SynDermix AG is pleased to announce the successful completion of the first SIV for the clinical trial of SDX-3101, in preparation for the recruitment of the first patient to the study.
ZURICH, SWITZERLAND – 18 December, 2019
SynDermix AG is pleased to announce the initiation of the clinical trial of the Company’s leading medical device project, SDX-3101, titled “Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)”.
The first Site Initiation Visit (SIV) to Kardinal Schwarzenberg Klinikum GmbH, Schwarzach im Pongau, Austria, was successfully completed today, under the leadership of Prof. Dr. med Florian Kral. This event is an important milestone in the preparation of the clinical trial, marking the readiness to promptly begin the recruitment of patients with CRSsNP. An extended total of 8 clinical investigational sites have been confirmed and contracted (5 in Germany, 2 in Switzerland, and 1 in Austria), each of which is scheduled to be activated very soon.
“This is an exciting time for SynDermix,” said Mr Dieter Hemmer, CEO of SynDermix AG. “We have invested considerable talent and resources into creating SDX-3101, a leading-edge Bioelesonic™ medical device; together with our evolution into a clinical-stage company, we believe that the device testifies to the Company’s capability to develop truly innovative therapeutic options for patients suffering from high-prevalence, chronic diseases where there is a significant unmet medical need, such as CRSsNP.” It is estimated that 12% of the global population suffers from chronic rhinosinusitis.
The SDX-3101 clinical trial aims to confirm the efficacy and safety of SDX-3101 to reduce or suppress the symptoms caused by CRSsNP, and, therefore, to significantly improve patients’ quality of life. SDX-3101, which has already undergone rigorous independent safety evaluations and certifications, is a non-invasive, drug-free, rechargeable, digitally controlled and portable medical device that can be easily used by the patients in an unsupervised, everyday setting.
Dr Carlos R. Camozzi, the project leader of the Company’s Bioelesonic™ technology platform, explained: “The therapeutic effect of SDX-3101 is based on a proprietary Precisely Modulated Acoustic Energy (PMAE) system, which is capable of rapidly and accurately restoring the normal function of cells in the sino-nasal cavities. Preliminary experiments with a device prototype, together with a series of Finite Element Method (FEM) resonance simulations using ANSYS Workbench (V19.2), have successfully provided proof of concept of the biological effects of PMAE (including the rapid mobilisation of mucus/secretions, improving ventilation of the sino-nasal cavities). SynDermix is very proud of this achievement and of the professional support of the teams of Creaholic, ISS and Damedics.”
Further information on the clinical trial is available on ClinicalTrials.gov (Identifier: NCT04158596) and the World Health Organization (WHO) International Clinical Trials Registry Platform.
About SynDermix AG
SynDermix AG is a Swiss developer of innovative health technologies funded by private investors. The Company focuses on the development of effective and safe treatments that meaningfully respect patient convenience and address important unmet medical needs.
SynDermix has built a diversified portfolio of innovative assets which correspond to three distinct proprietary technology platforms: smart medical devices based on digital acoustic modulation; drugs and medical devices based on a topical nitric oxide-releasing formulation; and drug candidates based on a recombinant plant lectin. Its business model is to a large extent virtual, driven by a strategy of in-licensing, outsourcing and out-licensing; the Company enters into strategic partnerships with third parties for the acquisition, development and commercialisation of a robust portfolio of assets with high innovation value and commercial potential. For more information please visit: www.syndermix.ch
SynDermix Management AG
+41 44 366 40 16
SIV Press Release – DE version: