Comphya launches clinical study with spinal chord injury patients

The clinical study was approved by the ethical committees CEP (Comitê de Ética em Pesquisa) and CONEP (National Research Ethics Commission), and the National Health Surveillance Agency ANVISA. 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.

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.

(Press release / SK)