A new bone regeneration product developed at the Royal College of Surgeons in Ireland (RCSI) has received the CE mark, certifying it for sale throughout the EU and clearing the way for a multimillion euro fundraising drive by the Irish business bringing it to market.

Surgacoll Technologies, a High Potential Start Up (HPSU) supported by Enterprise Ireland (EI), intends to raise venture capital in two rounds over the next three to four years. By 2019 they aim to be generating annual sales of more than €50m in the European and US markets, employing 15 people in Ireland by the end of 2016 and 25 by 2019.

SurgaColl is bringing to market two highly innovative biomaterial products, based on technology developed by the Tissue Engineering Research Group at RCSI, that repair tissue via the recruitment of the body’s own cells. 

The first, HydroxyColl, stimulates the regeneration of bone tissue and is a substitute for bone grafts taken from donors or the patient themselves. The second, ChondroColl, repairs articular joints by stimulating host stem cells to regenerate both bone and cartilage, using the composition and architecture of the biomaterial to actively direct tissue formation. HydroxyColl has just received CE approval and ChondrocColl will be submitted for CE mark approval in January 2016.

The products have been developed with extensive support from the Enterprise Ireland Commercialisation Fund initiative. Investors include EI, Enterprise Equity and a UK Private Equity Investment Group who supplied the initial €4m capital that has brought the first product, Hydroxycoll, to market entry and ChondroColl to regulatory submission. Funding from Science Foundation Ireland and the Health Research Board is now helping to translate ChondroColl to the clinic with first human studies expected in 2016.

HydroxyColl brings about bone healing equivalent to a patient’s own bone. It provides much more effective healing in the aftermath of high-impact bone fractures and the removal of bone tumours. It can strengthen the bone foundations of tooth implants and improve bone repair in those with low bone density such as people with osteoporosis.

ChondroColl is highly effective in the treatment of early joint cartilage damage, particularly in the knee. It is a significant advance for sports medicine. According to Prof John O’Byrne of RCSI and Cappagh National Orthopaedic Hospital; “This is a product with great potential for early intervention in joint injuries, minimising long-term damage and potentially reducing the risk of osteoarthritis and need for knee replacement surgery.”
SurgaColl has now launched HydroxyCollTM for commercial sale in selected EU markets. It is manufactured in Ireland on behalf of SurgaColl by Harmac Medical Products, with contract manufacturing facilities in the U.S., Ireland and Mexico. 

Dr John Gleeson, CEO, Co-Founder, and director of SurgaColl believes HydroxyColl and SurgaColl’s pipeline of products has significant potential to improve dramatically on the more traditional orthopaedic grafting procedures and recovery outcomes. Dr Gleeson explains: “Most products on the market support bone healing but don’t actively direct it. Products that do drive tissue repair do so with the aid of pharmaceuticals. Our products’ unique selling point is that they are drug-free and as such, free of drug-related safety concerns. We are now entering a very exciting period where we will see first human implantations of the approved HydroxyColl product in a diverse range of trauma indications at a number of sites across the EU.”

Prof. Fergal O’Brien, Professor of Bioengineering and Regenerative Medicine, Head of the Tissue Engineering Research Group in RCSI & SurgaColl Co-Founder explains: “The approval of HydroxyColl is the culmination of almost a decade of research, development and commercial scale up. I am delighted and proud to see technologies developed in our labs translate to the benefit of patients and society. This is also great for Ireland as it will potentially see the expansion of SurgaColl Technologies with more jobs created down the line as the follow–on technology, ChondroColl, developed in RCSI for cartilage repair is also expected to be in clinical studies in due course.” 

Dr Aoife Gallagher, RCSI’s Head of Innovation, said: “We are delighted to see the results of high quality research at RCSI now making its way to the international market. The most worthwhile medical research ultimately leads to better outcomes and quality of life for patients, and this is an example of success in bringing research from the lab to a point where it can improve the lives of real people.”