FDA Approves PerQseal Elite, Opening U.S. Large-Bore Closure Market
HAE has more than doubled off its 52-week low of $48.98.
Summary
The FDA cleared PerQseal Elite for large-bore arterial closure, the first U.S. approval for the sutureless, fully bioabsorbable patch platform Haemonetics picked up with its January 2026 Vivasure Medical acquisition. The device seals arteriotomies up to 26F and showed 0% major complications per VARC-3 with mean hemostasis under one minute in the ELITE study. This is the commercial payoff on the Vivasure deal and puts Haemonetics into the U.S. structural heart closure market alongside TAVR and endovascular procedures, a higher-growth area than its core apheresis business. It follows a strong stretch for the company: Q1 FY27 revenue rose 5.6% to $339.4 million with raised full-year guidance, and CSL Plasma committed in October to completing the NexSys PCS rollout across its U.S. network. Clinical data will be presented at the TCT Conference at the end of October.
At the time of this announcement, HAE was trading at $118.73 on NYSE in the Life Sciences sector, with a market capitalization of approximately $5.4B. The 52-week trading range was $48.98 to $123.77. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: PR Newswire.