Tend Announces Initiation of Clinical Study
Evaluating the Comparability of CAP Device for Processing Stool Samples Used for FMT in Critically Ill Patients
- Tend’s Gut Microbiome CAP device to standardize, simplify, and reduce costs of processing stool for use in Fecal Microbiota Transplant (FMT) for patients suffering from Clostridium difficile infection
- Massachusetts General Hospital (MGH) initiates clinical study validating Tend’s device as an encapsulation method for stool samples used in FMT
Seattle, March 16, 2022 – Tend (“the company"), a microbiome solutions company, today announced the initiation of clinical studies for its Gut Microbiome Collect and Prep (CAP) device to prepare capsules for later therapeutic use, for Fecal Microbiota Transplant (FMT) for patients with recurrent Clostridium difficile (C. diff) infections. The results of the Massachusetts General Hospital (MGH) study may support the use of the device for improved processing of transplant material for therapeutic use.
Common medical treatments, such as antibiotic administration and chemotherapy, can disrupt the microbiome, making patients more susceptible to serious health conditions, including infections like C. diff. C. diff is a condition that annually affects 500,000 patients in the U.S. and claims nearly 30,000 lives. FMT is a U.S. Food and Drug Administration (FDA) regulated and highly effective treatment for this condition. FMT has a clinical efficacy of approximately 92% in treating patients with recurrent C. diff. [1]
“Although FMT is highly effective in the treatment of recurrent C. diff, the process for creating FMT capsules is time consuming, messy and inefficient to the point that its availability to patients can be limited,” said Elizabeth Hohmann, M.D., Infectious Disease Division at MGH. “Advancing methods of mixing, filtering, and encapsulating transplant material for FMT may meaningfully improve access to this treatment for C. diff, and also facilitate the research of other uses. ”
Thomas Lendvay, M.D., Chief Medical Officer of Tend, commented, “Our goal is to make FMT therapies more accessible to patients by removing the existing barriers to administration and standardizing the processing, encapsulation, and delivery of therapy. With these improvements, we hope to help clinicians as they identify opportunities for broader applications of FMT, a therapy which has already proven effective in treating a very serious disease.”
Tend’s clinical studies are designed to evaluate the comparability of its CAP device to current methodologies for the processing of transplant material and the delivery of FMT to patients with recurrent C. diff. The study aims to show whether patients treated with capsules produced by the Tend device recover in a similar way to patients treated using existing processing methods. Patients will be recruited and randomized in a 1:1 ratio. Half the patients will be treated with oral capsules processed by Tend's CAP device while the other half of the patients will be treated using stool processed through conventional methodologies.
Tend closed a Series Seed Preferred round of $2.5 million in Q4 2021 and has employed the funds for further clinical evaluation of its technologies.
ABOUT TEND
Launched in 2020, Tend Health Inc. (Tend) is a private company with a mission to improve the understanding of and access to the incredible healing power of the gut microbiome. The Tend Gut Microbiome Collection and Prep (CAP) device - designed, developed, and manufactured by the company - collects, mixes, filters, and encapsulates a stool sample for therapeutic use. Its patent-pending design improves current preparation, making it easier to offer a less invasive and more affordable treatment for patients. Tend also offers a comprehensive microbiome testing and analysis solution, designed to offer clinicians and patients a more meaningful understanding of the gut microbiome.