Voluntis receives FDA 510(k) clearance for a new version of Insulia supporting an expanded range of basal insulins

Voluntis (Euronext Growth Paris, Ticker: ALVTX – ISIN: FR0004183960)a leader in digital therapeutics, today announced that it has received the FDA 510(k) clearance for a new version of Insulia supporting an additional basal insulin product, expanding the scope of insulins covered by the solution. Voluntis’ flagship diabetes digital therapeutic, Insulia, helps people with type 2 diabetes with dose titration. It is indicated for patients with type 2 diabetes initiating or uncontrolled on basal insulin, treated with a wide range of basal insulin analogues, including all approved insulin glargines.

In addition, Voluntis has integrated this new product version within the scope of its CE mark for Insulia, therefore enabling the use of this solution in countries of the European Union and the European Free Trade Association.

We are delighted to receive Voluntis’ 14th regulatory clearance for a digital therapeutic. The parallel US and EU regulatory process that we conducted to clear this new version of Insulia is an important achievement that further illustrates Voluntis’ global expertise and capabilities to effectively develop and bring to market Software as Medical Device solutions based on our Theraxium platform

Raffi Krikorian, SVP Global Quality and Regulatory Affairs

About Insulia®

Insulia® provides automated insulin dose recommendations and coaching messages for people with type 2 diabetes while enabling the health care team to remotely monitor progress. A healthcare practitioner prescribes Insulia® using their dedicated web portal and sets up the treatment plan rules that will adjust basal insulin dosing based on the person’s specific needs. The user then receives an activation code to get started with their personalized app. Once downloaded, the app uses blood glucose readings and any hypo symptoms to recommend doses in real-time. These are constantly updated using clinical algorithms built into the application. Data is automatically shared with the health care team, who can remotely monitor the patient’s progress toward their goal thanks to tailored notifications. This enables providers to deliver tailored telemedicine services, a practice increasingly supported by payers worldwide. For more information, visit www.insulia.com.

About Voluntis

Voluntis creates digital therapeutics that empower people with chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Voluntis’ solutions, combining mobile and web apps, use clinical algorithms to deliver personalized recommendations to patients and their care teams. For example, these recommendations are used to adjust treatment dosage, manage side effects or monitor symptoms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics, especially in oncology and diabetes. Voluntis has long-standing partnerships with leading life science companies. Based in Cambridge, MA, and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.

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