Comphya SA Receives Approval to Launch Clinical Study for CaverSTIM in Prostatectomy Patients in Brazil

23 August 2024

PRESS RELEASE

Lausanne, Switzerland, August 23rd, 2024 – Comphya SA, a pioneering medical technology company and the developer of CaverSTIM, the first implantable neuromodulator designed to treat erectile dysfunction, is pleased to announce that it has received approval from the Brazilian National Research Ethics Committees (CEP and CONEP) and the federal regulatory authority ANVISA to initiate a pilot clinical trial in patients undergoing prostatectomy. This new study will significantly bolster the ongoing clinical trials in prostatectomy patients in Australia and serves as a key component of Comphya’s global clinical development program, which also includes clinical studies in the United States.

The procedures will be conducted using minimally invasive laparoscopic surgery at the renowned Mario Covas Hospital, Faculdade de Medicina do ABC, in Sao Paulo. The study will focus on assessing the effectiveness and safety of the CaverSTIM system. Recruitment has already begun, marking the launch of this highly anticipated clinical trial that holds significant promise for advancing patient care in erectile dysfunction.

We are excited to initiate this pivotal study in Brazil, which represents a critical milestone in our mission to deliver groundbreaking solutions for erectile dysfunction,” stated Dr. Rodrigo Fraga, Ph.D., CEO of Comphya SA. “This approval not only reflects the progress of our clinical program but also underscores the growing global recognition of CaverSTIM’s potential to transform treatment outcomes for patients.

We are thrilled to be expanding our clinical research with this new study in prostatectomy patients. The first study we initiated last year in spinal cord injury patients has shown promising results so far, giving us strong confidence as we now extend our investigation to patients undergoing prostatectomy,” stated Dr. Sidney Glina, Principal Investigator at FMABC. “With CaverSTIM, if we continue with those exciting results, we may offer a groundbreaking therapeutic option that can significantly improve the quality of life for patients suffering from erectile dysfunction. We are eager to assess its effectiveness and safety in this new patient population and are optimistic about the potential outcomes“.

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

rodrigo.fraga@comphya.com