Comphya SA Launches Groundbreaking Clinical Study for Erectile Dysfunction Treatment in Spinal Cord Injury Patients in Brazil
10 July 2023
Lausanne, Switzerland, July 10th, 2023 – Comphya SA, a pioneering medical technology company, is excited to announce the initiation of a groundbreaking clinical study in Brazil. The clinical study was approved by the ethical committees CEP and CONEP, and the federal competent authority ANVISA. This study addresses the pressing need for effective treatments for erectile dysfunction (ED), particularly among spinal cord injury patients.
The clinical study, conducted in collaboration with esteemed institutions such as the Faculdade de Medicina do ABC (FMABC) and the Mario Covas Hospital, aims to evaluate the effectiveness and safety of Comphya SA‘s innovative CaverSTIM system. Recruitment of candidates has been initiated and marks the exciting beginning of our forthcoming clinical study, which holds tremendous potential to positively impact countless lives.
“We are thrilled to begin this important study in Brazil, as it represents a significant step forward in our mission to provide innovative solutions for erectile dysfunction,” said Dr. Rodrigo Silva, Ph.D., CEO of Comphya SA.
“We are delighted to contribute to this important study, which has the potential to transform the lives of patients suffering from erectile dysfunction. By evaluating the effectiveness and safety of Comphya‘s innovative technology, the CaverSTIM system, we aim to provide much-needed solutions for our patients,” stated Dr. Sidney Glina, Principal Investigator at FMABC.
“Participating in this clinical study is an exciting opportunity to advance our understanding of ED treatments and improve patient outcomes. We are proud to collaborate with Comphya in this groundbreaking research,” commented Dr. Luis Rios, study investigator.
Praxis Spinal Cord Institute, a supportive partner to Comphya, emphasized the importance of this study for spinal cord injury individuals. “As a T6 paraplegic living with SCI for the past 26 years, I feel this technology has the potential to be transformative for thousands of men around the world. As a newly injured 19-year-old, one of the first questions I had for my clinical team was erections and how this would work. There were no answers at that time. Pills became available a few years later; however, they’re not overly reliable. This technology provides an opportunity to safely and effectively solve and support these challenges for men living with SCI”, stated James Hektner, BC Interior Regional Community Liaison at the Praxis Spinal Cord Institute.
CaverSTIM is the first implantable neurostimulator to restore erectile function. This new technology is primarily intended for patients that are non-responders to oral drugs such as spinal cord injured patients or post-prostatectomy patients. CaverSTIM is a neurostimulation system composed of an implantable pulse generator (IPG), containing the rechargeable battery and electronics responsible for the generation of the electrostimulation signal; and connected to two electrodes array (with several electrodes) to be implanted in the pelvic cavity and which will activate and restore the nerves responsible for penile erection. The IPG is implanted subcutaneously in the lower abdomen and it is remotely operated by external controllers. The clinician controller allows the medical expert to adjust and tailor the system parameters to best fit each patient; and the patient controller, allows the patient to activate the device on-demand to evoke penile erection for the treatment.
About Comphya SA
Comphya is a medical device company based in Lausanne, Switzerland, developing CaverSTIM, the first implantable device to restore erectile function in patients non-responsive to oral drugs. Today, these patients resort to intrapenile injections or penile implants, which are the only available yet painful, problematic and outdated therapies. Comphya’s patented solution offers a unique and superior treatment for erectile dysfunction. The company’s goal is to offer physiological sexual function and quality of life to large parts of the male population in great need.
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Rodrigo Fraga-Silva, PhD
CEO & Co-founder