A next-generation nasal preparation designed to naturally support sinus drainage and significantly reduce symptom severity without surgical intervention. The product targets the global market of patients with acute and chronic sinusitis and rhinosinusitis—among the most widespread ENT conditions worldwide. The goal of the project is to obtain European regulatory approval (EU) and bring the product to the international market, where effective and accessible solutions in this category are currently lacking.
Current Status
The project is in its final pre-production stage. The formula is fully developed and has been tested under laboratory conditions. A documentation package is being prepared for European regulatory approval. There are no sales yet, as the product must first obtain the necessary authorizations.
Problem or Opportunity
Our client is an individual suffering from acute or chronic symptoms of sinusitis and rhinosinusitis: congestion, sinus pressure, difficulty breathing, and a reduced quality of life. These conditions are highly prevalent—according to international studies, 10–15% of the global population is affected. Despite the scale of the problem, the market offers almost no accessible non-surgical solutions that provide a real physiological effect and support natural sinus drainage. Clients are willing to pay because existing options are either insufficiently effective, provide only temporary relief, or require surgical intervention. Our product addresses this clear unmet need and offers a safe, accessible, and highly demanded alternative.
Solution (product or service)
We have developed a next-generation nasal preparation designed to naturally support sinus drainage and reduce the severity of sinusitis and rhinosinusitis symptoms without surgical intervention. The product works physiologically by improving nasal passage airflow, promoting natural sinus clearance, and enhancing breathing comfort.
The product is formulated as a ready-to-use nasal solution that can be applied both during acute symptom episodes and for preventive purposes. The formula is undergoing preparation for European regulatory approval, including laboratory testing for safety and purity. Production is planned at certified GMP facilities.
As a result, the product offers consumers a convenient, safe, and highly demanded solution that fills a clear gap in the market for effective non-surgical options targeting sinus-related symptoms.
Competitors
There are no direct competitors on the market with the same mechanism of action and positioning as our product—a nasal preparation that supports natural sinus drainage and targets symptom reduction in sinusitis without surgery.
Currently, patients primarily rely on substitute solutions, such as:
• standard nasal sprays (vasoconstrictors, steroids),
• saline rinses,
• antibiotic courses during flare-ups,
• and, in severe cases, surgical intervention.
This market is highly fragmented: there are many products available, but most provide only short-term effects, carry risks when used long-term, or ultimately lead to surgical treatment. This creates a strong and unmet demand for a safe, physiological, and truly effective non-surgical solution—precisely the niche our product fills.
Advantages or differentiators
Yes, the product has significant advantages that cannot be replicated by competitors. Its key advantage lies in a unique formula and physiological mechanism of action aimed at restoring the natural function of the sinus cavities and addressing the underlying factors responsible for the symptoms. This enables achieving a stable and sustained result without surgical intervention. The formula is based on proprietary scientific developments and is not a standard combination of known components, making it impossible to copy even through analysis of the external composition.
Unlike existing nasal products, which most often provide superficial or temporary effects, our product targets the physiological mechanism at the root of the problem. It is not based on vasoconstrictive or hormonal action, does not cause dependence, and does not belong to classical symptomatic solutions. The product occupies a unique niche among non-surgical approaches capable of supporting full restoration of normal sinus function.
An additional advantage is created by the closed technological process of developing and preparing the formula, which cannot be reproduced without access to our scientific foundation and methodology.
Thus, the product possesses a unique mechanism of action capable of delivering a stable resolution of the problem, offers high barriers to replication, and has no direct analogues on the market.
Money will be spent on
The investment is required to complete the full cycle of preparing the product for market launch and obtaining European regulatory approval. The main expenditure categories include:
1. Laboratory testing and safety confirmation of the formula
Conducting the necessary analytical and microbiological tests in accredited European laboratories.
2. Preparation of the CTD technical dossier for regulatory authorities
Compiling all required documentation, including test results, stability data, specifications, and manufacturing process information.
3. GMP production of the first product batch
Manufacturing initial series at a certified facility for subsequent registration and testing.
4. Regulatory fees and interaction with EU authorities
Payment of administrative fees, submission of documents, and legal/regulatory support.
5. Branding, packaging, and preparation for commercial launch
Design, primary packaging materials, and readiness for serial production.
6. Marketing and commercial expenses for market entry
Placement of the initial batch in pharmacies and clinics, and cooperation with distributors.
The investment is intended to secure all necessary approvals for the official market entry in the EU and to support further international expansion.
