Our product is a microbiome-based therapy distributed under the TGA transition provisions
Intended use includes the prevention of recurrent Clostridioides difficile infection and ulcerative colitis
Our product is distributed under the TGA transition provisions and is anticipated to be the first microbiome-based therapy approved as a biologic in the world. The product’s formulation includes encapsulated freeze-dried for oral delivery and syringe frozen for colonoscopy and enema delivery. We anticipate the encapsulated product to be available through hospitals and pharmacies shortly.
The product is manufactured in a GMP facility approved by the TGA, after a rigorous, quality controlled screening, and donation process. It is currently supplied to hospitals and clinics throughout Australia and can be administered by healthcare professionals. BiomeBank anticipates providing the healthcare prescribed product through pharmacies and is also seeking market authorisation in multiple countries throughout the world.
Results Backed By Science
Current Treatment (Antibiotics) vs Faecal Microbial Transplantation (FMT)
Microbiome-based therapies are currently being studied as a treatment for other chronic diseases such as ulcerative colitis, Crohn’s disease, and Irritable Bowel Syndrome (IBS).
In a randomised clinical trial published in JAMA, BiomeBank’s Chief Medical Officer Dr Samuel Costello and his team demonstrated that FMT can induce clinical remission in patients with mild to moderate Ulcerative Colitis. A recent study in Lancet further demonstrated the role of microbiome-based therapies in treating ulcerative colitis (Haifer et al. 2022 Lancet)
Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis
If you are interested in our product and haven’t purchased from us before please send us a message using the form below.
The product requires storage at -80°C and is delivered on dry ice. To store the product onsite you will need access to a -80°C freezer.
The product can be delivered by enema or colonoscopy. The product is supplied with detailed instructions regarding storage and administration. If you have any further questions please call us and we’ll connect you with our Chief Medical Officer.
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*for healthcare professional use only