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Endomag  is dedicated to improving the global standard cancer care for everyone, everywhere, by developing a new, effective clinical platform that uses safe magnetic fields to power diagnostic and therapeutic devices. Endomag’s first approved products are the Sentimag® and Sienna+®.

Endomag is 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. Endomag's patented technology was originally developed at University College London (UCL) 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-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
Endomag was founded by Prof. Quentin Pankhurst, SImon Hattersley and Prof. Audrius Brazdeikis. While no longer involved in day-to-day operations, the founders maintain an active role with Endomag 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 more than 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 Labroartory at the Texas Center for Superconductivity (TcSUH). He has authored over 50 original scientific publications in leading scientific journals and has issued three US patents.

History
Dec 2014 Received IDE approval to initiate US trials Endomagnetics rebrands as Endomag

Nov 2014 Additional £2m VC investment for pivotal US trial, market and product expansion

July 2014 Signed distribution agreement for Australia and New Zealand with Aurora BioSciences Ltd

June 2014 Acquired the asset portfolio of Actium Biosystems, LLC

May 2014 Introduced a higher-performance, slimmer Sentimag® probe

February 2014 Central-European multisite comparative trial results published in The Breast

December 2013 International multisite comparative trial results published in Annals of Surgical Oncology

August 2013 Additional £2.1m VC investment for team and market expansion

February 2013 Signed strategic distribution agreement for EMEA region with Sysmex Europe GmbH

October 2012 Certified to ISO 13485:2003 and upgraded to Annex II of the Medical Devices Directive (MDD)

February 2012 Started international multisite comparative clinical trial

December 2011 CE approval for magnetic tracer, Sienna+®

August 2011 Additional £1.8m VC investment and team expansion

December 2010 CE approval for magnetic sensor, Sentimag®

June 2010 Mayes joins as CEO alongside additional £350k VC investment

April 2009 £400k UK Technology Strategy Board (TSB) grant alongside £350k of VC investment

April 2007 Spin-out from University College London (UCL) and the University of Houston

Lymph Node Localisation
When a cancer spreads, it first travels to the lymph nodes: small, bean-shaped organs that form an important part of the body’s immune system. A sentinel lymph node is the first lymph node to which cancer cells are most likely to spread from a primary tumour.

Sentinel lymph node biopsy (SLNB) is a procedure in which the sentinel lymph node is identified, removed and examined to determine whether cancer cells are present. In 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 through minimally invasive surgery is preferable to the invasive ALND and its associated problems such as nerve damage or lymphedema, and it helps to ensure that patients’ quality of life is maintained. SLNB results in shorter breast cancer operations and better patient recovery, as well as saving money and freeing up resources for healthcare providers.

Despite the advantages of SLNB, the conventional method involves injecting a radioactive tracer with or without a blue dye, and then localising the lymph nodes using a gamma probe. While effective, this method comes with significant problems.

The conventional gamma probe method is limited by the supply of a substance called molybdenum‐99, the parent radioisotope to the short‐lived gamma‐emitting technetium-99m (99mTc) used in medical imaging. Molybdenum‐99 decays so quickly that it has to be supplied to hospitals every week, and is made in just a handful of nuclear reactors worldwide. . The handling of radioactive materials is subject to stringent regulations, requiring special staff training and segregating the waste from the operating theatre. The costs of providing and handling radioactive materials are high, so the majority of women with breast cancer will never be offered SLNB based on this method.

Competition to radioisotopes is now available. One promising technology is the use of fluorescent dyes (such as indocyanine green, ICG) in conjunction with near infrared (NIR) visualisation systems. While these fluorescent dyes are inexpensive and avoid the use of radioisotopes, the dye spreads throughout the lymphatic system and does not stop specifically at the sentinel lymph nodes. Moreover the system requires a change in working practice, as the surgeon must focus on a separate monitor, rather than the patient.

Endomag’s technology uses a magnetic tracer (Sienna+®) instead of the radioactive tracer and blue dye, and an ultrasensitive hand‐held magnetic probe (Sentimag®) rather than a gamma probe. This is the only solution that avoids the use of radioisotopes, but manages to maintain standard working practice and provide equivalent detection rates to the standard of care.

Lesion Localisation
The clinical procedures leading to the removal of a tumour include marking the lesion for location during surgery. The current standard of care for breast tumours is for a hooked guide wire to be fixed into the tumour. The tail of the guide wire protrudes from the breast and is taped to the patient, and the surgeon can later follow the wire to remove the tumour and along with a margin of healthy tissue.

If the guide wire moves in between implantation and surgery, it could result in the patient requiring additional surgery to correctly remove a safe margin of healthy tissue. This movement can also lead to the removal of more tissue than desired. In addition, due to the open incision created by the guide wire, surgery must be performed on the same day, creating workflow challenges for the hospital.

Many hospitals are now implementing radioactive seeds to replace the breast guide wire. This technique considerably reduces the incidence of additional surgery and removal of excess margin for the patient. The seeds also increase the time between lesion marking and surgery improving workflow, but they introduce new challenges regarding the ‘chain of custody’ for managing radioactive materials.

Endomag is developing a magnetic lesion marker for breast cancer that works in conjunction with the Sentimag® to maintain the benefits of radioactive seeds, but avoiding their challenges.

Hyperthermia
It is well established that heat can damage healthy tissue, but lower temperature heat, ranging from 37oC to 42oC (98.6oF to 108oF), can weaken and kill cancer cells while minimizing the impact on healthy tissue. This basic concept of treating cancer with low-temperature heat is called ‘hyperthermia’.

Endomag is developing therapeutic hyperthermia systems as an adjuvant to chemo- and radiotherapy using magnetic nanoparticles and external field generators. While adjuvant heating is applicable to many cancer types, the first indication under development is the treatment of non-muscle invasive bladder cancer.

Prototype systems have been validated by two pre-clinical in vivo studies, including Duke University Medical Centre and an independent contract research facility. The studies successfully demonstrated that the systems are able to achieve well-defined therapeutic temperatures in the bladder using a catheter-introduced magnetic nanoparticles and a safe, external magnetic field.

Breast Cancer
Globally, 1.7m new cases of breast cancer are diagnosed each year, with 522,000 deaths. Breast cancer is the most frequent cause of cancer death in women in less developed regions,and is now the second cause of cancer death in more developed regions after lung cancer.

Sentimag® and Sienna+® were initially developed for staging breast cancer. The system was developed in the clinic, with surgeons providing vital feedback during the design and prototyping. The resulting procedure involves injecting Sienna+® into the sub-areolar region of the breast. Depending on the patient’s age, weight and breast size, the average time for Sienna+® to produce a detectable signal in the sentinel lymph nodes is 20 minutes. This compares favourably to the competition as injections can be made near or in the operating theatre and following anaesthesia, improving patient comfort and convenience.

Since its launch in late 2012, the system has produced a strong base of clinical results confirming its safety and efficacy. Over 10 clinical studies and trials with over 1,500 patients across 12 European countries have completed, and all have demonstrated clinical equivalence to the standard of care for SLNB – either Technetium (99mTc) alone or the combination technique (99mTc and blue dye) [1-5].

Clinical References:


 * Douek et al. 2014: Sentinel node biopsy using a magnetic tracer vs. standard technique: The SentiMAG Multicentre Trial. Ann Surg Oncol; Vol 21(4): 1237-45
 * Thill et al. 2014: The Central-European Sentimag study: Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast; Vol 23(2): 175-9
 * Hopeau et al. 2013: Résultats intermédiaires de l’étude SENTIMAG évaluant un traceur magnétique pour l’identification du ganglion sentinelle dans le cancer du sein (poster presented at SFSPM 2013)
 * Ghilli et al. 2014: Italian multicentre study regarding sentinel node biopsy with superparamagnetic iron oxide versus radioisotope (poster P153 presented at EBCC-9 2014)
 * Rubio et al. 2014: The superparamagnetic iron oxide is equivalent to the 99 TC radiotracer method for identifying the sentinel lymph node in breast cancer (poster P071 presented at EBCC-9 2014)