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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.

Animal Tags, Satellites and the Path of an Aussie Agritech Going Global

  • CEO of Agritech startup CERES Tag, David Smith, talks to CRIISP Media about his journey.
  • David talks about getting into the agricultural sector and taking his agritech international. 
  • CERES Tag is utilising Low Earth Orbit Satellites to create efficiencies in the data analysis process. 
  • The technology uses a tag alone to retrieve all the data needed to make crucial decisions in the space of livestock monitoring.

With 3000 prototypes sold across 8 countries, Ceres Tag is the newest and most exciting agritech startup in animal welfare and monitoring. Encompassing livestock, wildlife, and companion animals, the tag acts like a FitBit, collecting data on an animal’s location, performance, and health. It doesn’t end there, the data is then sent to a Low Earth Orbit (nano)-satellite online interface, the ‘Cerescloud’, removing the need for additional infra

Automatic agricultural technology robot arm watering plants tree

structure and allowing farmers to instantly view crucial information regarding their stock.

So why is this important? Due to the current climate, consumers are demanding more cohesive data regarding where their food comes from, biosecurity, and the welfare of animals in general. The Ceres Tag has secured their palace in the industry with perfect timing in alignment with this new consumer trend and the widespread shift from traditional farming practices to a bigger focus on new technolo

gy and big data. We spoke to the founder, David Smith, about the ins and outs of the agritech space, establishing a client base, and raising capital for this newborn technology. 

Getting into Agri-Tech

When asked about entering the Agricultural sector, Smith was quite candid in his advice; “Agri-tech is not very competitive because most of the solutions are quite myopic.” There are no secret solutions around breaking into Agri-Tech, just the need for a strong idea that provides value at many levels of the supply chain and to multiple parties. Hence why the Ceres Tag is a strong initiative. It tackles three major concerns for farmers;

  • Where are my animals?
  • How many are there?
  • What condition are they in?

Yet it also has the capacity to expand on these parameters and apply them to finance, insurance, regulatory reporting, research, and many more fields. Furthermore, it transcends the agriculture industry and can be used on domestic pets and endangered species. Thus diversifying streams of income. 

The client base

Australia’s history of agriculture is established and successful. Despite being home to only 2% of the global cattle heard, Australia is the 3rd largest exporter in beef – just behind Brazil and India. The industry is a major contributor to the national economy, with total revenue of $18b and generating around 77, 000 jobs. Due to the high level of exports, there is a heavy reliance on international markets. Any product launching in the sphere will struggle to succeed if it doesn’t appeal to operators worldwide and align with international standards.

Smart farming, using modern technologies in agriculture. Female agronomist farmer with digital tablet computer in wheat field using apps and internet for crop protection, selective focus

On a more personal level, Smith describes the people involved as very direct – “What you see is what you get and “no” comes easy to say.” This creates a very comfortable environment for feedback so there is less time-wasting and a bigger focus on improving, inspiring, and delivering. Despite being a broad industry, it is deeply interconnected, and “a lot of people know each other”. There also isn’t a monopoly or any dominant players, so it is open to new insights and able to expand without disruption. 

Finding Agritech Capital

Ceres Tag has been incredibly efficient on their journey so far. They have done 3-4 smaller raises, and are now seeking bigger sums of capital before they launch into the global market. Despite receiving generous grants from the government, they, “have delivered everything we said we would and then some.” Smart use of smaller sums of money has allowed Ceres Tag to create a market-ready product that can now be applied globally without change. 

Scaling is their next big challenge, hence why they are currently seeking a US$10m capital raise to further expand their business domestically and globally. The agriculture industry is no exception to the wide-spread changes as a result of COVID-19. However, Smith believes this will work in Ceres Tag’s favour as consumers are, “now more than ever, concerned about biosecurity, where their food comes from, the welfare of animals in general and are becoming more comfortable with technology”.