Dive Brief:
- Haemonetics, which makes systems for processing and analyzing blood, has agreed to sell a manufacturing facility in Union, South Carolina, to CSL Plasma. The plant makes liquid saline and sodium citrate solutions used in the plasma collection process.
- Separately, the Braintree, Massachusetts-based company said it received FDA clearance for an expanded indication for its hemostasis system designed for use in trauma settings.
- The clearance was based on clinical data from a trial of about 500 patients comparing the company’s latest TEG 6s hemostasis analyzer to its TEG 5000 system which has been used in trauma settings for more than a decade.
Dive Insight:
It's been a busy few weeks for Haemonetics, a company in the midst of a turnaround effort to boost its business. Last week, Haemonetics reported a 6.7% rise in quarterly revenue to $249.3 million, compared with a year ago. Net income in the quarter climbed 37.4% to $32 million, boosted by strong plasma revenue growth.
The company is now rolling out its NexSys plasma collection system and NexLynk DMS donor management software. On its recent earnings call, CEO Chris Simon said the company is three years into a five-year turnaround effort that is on track for accelerating revenue growth and profitability. The company said it's seeing market growth above historic rates amid rising demand for plasma-based medicines.
Redeploying resources to higher-growth businesses is part of the turnaround strategy. The sale of the South Carolina plant to CSL will help Haemonetics improve its operating performance and focus on its core business, Simon said.
CSL Plasma provides plasma to CSL Behring, which uses the raw material to develop medicines for people with diseases such as immune deficiencies and bleeding disorders. The 200 Haemonetics employees working at the facility will have the opportunity to become CSL Plasma employees.
Haemonetics' 510(k) clearance gives the company an expanded indication for its TEG 6s Hemostasis Analyzer System for use in adult trauma settings. Jefferies analysts noted to investors that the company's estimated $50 million annual trauma opportunity will likely prove conservative over time.
It is the first cartridge-based system available in the United States to evaluate the hemostasis condition in those patients, according to the company. The indication adds to the system's current use in cardiovascular surgery and cardiology procedures. The TEG 6s system can provide test results within 10 minutes, the company says.
The technology consists of the analyzer, disposable cartridges and software. The cartridge automatically mixes a small blood sample with reagents and runs up to four assays at once, reducing the potential for human error and lowering wait time for results so physicians can quickly determine the course of treatment for a patient, the company said.
