Gyakran Ismételt Kérdések

Our application submitted to the idea and startup competition call of NKFIH (COVIDEA, project ID: 2020-2.1.1-ED-2020-00034) entitled „Reducing the risk of infection of hospital staff, developing wireless digital stethoscope suitable for early detection of pneumonia” was successful.

The prototype of the digital stethoscope has been completed. We decided to further development, involving doctors with significant experience in caring for patients infected SARS_CoV-2 and we have been looking for strategic partner.

Within the framework of cooperation agreement, Tradeflex Trading and Service Ltd. as a strategic partner, undertook the prototype development, construction and marketing.

„To discover something is to see what everybody sees, and to think what nobody else has thought.” /Albert Szent-Györgyi/

Bremotech Kft. was invited to the „ÁLMOK ÁLMODÓI 20” history-of-science exhibition, hosted by Millenáris. The exhibition presented the work of nearly 600 Hungarian geniuses.

Clinical validation studies and small-series manufacturing begin.

The project has been successfully completed.

• Characterization of the airflows near the mouthpiece of the inhalers and within the airways
• 3D scanning of the inhaler mouthpieces and their digital reconstruction in CAD software
• Design of add-on devices in CAD system
• Computational fluid dynamics simulations for the optimization of the size and shape of add-on devices
• Market analysis and elaboration of the marketing strategy

In 2023 we attended the European Respiratory Society Congress held in Milan (Italy), where we presented the project’s main features. Poster: „The effect of lung emptying on the airway deposition of aerosol drugs”

We also attended the Drug Delivery to the Lungs 2023 conference organised by The Aerosol Society in Edinburgh, in order to build professional relationships.

• Generation of the 3D geometry of the upper airways from HRCT (high resolution computed tomography) images
  • In line with the GCP (Good Clinical Practice – EU Directive 2005/28/EC) guidelines, it should be noted that the HRCT images would have been acquired independently of this research and development project. The individuals were not exposed to additional radiation. The HRCT images were transferred from the healthcare institution and processed in anonymised form.
  • During processing, digital segmentation was carried out with 3D Slicer, a visualisation, processing, segmentation and analysis software.
• Quantification of pharyngeal deposition in the combined geometry of the add-on and the upper airways
  • The aim of the task is to quantify the combined and individual fractions of the inhaled aerosol drug dose filtered out by the add-on and the upper airways.
  • Because in airway diseases the target area of the receptors is in the lung, the amount of drug remaining in the device or deposited in the mouth and pharynx does not contribute to the desired effect, and may even cause loss of effect or side effects.
• 3D printing of accessories optimised for modelling, and fitting them to the inhaler
  • As part of this subtask, our primary aim was to design and print the add-on geometries selected on the basis of the simulation results.
  • Producing add-ons that fit the inhalers properly is essential for recording the breathing curves required for the experimental research.
• Acquisition of the breathing profiles of patients through inhaler devices
  • Inhaled medicines are typically and, worldwide, most commonly used in asthma and chronic obstructive pulmonary disease.
  • Taking professional guidelines, the recommendations of pulmonologists and the later success of market launch into account, the experimental measurements were carried out for 4 commonly used inhalers — Breezhaler®, Turbuhaler®, NEXThaler® and Ellipta® — considering the properties of 5 medicines.
• Programming of the patients’ breathing profiles into a breathing simulator
  • In order to cover as many characteristics of the two patient populations as possible, we originally planned the digital recording of the breathing profiles of 6 men and 6 women with mild and severe asthma (24 persons) and of 6 men and 6 women in each of the 4 COPD severity classes (48 persons in total). During the work phase the statistics of these measurements were substantially strengthened, as breathing curves were recorded for 113 COPD and 50 asthma patients.
  • Because individuals cannot generate the same waveform twice, the breathing curves were programmed into a Piston PWG-33BT pulmonary waveform generator.
  • With the programmed curves we were able to repeat the modelling any number of times.
• Construction of the measurement equipment
  • The efficiency of the add-on devices (spacers) developed for the four selected inhalers (Breezhaler®, Turbuhaler®, NEXThaler®, Ellipta®) was also confirmed by laboratory measurements, in which the specialists of Envi-Tech Kft. assisted us.
• Pharyngeal deposition measurements
  • The measurements were performed at inhalation flow rates of 30 L/min, 60 L/min and 90 L/min. As four inhaler devices were involved, and the small- and large-particle fractions required separate measurements, nearly 1,000 measurements were carried out. During data processing, size-fractionated particle counts and particle masses were also compared.
  • Processing the measurement data and interpreting the results showed that the chosen and implemented measurement method is accurate and reproducible, with standard deviations of at most 5–10%.

We successfully presented the results achieved:

• at the European Respiratory Society Congress (ERS 2024, Vienna): Breathing parameters of COPD patients through two dry powder inhalers (Prof. Dr. Varga János Tamás)
• at the 16th Hungarian Aerosol Conference (Szarvas), in two presentations: Effect of breathing parameters on the lung deposition of inhaled medicines (Dr. Horváth Alpár); Registration of inhaled medicines (Szénási Georgina)
• at the 13th Emil Modrovicz Case Forum (Herceghalom): Spacers in everyday practice. Opportunities in use and development (Dr. Horváth Alpár).

Details of the project results were published in Respiratory Medicine, a prestigious, high-impact international medical journal, under the title Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients. https://doi.org/10.1016/j.rmed.2024.107916

In Medicina Thoracalis, the journal of the Hungarian Respiratory Society, we published results from a national survey, laying the ground for the planned market entry, under the title Spacers from the perspective of pulmonologists and patients with obstructive lung disease.

Within the task of the previous work phase, a large deposition-measurement database was created. It was processed in 2025 in order to decide which add-ons are the most suitable for the given inhaled medicines. Processing the database showed that:

• The results reflect a combination of two opposing effects: on the one hand the amount of drug reaching the lung increases because of the “flow-modulating” effect of the add-ons, and on the other hand the amount decreases because of deposition inside the add-on.
• The number of wall divisions amplifies both effects. Their magnitude, however, depends on the initial (unmodulated) flow leaving the inhaler and on the inhalation flow rate.
• Different add-ons are suitable for different inhalers, medicines and flow rates.
• The maximum relative increase achievable with an add-on varies between 0% and 150%.
• Cup-shaped add-ons were more effective with inhalers that produce a strongly turbulent flow (e.g. Turbuhaler®).
• Cone-shaped add-ons performed better with inhalers that show a more laminar flow (e.g. Breezhaler®).
• A higher number of internal divisions proved advantageous at low flow rates, while hollow add-ons (undivided, or divided into fewer parts) were more favourable at high flow rates.

Also within this subtask we created the final forms of the add-ons, taking into account:

• an airtight inhaler–add-on connection
• a secure inhaler–add-on connection (easy and unambiguous to attach, but it does not fall off during or outside use, so the patient cannot inhale it, swallow it, drop it, break it, and so on)
• a suitable mouthpiece (a design similar to the mouthpiece of pressurised inhalers)
• cost-effective manufacturability (the amount of material was optimised; safe, but not too thick)
• aesthetics (shape, design, colour, material, surface)
• freedom from irritation and easy cleaning (medical plastic; the first batch has also been obtained).

Finally, in the last work phase (2025):

• The product box was designed, and exhibition gift packaging was produced.
• The first tooling was completed, the final form of which is required for manufacturing.
• The add-ons were tested clinically.
• The patient information leaflet and the product description were completed.
• The marketing materials (strategy) required for market launch, the product identity, and the user and professional information materials were completed.

We published the results of the work and presented them at national and international professional forums (Kecskemét, Amsterdam, Edinburgh).

We also tested our results under real-life study conditions.

We received very positive feedback from distinguished representatives of the pulmonology profession, both in Hungary and internationally.