Comphya is delighted to announce the formation of the Clinical Advisory Board
10 February 2020
Lausanne, Switzerland, February 07th, 2020 – Comphya SA, the developer of CaverSTIM™, the first implantable neurostimulator to restore erectile function in non-responders to oral drugs, today announced the creation of the Clinical Advisory Board (CAB).
The CAB was formed to help shape and guide the clinical development of the company. The major goal of this independent body is to provide guidance and recommendations on all matters related to the clinical activities of the company, such as scientific design, adequacy of trial protocols, assessment of clinical risks and safety.
The CAB comprises highly skilled and renowned medical doctors based in the US and Switzerland. The initial appointees will be Prof Dr. Arthur Burnett, Prof. Dr. Jürjen Pannek, and Dr. Livio Mordasini. “I am pleased to be working with such pre-eminent clinical partners who will play a crucial role in guiding Comphya clinical development”; Founder Professor Nikos Stergiopulos, CSO, added. Steve Swinson, Chairman or Comphya, commented: “The creation of the CAB is a very important milestone that will give us informed guidance in our quest to deliver a unique solution that can help erectile dysfunction patients”.
Prof. Dr. Arthur Burnett
Arthur L. Burnett, II, MD is professor of Urology, at Johns Hopkins University School of Medicine, and is recognized for being a world-authority in the science and medicine of male erectile dysfunction (http://urology.jhu.edu/arthurburnett/). He is one of the pioneers of the neurostimulation concept to treat erectile dysfunction. Burnett contributed to original discoveries of the nitric oxide biochemical mechanisms in erectile tissue, that paved the way for the clinical development of oral medications to treat erectile dysfunction such as Viagra. He has also pioneered work to develop nerve-sparing techniques to minimize penile nerve damage during radical prostatectomy. His focus in the clinical practice of prostate cancer is reflected by his performance of over 2,000 radical prostatectomy surgeries.
When asked to support Comphya Dr. Burnett said:
“Comphya has shown tremendous vision and initiative in advancing a technology that will surely improve healthcare and impact the lives of patients”.
Prof. Dr. Jürgen Pannek
Jürgen Pannek, MD, is professor at the University of Bern and neuro-urologist at the Swiss Paraplegic Center (SPZ), Nottwil, Switzerland. He has over 20 years’ experience in the clinical care of patients with spinal cord injury (SCI), particularly on the treatment of dysfunctions of the bladder, as well as sexual dysfunction. He is a leading specialist in the implantation of the sacral neurostimulator for bladder incontinence and bladder reconstruction.
When asked to support Comphya Dr. Pannek said:
“I am delighted to support Comphya’s technology development, I strongly believe it will benefit many patients and their partners”.
Dr. Livio Mordasini
Livio Mordasini, MD, is urologist at Luzern Cantonal Hospital, Luzern, Switzerland. He last long experience in different fields of urology, particularly on the treatment of prostate cancer, urinary incontinence, and erectile dysfunction. Dr. Mordasini is a leader on pelvic- and retroperitoneal robotic-assisted surgeries, particularly in the field of prostate cancer.
When asked to support Comphya Dr. Mordasini said: “Comphya has a unique breakthrough technology which will bring substantial advance on the treatment of erectile dysfunction for patients non-responsive to oral drugs”.
“We are extremely fortunate to collaborate with these world-renowned clinical partners, their support will allow us to advance in the development of this unique therapy to benefit a large number of people”, said Rodrigo Fraga-Silva, CEO of Comphya.
CaverSTIM is a neurostimulator to be implanted in the pelvic cavity, which will activate and restore the neuronal path for penile erection. The technology consists of transmitting by radio frequency operating instructions to the implantable unit, using an external control unit. The system includes two paddle leads with 12 electrodes each and connect to an Implanted Pulse Generator (IPG) to deliver electrical stimulation. The IPG is wirelessly programmed using a Clinician Programmer Application to enable the appropriate sets of electrodes and program the stimulation pulse sequence. The patient is able to turn stimulation on/off, adjust the amplitude or select pre-defined stimulation pulse sequences using a Patient Remote Control. The IPG is periodically recharged using the external wireless Charger
About Comphya SA
Comphya is developing a novel implantable device to restore the erectile function in patients non-responsive to oral drugs (e.g. Viagra), particularly, spinal cord injury and post-prostatectomy patients. Today, these patients resort to intrapenial injections or penile implants, which are the only available yet painful, problematic and outdated therapies.
Comphya’s patented solution is based on neuroprosthetic principles and offers a unique and superior treatment for erectile dysfunction. The system stimulates the cavernosal nerve (pro-erectile nerve) via wireless external controllers, to restore natural penile erection. The company’s goal is to offer physiological sexual function and quality of life to large parts of the male population in great need.
The company is a spin-off from the Ecole Polytechnique Fédérale de Lausanne (EPFL) that emerged from the research group of Prof. Nikos Stergiopulos, at EPFL (https://lhtc.epfl.ch), one of the most active and successful academic labs developing medical technology from the lab bench to the clinic.
Rodrigo Fraga-Silva, PhD
CEO & Co-founder