# Identification of impedance measurement devices, heating hardware, and operating parameters to augment instrumentation for a commercial in vivo electroporation system

> **NIH NIH R41** · EF THERAPEUTICS CORP. · 2022 · $225,822

## Abstract

PROJECT SUMMARY / ABSTRACT:
EF Therapeutics, Inc is focused on adding proprietary/patented processes to the standard methods for
electrically mediated DNA delivery. This study is designed to help create a device with our
manufacturing partner that will be commercially viable for use in the US and eventually the rest of the
world. EF Therapeutics exists because gene therapy is not yet a reality, but it is moving in the correct
direction. One obstacle and general difficulty with gene delivery is that methods for delivering genes in
vivo have not yet achieved a desired level of reliability and control. In vivo electroporation is a method
for delivering DNA that has been successful in preclinical studies. These studies have been performed
using the technology for a variety of applications. Collectively, they prove that the physical basis of the
method makes it adaptable to any tissue. These studies paved the way for approximately 130 clinical
trials that use the technology in vivo. Thus, there are clear research and clinical applications for this
DNA delivery method. But, the method could be improved because it still suffers from lack of
control/reliability. One reason for this is that the characteristics of the electric pulses used to induce
DNA uptake are normally fixed for a particular tissue type based upon optimization in animal models.
These may have little translatability to analogous tissues in clinical settings as models may not be
identical to human tissues. In addition, there is variation from individual to individual. Thus, using the
same electric pulses (or dose of electricity) to deliver DNA to a particular type of tissue is not likely to be
optimal each time the method is used in that tissue type. Unfortunately, this is the current state of the
art. A means of customizing/adapting electrical treatment in real-time could circumvent this issue and
add to the efficiency/reliability of the method. Another issue with the state of the art is that in vivo
electroporation affects cell membranes and has traditionally been performed at ambient temperature.
Moderately increased temperatures could affect the results as they influence membrane fluidity. This
goal proposed is to move a small business named EF Therapeutics one step forward in addressing
these two aforementioned aspects in combination to ultimately improve DNA delivery. The basis for
this study is preliminary data that indicate approximately 10-fold increases in delivery when customized
pulses or moderate temperature increases are used alone. The research plan includes identifying and
verifying two key components that will ultimately be used in a commercial/clinical device. The first is a
system to heat and control temperature in target tissue. The second is a means for measuring tissue
impedance in real time during pulsation. Completion of this study will remove an obstacle to
commercialization that is currently in progress.

## Key facts

- **NIH application ID:** 10484502
- **Project number:** 1R41GM146569-01
- **Recipient organization:** EF THERAPEUTICS CORP.
- **Principal Investigator:** RICHARD HELLER
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $225,822
- **Award type:** 1
- **Project period:** 2022-05-17 → 2024-05-16

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484502

## Citation

> US National Institutes of Health, RePORTER application 10484502, Identification of impedance measurement devices, heating hardware, and operating parameters to augment instrumentation for a commercial in vivo electroporation system (1R41GM146569-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10484502. Licensed CC0.

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