Europe, the CE certified medical equipment (EC CERTIFICATE No. 09 0456 QS / NB,

EC Design-Examination Certificate No. 09 0458 CN / NB)

Precautions :Always follow aseptic technique throughout the procedure. Physical activities should be done according to the rehabilitation guidelines recommended by the patient’s physician.If adverse events occurs following surgery, we recommend treatment by a doctor.The safety of CartiFill™ has not been established for use in pregnant or lactating women, or children.

Contraindications :Medical doctors should not apply CartiFill™ in the following patients:If patients or their families suffer from or have ever suffered from an autoimmune disease. Patients who have ever suffered an anaphylactic reaction.Patients who have ever suffered hypersensitivity to an implant.Patients with a history of allergy to porcine or bovine protein.Patients who have ever suffered contraindications of the used Fibrin sealant. (The major contraindications are as follows : patients with hypersensitivity to aprotinin and those being treated for severe brisk arterial or venous bleeding.)

Storage and shelf life :CartiFill™ should be stored at 1-30˚C. Do not freeze it.Do not use after the expiration date stated on the label.

Warning :The use of this product is strictly limited to medical doctors.Closely examine the patient’s history regarding possible allergies before using CartiFill™, as hypersensitivity to atelocollagen and other adverse reactions can occur in such patients.CartiFill™ is for a single use only. Discard all remains in the syringe after use. If reused the single- use device has the potential for viral transmission and infection. Do not use a damaged product. The sterile packaging should be inspected for visible damage prior to use.Do not re-sterilize.The used medical device should be disposed of according to the hospital’s internal regulations based on the Waste Control Law.

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COLLAGEN FILLER FOR CARTILAGE SUPPLEMENT

RMS Innovations (UK) Ltd

Unit 310 Centennial Avenue, Centennial ParkElstree, Hertfordshire, UK WD6 3TJ Tel: +44 (0)208 9537781 / Fax +44 (0)208 9531944E-Mail: sales@rmsbio.net / http://www.rmsbio.net

CartiFill™

Advanced technique of bone marrow stimulation procedure for cartilage defects

• Simple procedure

• Secure stimulated bone marrow cells

• Stable chondrogenesis

CartiFill™

Package I

CartiFill™

Atelocollagen Implant (3%, 6%) 3ml syringe 1 EA

Stabiliser 2ml syringe 1 EA

Package II

Accessory Unit

3 way-connectors 2 EA

Disposable needles 2 EA

Chart-stickers 3 EA

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CartiFill™ has been tested on the following subjects for its safety and efficacy standards: technical

regulation, environmental control, product inspection, packaging and sterile validation. CartiFill™

meets all of the essential requirements of the EC Directive: Medical Devices Directive (MDD 93/42/

EEC amended by 2007/47/EC).

Indication :

Composition :

Advantages :

• Simple manipulation

• Secures migrated cells from bone marrow

• Induces cellular migration

• Activates cells for proliferation and differentiation

• Stabilises chondrogenesis

• No risk of BSE (Bovine Spongiform Encephalopathy)

• Proven safe collagen material used since the 1980’s

Safety and Efficacy :

Post market surveillance report :

COLLAGEN FILLER FOR CARTILAGE SUPPLEMENT

• CartiFill™ is implanted into patients who have focal cartilage defects.• CartiFill™ is an innovative injectable filler for treatment of cartilage defects using bone marrow stimulation procedures. (microfracture, multiple drilling and etc.)• CartiFill™ secures stimulated bone marrow cells, stabilises bone marrow cells and improves cellular viability.• CartiFill™ provides stable matrix structure in the implanted site with finely purified atelocollagen, cell stabilising media and commercially available fibrin glue.

Atelocollagen Implant -3ml porcine derived atelocollagen that induces cell conduction and inductionStabiliser -2ml supports cellular activities

The object of the report was to observe the efficacy and safety for treating chondral defects with

CartiFill™. Numerous cases of chondral implantation were observed for 6 months, with the results

showing that CartiFill™ is safe to use in the treatment of chondral defects.

CartiFill™

Procedure via Arthrotomy or Arthroscopically

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The Microfracture technique is used in the articular cartilage. These chondral injuries will

progress to arthritic change if left unaddressed. During the operation the full thickness articular cartilage defect is identified and the exposed boned debrided. Multiple holes or ‘microfractures’ are made in the subchondral bone plate. A blood clot rich in marrow elements: ‘super clot’, forms over the lesion. This clot provides rich media in which cells can divide. Injecting CartiFill™ into the defect site after microfracture acts as a scaffold to seal in the blood clot rich in bone marrow elements. Eventually this will form repaired cartilage that fills the original defect.

The atelocollagen is a thermo-sensitive regeneration agentand effectively restores damaged cartilage tissue.

CartiFill™ ImplantationStable Chondrogensis

Microfracture or Multiple Drilling

Mixing Procedure Schematic

Debride the defect area.Identify the defect area.

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Inject CartiFill™ (CartiFill™+Fibrin glue).

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Wait 5 minutes for CartiFill™ to set. Once set fill with saline to check stability.

CartiFill™ Procedure Arthroscopically

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Microfracture or Multiple drilling.

Drain all saline and dry out the defect area and/or inject CO² gas.

2nd 1ml 3rd 0.4ml

4th 1ml 4th 1ml

Total 2ml

Aprotinin Fibrinogen Thrombin

Stabiliser Atelocollagen

1st 1ml 2nd 1ml 3rd 0.4ml

4th 1ml 4th 1ml

Total 2ml

Aprotinin Fibrinogen Thrombin

Stabiliser Atelocollagen

1st 1ml

Rehabilitation

Walk applying partial weight to the leg or knee with the implanted CartiFill™.

Repeating the static contraction of muscles without any movement in the angle of the joint.

Walk applying body weight fullyon the leg or knee with the implanted CartiFill™.

Bending the knee after widening the feet shoulder width apart and keeping your back against the wall.

0-2 weeksafter operation

2-6 weeksafter operation

6-12 weeksafter operation

12-18 weeksafter operation

1. Protect the cartilage transfer- avoid weight bearing2. Attain and maintain full knee extension3. Gain knee flexion to 90 degrees 4. Promote quadriceps muscle strength5. Decrease knee and leg swelling

1. Protect the knee from overstress and allow healing2. Regain full motion3. Begin muscle strengthening

1. Walk normally2. Regain full motion3. Begin muscle strengthening

1. Regain full muscle strength2. Gradual return to full activity

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PWB(Partial Weight Bearing)

Squatting exercise

FWB(Full Weight Bearing)�

Isometric exercise

CPM(Continuous Passive Motion)

Hamstring exercise

1CartiFill™ Key Messages :

• Advancement on microfracture• One step procedure can be performed arthroscopically• Forms typeⅡ collagen• Safe and efficacious

Promise for Life..Promise for the future..

Strengthening of muscles in the back thigh.

Exercising by a machine to help restore extension and flexion or complete motion to your knee without the use of muscle groups.

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