PLATES AND SCREWS

PLATES & SCREWS

proof-of-concept

TRAUMA : First autograft-like orthopedic device.

No need for second surgery to remove plates and screws

Because of its outstanding recognized biological and physical properties, it outperforms its competitors with multiple INNOVATIVE ADVANTAGES, in key aspects, for example:

 

NO SECOND SURGERY to remove implants.

ADVANTAGES: 

Less stress for the patient (no need to be operated twice for the same fracture)

Less cost for health insurances only 1 surgery to be reimbursed.

Less social cost for governments and companies (reduction of days off work)

Increase of the treatment capacity for hospitals and surgeons (better revenues)

Easier to use for surgeons compared to the existing technologies

 

CAN REPLACE AUTOGRAFT in repair or replacement procedures.

ADVANTAGES: 

Comfort for patients (no mutilation, no multiple surgeries to get bone) 

Reduction of healthcare costs (obviously, less surgeries = less costs in many areas)

Safer procedures and faster recovery (reduction of the risk of clinical complications)

Better comfort for surgeons (Autograft is often a stress for surgeons)

BONE SUBSTITUTE

BIONACRE® - Human surgery at French Béclère Hospital by Doctor Philippe COTTIN

• After injury by gun 15 cm bone loss on the femur (27/02/1993).

• Use of Bionacre® as bone graft substitute

• Consolidation and remodelling of the medullar duct

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BIONACRE® - Autologous Bone regeneration

Advantages :

• Osteomimetic, osteoinductive, osteogenic 

• Moldable - Adhesive

 

• Can replace autograft or allograft

• Better efficacy (adaptation to the receiver site, quality of the tissue repair)

• Risk reduction

• No toxic release

• No adverse effect

• Bioresorbable

SPINE

SPINE

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BIONACRE® INJECTABLE CEMENT FOR VERTEBROPLASTY​

Fusion or non-fusion applications (no exothermic reactions), cement for vertebroplasty and kyphoplasty (no reduction volume, natural radio-opacity).

 

A BREAKTHROUGH TECHNOLOGY : 

NATURAL, SAFE, EASY TO USE, POTENTIALLY PREVENTIVE TREATMENT 

BIONACRE® OUTSTANDING PROPERTIES

Because of its outstanding recognized biological and physical properties, Bionacre® outperforms its competitors with multiple INNOVATIVE advantages in key aspects:

• Adaptation to surrounding tissues, like autologous graft

• Radio-opacity

• No exothermic reaction

• Hydrophylic

• Bioresorbable

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BIONACRE® - Osteomimetic behavior

• In vivo study : histology of screw implanted on a sheep (2 months)

• Erosion surface process: Bone resorption of the MBP biomaterial by giant cells with the characteristic TOOTH COMB shape.

catalogue

JOINT RECONSTRUCTION

JOINT RECONSTRUCTION

SCREWS - ANCHORS - PINS

BIONACRE®- Adapted to surrounding tissues​

Uni- or multi-compartmental implants, sealing cements, coatings : adapted to surrounding tissues

 

• Osteoinductive

• Osteomimetic

• Can replace allograft or autograft

• Fast healing process stimulation

• Coating : For fixation of porous implants

• No fibrous encapsulation

 

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Natural-Biomateriaux

MUSCULOSKELETAL AND SOFT TISSUE REPAIR

BIONACRE® - TECHNOLOGICAL OVERVIEW

Bionacre® Technology Issued from the natural "mother-of-pearl" bivalve shell

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HIGHEST Safety for a HIGHER Performance

 

Based on literature review, by itself does not raise toxicological concerns.

In order to demonstrate the full biocompatibility of BIONACRE®, biological studies are conducted by product, according to the regulatory requirements, e.g; ISO 10993-series such as cytotoxicity, genotoxicity, acute systemic toxicity, hemocompatibility, etc...

 

QUALITY CONTROL is applied during the whole process chain:

Since controlled sourcing shell selection, bases on detailed specifications

In each step of the manufacturing process

Until the final production and packaging of the devices (including Gamma sterilization)

 

SPECIFIC PATENTED TREATMENTS are applied in order to boost some physical properties and reinforce the natural efficacy of the biomaterial

Mega Bio Pharma®