The Insides Company Announces First-Patient-In (FPI) Milestone Completed For The REINFUSE Study

The Insides™ Company, a leading provider of automated chyme reinfusion solutions, today announced the first patient has been enrolled in the REINFUSE clinical study. REINFUSE is a Pivotal study to evaluate the safety and efficacy of The Insides™ System in the treatment of subjects with a double enterostomy and/or enterocutaneous fistula and type 2 intestinal failure.

The REINFUSE study is a world first in assessing the effect of chyme reinfusion therapy versus standard of care in a randomised controlled study. The first patient to be enrolled in the study is an important milestone towards US market approval for The Insides System.

The Insides System received Breakthrough Device designation from the US Food and Drug Administration (FDA) in 2019, and the REINFUSE trial received an investigation device exemption (IDE) for the study in 2021. The trial will be conducted at sites in the United States and the United Kingdom and will enrol 40 patients to investigate the clinical outcomes of chyme reinfusion therapy using The Insides System versus the standard of care for patients with type 2 intestinal failure.

Associate Professor Dermot Burke (Leeds Teaching Hospital, UK) and Dr Syed-Mohammed Jafri (Henry Ford Health, USA) lead the clinical trial. Associate Professor Burke said “Although type 2 intestinal failure is an uncommon problem, the consequences for an individual can be very severe and life changing. The Insides System has the potential to dramatically improve the quality of life for patients with this condition. This trial should enable the medical research team to confirm the value of The Insides System and so provide patients with hope of a better life”.

About Type 2 Intestinal Failure

Intestinal failure is when a large part of the intestine is missing or does not work properly. This means the gut does not digest and absorb food the way it should. Type 2 intestinal failure is prolonged intestinal failure which requires life-sustaining parenteral nutrition (feeding though a vein) for longer than 20 days.

Type 2 intestinal failure can be caused following an acute traumatic event such as a traffic accident, following surgical procedures associated with anastomotic leaks, vascular or viscous injury during other surgery, creation of laparostomy (open abdominal wound), and acute unpredictable events such as enterocutaneous fistulae, intestinal volvulus, and mesenteric infarction.

About Chyme Reinfusion Therapy

Chyme is the medical term used to describe partially digested contents of the small intestine. Chyme reinfusion therapy involves returning chyme collected in a patient’s ostomy appliance from the proximal (i.e., upstream) limb of the fistula or stoma, back into the distal (i.e., downstream) limb.

Chyme reinfusion is recommended by the European Society of Clinical Nutrition and Metabolism (ESPEN) and American Society for Parenteral and Enteral Nutrition (ASPEN) for the nutrition in patients with acute intestinal failure.

About The Insides System

The Insides System is a medical device that enables chyme to be refeed into the intestine for enterostomy and enterocutaneous fistula patients. The Insides System is commercially available in the United Kingdom, Europe, and New Zealand.

About The Insides™ Company

The Insides™ Company is a leading designer and manufacturer of purpose-built chyme reinfusion solutions for patients with intestinal failure. The company's devices demonstrate significant improvements in clinical and economic outcomes for patients requiring intestinal rehabilitation.

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