Periodic Reporting for period 1 - Lattice Cage (Titanium based Cervical Spine Implants manufactured using 3D laser sintering to produce a structure optimised for graft-free bone in-growth)
Période du rapport: 2016-08-01 au 2016-10-31
Age-related degeneration of the cervical spine (the neck) affects large numbers of people from middle age and causes pressure on the nerve roots in the neck. This pressure can cause pain in the neck and arms, numbness or weakness in the arms or hands and a lack of co-ordination. It is caused by two main physical factors; a herniated (bulging) disc, or the presence of bony spurs in the neck as a consequence of arthritis (cervical spondylosis). Pressure placed on the spinal cord as it passes through the cervical spine can be serious since most of the nerves for the rest of the body pass through the neck. Where conservative treatment is not effective a surgical procedure known as “an anterior cervical discectomy with fusion” (ACDF) is performed to alleviate the symptoms. The source of the compression e.g. herniated disc or bony spurs are removed to relieve the pressure on the nerves. A cervical implant and bone graft are placed in the intervertebral disc space to fuse the 2 vertebrae together (arthrodesis) in order to stabilise the neck.
Cervical anterior interbody cage implants (cages) are used in conjunction with a bone graft that promote osteogenesis (new bone growth) and fuse the 2 vertebrae together over a period of time. Recent research suggests that the osteoconductivity of the titanium implant can be improved by incorporating into the design an open lattice structure. We have developed a Ti based cervical fusion cage using a 3D additive manufacturing process which enables the creation of an internal lattice structure conducive to bone cell growth which eliminates the need for bone grafts or synthetic bone substitutes and aids fusion by promoting osteoblast proliferation (cells that make bone) and driving new bone growth. The project aims to produce an implantable device which reduces surgical time, costs, and increases patient recovery time.
Cervical anterior interbody cage implants (cages) are used in conjunction with a bone graft that promote osteogenesis (new bone growth) and fuse the 2 vertebrae together over a period of time. Recent research suggests that the osteoconductivity of the titanium implant can be improved by incorporating into the design an open lattice structure. We have developed a Ti based cervical fusion cage using a 3D additive manufacturing process which enables the creation of an internal lattice structure conducive to bone cell growth which eliminates the need for bone grafts or synthetic bone substitutes and aids fusion by promoting osteoblast proliferation (cells that make bone) and driving new bone growth. The project aims to produce an implantable device which reduces surgical time, costs, and increases patient recovery time.
TASK 1 - Validation of customer demand
We have establish a panel of KOLs to provide a steering team for the clinical strategy at an early stage and guide in the design and implementation of the Clinical Investigation. This will help us confirm price point acceptance, our forecasted market size, growth and future market potential.
TASK 2 – Engagement with manufacturing, supply & end user partners
We have gained written agreements from 3D manufacturing partners with the capability to manufacture to our specification and in sufficient volumes as well as packaging and sterilisation equipment provider while considering best value cost of goods development and market penetration
TASK 3- Determine clinical validation & regulatory pathway
We confirmed mechanical, corrosion & fatigue testing standards & develop a road map to complete this testing detailing costs, test centres & duration. We also collated all of the required evidence from the existing published pre-clinical studies & all the mechanical and material testing to fulfil regulatory requirements & achieve CE marking.
TASK 4- Development of an IP and commercialisation strategy
We established freedom to operate with the design by mapping the IP landscape and gained an understanding what we can be protect and integrate into the commercial strategy plan.
TASK 5 Validation of the technical feasibility and cost of getting to TRL 8/9
We explored the technical feasibility to manufacture 100 implants during Phase 2 by confirming the key technical challenges involved in the scale-up manufacturing. We confirmed material costs and developed a project technical plan including Gantt Chart and description of work to get to TRL 8/9.
TASK 6 Risk Analysis
We compiled a risk register detailing technical, commercial and other risks along with mitigation measures.
TASK 7- Development of an elaborated business plan
We produced a business plan incorporating information obtained through the above tasks. This details the necessary levels of investment, resource, distribution channels and key product offering.
We have establish a panel of KOLs to provide a steering team for the clinical strategy at an early stage and guide in the design and implementation of the Clinical Investigation. This will help us confirm price point acceptance, our forecasted market size, growth and future market potential.
TASK 2 – Engagement with manufacturing, supply & end user partners
We have gained written agreements from 3D manufacturing partners with the capability to manufacture to our specification and in sufficient volumes as well as packaging and sterilisation equipment provider while considering best value cost of goods development and market penetration
TASK 3- Determine clinical validation & regulatory pathway
We confirmed mechanical, corrosion & fatigue testing standards & develop a road map to complete this testing detailing costs, test centres & duration. We also collated all of the required evidence from the existing published pre-clinical studies & all the mechanical and material testing to fulfil regulatory requirements & achieve CE marking.
TASK 4- Development of an IP and commercialisation strategy
We established freedom to operate with the design by mapping the IP landscape and gained an understanding what we can be protect and integrate into the commercial strategy plan.
TASK 5 Validation of the technical feasibility and cost of getting to TRL 8/9
We explored the technical feasibility to manufacture 100 implants during Phase 2 by confirming the key technical challenges involved in the scale-up manufacturing. We confirmed material costs and developed a project technical plan including Gantt Chart and description of work to get to TRL 8/9.
TASK 6 Risk Analysis
We compiled a risk register detailing technical, commercial and other risks along with mitigation measures.
TASK 7- Development of an elaborated business plan
We produced a business plan incorporating information obtained through the above tasks. This details the necessary levels of investment, resource, distribution channels and key product offering.
We have designed and developed a unique device that will have a positive impact on patients receiving surgery for degenerative disease in the cervical spine. The key distinguishing features of “Lattice Cage” implants are;
- No need for graft surgery or additional screws and plates
- No risk of complications from graft surgery
- Quicker return to normal activities due to enhanced fusion time
- Low failure rate so reduced chance of needing revision surgery
- Lattice structure enhances osteoconductivity and osteogenesis
- Implant is designed with serrated surface to grip the adjacent bone
- Lattice structure will promote enhanced osteogenesis for rapid fusion without a graft
- Reduces cost of surgery due to low cost manufacturing, less surgery time and can be used without additional bone substitute products.
- No need for graft surgery or additional screws and plates
- No risk of complications from graft surgery
- Quicker return to normal activities due to enhanced fusion time
- Low failure rate so reduced chance of needing revision surgery
- Lattice structure enhances osteoconductivity and osteogenesis
- Implant is designed with serrated surface to grip the adjacent bone
- Lattice structure will promote enhanced osteogenesis for rapid fusion without a graft
- Reduces cost of surgery due to low cost manufacturing, less surgery time and can be used without additional bone substitute products.