KOSDAQElectrical Equipment419540

Bistos

₩3,020▲ 1.68%2026-10-02 close

Market Cap

₩17.2B

Turnover

₩20,184,466

Volume

6.9K

Shares out.

PER

—

PBR

1.0×

EPS

-₩168

Dividend Yield

0.00%

PER, EPS, PBR and BPS are calculated in-house from the last 4 quarters (2025Q3–2026Q2) · Dividend yield is based on ₩0 per share · Prices as of the 2026-10-02 close

Report overview

Ownership Change Tests a Fragile Turnaround

Bistos gained a new controlling shareholder in CU Medical Systems, but an operating loss in 2025 followed by continued quarterly losses through the first half of 2026 means an earnings turnaround has yet to show up in the numbers.

1
Consolidated 2025 revenue fell to KRW 17.1 billion (-15.6% year on year) for a fourth straight annual decline, and operating profit swung to a loss of KRW 1.1 billion (operating margin -6.4%) from a profit in 2024.
2
The operating loss in the second quarter of 2026 reached KRW 0.86 billion, the largest among the five reported quarters (2Q25-2Q26), and the sum of net losses attributable to owners over the most recent four quarters (3Q25-2Q26) was about KRW 1.0 billion.
3
In November 2025, CU Medical Systems agreed to acquire a 33.88% stake in Bistos for KRW 22 billion, and the ownership transfer was completed in January 2026 after final payment and a shareholders' meeting.
4
A KRW 3.5 billion third-party rights issue to CU Medical Systems in June 2026 secured KRW 2.5 billion for facility expansion, to be executed in stages through 2026-2027.
5
With more than 90% of revenue generated from exports to over 120 countries, results remain highly sensitive to currency swings and overseas demand cycles.

Business structure

Bistos, founded in 2001 and listed on KOSDAQ in 2022, is a vital-signal-based medical device maker.

Its core business centers on fetal and neonatal devices, including fetal monitors, neonatal jaundice phototherapy units and incubators, from which it expanded into home healthcare devices such as breast pumps and thermometers, as well as patient monitoring systems.

More recently the company has been broadening its portfolio into higher value-added areas such as a brain electrical stimulation device for ADHD treatment (BT-1000), a dementia-focused tDCS device, and a wearable baby monitor.

Over 90% of revenue comes from exports to more than 120 countries, and the company has secured major certifications including US FDA and European CE approvals across multiple product lines, building credibility in international markets.

In November 2025, emergency medical device specialist CU Medical Systems, known for automated external defibrillators (AEDs), agreed to acquire a 33.88% stake from existing major shareholders for KRW 22 billion, becoming the largest shareholder after the ownership transfer was completed in January 2026.

CU Medical's plan is to combine its Class 3 AED-centered lineup with Bistos's Class 1-2 patient monitoring and vital-signal technology to build a comprehensive medical device portfolio spanning emergency, diagnostic, monitoring and therapeutic devices.

The two companies are consolidating research labs and test infrastructure to reduce duplicate investment, while integrating manufacturing and quality-control know-how and joint parts procurement to improve cost competitiveness.

Bistos's ownership of the full value chain from basic vital-signal research to product design, manufacturing and data analysis is cited as a differentiating strength relative to peers.

Earnings trend

Quarterly revenue · Operating profit

₩4.5B₩6,975,30725Q2₩4.3B-₩500M25Q3₩4.6B-₩65,843,88125Q4₩3B-₩400M26Q1₩4.2B-₩900M26Q2

RevenueOperating profit

Annual revenue · Operating profit

₩24B₩900M2022₩21.3B₩300M2023₩20.3B₩300M2024₩17.1B-₩1.1B2025

RevenueOperating profit

Quarterly results · Last 5 quarters
Quarter	Revenue	Operating profit	Op. margin
2025Q2	₩4.5B	₩6,975,307	0.2%
2025Q3	₩4.3B	-₩500M	−10.7%
2025Q4	₩4.6B	-₩65,843,881	−1.4%
2026Q1	₩3B	-₩400M	−13.2%
2026Q2	₩4.2B	-₩900M	−20.4%

Annual results
Year	Revenue	Operating profit	Net income (parent)	Op. margin	ROE	Debt-to-equity
2022	₩24B	₩900M	-₩4.5B	3.8%	−28.3%	28.7%
2023	₩21.3B	₩300M	₩800M	1.3%	4.3%	16.1%
2024	₩20.3B	₩300M	₩800M	1.5%	4.4%	10.4%
2025	₩17.1B	-₩1.1B	-₩700M	−6.4%	−3.9%	15.6%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-08-23

Earnings analysis

Annual revenue declined for four straight years, from KRW 23.96 billion in 2022 to KRW 21.30 billion in 2023, KRW 20.25 billion in 2024 and KRW 17.10 billion in 2025.

The operating margin held at a modest positive level of 3.8% in 2022, 1.3% in 2023 and 1.5% in 2024, before turning negative at -6.4% in 2025 (an operating loss of KRW 1.10 billion).

Net income attributable to owners swung from a large loss of KRW 4.50 billion in 2022 to two consecutive profitable years of KRW 0.81 billion in 2023 and KRW 0.85 billion in 2024, before falling back into a loss of KRW 0.70 billion in 2025.

Total equity rose from KRW 15.92 billion in 2022 to KRW 19.42 billion in 2024 before declining to KRW 17.91 billion in 2025, while the debt ratio fell from 28.7% in 2022 to 10.4% in 2024 before edging back up to 15.6% in 2025.

Operating cash flow was a stable inflow of KRW 1.74 billion in 2023 and KRW 2.44 billion in 2024 but reversed to a net outflow of KRW 2.17 billion in 2025, pointing to weakening cash generation.

On a quarterly basis, operating profit was near breakeven at KRW 7 million in the second quarter of 2025 before deteriorating sharply to an operating loss of KRW 459 million in the third quarter; the fourth quarter loss narrowed to KRW 66 million, yet net income was positive at KRW 309 million, suggesting non-operating items were at play.

Revenue fell sharply on seasonality to KRW 2.97 billion in the first quarter of 2026 with an operating loss of KRW 391 million, and although revenue recovered to KRW 4.20 billion in the second quarter, the operating loss widened to KRW 856 million, the largest in the reported window.

As a result, the sum of net losses attributable to owners over the most recent four quarters (3Q25-2Q26) reached roughly KRW 1.0 billion, indicating that any earnings improvement from the ownership change has yet to show up in quarterly results.

Industry analysis

The fetal and neonatal medical device market grew quickly during the COVID-19 pandemic on the back of surging demand for home healthcare devices, but growth has been described as moderating since the shift to an endemic phase.

Declining birth rates across Korea and many developed markets structurally constrain the domestic base for fetal and neonatal devices, though Bistos generates more than 90% of revenue from exports to over 120 countries, diversifying its exposure to any single country's demographic trend.

The company continues to diversify export destinations toward emerging markets in the Middle East, Latin America and Asia, a strategy seen as offsetting demographic headwinds in developed markets.

Competitively, Bistos operates alongside global patient-monitoring and vital-signal device makers, and its ownership of the full value chain from basic research to product design, manufacturing and data analysis is cited as a differentiating strength.

CU Medical Systems, now the largest shareholder, is credited with a history as an early Asian developer of automated external defibrillators (AEDs) in the Class 3 emergency device category, and the combination with Bistos's Class 1-2 vital-signal monitoring devices is seen as having potential to broaden the combined portfolio across device classes.

Whether this potential synergy translates into measurable revenue and profitability gains, however, remains to be confirmed.

Outlook

The company is progressing through certification for several new products in stages; according to a brokerage report, the BT-380 and BT-700 devices completed domestic and European CE certification, the BT-1000 ADHD treatment device secured US FDA certification, and the BT-740/770/780 series completed domestic and CE certification with US FDA approval targeted for 2026.

Bistos continues to secure patents in existing product lines such as incubators as well as newer high-value areas including brain electrical stimulation devices and a wearable baby monitor within its healthcare wearables business.

In June 2026, a KRW 3.5 billion third-party rights issue to largest shareholder CU Medical Systems secured KRW 2.5 billion in facility funding, to be deployed in stages through 2026-2027 toward expanding medical device manufacturing capacity and supporting new business lines.

Since the ownership transfer, the two companies have been consolidating research and test infrastructure, standardizing quality-control systems, and pursuing joint parts procurement to improve cost competitiveness, while also exploring use of Bistos's distribution network across more than 120 countries to help expand exports of CU Medical's AED and other emergency devices.

SK Securities analyst Na Seung-du wrote in a December 2025 report that 2026 could be an important turning point for earnings as new product certifications are completed in stages, and identified maintaining profitability in existing fetal and neonatal products alongside progress on new certifications and export diversification as key items to watch.

Still, with quarterly operating losses persisting through the first half of 2026, the point at which this growth narrative translates into an actual earnings improvement has not yet been confirmed.

Valuation

PER

—

PBR

1.0×

ROE

-5.3%

EPS

-₩168

BPS

₩3,319

Dividend per share

₩0

With operating results having swung from profit to loss in 2025 and quarterly losses persisting through the first half of 2026, profitability-based valuation metrics remain difficult to compute in a meaningful way.

On a self-calculated basis, the share price sits close to per-share net asset value, suggesting neither a pronounced premium nor a pronounced discount to book value at present.

Brokerage estimates from the 2023-2024 profitable period had shown price-to-earnings multiples in the 40-60x range, a pattern often associated with small-cap growth names combining a low absolute profit base with elevated multiples.

The company currently pays no cash dividend, making dividend-based comparisons less meaningful.

With a change in controlling shareholder, new product certifications and facility investment all underway, whether earnings direction shifts back from loss to profit remains the central variable for any valuation discussion going forward.

PER, EPS, PBR and BPS are all calculated in-house (the same method as Naver and Toss) · Dividend yield = cash dividend per share from DART filings (supplemented by KRX) ÷ current price · As of 2026-08-23

Bull factors

Product and Channel Synergy from the CU Medical Deal

CU Medical Systems, an AED-centered Class 3 emergency device maker, is pursuing a combined portfolio spanning emergency, diagnostic, monitoring and treatment devices by pairing with Bistos's Class 1-2 patient monitoring and vital-signal technology.

The two companies plan to consolidate research and test infrastructure, standardize quality-control systems, and pursue joint parts procurement to improve cost competitiveness.

Bistos's distribution network across more than 120 countries could support CU Medical's overseas expansion, while CU Medical's brand strength and channels could in turn help expand sales of Bistos products.

A Diversifying New Product Certification Pipeline

The company is reported to have secured US FDA certification for its ADHD treatment device (BT-1000), and other product families such as the BT-740/770/780 series have reportedly completed domestic and CE certification with US approval targeted afterward.

Ongoing patent activity in brain-related and wearable healthcare areas, including a dementia tDCS device and a wearable baby monitor, could reduce reliance on the legacy fetal and neonatal product line over time. That said, the scale and timing of revenue contribution from these new products remain unconfirmed.

Geographic Diversification from a High Export Ratio

With more than 90% of revenue derived from exports to over 120 countries, dependence on demand weakness in any single country or region is limited.

The ongoing strategy of diversifying export destinations toward the Middle East, Latin America and Asia can partly offset domestic constraints from low birth rates in developed markets.

Operating cash flow was a stable inflow of KRW 1.74 billion in 2023 and KRW 2.44 billion in 2024, demonstrating the underlying business's cash-generation capability in those years.

Bear factors

Four Straight Years of Revenue Decline and Reversing Profitability

Annual revenue declined for four straight years, from KRW 23.96 billion in 2022 to KRW 17.10 billion in 2025, and the operating margin flipped from 1.5% in 2024 to -6.4% in 2025.

Net income attributable to owners also reversed from two consecutive profitable years in 2023-2024 back to a loss of KRW 0.70 billion in 2025. This trajectory shows that the positive factors of a shareholder change and new product pipeline have not yet translated into improved results.

Quarterly Losses Persisting Through First-Half 2026

Operating losses were recorded in three of the most recent four quarters from the third quarter of 2025 through the second quarter of 2026, and the second-quarter 2026 operating loss widened to KRW 856 million, the largest in that window.

The sum of net losses attributable to owners over the period reached about KRW 1.0 billion, showing that the earnings improvement expected from the shareholder change has not yet appeared in quarterly results.

Operating cash flow also turned to a net outflow of KRW 2.17 billion in 2025, warranting attention to the pace of cash usage.

Structural Low Birth-Rate Pressure and Slowing Market Growth

The home healthcare and fetal/neonatal device market, which grew rapidly during the COVID-19 pandemic, is seen as having entered a slower growth phase since the shift to an endemic environment.

Low birth rates across Korea and many developed markets structurally constrain the long-term demand base for the core fetal and neonatal device business. While export diversification partly offsets this, observers note inherent limits to the growth potential of the core product category itself.

Risk factors

Demographic Risk

The core fetal and neonatal device business is directly tied to birth numbers, so a prolonged low birth-rate trend across Korea and many developed markets could weigh on both domestic demand and export demand from countries with similar demographics.

The company is responding through export diversification into emerging markets and expansion of non-neonatal product lines, but this transition will take time to fully take hold.

Governance and Integration Risk

The largest shareholder changed to CU Medical Systems in January 2026, and a third-party rights issue to that same shareholder in June 2026 means the ownership structure continues to evolve.

The process of integrating research, manufacturing and quality-control systems could involve temporary cost burdens or organizational friction, and if the planned synergies do not materialize as expected, the gap between expectations and actual results could widen.

Currency and Export Concentration Risk

With more than 90% of revenue coming from overseas exports, results are heavily influenced by won exchange-rate movements and demand cycles in key export markets.

A past brokerage report cited rising exchange rates as a factor behind weaker results, underscoring that currency exposure remains an ongoing variable for the business.

What to watch next

Mid-November 2026 (expected)
Expected timing of the third-quarter 2026 report, when it will be important to check whether the widening operating-loss trend through the second quarter eases and whether revenue recovers.
Second half of 2026
A period to watch for progress on US FDA certification for the BT-740/770/780 product series and any early sales results emerging from distribution-network cooperation with CU Medical Systems.
During 2026-2027
Worth monitoring is the execution progress of the KRW 2.5 billion facility funding secured through the June 2026 rights issue, and whether the resulting capacity expansion translates into actual revenue.
Early 2027 (expected)
Expected timing of the fiscal 2026 annual business report, a point to comprehensively check whether the full-year operating result improves from the 2025 loss and to review trends in equity and cash flow.

Overall view

Bistos currently sits at the intersection of a weak near-term earnings trend—an operating loss in 2025 followed by continued quarterly losses through the first half of 2026—and a longer-term growth narrative built around diversification and new product certification following the entry of CU Medical Systems as controlling shareholder.

Annual revenue has declined for four consecutive years and operating cash flow turned to a net outflow in 2025, making near-term profitability metrics clearly weak.

On the other hand, an export network spanning more than 120 countries, a certification pipeline including an ADHD treatment device and a wearable baby monitor, and planned product and channel synergies with CU Medical are presented as the basis for a potential longer-term shift in the business structure.

Which of these two dynamics shows up first in the numbers will likely be central to how results are interpreted going forward.

In particular, the timing of new product certification completions, the results of facility-investment execution, and whether quarterly earnings direction turns from loss to profit remain important items to watch from the second half of 2026 onward.

Investors should also weigh the ongoing organizational integration process following the shareholder change and the possibility of related one-off costs.

Sources

Korea Exchange (KRX) — Prices · Market Cap · Volume
FSS electronic disclosure system (DART) — Financial statements · Dividend filings

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Report written 2026-09-05 · Data as of 2026-09-04

This content is AI analysis of market data and web search results, provided for information only. It is not a solicitation or recommendation to invest. Investment decisions and their consequences are the investor's own responsibility. Data may be delayed or contain errors.