Treace publishes four-year bunion surgery study results

Treace Medical Concepts Inc. (NASDAQ: TMCI) announced the publication of four-year interim results from its ALIGN3D multicenter study in the Journal of Foot & Ankle Surgery. The study evaluated outcomes of the company's Lapiplasty procedure for bunion correction.

The published results included data on 139 of 173 study patients treated with at least four years of follow-up. The study showed patients returned to protected weight bearing at an average of 7.7 days and returned to athletic shoes at 6.5 weeks following the procedure.

Radiographic recurrence rates were 0.8% using HVA>20° and 8.4% using HVA>15° at 48 months. The study reported an 81% improvement in pain and 89% improvement in walking and standing scores through 48 months on the MOxFQ scoring system.

"We are pleased to announce this new peer-reviewed publication from our flagship ALIGN3D study demonstrating sustained, successful patient outcomes from our proprietary Lapiplasty procedure out to four years," said John T. Treace, CEO and founder of Treace.

The ALIGN3D clinical study is a prospective, multicenter, post-market study designed to evaluate outcomes of the Lapiplasty procedure in surgical management of symptomatic hallux valgus. The study enrolled 173 patients aged 14 to 58 years at seven clinical sites in the United States with 13 participating surgeons.

Final patient follow-up for the primary endpoint was completed in the first half of 2023. Study completion with five-year data is expected in 2026, according to the company's statement.

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