CeQur Raises $115 Million Series C5 Financing to Support Commercialization and Scale-Up of Automated Manufacturing for CeQur Simplicity Wearable Insulin-Delivery Device

Rhea-AI Summary

CeQur has completed an oversubscribed $115 million equity financing to support commercial plans for its insulin-delivery device, CeQur Simplicity. The funds will enhance market development, initiate a phased launch in 2021, and scale manufacturing. CeQur Simplicity is FDA cleared and CE-marked, designed to replace multiple daily injections for over 3 million Americans. Clinical studies show significant improvement in insulin regimen adherence and glycemic control. The device targets a $7.5 billion U.S. market, aiming to ease insulin delivery for diabetes patients globally.

Positive

• Successfully closed a $115 million oversubscribed equity financing.
• CeQur Simplicity is FDA cleared and CE-marked.
• Clinical studies show nearly 90% of patients reported better adherence to insulin regimen.
• Targets a $7.5 billion U.S. market for simple insulin-delivery devices.

Negative

• None.

CeQur^®, a medical device company committed to simplifying the lives of people with diabetes by revolutionizing insulin-delivery solutions, today announced the close of an oversubscribed $115 million equity financing. The company will use the funds to advance commercial plans for CeQur Simplicity™, including market development activities, a phased commercial launch strategy that includes a limited market release in 2021, and the scale-up of high-volume manufacturing. CeQur Simplicity is both FDA cleared and CE-marked.

Credit Suisse Entrepreneur Capital Ltd. and Endeavour Vision led the financing with significant participation from new investors, including Tandem Diabetes Care, Inc. (NASDAQ: TNDM), Ypsomed Group (SWX: YPSN), Federated Hermes Kaufmann Funds, Kingdon Capital, and GMS Capital, as well as existing investors, Schroder & Co. Bank SA, and VI Partners.

“We are grateful for the support from this group of world-class investors, who share our vision to transform the lives of people with diabetes who require daily insulin therapy. In the pilot launch of CeQur Simplicity, we’ve been very encouraged by the feedback from healthcare professionals, payers, and people with diabetes, which validates that this novel device offers meaningful benefits to a large segment of people who are insulin dependent,” said Bradley Paddock, President and CEO at CeQur. “We look forward to advancing our commercial and manufacturing plans in preparation for our broadscale launch.”

Currently, people with diabetes who require intensive insulin management utilize either multiple daily injections (MDI) or advanced insulin-delivery devices. Research among individuals who manage their diabetes with MDI, and the medical professionals who treat them, demonstrates that many patients are not achieving their glucose targets in part due to lifestyle restrictions, social challenges, and fear of social stigma associated with insulin injections. For example, nearly two-thirds of patients studied do not feel comfortable injecting insulin in front of others.ⁱ Additionally, healthcare professionals report that among the most challenging aspects of starting a patient on rapid-acting insulin are getting patients to perform multiple daily injections and the complex education required for patients.ⁱⁱ Given the challenges with current approaches to insulin injections and the global impact of diabetes, it is estimated that the potential market for simple insulin-delivery devices is approximately $7.5 billion in the United States and roughly twice this amount globally.ⁱⁱⁱ

“CeQur Simplicity offers a simple solution to a major barrier for many people who need mealtime insulin. This financing, which is transformative for CeQur, provides additional validation for the value of CeQur Simplicity as a simple, convenient and discreet bolus insulin-delivery device that is designed to address the burden of multiple daily injections for over 3 million Americans – and many more individuals around the world,” said Richard Mott, Chairman of the Board at CeQur.

CeQur Simplicity is a simple, three-day, wearable insulin device for discreet, convenient and injection-free bolus dosing. One Simplicity patch holds up to 200 units of rapid-acting insulin administered in two-unit increments and replaces, on average, nine mealtime injections over three days. Clinical research has shown that nearly 90% of patients using CeQur Simplicity reported following their insulin regimen better as compared to MDI. The device is clinically proven to improve glycemic control, with patients achieving significantly improved HbA1C and time-in-range (TIR) goals.^ii,iv

“CeQur Simplicity is designed to address a large, underserved segment of the diabetes market by providing a simple, low-profile and comfortable alternative to injections,” said John Sheridan, President and CEO at Tandem Diabetes Care. “We recognize that there is not a one-size-fits-all solution for people living with diabetes, and this investment aligns with our goal to advance diabetes care by expanding the set of tools available to provide customer choice and ensure optimal therapeutic outcomes.”

About CeQur

CeQur is commercializing advanced, simple-to-use insulin-delivery devices that make it easier for people living with diabetes to adhere to therapy and stay in control of their disease. The Company’s simple, three-day, wearable devices provide freedom from multiple daily insulin injections. More information can be found at www.cequr.com.

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ⁱ Mehmet S, Hussey C, Ibrahim S. Patients’ perceptions of injecting insulin and self-monitoring of blood glucose in the presence of others. Practical Diabetes. 2014;32(2):59-63.
ⁱⁱ Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012;29(5):682-689.
ⁱⁱⁱ Based on global incidence and prevalence of patients on basal-bolus therapy and CeQur management estimates.
^iv Johnson ML, Dreon DM, Levy BL, et al. Comparing patch versus pen bolus insulin delivery in type 2 diabetes using continuous glucose monitoring metrics and profiles. Paper presented at: 54th Annual Meeting of the European Association for the Study of Diabetes; October 1-5, 2018; Berlin, Germany.

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FAQ

What is CeQur Simplicity and how does it work?

CeQur Simplicity is a three-day wearable insulin device that delivers bolus dosing without injections, replacing up to nine mealtime injections.

Who led the recent financing for CeQur?

The financing was led by Credit Suisse Entrepreneur Capital Ltd. and Endeavour Vision, with participation from Tandem Diabetes Care and other investors.

What are the commercial plans for CeQur Simplicity?

CeQur plans to advance market development and initiate a phased commercial launch for CeQur Simplicity starting in 2021.

What is the estimated market size for simple insulin-delivery devices?

The potential market for simple insulin-delivery devices is estimated at approximately $7.5 billion in the U.S. and around $15 billion globally.

How does CeQur Simplicity improve insulin therapy for patients?

Clinical research indicates that CeQur Simplicity improves glycemic control, helping patients better adhere to their insulin regimens.