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ORTOBRAND young, dynamic and

independent company specialized in

manufactures and distributes  products are

based on hyaluronic acid (HA),used for the affected synovial joint.

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It all started with a desire to help people in need and to

be able to understand that a medical device is not just a product, but rather a chance

to return to a normal life.

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ORTOBRAND team’s objective is to develop

international business by establishing partnerships with specialized foreign distributors all over the

world

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Our goal is to build up strong and sustainable

relationships with partners operating in the

medical industry, strategic collaborations

distribution license , national partnerships to supplement its product

portfolio

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We know what it takes to make relationships

succeed: respect, trust and flexibility

around each partner’s interests.

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ORTHOFLEX forte-Hyaluronic Acid –

Synovial fluid supplement

ORTHOFLEX forteOrthopedic Viscosupplement

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Sodium hyaluronateHyaluronan (also known as sodium hyaluronate

or hyaluronic acid) is a polysaccharide composed of repeating disaccharide units of glucuronate and N-acetyl glucosamine and counter ions. Hyaluronan is a physiological substance that is widely distributed in the

extracellular matrix of connective tissues in both animals and humans. It is found in high

concentration in the aqueous humor of the eye, synovial fluid, skin, and umbilical cord

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Viscosupplementation with ORTHOFLEX forte for the treatment of

Osteoarthritis Knee Pain • Hyaluronic acid HA is responsible for the

viscoelastic properties of synovial fluid.• Compared with healthy joints , synovial fluid

in ostheoarthritic joints contains HA of a lower concentration and molecular weight.

Potential mechanisms of actionsMechanical

-Higher molecular weight hyaluronans may increase viscosity

Biological-May reduce degradation of hyaluronan and

orther key component of cartilage and synovium.

- Affects inflammatory process- -Provides direct analgesic effect on nerve

impulses sensitivity.

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Viscosupplementation refers to a procedure that involves

the use of HA solution to supplement or replace synovial fluid in joint with pathological conditions

to alleviate pain and promote the healing of intra-articular wounds.

• The viscosupplementation improve the physiological

environment of an osteoarthritic joint by restore the protective

viscoelasticity of synovial fluid, reduce friction, and improve

mobility.

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• When the normal viscoelasticity of a solid tissue compartment or the elasto viscosity of a liquid tissue compartment is decreased under pathological conditions, normal

function and regenerative processes are impaired

• . By introducing viscosupplementary devices, the normal rheological state of such compartments is restored or

augmented. • These devices stay in the tissue compartment for various periods of time, depending on the nature of the

viscosupplement and the pathophysiology of the tissue

compartment.

BE ACTIVE

• Restore mobility with Orthoflex forte

• Do your patients suffer from pain associated with

osteoarthritis?• If their active lifestyle is

being restricted by join pain , relief is in sight.

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What is Osteoarthritis?

• Osteoarthritis is a disease that affect the joints in your body.

• While it can affect any joint , osteoarthritis most commonly in the hands , hip, Knees, neck and

lower back.• Osteoarthritis (OA) is the most common joint disease and cause of disabilities, especially in the

elder people (more than 80 percent of the population over 55 years of age is affected by

osteoarthritis).

• Also known as degenerative arthritis, degenerative joint disease or OA, it occurs when the cartilage that normally covers and cushions the ends of

bones wears down over time. It is characterized by cartilage erosion, changes in subchondral bone, osteophyte formation and synovial inflammation.

• The main symptoms of OA are chronic pain, stiffness and loss of mobility.

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How does OA develops?

• Osteoarthritis is caused by cartilage resulting in a joint pain.

• The smooth cartilage surface wear down. Then this happens, the cartilage

loses its elasticity and more easily damage by excess use or injury.

• With time section of cartilage may wear away completely. As a result the

bone rub together.• As the cartilage wear down , the join

may lose its normal shape. The bone end thicken. The bone at the edge of

the joint mat grown outward and form body spurs.

• Fluid – filled cysts may form in the bone near the joint . Bit of bone or

cartilage may float loosely in the joint space.

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Osteoarthritis of the Knee

• When osteoarthritic joints became swollen and damaged , they can be painful and

difficult to move.• If you have OA of the knee the symptoms

pain, stiffness limited range of motion.• In the arthritic joints , the normal

concentration and molecular weight of hyaluronate ( HA ) is decreased by 33% to 50%, limiting its role in maintaining normal

joint biomechanics. • Purpose of viscosupplement : replace this

lost HA• ORTHOFLEX forte , it helps lubricate ,

protect and cushion the knee. It can reduce and help improve your ability to

perform every day activities.

ORTHOFLEX forte product of visco supplementation which is

safe effective and well – established treatment in OA consisting in injecting a hyaluronic acid based solution into the

affected synovial joint.• Hyaluronic acid- HA is a major component

of the synovial fluid and cartilage and thanks to its viscoelastic and rheological

properties is responsible for the lubrication and cushioning in joint.

• It decreases friction between join surfaces and protect soft tissue from trauma by

acting as a shock absorbant.• HA also have analgesic, anti inflammatory,

antioxidant effect , stimulates proteoglycan synthesis and facilitates the evacuation of

cartilaginous remains.

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• The quantity and quality of the HA in the synovial fluid are reduced in the patient who have osteoarthritis

because its synthesis by the synovial and cartilage cell is

disturbed.• The protection of particular

surfaces thus is strongly altered , the cartilage becomes vulnerable

and exposed to structural degradations due to the forces of

friction and compression.• Orthoflex forte relieves joint pain

improves articular mobility and protects cartilage.

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Indications

•    Orthoflex forte is indicated as a viscoelastic supplement or a substitute for

synovial fluid of human joints.•Orthoflex forte is recommended for patients that have joints pain coupled with reduced mobility. These symptoms can occur as a result of degenerative disease or trauma.

•Orthoflex forte greatly reduces pain, treating and restoring joint mobility and elasticity.

•The treatment consists in administration of intra articular injections between 1 - 3

Orthoflex forte/1 at weekly intervals depending on the severity of the degenerative or traumatic change to the synovial joint.

•Indications like Gonarthritis, Coxarthritis, Omarthritis, Arthritis of the elbow, Rhizarthritis

and Ankle arthritis.

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Physicochemical Properties:

Treatment  1-3 injection30mg/2ml (1.5%) sodium hyaluronateEstimative molecular weight sized

into 2.0÷2.9 million Daltons (viscometric data)

Average molecular weight 2.4 million Daltons (viscometric data)

Intrinsic viscosity 1.5 - 3.8m3/kg Osmolarity300 - 370 mOsmol/kg Endo toxin limit -less than 0.5 EU/mg

sodium hyaluronate pH 5.0- 8.5 Elasticity minimum 60 Pa (2.5Hz,

maximum effort) Viscosity minimum  45 Pa (2.5Hz,

maximum effort)

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Orthobiologics information:

• biofermentative origin of sodium hyaluronate

• up to six months with just 1-3 injections recommended

• for all large synovial joints

Technical Data

• Ready-to-use syringe;• Filling volume minimum 2 ml;

• Luer lock connection;• Terminal steam sterilization

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Application:

• Just one syringe / week, intra articular administration• About 1 to 3 weeks for best results and long term

effect

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Benefits

• High molecular weight (2,0- 2,9 million Daltons);• No protein of animal origin (fermentative process);• Sterilization using aluminium blister.• Fully self-contained system provides safety and

purity;• Easy to use;• Store at room temperature possible;• Luer Lock.

Injection:

The affected knee is first aspirated to remove any

effusion that may be present, decreasing the concentration of inflammatory mediators that may be present and limiting

the dilution effect the effusion would have on the injected

material;Superolateral or lateral

midpatellar injection site is the most reliable for reaching the

synovial joint space of the knee

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Method of administration and dosage• ORTHOFLEX forte is administered only by medical professionls trained for Intra -articular administration

tehnique.• ORTHOFLEX forte must be administered strictly

intra-articular.• Do not administer intravenously.

• The volume will vary depending upon the size of the joint space , not to exceed 2ml for the knee

and other large joints or 1ml for small joints.• It is the physician ‘s responsibility to determine the appropriate volume and ensure that the joint is

not overfilled.• ORTHOFLEX forte is administered in the affected

joint once a week for 3 consecutive weeks.• Several joints may be treated simultaneously.• Not to exceed one treatment course for any

individual joint in any 6- month periods.• Any joint effusion present should be removed by

joint aspiration before injecting ORTHOFLEX forte.

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The intra -articular space should not be overfilled.

• ORTHOFLEX forte is available as a ready to use pre-filled syringe and must not be diluted.

The content of a pre-filled syringe Orthoflex forte is sterile and must be used immediately

after the packaging has been opened.• Orthoflex forte should be injected slowly into

the joint space using a standard intra –articular injections technique.

• Remove the pre-filled syringe from the package. Before administration break the

visible seal and remove the cap of the pre-filled syringe. Attach the hypodermic needle and

make sure you have it properly fixed by turning it slightly.

• Remove the air from syringe before the injection.

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Precautions

• General precautions should be observed for the intra-articular injection administration. Sodium hyaluronate should be administered in the synovial space only by medical professionals trained in intra-articular administration technique.

• An excess amount of sodium hyaluronate is not to be used and the patient should be monitored closely. The intra-araticular space should not be overfilled.

• If pain increase during the injection procedure , the injection should be stopped and the needle withdrawn.

• Patient should be carefully examined prior to administration to determine signs of acute inflammation and the physician should evaluate whether Orthoflex forte treatment should be initiated in this case. As in any invasive joint procedure it is recommended caution to avoid over using the joint immediately after the intra-articular injection. To date ,there are insufficient data to recommend the use in children and adolescents. Orthoflex forte should not be intra-articularly administered simultaneously or mixed with other products.

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Contraindications

The following pre –existing conditions may constitute relative or absolute contraindications to the use of ORTHOFLEX forte.

- allergy( hypersensitivity) to any of the component of Orthoflex forte.

- - pre-existing infections of the skin region at the injection site

- -know infections of the index joint

- - know systemic bleeding disorders.

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Adverse reactions

• Sodium hyaluronate is a natural component of the human tissue s.

• Since sodium hyaluronate was found to be non-inflammatory any inflammatory response is considered to be caused by the injection procedure itself.

• Episodes Mild to moderate episodes of transient swelling and discomfort have occasionally been observed following intra-articular injections of sodium hyaluronate preparations.

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Approved for all synovial joints (particularly the knee and hip,but also the ankle, shoulder, elbow, wrist, fingers, toes, and

the temporomandibular and facet joints)

Additional indications:

-Post arthroscopy;-Following meniscal repair;-Following anterior cruciate ligament reconstruction;-Adjunctive treatment for patients with osteochondral defects;-Postmosaicplasty;-Patients with isolated patellofemoral pain.

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Alternative treatments

• Nonsteroidal anti-inflammatory drugs (NSAIDs):– significant side effects and are not well tolerated by all patients;– cardiovascular risk;– gastrointestinal adverse effects;– risk of developing significant ulcer disease while taking even a short course (6 days to 2 weeks) of NSAIDs is 16% to22%;– 44% of patients can develop significant dyspepsia, requiringadditional medical treatment.• Corticosteroid injections:‒ risk of advancing articular cartilage degradation .

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ORTHOFLEX forte

Composition Sodium hyaluronate

Molecular Weight 2.4 Mio. Daltons

Indications Osteoarthritis

Effect Pain relief , mobility improvement, cartilage protection.

Duration of effects Up to 6 months

Administration 1-3 intra - articular injection- 1 per week

Packaging 2ml prefilled syringe in medical blister30 mg/2 ml sodium hyaluronate

Sterilization Autoclave

Shelf life 3 year

Storage Between +2 and + 25 C

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Thank you for your interest in our

products and services.Please contact our

business development team