Haemonetics Gains FDA Clearance for NexSys PCS, Persona PLUS Boosts Yield by Mid-Single Digits
Haemonetics secured FDA 510(k) clearance for its NexSys PCS plasma collection system featuring Persona PLUS technology, backed by a multicenter pivotal trial of over 30,000 donations from nearly 3,000 donors. The trial demonstrated a mid-single-digit percentage increase in average plasma volume per donation compared to the prior Persona system.
1. FDA Clearance Secured
Haemonetics obtained FDA 510(k) clearance for its NexSys PCS plasma collection system equipped with Persona PLUS technology, enabling tailored plasma donations for improved yields. This clearance authorizes U.S. marketing and distribution of the next-generation integrated collection platform.
2. Robust Clinical Trial
The clearance was supported by a prospective, randomized, controlled, multicenter pivotal trial involving over 30,000 plasma donations from nearly 3,000 donors. Results showed Persona PLUS delivered a mid-single-digit percentage increase in average plasma volume per donation versus the original Persona technology.
3. Commercial and Market Implications
With growing demand for plasma-derived therapies, the upgraded system is expected to lower cost-per-liter and enhance operational efficiency for plasma centers. Broad adoption could accelerate Haemonetics' revenue growth and reinforce its leadership in plasma collection technologies.