Below is a list of the most commonly used terms in the markets BONESUPPORT operates in.
BONESUPPORT uses different performance measures, some are taken directly from financial statements and some are Alternative Performance Measures (APM). The most common measures are listed below.
Clearence from the FDA to market a medical device in the US, based on the FDA deeming the medical device to be substantially equivalent to another medical device already on the US market.
An individual, company, institution or organization, which takes responsibility for the initiation, management and/or financing of a clinical study.
Osteoconduction means that a bone graft material can serve as a scaffold for new bone growth.
Osteogenesis is the process of new bone tissue production by osteoblasts.
A bone graft harvested from the patient’s own skeleton, usually from the iliac crest.
A processed form of allograft, an acid-extracted organic matrix from human bone sources.
Surgery following arthroplasty (joint replacement) to replace a worn-out prosthesis.
A type of calcium phosphate (Ca5(PO4)3OH) that occurs as a mineral and is the chief structural element of bone.
A family of materials and minerals containing calcium ions and phosphate anions, used in synthetic bone graft substitutes.
A disease characterized by reduced bone mass. This leads to increased bone fragility and risk of fracture.
Synthetic material used as bone grafts instead of biological bone tissue.
A group of growth factors. Bone morphogenetic proteins orchestrate tissue architecture throughout the body, especially the formation of bone and cartilage.
Surgical replacement of damaged or missing bone tissue by transplanting other bone tissue or by using synthetic materials.
Scientific discipline that quantifies the economic and clinical outcomes of medical technology.
A bone graft transplanted between genetically non-identical individuals of the same species. Allograft can be living related (harvested from femoral heads during hip arthroplasty) or cadaveric.
A calcium sulfate compound, which exists in different levels of hydration (CaSO4, CaSO4(H2O)2 and CaSO4(H2O)0.5) and has been used extensively in medicine, for example as material in bone regeneration.
Orthobiologic products support tissue healing and restoration by harnessing regenerative potential with the body’s own cells to replace or regenerate musculoskeletal structures. The applications stretch across joint reconstruction, trauma, soft tissue repair and spine.
Bone cells that break down and resorb old bone tissue.
Bone cells that produce bone tissue.
The branch of surgery concerned with conditions involving the musculoskeletal system.
Study on human participants of e.g. a medical device or a pharmaceutical.
Osteoinduction means that a bone graft material or a growth factor can stimulate the differentiation of osteoblasts, that in turn form new bone tissue.
A bacterial infection affecting bones.
Bone or bony.
Bacterial contamination of a hip or knee prostheses with bacterial infection of the surrounding bone and joint tissue. This condition can lead to the septic loosening of a prosthesis.
Numerical scale used to specify acidity of a solution.
Market pre-approval from the FDA in the US for class III medical devices.
Poly methyl methacrylate, often called “bone cement”.
Biological cell that can advance into a specific type of cell.
Systemic administration of a substance means that the substance is delivered through the bloodstream and is spread throughout the body. Local administration means that a substance is delivered locally to a specific part of the body, e.g. a bone void.
The patient’s own bone (bone tissue).
The spread of a cancer from one organ or part of the body to another without being directly connected with it. The new occurrences of disease thus generated are referred to as metastases (mets).
Implant failure of a joint prostheses causing the prostheses (or part of the prostheses) to loosen, and the reason for which is not related to bacterial infection.
Storage for bone and bone tissue, typically allograft.
A ceramic material that is biocompatible, i.e. can interact with biological materials such as the human body.
Bone tissue is composed of bone which is cortical (compact) on the outside and cancellous (spongy) on the inside.
A type of drugs that inhibits resorption of bone tissue.
A state or federal system for categorization and remuneration of healthcare. Originally from the US, but is now common in many countries.
A physical injury caused by slipping, stumbling or a low-height fall in combination with a disease which has affected the integrity of the bone (e.g. osteoporosis or metastatic disease).
External fixation is a surgical method for stabilizing and supporting bone defects with external fixation devices. Internal fixation uses implants, e.g. plates, nails and screws, which are placed into the bone.
A localized collection of blood outside the blood vessels.
The upper wing of the hip bone.
Exemption from regulatory approval in the US to conduct clinical studies on a medical device. An IDE study is thus a clinical study conducted by such exemption after approval from the FDA.
Radiocontrast agent used in various forms of radiology and which enhances visibility.
Bony and cartilaginous material forming a connecting bridge across a bone fracture during healing and repair.
A high energy trauma typically caused by a motor vehicle accident, a high-height fall, or an industrial accident.
Cells that grow out of control and are cancerous. Cells in malignant tumors can invade nearby tissues and spread to other parts of the body.
Mature stem cells, usually harvested from the bone marrow.
Dead bone tissue.
Foot infections due to a compromised vascular supply, neuropathy (nerve damage) and osteopathy secondary to diabetes mellitus.
A tumor that lacks the ability to invade neighboring tissue or metastasize.
The federal medical authority in the US.
Net result divided by average number of shares before dilution.
Operating result shows the operative result including depreciation. Management uses this to assess operational performance, including depreciations and amortizations.
Difference in net sales between periods in relation to sales in the same period the previous year. Management uses this measure to monitor the sales performance of the business.
Revenues minus directly allocated cost of sales, selling and R&D expenses. Contribution shows the operational performance for each segment.
Interest bearing debts (borrowings) minus cash and cash equivalents. Management uses this measure to monitor the leverage level of the Company.
Operating profit/loss including deprecations. Management uses this measure for external comparisons.
Net Sales minus cost of sales. Management uses this measure to monitor the profit needed to cover other costs and profit margin.
(Net sales minus cost of sales) divided by net sales. Management uses this measure to monitor the profit in relation to Net sales, an indication of the margin to cover other costs and profit.
Borrowings from banks and other financial institutions, short and long term. Management uses this to monitor the debt level of the Company and forms also the basis for interest costs.