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TECHNOLOGY AND SERVICES

HCmed’s advanced technology is the product of YEARS OF EXPERIENCE DEVELOPING PRODUCTS AND PROVIDING SERVICES TO DELIVER TOP SOLUTIONS FOR INHALATION THERAPY

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patents

HCMED’S INTELLECTUAL PROPERTY

In order to foster innovation, HCmed foments intellectual property protection. Our patents include different aspects of our device structure and technologies, including mesh module, breathing sensors, cleaning methods, and wireless authentication systems. We assess intellectual property matters when engaging in CDMO and ensure Freedom to Operate for customized products.

Advanced Technology

  • BREATH ACTUATION

    HCmed's breath-actuated technology enables aerosolization of medication during inhalation only, avoiding excessive amounts of API being wasted during exhalation. Moreover, it prevents emission of fugitive aerosols that could otherwise be unintendedly inhaled by those surrounding users during their treatment.

  • CONNECTIVITY AND IOT

    HCmed has developed devices with connectivity functions and a demo application to link mesh nebulizers to mobile devices. The collected data can be used to monitor patient adherence as well as manage nebulization treatment.

  • LOCK AND KEY SYSTEM

    Device activation has been incorporated to link the nebulizer to a specific formulation, reinforcing patient adherence. This close system also prevents the use of off-label drugs and controlled substances.

CUSTOMIZATION PLATFORM

ENHANCE DRUG DELIVERY BY PERFORMING DEVICE TAILORING

Novel platforms for your drug-nebulizer combination product:

  • Optimized nebulizer configurations based on our Pulmogine and AdheResp Technology platform.
  • Re-engineering or new development of device components to meet specific requirements.

Manufacturing and Commercialization

At HCmed, our manufacturing expertise ensures a seamless production scale-up of our nebulizers, guaranteeing their performance and meeting the necessary regulatory requirements. We go beyond manufacturing and offer extensive support in post-market surveillance, continuously monitoring the device's performance and helping in resolving any issues that may arise. Our commitment is driven by the goal of ensuring patients' comfort, safety, and the overall efficacy of the drug-nebulizer combination product. We make sure our partners bring their products to the market with confidence.

Production Ready Intelligent Mesh System

With the advanced production system, our mesh nebulizer platforms are ready to fulfill the testing and clinical study supply needs from our pharmaceutical partners. The manufacturing of our devices for clinical studies is carried out at HCmed's GMP compliant manufacturing facility.

De-risking Combination Product Development

We offer:

  • Support regulatory filings in several markets, including the US and EU.
  • Collaboration with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs).

Our Partners:

Aerosol characterization analytical services

At HCmed, we offer comprehensive aerosol characterization analytical services to support the development and optimization of inhalation products. Our experienced scientists and state-of-the-art laboratories ensure accurate and reliable data for regulatory submissions. We offer analytical support in compliance with Pharmacopoeia guidelines (EUP, USP).

Our extensive experience in aerosol testing includes:

  • Aerodynamic particle size distribution
  • Droplet size distribution
  • Delivered dose under the standardized and non-standard breathing profiles
  • Delivery rate and residue tests
  • Physicochemical Property Characterization of formulations (surface tension, viscosity, osmolarity)

We have expertise in conducting tests with:

  • Small molecules (solutions and suspensions)
  • Large molecules (proteins, peptides, oligonucleotides, liposomal formulations)
  • Biocontainment contained agents (Biosafety level 1 materials)
Laser Diffraction Particle Size Analyzer – Malvern Spraytec
Droplet Size Distribution Analysis
Breath Simulator – Copley BRS
Assessment of Delivered Dose, Output Rate, and Delivery Rate
UV-Vis Spectrophotometer
Quantification of Active Pharmaceutical Ingredients
Next Generation Impactor – (NGI)
Aerodynamic Particle Size Distribution