Voluntis receives CE Mark to add NPH/Isophane to Insulia

Today, Voluntis announced that it had obtained the CE mark for the new version of Insulia that integrates intermediate-acting neutral protamine Hagedorn (NPH) insulin, also known as isophane insulin. Insulia is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulin, including NPH insulin as well as all first and second generation long-acting basal insulin analogs.

“Insulin treatment, while effective, can also result in a number of clinical, emotional and financial challenges for all stakeholders. We are delighted to make Insulia accessible to people with Type 2 diabetes regardless of their basal insulin treatment. We hope that this new version will also help meet the demand from a growing number of providers and payers wishing to offer affordable therapeutic options for patients without sacrificing the quality of care.”

Genevieve d’Orsay, Chief Medical Officer at Voluntis

NPH insulin often requires twice-daily injection, which results in lower treatment adherence and treatment satisfaction. Yet NPH insulin is sometimes recommended as a first-line treatment due to its cost effectiveness. Insulia provides necessary support that can reduce the day-to-day challenges for people taking NPH insulin. Voluntis is in active discussions with provider groups, health systems, pharmacy benefit managers and insurance companies to offer access to this new version of Insulia. 

The United Kingdom and Germany, where Voluntis has launched pilot programs, will be the first countries to benefit from this upgraded version of Insulia.  Voluntis has also filed for FDA 510(k) clearance to extend the scope of Insulia to NPH insulin in the United States, where the rising cost of insulin has become an important public health issue. 

About Insulia

Insulia® provides automated basal 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. Insulia is available for people using any brand of basal insulin, including Basaglar®, Lantus®, Levemir®, Toujeo®, Tresiba®(U-100) as well as NPH insulins (Humulin®, Insuman® and Insulatard®) in the EU. 

For further information: http://www.insulia.com

About Voluntis

Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self- manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real- time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics, especially in diabetes and oncology. Voluntis has long-standing partnerships with leading life science companies such as Abbvie, AstraZeneca, Roche, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance. 

For further information: http://www.www.voluntis.com

Voluntis is traded on the Euronext Paris – Compartment C market

Ticker: VTX – ISIN: FR0004183960

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