Extremities startup designs a better thumb implant
Loci Orthopaedics Ltd. announce the closing of a €2.75M seed round investment to commercialise a new orthopaedic joint implant for a common but crippling joint condition.
Loci Orthopaedics is an independent leader in the development of a potentially life-changing, ergonomic, and clinically evidence-based solution to address the increasing unmet clinical need of thumb base joint arthritis.
The company is a medical device spin-out from the National University of Ireland Galway (NUIG) and is based in the Business Innovation Centre on the NUIG campus.
The company is developing the “InDx Implant” to meet this need and access a surgical market estimated at over €550 million per annum.
The finalization of a third-party investment round of €2.75M to date is a primary indicator of the strength of the business case and the future potential of Loci Orthopaedics.
Arthritis of the thumb base joint causes significant functional impairment of the hand. Those with this condition are either restricted in, or often lose the ability to perform, everyday tasks such as using a mobile phone, turning keys in a door, and even writing due to increasingly severe pain.
This unmet clinical need was identified by the co-founders of the company, Dr. Brendan Boland a clinician, and Mr. Gerry Clarke a medical device industry veteran with over 40 years medical device experience, while they were Fellows on the prestigious BioInnovate Fellowship program.
Bioinnovate is an Enterprise Ireland supported program and is an international affiliate program to the internationally renowned Stanford Biodesign.
5% of the population suffer severe thumb base arthritis, making the condition more prevalent than arthritis of the hip.
This equates to over 40 million people in the US and EU with significant symptoms of thumb base joint arthritis.
This condition is most common in those aged over 65. As the population of the US and EU ages, the number affected by this debilitating condition is set to increase dramatically in the next 15 years.
There are more than 200,000 surgical procedures carried out each year in the EU and the US combined for severe thumb base arthritis.
However, it is estimated that only 10% of those who are clinically indicated for surgery progress to surgical intervention for this condition due to the lack of a reliable and clinically satisfactory solution. The current most commonly performed surgical intervention for this condition was first developed back in the 1940s.
This wide gap between symptomatic patients and patients currently progressing to surgery, demonstrates the substantial growth potential for new therapy solutions.
The total current total addressable surgical market for thumb base arthritis procedures in the US and EU is estimated at over €550 million per annum. This market size is set to increase further due to several concurrent market growth drivers, such as an aging population, an increase in those most affected, and a lack of tolerance of poor hand function.
While Orthopaedics Extremities is the fastest growing area of orthopaedic surgery, and intervention for thumb base joint arthritis is the commonest non-trauma upper limb surgical intervention, the fact that so many patients are going untreated indicates the huge growth potential for this market sector.
Key device features
The Loci Orthopaedics team have been working with three of the world’s leading hand surgeons and have used their cutting-edge research as the basis for the implant design. These surgeons based in Stanford University, Brown University and KU Leuven in Belgium are key thought leaders in this area of orthopaedic medicine.
The InDx implant is the only implant that can fully mimic the natural but complex motions of the thumb joint providing a more physiologically correct surgical outcome.
The device is also easier to insert and less invasive than any currently available surgical treatment option for this condition. Therefore, the InDx implant will provide excellent clinical outcomes and decrease the risk of surgical and clinical complications.
The InDx device offers an exciting new, patient-sensitive treatment option to patients and surgeons and has been designed in conjunction with three of the world’s leading hand surgeons ensuring all end-user requirements are met.
Preliminary research indicates that this device design may also have clinical indications in other small joints of the hands and feet, as well as other joints with complex biomechanics such as the shoulder and elbow.
Third-party funding of €2,750,000 has been committed to provide financing for 24 months.
Milestones over the next 24 months
- 510(k) approval i.e. regulatory approval by the US Food and Drug Administration.
- First-in-Man (FIM) clinical use
- Initiation of CE marking i.e. EU regulatory approval
- Initiation of US commercialization
- 6-month clinical follow-up
Dr Brendan Boland MB BCh BAO MSc – CEO co-founder
Brendan graduated with honours from University College Dublin Medical School in 2006. As a post-graduate, he became a Member of the Royal College of Physicians of Ireland and also a member of the Irish College of General Practitioners.
Brendan was a BioInnovate Ireland Fellow 2014 during which time he developed his skills in identifying and determining opportunities in the lifescience and health technology landscapes.
The BioInnovate Fellowship provided Brendan with the knowledge tools to de-risk a medical device development, and project manage such an undertaking to key successful milestones.
Mr Gerry Clarke MBA MSc – CTO co-founder
Gerry has worked consistently in medical devices and diagnostics since the late 1970s, spending ten years in the USA industry sector during that time. He has had a number of increasingly responsible technical roles within Technicon, Sherwood Medical and C.R. Bard/Medtronic, most recently that of senior engineering manager within R&D at Medtronic.
His expertise lies in process development, new technology investigation and product design methodologies. He has several patents and trade secrets to his credit and has been charged with IP development at leadership level.
Gerry was a BioInnovate Ireland Fellow 2014, during which time he further developed his skills at identifying unmet clinical needs and finding solutions through the application of experience and good engineering practice.
Loci Orthopaedics have begun a staff recruitment drive, with early hiring completed. The company aims to employ 10 staff in the coming three years.
The company has developed IP which has a platform of potential applications across several clinical areas. The company is also extending its IP portfolio in the areas of smart tooling, additive manufacturing, and virtual pre-implantation assessment. Loci Orthopaedics aims to use revenues generated from its first core product, the InDx implant, to grow and commercialize its IP portfolio.
Recent news items
- Nominated for the Emerging MedTech Company of the Year at the Irish MedTech Association Awards 2017
- Winner Medtec Ireland Start up Competition 2017
- National Winner Best New Business Idea at the Ireland’s Best Young Entrepreneur competition.
- “Securing this seed round funding will put Loci Orthopaedics firmly on track to achieve the short and medium-term goals required for getting this product to market to relieve the daily suffering of many patients”.
- “Our investors are made up of a combination of institutions including the investment arm of KU Leuven University in Belgium, which was recently ranked by Forbes as Europe’s most innovative university, as well as Enterprise Ireland and the Western Development Commission. These institutions are complemented by some MedTech industry veterans who have taken their own companies from start-up, through huge growth, and on to significant exits”.
- “Thumb base arthritis has a huge impact on the quality of life, and on the independence of patients as they age. Can you imagine having pain on simple day to day tasks such as turning keys in a door, opening a jar, or using your phone? This is the prospect faced by millions of people who are restricted in their daily activities and enjoyment of life. It is these patients we want to help, by bringing the first evidence-based implant design to market for this common but disabling condition”.
- “Extremities Orthopaedics i.e. that branch of orthopaedics that deals with the limbs, is the fastest growing area of orthopaedic medicine. The number of patients being referred from Primary Care to an Orthopaedic surgeon for hand arthritis has increased about 400% in a ten-year period. Despite this, the commonest procedure performed for this condition has been around since the 1950’s and is associated with sub-optimal outcomes for the patient. In view of this, we used evidence-based data as key design inputs to develop this implant, which as the potential to totally disrupt the current treatment landscape for this common yet often crippling condition.”
Dr. Brendan Boland
Loci Orthopaedics, 209 Business Innovation Centre, NUIG, Galway.