A CE-Marked Silicone Ring with a New Research Purpose
The Circunaro ring was originally developed and CE-marked as a reversible simulated mechanical circumcision device for the treatment of premature ejaculation due to genital hypersensitivity. We are now investigating its potential to modulate the penile microbiome and reduce partner transmission of BV-associated bacteria.
Medical-Grade Silicone, Non-Invasive Design
From Medical Device to Research Tool
The Circunaro ring was CE-marked as a Class I medical device indicated for simulated mechanical circumcision for the treatment of premature ejaculation caused by genital hypersensitivity. Manufactured in medical-grade silicone and commercially available for six years, the device's pivot to a research focus came from recognizing its potential relevance to a growing body of literature on the male genital microbiome and maternal health.
- Jan 2019 CE marking achieved. Class I, non-sterile device under Medical Device Directive 93/42/EEC (as amended by 2007/47/EC).
- 2019–2025 Commercial availability. Thousands of units sold across multiple markets. Zero adverse events reported.
- Dec 2025 Strategic research pivot. New collaborations initiated to investigate the device's potential impact on reproductive health.
- 2026 First research collaboration established. Pilot study participants being recruited in East Africa to evaluate device efficacy, safety, and adherence in the context of genital hygiene and reproductive tract infections.
Originally designed for male hygiene and comfort, we are now investigating its potential impact on couples' reproductive health.
The Circunaro ring was commercially manufactured and CE-marked as a Class I medical device.
Established Safety Basis
- Regulatory status
- CE-marked under the Medical Device Directive as a Class I device. Medical-grade silicone meets biocompatibility standards.
- Adverse events
- Zero adverse events reported across thousands of units sold over six years of commercial availability (January 2019 – May 2025).
- Wearable penile device precedent
- Published research on comparable continuous-wear penile devices (TechRing, 2024) reported no cases of priapism or skin reactions after 14+ months of use, with only minor transient discomfort reported.
- User control
- The ring is fully flexible and can be removed by the user at any time, distinguishing it from rigid constriction devices associated with known risks.
Available to Qualified Investigators
The Circunaro device design is openly available. We are open to licensing, technology sharing, and providing devices at cost to research teams. We actively seek collaborators who want to explore this intervention — our goal is maximum impact, not exclusivity. We place no restrictions on the publication of research results.
- Device supply at cost (materials + shipping only)
- CE marking documentation and safety history
- Scientific rationale and literature review support
- Willingness to co-develop study protocols
- No restrictions on publication of results
- Open to co-authorship arrangements