Medical devices · Private label
NesosprayColds and
rhinosinusitis
Relieving nasal congestion from 30 minutes and easing sinus discomfort: local physical action against cold and rhinosinusitis symptoms. Nesospray is a nasal spray for the treatment of rhinopharyngitis and rhinosinusitis, suitable from age 3. It helps clear a blocked nose, mobilise secretions and relieve sinus pain. Its film combines osmotic cleansing with protection of the nasal mucosa.
Supplied in a 15 mlbottle, with carton and instructions for use, this medical device offers simple spray application. Its film-forming glycerol and selected polymer technology addresses congestion while helping protect the nasal surface. Nesospray is available to partners looking to market this product under their own brand.
Your product for colds and rhinosinusitis,
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Clinical study
Randomised, single-blind pilot study; 103 adults analysed.
Population
Adults and children aged 3 and over.
Indication
Treatment of rhinopharyngitis and rhinosinusitis.
Benefits
for patients
- Immediate action (osmotic mechanical action).
- Helps relieve nasal congestion from 30 minutes.
- Helps relieve sinus pain.
- Thins mucus and helps remove it.
- Forms a protective barrier on the nasal mucosa.
- Ages 3 and over.
- 100% plant-derived ingredients.
Mode of action
Nesospray forms a film on the surface of the nasal mucosa. Polymers from plant extracts in the Rhinocyanidin complex help stabilise this film and capture agents involved in the condition. Three complementary functions act simultaneously:
- Decongesting and cleansing: osmotic action draws fluids towards the nasal surface, helps reduce congestion and facilitates the mobilisation and removal of mucus and impurities.
- Protecting the mucosa: the film forms a barrier that limits direct contact with irritants and external agents.
- Capturing the relevant agents: selected polymers retain these agents within the surface film, helping remove them along with secretions.
Osmotic mechanical action begins on application. The polymers act within the film without entering the tissues.
Clinical study · Rhinosinusitis
Clinical study
Congestion relief observed from 30 minutes, followed by an improvement in sinus pain on day 1. A randomised, single-blind pilot study compared Nesospray with a 3% hypertonic saline spray for up to 21 days in adults with acute or chronic rhinosinusitis. Of 113 randomised participants, 103 were analysed: 58 on Nesospray and 45 on saline.
| Decrease in mean score from baseline | Nesospray | 3% saline | Between-group comparison |
|---|---|---|---|
| Nasal congestion at 30 minutes | 31.0 % | 20.4 % | p = 0.0004 |
| Sinus pain on day 1 | 58.6 % | 2.5 % | p < 0.0001 |
| Nasal congestion on day 7 | 73.8 % | 30.3 % | p < 0.0001 |
Each symptom was rated from 0, absent, to 4, very severe. Percentages represent a reduction in mean symptom intensity relative to each group's baseline. P-values compare between-group scores at the stated time point; a value below 0.05 indicates a statistically significant difference. Increased nasal discharge was observed at the start of treatment, before falling below baseline by day 7.
Good tolerability observed in this study.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Nesospray is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | NS |
| Public name | Nesospray |
| Product type | Medical device |
| Regulatory class | Class IIa |
| Regulatory framework | Regulation (EU) 2017/745 on medical devices |
| Notified body | GMED |
| Population / age | Ages 3 and over |
| Category | Colds and rhinosinusitis |
| Full official indication | Treatment of rhinopharyngitis and rhinosinusitis |
| Composition | Film-forming glycerol, Rhinocyanidin |
| Format / volume | 15 ml nasal spray, with carton and instructions for use |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture; do not refrigerate or freeze |
| Shelf life after opening | 1 month |
| Legal manufacturer | Vitrobio SAS |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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