L&K Bio Obtains Vietnamese Medical Device Approval for Height-Expandable Cage 'PassLock-TM'

LNKBioMed announced on the 11th that it has obtained medical device sales approval for the height-expandable cage ‘PassLock-TM’ from the Vietnam Ministry of Health.

‘PassLock-TM’ is a height-expandable cage product most frequently used for posterior and posterolateral insertion procedures. The core competitiveness of height-expandable products lies in how accurately the implant height can be ergonomically adjusted. It is designed to allow selection of the spinal insertion angle (up to 20 degrees) and length (up to 25 mm) according to the patient’s spinal environment, and to increase the height (up to 4 mm), making it a highly competitive product in the global market.

Additionally, ‘PassLock-TM’ is a key product for LNKBioMed’s growth, having been used in over 2,500 spinal surgeries in the United States as of last September. This record was achieved in about 2 years and 4 months, showing steady growth. Most importantly, among the 2,500 PassLock-TM units used, there have been no cases of malfunctions or postoperative complications caused by the product, proving the product’s safety and excellence as well as high patient satisfaction.

LNKBioMed entered the Vietnamese height-expandable cage market in June with ExcelFix-XT. An LNKBioMed official stated, "Following the launch of ExcelFix-XT, we aim to actively expand the height-expandable cage market in Vietnam with the approval of PassLock-TM."

An LNKBioMed official added, "Vietnam is a steadily growing medical device market with great potential. Using the medical device approval of PassLock-TM as a milestone, we plan to increase our brand awareness and influence throughout Southeast Asia beyond Vietnam, expanding the sales channels for height-expandable cage products."

Last month, LNKBioMed successfully entered new overseas markets such as Indonesia and Uzbekistan. The company is preparing certifications in various countries including Taiwan, Singapore, and Europe to expand sales and supply chains. Based on the achievement of obtaining the second approval in Vietnam, LNKBioMed plans to further expand export scale through more active global activities in the United States, Southeast Asia, Europe, and Central Asia.