[Edaily Reporter NA EUN-KYUNG ] CureStream, a developer of insulin pumps, has received approval for its AI-based, fully autonomous insulin delivery algorithm as an independent software medical device and is launching a subscription and licensing business. The company’s strategy is to expand its business scope beyond that of a hardware manufacturer to become an AI therapeutic solutions provider by making the algorithm available for use on third-party insulin pumps, rather than tying it exclusively to its own “ModuStream” insulin pump. CureStream aims to go public (IPO) in 2028, building on the commercialization of the algorithm and the successful market launch of ModuStream.

Counting Carbs at Every Meal… AI Does It

for You Park Seong-min, CEO of CureStream, recently met with Edaily at the company’s headquarters in Guro-gu, Seoul, and stated, “Ultimately, CureStream aims to become a company that uses AI to automatically control actual drug administration, rather than just a company that makes a single insulin pump.” He added, “The commercialization of AI algorithms will be a crucial part of CureStream’s future growth.”

The AI-based, fully autonomous insulin delivery algorithm currently under development by CureStream is a technology that analyzes blood glucose data received in real time from a continuous glucose monitor (CGM) and the changes in blood glucose levels following insulin administration to automatically calculate the required insulin dose on the spot. The system works by transmitting the calculated dose to an insulin pump, which then delivers the insulin into the body.

Many of the currently available automated insulin delivery (AID) systems also use CGM to measure blood glucose levels and automatically adjust insulin doses. However, in many cases, patients must manually enter information—such as the amount of carbohydrates they will consume—to calculate the additional insulin needed for meals.

The problem is that it is not easy for patients to calculate this accurately every time. Even when consuming the same amount of carbohydrates, the extent to which blood glucose rises varies depending on how the food is prepared, and there are individual differences in insulin response even when eating the same food. If a patient enters a carbohydrate amount based on experience that is higher than the actual intake, there is a possibility that more insulin than necessary will be administered.

CEO Park explained, “Eating 100 grams of rice does not raise blood sugar levels the same way as eating 100 grams of tteokbokki. Since tteokbokki contains not only rice cakes but also sugar, patients must take all of this into account,” he explained, adding, “While some experienced patients who have managed their blood sugar for a long time have a good understanding of their insulin response, most patients find it difficult to calculate this accurately every time in their daily lives.”

CureStream aims to minimize such patient intervention. It uses CGM to continuously monitor changes in the patient’s blood glucose levels, and AI learns how blood glucose levels change in response to different insulin doses to automatically determine the appropriate dosage for each patient.

CEO Park said, “We determined that having AI analyze real-time data to determine the appropriate insulin dose would reduce the risk of overdosing and thus be safer.”

Not Tied to ModuStream… ‘AI Subscription’ for Third-Party Pumps Too

Instead of obtaining approval by bundling its AI-based fully autonomous insulin delivery algorithm with ModuStream as a single system, CureStream plans to seek approval as an independent software medical device. This is to enable the company to supply the algorithm not only to its own products but also to insulin pumps from other companies.

CEO Park stated, “Rather than seeking approval by bundling the AI algorithm with AlloStream as a set, we plan to obtain separate approval as a software medical device,” adding, “This is a strategy to avoid tying the algorithm to a specific insulin pump and to open it up so that other companies can license the algorithm and users of third-party pumps can also subscribe.”

There is also no need to wear an additional device. The algorithm is embedded in a smartphone application (app), which calculates the required insulin dose based on CGM data and sends a command to the pump; the pump then administers that dose of insulin into the body.

According to the company, the development of the algorithm itself has already been completed. An exploratory clinical trial targeting patients with type 2 diabetes was completed at Gangbuk Samsung Hospital, and the company is currently preparing to write a research paper. Next, an exploratory clinical trial targeting patients with type 1 diabetes will be conducted at Samsung Seoul Hospital. The company aims to submit a clinical trial application this month and commercialize the algorithm by 2027.

During the clinical trials, the company plans to evaluate metrics such as the “Time in Range” (TIR), which is the percentage of time a patient’s blood glucose remains within the normal range of 70–180 mg/dL. A higher TIR indicates that blood glucose levels remain within the optimal range for a longer period throughout the day.

Allustream as a First Stepping Stone… “Next Valuation to Exceed 100 Billion”

The hardware foundation for the AI business is the ModuStream insulin pump, which recently received product approval from the Ministry of Food and Drug Safety. CureStream plans to conduct a post-market clinical trial involving 5 to 10 participants at Gangnam Severance Hospital starting this month. Since the product has already been approved, this trial is more of a marketing-oriented effort to gather real-world patient experience and ensure product reliability rather than a trial aimed at obtaining approval.

Unlike systems that require replacing the entire disposable patch, Modustream is designed so that the main unit is reusable, while only consumables—such as the insulin reservoir—need to be replaced. The main unit is designed for one year of use, and consumables need to be replaced approximately every 3.5 days. CureStream’s strategy is to use this approach to reduce the total cost patients must bear when using an insulin pump over the long term.

CureStream aims to secure at least 500 ModuStream users in its first year of launch. With the current production capacity (CAPA) of its existing factory, the company can support approximately 500 patients, and it plans to consider building additional production facilities if the number of users increases in the future.

CEO Park stated, “Since insulin pumps are medical devices that patients must use for decades, not only usability but also the financial burden is important,” adding, “We are focusing our business on creating a pricing structure that allows patients to use the device continuously.”

With the commercialization of ModuStream and the development of an AI-based, fully autonomous insulin delivery algorithm now in full swing, the company plans to accelerate its efforts to secure investment and prepare for an initial public offering (IPO). CureStream is currently pursuing a Series B funding round and plans to decide—based on business progress—whether to proceed to a pre-IPO or IPO process or to conduct an additional investment round.

The target date for the IPO is 2028. Aiming for a corporate valuation of at least 100 billion won, the company plans to begin IPO preparations by the end of this year and select an underwriter as early as the beginning of next year.

CEO Park emphasized, “There are limits to the opportunities that can be created with hardware alone. Becoming a company equipped with algorithms and solutions is the direction CureStream must take.”