Since 2019:
R&D, commercialisation, scale-up — three stages

Founded in 2019, launching development of the ultrasonic dissecting system — feasibility assessment completed and key technical breakthroughs achieved. In 2020 the Ministry of Science and Technology approved our entry into the Central Taiwan Science Park; the quality system was established and ISO 13485:2016 certification obtained. In 2021 we were admitted to the Emerging Stock Board (7608) — the first step into the capital market — and obtained TFDA GMP 1830 the same year.

In 2022 the first-generation product (Gen 1) obtained TFDA market licences (7356, 7518), shipped in Taiwan, with contract manufacturing guided through Hualien Jiatai Enterprise. In 2023 revenue doubled and gross margin turned from negative to positive, proving profitability. In 2024 Taiwan market share passed 10%, gross margin reached 39%, and the Central Taiwan Science Park R&D centre broke ground.

In 2025 we acquired the channel subsidiary "Kang De Biomedical"; the Science Park R&D centre was completed. In 2026 we entered volume production: the Central Taiwan Science Park plant produces the first-generation system, while Qisda produces the second-generation system. In the same year Gen 1.5 obtained TFDA clearance and launched — the only curved-jaw cordless system whose battery can be sterilised directly; Gen 1 extended shipments to Mongolia. Cumulative clinical use stands at >7,000 cases across 80 hospitals, 20 medical centres and 9 specialties.

The first wired ultrasonic dissector appeared in 1988 (UltraCision, later acquired by Ethicon / J&J); the first cordless device was cleared in 2011 (Covidien / Medtronic, FDA 510(k) K101797). Maxima is the team that followed — the second to commercialise a cordless ultrasonic dissector.

Surgeon trials run in late October; hospital code registration and inventory conversion continue.

The Gen 2 (MAXXONIC) filing K263177 was submitted on 2026-09-11; substantive interaction is expected 2026-11-10, with final decision expected 2026-12-10.

Contracted with the notified body BSI; the quality management system (QMS) audit is scheduled for 1–3 December 2026.

Once Gen 2 receives its 510(k), the following markets can file on an abridged or reliance route built on an existing clearance — without starting a full review from scratch in each country.
(i) 13 markets whose authority expressly accepts reliance on a US 510(k): Taiwan, Singapore, Sri Lanka, Kenya, Kuwait, Pakistan, Nigeria, Mongolia, Canada, Mexico, Peru, Malaysia, Morocco.
(ii) 13 markets that accept a reference-country approval (incl. GHTF founding members) to reduce the dossier: South Korea, Saudi Arabia, United Arab Emirates, Israel, Hong Kong, China, India, Chile, Philippines, Thailand, Türkiye, Kazakhstan, Brazil, Mainland China.
All 26 are markets where G1 (patents) is already clear (16 traceable to an official source, 10 secondary and pending confirmation); actual applicability and timing rest with each authority.

Continually in progress — not a single dated event, and not expressed as "expected on" any date. Three tracks are running in parallel, each gated on a different precondition. The table below shows what each track is waiting on, not a completion date:

Markets where all three conditions hold — G1 patents clear, the route accepts 510(k) reliance, and a channel is named: Singapore, United Arab Emirates, Canada, Israel, Malaysia, Saudi Arabia, India, Mexico. These are the first batch of the 26 markets in item 04 above; the remaining 18 follow as their conditions are met. The fastest is Singapore (3-9 months), the longest 18 months, in each case as the local authority decides.

Patents clear and the regulatory route mapped, but these do not draw on first-priority resources. 13 of them (Switzerland, Belgium, Czechia, Denmark, Spain, Finland, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Sweden) proceed through the CE / EU MDR system, separately from the 510(k) track — two regulatory lines running in parallel, so the work does not pile up behind one single clearance.

Austria, Australia, Germany, France, United Kingdom still hold originator-maintained patents; all five open on the same date, 2028-12-01.

United States: the Gen 2 510(k) filing declares that we will not enter the US market — that 510(k) is a passport for accelerated clearance elsewhere, not a ticket to the US. Mainland China: a Class III registration of 12–24 months, and even then hospital sales require winning a provincial alliance tender; not in the launch sequence at this stage.

The 510(k) decision and the EU MDR audit outcome rest with the authority and the notified body. Scheduled dates may move with additional information requests, queries or audit findings — scheduled is not obtained. The final decision on Gen 2 K263177 is expected 2026-12-10; the accelerated filings in the 26 markets and the launch of the 8 S1 markets in section 02 all presuppose that clearance — if it slips, both slip with it.

Patent clearance fails in 7 markets (AT / AU / DE / FR / GB / JP / US) as at 2026-10-09. For 5 of them the blocking date is the same, 2028-12-01; the United States is excluded by declaration made in the Gen 2 510(k) filing, and Japan's candidate ceiling is 2032-04-16 (previously listed as design-around under assessment; reclassified as FAIL by ruling on 2026-10-21). While those rights subsist, these seven markets are outside the addressable range.

A patent-clearance PASS means only that no blocking right was found within the scope searched — not that the country has no third-party patents; the public label is therefore a pass with scope limited. Where liveness passes, third-party patents still require separate search.

Our people and capital are finite, so we do not cast the net everywhere at once — markets are advanced in batches by priority, one step at a time. This is the risk-controlled approach; it also means each market's actual entry timing depends on its priority and on resource allocation at the time, rather than on a single date.

The Gen 2 patent candidate ceiling of 2028-12-01 carries meaning only for markets affected by those rights. It is not a single global launch date and does not apply to markets where patents are already cleared.