[메드테크, 우리가 국대다]② Measure blood sugar each minute with a finger dimension sensor … “If profitable, annual gross sales might attain 500 billion gained. “

Nam Hak-hyun, CEO of i-Sense, is interviewed by Chosun Biz on the headquarters in Gangnam-gu, Seoul. CEO Nam mentioned, “Steady blood glucose screens are an amalgamation of nanotechnology.” /Chosun Biz

As we speak, there was a noticeable enhance within the quantity of people that train on the health club with blood sugar screens connected to their our bodies 24 hours a day. These aren’t folks with diabetes, however people who find themselves attempting to drop a few pounds. Instagram, a social media web site, is stuffed with affirmation pictures that seize the hashtag (#) and a blood sugar graph display.

The variety of diabetes sufferers in Korea has elevated dramatically through the years. The variety of sufferers identified with diabetes or taking blood sugar remedy is shut to six million. The variety of sufferers with excessive blood sugar (quick blood sugar stage 100-125 mg), which is handled as pre-diabetes, can also be rising quickly. There are a lot of individuals who select to eat it to manage their blood sugar ranges. For this reason real-time blood sugar screens are so well-liked.

A steady blood sugar meter is a medical machine that may monitor blood sugar ranges with out pricking a finger. Blood sugar is measured by pricking the pores and skin with a 200㎛ needle (micrometer, 1 millionth of a meter), which is thinner than a human hair, within the type of a patch. Developed ‘CareSense Air’, the primary steady blood glucose meter in Korea iSense (099190) CEO Nam Hak-hyeon mentioned, “The continual measurement machine is a set of nanotechnology that generates a steady sign utilizing pores and skin electrodes, enzyme reagents, and a protecting coating. “

◇ Able to dominate the home marketplace for steady blood glucose meters

CEO Nam, whom we met on the headquarters in Seocho-dong, Seoul on the twenty sixth of final month, rolled up his sleeves and confirmed off the continual blood sugar screens connected to each arms. On the fitting arm was the ‘CareSense Air’ that was launched this yr, and on the left arm was the ‘CareSense Air 2’, which is attempting to enter the US market. CEO Nam mentioned, “I went abroad with a measuring machine put in on a aircraft to see if it was working correctly,” and added, “After I confirmed that each CareSense and the upper model, CareSense 2, measuring with none interruption, it was a superb time.”

iSense is already the primary firm in Korea within the area of self-monitoring gadgets that measure blood sugar ranges by amassing blood from the finger. In 2000, when multinational medical machine firms dominated the home market, they developed low cost home merchandise and dominated the market. With the appearance of i-Sense, the value of self-measuring gadgets dropped from 300,000 gained to the 30,000-40,000 gained vary.

Consultant Nam graduated from the Division of Chemistry at Seoul Nationwide College and obtained his grasp’s and doctorate from Michigan State College in america. A do-it-yourself self-made blood sugar meter was developed as a nationwide challenge by Nam, who was a professor within the Division of Chemistry at Kwangwoon College. CEO Nam mentioned, “On the time, overseas gadgets had to attract blood from the finger to measure blood sugar stage, however we developed a product that might measure blood sugar stage by pouring a small quantity of blood. ” to launch, new merchandise from overseas nations that weren’t out there in Korea “They got here in like rain,” he mentioned with a smile.

iSense researchers measure blood sugar ranges within the blood sugar measurement laboratory at iSense headquarters in Seocho-dong, Seoul./Chosun Biz

◇ Collaborate with enterprise organizations throughout the federal government, selling entry into america

As with self-measuring devices, i-Sense has set a purpose to dominate the home marketplace for steady measuring devices inside 5 years. Presently, the home market is dominated by overseas merchandise corresponding to Abbott and Dexcom. The month-to-month price of overseas merchandise is 200,000 to 300,000 gained, however iSense units the value at 165,000 gained, which is half the value. It has already partnered with Kakao Healthcare and Handok to begin gross sales this yr.

It can additionally enter the European market inside this yr. iSense just lately signed an settlement with a Hungarian medical machine distributor. Rep. Nam mentioned, “I am not too fearful concerning the Korean and European markets.” Presently, the largest problem for i-Sens is coming into the US market. iSense has developed an ultra-lightweight product that reduces the scale of a 500 gained coin to the scale of a fingernail, and is at the moment engaged on getting a license in america.

The explanation why the No. 1 Korean firm reached out to the pan-government Life Cycle Medical System Growth Undertaking is due to the US market. Participation in authorities initiatives could be very troublesome. Paperwork should be submitted in a well timed method and should be blocked. Rep. Nam mentioned, “There was an inside notion that ‘we do not help authorities initiatives,'” and “However we determined we would have liked the assistance of a government-wide enterprise group to go in.” to the US market and succeed.”

iSense plans to use for scientific trial approval for CareSense Air 2 to the US Meals and Drug Administration (FDA) this yr. The plan is to finish scientific trials subsequent yr, get hold of approval in 2026, and launch in 2027. To attain this purpose, home approval should first be achieved. It’s because for a medical machine to achieve success, it should have enough scientific proof based mostly on its use elsewhere.

The pan-ministerial enterprise group took steps to advertise home-made medical gadgets to the worldwide market. CEO Nam mentioned, “The enterprise group had a superb understanding of what the corporate needed,” and “By way of the association of the enterprise group, we had been in a position to get the chance to clarify the idea of the product to the Ministry of Meals and Security Medicine.” Consultant Nam mentioned, ‘I sympathized with the imaginative and prescient of the pan-ministerial challenge group to develop home-made medical gadgets that could possibly be offered within the world market.

iSense CEO Nam Hak-hyeon holds CareSense Air 2, a steady blood sugar meter developed for the US market, at iSense headquarters in Seocho-dong, Seoul./Chosun Biz

◇ “International medical machine purpose inside 5 years”

In keeping with Nam’s CEO, CareSense Air 2 is at the moment the best specification product on this planet. The patch dimension is the smallest, and blood sugar values ​​are transferred to the smartphone at one-minute intervals through Bluetooth. There is no such thing as a must appropriate blood sugar ranges by blood assortment. The time to make use of one patch can also be the longest (21 days). CEO Nam mentioned, “To enter the US market, we analyzed hundreds of competitor patents and registered tons of of patents to guard.”

After all, after gaining approval within the US market, a competitor could launch a product with higher specs. Mentioned CEO Nam, “We’re even contemplating correcting the accuracy of measurement values ​​or creating an ‘synthetic pancreas’ that connects a blood sugar meter to an insulin pump. Nam’s CEO can also be on the lookout for a accomplice firm that may develop an app that may analyze blood sugar measurements in actual time and supply recommendation on blood sugar administration.

Relating to coming into the US market, CEO Nam mentioned, “The way in which the corporate is doing is determined by it, so I undoubtedly need to make it profitable. ” Amongst Korean digital medical machine firms, nobody has but grown within the world market. Nevertheless, if it succeeds, it may well develop into a worldwide firm instantly. iSense’s purpose is to develop into a worldwide firm inside 5 years with CareSense Air 2.

There are many alternatives. In keeping with a current report by Analysis & Markets, the worldwide steady blood glucose meter market is anticipated to develop to $7.5 billion (roughly 10.34 trillion gained) by 2030. iSense’s world market share for self-testing gadgets is 5%. It’s estimated that annual gross sales of 500 billion could be earned by taking solely 5% of the world market.

CEO Nam mentioned the most typical query he obtained after beginning iSense was, “Why do you make blood sugar screens?” The query was whether or not a professor needs to be creating merchandise that exist already reasonably than creating new merchandise that don’t exist on this planet. At the moment, the CEO responded as follows. “An organization will not be about creating new issues, it is about creating wealth. “I’ll see a giant market. “