The past 5 years have been exciting and challenging in equal measure for OrthoXel as the development of its innovative medical devices has moved from the drawing board to a reality in hospital operating theatres. "The development of medical device technology is a slow and rigorous process involving design, development, prototyping and testing before arriving at a final design that can be submitted for regulatory approval — which in itself can be a challenging process with no guarantee of success." OrthoXeI CEO Pat O'Connor explains, Having spent the past five years working through the development cycle for OrthoXel's first two products, the Apex Tibia and Apex Femoral Nail and successfully negotiating technical and regulatory hurdles, the company stands poised for a potentially consequential 2020. Developed to accelerate the healing process for fractures of the shin and thigh bones. OrthoXeI has secured regulatory CE Mark approval in Europe and FDA 510k clearance in the US, opening the way into these key markets.
"With development work completed, regulatory approvals in place and our current clinical study nearing completion, we are now quickly transitioning from product development to commercialisation. We have built a strong foundation and we know that 2020 will be a pivotal year," Mr O'Connor says. As the former CEO of ABK Biomedical, Mr O'Connor has over 20 year’s experience in the medical device industry having worked with Boston Scientific. Sherwood Medical and Stryker Orthopaedics. He also worked with Cork Institute of Technology to establish the Medic Centre to work with surgeons on developing medical device technologies. "The ongoing clinical study in Cork University Hospital is extremely important for us. Having completed all the rigorous technical and regulatory work, determining the performance of our technology in clinical use is the final step ahead of product launch and securing a commercial partnership," he adds. The objective of the study is to compare OrthoXel's Apex Tibia Nail to competing products already on the market,
particularly with regard to speed of healing: "To date. the results have been excellent. We are observing significant reduction in fracture healing time in healthy patients with fractured tibia as well as excellent clinical outcomes for patients considered high risk of delayed or non-union fracture. The performance of our products in this study allows us to determine the value of our technology not just in terms of patient health and well-being but also from a business perspective, what is the monetary benefit of the superior clinical performance of our device versus the competing products and what will this 100k like as a business proposition for commercial partnerships." OrthoXel is working to determine this value focusing on health economics, surgeon feedback and market expansion opportunities for commercial partners. The global intramedullary nail market is valued at almost €2 billion, with the tibia and femoral market segments estimated at €800 million. OrthoXel signed a purchasing agreement with its first US hospital network in October and implanted its first US patient a few days later. "We in the process of establishing our first beachhead in the US and look forward to building on that throughout 2020. The US is a large and very lucrative market and getting further traction there will be a big objective for us over the next 12 months. The most cost effective way for us to scale in the US is via a partnership with an established player, an orthopaedic multinational which already sells a range of complimentary products to the hospitals via established distribution channels," Mr O'Connor explains. "Generating US surgeon endorsement, initial market
validation and thereafter securing an appropriate US commercial partnership will completely transform Orthoxel." The support of local institutions and funding agencies has been key to the success of OrthoXel as the initial proof of concept work and background Intellectual Property generation for its product systems was completed in CIT's Medic Centre. Since its incorporation, the company has been based in CIT's Rubicon centre, and working with Cork University Hospital on its clinical studies. It also works with the UCC Health Innovation Hub and the Clinical Research Facility. which provides access to the hospital system and independent monitoring of the ongoing clinical studies Cork University Hospital. "We have received funding from Local Enterprise Office and Enterprise Leland, as well as several private investors who continue to support us. In addition to funding. Enterprise Ireland has provided access to their international network and have supported our entry into the US market via their international offices." With his two decades experience in this field. Mr O'Connor cites the personal rewards involved in creating products that bring such enhanced quality of life to patients.
"It is always rewarding to have a in developing and launching innovative medical devices that you know will make a positive impact on people's lives. Whether this is done in a multi- national setting or within a start-up company, the key to a successful project is not down to any one individual but rather having the right team on boat." he says. Taking a medical device concept all the way through to market launch readiness is a significant undertaking with several moving parts at any one time and requiring a broad range of skills and experience. "OrthoXel has a strong core team with skills in all of the required areas and we also leverage external resources to provide capacity and specialist knowledge as required. It is very rewarding to be part of a successful team developing what we believe to be new standards of care in orthopaedic trauma." he adds. With 2020 just around the corner, Mr
O'Connor and OrthoXel are looking at the prospect of a busy new year: "The key objective for us in 2020 is to secure an appropriate commercial deal with an established player. This could take one of several forms including a distribution deal, a licensing agreement, a sale of the company or perhaps some combination of the above. We have an open mind at this juncture and will assess all options. The planned commercial interactions throughout the first half of 2020 will inform us as to the most appropriate path for the company."
Source: Irish Examiner