EOFlow Selects bioaccess.™ as its CRO in Colombia for the First-In-Human Study of its Breakthrough EOPancreas Medical Device
[ORLANDO, FL., March 15, 2019] — EOFlow Co., Ltd., an emerging medical device manufacturer with offices in Seoul, South Korea and San Jose, California, is on a mission to offer the best, the safest, the most reliable, and the most economical ways to manage diabetes disease. EOFlow's device integrates a continuous glucose sensor and an insulin pump in one small wearable module and autonomously controls insulin infusion to ensure that the patient’s blood glucose level stays within the normal range most of the time with little input from the patient. EOFlow has selected bioaccess.™ as its contract research organization (CRO) for the first-in-human (FIH) clinical trial of its EOPancreas medical device. The clinical trial will be conducted at CIMEDICAL in Barranquilla, Colombia — a top-performing clinical research center known for its ability to recruit patients and for the quality of the data it gathers from its research activities.
bioaccess.™ will assist EOFlow in obtaining CIMEDICAL’s ethics committee approval for its planned EOPancreas’s first-in-human clinical trial. bioaccess.™ will also handle the regulatory submission to help EOFlow obtain Ministry of Health (INVIMA) approval in Colombia; along with the importation of the investigational devices, project management, study monitoring, and other necessary activities to ensure a successful trial. No specific time frame is being announced for the approvals, however, the companies expect to have all necessary approvals and paperwork in place to begin recruiting patients by the second quarter of 2019.
Besides the EOPancreas EOFlow also makes an EOPatch wearable insulin pump system, the thin and light disposable pump unit (patch), and the smart-phone like color touchscreen controller (ADM); together with the advanced managing software tools, is designed to take off some of the burden of managing diabetes and make patients’ life a little bit easier. So far, EOFlow has successfully attracted $22 million dollars in several rounds of financing.
Most people with type 1 diabetes are insulin resistant in which insulin is not produced in their body. No oral medications have been developed and most patients are self administering to the abdomen subcutaneously 4 to 7 times a day with a pen-type insulin injector. However, the self-administration method has a limitation in the administration of an appropriate amount. Recently, the insulin pump has been developed into a wearable insulin patch pump which injects insulin into the body of a patient and injects an appropriate amount of insulin.
In December 2017, EOFlow received a license from the Korea Food and Drug Administration(KFDA) to sell the company's first product, the fourth grade medical device of the wearable insulin injection patch pump: the EOPatch.
In 2018, EOFlow has concentrated on the development of its EOPancreas wearable artificial pancreas. EOPancreas is a miniaturized disposable wearable artificial pancreas performed by a closed-loop system. Type 1 and type 2 diabetic patients can automatically and precisely administer adjusted insulin doses to individual themselves via a controller and bluetooth connection. The EOPancreas is waterproof and dust-proof, and diabetic patients will be able to carry out activities such as showering or swimming while having the EOPatch product attached to their body.
Particularly, the application of the electro-osmotic pump technology makes it possible to use the insulin patch in a smaller size and with only one attachment. With the EOPancreas, insulin can be injected for up to 3 days without any pain, so that diabetes patients who have difficulties with insulin self-injection —including pediatric patients— can easily use it.
The EOPancreas system is designed to provide closed loop blood glucose control for primarily type 1 diabetics (T1D) and consists of a novel, integrated wearable, disposable patch containing insulin delivery and continuous glucose monitoring (CGM) subsystems running a clinically-validated closed loop blood glucose control algorithm. The EOPancreas contains a unique, connected architecture, allowing the device to benefit from artificial intelligence (AI) algorithms running on a private, validated cloud —termed EOCloud— to allow customization of the closed loop control for each patient.
The EOPancreas System is being developed to address the continuing global challenges associated with diabetes management through lowering the barriers to blood glucose control for subjects living with this chronic condition. According to David Klonoff, M.D., FACP, FRCP (Edin), Fellow AIMBE (Clinical Professor of Medicine, U.C. San Francisco and Editor-in-Chief, Journal of Diabetes Science and Technology), “Recent published results such as those from the T1D Exchange registry(1) emphasize the continuing challenge for achieving target levels of glucose control for patients with type 1 diabetes. Even with the increasing use of CGM systems, greater improvements in clinically meaningful endpoints, such as Hemoglobin A1c and time in range are needed. Closed loop systems, such as the EOPancreas System, can be attractive tools to improve glycemic control.”
In 2017, EOFlow and the Juvenile Diabetes Research Foundation (JDRF) announced a partnership to accelerate the development of the artificial pancreas. "We are very excited that EOFlow is partnering with the world's leading private nonprofit funder of [type 1 diabetes] research to accelerate the development of this wearable automated insulin delivery system," EOFLow CEO Jesse Kim, said in a statement. "JDRF is a partner that believes in our vision of a small, practical, fully functional artificial pancreas system that can be used by anyone with [type 1 diabetes] to help live a fuller life." Before founding EOFlow, Mr. Kim previously ran a semiconductor startup in Silicon Valley after graduating from the Massachusetts Institute of Technology.
"JDRF is working hard to reduce the burden of living with type 1 diabetes while we search for ways to cure this disease," Jaime Giraldo, Ph.D., research scientist at JDRF, said in a statement. "Innovation in automated insulin delivery devices and artificial pancreas (AP) systems will help to significantly improve health and quality of life for people with [type 1 diabetes]. Next-generation wearable designs that are smaller and employ user-centric design will remove barriers that prevent some people, especially small children, from using these life-saving and life-changing glucose management devices."
JDRF has funded clinical trials for EOFlow's EOPatch device, which it hoped eventually act as not only an insulin pump, but as a full closed-loop system to deliver insulin, a significant step along the way to EOFlow's artificial pancreas. EOPatch is a wearable, adhesive insulin pump with a handheld touchscreen-enabled controller that closely resembles a smartphone. The device's size is its primary differentiator. It measures 49.5 by 32 by 12.6 millimeters and weighs less than an ounce. This makes the device especially good for children, JDRF said, since they are smaller and more burdened by bulky devices.
JDRF is a mission-driven nonprofit that has invested quite a bit in various digital health companies working on type 1 diabetes. It helped fund Bigfoot Biomedical's automated insulin delivery service smartloop last year. It has also worked with IBM on using machine learning to identify and treat type 1 diabetes and worked with the DIY diabetes patient community, as well. JDRF is the leading global organization funding type 1 diabetes (T1D) research. Its strength lies in our exclusive focus and singular influence on the worldwide effort to end T1D.
Since JDRF launched the Artificial Pancreas Project more than a decade ago, significant progress has been made in automating insulin delivery. However, a major factor when considering AP therapy is that the system becomes a major part of the life of a person with T1D. Currently, AP system hardware is bulky and either in direct contact, tethered to, or in very close proximity to the body, which may be barriers to the subsequent wide-scale adoption of AP systems. This factor is especially compounded in children, where skin real estate is at a premium.
JDRF wishes to reduce obstacles preventing AP system use for people with diabetes, in part by reducing on-body burden. In addition, now that AP systems have been consistently demonstrating sufficient safety and efficacy, user centric design is becoming an important consideration to be addressed in next-generation AP systems. These ease-of-use factors include minimizing the number of steps to fill, replace and install AP system components; integrating various AP system components into a single device to reduce the burden of managing disparate components at different intervals; and the size of the wearable devices.
“The product became the first device to be selected by the U.S. Juvenile Diabetes Research Foundation last year for its technological innovation and product excellence,” EOFlow said.
Recently, EOFlow's closed loop Automated Insulin Delivery /Artificial Pancreas Device (AID/AP), the EOPancreas System, received Breakthrough Device Designation (BDD) by the U.S. Food and Drug Administration. Replacing the Expedited Access Program (EAP), the BDD program is designed to assist expedited access to the US market for innovative medical device solutions which are intended to treat serious conditions. “The Breakthrough Device designation will assist us in developing clear design and development milestones in concert with the FDA, greatly accelerating our ability to commercialize this important new technology,” says Luis Malave, the president of EOFlow.
“EOFlow was founded to democratize wearable drug delivery solutions by providing intelligent, connected solutions for patients managing chronic conditions at globally-competitive price points”, according to Jesse Kim, founder and CEO of EOFlow, “and we see the FDA's Breakthrough Device designation as an important validation of our business model.”
With the BDD approval, the company has become the first medical device manufacturer to receive the BDD designation. The BDD is an expedited screening system that the FDA designates through a preliminary examination for products that the agency considers to have a high market demand among non-existent medical devices. All companies designated with the BDD will receive many benefits, such as priority review and additional review panels, which allows for a much faster product approval than a general review. However, the selection criterion is quite difficult with only 100 products receiving designation under the previous EAP program since it began in 2016.
About EOFLOW Co., Ltd.
EOFLOW is a wearable medical device company founded in 2011, with offices in Seoul, South Korea and San Jose, California, developing several innovative drug delivery systems based on its proprietary pumping technology. The Company’s first product is EOPatch, a fully functional wearable, disposable insulin pump for people with diabetes. For more information, please visit www.eoflow.com.
bioaccess.™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research clients with support services to ensure their first-in-human trials are a success in Colombia (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). For more information, please visit www.bioaccessla.com.
bioaccess.™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210