An innovative ostomy device
Ostomy surgery is a life-saving procedure where stool or urine is diverted into an exterior prosthetic pouch. It is a temporary or permanent procedure that can occur at any age and considerably improves patient lives. However, nearly 66 % of ileostomy patients have to cope with prosthesis leaks and the discomfort of damaged peristomal skin. Via a user-centred approach, the EU-funded OSTOF(opens in new window) project aimed to address this issue. “The Ostoform device was born out of a need to improve skin health in ostomy patients,″ explains Kevin Kelleher, co-founder and CEO of Ostoform Ltd, a spin-off company from the University of Limerick in Ireland. The company offers a range of patented technologies and envisions becoming a global leader in the area of ostomy skin health. Innovative design Following several years of speaking with patients and understanding their needs, Ostoform’s experienced designers and material experts have come up with an innovative seal. The novel design uses FLOWASSIST™ protection, a combination of advanced absorbent and non-absorbent materials that prevent acidic output from contacting the patient’s skin. The mouldable seal is placed around the stoma to direct the flow of ostomy effluent away from the skin and into the ostomy bag. Consequently, the skin is better protected, and if already damaged, heals quicker and more effectively. Ostoform has completed a patient trial, with 12 patients wearing the device for 6 weeks. On average, a 45 % reduction in skin complications was identified. Additional benefits include better usability, increased patient confidence and improved quality of life. As Kelleher reveals “results from our clinical trial have proven to be very encouraging and Ostoform has taken steps towards commercialisation of the device. This has involved developing a reimbursement and commercialisation strategy as well as a manufacturing plan.″ Future endeavours Recently Ostoform has raised EUR 1.1 million in investment from the Halo Business Angel Network (HBAN) and Enterprise Ireland to fund further patient trials and obtain regulatory approval for bringing the Ostoform™ seal system to the United States (US) and European markets. The company’s award-winning product has the potential to help over 1 million patients in the US and EU. The investment will also establish a final manufacturing process for the device, along with a reimbursement pathway. Kelleher confesses that “navigating the reimbursement landscape within different countries has proved challenging, especially in Europe, because of language barriers.″ Undoubtedly, with ostomy surgery being necessary for certain types of cancer, and severe abdominal or pelvic trauma due to accidents or injuries, there is an imminent need for managing and preventing irritation of skin around the stoma. Winner of the Enterprise Ireland ‘One to Watch’ award, Kelleher is confident that “the Ostoform seal system will help ostomy patients maintain a positive quality of life.″