[Edaily Reporter KIM JI-WAN ] SCL Science(246960) “InnoSEAL Plus DL,” a Class 4 absorbable hemostatic agent, is accelerating its market expansion by securing listings in the in-hospital coding systems of major tertiary general hospitals across the country.
Class 4 absorbable hemostatic agent InnoSEAL Plus DL.
SCL Science announced on the 11th that “InnoSEAL Plus DL” recently passed the review for new medical devices at Yonsei University Severance Hospital in Sinchon. With only the hospital code registration process remaining, actual use within the hospital is expected to begin shortly.
Previously, in July, the company obtained a medical device code from Seoul St. Mary’s Hospital of the Catholic University of Korea and completed the shipment of its initial batch. With Sinchon Severance Hospital passing the review approximately one month after the company’s entry into Seoul St. Mary’s Hospital, and review applications now being submitted to other “Big 5” hospitals, the product’s expansion into the “Big 5” and major tertiary general hospitals appears to be gaining momentum.
InnoSeal Plus DL is a third-generation biodegradable hemostatic agent based on the chemical polymer “chitosan-catechol (CHI-C),” inspired by the structure of mussel adhesive proteins. Since it achieves hemostasis independently of blood clotting proteins, it can be used even in patients taking anticoagulants or those with blood clotting disorders. Following the securing of a Class 4 medical device manufacturing license and inclusion in the National Health Insurance reimbursement list in 2025, the company received approval from the Ministry of Food and Drug Safety in May of this year to reclassify the product as a general-purpose hemostatic agent for intra-abdominal surgery, significantly expanding its indications for use.
The company previously announced a domestic distribution and sales agreement with Jeongseon Medical Co., Ltd. for InnoSeal Plus DL, totaling 100,000 units over three years at a value of 8.5 billion won (including VAT). With approval already granted by Severance Hospital in Sinchon and in-hospital code reviews proceeding sequentially at numerous tertiary general hospitals, the foundation for the actual fulfillment of this supply contract is considered to be firmly established. Since hospital code registration is a prerequisite for hospital deliveries, the company explains that expansion into each tertiary general hospital directly leads to the fulfillment of the contract volume and the potential for follow-up contracts.
An SCL Science official stated, “Following the general approval of InnoSeal Plus DL for intra-abdominal surgery, we began with code listing at Seoul St. Mary’s Hospital, then passed the in-hospital review at Severance Hospital in Sinchon, and have completed the submission of review applications to the other Big 5 hospitals.” The official added, “As in-hospital reviews are currently underway at numerous tertiary general hospitals, we do not anticipate any significant difficulties in fulfilling the announced supply contract volume or expanding additional sales.” The representative further emphasized, “Given our business structure, where the number of hospitals with the product listed in their internal codes directly corresponds to the number of revenue recognition channels, the expansion of code listings at tertiary general hospitals in the second half of the year will mark the beginning of a full-scale ramp-up in hemostatic agent sales.”
Meanwhile, InnoSeal Plus DL is also preparing for overseas expansion, having recently completed the registration of a European patent, and the company plans to continue expanding the review process with the goal of securing in-hospital code listings at additional tertiary general hospitals by the end of the year.
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