NanoVi Exo Clinical Evidence

Clinical governance statement

All treatments undertaken by MansMatters (Shockwave Clinics Ltd) are subject to clinical review before they are introduced into practice and at regular intervals thereafter. This review considers the safety profile of each intervention, including contraindications and adverse effects as specified in the manufacturer’s instructions for use or the Summary of Product Characteristics; the regulatory status of each medical device and medicinal product; the position of current UK and European clinical guidance, including the European Association of Urology (EAU), the National Institute for Health and Care Excellence (NICE) and the British Association of Urological Surgeons (BAUS); the qualifications and scope of practice of the treating clinicians; the stage and severity of the condition being treated; and the requirements for informed consent. Each patient is assessed individually, and treatment is offered only where it is clinically appropriate.

The basis of clinical evidence

Clinical evidence is derived from several sources, which carry different weight. Systematic reviews and meta-analyses pool the results of multiple studies and provide the highest level of evidence. Randomised controlled trials, including sham-controlled trials, compare a treatment against a control group under defined conditions. Prospective and retrospective cohort studies, published in peer-reviewed journals, describe outcomes in defined groups of patients over time, and the replication of results by independent research groups in different countries strengthens confidence in a finding. Laboratory and mechanistic studies explain how a treatment is thought to act. In-clinic observational studies and structured outcome audits record the results achieved in routine practice and contribute to the developing evidence base, particularly for newer and combined treatments. Long-term follow-up establishes the durability of results and the safety of a treatment over time.

The evidence relevant to this treatment is summarised below. All citations are hyperlinked to the original source.

Is it safe?

NanoVi Exo is a CE-marked medical device made by Eng3 Corporation, used alongside our other treatments. You simply breathe normally through a soft tube placed beneath your nose. The manufacturer’s user manual reports no known contraindications or side effects. It is not used in oxygen-rich environments, so please tell us if you use supplemental oxygen.

What the evidence shows

NanoVi Exo is designed to support the body’s natural response to oxidative stress, a process that research shows plays a part in Peyronie’s disease (Paulis et al. 2022). Laboratory research has shown it improves the recovery of damaged proteins (Int J Mol Sci 2022). In our practice, we have seen improved outcomes since introducing NanoVi Exo alongside our other treatments, and we are now auditing our results to measure its contribution in Peyronie’s disease.

Guidelines and regulation

NanoVi Exo is a CE-marked medical device (user manual). As a newer, specialist technology, it is not yet included in European (EAU) guidance; we use it alongside established treatments such as Focused Shockwave Therapy (fSWT) and traction devices, and are auditing our results. The manufacturer reports no known side effects, and our clinicians include it as part of our clinical approach, explaining its role to you before treatment.

Independent research

The laboratory research on NanoVi technology was carried out by university research teams and published in the peer-reviewed International Journal of Molecular Sciences (Yablonskaya et al. 2022). The role of oxidative stress in Peyronie’s disease has been studied separately by independent research groups (Sikka & Hellstrom 2002; Paulis et al. 2022). We are also measuring results in our own patients.

How NanoVi Exo compares

We use NanoVi Exo to complement treatments with stronger evidence: Focused Shockwave Therapy (fSWT) for pain, and traction or vacuum devices for curvature (EAU guidelines). Our outcome audit will help show what it adds to your programme.

How NanoVi Exo is thought to work

NanoVi Exo passes humidified air through a specific infrared field before you breathe it in. The manufacturer describes this as creating a signal similar to the one the body naturally uses to trigger repair after oxidative stress, and laboratory research has shown that air treated in this way helps damaged proteins recover their activity (Yablonskaya et al. 2022). As oxidative stress is thought to play a part in Peyronie’s disease (Paulis et al. 2022), we include it to support this process alongside our other treatments.

Long-term results and our experience

We have used it alongside our other treatments for men with Peyronie’s disease for four years without side effects, and we are recording outcomes for every patient so that we can report its long-term contribution.

Who is most likely to benefit

With no known side effects, NanoVi Exo is suitable for most men on our programme, except those using supplemental oxygen, and our outcome audit will help show who benefits most.

Before your treatment

Your clinician will talk you through what NanoVi Exo involves and why we include it in your programme before your treatment starts.