Comphya announces that two new patents have been granted in the U.S. for the CaverSTIM system

02 December 2021

PRESS RELEASE

Lausanne, Switzerland, December 02nd, 2021. Comphya SA, a medical device company focusing on the treatment of erectile dysfunction by neuromodulation for non-responders to oral drugs, today announced that the United States Patent and Trademark Office (USPTO) recently issued two new patents. U.S. Patent No. 11,141,589 is covering functional aspects, including nerve rehabilitation and rapid response models for device programming. U.S. Patent No. 11,141,590 is directed to penile rehabilitation therapy following prostatectomy.

The first new patent is an omnibus patent and covers functionals aspects of the neurostimulation system for the treatment of erectile dysfunction. It comprises of a system and methods for better and faster programing of the device. Additional issued claims cover the use of the system for restoration of neural transmission, artificial intelligence, laparoscopic implantation approach as well as functional and safety design.

The second new patent is directed to the use of neurostimulation system for the treatment of erectile dysfunction by preventing penile fibrosis or tissue remodeling following prostatectomy, today commonly referred as penile rehabilitation. The lack of penile erection after prostatectomy leads to an increase in fibrosis within the penile tissues (remodeling process), worsening the chances of erectile function recovery. Comphya’s new patent covers a concept that can promote penile rehabilitation, avoiding intrapenile fibrosis following prostatectomy.

These are the fourth and fifth patent granted around Comphya’s technology in development, CaverSTIM system. Additional patents are in the pipeline to be filed to broaden and strengthen Comphya’s intellectual property protection.

“We are pleased to have secured the new patents for our CaverSTIM System in the U.S.” said Rodrigo Fraga-Silva, CEO and co-founder of Comphya. “The strong patent portfolio is confirmation of our robust technology underpinning Comphya’s pursuit of excellence in serving erectile dysfunction patients with a unique and high-quality device.”

This announcement is for informational purposes only.

Forward-Looking Statements This press release contains forward-looking statements and forward- looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Comphya SA control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances.

About CaverSTIM

CaverSTIM is the first implantable neurostimulator to restore erectile function, focusing on patients that are non-responders to oral drugs. CaverSTIM is a neurostimulator composed of a pulse generator and electrodes to be implanted in the pelvic cavity, which will activate and restore the neuronal path for penile erection. The technology consists of transmitting by radiofrequency operating instructions to the implantable unit, using an external control unit. The system includes two paddle leads with several electrodes each and connects to an Implanted Pulse Generator (IPG) to deliver electrical stimulation.  The IPG, placed subcutaneously in the lower abdomen, is wirelessly programmed using a Clinician Programmer to enable the appropriate sets of electrodes and program the stimulation pulse sequence. The patient can turn stimulation on/off, adjust the amplitude, or select pre-defined stimulation pulse sequences using a Patient Programmer.  The IPG is periodically recharged using the external wireless Charger.

About Comphya SA

Comphya is a medical device company based in Lausanne, Switzerland, developing a novel implantable device to restore 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 intrapenile 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 external wireless 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.

For more information, visit www.comphya.com.

Contact

Comphya SA

Rodrigo Fraga-Silva, PhD

CEO & Co-founder

rodrigo.fraga@comphya.com