Comphya Receives FDA IDE Approval to Initiate U.S. Clinical Trial for CaverSTIM
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Comphya SA, a pioneering medical technology company based in canton of Vaud and the developer of CaverSTIM, the first implantable neuromodulator designed to treat erectile dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a clinical trial to evaluate CaverSTIM in the United States.
This FDA IDE approval marks a pivotal milestone for Comphya, enabling the company to expand its clinical activities to the U.S. and further validate the safety and efficacy of its groundbreaking technology in addressing erectile dysfunction (ED).
Dr. Rodrigo Fraga, CEO of Comphya, stated “We are excited to achieve this major milestone. The FDA IDE approval not only underscores the potential of CaverSTIM to address a critical unmet medical need but also reflects the dedication of our team and clinical partners to advancing patient care. I would like to extend special thanks to Mikael Sturny, CTO, and Fiona Joseph, Head of Clinical Affairs, for their outstanding work, which was instrumental in achieving this milestone. With this approval, we take an important step towards making this breakthrough therapy available to patients in the U.S. and globally.”
The U.S. clinical trial will build on the promising results of ongoing international studies, which have demonstrated CaverSTIM’s potential as an innovative therapeutic option for prostate cancer patients undergoing prostatectomy. These patients often face limited options, relying on outdated treatments or experiencing inadequate responses to oral medications. By utilizing advanced neuromodulation technology, CaverSTIM offers a minimally invasive and long-term solution to address erectile dysfunction post-prostatectomy, aiming to significantly improve patient outcomes and quality of life.
Dr. Arthur Burnett, the Principal Investigator of the U.S. clinical trial, shared his thoughts: “Erectile dysfunction after radical prostatectomy remains a significant issue for many patients. CaverSTIM may offer a much-needed alternative for those who have limited treatment options. We are excited to lead this study and further explore the role of neuromodulation in addressing this challenging condition.”
Comphya’s groundbreaking work has been made possible through fundamental collaborations with clinicians and researchers worldwide, along with regulatory support. The company remains unwavering in its commitment to delivering life-changing therapies and addressing significant gaps in care.
For more information on Comphya’s technology and clinical progress, visit www.comphya.com.
About CaverSTIM
CaverSTIM is the first implantable neurostimulator designed to restore erectile function. This innovative technology is primarily intended for patients who are non-responders to oral medications, such as post- prostatectomy patients. CaverSTIM is a neurostimulation system composed of an implantable pulse generator (IPG) containing a rechargeable battery and electronics responsible for generating the electrostimulation signal. It is connected to an array of two electrodes (with multiple individual electrodes) to be implanted in the pelvic cavity, where they will activate and restore the nerves responsible for penile erection. The IPG is implanted subcutaneously in the lower abdomen and is remotely operated by external controllers. The clinician controller allows the medical expert to adjust and tailor the system parameters to best suit each patient. The patient controller enables the patient to activate the device and deliver electrical stimulation to the cavernous nerves with the aim of restoring their function.
➡️ Source: Press Release