Tend announces the initiation of a clinical study evaluating the comparability of the CAP device for the administration of FMT in critically ill patients
– Tend’s Gut Microbiome CAP device to standardize, simplify and reduce the costs of fecal microbiota transplantation (FMT) for patients suffering from Clostridium difficile infection
– Massachusetts General Hospital (MGH) initiates clinical study validating Tend’s device as an encapsulation method for FMT
SEATTLE, March 16, 2022 /PRNewswire/ — 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 transplantation of faecal microbiota (FMT) for patients with Clostridium difficile (C difference.) infections. The results of the Massachusetts General Hospital (MGH) study may support the use of the device to improve the processing of graft material for FMT.
Common medical treatments, such as the administration of antibiotics and chemotherapy, can disrupt the microbiome, making patients more susceptible to serious health problems, including infections such as C difference.. C difference. is a disease that affects 500,000 patients in the United States each year and kills nearly 30,000. FMT is a U.S. Food and Drug Administration (FDA) regulated and highly effective treatment for this disease. FMT has a clinical efficacy of approximately 92% in the treatment of patients with C difference.. 1
“Although FMT is very effective in treating recurrences C difference.the process of creating FMT capsules is time-consuming, messy and inefficient to the point that its availability to patients may be limited,” said Elizabeth Hohmann, MD, Division of Infectious Diseases at the MGH. “Advancing methods of mixing, screening and encapsulating transplant material for FMT can significantly improve access to this treatment for C difference., and also facilitate the search for other uses. “
Thomas LendvayMD, Tend’s Chief Medical Officer, said, “Our goal is to make FMT therapies more accessible to patients by removing existing barriers to administration and standardizing therapy processing, encapsulation and delivery. With these improvements, we hope to help clinicians identify opportunities for broader applications of FMT, a therapy that has already been shown to be effective in treating a very serious disease.”
Tend’s clinical studies are designed to assess the comparability of its CAP device to current methodologies for processing transplant material and administering FMT to patients with C.diff. The study aims to show whether patients treated with capsules produced by the Tend device recover in the same way as patients treated with current standards of care. Patients will be recruited and randomized in a 1:1 ratio. Half of the patients will be treated with oral capsules produced by Tend’s CAP device while the other half of the patients will be treated using conventional methodologies.
Tender closed out a round of Series Seed Preferred $2.5 million in the fourth quarter of 2021 and used the funds for further clinical evaluation of its technologies.
Launched in 2020, Tend Health Inc. (Tend) is a privately held company whose mission is to improve understanding 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 fecal microbiota transplantation (FMT) for the treatment of recurrent infections. Clostridium difficile (C.diff), a debilitating and disruptive intestinal infection that affects 500,000 patients a year. Its patent-pending design improves the current preparation, making it easier to provide a less invasive and more affordable treatment for patients. Tend also offers a comprehensive microbiome testing and analysis solution designed to provide clinicians and patients with a more meaningful understanding of the gut microbiome.
For more information, visit our website and follow us on Twitter and LinkedIn.
Russo Partners, LLC
1 Food Pharmacol Ther. 2017;46:479–493
View original content to download multimedia: https://www.prnewswire.com/news-releases/tend-announces-initiation-of-clinical-study-evaluating-the-comparability-of-cap-device-for-the -delivery-of-fmt-in-critically-ill-patients-301503776.html