[Edaily Reporter NA EUN-KYUNG ] The domestic patch-type insulin pump market is entering a competitive phase. CareMedi’s CareRevo—the second domestically produced insulin pump to receive approval in five years—was recently launched, and CureStream is also set to join the competition later this year as a follow-up product. Additionally, with speculation mounting about the potential return of IoPatch by EOFlow Co., Ltd.(294090)—which has resolved its patent dispute with U.S.-based Insulet—attention is focused on how the market landscape might shift.

CareRevo Sells Out Continuously… Full-Scale Push into the Domestic Patch-Type Market Begins

According to the insulin pump industry on the 22nd, CareMedi launched its

patch-type

insulin pump, CareRevo, on May 26.

CareRevo’s key differentiators include a capacity of up to 300 units and a design that allows for up to 7 days of use. Compared to the existing IoPatch and Omnipod—the global market leader—which have capacities of around 200 units, CareRevo has significantly increased its storage capacity. CareMedi explains that by adopting a different internal structure from competing products and utilizing electroosmotic pump technology, they have achieved a smaller, lighter design while also reducing noise.

CareRevo offers the advantage of being able to sync data with CareSense Air, the continuous glucose monitor (CGM) from i-SENS, Inc.(099190). i-SENS, Inc. has been investing in CareMedi since 2021 and holds a 5.5% stake (as of the end of March). There are high expectations for the future development of an ecosystem that allows management of everything from blood glucose monitoring to insulin delivery within a single platform.

A CareMedi representative stated, “Children receiving multiple daily insulin (MDI) therapy must take insulin injections several times a day. However, using CareRevo can reduce the number of injections,” the representative explained, adding, “It is also receiving positive reviews for its convenience, as users can immediately administer insulin via the app even when additional insulin is needed outside of scheduled times, without worrying about others’ gazes.”

He continued, “There are also positive reviews noting that, compared to previously used insulin pumps, there is less pain upon needle insertion and a reduction in skin indentation.”

Although it has been a month since the product’s launch, demand has outstripped supply, making it difficult to purchase the product. i-SENS, Inc. is solely responsible for CareRevo production, but since continuous sales are difficult, the company is responding to market demand through a weekly scheduled sales system.

A CareMedi official stated, “We expect product sales to stabilize starting this fall,” adding, “To meet the growing demand, we plan to gradually expand our production capacity (CAPA) by introducing automated production facilities.”

CareMedi is currently conducting post-market clinical trials. The trials aim to verify whether insulin is delivered stably and whether the device can be used for up to seven days. The company aims to complete the post-market clinical trials by the end of the year.

‘Appeal Victory’ for EOFlow Co., Ltd.… Will IoPatch Sales Resume?

Attention is also focused on the possibility of the IoPatch’s return to the market. This is because EOFlow Co., Ltd. recently won its appeal in the U.S. Court of Appeals for the Federal Circuit (CAFC) against a trade secret and patent infringement lawsuit filed by Insulet.

The appellate court overturned the previous ruling, finding that Insulet had filed the lawsuit after the statutory filing period had expired from the time it could have become aware of the trade secret infringement. Although the remand proceedings are still pending, EOFlow Co., Ltd. expects to resume domestic sales of the IoPatch in the second half of the year.

Yoon Min-wook, Chief Financial Officer (CFO) of EOFlow Co., Ltd., stated, “We are making preparations on various fronts to expand production of the IoPatch 2 and strengthen our sales organization,” adding, “We are aiming to resume sales in August or September. Following the resumption of domestic sales, we will also accelerate our expansion into overseas markets such as Europe, the Middle East, Russia, and China.”

The IoPatch, which received product approval from the Ministry of Food and Drug Safety in June 2019, is Korea’s first patch-type insulin pump, and EOFlow Co., Ltd. is the pioneer that opened up the domestic market for patch-type insulin pumps. It garnered attention for its design, which attaches directly to the body without an infusion tube, and entered overseas markets after obtaining European CE certification in 2021. The IoPatch 2, for which EOFlow Co., Ltd. is currently preparing to resume sales, features a reduced size and weight compared to the IoPatch 1, along with improved ease of use.

CureStream: “AI Automatically Calculates Insulin Doses”

As a latecomer to the market, CureStream is positioning convenience and cost competitiveness enabled by artificial intelligence (AI) as its key differentiators. CureStream is currently undergoing the regulatory approval process for its insulin pump, with the goal of launching it within the year. Following the launch, the company plans to verify product reliability through a post-market clinical trial involving approximately 10 participants. Production will be handled directly at its own factory.

A key feature of CureStream’s insulin pump is an algorithm that automatically calculates insulin dosage based on data from a continuous glucose monitor. Many insulin pumps currently on the market require users to manually enter information such as meal size or carbohydrate intake. However, CureStream aims to minimize this input process.

Cost competitiveness is also cited as a key strength. While CareRevo and OmniPod feature a disposable patch-type design, CureStream separates the reusable main unit from the consumables, allowing users to repurchase only the consumables. CureStream expects this approach to lower long-term usage costs.

Park Seong-min, CEO of CureStream, said, “Since insulin pumps are medical devices that patients must use for decades, not only usability but also the financial burden is important.” He added, “We are focusing on creating a pricing structure that allows users to continue using the device. We plan to officially launch the product within this year after completing post-clinical trials.”

Why Do Patent Wars Keep Erupting Over Insulin Pumps

? The patch-type insulin pump sector is considered to have high patent barriers due to the nature of the technology, which requires the precise delivery of medication within a small device. The core technologies are broadly divided into actuator technology—which generates the force to push insulin—and precision delivery technology, which ensures the insulin is delivered to the patient without error. In particular, since the system must accurately administer extremely small amounts of insulin in response to changes in blood glucose levels, a significant number of patents are concentrated in this area.

The global market for patch-type insulin pumps took off in 2005 when Insulet commercialized the OmniPod, the world’s first tubeless patch-type insulin pump. Since then, Insulet has expanded its intellectual property (IP) portfolio by securing hundreds of patents. In 2023, the company further strengthened its patent defenses by acquiring the insulin pump-related patent assets of Bigfoot Biomedical, a U.S.-based diabetes management company.

The issue is that a patch-type insulin pump is not a simple medical device, but rather a complex device that combines mechanical, electronic, software, and drug delivery technologies. Patents cover not only the pump’s drive mechanism but also various areas such as △drug reservoirs △cannulas △wireless communication △and automatic injection algorithms. For this reason, even if a latecomer develops a product, there is a high likelihood of conflict with existing patents. In fact, Insulet has been involved in patent disputes with several competitors in addition to EOFlow Co., Ltd.

In the dispute between EOFlow Co., Ltd. and Insulet, the litigation centered on multiple layers—including the internal design structure of the patch-type pump, the precision delivery mechanism, and allegations of trade secret infringement—rather than simply the function of insulin delivery itself. Insulet claimed that the IoPatch was similar in appearance and internal structure to its OmniPod and infringed on its core technologies. EOFlow Co., Ltd. countered that the product was developed using its own proprietary technology.

An industry insider in the insulin pump sector explained, “Insulet is a company that has secured not only the technology to generate force but also the technology to deliver medication with precision,” adding, “Since patch-type insulin pumps must incorporate both of these technologies, the technical barriers are high.”