Diabeloop and SOOIL Development Company announce global development and commercial agreements incl. clinical trials and commercial launches in the US, Europe and Korea
PARIS, June 3, 2022 /PRNewswire/ —
- ADA 2022 – On the occasion of the 2022 American Diabetes Association Scientific Sessions, Diabeloop, a leader in therapeutic AI applied to insulin delivery and SOOIL Development Company, leader in superior diabetes therapy announced today that they entered into global development and commercial agreements.
- Technical integration to be pursued and expanded
With these agreements, Diabeloop and SOOIL Development Company re-establish their commitment to work together by combining their technologies and expertise.
The cooperation between the two companies was initiated in February 2020 with the launch of a large clinical study, including 9 University hospitals and 184 patients using DBLG1, Diabeloop’s i-controller and SOOIL’s DANA-i ACE pump. The study was unfortunately affected by the COVID-19 pandemic, however, the companies have continued to forge ahead with their respective product development roadmaps. Combining forces has enhanced the evolution of their business opportunities in a global manner.
Diabeloop, pioneer in therapeutic artificial intelligence applied to diabetes management and SOOIL Development Company, one of the leading established players in the insulin pump therapy market, announce today global development agreements which will address four key areas of collaboration.
“We are addressing a fast-moving market, asking us to make constant adaptations. Our products have received outstanding feedback from patients and doctors alike, while demonstrating fast growth across Europe. Our reinforced partnership with SOOIL Development Company is one of the ways to make our products available to patients beyond Europe. These agreements offer high-potential perspectives and a promising international collaboration for our two companies,“ comments Erik Huneker, CEO and co-founder of Diabeloop.
Pursuing the technical integration of the Dana-i pump within DBLG1 System will be the entry point of this newfound collaboration between the two companies.
Set up for clinical trials and commercial collaborations in the US, Europe and Korea
The extended partnership with SOOIL Development Company will enable Diabeloop to continue its international expansion beyond Europe and support its sustained growth. This strategy will help drive towards the following main business objectives:
1) Entering the American market with an approved Automated Insulin Delivery solution is an important goal for both companies. A clinical trial will be performed to meet the requirements of the US health authorities, allowing the two partners to submit an application for Diabeloop’s DBLG1 AID solution with SOOIL’s Dana-i insulin pump to the FDA.
2) The companies plan to make DBLG1 System with the Dana-i pump available in the European market. Obtaining the CE marking under the European Medical Device Regulation (MDR) will be the first main step. Not only does this follow the interoperability strategy of Diabeloop, it aligns with a firm belief that having a choice matters for people living with diabetes as well as health care professionals.
Diabeloop and SOOIL Development Company also will target their respective home markets:
3) In France, reimbursement of DBLG1 hybrid closed-loop system with the Dana-i insulin pump will be pursued, leaning on Diabelooop’s existing reimbursement pathway.
4) In Korea, obtaining approval from the Korean Food and Drug Administration (KFDA), may require an explanation of technical and usability improvements, as well as clinical studies, positioned accordingly, as per existing national guidelines.
“SOOIL Development Co Limited has the longest history – 42 years of proudly manufacturing insulin pumps, leading technology and bringing joy to people with diabetes. DANA insulin pumps are intended for interoperability and this collaboration with Diabeloop will help provide people affected by diabetes more options and choice,” said Soo Bong Choi, owner and founder of SOOIL Development Co Ltd.
Diabeloop and SOOIL Development Company are considering further opportunities to expand their partnership and enable the highest number of patients possible to access their products via new innovative products and additional geographic areas of distribution.
Diabeloop’s mission: Making innovation accessible to people living with diabetes, improving clinical results while relieving them of their constant mental burden.
Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to improve clinical outcomes for people with diabetes while relieving them of their constant mental burden. DBLG1 System, Diabeloop’s first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe.
Diabeloop just completed its Series C financing round, securing 70 million euros, to accelerate its commercial roll-out, support its sustained growth strategy and its high-impact projects.
Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.