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Endomagnetics Ltd.

File:Endo Logo Large 3 Endomagnetics Logo
Industry	Medical Devices
Headquarters	Cambridge, UK
Area served	EMEA
Products	SentiMag® and Sienna+®
Website	www.endomagnetics.com

Endomagnetics Ltdis a Cambridge based medical device company which uses advanced magnetic sensing technology and nanotechnology to aid in cancer staging in the treatment of breast cancer and melanoma. Endomagnetics' patented technology was originally developed at University College London and the University of Houston.

The company’s first product, the SentiMag®, is used as part of the current standard sentinel lymph node (SLN) biopsies technique, used by surgeons to monitor the spread of cancer and to plan interventions. The SentiMag® comprises an ultrasensitive hand-held probe for detecting nanoscale magnetic materials in the human body, and works by tracking the presence of clinically introduced magnetic nanoparticles (Sienna+®), avoiding the need for traditionally used radioactive tracers.

Founders

Endomagnetics was founded by Prof. Quentin Pankhurst, Simon Hattersley and Prof. Audrius Brazdeikis. While no longer involved in its day-to-day operations, the founders maintain an active role with Endomagnetics through a variety of technical collaborations.

Prof. Pankhurst is the Director of the Institute of Biomedical Engineering at University College London and Director of the UCL Healthcare Biomagnetics Laboratory. He is also the Director of the Davy-Faraday Research Laboratory and Wolfson Professor of Natural Philosophy.

Simon Hattersley has a Cambridge Physics background, and over 25 years’ experience designing systems, electronics and embedded software for advanced instruments.

Prof. Brazdeikis is Research Associate Professor of Physics at the University of Houston and an Adjunct Associate Professor at UT-Health Science Center-Houston. He is a principal investigator of HTS Biomagnetic Imaging Laboratory at the Texas Center for Superconductivity (TcSUH). He has authored over 50 original scientific publications in leading scientific journals and has 3 issued US patents.

History

In June 2010, following venture capitalist investment and funding from the UK Technology Strategy Board, Eric Mayes joined Endomagnetics as CEO.

In December 2010 the SentiMag® received CE approval, and a year later, the magnetic tracer, Sienna+® was also approved.

In February 2013 Endomagnetics signed a strategic distribution agreement for EMEA region with Sysmex Europe GmbH.

An additional £2.1m venture capital was invested in Endomagnetics in August 2013.

Lymph Node Localisation

When a cancer spreads, it first travels to the lymph nodes. Lymph nodes are small bean‐shaped organs, ranging 2-20 millimetres in size that act as filters to clean the lymph as it passes through. The node first in line to receive lymphatic drainage from a tumour is called the sentinel lymph node.

Sentinel lymph node biopsy (SLNB) is a procedure to determine whether cancer has spread, so that the right treatment can be given to every patient. In the case of breast cancer, if no cancer is detected in the sentinel lymph node, then there is no need for an axillary lymph node dissection (ALND) in which the 30 or so lymph nodes in the armpit are removed.

Locating and testing the sentinel lymph node via keyhole surgery is considered preferable to the invasive ALND procedure with its associated problems, and so helps to ensure that patients are not over-treated. The SLNB procedure results in shorter breast cancer operations and better patient recovery.

The conventional method of sentinel lymph node localisation involves injecting a radioactive tracer and blue dye, and localising using a gamma‐ray detector. While effective, this method is limited by the supply of a substance called molybdenum‐99, the parent radioisotope to the short‐lived gamma‐emitting technetium-99m used in medical imaging applications. Molybdenum‐99 decays so quickly that it must be supplied to hospital nuclear medicine departments every week, and is made in limited amounts in just a handful of nuclear reactors worldwide. Second, the handling of radioactive materials is subject to stringent regulations, requiring special staff training and segregation of the waste from the operating theatre. Third, the costs in providing and handling the radioactive materials are high. Consequently, the majority of women with breast cancer will never be offered sentinel node biopsy based on this method.

Endomagnetics' SentiMag system avoids these disadvantages by using a detection system based on magnetic, rather than radioactive tracers, to identify the sentinel lymph nodes.

Breast Cancer Clinical Trial

In 2012, Endomagnetics supported a significant clinical trial of 160 patients at seven major hospital sites in the UK and The Netherlands. The trial was co-sponsored by King’s College London (KCL) and Guy’s & St Thomas’ NHS Foundation Trust, and was adopted by the UK Clinical Research Network. The trial was designed to establish the clinical equivalence of Sienna+® and the SentiMag® to the combination technique (99mTc and blue dye).

The results of the trial were presented by lead surgeon, Mr. Michael Douek (KCL), at the 14th Annual Meeting of the American Society of Breast Surgeons (ASBS 2013) in Chicago on May 4th, 2013. The abstract reported that the proportion of successful procedures with the magnetic technique was 94% (151/160) versus 95% (152/160) for the standard technique, confirming that the magnetic technique is non-inferior.

Using 99mTc and/or blue dye as the gold standard, the SLN identification rate was 91% (146/160) for the magnetic technique, and 90% (144/160) for radioisotope with/without blue dye. Lymph node retrieval rate was 2.5 nodes per patient overall, with 1.8 nodes/patient with the standard technique and 2.0 nodes/patient with SentiMag/Sienna+. The abstract concluded that “The magnetic technique is a feasible technique for SLNB with a high sentinel node identification rate. This trial is practice changing, particularly for those surgeons utilizing blue dye alone, for SLNB.”

Melanoma Clinical Trial

In August 2012, Endomagnetics announced that it had been awarded government funding to evaluate the clinical feasibility of applying magnetic sentinel lymph node (SLN) detection to melanoma. Support for the project is provided by the Medical Research Council (MRC) and the Technology Strategy Board under the joint £180 million Biomedical Catalyst.

The MELAMAG trial evaluates a new technique for SLNB against the standard technique. This new technique uses 2 devices: a intradermal injection of a magnetic tracer (Sienna+) and the use of a hand-held device (a magnetometer, SentiMag) to detect the sentinel node(s) intraoperatively.

Endomagnetics is working in partnership with King’s College London and Guy’s and St Thomas’s Hospital to deliver the project, and clinical trials are underway with further details available on Cancer Research UK and the UK Clinical Research Network (NIHR)

Academic Publications

L. Johnson, Q.A. Pankhurst, A. Purushotham, A. Brazdeikis, and M. Douek, “Magnetic Sentinel Lymph Node Detection for Breast Cancer,” Cancer Research 70 (24), P1-01-23 (2010).

T. Joshi, Q. Pankhurst, S. Hattersley, A. Brazdeikis, M. Hall-Craggs, E. De Vita, A. Bainbridge, R. Sainsbury, A. Sharma and M. Douek, “Magnetic nanoparticles for detecting cancer spread”, Breast Cancer Research and Treatment, 106, pp. S129 (2007).

T. Joshi, Q. Pankhurst, S. Hattersley, A. Brazdeikis, M. Hall-Craggs, E. De Vita, A. Bainbridge, R. Sainsbury, A. Sharma and M. Douek, “Magnetic nanoparticles for detecting sentinel lymph nodes”, European Journal of Surgical Oncology (EJSO), 33 (9), 1135 (2007)