Our Products

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

An Overview

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. 

BiomeBank-Microbiome GMP Facility 1

Results Backed By Science

Published clinical studies have shown that Microbiome-based therapies are effective at treating chronic disease by restoring a patient’s gut microbial ecology. This has traditionally been done by Faecal Microbiota Transplantation (FMT) which involves transplanting the microbial community from a healthy donor into a person with chronic disease.
 
Current Treatments
 
Clinical studies have repeatedly demonstrated that by using FMT, the gut ecology from a healthy donor can be transplanted into a patient suffering from recurrent Clostridioides Difficile infection, a condition which causes severe diarrhoea and is becoming more common due to the widespread use of antibiotics. Studies have shown that microbial restoration can prevent recurrent C.difficile infection in 81% – 96% of patients far exceeding the outcomes from the standalone use of antibiotics.

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

9%

Control Group

32%

FMT

Hospitals FAQ

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.

If the product is damaged in any way upon receipt please contact safety@biomebank.com with photos of the product and description of the issue.

Order our products directly from us.

Get in touch with our team by filling out the form below. 
*for healthcare professional use only