"An insulin pump that boosts sustainability with a reusable design 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 can use much more conveniently, beyond Korea."
Park Sung-min, CEO 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."
Korea-based medical device startup Curestream on the 29th received item approval from the Ministery of Food and Drug Safety for ModuStream, the country'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, has achieved its first item approval about seven years after its founding.
Park led the development of an implantable pacemaker that operates safely in magnetic resonance imaging (MRI) environments at the headquarters of U.S. medical device company Medtronic, serving as a senior scientist and research and development (R&D) manager. Park then handled the digital health business in the wireless division at Samsung Electronics and, based on experience in implantable medical devices and digital health, set out to develop an artificial pancreas system.
◇"Korea's first 'reusable' patch-type insulin pump… capturing both sustainability and cost-effectiveness"
Diabetes is a chronic disease that requires lifelong management because insulin, which controls blood sugar, is insufficient or does not work properly. In particular, patients with type 1 diabetes must inject insulin several times a day.
Recently, with continuous glucose monitors (CGMs) and insulin pumps, patients can check blood sugar in real time and inject insulin as needed, greatly improving convenience. However, patients still have to manually adjust insulin dosing based on blood sugar changes and meal size, and because these devices must be used over long periods, high maintenance expense remains a burden.
An insulin pump is a device that attaches to the skin and continuously injects insulin as needed, developed to reduce the burden of multiple daily injections for people with type 1 diabetes.
The insulin pump market has long relied on overseas products such as the OmniPod by U.S.-based Insulet. Later, in 2021, domestic corporations EOFlow launched the EOPatch, and in 2024, CareMedi introduced CareRevo, expanding patient options.
However, most patch-type insulin pumps currently on the market are disposable designs where the entire main unit is used for a set period and then discarded. Patients must shoulder high maintenance expense and frequent replacements, and corporations also face significant burdens in mass production and waste disposal.
In contrast, ModuStream has a structure that separates a reusable main unit from replaceable consumable parts. The consumable module that delivers insulin is replaced every 3.5 days, while the main unit is designed to last up to three years.
For product upgrades and stable management, the company plans to set the actual replacement cycle at one year. After launch, it plans to verify the product's safety and efficacy through a post-market clinical study, and begin full-scale sales starting in the fall.
Park said, "Sustainability in medical devices is not only about the environment but also about price," adding, "Once diagnosed, people with diabetes must use devices 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 competitive edge is an artificial pancreas system that is fully automated with artificial intelligence (AI). The company is developing a single integrated system that combines the ModuStream insulin pump, the AI autonomous insulin delivery algorithm AI Pancreas, and the blood sugar management platform CureLoop.
Many of today's commercial automated insulin delivery systems require users to manually input various information such as meals or exercise. AI Pancreas calculates insulin dosing using only CGM data, automatically adjusting insulin delivery by analyzing blood sugar changes without requiring users to enter meal size or carbohydrate intake.
Park said, "It is closer to an autonomous algorithm that makes its own judgments than to general 'automated' control," adding, "Ultimately, the goal is to implement a fully automated artificial pancreas system that requires little patient involvement."
Curestream plans to begin an exploratory clinical trial within the year with 50 people with type 1 diabetes for AI Pancreas approval. If it obtains approval next year, the company expects that the AI algorithm can be combined with ModuStream to implement a fully automated artificial pancreas system.
Most commercialized automated insulin delivery systems so far 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.
Park explained, "Type 2 diabetes is actually a more difficult area because of high insulin resistance and diverse 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 technological feasibility."
In the long term, Curestream is considering an open platform strategy so that AI Pancreas can be used not only with its own insulin pump but also with various other insulin pumps.
Park said, "The competitiveness of an insulin pump ultimately depends on how stably it manages blood sugar, and the core of that is the algorithm," adding, "If we can deliver the same level of performance not only on our product but also on other devices, there is no reason to monopolize it."
Park added, "We may be able to offer price benefits to users of our own pump, but ultimately the goal is to allow external customers to use AI Pancreas as well," noting, "We are also discussing related collaborations with domestic corporations."
◇"Up to 600 units per month… eyeing expansion into Europe and the Middle East"
With this item approval, Curestream is also accelerating the establishment of its production system. The company plans to expand automated production to continually enhance supply stability and price competitiveness.
Park said, "At first, the high proportion of manual work makes it hard to expect significant revenue right away, but once an automated production system is in place, we can stabilize quickly," adding, "Above all, it is important that we have built a production base capable of supplying patients reliably."
Overseas expansion will also proceed in phases. While the company focused on domestic approval procedures and its overseas regulatory work was somewhat delayed, it plans to first pursue European medical device (CE) certification and then seek entry into Southeast Asian and Middle Eastern markets.
Park said, "Once we complete the confirmatory clinical trial for the AI algorithm, we will not only improve treatment convenience for domestic patients but also have the basis 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."