AVB Biotechnology has initiated formal regulatory processes in the CE zone and in countries subject to national registration systems for the market introduction of the Dr Biolyse® device, which is developed based on Bioelectrical Epigenetic Programming (BEP) technology. By their nature, official registration procedures require a specific and unavoidable timeframe.
In order to expedite the delivery of the therapeutic potential offered by the Dr Biolyse® device to pathologies defined as "unmet medical needs" or "urgent medical needs" by international medical regulatory authorities, our company actively pursues applications for specialized prioritization and accelerated approval programs, such as the "Breakthrough Device" designation.
The Bioelectrical Epigenetic Programming (BEP) methodology is an innovative medical approach aimed at the synchronized regulation of more than 20,000 genes and over 100,000 protein expression networks through a single master signaling pathway. Data obtained from our pre-clinical and clinical research demonstrate that this technology—which has successfully completed its human clinical trial phases and is not yet approved for commercial distribution—possesses a strong clinical monotherapy potential in systemic pathologies, particularly within the "unmet medical need" profiles published by global authorities. This developed approach exhibits full methodological alignment with the next-generation, cellular, and systemic homeostasis-oriented therapeutic vision highlighted in "Breakthrough Device" guidelines.
Even within these expedited programs integrated into the guidelines of regulatory health authorities, the statutory period required by official approval mechanisms creates a time barrier that must be overcome globally for critically ill patients in need of urgent medical solutions. In accordance with our corporate policies and commitment to medical ethics, while official regulatory processes remain ongoing, we view it as a humanitarian responsibility to clinically evaluate the "Compassionate Use / Early Access" potential of our technology in the face of these urgent and unmet medical pathologies worldwide.
To this end, in light of the clinical findings of our technology, which is not yet approved for commercial distribution, our company has established an Expanded Access Program to evaluate requests on a non-profit basis for the pathology models specified below. We present our solution profiles in these categories—which focus on pandemics and outbreaks, antimicrobial resistance (AMR), cardiovascular system pathologies, and immune system deficiencies, including sepsis-associated systemic inflammation, all of which represent leading causes of global mortality and are designated as "unmet medical needs" or "urgent medical needs" by international regulatory health authorities—supported by our pre-clinical and clinical summary findings for the review of the medical community and independent researchers.
Following these scientific reviews, physicians and institutions that foresee the implementation of BEP technology within the scope of compassionate use for urgent intervention in acute clinical pictures or mass health crises under their supervision may review the [Compassionate Use Access Module] section to obtain detailed information regarding application and field operation processes, or may request additional information directly.
Disclaimer: This policy document does not intend to serve as a commercial sale, advertisement, pre-commercialization, or marketing of the Dr Biolyse® device or the Bioelectrical Epigenetic Programming (BEP) technology. This text has been prepared solely for the purpose of informing healthcare professionals regarding clinical research ethics and early access processes within the scope of "unmet medical needs." Requests for compassionate use will be evaluated exclusively within the framework of reasoned medical reports provided by independent physicians and the approval mechanisms of local regulatory authorities.