"An insulin pump that improves sustainability with a reusable structure has received item approval. If we combine it with an AI algorithm, we can build a fully automated artificial pancreas system that patients around the world, beyond Korea, can use much more conveniently."
Park Sung-min, head of CureStream, met with ChosunBiz at the company's headquarters in Guro-gu, Seoul, on the 26th of last month and said, "This item approval is the first step toward a fully automated artificial pancreas system."
Korean medical device startup CureStream on the 29th received item approval from the Ministery of Food and Drug Safety for ModuStream, the nation's first patch-type insulin pump that separates a reusable main unit from replaceable consumables. It is a new type of insulin pump that improves on the high maintenance expense and short usage period of existing disposable patch pumps.
CureStream, founded in 2019 by Park Sung-min, a professor at Pohang University of Science and Technology POSTECH's Innovative Medical Solutions Lab, achieved its first item approval about seven years after its founding.
Park served as a senior scientist and research and development (R&D) manager at Medtronic headquarters, a U.S. medical device corporations, leading development of an implantable pacemaker that operates safely even in magnetic resonance imaging (MRI) environments. Park then led the digital health business in the wireless division at Samsung Electronics and, based on experience in implantable medical devices and digital health, moved into developing an artificial pancreas system.
◇"The nation's first 'reusable' patch-type insulin pump… achieving both sustainability and affordability"
Diabetes is a chronic disease that requires lifelong management because insulin, which controls blood sugar, is insufficient or does not function properly. In particular, people with type 1 diabetes must inject insulin several times a day.
Recently, using continuous glucose monitors (CGMs) and insulin pumps to check blood sugar in real time and inject insulin as needed has greatly improved management convenience. However, users still must directly adjust insulin dosing according to blood sugar changes and meal size, and, because the device must be used long term, the high maintenance expense remains a burden for patients.
An insulin pump is a device attached to the skin that continuously injects insulin as needed, developed to ease the burden of multiple daily injections for people with type 1 diabetes.
The insulin pump market has long relied on overseas products such as Insulet's Omnipod in the United States. Later, in 2021, domestic corporations EOFlow released the EOPatch, and in 2024, CareMedi launched CareRevo, expanding patients' options.
However, most patch-type insulin pumps currently on the market are disposable structures that discard the entire main unit after a set period of use. Patients must shoulder high maintenance expense and frequent replacements, and corporations also face significant burdens in terms of mass production and waste disposal.
By contrast, ModuStream separates a reusable main unit from replaceable consumables. The consumable module that delivers insulin is replaced every 3.5 days, while the main unit is designed to be used for up to three years.
To support product upgrades and stable management, the company plans to operate an actual replacement cycle of one year. After launch, it will verify the product's safety and effectiveness through a post-market clinical study and begin full-scale sales starting this fall.
Park said, "For medical devices, sustainability is not just about the environment—price also matters," adding, "Once diagnosed, people with diabetes must use the device for life, so the key is to build a cost structure that anyone can afford."
CureStream aims to cut maintenance expense to about half that of existing products.
◇"AI that doesn't even need an 'I ate' button… aiming for a 'fully automated' artificial pancreas"
CureStream's core edge is an artificial pancreas system that is fully automated based on artificial intelligence (AI). The company is developing a single integrated system that combines the ModuStream insulin pump, the AI autonomous insulin dosing algorithm AI Pancreas, and the blood sugar management platform CureLoop.
Most automated insulin delivery systems currently in commercial use require users to manually enter various information such as meals or exercise. AI Pancreas calculates insulin dosage using only CGM data, so even if users do not enter meal sizes or carbohydrate intake, the algorithm analyzes blood sugar changes and automatically adjusts insulin delivery.
Park said, "It is closer to an autonomous algorithm that makes its own judgments than general automated control," adding, "Ultimately, the goal is to implement a fully automated artificial pancreas system that requires little patient intervention."
CureStream plans to begin an exploratory clinical trial within the year with 50 people with type 1 diabetes to seek approval for AI Pancreas. If it secures approval next year, the company expects to combine the AI algorithm with ModuStream to realize a fully automated artificial pancreas system.
To date, most commercialized automated insulin delivery systems have been developed for people with type 1 diabetes. CureStream recently completed an exploratory clinical trial for people with type 2 diabetes and plans to expand the application scope to type 2 diabetes going forward.
Park explained, "Type 2 diabetes is actually more challenging because of high insulin resistance and more varied eating patterns," adding, "It is meaningful that the automated algorithm showed a certain level of performance even in type 2 patients, as it confirms the technology's feasibility."
In the long term, CureStream is also considering an open platform strategy so that AI Pancreas can be used not only with its own insulin pump but also with various insulin pumps.
Park said, "The competitiveness of an insulin pump ultimately depends on how reliably it manages blood sugar, and the core is the algorithm," adding, "If we can deliver the same level of performance not only with our product but also with other devices, I don't see a reason to monopolize it."
Park added, "We may be able to offer price benefits to our own pump users, but ultimately our goal is to allow external customers to use AI Pancreas as well," noting, "We are also discussing related collaboration with domestic corporations."
◇"Up to 600 units a month… exploring entry into Europe and the Middle East"
CureStream is also accelerating the buildout of its manufacturing system in step with this item approval. The company has already secured the capacity to produce 500 to 600 units per month and plans to expand automation to steadily improve supply stability and price competitiveness.
Park said, "At first, the high proportion of manual work makes it hard to expect large revenue right away, but once the automated production system is in place, we can stabilize quickly," adding, "Above all, it is important that we have built a production base that can supply patients reliably."
Overseas expansion will also proceed step by step. The company focused on the domestic approval process, so overseas approvals were somewhat delayed, but it plans to first pursue European medical device (CE) certification and then seek entry into Southeast Asia and the Middle East.
Park said, "Once we complete the confirmatory clinical trial for the AI algorithm, we will not only enhance treatment convenience for domestic patients but also have a foundation to expand into overseas markets," adding, "Ultimately, our goal is to build a fully automated artificial pancreas that anyone can use at an affordable expense."