Innovation finalists: making a difference in medical industry

Caterpillar blood clots, fooling the immune system and online doctors

Embo Medical

Embo Medical has created a new medical device which makes embolization procedures faster and less expensive while also offering more certainty in terms of success. Embolization is a surgical procedure that permanently shuts down blood flow in blood vessels and is employed to treat a number of diseases such as cancer where it is used to prevent blood from feeding a tumour thereby inducing tumour shrinkage.

The current practice for the procedure is the permanent implantation of small metallic springs or coils delivered sequentially to create a form of nest. The blood clots within and around the nest and eventually shuts down the blood vessel. The problem is that it takes an average of nine coils to complete a procedure at a cost of several hundred euro per coil and up to four minutes each to implant. A further issue is that the coils can break loose causing accidental blockages elsewhere.

The team at Embo has created a new single device known as a Caterpillar which takes the place of the coils making the procedure much faster and eliminating the risk of individual coils migrating to other blood vessels around the body.

The innovation has its origins in the Enterprise Ireland BioInnovate Programme, a medical device innovation programme based on the Biodesign programme at Stanford University in the US. The company's three founders chief executive Wayne Allen, chief technology officer Liam Mullins, and chief operating officer Colin Forde participated in the inaugural programme in 2011, with the aim of unearthing an unmet clinical and market need on which a business could be built.

None of the three knew each other before the programme but came together as a result of it. “The programme put participants together in teams of three or four”, says Wayne Allen. “We all had backgrounds in the medical device industry and wanted to build a business in the sector. As part of the programme we spent three months in St James’s Hospital in Dublin observing surgical procedures to see if we could identify an area to work on.”

The first embolization observed by the team was a procedure being carried out on an elderly patient with liver cancer. A number of difficulties arose with the surgeon becoming increasingly frustrated as a result. This gave them the idea of developing a device which would address those frustrations and make the procedure safer for the patient.

Progress was rapid from that point with early stage funding being secured in 2012 and the first animal trial of the device being carried out in 2013. The company now employs eight full-time and three part-time staff, and plans to continue hiring in 2015.

Recognition has not been slow in coming either. In October of 2013, it was voted "one to watch" by the CorkBIC Venture Academy and two months later received a special commendation at the ICI Innovation Awards, Israel.

The company raised €3 million in first-round funding last August and is aiming for a first human clinical trial as well as US FDA approval for the device later this year.

Ongoing innovation is an underlying theme. The Caterpillar is designed to open out and fill the width of the blood vessel when it is deployed. Getting it there is another question. “The device is delivered into the body through a very small tube just 1mm in diameter,” Allen explains. “A lot of work went into getting it down to the right size to fit in that space and then be able to open out into the size required.”

A number of patents have been filed already and there are plans to run a major patient study in 2016. This will be followed by a further evolution in the technology which will enable it to treat a wider range of blood vessels. “We will also continue to work with clinicians to look for new applications for the technology,” Allen adds.

Fusion Antibodies

Belfast-based Fusion Antibodies has created a new system which enables the rapid humanisation of antibodies aimed at treating a range of different diseases. Antibodies are produced naturally by the immune system and target harmful agents such as viruses and bacteria. Over the past 20 years the pharmaceutical industry has become adept at producing antibody-based drugs such as Herceptin which mimic the human immune system in the treatment of serious diseases such as breast cancer.

The problem, however, has been in finding antibodies which will attack the target disease but not be attacked by the human immune system when it identifies them as foreign objects. The breakthrough came through understanding how antibodies work at a DNA and amino-acid level which allowed new drug-antibody candidates to be “humanised” to effectively trick the immune system into treating it as one of its own antibodies and not as an invader or harmful pathogen.

However, the original humanisation method was patented and came with high costs and royalty payments which meant the technology was the exclusive preserve of the major pharmaceutical companies, as Fusion Antibodies managing director Paul Kerr explains. "It was effectively impossible for smaller biotechnology and pharmaceutical companies to get into the market and this meant that many new drugs targeting a variety of illnesses have never had an opportunity for development," he says.

The Fusion system is a combination of the traditional humanisation method, which has come off patent, and a powerful software algorithm. “We discussed the issue with IT experts and looked at ways in which the process could be speeded up”, Kerr adds. “We started working with people who had never been to a biology class in their lives and we brought computer technology and our expertise together to create this new innovation.”

The system works at a DNA level to take an antibody and make minute but critical changes which allow it to continue to act in the way intended but to fool the human immune system into accepting it as part of its own response. What makes it stand out from other humanisation platforms is its speed, scalability and the fact that Fusion Antibodies is the first company to guarantee the output of the performance of the humanized antibody.

“We have kept the process as close as possible to the natural processes the human body performs when generating an antibody,” says Kerr. “We combined this with a software platform that can perform the sorting, ranking and selection of tens of thousands of fully-human antibody sequences to match the donor sequence as closely as possible.”

The platform works by a client company academic institution sending Fusion either the DNA sequence of the antibody it is working with or a sample of the actual antibody. Fusion will then either sequence the DNA of the sample or use the sequence received from the client and analyse it in comparison to its database of human antibodies. By changing just a few letters in the sequence the antibody is made to appear human with no impact on its function or behaviour.

The platform has already proven itself on the market and the company’s client list now numbers some of the leading pharmaceutical companies that have pioneered in the antibody field which have chosen to outsource projects to Fusion Antibodies to take advantage of its unique software platform. However, the main market will be small and medium-sized enterprises (SMEs) which can use the technology to advance new drug concepts that would not otherwise have made it past the discovery concept stage.

“The business has doubled in size over the past two years and the potential for growth in areas such as biologics development is enormous,” says Kerr. “Our focus for the near term will be on creating awareness of the platform in key markets. We can also see potential to license it to partner institutions and companies around the world as well as the development of a software as a service model. Our main hope is that it will help in the development of new drugs to meet as yet unmet clinical needs.”

Lloyds Online Doctor

More than 30,000 Irish patients are now registered with the Lloyds Online Doctor (lloydsonlinedoctor.ie) service which was set up 18 months ago to help address the problem of a lack of affordable primary healthcare in Ireland. The online service provides a responsible and affordable alternative for a select number of GP treatment areas including repeat prescriptions for the contraceptive pill or patch, erectile dysfunction treatment and STI test kits.

"The service had been doing very well in the UK market where we had more than €1 million patients registered", says international development manager Rebecca Matthews. "We saw that people in Ireland were losing their medical cards and that there were other issues such as GPs being overstretched and the general increase in the requirement for primary care."

But it was not as simple as just making the UK service available to Irish patients. “The Irish market is a lot more complex than the UK,” Matthews explains. “For example, online and electronic prescriptions are not legal in Ireland so we had to redesign the business model to meet the needs of the Irish market.”

Extensive research into patient needs revealed that a lot of people are embarrassed about going to their GP for STI or erectile dysfunction treatment. “People can be embarrassed about speaking to someone they feel they know in relation to such conditions. The biggest area identified was the contraceptive pill. Many young women simply aren’t able to get time off work to go to the doctor for a repeat prescription.”

The service works through what is effectively an online consultation with a doctor. A series of clinically designed algorithms enable the Lloyds Online doctors to triage patients by risk, enabling them to determine which patients require the most attention. At the end of the consultation if the doctor deems it prudent a prescription is issued and posted to the patient who can get it filled by a pharmacy.

"This improves efficiency, which drives down costs which we pass on to patients," says Matthews. "The average consultation fee for a GP in Ireland is €51 and we charge €25 for an online consultation. All our doctors are registered with the Irish Medical Council and we monitor changes over time using online patient records."

Matthews agrees that there is no online equivalent to a face-to-face GP consultation but not everything that a GP does requires an in-depth consultation. “Of course, anything that requires a physical examination has to be carried out in a face-to-face consultation. Also, we find that the online assessment indicates that around 10 per cent of patients may need further investigation. Our doctors will phone them in some cases and in others will let them know that they should go to a GP for a consultation. For all other cases technology enables patients and doctors to interact in a much more efficient and cost-effective way, significantly reducing costs for a strictly limited set of treatments areas.”

The accessibility of the service is also a significant advantage. “There is no waiting time. Patients can go online at 2 in the morning and complete an online assessment and they will receive a response within a few hours. Our doctors also work at weekends and this is particularly helpful for patients out at work all week.”

The service has proved popular with Irish patients and is growing all the time. "It has exceeded all expectations and has grown 50 per cent year-on-year. For the future we would hope to see some changes in legislation to make electronic prescriptions legal in the same way as they are in the UK. This will make life easier for patients. We are working closely with regulators such as the Medical Council and the HPRA [Health Products Regulatory Council] to ensure that Lloyds Online meets their standards. We are also working with partners such as the Irish Family Planning Association to promote awareness for telemedicine and for Lloyds."