Indigo Diabetes Business Update

PRESS RELEASE

Indigo Diabetes Business Update

BELGIUM – Ghent, December 21, 2021 – Indigo Diabetes N.V. (‘Indigo’ or the ‘Company’), a pioneering developer of medical solutions using nanophotonics, today provides an update on recent and ongoing business activities.

Clinical study progress
The GLOW study, which was initiated in March 2021 and is the first in human clinical study of its continuous multi-metabolite (‘CMM’) sensor, was recently completed. GLOW, listed on www.clinicaltrials.gov under the identifier NCT04782934, was designed to evaluate the safety of the sensor and the short-term integration into the tissue and was a prospective, single-center early feasibility study conducted at Antwerp University Hospital, Belgium. Data was also collected from the seven study participants and used to develop the device to allow real-time, continuous measurement of key metabolite levels in adults with diabetes. The GLOW study results are currently being analysed and due to be submitted for publication in the New Year.

Key appointments
In May, Indigo appointed Paul Moraviec as Chairman of its Board of Directors. Paul has amassed over three decades of global experience in the healthcare sector, having held multiple senior leadership positions and has brought highly relevant diabetes experience, having been Vice President of Abbott’s Diabetes Care International division between 2002 and 2007.

In addition, Indigo appointed seven internationally recognised experts in endocrinology, diabetes and metabolic disease to form its newly created Scientific Advisory Board (SAB). The SAB members are all leaders in their field and will serve as a strategic resource to Indigo as it progresses its device and continues its journey to transforming diabetes management. The SAB, which held its first meeting in June 2021, comprises:

• Prof. Dr. Tadej Battelino, Head of Department of Endocrinology, Diabetes & Metabolism, Faculty of Medicine, University of Ljubljana, Slovenia
• Prof. Dr. Michael C. Riddell, School of Kinesiology & Health Science, York University, Canada
• Prof. Dr. Eric Renard, Head of Department Endocrinology, Diabetes & Metabolism, Medical School, University of Montpellier, France
• Prof. Dr. Christophe De Block, Head of Department of Endocrinology, Diabetology and Metabolic disease, University of Antwerp, Belgium
• Prof. Dr. Thomas Danne, Director of Department of General Pediatrics Endocrinology/Diabetology & Clinical Research, Hannover Medical School, Germany
• Prof. Dr. Ananda Basu, Division of Endocrinology, University of Virginia, USA
• Dr. Anne Peters, Keck School of Medicine, University of Southern California, USA

In December 2021, Indigo appointed Daniel Verstappen as VP Quality Assurance and Regulatory Affairs where he will form part of the senior management team. Daniel has approximately 30 years’ experience working for medical device companies, most latterly as Global VP, Quality, Regulatory Affairs and Standard Management at Philip Morris, which is currently transforming into a life science company.

Daniel’s appointment takes the total number of employees at Indigo to 40, representing almost a doubling in headcount over the last year.

Grant awarded to validate next generation system
In September, Indigo received a €3 million grant from VLAIO, the Flanders organisation for Innovation & Entrepreneurship, to conduct research into high volume production of its next-generation CMM system. Specifically, Indigo will use the grant to validate its CMM system in a large-scale clinical pivotal study, ENLIGHT.

Earlier this year, Indigo successfully closed the DiaMOND grant, awarded in 2018 under the umbrella of the EU Horizon 2020 SME Instrument framework. The grant was used to accelerate the development of Indigo’s CMM system, a next-generation Continuous Glucose Monitoring (CGM) device by obtaining severe clinical event prediction data and creating an excellent user experience via the GLOW study, a first-in-man trial.

Dr Danaë Delbeke, CEO, Inventor and Co-founder of Indigo Diabetes, commented: “I am very proud of the significant progress made by our multidisciplinary team at Indigo to develop our CMM sensor in 2021. We are looking forward to sharing the full GLOW trial data when it is available next year as we continue to work towards our mission of providing an innovative, accurate and convenient monitoring solution to light up the life of millions of people living with diabetes.”

– Ends –

About Indigo Diabetes N.V.
Indigo Diabetes N.V. (Indigo) is a pioneering developer of medical solutions utilizing nanophotonics. Indigo was founded by Danaë Delbeke and her team in 2016. Today Indigo is developing the world’s first invisible sensor for people living with diabetes to address their need for continuous accurate glucose and ketone monitoring with an improved user experience. Indigo exploits groundbreaking photonics technology responsible for revolutionizing the Internet to transform diabetes management. Indigo is based in Ghent, Belgium. Find out more at www.indigomed.com.

About Indigo Diabetes’s CMM sensor
Indigo Diabetes’s CMM sensor is a small spectrometer-on a-chip to monitor in-vivo simultaneously and continuously multiple metabolites. The inert, miniature integrated silicon photonics spectrometer chip measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites simultaneously without the use of enzymes or fluorophores. Once inserted under the skin the CMM sensor is invisible to the naked eye and will connect securely and wirelessly to mobile devices to show and capture the concentration profiles of the metabolites for the user. A rechargeable sensor battery powers the measurements. It is expected that the sensor will have a lifetime up to 2 years. Preclinical studies have successfully demonstrated proof of concept with promising accuracy.

Contacts

Indigo Diabetes N.V.
Dr Danaë Delbeke, CEO
Email: info@indigomed.com

Communications
Consilium Strategic Communications
Ashley Tapp, Alexandra Harrison, Isobel McLeod
Tel: +44 (0)20 3709 5700
Email: indigodiabetes@consilium-comms.com