At Minnetronix, we are experts at developing high-quality in vivo electroporation systems that get to market quickly. We believe that commercializing clinical electroporation technology should be fast, predictable, and forward-thinking.
The Allure of Electroporation
Electroporation is used for drug delivery, gene therapy, immuno-oncology, and tissue-selective ablation. Reversible electroporation is a method to increase uptake for in vitro cellular biology that has also recently become popular in various in vivo applications (such as nucleic acid-based vaccines). Irreversible electroporation has the potential to ablate diseased tissue while preserving critical structures (such as nerves, blood vessels, and the extracellular matrix). Reversible and irreversible electroporation share many of the same technical and commercialization challenges and require specialized expertise to develop a successful medical device using these technologies.
Reversible Electroporation Applications
The nucleic acids found in DNA and RNA are naturally hydrophobic, meaning it is difficult to transfer these substances through a cell membrane. Cells are therefore hard to transfect without a method to penetrate the cell membrane. Electroporation is an engineering solution to this biological problem – brief pulses of strong electric fields temporarily permeabilize cells, allowing easy access for delivery of nucleic acids, proteins, or other cargo.
Irreversible Electroporation Applications
Treatment of diseases and disorders such as cancers, heart arrythmias, and neuralgia often rely on thermal (RF or microwave) ablation, which indiscriminately damage tissue. Irreversible electroporation attempts to leverage morphological differences between targeted and collateral tissues to provide tissue-selective ablation and does so without the post-therapy inflammatory processes associated with thermal ablation.
Electroporation technologies are rapidly maturing from laboratory-level research projects to commercial medical devices with broad potential health impacts. Unlike in vitro applications, clinical applications of electroporation operate at higher absolute voltages and with larger treatment volumes, requiring specialized expertise to translate laboratory-level protocols to human use. Obviously, the safety considerations for applying high voltages to patients, as well as complying with combination drug-plus-device regulations, add layers of complexity and risk that requires special expertise to successfully navigate.
Medical Electroporation Applications Include:
- Gene/drug delivery
- Immuno-oncology
- Vaccine delivery
- Pulsed field ablation
Commercializing Electroporation Technology
Developing an electroporation technology for manufacturing and commercializing should be one complete solution that accounts for both the biologic and electro-mechanical considerations. We can handle the entire development and manufacturing process for you, as you focus on the bigger picture. Our experts focus on:
Accurate & Precise Energy Delivery
Clinical efficacy of electroporation relies on achieving specific electric field strengths, which can be influenced by varying impedance of tissue or sample. Specialized measurement equipment and protocols improve accuracy and performance.
Fast and Affordable Design Elements
Most medical devices require ancillary features (such as data logging, user interfaces, and power supplies); our robust library of such design elements let us implement these features quickly and inexpensively, letting the team focus on novel elements of the electroporation therapy.
Life-Cycle Manufacturing
More than just timeliness, we want to help develop products and processes that will stand the test of time. To avoid delays and ensure quality and availability of the best components and materials, we think about supply chain needs from the outset of the project.
New Product Introduction
After product development is complete, we want customers to be confident in a seamless transfer to high-volume manufacturing. Our New Product Introduction (NPI) process streamlines transfers, reduces risks, and increases speed to market for the finished product.
Expert Support from Product Development Through Commercialization
Our expertise, foresight, and proven foundations enable rapid commercialization of your electroporation solutions. We deliver comprehensive solutions for electroporation device development through each stage of product evolution:
- Design and Development ene/drug delivery
- Product Verification Testing
- Regulatory Support
- New Product Introduction
- Manufacturing
- Supply Chain Management, Lifecycle Support, and Warranty Service
Helping our clients develop life-changing products and accelerate the next medical breakthrough is what we do. If you are looking for a partner to bring your technology to market, Minnetronix is the solution. Contact us today by calling (651)917-4060 or email us at info@minnetronixmedical.com.