An Israeli company has developed an innovative microneedle-based device for nearly painless intradermal delivery of vaccines and drugs. Advantages include significant economy of expenses and injected materials, improved immunogenicity pain absence, fear reducing etc. The target partners are distributors qualified in aesthetic, allergy testing & treatment, pharma, vaccination field etc. The company is looking for distribution services and/or license agreements.
The Israeli pioneer develops and commercializes virtually painless intradermal delivery solutions for vaccines and drugs. Intradermal (directly into the skin) vaccine delivery shows significant dose sparing versus usual methods - intramuscular (IM) and subcutaneous (SC) administration. The human skin dermis & epidermis are rich of antigen-presenting cells, which play critical role in induction of immune responses. Injection of vaccines into these layers delivers antigens closer to these cells so smaller doses of antigen might induce immune response equivalent to the standard dose. Intradermal delivery may also improve vaccines efficacy. The company offers significant edge over current intradermal delivery with its high consistency, low leakage rate and high success evaluated by bleb / wheal formation. Its microscopic size causes less fear, less pain and is preferred by majority of subjects. Intradermal injections are used in skin tests and allergy, aesthetics, vaccines. Injecting well and consistently into the dermis with a regular needle is very difficult. The company developed the world’s smallest needle (microneedle); FDA- approved as an intradermal delivery device for substances to deliver into skin.
The device is made of three micro-needles 0.6 mm long, made of silicon wafers, the first of the kind, and believed to be the smallest needles in the world. The device can be mounted on any standard syringe, is easy-to-use and has demonstrated improved immunogenicity to full-dose vaccines, significant dose sparing (4-40% of the dose) with various vaccines (seasonal and pandemic influenza, zoster, polio). Clinical trials have shown superior clinical outcomes over other intradermal devices in tests with different vaccinations (e.g., improved immunogenicity compared to other techniques); in certain cases the same results were reached with one third of the injection dose. The major commercial promotion applications of the offered device: 1)Aesthetic medicine - mesotherapy, Botox for axillary hyperhidrosis, 2)Local anesthesia for small surgical procedures (i.e. removal of nevus), 3)Allergy tests - including antibiotic allergy and PPD, 4)Allergy treatment (for the products approved for this delivery route), 5)Outpatient/travelers clinics – BCG, rabies and polio vaccinations.
The potential end-users are private physicians in the field of aesthetics / travelers’ immunity/diagnosis and treatment of allergy and hospitals in the field of PPD skin testing. Supported by extensive clinical data and regulatory approvals in leading markets, the company is ready for partnering with pharma companies, vaccine developers aiming to provide better patient care worldwide. The company is looking to expand its commercial operations by distributing its device for approved applications and testing it when used with variety of new vaccines under license (or possibly) distribution services agreement. The company was the first to register the smallest microneedle device with the US FDA, as well as in Europe, China, Hong-Kong, Canada, Korea, Russia, Brazil and others. This year, the technology was commercialized and it was first sold to the Chinese market for allergy testing. Today the needle is produced in the amount of half a million-million needles per year. Production is planned to be up to 5 million units per year by 2019. Currently, the company is in the process of mapping the various applications according to countries.
The potential partners for cooperation might be: distributors of materials and equipment for aesthetic medicine, of disposable devices; distributors/companies in mesotherapy, pharma, in the field of allergy, drug delivery companies, injectable aesthetic companies.
- Specific area of activity of the partner: -TYPE - business, trade
-ACTIVITY – 1. Distributors of materials and equipment for hospitals,
2. Distributors for companies in the field of mesotherapy,
3. Pharma companies, drug delivery companies, vaccine, anti-allergy.
4. Companies in the field of allergy (testing) – here the regulatory aspects are usually simpler.
5. Distributors of disposable devices, medical devices (injection system, disposable system)
- under distribution services agreement the partner is expected to find local customers for use of the offered device.
- under license agreement the partner is expected to get authorized by the company-developer to use the licensed material in return for a fee or share of royalties.
The company clinical trials have shown superior clinical outcomes of the offered device over other delivery routes (IM and SC) as well as over other intradermal devices in tests with different vaccinations:
1)improved immunogenicity as compared to other techniques.
2)significant dose sparing (4-40% of the dose) with various vaccines compared to IM/SC.
3)easy, consistent and almost painless injection into dermis due to the short needle 4)cost-efficiency - 5-10 times less injected material is required than that by using standard needle
5)people are less afraid of injecting with the device; thus using it can lead to higher percentage of testing / immunization in certain types of population.
6)consistency - blebs of >6 mm were observed 99% of the time, evaluated in over 1,000 injections on more than 800 subjects
7)pediatrics applicability, as demonstrated by large Phase III studies on 6-week-old infants
The benefits of the device have been proven in various clinical studies and include: easy-to-use, consistency, efficiency and near-painless delivery. It can be used with any standard syringe to inject substances directly into the skin.
Already on the market
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