Regulatory Standards and Ethics Committee Approvals All experimental and clinical research processes conducted have been completed under the legal authorization and oversight of national and international competent authorities: Experimental Animal Studies: Conducted in accordance with Local Ethics Committee approval. Clinical Studies on Owned Animals: Executed pursuant to Local Ethics Committee approval and official permissions from the Republic of Türkiye Ministry of Agriculture and Forestry and the Istanbul Provincial Directorate of Agriculture and Forestry, within the framework of global VICH GL9 (Good Clinical Practice) standards and guidelines. Human Clinical Trials: Completed in accordance with the approval of the relevant Clinical Research Ethics Committee and official authorizations from the Republic of Türkiye Ministry of Health and the Turkish Medicines and Medical Devices Agency (TİTCK), within the framework of Good Clinical Practices (GCP) and in full compliance with the requirements of the European Medical Device Regulation (MDR 2017/745). Ongoing Processes CE Marking: The regulatory and certification process for Dr Biolyse® has been initiated for the purpose of placing the device on the market in the European Union and Türkiye. National Registration: Registration processes are being conducted in countries that fall outside the scope of the CE mark and maintain independent national legislation. Breakthrough Device Designation: In alignment with expedited market access programs established by international regulators to address "unmet medical needs", efforts are ongoing to secure "Breakthrough Device" status for Dr Biolyse® technology based on its existing clinical evidence.