The most significant recent event was the resumption of trading on May 4, 2026, after the Korea Exchange decided to exclude Hironic from the substantive listing eligibility review, ending a suspension that had lasted more than a year.
Hironic announced on the 30th that its share trading suspension would be lifted after being excluded from the substantive listing eligibility review, with the suspension lifted effective May 4, 2026.
In a July 2026 disclosure, the company said it expected US FDA approval for its needle-free device SYNERJET within the third or fourth quarter of 2026, after which it plans to launch full-scale North American sales based on its existing distribution agreement.
The company expects US Food and Drug Administration approval for the combination device SYNERJET within the third or fourth quarter.
However, reports differ on the US regulatory status of the successor product SYNERJET PRO, with some describing the review as still ongoing while the FDA's public database shows a substantial equivalence determination already recorded, a discrepancy that warrants confirmation.
Reports on the US regulatory status differ. One outlet said Hironic was still undergoing the FDA's 510(k) review process for SYNERJET PRO, while the FDA's public 510(k) database shows the product received a "substantial equivalence" determination on April 6, 2026.
In North America, the company plans to expand installed equipment and dedicated consumable supply following the initial shipment through its Venus Concept partnership.
Starting with initial equipment supply, Hironic plans to increase the number of installations in North America and expand supply of dedicated consumables such as tips.
Domestically, expanding sales of SYNERJET PRO and MIGLOW has been set as a second-half priority, alongside plans to establish a new Japanese subsidiary to begin local sales operations targeting the Asian market.
The company plans to establish a new Japanese subsidiary, Hironic Japan, within the year to begin full-scale sales operations, leading with SYNERJET PRO, which has been approved for export to that market.
On shareholder returns, the company has stated its intention to continue returning capital based on earnings and financial capacity following its first quarterly dividend payment.
The company stated its policy of continuing a shareholder-return approach based on earnings and financial capacity rather than a one-off dividend.