BIOCORP and ROCHE DIABETES CARE FRANCE Launch Mallya, an Innovative Medical Device to Better the Daily Life of Patients With Diabetes

• Available in pharmacies, Mallya is compatible with most disposable insulin pens¹
• Patients have a digital solution to accurately² and safely monitor their day-to-day treatment

Regulatory News:

BIOCORP (Paris:ALCOR) (FR0012788065 – ALCOR / Eligible PEA PME) , a French company specialized in the design, development and manufacturing of innovative medical devices, and Roche Diabetes Care France, a reference company in the support of patients with diabetes, announce the launch in France of Mallya, a medical device available in pharmacies. Developed by BIOCORP, this smart insulin pen device collects and transfers insulin data with near 100% accuracy². Rechargeable via its USB port, Mallya is compatible with most disposable insulin pens¹. This innovation aims to simplify the daily life of patients with diabetes undergoing insulin therapy, and could help avoid errors or oversights.

Healthcare companies BIOCORP and Roche Diabetes Care France are finalizing their collaboration - announced last June - with the distribution of Mallya smart devices for insulin injection pens since the beginning of April. Manufactured in Clermont-Ferrand (France), this innovation for patients taking insulin is the first in its category to receive the CE-mark (medical device).

Reusable and compatible with 91%¹ of disposable insulin pens, Mallya automatically collects insulin data (dose, date, time) and transfers it to the Gluci-Chek application developed by Roche Diabetes Care France, ensuring qualified information on which the patient can rely and the physician can then make decisions³. With integration into the Roche Diabetes Care France digital ecosystem, patients benefit from solutions that lighten the mental burden of their disease, in a context where more than 750,000 people⁴ are treated with insulin injections in France (excluding insulin pumps).

“The commercial launch of Mallya represents an important milestone for BIOCORP. We are really proud to be leading it with Roche Diabetes Care France. Its leading position, its vast distribution network in pharmacies and the connection of our innovative device to its Gluci-Chek solution present undeniable benefits for all healthcare professionals but also and above all for diabetic patients looking for a better quality of life, a better comfort in the management and daily follow-up of their disease", said Eric Dessertenne, CEO of BIOCORP.

"For more than 40 years, we have been helping people with diabetes think less about the day-to-day management of their disease. We are committed to the autonomy and quality of life of patients with diabetes, empowering them to understand and act on their condition. This is precisely what Mallya allows, when integrated with our digital ecosystem for patients and healthcare professionals. We are currently the only company to offer a quality solution based on a CE marked medical device", added Frédéric Jacquey, President of Roche Diabetes Care France.

An innovation to improve the daily life and monitoring of diabetic patients on insulin

After the creation of insulin for therapeutic purposes 100 years ago, innovation continues in the field of diabetes, with the same ambition: to enable more and more patients to live better with their diabetes on a daily basis, a strong challenge for patients treated with insulin. To this end, Mallya collects and transfers insulin data in real time⁵ to their smartphone.

Once the device is installed, the patient selects and injects his or her insulin units as usual, with data transfer (date, time, selected dose) being done automatically. While 37%⁶ of patients with diabetes felt more anxious about their condition during the first Covid19 confinement, the simple and accurate² Mallya device makes it easier for them to follow the evolution of their disease. It could thus contribute to more serenity, more security and less error or forgetfulness in taking their treatment.

Shared with healthcare professionals³ through the dedicated Roche Diabetes Care Platform, accurate and comprehensive insulin data² allows them to monitor - face-to-face or remotely - the progress of their patients' disease, refine their interpretation and help adjust treatment decisions.

A device integrated into a global solution to facilitate diabetes management

The device enhances Roche Diabetes Care France's digital ecosystem for integrated personalized diabetes management. This solution was previously based on three elements: connected blood glucose meters (Accu-Chek® Mobile, Accu-Chek® Guide), the Gluci-Chek application and the Roche Diabetes Care platform dedicated to healthcare professionals. Mallya is adding insulin data for more comprehensive patient monitoring.

Used regularly by more than 60,000 diabetic patients in France, this smartphone application combines three major functionalities for personalized diabetes management: a carbohydrate calculation tool with a visualization of the portions on the plate, a self-monitoring of blood glucose diary and a graphic visualization of glycemic results.

Once Mallya is connected to Gluci-Chek, the patient no longer has to manually report his or her insulin doses, as the data is automatically displayed in the patient's blood glucose logbook, for any compatible insulin pen¹. In a context where French people are confined again and where 58%³ of patients with diabetes did not feel they had received any particular help during their first confinement, this connected device can provide real close monitoring.

ABOUT ROCHE DIABETES CARE FRANCE

Roche Diabetes Care is a healthcare company specializing in diabetes. For more than 40 years, it has been pioneering solutions to meet the needs of patients and healthcare professionals: medical devices (blood glucose meters, auto-pickers, insulin pumps), digital solutions (applications, platform for sharing blood glucose data between patients and healthcare professionals) and services (information and therapeutic education support). Through the implementation of a global solution connecting medical devices and digital solutions, Roche Diabetes Care is paving the way for integrated Personalized Diabetes Management (iPDM), with the aim of facilitating and optimizing the management and monitoring of this complex disease.

Roche Diabetes Care France is a subsidiary of the Roche Group in France, alongside Roche SAS France and Roche Diagnostics France. For more information, please visit www.roche.fr.

ABOUT BIOCORP

Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 70 employees. BIOCORP is listed on Euronext since July 2015 (FR0012788065 – ALCOR). For more information, please visit www.biocorpsys.com.

¹ The Mallya medical device is compatible with Solostar pens (ref. 9828648001), FlexPen pens (ref. 9832360001) and KwikPen pens (ref. 9827587001) with the exception of Junior KwikPen pens as of January 1, 2021. Calculation of market share for disposable insulin pens from Caisse Nationale d'Assurance Maladie. Open Medic 2019 database.

² 99% according to Mallya IFU version 6. Caution: some external factors may affect the accuracy of dose measurement or data transfer.

³ If the patient decides to share his/her data.

⁴ Source: IQVIA - LTD : Analysis of BGMin real life – Meters and strips markets - CMA February 2020 - Patients and volume.

⁵ As soon as Bluetooth is activated.

⁶ Online study conducted by CSA Research for Roche Diabetes Care France from May 18th to 27th, 2020, with 504 diabetic patients (101 type1 diabetic patients and 403 type2 diabetic patients)

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