CyMedica wins CE Mark for QB1

CyMedica said yesterday it won CE Mark approval in the European Union for its QB1 muscle activation system.

The QB1 combines a postoperative knee brace, form-fitting conductive garment and a neuromuscular electronic stimulation control interface, and is the 1st to use a close-loop power system that delivers high-intensity electrical muscle stimulation, the Scottsdale, Ariz.-based company said.

“Securing the CE Mark for the QB1 System marks an important milestone for our company, greatly expanding our market opportunity to patients in Europe and paving the way for a global sales and distribution network. We are excited to have the clearance to deliver our revolutionary technology to millions of patients outside of the United States. Having recently launched domestically, we will continue to dedicate ourselves to expanding our market penetration within the US as we evaluate the timing and structure of our plans to commercialize the QB1 internationally,” CEO Rob Morocco said in a press release.

The device received FDA 510(k) clearance in April, and the company said it has already seen a “a tremendous reception from orthopedic surgeons and knee patients across the United States.”

In June, CyMedica said it raised $11.5 million in a Series A financing round, with funds slated for expanding sales and distribution of the company’s QB1 device.

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