Terumo Blood and Cell Technologies has announced regulatory approvals for its Spectra Optia Apheresis System in 14 Latin American countries, covering new therapeutic indications for sickle cell disease, Guillain-Barré syndrome, and myasthenia gravis. The approvals expand treatment options for patients with rare and chronic conditions and align with the World Health Assembly’s historic resolution on rare diseases adopted in May 2025.

The approvals enable clinicians to use automated red blood cell exchange and therapeutic plasma exchange to manage these conditions, offering a minimally invasive treatment pathway that can improve patient outcomes.

“Proven therapies are now within reach for thousands of people living with rare and often life-threatening conditions,” said Antoinette Gawin, president and CEO of Terumo Blood and Cell Technologies. “These approvals matter — they are a step toward clinical inclusion, establishing a new standard of care in the region and broader health equity.” She added: “Our goal is to ensure these therapies are not limited to a few, but integrated into clinical guidelines and hospital protocols and covered by insurance systems.”

The newly approved therapy indications are now available in Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, and Uruguay. Approvals were granted by regional health authorities based on clinical evidence demonstrating that automated red blood cell exchange and therapeutic plasma exchange are safe and effective in managing these diseases.

Sickle cell disease is a genetic blood disorder that causes red blood cells to take on a sickle shape, increasing the risk of pain episodes and other complications. Automated red blood cell exchange replaces sickled cells with healthy ones, reducing disease complications. In Brazil alone, an estimated 60,000 to 100,000 people are affected.

Guillain-Barré syndrome is a rare autoimmune disorder in which the immune system attacks peripheral nerves, leading to weakness, numbness, or paralysis. Therapeutic plasma exchange removes antibodies from the blood to ease symptoms and support recovery, with an estimated 7,200 to 11,800 cases annually in Latin America.

Myasthenia gravis is a chronic neurological condition causing muscle weakness. Severe cases can trigger myasthenic crises, where breathing muscles fail and ventilatory support is required. Plasma exchange or intravenous immunoglobulin is used in such cases, with global prevalence estimated at over 700,000 people.

The approvals from Terumo BCT aim to broaden clinical access and integrate rare disease therapies into standard practice across Latin America, offering new hope to patients and caregivers in the region.