Indigo Diabetes Business Update

Press release

indigo diabetes business update

  • shining Clinical trial enrollment on track after positive results from GLOW Initial feasibility trial
  • Several important senior appointments made in Europe and America, reflect growth and Evolution from early-stage to development-stage organization and clinical proof-of-concept

Belgium Ghent, Four January 2023 – Indigo Diabetes NV (“Indigo” or the “Company”), a pioneering developer of continuous metabolite monitoring (CMM™) devices utilizing proprietary nanophotonics technology, today announces We provide the latest information.

Indigo develops a fully implantable CMM system to give diabetics access to accurate information on their glucose, ketone and lactate levels. CMM sensors are inserted subcutaneously, eliminating the need for diabetics to wear external devices on their bodies. It is designed to give people with diabetes and their caregivers instant access to the extended metabolic information they need to better manage their diabetes and improve therapeutic decision-making.

Clinical trial progress
In September 2022, Indigo announced enrollment of the first participant in the SHINE clinical trial at the University Hospital of Antwerp, Belgium. SHINE is designed to assess the long-term stability of Indigo’s sequential multi-metabolite (“CMM”) devices. This is the first of a maximum of 15 participants to be recruited in trials in Belgium, France and Slovenia, where he will begin enrollment in the first quarter of 2023 at his two sites. I plan to

The GLOW clinical trial was a prospective, single-center, early-feasibility study conducted at the University Hospital of Antwerp, Belgium, to evaluate the safety of the Indigo CMM sensor and its short-term integration into tissues. Data were collected from seven study participants (three healthy and four with type 1 diabetes) and the results will inform the development of a device capable of continuous real-time measurement of glucose, ketone and lactate levels in adults. helped me move forward. with diabetes. The full results of the GLOW trial were recently submitted to a peer-reviewed journal.

Towards the end of 2022, Indigo has received ISO 13485:2016 medical recertification from TüV SUD for the design and development of biomarker sensing devices and service offerings. This achievement is an important milestone that underscores Indigo’s quality management system fit and commitment to quality. ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry that ensures the quality of medical devices.

Main schedule
In 2022, a number of senior positions have been hired, bringing the total headcount to 45. This reflects the continued growth of the business and evolution from an early stage to a development stage organization with a clinical proof of concept.

In October, Indigo appointed Peter Devlin as President of Indigo Medical US Inc, establishing a presence in the US as a market with great potential for CMM devices. Based in Boston, Peter manages and oversees Indigo Medical’s activities. He is focused on accelerating the company’s product development of his CMM devices, driving business development, and facilitating talent acquisition in the United States.

Another significant hire was made in May with the appointment of Emmett Lydon as Chief Operating Officer. Emmet brings her over 30 years of experience as a senior her leader working in a multinational life her science environment, with extensive experience in Asia, North America and Europe.

Additionally, Indigo has appointed Michael Malecha as Vice President of Digital. Michael currently leads his software team to develop digital strategies for his CMM devices at Indigo.

Doctor. Danaë Delbeke, CEO, inventor and co-founder of Indigo Diabetes, commented: 2022 is great year for the indigo team where achievement Several significant milestones including admission of the first participants in the SHINE trial And establish a presence in the United States. looking forward to it of Year first where we continue Working towards our mission to provide of Innovative, accurate and convenient monitoring solutions that brighten the lives of millions of people with diabetes

Indigo Diabetes CEO Dr. Danaë Delbeke and President Peter Devlin will visit San Francisco on January We attended the JP Morgan Healthcare Conference and are currently arranging meetings with investors and partners. If you would like to schedule a meeting, please contact the company directly.

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contact address

Indigo Diabetes NV
Dr. Danaë Delbeke, CEO

strategic communication plan
Ashley Tapp, Alexandra Harrison
Phone: +44 (0)20 3709 5700

About Indigo Diabetes NV
Indigo Diabetes NV (Indigo) is a pioneering developer of medical devices utilizing proprietary nanophotonics technology. Indigo was founded by her Danaë Delbeke and her team in 2016. Indigo is now developing the world’s first subcutaneous sensor to address the need for continuous and accurate glucose, ketone and lactate monitoring by diabetics without any physical attachments. Indigo transforms diabetes management with breakthrough photonics technology. Indigo is based in Ghent, Belgium.Click here for details

About Indigo Diabetes CMM sensor
Indigo Diabetes’ CMM™ sensor is the world’s first subcutaneously implanted evanescent field sensor to measure multiple metabolites. of in vivo at the same time and continuously. An inert, miniature integrated silicon photonics chip measures the absorption of light in interstitial fluid and simultaneously quantifies the concentration of a wide range of metabolites without the use of enzymes or fluorophores. Once inserted under the skin, the CMM sensor becomes invisible to the naked eye and is securely and wirelessly connected to a mobile device to display and capture metabolite concentration profiles to the user. A rechargeable sensor battery powers the measurement. Sensor lifetime is expected to be up to 2 years. Preclinical studies have successfully demonstrated proof-of-concept with promising accuracy, with results from early feasibility studies of GLOW providing further validation.

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