Clinical need

Lightpoint Medical receives CE Mark for world’s first approved robotic gamma probe

January 25, 2021

Lightpoint Medical, a medical device company developing miniaturised surgical tools for advanced intra-operative cancer detection, announced today that it has received CE Mark approval for SENSEI®, the first robotic gamma probe to be commercially available to European hospital systems.

SENSEI® has been designed for intra-operative detection of sentinel lymph nodes as well as cancer metastasis through the lymphatic system. The technology promises more precise, targeted cancer surgery and is applicable across a wide range of major cancer types, including lung, colorectal, stomach, gynecological, and prostate cancer.

Dr. David Tuch, CEO of Lightpoint Medical, says:

“Lightpoint is developing the most advanced intra-operative cancer detection technologies. Securing CE Mark for SENSEI® is an important milestone in our efforts to transform cancer surgery and underscores our commitment to meet surgeons’ needs for miniaturised cancer detection tools as robotic platform technologies grow to dominate surgical practice.

“SENSEI® promises accurate real-time cancer detection for robot-assisted cancer surgery. Currently, surgeons have no way to precisely detect cancer intra-operatively. As a result, millions of patients suffer every year as cancer is frequently left behind or healthy, functional tissue is needlessly removed.”

Robotic surgeon, Dr Jim Adshead, at the Lister Hospital, East and North Herts NHS Trust, UK says:

“I am very excited about regulatory approval for SENSEI® and now eager to start using it in surgery. I have been closely involved in the development of the technology since early usability testing and I’m extremely hopeful for its potential in advancing the treatment of prostate cancer.”

Professor Declan Murphy, robotic surgeon at Peter MacCallum Cancer Centre, Melbourne, Australia added:

“I am delighted that SENSEI® has received CE Mark. Our team is very keen to start using the technology in prostate cancer surgery using the da Vinci robot. As a leader in research in robot-assisted prostate cancer surgery and molecular imaging using PSMA, we are extremely excited about the prospects for SENSEI® to improve outcomes for our patients.”

SENSEI® locates SPECT radioligands such as 99mTc-nanocolloid for sentinel lymph node detection or cancer-targeted drugs for cancer metastasis detection such as 99mTc-PSMA (Prostate Specific Membrane Antigen) in prostate cancer surgery.

CE Mark approval of SENSEI® is for sentinel lymph node detection.

Lightpoint Medical successfully registered SENSEI® with the FDA in September 2020, which means the technology is now authorised for sale in the US. The award-winning UK company is being supported with their US Strategy by the ABHI – a UK based trade association – and are part of ABHI US Accelerator programme in partnership with Dell Medical School, Texas. The programme aims to de-risk market entry into the world’s biggest medical device market.

Paul Benton, Managing Director, International, added:

“We are thrilled to hear of Lightpoint Medical’s latest achievement in obtaining CE for their ground-breaking miniaturised device. As a member of the ABHI US Accelerator, which exists as a catalyst for growth, it is great to see their success extending both sides of the Atlantic. With cancer rates increasing globally, the device offers a valuable tool allowing surgeons to detect cancer more accurately and is a fantastic example of UK innovation.”

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by Editor