Theraclion secures Saudi approval for Sonovein and targets the Middle East
Marketing authorization, granted on October 28, 2026 by the Saudi Food and Drug Authority (SFDA), gives access to a market that the company describes as one of the leading markets in the Middle East. Theraclion announced it in a press release published on November 3, 2026 and linked it to its international commercial strategy.
The Middle East designated as a development priority
On this occasion, Theraclion recalled the focus areas of its commercial strategy, adapted to its key markets. In the United States, the company is preparing its entry, subject to FDA authorization; Sonovein is not yet available for sale there. In Europe, where the platform holds CE marking under the MDR regulation, the rollout is continuing.
In China, market access development relies on partner Furui and their local joint venture. In the rest of the world, presence is expanding through local distributors, and it is on this latter front that management designates the Middle East as a “development priority.”
Local distributors to expand the network of user centers
The group already has several Sonovein systems installed in the region and states it intends to rely on this nascent presence to strengthen its commercial momentum there. The Saudi approval allows it to extend its development in this country with local distributors and to support the expansion of the network of user centers in the Middle East.
Martin Deterre, Chief Executive Officer, described this authorization as a “concrete step forward” for the group's commercial development in the region. “Our objective is to turn this opening into new installations and growing use of Sonovein, as part of our international commercial strategy,” he said.
For reference, Sonovein has to date been adopted by more than twenty centers worldwide and used in more than 4,000 procedures. The company, listed on Euronext Growth Paris and based in Malakoff, has around forty employees.
