Trellus Health. Regulatory News (TRLS)

Trellus Health plc

("Trellus Health" or the "Company")

Launch of D2C IBS Offering, Expansion of Mount Sinai Agreement

and Related Party Transaction

Trellus now offering comprehensive Digestive Health solutioncovering both IBD and IBS across both D2C and B2B2C channels

LONDON, U.K. AND NEW YORK, U.S. (17 February 2023): Trellus Health plc (AIM: TRLS), which is commercializing a scientifically validated, personalized resilience-driven self-management solution for chronic health conditions at their intersection with mental health, announces the launch of its Direct-to-Consumer ("D2C") offering for people living with Irritable Bowel Syndrome ("IBS").

The Company also announces the expansion of one of its existing agreements with the Mount Sinai Health System ("Mount Sinai"), under which the Trellus Resilience Training and Self-Management Solution (the "Trellus Method") is being made available as a wellness benefit to members of a large New York State labour union which provides health services and benefits to its members through Mount Sinai. This contract is now expanded to make the Trellus method available to people living with IBS as well as to patients with inflammatory bowel disease ("IBD"). The original contract with Mount Sinai was disclosed in regulatory announcements made on 17 October and 20 December 2022.

Trellus Health has now launched its D2C offering for IBS, providing its resilience-based methodology to support IBS patients' through coordinating and delivering personalized behavioural, emotional and nutritional support remotely via digital solutions, and provide access to an expert resilience team via telehealth. The D2C offering will also help to drive awareness and demand and further build an evidence base to support B2B2C engagement by providing real-world evidence of the health and economic outcomes of the Trellus Method and its application to chronic conditions.

The terms of the amended and restated Mount Sinai contract described above (the "Contract") are not materially changed, save for the expanded availability of the Trellus Method to members of the union with a diagnosis of IBS in addition to those members diagnosed with IBD. As previously disclosed, the Contract does not provide any guaranteed revenue but demonstrates further execution of the Company's strategy to make the Trellus Method available to a larger target patient population by addressing resilience in an IBS as well as an IBD context.

IBS is a common condition affecting the digestive system, that has significant similarities with IBD from a symptom burden and emotional perspective. IBS is a chronic, lifelong problem which can have a big impact on an individual's quality of life through both physical and mental psychological challenges. IBS has a much higher population prevalence than IBD, impacting c. 30 million patients in the United States (U.S.), compared to c. 3 million for IBD.

Whilst there is currently no cure for IBS, behavioural health approaches are essential to managing and supporting the condition and its symptoms. Trellus Health's personalized, resilience-driven self-management training programs are designed specifically for people looking to overcome symptoms and emotional burdens associated with IBS and IBD, and the Company believes its methods have utility across a number of other chronic conditions.

Dr. Marla Dubinsky, Chief Executive Officer of Trellus Health, said: "I am delighted to be in a position to launch the Trellus Method for IBS program, through both our D2C offering and by expanding one of our contracts with Mount Sinai. Trellus now offers a comprehensive gastroenterology (GI) solution for both IBS and IBD, and this represents the culmination of a lot of hard work by the team.

"IBS affects around 30 million people in the U.S., and often has a significant impact on a person's quality of life. We look forward to working with patients and partners to further evaluate how the Trellus Method can empower those suffering with IBD, and now also IBS, to achieve better health outcomes and increased quality of life, with reduced healthcare costs."

Related Party Transaction Disclosures

The Trellus Method is based on technology developed by Mount Sinai faculty and licensed to Trellus Health. Mount Sinai and Mount Sinai faculty, including Dr. Marla Dubinsky, have a financial interest in Trellus Health. Mount Sinai has representation on the Trellus Health Board of Directors.

Dr. Marla Dubinsky, CEO of Trellus Health, is a professor of pediatrics (gastroenterology) and medicine (gastroenterology) at the Icahn School of Medicine at Mount Sinai. As the Contract has the potential to generate revenue which could exceed the relevant threshold for classification as a related party transaction under the AIM Rules, the Contract is classified as a related party transaction pursuant to the AIM Rules for Companies.

The independent directors of the Company (being Dr. Daniel Mahony, Mike Salter, Christopher Mills and Traci Entel), having consulted with Singer Capital Markets as the Company's Nominated Adviser, consider that the terms of the Contract are fair and reasonable insofar as the Company's shareholders are concerned.

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About Trellus Health plc (www.trellushealth.com)

Trellus Health (LSE: TRLS) is the first resilience based digital health company focused on the intersection of chronic illness and mental health. Trellus Health integrates its proprietary resilience-based methodology with the technology, tools and team to deliver a whole-person technology-enhanced experience that results in relieving disease burden, building self-management skills and promoting individual health behaviours that enable thriving in the face of a chronic condition. Through its TrellusElevate™ connected health platform and companion App, the company addresses both physical and behavioural health together, in context, to improve outcomes and reduce healthcare costs across the healthcare ecosystem.

The Company was initially focused on Inflammatory bowel disease ("IBD"), which includes the chronic incurable conditions of Crohn's Disease and ulcerative colitis but has now added Irritable Bowel Syndrome ("IBS"). Given the common struggles of self-management, Trellus Health considers its approach to have potential utility and demand across many chronic conditions.

The TrellusElevate™ platform is the Company's proprietary connected health platform that incorporates the GRITT™ methodology and learnings on resilience from clinical research and practice conducted at the Mount Sinai IBD Center for more than five years. This proprietary, resilience-driven methodology has been scientifically validated to demonstrate meaningful improvements in patient outcomes, 71% reduction in Emergency Department (A&E) visits, and 94% reduction in unplanned hospitalisations, which the directors of the Company believe indicates the potential for significant cost savings for healthcare payers. Patients with IBD treated using the methodology also experienced a 49% reduction in required opioid use and a 73% reduction in corticosteroid use 12 months following starting the program2.

The Company was founded by Mount Sinai faculty members Marla C. Dubinsky, MD and Laurie Keefer, PhD, both with decades of combined experience in IBD and psychogastroenterology, respectively. Trellus Health's patent-pending GRITT™ resilience assessment and personalized resilience training methodology was developed and validated at the Mount Sinai Health System to build resilience and wellness for improved outcomes at lower cost.

Shares in Trellus Health were admitted to trading on AIM in May 2021, under the ticker TRLS. For more information on Trellus Health, visit:  www.trellushealth.com

1) Source: https://www.cdc.gov/chronicdisease/about/costs/index.htm)

2) Source: https://www.sciencedirect.com/science/article/pii/S1542356521012258)

About the Trellus Health Digestive Health program

Trellus Health is pioneering a scientifically validated, personalized resilience-driven self-management solution for chronic digestive health conditions which addresses the intersection of chronic illness with mental health, estimated to cost the US economy $3.7 trillion annually.1 The Trellus approach transforms chronic condition management and changes the lives of patients living with debilitating, incurable conditions, initially focused on IBD, including Crohn's Disease and ulcerative colitis, and IBS, but with potential utility and demand across many chronic conditions.

The Digestive Health program is a self-management solution driven by personalized resilience training. The program empowers and enables members to manage their condition by teaching them to set goals, actively identify challenges and solve problems associated with their condition, driving a change of health behaviour to deliver improved outcomes and health status at lower cost.

Patients with IBD and IBS face many challenges which are common across many chronic conditions: the management of complex medication regimens, dealing with symptoms and disability, monitoring physical indicators, maintaining proper levels of nutrition, adjusting to the psychological and social demands including difficult lifestyle adjustments, as well as engaging in effective interactions with health providers.

Trellus Health'spersonalized resilience-driven self-management training programs are designed specifically for people looking to overcome these challenges. The aim is to enable patients and their physicians to achieve better quality patient outcomes at a lower cost to health plans and employers, and the proprietary resilience method has been proven to reduce unplanned hospitalizations by 94% at the Mount Sinai IBD Center, New York, NY.2

About Irritable bowel syndrome (IBS)

IBS is a common condition that affects the digestive system. It causes symptoms like stomach pain, bloating, diarrhoea and constipation. These tend to come and go over time, and can last for days, weeks or months at a time. It's usually a chronic, lifelong problem which can be very frustrating to live with and can have a big impact on an individual's everyday life. Whilst there is currently no cure for the condition, behavioural health techniques, diet changes and medicines can often help control the symptoms. The exact cause is unknown - it's been linked to food passing through your gut too quickly or too slowly, oversensitive nerves in a patient's gut, stress and a family history of IBS.