Loci Orthopaedics and the EIC Accelerator: Thumb Implant Waits
Loci Orthopaedics, a University of Galway spin-out, wants to give people with arthritis at the base of the thumb an implant that moves like the original joint. Its EIC project put the number of EU residents with the condition at over 30 million. The study's lead investigator called InDx "the first implant to mimic the complex biomechanics of the thumb base joint".
The European Innovation Council granted €2,500,000 towards a €3.7 million project from November 2022 to April 2024, and Silicon Republic reported €8 million in EIC grant and equity funding for 2022. The final report calls the clinical outcomes "very positive". In July 2024 Loci closed a €12.8 million Series A with the EIC Fund among the leads. Its website still states: "The InDx® implant is not currently available for human use."
Company file
- Legal entity
- Loci Orthopaedics Limited, Galway, Ireland
- Origin
- University of Galway spin-out
- Co-founder and executive chair
- Brendan Boland
- Product
- InDx implant for thumb base joint arthritis
- Investors
- Seroba, Johnson & Johnson Innovation (JJDC), EIC Fund
- EIC project
- InDx CMC Implant, 1 Nov 2022 to 30 Apr 2024, closed
- EIC funding
- Blended finance: grant plus EIC Fund equity
Where Loci Stands Now
The Series A of July 2024 was led by Seroba, Johnson & Johnson Innovation's JJDC and the EIC Fund, to expand clinical programmes, submit applications for regulatory approval and prepare commercialisation. Since then we found no announcement of a submission, an approval, a new study or new funding. The company's website lists no chief executive in its leadership team; in 2024 the CEO was Barry Russell.
The record
A thumb implant still waiting for approval
Loci finished a 15-patient feasibility study in 2024 and raised a Series A with the EIC Fund. Its website says the implant is not yet available for human use.
- Aug 2021THANKS study startsFeasibility study at KU Leuven, Belgium
- Mar 2022EIC Accelerator cut-offInDx implant for thumb base joint arthritisblended finance
- Nov 2022EIC project startsClinical and regulatory work€2.50M grant
- Oct 2023Enrolment complete15 patients
- Apr 2024EIC project endsReport calls clinical outcomes very positive
- Jun 2024THANKS study completedNo results posted on the registry
- Jul 2024Series ASeroba, J&J Innovation and the EIC Fund€12.8M
CORDIS, ClinicalTrials.gov, Silicon Republic and Loci Orthopaedics.
"Thumb base joint arthritis is a painful and disabling condition with a significant unmet clinical need for an effective, evidence-based, surgical solution."
Brendan Boland, co-founder and executive chair, Loci Orthopaedics, July 2024The Technology: Copying the Thumb Base Joint
The company tested InDx in THANKS, Thumb Hemi-Arthroplasty with Natural Kinematics, a feasibility study at KU Leuven in Belgium. According to ClinicalTrials.gov, it enrolled 15 patients, ran from August 2021 to June 2024 and has no results posted. In October 2023 the company said the device has De Novo status with the US FDA, the FDA pathway for novel devices.
The evidence
One small study, results not published
The THANKS feasibility study on ClinicalTrials.gov. Months from start to completion, and patients enrolled.
ClinicalTrials.gov, NCT05644132.
What the EIC Project Promised, and What CORDIS Shows
The EIC project
The EU paid 68% of a €3.7M project
The InDx CMC Implant project ran from November 2022 to April 2024.
CORDIS project 190131605. Values in € millions.
The project aimed to give patients "a superior clinical outcome". The final report says the implant was "out-preforming implant and non-implant competitors across key domains of pain reduction, hand function and quality of life improvement", but gives no numbers. Its next steps were regulatory clearance in the EU and US, reimbursement and more private equity. The equity came; the clearances and the data have not been made public.
- Feasibility studyCompleted15 patients, June 2024.
- Published clinical resultsNot publishedNone on registry.
- EU and US clearanceNot announcedNot for human use.
- Follow-on equityRaised€12.8M, July 2024.
The Money
Loci's website credits its executive chair with raising "over EUR16M to date in a mix of grant and equity funding". The company does not publish revenue, and has no product on sale.
The money
EIC money and the Series A
In € millions. The €8M is the grant and equity package Silicon Republic reported for 2022; the sources do not say whether the EIC Fund's Series A participation is that equity.
CORDIS; Silicon Republic, July 2024.
What Cannot Be Checked
Questions for the EIC
The THANKS study results, whether an FDA De Novo request or CE application has been filed, and how much the EIC Fund invested are not public.
Why Europe Should Care
The EIC put grant money and equity into an Irish implant company, alongside a Johnson & Johnson investment arm. Two years after the Series A, the public record shows a completed 15-patient study with no published numbers and no approval.
What the project promised
A thumb base joint implant with a superior clinical outcome, heading for EU and US approval.
What the record shows
A finished feasibility study, a €12.8 million Series A, unpublished results and no approval.
The Verdict
Funded, still unapproved
Loci did the clinical work the EIC paid for and attracted private investors. The claim that its implant beats the alternatives rests on a report sentence without numbers, and the device still cannot be used on patients.
Loci Orthopaedics and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Industry
HealthMedical devices
- Focus
- Orthopaedic and spine devices
- Technologies
- Implantable devices
- Keywords
- Thumb arthritis
- Joint replacement
- Hand surgery
- Osteoarthritis