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Innovative Australian Drug receives Break-through Therapy “Barrier to Innovation” Waiver by the FDA CVM (USA Federal Drug Agency)

The FDA CVM is the FDA’s veterinarian department.

The assessment criteria are
  • Innovation: a drug must be highly innovative, novel, a medical break-through.
  • Efficacy: Is there sufficient information for proof of concept in a validated in vitro system or in the target animal or an animal model of the target animal (e.g., laboratory rodent species)?
  • Small-Medium Company: Is the company below $20 million in market size.

We were able to satisfy the criteria and examiners with a detailed application outlining the scientific evidence, they do not give these out lightly.

This success adds serious credibility to our dealings with the government, regulators and the market.

SnoreTox Pty Ltd : Drug Solution for Hypotonic (Low tone) Muscle Disorders.

A RMIT University spin-off, we have produced modified Tetanus Toxins for Weak and Low Tone Muscle Disorders. They are revolutionary First-in-Class Pharmaceuticals.

There are no FDA approved drugs for increasing the tone and strength of skeletal and sphincter muscles for humans or animal usage. We have developed modified tetanus toxin molecules to achieve this end, to be called Tonetox (general use) and Snoretox (for snoring and sleep apnoea).

Botox was successfully developed to reduce muscle tone for cosmetic and medical purposes such as sphincter relaxation, muscle stiffness and spasms, and so it was considered that Tetanus toxin, a molecule that does the opposite of Botox, would have significant medical applications should a workable version be developed, a version that could avoid the vaccination-induced antibodies.

The innovative step is the cloning and production of modified tetanus toxin molecules to achieve that end, research performed at RMIT University over the last 10 years and supported by an ARC ran CVT and internal RMIT Grant funding.

The objective is to create a whole new market of treatment capability in the area of increasing muscle tone.  Conditions resulting from low muscle tone include snoring, sleep apnoea, sphincter laxity (gastric reflux, anal and urinary incontinence), cosmetic conditions such as ectropion (lower eyelid laxity), eyelid lifting and facial muscle toning, pelvic floor and limb weakness, and neurological conditions of low muscle tone such as Motor Neurone Disease, MS, stroke and Myopathy in both in humans and animals. There are currently no drugs in this space.

Venture & Capital Interviews | Anthony Millet

Steve interviews Anthony Millet, Partner at Antler, to discuss the operations and processes of Antler.

In this Video, Anthony Millet, Partner at Antler, shares:

  • Antler’s process in constructing compatible high-performance teams and nurturing the growth of innovative ideas
  • The impact Antler has on de-risking a Founders path by matching them with a valuable and successful startup and assisting them in raising capital
  • Companies Antler has worked with that have expanded globally
  • Advice for Investors and for Founders to overcome the challenges due to Covid-19 over the next 12-28month period

 

 

Venture and Capital Interviews | Andrea Gardiner

Steve interviews Andrea Gardiner, Founder of Jelix Ventures to learn more about Jelix and their investment criteria.

In this video, Andrea Gardiner, Founder & CEO Jelix Ventures, discusses:

  • The inception of Jelix Ventures highlights one of the first investments which saw investors in the fund receive 10x returns in the first year
  • The role a Founder has on its company and on an investor’s decision to contribute to capital
  • The investment criteria of Jelix and current portfolio companies including an innovative company striving to manufacture a flying car
  • Trends she expects to see over the next 10 to 20 years

Venture and Capital Interviews | Alan Jones

 
  • The first thing Alan Jones looks at when considering a founder is if he likes the person – he would much rather choose someone with a smaller portfolio who he enjoys spending time with
  • One of the ways to be interesting to an investor is by growing fast.
  • Deconstructing a business problem into different engineering problems will show you understand the problems with the current.
  • Establish trust with employees, customers and investors by doing what you say you’re going to do.
  • Never offer your services for free – there will always need to be some sort of financial transaction involved.