Cannabis has been used for medicinal purposes for thousands of years and in many cultures around the world. Its many therapeutic properties include relieving symptoms of chronic pain, nausea, loss of appetite and PTSD, and even, some claim, curing illness.
In recent years, cannabis has become the preferred solution for many patients who are reluctant to use prescription narcotics, which are addictive, in many cases less effective, and often have serious side effects.
The growing use of cannabis for medical purposes, along with regulatory changes in many countries, including Canada and the United States, is expected to make the cannabis market one of the most profitable in the world in less than a decade.
Need and Solution
Medical cannabis can be consumed in several ways: smoking, inhalation, eating, drops and pills. However, each of these methods has significant drawbacks, among them - toxin formation, inaccuracy of dosage, slow and ineffective absorption, sore throat, bitter taste that discourages use and more.
If cannabis could be inhaled effectively and measurably, without smoking and without evaporation and it's accompanied toxins, many patients would receive effective treatment while retaining only natural substances; neither the patients nor their environment would be harmed.
In recent years, a number of technologies have been developed that seek to promote and refine inhaled medical cannabis (evaporation, smoking), but all of them are deficient in the transmission of the substance, the dosage and the accuracy of the treatment. Veoli's technology solves the variety of problems involved in effectively transferring the active substance to the lungs:
1. The products available in the market use burning, heating or evaporation, all of which damage the natural substance (cannabis) and eliminate much of its medical effect.
Veoli's technology does not involve burning (like a cigarette), heating or evaporation of the active substance and therefore does not harm the natural ingredients. Veoli's product produces an aerosol employing only mechanical energy, and using a unique formulation developed by the company.
2. The process of combustion and / or evaporation creates toxins, leaving both the patients and the people around them exposed.
The dose inhaled with Violi's device is accurate because it is not smoke or vapor. It is a fluid that turns into spray and is absorbed effectively through the lungs into the blood, as applied in the pharmaceutical world. Thus, the amount of active substance inhaled is absorbed entirely, as opposed to evaporation or smoking, where most of the smoke entering the lungs is not absorbed. Since the spray(aerosol) is produced by using only mechanical energy, without burning or evaporation, no toxins and by-products are produced in the process.
3. With today's existing solutions, medical efficacy is low, as only a small percent of the substance is absorbed into the blood and most of the smoke is exhaled. The dosage is inaccurate, uncontrolled and does not allow for personalized treatment. There is no control over the rate of smoking and absorption of the active substances into the blood.
With Veoli's technology, the activity of the device is automatically synchronized with the inhaling activity of the patient. Inhaling aerosol via lungs has the most effective bioavailability. The inhaled aerosol is fully absorbed into the blood, thus enabling "economical" and effective use of active ingredients.
In summary - With smoking or evaporation, the smoke or vapors created by heating the cannabis are inhaled and exhaled, so that very little is absorbed by the lungs, in an unmeasurable and uncontrolled manner. In addition, not only does the combustion of the cannabis damage and alter the ingredients, but it also introduces toxins into the inhaled material, which is harmful to the patients and their environment.
Custom Treatment - The dosage of the active ingredient is provided in a precise and customized capsule. Veoli’s capsules include an RFID chip which contain all data about the manufacturing date dosage and concentration of the cannabis ingredients as prescribe personally to the user, usage timetable and puff control etc. Since the substance in the entire capsule is absorbed into the blood seconds after inhalation, dose accuracy is maximally controlled and is specific for each patient.
Veoli's device will enable two-way Bluetooth communication; the product will report to a medical service center via smartphone, allowing full control of patient care and compliance while including the patient in the process.
Veoli's technological innovation comprises two parts:
1. A unique oil-free liquid formula developed by the company, based on cannabis oil -free extract infused with other medicinal substances, stored in a dedicated capsule.
2. Electrical cannabis nebulizer: Mechanical energy-based technology, which turns the liquid into inhalable spray (aerosol) without burning, heating or evaporation. The inhaler is loaded with a unique cartridge containing capsules holding an exact amount of formulation fluid. Each capsule has an RFID chip ID number which allows the device to read its exact data, such as: date of manufacture, expiry date, ingredients, dosage, suitability for customer, and so on.
The technology is an innovative technology for providing medical cannabis inhalation spray.
Using mechanical energy, the device enables the decomposition of the cannabis liquid-based formulation and transforms it into tiny droplets of 0.001 - 0.005 millimeters in the form of aerosol (a gentle spray).
The process of changing cannabis-based liquid to aerosol does not involve heating, evaporation, or burning the cannabis, allowing for the preservation of active ingredients and maximum clinical effect. The tiny drops, up to 5 microns [0.005 millimeters], enter the lungs and proceed into the bloodstream, a process that produces an immediate medical effect. The device emits an accurate dose of the substance, which is absorbed entirely into the blood through the lung vapor. Smoke or evaporation, on the other hand, enters the lungs and is exhaled with almost no absorption into the blood through the lungs, thereby requiring a large amount of uncontrolled and non-filtered smoking. Veoli technology does not create smoke or steam but only clean liquid spray. Veoli is the only company today that allows the transfer of medical cannabis in the manner described above.
The product includes the inhaler and the cartridge with the capsules. Each capsule contains a unique, precise and uniform formulation of medical cannabis composition produced under strict and stringent conditions (GMP level production). The sterile liquid in each capsule adheres to and meets medical standards. The inhaler provides the patient with measured amounts of active substance, thus allowing control and accuracy of treatment. The measurable dosage consumed using the inhaler is consistent, and the dosage and daily treatment regimen are individually tailored to each patient.
Reproducibility - The formulation is composed of cannabis ingredients in line with the Ministry of Health specifications, a specific medical indication, and the approved Ministry of Health process (GMP). The composition of the active substances is measured before the formulation is made and is based on a predetermined cannabis strain; thus the contents of each capsule are reproducible.
Consuming medical cannabis in this way maximizes the therapeutic effects of the substance and relieves pain quickly. The technology eliminates exposure to smoke and vapor damage. The inhaler is comfortable to grip, simple to operate and allows for discreet use.
Steps made, and achievements so far:
- Violi has developed a laboratory model based on the unique technology that enables the creation of a very thin spray of cannabis extraction. The aerosol (very thin spray) looks like steam or smoke produced from the liquid by applying only mechanical energy - without heating or combustion. In order to obtain aerosol droplets that comply with the strictest standard for lung aspirants, a laboratory experiment was performed on laser-based equipment (Spray Tech Lab Test Equipment) which can measure the size of the aerosol droplets. The following is an example report showing the aerosol droplet size distribution derived from laboratory sample cannabis extraction. 1 micron to 5 micron droplets were obtained as required by the FDA standard.
2) The company conducted a preclinical study in which the end-product mechanism was tested in combination with a PK study of several animals at different doses. The experiment was successfully completed and cannabis was found in the blood tests throughout the 24 hours.
3) Veoli designed the final device containing a Nebulizer (unique smart inhaler) and a capsule containing the unique Veoli formulation for daily use. Product planning of stage is completed and ready for stage ii design finetuning and transfer to production. Several working products, in final design, are being used for dose fine tuning study and testing.
4) A formula based on oil-free CBD was developed for the preclinical trial. The formulation was tested for stability and sterilized before use. The formula was developed as a platform that will enable the company to collaborate with business partners in various markets engaged in the manufacturing and distribution of medical cannabis, with the aim of converting existing cannabis-based liquid solutions/brands for different medical purposes, into inhalation solutions/ products.
Next Steps Based on Fundraising:
- Completion of design stage ii and transfer to production assembly of 50-100 final products and capsules with sterile formulation for clinical trial - final design
- The company has installed a lung simulator (Cascade Impactor NGI Lung) in the formulation development lab with the aim of completing the dose precision phase. This step will also prepare the product for submission to the highest medical standards, as required by pharmaceutical companies. The laboratory dosage and accuracy tests will be conducted using the Veoli device and the Veoli formulation.
- A second preclinical trial to validate laboratory precision testing
- Longer term formulation stability tests
- A clinical trial with a few dozen subjects and blood tests (PK study)
- Preparations for regulatory submissions in Israel, Europe and the United States in Phase B. At this stage, the regulatory strategy will be formulated.
- Transfer to Production - Production of final product molds for the device and capsule
- Develop a remote control and control management app