Spinal implant specialist L&K Biomed announced on the 18th that it has completed the regulatory approval application to the Brazilian Health Regulatory Agency (ANVISA) for its five types of height-expandable cages.
The items L&K Biomed applied for to the Brazilian Health Regulatory Agency (ANVISA) are currently its flagship products: ▲PassLock-TM ▲ExcelFix-XT (posterior and lateral minimally invasive surgery height-expandable cage) ▲PassLock-TA (anterior surgery height-expandable cage) ▲ExcelFix-XL (lateral surgery height-expandable cage) ▲ExcelFix-XTP (anterolateral surgery height-expandable cage), totaling five types of height-expandable cages. PassLock-TM and ExcelFix-XT are the most frequently used posterior and lateral insertion types during spinal surgery and can achieve a maximum angle of up to 20 degrees. They are considered competitive products in overseas markets.
Brazil, the largest market in South America, is one of the markets that quickly absorbs innovative and trendy new products. According to the global market research firm Research and Markets, the spinal-related market in Brazil in 2023 is approximately $410 million USD (about 533 billion KRW), which is about twice the size of the spinal-related market in Korea.
Due to its geographical proximity to the United States, the U.S. spinal implant company G has pioneered and supplied the height-expandable cage market in Brazil. However, in fast-changing markets like Brazil, there is no company with a full expandable lineup of height-expandable cages within the Brazilian market to meet the high interest and demand, resulting in insufficient supply.
To activate the supply of height-expandable cage products in Brazil, L&K Biomed signed a strategic sales contract worth $24 million USD (about 30 billion KRW) over seven years last year with a new Brazilian company, Company A.
The approval process with the Brazilian Health Regulatory Agency (ANVISA) was somewhat delayed due to the need to register a full lineup, including the anterior surgery height-expandable cage (PassLock-TA), which was not previously available in the market. PassLock-TA is the first product registered in the Brazilian market that even the existing implant company G does not supply. It is expected to attract significant interest and demand. Product sales in Brazil are expected to begin by the second half of next year at the latest.
An L&K Biomed official stated, "To meet the demand for height-expandable cages in Brazil and the Latin American region, we will work closely with our local Brazilian partner to accelerate the acquisition of ANVISA approval." He added, "We plan to launch a full lineup of height-expandable cages in the Brazilian market, which has never existed since company G, expand the market, and increase our product market share."
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