SHARE

News Alert: Citius Pharmaceuticals Receives FDA Approval For LYMPHIR™ (Denileukin Diftitox-Cxdl) Immunotherapy For The Treatment Of Adults With Relapsed Or Refractory Cutaneous T-Cell Lymphoma. Click to Read More.

Transenterix Inc (NYSEMKT:TRXC) has penetrated  the Japanese market where is has succeeded in selling off its first Senhance system. The buyer was the Saitama Medical University International Medical Center which is located near Tokyo. The provider is looking forward to that moment when the U.S. Food and Drug Administration will approve Senhance.

A top analyst by the name Rick Wise while recently speaking to a number of top news reporters said, “While Senhance is currently not approved for sale in Japan, this placement falls under the Japanese physician import license which allows clinicians to purchase unapproved cutting-edge medical devices. This would seem to suggest a high level of clinician interest in Senhance and is highly encouraging as we think about broader potential global adoption. … Looking ahead, we believe U.S. Senhance approval remains the most critical near-term value creating event.”

According to Bizjournals.com, TransEnterix back in the year 2015 acquired Senhance from Italy’s Sofar, and the system features a CE Mark approval across Europe.

At the moment, FDA is reviewing Senhance and according to some trusted sources, clearance is expected in the late stage of this particular year. Some top officials working with the provider are looking forward to this approval with much anticipation. They say the approval will mark a new beginning for them since they will be able to accomplish so much within the shortest time frames.

In February, St. Marien-Krankenhaus Siegen hospital in Germany made the move to purchase Senhance system from the top notch provider. As a result, TransEnterix recorded revenue of $1.9 million for the first quarter of 2017 which analysts have termed as “a show of much more to come” for the provider after in dawned on them that it was primarily related to  the sale of one Senhance in that particular quarter.

Japan happens to be the second biggest market for the robotic assisted surgery devices and the medical devices.