A novel tendon repair product
Helping to improve the repair of severed tendons
Tendons are susceptible to injury and their successful repair remains an unmet clinical need as emphasised in the latest comprehensive international text (Tang, 2014), which records ‘good or excellent recovery of function’ in ‘only three fourths of patients treated in the finest hand centers worldwide’. The five main sites of tendon injury are flexor, Achilles, rotator cuff, quadriceps and biceps. With an aging population and rising trauma cases orthopaedics accounts for the largest share of the growing soft tissue repair market which was estimated at $5.73 billion in 2016, with orthopaedics at $1.47 billion (Grand View Research, Aug 2017).
Tendon injuries can be severely disabling, with significant rehabilitation time and high healthcare costs. Currently surgical procedures are inadequate for injured tendons; repair is focused on a mechanical approach of suturing the two tendon ends together which results in the formation of scar tissue which is biochemically and biomechanically inferior to natural tendon tissue. This novel product represents a paradigm shift with an innovative device designed to be delivered by keyhole surgery which specifically addresses the biology of a regenerating tendon to improve outcomes for patients.
The University of Manchester research group has developed a novel product which addresses both the biological and mechanical requirements for successful tendon repair. The product consists of a novel scaffold made from biodegradable, FDA approved poly(ε-caprolactone) (PCL) which is electrospun to quickly produce a high volume of nanofibres. This nanofibre architecture confers contact guidance cues to the cells/matrix and cells are able to penetrate through to the core of the scaffold. This promotes cell and tissue ingress for complete integration with the surrounding tissue, facilitates regeneration of tendon tissue, confers physiologically relevant mechanical properties throughout the healing process and ultimately is fully resorbed over time and at a rate that corresponds to new and load-bearing tissue. This approach represents a step change in tendon repair by improving the outcome of surgery and reducing both the patient subset requiring re-operation and those left with permanent loss of function.
- The product has been designed to address the biology of the regenerating tendon, in particular to guide the extracellular matrix across the repair
- In vitro and in vivo studies have validated the cellular response
- PCL is an FDA approved product with established safety data which degrades in a clinically relevant timeframe and has demonstrated no complications in experimental models
To the surgeon-
- Off-the-shelf product
- Biomechanical properties provide a product designed to be sutured and maintain integrity through the tendon regeneration timeframe
- Multiple devices can be used according to the size of the tendon injured, allowing surgeons flexibility regarding the site of use and to utilise it in both trauma and elective surgery
- No surgical training required
To the patient-
- Specifically designed to promote the biology of tendon regeneration; good tendon recovery
- Provides an alternative to sacrificing a healthy tendon for those patients requiring autograft reconstructive surgery
- Absorbable device ensures no long-term problems
- Single surgery that can be performed using minimally invasive techniques with less trauma to the body, faster recovery and reduced scarring
To the manufacturer-
- Transferable manufacturing process and upscale production
- Platform technology
- Low cost of goods
- Materials are fully FDA approved
- Ability to produce a range of product sizes
- Established stability up to 6 months real-time and 12 months accelerated time
- Potential design options available to extend product range
The tendon repair device, which is initially being developed for hand surgery, would provide a platform technology for a suite of future products adapted to treat a range of soft tissue injuries. The device would have scope for worldwide usage, particularly in the EU and US markets.
The device is protected by University of Manchester granted patents: EP2373354(B1); US9770529(B2)
This novel tendon product repair technology is an excellent collaboration, development and license opportunity for medical device companies active in soft tissue repair.
Dr Roisin McCallion, UMIP, Core Technology Facility, 46 Grafton Street, Manchester M13 9NT E:firstname.lastname@example.org T: +44 (0)161 603 7772