Comphya SA advances clinical development program with successful inaugural surgery for erectile dysfunction in Spinal Cord Injury Individuals
02 November 2023
PRESS RELEASE
Lausanne, Switzerland, November 02nd, 2023 – Comphya SA, a leading innovator in medical technology for erectile dysfunction solutions, announces a significant advance in the clinical development program of its groundbreaking device. The first implantation of CaverSTIM in spinal cord injury individuals has been successfully completed, heralding the commencement of a pivotal phase in research to address the specific needs of spinal cord injury patients.
In collaboration with FMABC (Faculdade de Medicina do ABC), the clinical study is being conducted at Hospital Mario Covas in Brazil. The initial surgery took place on October 30, 2023, with additional surgeries scheduled for the following weeks, all under the expert guidance of Dr. Sidney Glina, the study’s Principal Investigator. This research aligns with Comphya’s ongoing clinical development efforts in Australia, which addresses post-prostatectomy patients.
“Our first successful implantation of CaverSTIM in a spinal cord injury patient marks a significant milestone. This accomplishment signifies the inception of a promising journey. The potential of this device to address the critical needs of spinal cord injury patients is substantial, and we are unwavering in our commitment to advancing it further to enhance the lives of many,” emphasized Dr. Sidney Glina.
“The successful completion of our inaugural surgery in Brazil is an exciting achievement, underscoring our dedication to providing innovative solutions for erectile dysfunction. This milestone emphasizes our commitment to addressing the specific needs of spinal cord injury patients and offering them hope for a better quality of life,” remarked Dr. Rodrigo Silva, CEO of Comphya SA.
Additionally, the clinical study involves Dr. Luiz Rios, who will perform surgeries at Hospital do Servidor Publico de São Paulo, serving as the study’s second center. The study’s primary focus remains on spinal cord injury patients, a population with significant unmet needs in terms of restoring penile function.
“We are honored to be a part of this significant research and are eager to contribute to the well-being of spinal cord injury patients,” said Dr. Luiz Rios.
About CaverSTIM
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.
For more information, visit www.comphya.com.
Contact
Comphya SA
Rodrigo Fraga-Silva, PhD
CEO & Co-founder