Lifespot plans to start clinical trials of its Medihale medical cannabis vape device by the 2021 second quarter.

Lifespot Health (ASX: LSH) is further enhancing its leadership team and topping up cash reserves as it advances the development of its medical cannabis inhaler device program it claims will “significantly evolve the treatment options for patients both in Australia and overseas”.

Investors are also seeing the value as Lifespot Health leads the way in the inhaled Medical Cannabis market, developing a solid clinical trial program to establish the clinical safety and pharmacokinetics of its inhaler devices, with medical cannabis company Cannvalate Pty Ltd and investment group MDI Wealth Pty Ltd recently joining the LifeSpot Health family.

Speaking with Small Caps, Lifespot chief executive officer Matthew Golden described the standout features of Lifespot’s technology that gave Cannvalate and MDI Wealth the confidence to invest.

“Lifespot has viewed cannabis as a medical solution for patients from its inception, and it’s backed that position with the development of its inhaler devices to meet the needs of patient and physicians. It’s a position that aligns not only with medical professionals but also knowledgeable investors such as Cannvalate and MDI.”

“By developing pharmaceutical-grade GMP manufactured vaping devices, that meet the clinical needs of doctors such as accurate dosing and tamperproof systems, further supported by clinical data, Lifespot aims to further accelerate the industries transition from pseudo medicine in to the realms of mainstream medical treatment”.

Vaping versus smoking

According to Lifespot, vaping differs from smoking in that it does not burn cannabis; it heats it to just above its critical temperature to transform it into a vapour, releasing the medicinal compounds.

It’s generally well accepted that most of the harm derived from smoking tobacco is due to the byproducts (eg Carbon Monoxide and carcinogenics) generated by combustion of the tobacco and the chemical additives in cigarettes rather than the nicotine. Whilst there is less available data for Cannabis, the same is most likely true.

As Vaping does not cause combustion, authorities in places such as the UK consider vaping to be much safer than smoking.

According to Mr Golden, vaping is the fastest growing cannabis segment with around 20% of all cannabinoids vaped globally.

He said other advantages of the method include its cheaper cost, fast onset, and the avoidance of many side effects of smoking combustible cannabis or ingesting oil such as gastric irritation or bad taste.

Vaping is also considered very efficient as about 60% of all cannabis ends up in the bloodstream, compared with about 5-10% with orally consumed cannabis oil. This works out to be “profoundly cheaper” if you worked it out based on the per-milligram cost of the active cannabis component.

“When you take oil orally, about 95% of the drug ends up being broken down in the liver. So, you are taking, and paying for, a lot of the drug, but getting the benefits from only 5% of that,” Mr Golden said.

It is also seen as a smaller shift for existing cannabis smokers to move to vaping, as opposed to consuming oil, he added.

The vaping crisis

However, vaping hasn’t had the greatest reputation recently due to the ‘vaping crisis’ of September 2019 when a cluster of US users reporting suffering from ‘e-cigarette or vaping product use associated lung injury’, or EVALI.

As a result, vaping sales dropped by more than 25% overnight in all legal US jurisdictions with some states even banning vape pens.

“The clusters of EVALI seen in the USA in late 2019 were investigated by the US Centre for Disease Control and they concluded that EVALI patients had used cannabis vape oil purchased from an illicit source and that the key additive most likely responsible for EVALI is Vitamin E Acetate. Vitamin E Acetate is sometimes used as a thickening agent or to dilute THC oil in vape cartridges to make it go further and is banned in many states as an additive in vaping oils.” Mr. Golden said.

“The EVALI outbreak in the USA was unacceptable and further highlights the importance of regulating manufacturers to high GMP standards and moving the industry from black market suppliers to legal, regulated, high quality manufacturing. That is the way the industry is moving and that is the direction Lifespot is leading.” added Mr. Golden

Medihale’s value proposition

According to Mr Golden, the CBD formulations to be sold in Lifespot’s novel device contain none of the additives that have been known to cause lung damage.

“We’re only working with suppliers who are able to certify that they are Vitamin E Acetate Free, it’s important to us that our products deliver the highest quality products with strong quality assurance protocols.”

Mr Golden also described Lifespot’s Medihale device as similar to an insulin pen, in that it contains a cartridge that cannot be tampered with or refilled, so as to further secure the supply chain against black market players.

Other benefits specifically related to Medihale include the assurance of dose precision with the mouthpiece “locking out” if the consumer attempts to inhale more than the required amount.

Mr Golden said while sales dropped over EVALI fears last year, it didn’t kill the market with vaping still worth “about $10 billion globally and growing fast”.

In a recent presentation, Lifespot estimated a market gap of around 5-8% of the global cannabis market for a safe, pharmaceutical-grade vape solution which is scientifically validated as not being injurious to health.

“There isn’t really a cannabis vaping market at the moment in Australia; 80% of sales here are from cannabis edibles such as oils and capsules,” Mr Golden added.

“Whilst edibles, oral-mucosal sprays and capsules have an established place in patient treatment, they lack the fast onset of action, bioavailability and cost effectiveness offered by vaping that is pivotal for treatment of acute conditions where rapid efficacy is need such as insomnia, anxiety and pain.”

Medical expertise added to Lifespot Health

Mr Golden brings close to two decades of experience in the pharmaceutical industry and a strong track record of new product launches and sales growth.

In particular, he drove sales of pain management, asthma and resuscitation at Medical Developments International, including the global supply of Penthrox or the “green whistle” for acute pain relief.

He also built a wealth of knowledge over 17 years working for Pfizer both in Australia, Pfizers New York Head office and various regional and country offices around the world, including the global launch team for Eliquis, currently the number two selling pharmaceutical drug in the world, the Launch of Caduet in Australia, recognised as the most successful launch of that drug globally by Pfizer and also as Head of Marketing in Indonesia.

New funds for Medihale trials

Earlier this week, the company announced it had raised $720,500 via a private share placement to MID Wealth, an investment vehicle owned by a network of service providers in the Australian healthcare industry.

The capital raising follows a $960,000 private placement issued to Cannvalate a month earlier, giving the cannabis-prescribing clinical network a 20% anchor stake in Lifespot.

Lifespot said the funds raised from both placements will allow it to advance the development of Medihale and other medical devices and technologies for its chronic disease, health monitoring and medicine delivery software platform, the BodyTel system.

Trials to start in early 2021

Lifespot is aiming to secure licences to non-company inhaler devices by the first quarter of 2021 for the purpose of the clinical trials. The scoping process to define initial target disease areas and the general outline of study protocols is also expected to be completed by this time.

The company is anticipating clinical safety, proof-of-concept and pharmacokinetic trials will start by the 2021 second quarter.

If the trials are successful, this would lead to advanced phase two trials and greater commercialisation opportunities, Lifespot said.

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