Fe-Free targets the root cause of treatment-resistant biofilm infections - without antibiotics, surgery, or chemicals. Validated at Bar-Ilan University.
Up to 80% of chronic wound infections involve bacterial biofilm - a protective matrix that renders standard antibiotics 1,000 times less effective. Current treatment options are expensive, painful, or logistically prohibitive.
Bacteria within biofilm tolerate antibiotic concentrations 100-1,000 times higher than planktonic cells. Repeated antibiotic courses accelerate resistance development, reducing future treatment options.
Negative Pressure Wound Therapy addresses fluid management and symptom relief but does not target the underlying biofilm. Requires facility attendance, is painful, and is associated with high equipment costs.
Demonstrated efficacy in some chronic wound indications but requires specialized pressurized chambers, limits treatment to clinical settings, and is inaccessible to most patients globally.
Antimicrobial resistance is classified by the WHO as one of the top ten global health threats. Diabetic foot ulcers represent a primary driver of antibiotic overuse and resistance amplification in community and hospital settings.
World Health Organization. Global antimicrobial resistance and use surveillance system (GLASS) report, 2022.
Rather than attacking bacteria chemically, Fe-Free deprives them of iron - an absolute physiological necessity for bacterial survival, biofilm formation, and quorum sensing. Iron is a chemical element; bacteria cannot develop genetic resistance to its absence.
Precision-tuned electromagnetic fields create subtle molecular vibrations in siderophore molecules - the iron-capturing proteins bacteria rely on. These vibrations prevent siderophores from binding iron to their receptors, triggering iron starvation without any chemical agent.
When iron uptake is disrupted, bacteria lose the capacity to maintain biofilm structure, coordinate quorum sensing, or sustain cellular respiration. The biofilm matrix collapses. This mechanism is not susceptible to evolutionary circumvention.
Integrated Pulsed Electromagnetic Field therapy stimulates microcirculation, enhances cellular repair activity, and accelerates wound closure. PEMF has an established clinical safety profile spanning two decades.
The dual-action device combines bacterial elimination (MKE) with active tissue repair (PEMF) - addressing both infection and healing simultaneously within a single non-invasive treatment session.
No surgery. No chemicals. No direct tissue contact. The device is applied externally to the wound area and operates via a controlled electromagnetic field.
The device generates a precision-tuned electromagnetic field around the wound area. No direct contact with tissue is required.
The field induces resonant vibrations in bacterial iron-carrying siderophore molecules within the biofilm matrix.
Vibrational interference prevents iron from binding to bacterial receptors. Bacteria enter iron starvation and lose biofilm integrity.
As biofilm collapses and bacteria die, concurrent PEMF stimulation activates the body's natural tissue repair mechanisms.
Fe-Free's mechanism has been validated in controlled laboratory studies by leading research institutions. Phase 2 optimization is planned for 2026.
Research conducted by Prof. Ehud Banin, a recognized international authority in biofilm biology, demonstrated significant bacterial reduction against resistant strains of Pseudomonas aeruginosa PAO1 - one of the most treatment-resistant biofilm-forming pathogens in chronic wounds.
Bar-Ilan University, Faculty of Life Sciences. In vitro study, 2024. Phase 2 studies targeting ≥90% reduction are planned for 2026.
Iron regulates three interdependent systems in bacterial survival: biofilm matrix gene expression, cellular respiration and ATP synthesis, and quorum sensing signal coordination. Disrupting iron uptake collapses all three simultaneously.
Unlike antibiotic mechanisms, which can be circumvented through gene mutation, iron is an elemental physiological requirement. No genetic pathway exists by which bacteria can bypass the need for iron in cellular metabolism.
Human cells regulate iron via transferrin-mediated pathways, not siderophores. The MKE frequency parameters are tuned to bacterial siderophore resonance exclusively. Human iron metabolism is unaffected at therapeutic field intensities.
MKE operates within ELF/VLF frequency ranges. The device generates no thermal effect, no ionizing radiation, and introduces no chemical agents into the body.
60+ years of combined medical device development, regulatory clearance, and clinical research experience.
Serial MedTech entrepreneur with four successful exits including Syqe Medical (Philip Morris), SteadyMed (United Therapeutics), and VersaMed (GE Healthcare). Five registered patents, multiple FDA clearances.
PhD in Biology (Hebrew University), Postdoctoral Fellow at Yale University. Professor Emeritus with 25+ years of senior research. 69 peer-reviewed publications in cellular biology and immunology.
30+ years of medical device R&D. Co-inventor of four US patents in electromagnetic therapy systems. Former CTO at OrthopCure and Venus Concept, specializing in EM and PEMF device development.
20+ years of international marketing, sales management, and commercial operations across medical device companies and clinical institutions in Europe and the United States.
30+ years of experience in medical device engineering, strategic R&D planning, and advanced technology development.
Orthopedic foot surgeon with 30+ years specializing in diabetic foot ulcers. Founder and past president of the Israeli Society for Foot & Ankle. Director of DFU Clinics at Shaare Zedek Medical Center, Jerusalem.
Diabetic foot ulcers represent a convergence of impaired healing, recurrent infection, and rising antibiotic resistance. Up to 80% of DFU infections involve biofilm, which reduces antibiotic efficacy by 100-1,000 fold and is a leading driver of wound chronicity.
Fe-Free offers a physical, drug-free adjunct to standard wound care protocols - targeting biofilm directly without increasing antimicrobial pressure or introducing systemic drug burden.
Request Clinical InformationBiofilm presence correlates with persistent inflammation, delayed wound closure, recurrent polymicrobial infection, and increased amputation risk. Debridement alone does not eliminate biofilm; bacterial colonies re-establish within 24-72 hours.
Schultz G et al. Wound biofilm consensus document. Wound Repair Regen. 2017.
The Fe-Free device is designed for use in both clinical settings and the home environment. No specialized training is required for operation. No consumables. No chamber. Treatment is painless and sessions are brief.
By Dr. Haya Friedman, Chief Scientist & Co-Founder, Fe-Free Medical Technologies.
Iron ions act as a double-edged sword in bacterial biology. On one hand, iron enables cellular metabolism and survival. On the other, iron overload induces ferroptosis - cell death via the Fenton reaction with ferric ions, generating reactive oxygen species (ROS) that damage cellular structures.
Blocking iron entry into bacterial biofilm is a strategy supported by a substantial body of evidence. Removal of iron by chelators has been demonstrated to reduce biofilm formation and improve healing in infections caused by multiple bacterial species.
When iron entry is blocked, bacteria do not simply die quietly. They upregulate siderophore production and export - attempting to capture more iron from their environment. Fe-Free exploits this desperation response by disrupting the siderophore-receptor binding step at the molecular level.
Iron depletion does not only disturb biofilm structure - it simultaneously impairs the bacteria's capacity to sense and respond to their environment, coordinate collective defense, and maintain the energetic requirements of infection persistence.
Weinberg ED. Iron availability and infection. Biochim Biophys Acta. 2009.
Download the complete research paper on iron depletion in bacterial biofilms, including mechanism review, experimental data, and literature citations.
Download Research Paper (PDF)The Magneto-Kinetic Excitation mechanism is not wound-specific. Any infection site accessible to an electromagnetic field, where bacterial biofilm is the primary treatment obstacle, represents a potential application.
Primary indication. Wound accessibility, defined outcome measures, and significant unmet clinical need make DFU the optimal initial regulatory pathway.
Biofilm on orthopedic implants and cardiac devices is a major driver of treatment failure and reoperation. A non-invasive physical intervention addresses this without revision surgery.
Antibiotic-resistant organisms in deep soft tissue present limited options. Resistance-proof iron starvation offers a mechanism that functions regardless of antibiotic sensitivity profile.
The Magneto-Kinetic Excitation platform addresses a universal biological problem - bacterial iron dependence - using a scalable, manufacturable, non-consumable device. The initial DFU indication represents a fraction of the addressable clinical opportunity.
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