Definitions

Below is a list of the most commonly used terms in the markets BONESUPPORT operates in.

Common terms

Demineralized Bone Matrix (DBM)

A processed form of allograft, an acid-extracted organic matrix from human bone sources.

510(k) clearance

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.

Bioceramic

A ceramic material that is biocompatible, i.e. can interact with biological materials such as the human body.

Calcium phosphate

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.

Benign tumor

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.

Hydroxyapatite (HA)

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.

Bisphosphonates

A type of drugs that inhibits resorption of bone tissue.

Bone graft

Surgical replacement of damaged or missing bone tissue by transplanting other bone tissue or by using synthetic materials.

Autograft

A bone graft harvested from the patient’s own skeleton, usually from the iliac crest.

Revision arthroplasty

Surgery following arthroplasty (joint replacement) to replace a worn-out prosthesis.

Hematoma

A localized collection of blood outside the blood vessels.

Allograft

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.

Bone bank

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

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

Bone tissue is composed of bone which is cortical (compact) on the outside and cancellous (spongy) on the inside.

pH

Numerical scale used to specify acidity of a solution.

Progenitor cell

Biological cell that can advance into a specific type of cell.

Osteoconduction

Osteoconduction means that a bone graft material can serve as a scaffold for new bone growth.

Osteoblasts

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.

Callus

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.

Aseptic loosening

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.

Host bone

The patient’s own bone (bone tissue).

Iliac crest

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.

Simple trauma

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

Osteogenesis is the process of new bone tissue production by osteoblasts.

Orthobiologics

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.

Complex trauma

A high energy trauma typically caused by a motor vehicle accident, a high-height fall, or an industrial accident.

Clinical study

Study on human participants of e.g. a medical device or a pharmaceutical.

Osteomyelitis

A bacterial infection affecting bones.

Iohexol

Radiocontrast agent used in various forms of radiology and which enhances visibility.

Osteoclasts

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.

Metastasis

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.

Sponsor

An individual, company, institution or organization, which takes responsibility for the initiation, management and/or financing of a clinical study.

PMMA

Poly methyl methacrylate, often called “bone cement”.

Osteoporosis

A disease characterized by reduced bone mass. This leads to increased bone fragility and risk of fracture.

Osseous

Bone or bony.

Orthopedic

The branch of surgery concerned with conditions involving the musculoskeletal system.

Malignant tumor

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.

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.

Common performance measures

Bidrag

Net sales minus cost of sales, minus directly attributable selling expenses and research and development expenses. A measure of result showing the performance of segments and their contribution to cover other Group costs.

Net debt

Interest bearing debt minus cash and cash equivalents. Shows the Group’s net debt and is used to measure the leverage level of the Group and future funding needs.

Gross margin, %

Net sales minus cost of sales, divided by net sales. Shows the gross profit in relation to net sales and the margin to cover other expenses and profit margin.

Sales growth, %

The difference in net sales between two periods in relation to net sales for the earlier period. Shows the operations’ sales performance. BONESUPPORT’s objective during 2023-2025 is to grow sales with 40 percent per year, measured as an average and normalized sales growth CAGR from 2023-2025.

Gross profit

Net sales minus cost of sales. Shows the profit to cover other costs and profit margin.

Interest-bearing debt

Leasingskulder, kort- och långfristiga. Visar koncernens skuldnivå och utgör grund för ränteko

Lease liabilities, short and long term. Shows the debt level of the Group and forms the base for interest expenses.