Comphya receives approval for first pilot clinical trial in Australia
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A swissmade neuromodulator to treat erectile dysfunction starts clinical trials in Australia
Comphya SA, developer of the first neuromodulator to treat erectile dysfunction (ED), announced today that Australian regulatory authorities (Human Research Ethics Committees (HREC) and Therapeutic Goods Administration (TGA)) have approved the pilot clinical trial for CaverSTIM in patients undergoing prostatectomy.
This will be the first long-term implantation clinical trial of CaverSTIM, and is part of a clinical development program including other pilot clinical trials in United States, France and Brazil. The pilot clinical trial in Australia will assess the safety and preliminary efficacy of the CaverSTIM system. The implantation will be performed by minimally invasive robotic-assisted laparoscopic surgery at the Royal Melbourne Hospital, Victoria, Australia.
“We are pleased to have completed all preparations and will soon initiate this first-in-human trial to assess efficacy of Comphya’s unique solution”, stated Fiona Joseph (Head of Clinical Affairs).
Rodrigo Fraga-Silva, CEO and co-founder of Comphya commented “I’m excited to start this new phase of clinical activities. Comphya’s team did excellent work and we’re very happy to work with the brilliant clinical team in Australia, led by Dr. Tony Costello and Dr. Philip Dundee”.