High Frequency Irreversible Electroporation (H-FIRE) is a new, minimally invasive, non-thermal tissue ablation technique in which a tumor is exposed to bursts of very short electric fields for approximately 2 minutes. These pulses structurally rearrange the lipid bilayer of cells a target region inducing cell death. As opposed to other focal ablation techniques, H-FIRE does not affect major blood vessels, nerves or the extracellular matrix making unresectable tumors treatable. The goal of this project is to transfer fundamental technology for solid tumor treatment from the laboratory to clinical application.
Development of this minimally invasive technology facilitates the treatment of tumors currently inoperable with surgical resection or other focal ablation technologies due to their proximity to critical structures such as nerves and major blood vessels. Some tumor types are known to become chemo-resistant and radiation exposure must be closely regulated, especially in younger patients. Thermal-ablation techniques suffer from heat sinking effects by local vessels and tight control of treated regions is challenging. H-FIRE has the potential to complement these other technologies as a standard of care. If successful, a direct result of this project will be the development of an instrument which will be made available for clinicians and researchers to evaluate H-FIRE based therapies.
Progress on the commercial development of high frequency irreversible electroporation (H-FIRE) has been focused on completing extensive customer discovery and identifying the required features for a minimum viable product. Five members of our team including the PI, two postdocs, and a graduate student attended the NSF I-CORPs training in Michigan. After over 100 interviews with potential customers, users, buyers, and others in the economic ecosystem surrounding the focal ablation market, we have determined that an appropriate and viable market exists in the realm of endoscopic ablation tools. H-FIRE is uniquely positioned to become a leading technology in the endoscopic ablation market for two unique reasons. First, unlike most other focal ablation techniques (cryo-, radiofrequency-, and microwave-ablation), irreversible electroporation (IRE) techniques can use small flexible electrodes which can be easily placed via an endoscopic approach. Second, unlike other pulsed electric field therapies (including IRE), H-FIRE pulses do not induce muscle contractions. This enables us to deliver H-FIRE treatments without the need for adjunctive neuro-muscular paralytic agents. This unique advantage means that patients do not need to be on artificial ventilation allowing us to access the lungs, kidney, liver, and pancreas using an oral endoscopic approach. In addition to customer discovery, we have been diligently validating the H-FIRE platform to ensure that the procedure can achieve suitable ablation volumes within the constraints of an endoscopic system. This includes the design, simulation, and testing of advanced endoscopic probes which must be able to travel down the narrow working channel (<3 mm) working channel of an endoscope and withstand delivery of high voltage (>1000V), high frequency pulses (>500kHz) without sustaining damage or fundamentally altering the pulse shape. We have also created and enclosed a H-FIRE pulse generator system capable of delivering H-FIRE pulses of 6000V and 50A.To the best of our knowledge, is the only system in the world with such capabilities. Additional experiments have been conducted to validate and predict the lesion volumes produced by H-FIRE pulses and ensure that the endoscopic probes are capable of ablating typical tumors (~1cm) found in the lung. The encouraging results from the customer discovery process have led to the formation of a student led company, VoltMed Inc. The creation of this company has already created jobs for two Virginia Tech students with strong background in electroporation-related technologies and an NSF STTR Phase I award.
