Sentinal Lymph Node Detection -- MEDICA - World Forum for Medicine


Integrated Technologies Ltd.

Sentinal Lymph Node Detection

ITL & Endomagnetics – Overcoming the radioactive bottleneck
We frequently see references to the use of technology in medical applications but it’s less often we see so clearly how much of a difference a new idea can make. Radioactive materials have long played a part in the diagnosis and treatment of cancers, but when two professional organisations combine their skills to eliminate the need for radioactive materials in cancer staging techniques and deliver a ground-breaking technology out into the field, dramatic improvements to the availability of cancer treatment is made possible.

This study looks at how a dynamic medical technology start-up, recently selected as one of top twenty UK health-tech companies, took a radically new idea and forged a strong and successful partnership with a respected design, prototyping and manufacturing house to make this happen.
London-based medical technology ‘start-up’, Endomagnetics, a pioneer in the use of magnetic sensors for cancer staging and its treatment, has developed and patented SentiMag™ - an ultra-sensitive hand-held probe that is capable of detecting magnetic materials in the human body. The use of the SentiMag™ in conjunction with magnetic tracers eliminates the need for radioactive materials and dramatically extends the availability of, for example, breast cancer screening technology.
‘Bringing Instruments to Life’ is what ITL does. It has been doing so with great success for 35 years and its strength lies in its ability to support customers throughout every stage of the concept, design, development, prototyping and manufacturing cycle. Being a relatively small company has distinct advantages when it comes to being dynamic and flexible and it was ITL’s skills in this area that caught the attention of Endomagnetics’ CEO Dr Eric Mayes.

Here we look briefly at how ITL responded to the challenges, partnering Endomagnetics and applying its broad skill-set from project funding through to delivery of a commercially viable, regulatory qualified product.

The Challenge
When Endomagnetics first recognised the potential of its magnetic sensor technology to revolutionise the ability for a practitioner to perform SLNB (Sentinel Lymph Node Biopsy), it began detailed investigations in 2008. For the first time, it would make testing possible virtually anywhere, with hand-held equipment, with no dependency on access to radioactive materials and virtually no impact on their regular working practice.
The technology is challenging, but with nothing else available in the market to do this, successful creation of a ‘manufacturable’ product would clearly present great commercial potential on a worldwide basis. With this in mind, Endomagnetics embarked on the parallel activities of creating a concept demonstrator and pursuing investor funding.
The first concept prototypes were developed between University College London and the University of Houston. This was a system that was functionally similar to the target product but required the use of a liquid nitrogen cooled sensor, so while very effective for concept demonstration and initial medical trials, was not practical for commercial use or manufacture. On this basis, following concept demonstrations in December 2008, Endomagnetics needed a company to help with a commercially viable product designed for ease of manufacture, and it set about securing a development and manufacturing partner to undertake this. At this point it engaged in discussions with UK-based instrumentation design consultancy and manufacturer, Integrated Technologies Limited (ITL) in Ashford, Kent.
Mayes is enthusiastic, “From the outset of our great relationship with ITL, it was clear they were on our wavelength. As a small start-up looking to raise funds and commercialise IP, we need to be dynamic and responsive to opportunity and anyone working with us needs to be so too. This is not what you might expect in a manufacturing partner, but ITL is clearly much more than just that, and from the outset it demonstrated the natural ability to absorb the enthusiasm of a start-up.”
At that critical early stage, where Endomagnetics had embarked on securing its first round of investment, ITL was willing to support early stage development and Endomagnetics leveraged ITL’s established credibility to secure a joint £400k R&D grant from the UK Technology Strategy Board (TSB). This was matched by a £350k seed venture capital investment in June 2009 and the SentiMag™ programme was underway.
The Solution
After the initial liquid nitrogen cooled trials were successful and the specifications of the features required for a commercially viable version were complete, ITL’s skills were engaged and the team took on responsibility to create a design for production prototyping and volume manufacture.

Mayes adds, “As soon as we engaged with ITL, the project really took off. Whenever there were any technical or qualification related issues, ITL was always there on the phone and ready to solve any problem with us. ITL continues to act seamlessly as an integral part of our R&D team today and guides us on all manufacturing aspects too.” Mayes added that “having visited several times, it is clear there is continual investment in ITL’s facilities and the all round level of commitment has really sold home the nature of the relationship – they really are committed to their customers.”.
“From a quality perspective too, we sit under their established ISO 13485 medical devices accreditation, so there is really no need for us to spend additional time or resources on achieving that for ourselves - this is a major advantage for us”.
At this point Eric Mayes recalls the commitment shown by ITL to meeting his needs in preparation for an important event in December 2010.
“Knowing and being so pleased that we had the CE mark in place, we were fully committed to attend the Annual San Antonio Breast Cancer Symposium Dec 8-12 and it was fundamentally important to put the first prototype in front of the many eminent surgeons that were guaranteed to be there.”
“Unfortunately the weeks running up to this were plagued with snow in the UK which seriously hindered ITL’s activities. However, knowing the importance of the San Antonio conference, the CEO of ITL and the Head of R&D personally took on the challenge of securing delivery of the prototypes to us on time and the team battled the snow to ensure that SentiMag prototypes did indeed make it to the all-important conference demonstrations”.
Achieving CE certification in time for the San Antonio conference was the icing on the cake for Endomagnetics. Mayes adds, “We simply could not have achieved the whole project either in the timescale or with the same robustness without ITL.”
The Results
Endomagnetics generated huge interest in its innovative magnetic sensor technology when it exhibited at the 33rd Annual San Antonio Breast Cancer Symposium in early December 2010. At the show the company announced that it had received CE approval for SentiMag™, opening the way for commercialisation in Europe. So the results of ITL’s proactive approach really speak for themselves.
Eric Mayes adds, “In just two years, from ‘the word go’, we have CE marked manufacturing prototypes and the first four are now complete. The manufacturing line at ITL is set-up for a number of additional units, which are dedicated to early 2011 clinical equivalency trials and we expect to ramp production for volume shipments into CE countries in Q4 2011.
“Visitors to our stand were able to see two working models and we demonstrated to over 100 surgeons and oncologists from around the globe. They also saw a clinical video from the first sentinel lymph node biopsy (SLNB) with the SentiMag™ at Guy’s and St Thomas’ Hospitals, London. We were overwhelmed with the response in San Antonio. There was international interest in SentiMag and it was clear from the feedback that it addresses the big hurdles to adoption of SLNB.”

“Achieving this so swiftly is testament to ITL’s established accreditation skills being put into practice. ITL’s knowledge of the relevant regulatory processes and requirements were fundamental to our achievement in this timeframe and without them, we could never have achieved CE certification in time for the San Antonio conference. I cannot stress how important this achievement has been in cementing the credibility of SentiMag™”.

So, in just two years, ITL has become an essential partner for Endomagnetics, supporting it in every stage of the business from early seed funding to fully certified, commercial production prototypes. Endomagnetics expects this to grow further as it extends its early European certification and sales to address the US and then broader worldwide markets.
Mayes continues, “Europe is clearly our business entry point for SentiMag. This is largely driven by ITL’s rapid achievement of the CE qualification for us, but is also a reflection of the very lengthy nature of US approvals processes. Our plan is to fully engage these in 2011 in parallel with our production ramp in Europe.

The future for ITL
So what comes next for the partnership? Well, Endomagnetics will clearly look to ITL for manufacturing under their 13485 qualification but will then also need ITL to implement its logistics support, quality management, field support and product returns processes, further extending ITL’s involvement in the major activities of the business. It is expected that ITL will deliver the full supply chain and all product distribution: Endomagnetics will place orders on ITL’s logistics organisation, which will ship direct to the end customer.

Mayes closes by saying, “Based on the relationship so far, I fully expect ITL will continue to play a fundamental role in Endomagnetics’s future design, manufacturing and delivery processes – regulatory approvals, qualifications, outsourcing and order fulfilment. They are part of the team.”

With qualified manufacturing facilities opened in China in 2010, ITL is well placed to support Endomagnetics’ manufacturing on a worldwide basis, when the time comes.