25.10.2019 – Comphya SA, a developer of a novel implantable neurostimulator to treat erectile dysfunction in non-responders to oral drugs, today announced a strategic development and manufacturing relationship with Cirtec Medical Corporation.
This partnership will lead to the system development of CaverSTIM, the first implantable neurostimulator to treat Erectile Dysfunction. Cirtec Medical will design and develop the complete system including the implantable pulse generator and the electrode paddle for Comphya, via access to the unique, Solace™ implantable neurostimulation platform. As a result, Comphya will reduce technology risks and time-to-market. “We are delighted to be working with a highly professional and outstanding Cirtec team”; Founder Professor Nikos Stergiopulos added.
The development of CaverSTIM started on Q2.2019 when our agreement between Comphya and Cirtec Medical was signed. Recently, the first prototypes have been built and the complete system is expected to be ready for first-in-human on Q2.2020. Steve Swinson, Chairman, commented “We have a unique solution that can help ED patients and our partnership with Cirtec is very important to finalize faster our solution to start our pilot clinical trials in 2020”.
Cirtec Medical is a leading provider of outsourced medical device design, engineering, and manufacturing. For over 30 years, the Company offers outsourced solutions for complex medical devices by offering a uniquely comprehensive range of resources and expertise including the design and manufacturing of neuromodulation, drug delivery, cardiac rhythm management, mechanical circulatory support, and minimally invasive surgical devices. “Cirtec is excited to partner with Comphya to bring this unique therapy to market”, says Brian Highley, CEO of Cirtec Medical “We are excited to be partnering with a leading manufacturer in neuromodulation, which will enhance our ability and reduce the time to serve better ED patients”, 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.
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 ED. 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.
About Cirtec Medical
Cirtec Medical is a vertically integrated, full-service outsource partner providing end-to-end product design, development, manufacturing and product transfer services for Class II and III medical devices and components. Headquartered in Brooklyn Park, MN; the Company has facilities in Chandler, AZ; Enfield, CT; Los Gatos, CA, Lowell, MA, Birkenfeld, Germany and is currently building a facility in Costa Rica. The company specializes in today’s most advanced product technologies, including neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and minimally invasive systems including TAVR/TMVR. Companies rely on Cirtec’s expertise throughout the entire development cycle to bring life-enhancing therapies to market.