBeams plans to develop a microinjector called Bold-Jet for the market of medical pigmenting, recreational tattooing and permanent make up. In a first step, a
demonstration device is to be built to show the previously achieved results. FlowBeams plans has started to build the demonstration device in collaboration with an independent engineering
partner having expertise in the development of drug delivery devices and needle-free injectors.
The Demo Handheld contains a holder for the microfluidic chip that generates the jet, small low power lasers for aiming the fluid jet, a magnification loupe for visualizing the microfluidic chip and buttons to control the demonstration.
We have initiated work regarding Legal/IP aspects, and after receiving a loan from the Dutch Government, this company has started paying back costs related to IP protection.
We have also advanced work regarding Regulatory aspects needed to perform tests with healthy volunteers in 2024.
FlowBeams is a spin-off from the University of Twente and aims at developing and commercializing a novel, needle-free jet injector technology. Currently available needle-free devices can be painful, noisy, and lack precision in perfusion and dosing.
FlowBeams plans to develop a microinjector called Bold-Jet for the market of medical pigmenting, recreational tattooing and permanent make up. In a first step, a
demonstration device is to be built to show the previously achieved results. FlowBeams plans has started to build the demonstration device in collaboration with an independent engineering
partner having expertise in the development of drug delivery devices and needle-free injectors.
The Demo Handheld contains a holder for the microfluidic chip that generates the jet, small low power lasers for aiming the fluid jet, a magnification loupe for visualizing the microfluidic chip and buttons to control the demonstration.
We have initiated work regarding Legal/IP aspects, and after receiving a loan from the Dutch Government, this company has started paying back costs related to IP protection.
We have also advanced work regarding Regulatory aspects needed to perform tests with healthy volunteers in 2024.