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.
Demineralized Bone Matrix (DBM)
A processed form of allograft, an acid-extracted organic matrix from human bone sources.
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.
A ceramic material that is biocompatible, i.e. can interact with biological materials such as the human body.
A family of materials and minerals containing calcium ions and phosphate anions, used in synthetic bone graft substitutes.
Calcium sulfate (gypsum)
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.
A tumor that lacks the ability to invade neighboring tissue or metastasize.
Bone graft substitute
Synthetic material used as bone grafts instead of biological bone tissue.
A type of calcium phosphate (Ca5(PO4)3OH) that occurs as a mineral and is the chief structural element of bone.
Bone morphogenetic protein (BMP)
A group of growth factors. Bone morphogenetic proteins orchestrate tissue architecture throughout the body, especially the formation of bone and cartilage.
A type of drugs that inhibits resorption of bone tissue.
Surgical replacement of damaged or missing bone tissue by transplanting other bone tissue or by using synthetic materials.
A bone graft harvested from the patient’s own skeleton, usually from the iliac crest.
Surgery following arthroplasty (joint replacement) to replace a worn-out prosthesis.
A localized collection of blood outside the blood vessels.
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.
Health Economics and Outcomes Research (HEOR)
Scientific discipline that quantifies the economic and clinical outcomes of medical technology.
Storage for bone and bone tissue, typically allograft.
Diabetic foot infections
Foot infections due to a compromised vascular supply, neuropathy (nerve damage) and osteopathy secondary to diabetes mellitus.
Osteoinduction means that a bone graft material or a growth factor can stimulate the differentiation of osteoblasts, that in turn form new bone tissue.
Bone tissue is composed of bone which is cortical (compact) on the outside and cancellous (spongy) on the inside.
Numerical scale used to specify acidity of a solution.
Biological cell that can advance into a specific type of cell.
Osteoconduction means that a bone graft material can serve as a scaffold for new bone growth.
Bone cells that produce bone tissue.
External / internal fixation
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.
Bony and cartilaginous material forming a connecting bridge across a bone fracture during healing and repair.
FDA, Food and Drug Administration
The federal medical authority in the US.
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.
The patient’s own bone (bone tissue).
The upper wing of the hip bone.
DRG (Diagnosis-related groups)
A state or federal system for categorization and remuneration of healthcare. Originally from the US, but is now common in many countries.
PMA (Pre-market approval)
Market pre-approval from the FDA in the US for class III medical devices.
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).
Osteogenesis is the process of new bone tissue production by osteoblasts.
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.
A high energy trauma typically caused by a motor vehicle accident, a high-height fall, or an industrial accident.
Study on human participants of e.g. a medical device or a pharmaceutical.
A bacterial infection affecting bones.
Radiocontrast agent used in various forms of radiology and which enhances visibility.
Bone cells that break down and resorb old bone tissue.
Mesenchymal stem cells
Mature stem cells, usually harvested from the bone marrow.
Necrotic bone tissue
Dead 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).
IDE (Investigational Device Exemption)
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.
Periprosthetic joint infection (PJI)
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.
An individual, company, institution or organization, which takes responsibility for the initiation, management and/or financing of a clinical study.
Poly methyl methacrylate, often called “bone cement”.
A disease characterized by reduced bone mass. This leads to increased bone fragility and risk of fracture.
Bone or bony.
The branch of surgery concerned with conditions involving the musculoskeletal system.
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.
Systemic / local administration
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.
Common performance measures
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.
Gross 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.
Sales growth, %
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.
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.
Operating result (EBIT)
Operating result shows the operative result including depreciation. Management uses this to assess operational performance, including depreciations and amortizations.
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.
Earnings per share (EPS)
Net result divided by average number of shares before dilution.