Impact case study database

Inductigraft (AltaPore in the US) is a bone void filler intended for gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created or from traumatic injury. The product is reabsorbed and replaced by bone during the healing process.

Inductigraft and AltaPore are delivered through Baxter, and are based on the 2003 and 2009 ApaTech/Baxter patents [5.1]. AltaPore received FDA approval for use in orthopaedic procedures in extremities and the pelvis in 2013 and posterolateral spine fusions in September 2018 [5.2]. The Shape version (malleable putty instead of granules delivered dry or in a sculptable carrier, ABX) was launched in 2019.

Enhanced patient health and well-being

Clinical superiority of Inductigraft/Altapore

Inductigraft/AltaPore has been clinically reported to have “excellent fusion rates” [5.3] according to Michael Mokawem, Consultant Orthopaedic and Spinal Surgeon, Royal National Orthopaedic Hospital NHS Trust, with 98.9% fusion rates in transforaminal lumbar interbody fusion and lateral lumbar interbody fusion surgery.

Mr. Mokawem further reported “12 months CT scans showing close to 100% fusion (1 out of 150 failed), whereas for other SBGs it would be 80-92%.” Mr. Mokawem added that the Baxter products’ optimised levels of silicate and pore structures (to facilitate development of interpenetrating vascular networks) to “provide a microenvironment that facilitates osteoblasts to start bone formation” and have, thus, more reliable outcomes in surgery. The chemistry (apatite based rather than tricalcium phosphate/calcium sulphate/calcium carbonate based) means that these materials do not degrade chemically in the physiological environment. Any remodelling that happens is entirely cell mediated (use of chemically biodegradable materials can result in complications). Additionally, unlike traditional growth factor based treatments, Inductigraft/AltaPore is not contraindicated in skeletally immature individuals, which has enabled successful treatment of children and adolescents [5.4].

Improved patient outcomes

First, with use of Inductigraft/AltaPore, the surgeon is “able to reliably use Inductigraft without the need to harvest iliac crest bone to achieve excellent fusion rates, so eliminating the need for a second donor site with associated risks of infection, pain and complications associated with donor site morbidity,” according to Robert Lee, Consultant spinal surgeon at the Royal National Orthopaedic Hospital Stanmore [5.5]. Additionally, the use of SBGs means there is a reduced need for anaesthesia and, thus, reduced surgical risks to patients. This is because without the need to obtain autograft bone (from the iliac crest), the operative procedure is shorter so patients are anaesthetised for a reduced length of time.

Second, a patient treated with Inductigraft/AltaPore has a greater chance of avoiding reoperation or revision surgery because “the excellent fusion rates significantly contribute to the improvement in patient reported outcomes,” according to Mr. Lee [5.5]. Further, patients are typically released from hospital two to three days earlier, which has a positive effect on both the patient’s quality of life and that of their family, friends and work colleagues.

Finally, in clinical trials at month 12 post fusion, clinically significant decreases in disability were observed. Patients also reported reductions in pain and an improved quality of life post-surgery. Motor, sensory functions, reflexes, straight leg raise and femoral stretches were either maintained, or improved in over half of patients [5.6].

Improved health economics [5.4]

Use of autograft involves two surgeries (harvesting of the bone followed by implantation), meaning

• The operation itself is prolonged

• Autograft harvesting procedures routinely have complications

For allograft and autograft, the risk of infection or immune rejection is significant vs SBGs where it is virtually zero. The percentage of patients returning with complications and requiring further surgery is therefore higher for allo/autograft, as, in the case of allografts, the bone has to be treated and sterilised before it is used. The faster bone growth associated with Baxter products also means that there is a reduced need for hardware, for example the insertion of metal supports.

The associated cost implications of the above are detailed in the table below:

Based on approximately 24,000 procedures per year, Baxter products are estimated to save

• USD31,000,000 per year when compared to autograft-based procedures

• USD74,000,000 per year when compared to growth factor-based procedures

Continued use of Actifuse™ (launched in 2005) in the current REF time period

Actifuse, launched in 2005 and the subject of a Queen Mary REF 2014 impact case study, is continuing to have a health impact. This is now expanding to areas outside of spinal injuries to knee injuries. A clinical study conducted between 2012 and 2015 found that clinical function outcomes after knee surgery using Actifuse vs autograft were comparable 3 years after surgery. The average operative time in the autograft group was 114 minutes, nearly double that in the Actifuse group (64 minutes), as using the SBG is a technically less demanding procedure than using harvested cancellous bone from the iliac crest. No complications occurred in the Actifuse group. In contrast, 1/20 patients in the autograft group required revision surgery at the donor site [5.8].

In 2018, a ‘flow’ version of Actifuse was launched, which provides a finer fraction of granules for narrow bore application. It is unique in that it is non-setting when injected [5.4]. Actifuse Flow comes ready to use with no mixing or preparation involved and maintains its consistency throughout surgery. The SBG is delivered directly from a pre-loaded syringe with the ability to start and stop delivery, making use of Actifuse compatible with minimally invasive surgical techniques in addition to more traditional open surgery, increasing potential market size.

Stimulated academic and public interest and attracted national/international recognition

In 2014, the Academia/Industry partnership, TERMIS-EU (Europe) and TERMIS-AM (Americas) Industry Committees used Baxter (and ApaTech) as a case study to demonstrate that there are a number of mechanisms by which industry can interact effectively with academia to transfer technologies to commercial partners [5.9].

Outside of Queen Mary, Baxter products have been used as a biomedical technology ‘Laboratory Bench to Clinic’ case study in the syllabus of various undergraduate biomaterials/bioengineering degree programmes across the country. This includes Kings College London (delivered to approx. 20 students, in 2017, 2019) and the University of Manchester (delivered to approx. 30 students from 2014 to 2019) [5.10] [5.11].

The development of Actifuse and Inductigraft/AltaPore bone graft substitutes has achieved national/international recognition though the issue of a Royal Mail stamp (priced at £1.60) dedicated to the innovation of SBG materials able to enhance bone growth. The stamp was released in the British Engineering Stamp Issue (May 2019) celebrating seven key British engineering achievements of the last 50 years [5.12] and was described by Mr Philip Parker (Stamp Strategy Manager, Royal Mail) as a “very well received and successful” [5.12] stamp issue.