In conversation with Praxis SCI Accelerate Cohort Member, Comphya

Novel Therapy to Restore Erectile Function

Interview with Rodrigo Fraga-Silva, co-founder and CEO, Mikael Sturny, co-founder and CTO, and Fiona Joseph, Director of Clinical and Regulatory Affairs

Comphya, a Swiss medical device company, is developing the first implantable neurostimulator to treat erectile dysfunction (ED). The device, CaverSTIM, aims to replace current treatments such as intrapenile injections and penile implants that many patients with spinal cord injury (SCI) avoid. This is often due to the severe side effects, such as pain, discomfort, bleeding, hematoma, priapism, and penile fibrosis. A penile prosthesis is also the last therapeutic option as it is an irreversible.

CaverSTIM offers a safer, non-traumatic, comfortable, spontaneous and more effective alternative to traditional treatments. The technology implants electrodes in the pelvic cavity to selectively activate and trigger penile erection. With SCI this pathway is often disrupted, which in turn may prevent intercourse and ejaculation. CaverSTIM will provide self-controlled stimulation to achieve and maintain a physiological penile erection.

CaverSTIM is an active implantable medical device composed of: I) the implantable pulse generator (IPG) connected to II) an electrode paddle, III) external controllers (physician and patient control units), and IV) wireless recharger.

Comphya emerged from EPFL in Lausanne, Switzerland (École Polytechnique Fédérale de Lausanne), a rich academic environment with existing technology development aimed to improve the quality of life for people with SCI.

What led you (education, experience, people) to a career focused on medical technology and, in particular, medical technology for people living with SCI?

MS: Our three co-founders, Rodrigo Fraga, Nikos Stergiopulos and myself (Mikael) have our roots in basic science and academia. But we realized that more was needed to translate science into real impact and benefit society. The reason why we founded Comphya was to deliver technology and improve the quality of life for people. In my case (MS), I did a PhD in bioengineering, so I was immersed in the field of medical technology. The next step was to found the company, to make it real, and not just research and science.

RD: Indeed, the creation of Comphya will allow our research to reach individuals and benefit their lives. Comphya emerged from EPFL in Lausanne (École Polytechnique Fédérale de Lausanne), a rich academic environment with existing technology development aimed to improve the quality of life for people with SCI.

Team (L-R): Mikael Sturny, CTO and co-founder, Fiona Joseph, Head of Clinical Affairs, Rodrigo Fraga-Silva, CEO, Board member and co-founder, Nikos Stergiopulos, CSO, Board member and co-founder

The development of new technology needs to be focused on the end-user, and we tend to miss it along the journey.

What was your biggest learning/takeaway from the program?

FJ: We have learned how important is to have users’ feedback in the development of a product. We knew it was important from the beginning; the Praxis program provided us with key access to interact with the end-user, and this was really valuable. We learned many aspects on living with SCI that we didn’t know, such as the rehabilitation challenges that patients faced at the hospital and in daily life.

RD: I agree with Fiona. The development of new technology needs to be focused on the end-user, and we tend to miss it along the journey. Praxis promoted an open and frank discussion with people with SCI so our team got consistent feedback to support development.

Do you have a specific example of how that played a role in your learning?

FJ: Yes — it gave us an additional potential application for our device. We learned that triggering a semi erection with lower intensity stimulation could help with [urinary bladder] catheterization. People with SCI have to undergo this procedure several times every day; if our device could trigger a semi erection that could facilitate this catheterization.

MS: We also learned that conception is quite difficult for people living with SCI, and that our technology could potentially also trigger ejaculation; this might be great to help people living with SCI to conceive.

What were the biggest changes to your company’s structure and/or business strategy after or during the program? Are there any shifts you plan on making in your company’s structure and/or business strategy in the next few months?

MS: The program was particularly valuable for us in terms of validating, refining and improving. For example, the feedback really allowed us to validate and refine our reimbursement strategy, confirming the assessment of our consultants on the best strategy possible for North America.

And we had great feedback from the focus group and from the weekly monitoring meetings. They helped us improve the clinical protocols, including the assessment of the new potential benefits, catheterization and ejaculation.

In sum, the general strategy is the same, but it was refined and more features added.

FJ: We also learned an additional reason for payers to reimburse our device. In addition to treating erectile dysfunction, if it helps with catheterization and leads to a decreased number of patients ending in a hospital because of infections, it could be a good reason for payers to reimburse it.

CaverSTIM could be positioned as a second line treatment for patients that are not responding or that have side effects with the oral drugs or penile injection, and who are not willing to have the surgery to implant a prosthesis.

Prior to the program, how did you view the challenges faced by your customers/potential customers that your company’s medical technology is aiming to solve? Has there been any change in this perception now that you’ve graduated from the program?

FJ: The challenges we had in mind before the program were confirmed during the focus group discussion and by the partner survey. Patients complained that oral drugs are not reliable and don’t always work, and that there is a lack of spontaneity. Side effects from penile injections such as priapism mean this treatment is not well accepted. For penile prosthesis, they fear the surgery because it’s irreversible and destroys the penile structures. These confirm our idea that CaverSTIM could be positioned as a second line treatment for patients that are not responding or that have side effects with the oral drugs or penile injection, and who are not willing to have the surgery to implant a prosthesis.

Did your perspective change on how consumers and/or clinicians would use your product in the course of their daily or routine activities? If so, what aspect of the program helped make this shift and how has it impacted your company’s approach to product development.

FJ: It changed because we got two more potentially beneficial uses for the device — semi erection to facilitate catheterization, and triggering ejaculation.

MS: Clinicians could offer patients another option instead of penile injection and penile prosthesis.

For erectile dysfunction, regardless of SCI or not, today there are only two options for non-responders to oral drugs; they are outdated and problematic solutions, associated with a lot of side effects or even irreversible and destructive surgery.

What differentiates your company and its value proposition from the competition? How are you disrupting your marketplace? Why are you disrupting your marketplace….?

MS: If a man has erectile dysfunction, regardless of SCI or not, today there are only two options for non-responders to oral drugs; they are outdated and problematic solutions, associated with a lot of side effects or even irreversible and destructive surgery. Our solution really does fill a large unmet clinical need since the treatment can provide a solution that is spontaneous, that is safe, that is easy to use, and is painless. We are developing the first implantable neurostimulator to treat erectile dysfunction; this is the first treatment of its kind.

Is there a story you’d like to share from the program where engagement with a person with lived experience (clinician, person with SCI, care provider) was impactful to you or your company’s development?

FJ: We have a story from a man living with SCI from one of the first Praxis meeting where we explained CaverSTIM technology to the consumers. For him. oral drugs stopped working; he then used penile injections but ended up at the hospital many times because of priapism, a long painful penile erection that may need intervention. His doctor now recommends a penile prosthesis but he doesn’t want to have it implanted because it’s a no way back solution. This consumer story highlights the clinical problem that we aim to solve.

The program helped to connect with experts in the field, getting their experience on the challenges from those who know what people living with SCI face every day.

What did you hope to get out of the SCI Accelerate program, and did you achieve this? What makes the Praxis SCI Accelerate program unique?

MS: When we started the program, we hadn’t engaged yet with men living with SCI. The first outcomes we were expecting from the program were experience and some feedback from people living with SCI. And the program definitely delivered on that. It was really helpful to connect with experts in the field, getting their experience on the challenges from those who know what people living with SCI face every day.

What would you say to company founders who may be undecided about participating in the SCI Accelerate program? What value has it added to you and your company?

MS: There are two components. One is direct access to experts and to consumers. And the other point is that the program is well tailored to the company’s aims. Thanks to the program, we improved our clinical protocol. We obtained more clarity on our reimbursement strategy. We got the opinion of the consumer but also the opinion of the partners of men living with SCI.

Praxis has a lot to offer, and their passionate team provides support for the company’s specific needs. Following the program, Comphya wants to stay in touch with Praxis along the way, to support our mission to improve the quality of life of people living with SCI and their partners.

What would you say the other company founders who may be on the fence about participating in the SEI accelerator program? What value will it add to their companies?

FJ: The Praxis program exceeded our expectations, especially regarding consumer feedback. Since the program is tailored to your company needs, it’s really valuable in addressing current challenges. We would encourage any company to take part in the program because it’s definitely worth it.

RD: I fully agree with Fiona. Praxis has a lot to offer, and their passionate team provides support for the company’s specific needs. Following the program, Comphya wants to stay in touch with Praxis along the way, to support our mission to improve the quality of life of people living with SCI and their partners.

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