25 November 2020

An innovative thumb implant: From concept to clinical use

Loci Orthopaedics is a multi-award winning medical device company specialising in the development of orthopaedic technologies to meet unmet clinical needs in the orthopaedics extremities space. Most recently the company was listed by Silicon Republic as one of the top 100 start-ups in Europe to keep an eye in 2020. International Hospital speaks to Brendan Boland, CEO and Co-founder of the start-up, about the start-up process and the implant devices they have developed.

International Hospital: The start-up company, Loci Orthopaedics has two key products: the InDx, an implant to treat thumb-base arthritis, and OsteoAnchor, a surface architecture for orthopaedic stem components to facilitate bone fixation of implants.

We’ll come back to these products, but first let’s look at the company. What was the seed idea that lead to you starting up Loci Orthopaedics and when and where did the idea originate?

Brendan Boland: My co-founder Mr Gerry Clarke and I, were Fellows on the BioInnovate Fellowship in 2013. My background is in clinical medicine, having graduated from University College Dublin Medical School in 2006. I practiced as a doctor for seven years before gaining a place on the prestigious BioInnovate Fellowship Program.

The BioInnovate Fellowship Program is based in the National University of Ireland Galway. It is an international affiliate to Stanford Biodesign. The aim of the program is to educate Fellows in needs-led medical technology innovation.

Gerry had worked in the engineering side of medical technology for over 30 years before the program. He had worked in several areas across medical devices and had a vast knowledge and skill set to bring to any project.

Gerry and I, along with two other colleagues who had backgrounds in mechanical engineering and biotechnology spent 10 months looking at unmet clinical needs in Orthopaedic Medicine. One area which really stood out was Orthopaedics Extremities i.e. upper and lower limb (below the knee) implants. This is one of the fastest growing areas of orthopaedics and so one of huge commercial interest.

During the Fellowship we observed patients with many different pathologies, but one patient really stood out. She was a 65-year-old lady who had severe arthritis of the thumb base joint. This was having a major impact on her quality of life and independence. However, when she was presented with the treatment options such as trapeziectomy (a surgery where a bone of the joint is removed but one which results in significant loss of hand function) she chose not to proceed with any intervention as her disease was not yet worse than the cure.

It really struck us that this unmet clinical need was one which affected hundreds of thousands of patients, but for which the primary intervention has remained unchanged since the ‘50s. We thought we could do better.

IH: Can you outline some of the initial processes and research that led to the establishment of the company?

BB: Loci Orthopaedics is a company that firmly believes that all technical solutions should have a very strong base in clinical evidence-based research. In 2015, a research consortium at Brown University and Stanford University, led by JJ Crisco, Dr Peter Weiss and Dr Amy Ladd, published a paper which further identified the exact kinematics and motions of the thumb base joint. This paper clearly showed that the joint has two axes of motion that are separated by an average of 9 mm. It made sense to us as to why implants in the thumb base joint have had higher than expected failure rates.

The implants available require the surgeon to try and refashion the joint to suit the implant instead of using an implant designed to meet the biomechanical requirements of the joint. Gerry and I set about designing the first evidence-based implant for the thumb base joint to try and provide patients, like the lady I mentioned, with a really viable and lasting treatment option.

IH: Seed funding is a key issue for start-up initiatives. Can you explain how you raised seed funding and what was the seed funding intended to be used for?

BB: Gerry and I first worked on this project and designed what has become known as the “InDx Implant” while Research Fellows at the National University of Ireland Galway (NUIG). We then formed Loci Orthopaedics and spun out of the university in 2017.

Galway is a MedTech town, with a lot of start-ups, mid-sized companies, and major multinationals across all fields of medicine based in the city. In view of this, there is a strong investor network in the city, and we used this network to raise seed investment. Our investors are a mix of seasoned MedTech angels, institutions such as Enterprise Ireland and the Western Development Commission (the WDC is an investment fund that focuses on businesses located in the west of Ireland), as well as the Gemma Frisius Fund, the venture capital arm of KU Leuven in Belgium. This seed funding was used to get the InDx Implant from concept stage to the point we could apply for regulatory approval in the EU and US.

IH: Can you let us know how you have managed to expand the growth of the company?

BB: The company has developed the InDx Implant to the point where we can now begin the formal process for Regulatory Approval. In the EU this is expected to take another two years with an estimated commercialisation date in 2023.

The company has increased its staff numbers specifically in the area of engineering and we continue to use Galway-based subcontractors and sub-suppliers where possible to ensure maximum oversight of any outsourced work and the production of a premium quality implant for our potential patients.

The company also licenced a technology from the National University of Ireland, called OsteoAnchor. This is a technology that had been developed by NUIG researchers and has an amazing potential to revolutionise the fixation of implants into bone. It is a 3D printed surface morphology that provides unrivalled immediate and secondary fixation.

Loci Orthopaedics is patent protected in the US, Europe and China and continues to expand its IP Portfolio with several further patents in the pipeline from conception stage to filing.

The company’s focus is always on unmet clinical needs in the rapidly growing area of Orthopaedics Extremities and needs for which we can develop evidence-based solutions.

IH: What were some of the main hurdles you faced along the way and how did you clear them?

BB: For any medical device development there are always hurdles in the development pathway. Most medical devices take between 8 to 10 years from first concept to clinical use. The company has faced technical hurdles, clinical hurdles, and intellectual property hurdles, however we have been able to surmount each in turn to keep the progress of development going. The company does not view a lot of these issues as hurdles though, just great questions that must be answered.

The products that the company is developing may be implanted in a patient for over 15 years. There is no room for error, so any questions or “hurdles” that are put in front of us have to be answered thoroughly, as the company only wants the very best for the patients that will use these implants.

IH: Can you give us some detail about the InDx Implant device and the OsteoAnchor? What sets them apart from any competitive products?

BB: For patients with arthritis of the thumb base joint, the most common procedure performed is a trapeziectomy with ligament reconstruction tendon interposition (LRTI). During this surgery, the trapezium bone is removed which inevitably leads to a shortening of the thumb and a loss of hand strength. While it is a reasonably successful procedure for pain reduction, it comes at the cost of a significant loss of hand function.

In the older population affected by thumb base arthritis, any loss of hand function can have a major impact on independence and quality of life. Some surgeons use total arthroplasty implants to try and maintain the thumb length and attendant strength. These implants are anchored by a stem in the metacarpal and a cup in the trapezium. However, as we now know, the thumb base joint is a dual axis joint. Hence, it is unsurprising that the commonest failure mode of these type of implants is loosening and failure of the trapezial cup, as all joint forces are focussed on one axis while the joint naturally wants to move around a variable axis between the base of the metacarpal and the trapezium.

The InDx Implant is an articulating hemi-arthroplasty that does not require the fixation of a cup within the trapezium. The implant provides two axes of movement, one at the ball-and-socket place in the base of the metacarpal where one of the natural axes of rotation sits, and the other at the implant-trapezium bone interface where the other natural axis is located. In this way the implant provides a dual axis of movement, recreating the location and function of the joint’s own axes of movement. This allows a more natural dispersal of joint forces. As the implant is a hemi-arthroplasty, it does not require placing a cup in the trapezium hence avoiding the most common failure location of other implants.

In summary, the InDx Implant provides a dual axis of motion recreating the natural biomechanics of the joint, it does not require cup placement so avoids the most common failure mode of traditional arthroplasty designs, and does not require removal of the trapezium bone thereby maintaining the thumb length and strength of the hand.

Looking toward the OsteoAnchor technology, this is a 3D-printed surface morphology for orthopaedic implants. The surface has hooks which lodge into the bone on insertion providing excellent primary fixation. These hooks overlay a series of cavities which the bone then grows into. This secondary fixation has been found to be 76% better than traditional surface coatings that try to provide the same outcome.

The fact that it is 3D-printed means that the technology can be applied easily to any implant design or shape and is applicable across all implant technologies. Given the OsteoAnchor superior fixation, it means that implants that incorporate it can be much smaller, preserving much more of the patient’s bone, or providing new treatment options in the case of revision surgery.

IH: What other products do you have in the pipeline?

BB: Loci Orthopaedics believes that the implantation set for any implant should be specifically designed for that implant to optimise the ease of use of the product. An implant that has great tools, making it easy to inset, is an implant that is going to have great clinical results. The team at Loci Orthopaedics have designed a bespoke user-friendly implant set to go with the InDx Implant, which in a way, could be considered a product in its own right as it provides such a great user experience.

The company continues to focus on the application of evidencebased biomechanics and kinematics to small joints of the upper and lower extremities. The company has developed patents for products in the shoulder, elbow and toes, and are continuing to develop potential products in these spaces. However, each of these joints have very specific biomechanical functions so designing implants to meet such complex kinematic requirements takes time.

IH: In which markets are these products available and into which markets are you looking expand?

BB: The InDx Implant and OsteoAnhcor are both precommercial. The company estimates that the InDx Impact will be CE-marked and available for clinical use outside of a clinical trial setting towards the end of 2023. It is estimated that an OsteoAnchor shoulder implant will be available towards the end of 2024.

While this may seem like some time away, as I mentioned, everything in the development of a medical device must be right, and that takes time and a whole lot of effort, not to mention money.

IH: Is the InDx implant in clinical trials at the moment?

BB: The InDx Implant is due to start clinical trials this year. This has been slightly delayed due to C19, but trials at two sites should still begin this year.

IH: What is the position of OsteoAnchor in this regard?

BB: A clinical investigation for OsteoAnchor is approximately months from now.

IH: How can parties who are interested to invest in your company go about doing this?

BB: Loci Orthopaedics is not currently seeking investment but will be looking at our next fundraising round soon. Any interested parties are welcome to contact the company directly through the company’s website and communication portals.

For clinicians and healthcare professionals interested in using any of the company’s products I would ask them to reach out directly to myself or one of the team where we can provide more information on pre CE-marked use of the InDx Implant.

IH: Lastly, what are the some of the key things you have learnt in this process that you can pass on to others who are about to begin this journey?

BB: Patience and perfection.

Perfection takes patience, but perfection is what is required when you are designing or developing something for clinical use. While patients may seem far away to some medical device companies, all the team at Loci Orthopaedics have the sole mission to improve the lives of those suffering from debilitating arthritis. The very last thing that this company wants to do is provide a product that could in anyway fall short of the highest standard.

Patients deserve patience and perfection.

Loci Orthopaedics
Loci Orthopaedics is based at the Business Innovation Centre
in the National University of Ireland Galway. For more information,
visit: http://www.lociorthopaedics.com/

Or contact Dr Brendan Boland:
info@lociorthopaedics.com