Two main processes streams for the powder or solid forms of Bionacre®.

Specific process allow to transform the natural Nacre biomaterial and manufacture devices for a large range of medical applications.
Through patented process types for the Powder or the Solid forms, treatments are applied in order to reinforce some targeted physical and biological properties.

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OUR TECHNOLOGY

Studies in Vitro, in Vivo & Human clinical track record

 In Vitro Proof of concept 

In vitro

Proof of concept

These studies demonstrate that nacre has strong osteogenic effects on human osteoblasts when placed in proximity to bone in vitro.

Demonstrate the ability of nacre to stimulate osteogenesis in vitro should allow the clarification of the events involved in this process.

Nacre can also promote the formation by osteblasts.

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SCIENTIFIC PUBLICATIONS

In vitro

Mineralization process of BIONACRE® grains exposed to Simulated Body Fluids

1) BIONACRE® 250 µm grains

 

2) Grains within a surface slide in a test tube: average porosity of 39% with an average density of 3,94 grains/mm, and average distance between two grains of 93 µm. The open interconnected porosity occupies almost 100% of the total porosity.

 

3) After 7 days of exposure: appearance of a layer all over the surface of the grains. This layer is mainly composed of Calcium Carbonate with traces of Calcium Phosphate.

 

4) After 21 days of exposure: appearance on the layer of “calcospherites”, richer in calcium phosphate, with a structure similar to hydroxyapatite, which grow and multiply until recovering the layer.

The mineralization process is in 2 steps (layer then calcospherites generated by the layer) and seems to mimic the early stages of calcification.

 In Vivo Proof of concept 

In vivo - Proof of concept

These nanotomographic radios of devices implanted on rabbits show the bio-integration of BIONACRE® plates and screws.

 

Examples of BIONACRE®devices (wedge 1 and screw 2) implanted on sheep, using a calcein marker : the brighter green parts show the creation of new bone and the tight welding with the device (Green pictures).

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In vivo - Proof of concept

OSTEOMIMETIC BEHAVIOR 

In Vivo study: Lifting of a humanhemimaxillarycrest- Biopsyimages after6 months.

 

Filling biomaterial, showing creation of NODULES of mineralization.

Alveolar NEWLY BONE trabeculae, with osteocyte lacuna.

Smooth interface and DIRECT BONDING between bone and biomaterial, NO FIBROUS INTERFACE.

Line of very ACTIVE OSTEOBLASTS, showing an intense OSTEOGENIC activity.

 

 

SCIENTIFIC PUBLICATIONS
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In vivo - Proof of concept

OSTEOMIMETIC BEHAVIOR 

IN VIVO STUDY: HISTOLOGY OF SCREW IMPLANTED ON A SHEEP (2 MONTHS)

A face of a Bionacre implant in contact with the medullary cavity.

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

 

SCIENTIFIC PUBLICATIONS

 Human clinical track record - ORTHOPEDICS 

 

Clinical Track record - Trauma 

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

1) Injury by gun (buckshot), with bone loss of 15 cm on the femur.

 

2) After multiple complications and the failure of two autograft from iliac crest, decision by the surgeon to use BIONACRE®bone substitute in order to remodel the sequestrum.

 

3) 5 years after, good consolidation of the femoral core bone. No septic process nor fistula for the last 3 years.

 

4) 20 years after, consolidation and remodeling of the medullar duct.

 Human clinical track record - DENTAL 

Article Drs Camprasse 1991

Clinical Track record - Implantology - Proof of concept

Human cases in dental : 4 human cases in implantology made by Doctors Serge & Georges Camprasse.

 

Human case n°1 : Reimplantation of an impacted tooth, after implementation of a tooth socket and use of BIONACRE®in the cavity and canine impaction without aiding splint. Healing and physiological retention observed after 15 days.

 

 

Human case n°2 : Repair of sequels after root resection causing a vestibular fistula resistant to antibiotics, and the destruction of the outer cortex. After an alveolar excision and procedure on the granulation tissue, setting of BIONACRE® in the injury. Healing of mucosa observed after 1 week, new bone formation after 3 weeks.

 

 

Human case n°3 :  Grafting of cyst cavity, with a 27 mm diameter size, showing a nasal fistulation and the destruction of the vestibular cortex. BIONACRE® powder was applied after levelling and scaling. After 1 week, mucosa healing and ad integrum reconstruction of the bone volume.

 

 

Human case n°4 : Repositioning of lateral incisor showing at the apex a 10 mm granuloma, causing a type II mobility. After a surgical extraction, endodontic treatment and alveolar scaling, setting of a BIONACRE® putty, repositioning of the tooth and ligature. Light surgical outcomes were observed, and the ligature removed at 4 weeks, showing only the natural physiological tooth mobility.

 

 

Conclusions :

 

After 4 years clinical track record Bionacre® has proved its efficiency to induce new bone in very safe and performing way.

 

 

 

Clinical Track record - Dental

Augmentation of the alveolar ridge using Bionacre®

Augmentation of the alveolar ridge using expanders, then filling expansion space with BIONACRE® powder form, before the setting of BIONACRE® solid implants.

 

1) Setting of expanders on each side of the ridge.

2) Ridge augmentation (height and volume) after filling with BIONACRE® bone substitute.

3) BIONACRE® dental implants with their supra-structures.

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Clinical Track record - Dental

Reconstruction of Human  maxillary defects

8 patients with defective areas in the premolar region of maxillary alveolar were reconstructed using nacre powder.

Histological and micro radiographic examination of drill biopsies taken 6+ months later showed that nacre implants were perfectly tolerated and had induced the formation of new bone leading to rebuilding of the deficient maxillary ridge.

 Human clinical track record - DERMATOLOGY 

Clinical Track record - Dermatology

Burning Wounds

Burning wounds treated with Bionacre® 

BIONACRE® components inhibit the production of inflammatory factors

and stimulate the local tissue and cell immunity factors.

Through its anti-biomimetic properties, BIONACRE® also controls the microbial proliferation,

reduces the healing time and allows the heat sedation by inhibiting the inflammatory markers such as bradykinin.

 

Example of a patient treated with BIONACRE® cream for burning wounds.

 

BIONACRE® is able to treat deep 2nd degree burns.

Clinical Track record - Dermatology

Bedsores

Bedsore treatment with BIONACRE® 

BIONACRE® cream was applied on the heel of a patient suffering from bedsore related in particular to a severe level 1 diabetes.

BIONACRE® use allowed to obtain a spectacular healing progress of the wound after 12 days.

New revascularization caused by the growth factors properties of BIONACRE®.

Restauration of skin integument through the fibroblast proliferation and increased production of collagen.

 

 

BIONACRE® PROVEN EFFICACY

 

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BIONACRE is the ONLY biomaterial to show real OSTEOMIMETIC properties.

It behaves like an AUTOLOGOUS graft, under the CONTROL of the SYSTEMIC REGULATION of the RECIPIENT SITE.

Depending on its FORM of use (POWDER or SOLID), its BEHAVIOR will be different :
POWDER : BIO-DISSOLUTION process in the recipient tissue, until total replacement in situ by progressive and regulated multi-centric bone formation
SOLID : like AUTOGRAFTS, TIGHT WELDING to the bone through a very particular SURFACE EROSION PROCESS

Mega Bio Pharma®