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press release
Indigo diabetes Business update
- Shiny Following positive results from GLOW, clinical trial enrollment is progressing well. Early feasibility Experiment
- Several Major appointments in Europe and America; Shining growth and Evolution from early stage to development stage organization clinical proof of concept
Belgium – Gent, 4 January 2023 – Indigo Diabetes NV (‘Indigo’ or ‘the Company’), a pioneering developer of Continuous Metabolite Monitoring (CMM™) devices using proprietary nanophotonic technology, today offers the latest and ongoing business activities.
Indigo is developing a fully implantable CMM system to provide accurate data on glucose, ketone and lactate levels for people with diabetes. The CMM sensor is inserted under the skin, avoiding the need for people with diabetes to wear an external device on their body. It is designed to provide people with diabetes and their caregivers with rapid access to the augmented metabolic information they need to better manage their diabetes and improve medical decision making.
Advances in clinical research
In September 2022, Indigo announced the enrollment of the first participant in the SHINE clinical trial at Antwerp University Hospital, Belgium. The SHINE Indigo Continuous Multiple Metabolite (‘CMM’) instrument is designed to assess long-term stability. This represents the first of up to 15 participants recruited for the trial across Belgium, France and Slovenia, with the latter two locations beginning to enroll in Q1 2023.
The GLOW clinical trial was a single-center early feasibility study conducted at Antwerp University Hospital, Belgium, to evaluate the safety and short-term integration into tissue of the indigo CMM sensor. The data was collected from seven trial participants (three healthy people and four people with type 1 diabetes), and the results helped the development of a device to measure glucose, ketone and lactose levels in real time in adults. with diabetes. The full GLOW trial results were recently submitted to a peer-reviewed journal.
In the year By the end of 2022, Indigo has received ISO 13485:2016 medical re-certification from TüV SUD to provide design and development of biomarker sensing devices and services. This achievement is a major milestone for Indigo, highlighting the suitability of the company’s quality management system and its commitment to quality. ISO 13485:2016 is an internationally recognized quality standard for the medical device industry that certifies the quality of medical devices.
Key appointments
In the year A number of senior staff members have been hired, bringing the total headcount to 45 by 2022, which will enable the business and evolution from an early-stage to a growth-stage organization with clinical proof of concept.
In October, Indigo appointed Peter Devlin as president of Indigo Medical US Inc., establishing a presence in the U.S., a market it has identified as having great potential for its CMM devices. Based in Boston, Peter manages and oversees Indigo Medical’s operations. The focus is on accelerating product development, driving business development and facilitating talent acquisition in the US for the company’s CMM equipment.
Another key hire was made in May with the appointment of Emmett Lydon as Chief Operating Officer. Emmett brings over 30 years of experience working in senior leadership positions in the Biodiversity Science environment with extensive experience in Asia, North America and Europe.
Indigo also appointed Michael Malecha as VP, Digital. Michael now leads the software team developing digital strategies for the Indigo CMM tool.
Dr. Danae Delbeke, CEO of Indigo Diabetes, commented. “It was 2022. A great year For the group Indigo where we succeeded Several including key events Registration The first participant in the SHINE trial and establishing our presence in the US. We look forward to it. of year in the future We continue Let’s work towards our mission to deliver one An innovative, accurate and convenient monitoring solution to brighten the lives of millions of people with diabetesHe said.
Dr. Dana Delbeck, CEO and Peter Devlin, President of Indigo Diabetes will visit San Francisco in January 41.St JP Morgan Healthcare conferences and are currently organizing meetings with investors and partners. Please contact the company directly if you would like to arrange a meeting.
– It ends –
Contacts
Indigo Diabetes NV
Dr. Dana Delbeke, CEO
Email: info@indigomed.com
Strategic communication planning
Ashley Tapp, Alexandra Harrison
Phone: +44 (0)20 3709 5700
Email: indigodiabetes@consilium-comms.com
About Indigo Diabetes NV
Indigo Diabetes NV (Indigo) is a leading developer of medical devices using proprietary nanophotonic technology. Indigo was founded by Dana Delbeke and her team in 2008. Indigo uses ground-breaking photonics technology to revolutionize diabetes management. Indigo is located in Ghent, Belgium. Learn more at www.indigomed.com.
About Indigo Diabetes CMM™ Sensor
The Indigo Diabetes CMM™ Sensor is the world’s first, subcutaneously implanted evanescent field sensor to measure multiple metabolites. in vivo Simultaneously and continuously. To simultaneously measure a wide range of metabolites without the use of enzymes or fluorophores, a small integrated silicon photonics chip measures light in the interstitial fluid. Once embedded under the skin, the CMM sensor is invisible to the naked eye and securely and wirelessly connects to mobile devices and displays concentration profiles of metabolites to the user. A rechargeable sensor battery supplies the measurements. The sensor is expected to last up to 2 years. Pre-clinical studies have demonstrated successful proof-of-concept, further corroborating GLOW’s early feasibility study results.
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