Bone cure guided bone regeneration membrane

INNOVATIVE MEMBRANE FOR BONE REGENERATION & FRACTURE HEALING

November 2011

Confidential

The Product: AMCA BoneCure™ MembraneCharacteristics

Sterile & Pyrogen free AMCA (Ammonio

Methacrylate Copolymer type A) membrane polymer;

Biocompatible- 6 months studies, ISO 10993-1 Biological evaluation of medical devices – Part 1; Manufactured under GMP conditions in clean room;

Physical Properties:

Thickness – 350 µm (±15%) Flexible & strong, tensile strength 4 - 8 Mpa Micro porous (11%), pore size 0.2 – 1.6 µm Moisture content <1.5%

REGENECURE Solution for Fracture Repair: Regenerative Membrane Implant

• AMCA membrane provides optimal conditions for rapid & natural fracture healing:

√ Barrier – provides protected healing space, retains cells & growth factors; √ Osteoconductive scaffold that supports Mesenchyemal Stem Cells (MSC) :

Adherence Proliferation Differentiation of MSC into bone tissue

√ Promotes Guided Bone Regeneration (GBR);

Effective carrier for drugs and MSC;

Preclinical Rabbit Study: AMCA BoneCure vs. Bone Void Filler

• 11 male New Zealand rabbits underwent midshaft resection of radial bone (1cm in length);

• 4 rabbits - tubular BoneCure membranes were implanted;

• 4 rabbits - SYNTHES Bone Void Filler Granules were implanted;

• 3 rabbits – control, no treatment;

• Safety evaluation;

• Evaluation of fracture healing process – lateral radiograph 2 – 8 weeks postoperatively,

total area of the new bone formed was calculated;

• 8 weeks post surgery – animals were sacrificed, histological evaluations were performed;

Implantation of BoneCure

Bone Void Filler Implantation

Study Protocol:

Preclinical: 8 Weeks Post Implantation SYNTHES bone void filler implant No treatment BoneCure membrane

Gap is not bridgedGap is not bridged Gap is bridged

Micro CT- 8 W Post Implantation No treatment BoneCure membrane SYNTHES bone void

filler implant

Histological Evaluation – Radiograph & Scanned Slides of the Specimens

BVF – HA Granules BoneCure Membrane No treatment

Preclinical: Sheep Study In Critical Size Model

• Segmental defect in the Tibia (3.5 cm in length);

• 8 sheep - tubular BoneCure membranes were implanted;

• 8 sheep - SYNTHES BVF Granules were implanted;

• Safety evaluation;

• Evaluation of fracture healing - total area of the new bone formed

was calculated; - 16- 24 weeks post surgery –

animals will be sacrificed, histological evaluations will be performed

BoneCure membrane being implanted, in critical size defectStudy Protocol:

AMCA Membrane Supports Cells Adhering and Spreading in Spindle Like Shape

Scanning electron microscopy of human mesenchymal stem cells upon AMCA membrane

Case study no 100-01: 5 years Old St. Bernard with Comminuted Fracture of the radius, ulna. Cranio medial approach to the radius expo

Time Zero 3 weeks post surgery 6 weeks post surgery

Healing time 3 weeks (average healing time 3 months)

• Medical Procedure of the 5 yr. old St. Bernard: A 5 years old spayed St. Bernard female. Comminuted fracture of the Radius and Ulna Cranio medial approach to the radius; exposure of the proximal and• distal fracture edges. BoneCure® membrane was placed from the top and surrounded about • 270 degrees of the circumference of the radius. The BoneCure ® membrane was tucked under the muscles and sutured • to them along its length. Routine closure. Insertion of 3 smooth IM pins in a Type ll • configuration (Uniplanar bilateral) with acrylic bars to support the • frame. Bandaging of the leg for 7 days.

•: A 5 years old spayed St. Bernard female. •Comminuted fracture of the Radius and Ulna,• caused probably by a low energy, heavy weight (Jeep wheel) passing over the leg.•Cranio medial approach to the radius; exposure of the proximal and distal fracture edges.• The membrane was placed from the top and surrounded about 270 degrees of the circumference of the radius.• It was tucked under the muscles and sutured to them along its length. Routine closure. Insertion of 3 smooth IM pins in a Type ll configuration (Uniplanar bilateral) with acrylic bars to support the frame. Bandaging of the leg for 7 days.

Case study no 102-003: S-A dog, female. Fracture of femur.

4 weeks Post – op. 7 weeks Post – op. Post – op.


Case study 001-006 (chello)

3 weeks Post – op. 6 weeks Post – op. Post – op.

Medical Procedure of 3 mo. Old Dog with suspected OI Disease• A 3 months old mixed breed male.• Comminuted fracture of the femur (while playing with owners at home, on a

slippery floor).• Initially NOT a candidate for BoneCure, but during the operation bones were

splitting to the weakest of handling, and it was thought that any extra help would be in place. Hence the membrane was used.

• It appeared post op that the pup comes from a litter of 7, 4 of which have suffered low velocity fractures such as itself. A bone sample from his sister was analyzed histologically by a qualified veterinary pathologist and was found to suffer from Osteogenesis Imperfecta (O.I.)

• Six weeks post op. the puppy is doing well and the bone seems to be healing in time

• Average Healing time- 4-6 wk. in a healthy puppy.


Case study no Le chat

3 weeks Post – op 6 weeks Post – opPost – op.

Medical Procedure in a 4yr. Old, Cat, DSH A 4 years old DSH cat, that fell off the 4th floor (High Rise Syndrome). Comminuted fracture of the femur No attempt was made to reduce the fragments with cerclage wires, rather the

membrane was wrapped around the whole area after an IM pin was introduced into the bone. Averege healing time - 7-12 wk.


Case study no Wassily

3 weeks Post – op 6 weeks Post – opPost – op.

Medical Procedure of 4 yr. old Dog A 4 years old Chinese Poodle Simple, distal third fracture of the Radius and Ulna NOT a comminuted fracture, but as it appears in a size of dogs (breed) known to

suffer from higher than average non unions, it was decided that in addition to a plate, the membrane will be used.

A 2.7 mm DCP was used, with 7 screws. The fracture in the radius (under the plate) seems to be totally healed in 6 weeks,

while the ulnar fracture is completing the process albeit a little behind the radius. Average healing time - The expected time to healing under a plate in a mature

skeleton is 5 - 12 months.

Case study no 2: Nuredin Dog - 6mo. M-fracture of femur left side

Post – operational X-ray. The gap is

evident

11 weeks Post – operational X-ray. The gap

is closed. Yet, the Gap edges are seen

Scanned from: 1. Denny HR, Butterworth SJ. Fracture Healing. In: A Guide to Canine and Feline Orthopaedic Surgery. Blackwell Science Ltd; 2008. p. 1–17.


Interim analysis of Canine & Feline study:

• The purpose of the study is: To evaluate the safety, performance and initial efficacy of a guided bone regeneration membrane.

•12 mature skeletally dogs and cats, enrolled during (01-04/12), suffering from:3 radius/ulna fracture5 femural fractures 2 pancarpal artrodesis fracture2 humeral condyl fracture

• Out of 12 patients 4 were enrolled during the first 2 months the other 8 were enrolled during the last two months, currently 11 out of 12 pt. show clinical improvement in their medical condition and quality of life


clinical improvement gap bridging0

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מפרק של ארטרודזהבעזרת הקרפוס

שתל ללא ממברנהשבועות 12עצם – הניתוח .לאחר

חסך בממברנה השימושהפקת של נוסף ניתוח

, , בזיהום סיכון עצם שתלבמקום ובכאבים בשבר

את, והשיג הניתוחשל המבוקשת התוצאה

במפרק .ארטרודזההשימוש ידיעתי למיטב זהו

ארטרודזה של הראשוןעצם שתל .ללא

Bone cure guided bone regeneration membrane

Health & Medicine

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