BonoFill Bone Graft

BonoFillTM is a personalized, injectable, 3D, high-density, viable bone graft derived from the patient’s own adipose (fat) tissue.

BonoFillTM is classified as Advanced Therapy Medicinal Product (ATMP), subcategory Somatic Cell Therapy, and was developed according to GMP and GCP principles.

 

BonoFillTM Properties and Advantages

Bonus BioGroup’s innovative product possesses the following properties:

An autologous cell source:

BonoFillTM is manufactured individually for each patient from hers/his own adipose tissue-derived mesenchymal cells. Consequently, when transplanted back into the deficient bone, the cells autologous (self) origin eliminates the risk of tissue rejection and surgery failure. The adipose tissue required for the production of the bone graft is harvested in a simple and minimally invasive liposuction procedure, with little discomfort to the patient.

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A multi-cell bone graft:

BonoFillTM consists of mesenchymal cells at varying stages of osteogenic differentiation. Upon transplantation, the bone graft-derived cells continue to proliferate and differentiate into mature osteoblast (bone-forming cells) that also secrete various factors, thereby further enhancing the bone regeneration and healing of the bone defect and prompting the body’s intrinsic recovery mechanisms at the transplantation site by recruiting cells from the surrounding healthy tissue.

A three-dimensional supporting matrix (scaffold):

BonoFillTM consists of an FDA-approved, natural, calcium-based mineral scaffold. The scaffold's unique nano-structure optimally supports cell expansion in vitro (in the laboratory) and provides the desired supporting properties in vivo (in the patient). Furthermore, the mineral particles serve post transplantation as an osteoconductive scaffold further supporting new bone formation.

Scaffold particles used in the production of BonoFill
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The scaffold can also be customized according to the CT images of the deficient bone
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A dynamic cell cultivation platform:

The cells are grown in multi-layers within a specifically designed bioreactor. The bioreactor technique not only ensures a well-mixed homogenous environment, but also enables scalability, facilitates automated control, reduces cell handling and shortens the culturing period. These advantages contribute to BonoFillTM’s unique product properties, safety and cost-effectiveness.

A tailor-made bone graft:

BonoFillTM is a personalized, available-on-demand product aimed to treat a variety of bone deficiencies. It is individually designed to precisely fit the anatomical shape of the specific bone void in need of healing.

Short manufacturing process:

The patient’s adipose-tissue is retrieved by a simple procedure of liposuction aspiration with little discomfort to the patient. In Bonus BioGroup’s GMP and ISO 9001 compliant facility, BonoFillTM personalized bone graft is manufactured in only about two weeks, after which it can be transplanted into the bone defect in need of regeneration.

A valid proof of concept - Pre-clinical study results:

Preclinical studies with BonoFillTM have demonstrated high safety and efficacy of the cell-based bone graft product in animal studies. Specifically, in the orthopedic indication, BonoFillTM was demonstrated to efficiently heal critical-sized long bone defects.

Currently there are two ongoing phase I/IIa clinical trials for the evaluation of the safety and efficacy of BonoFillTM bone graft for purposes of bone regeneration in the maxillofacial and orthopedic indications.

Two BonoFill-based bone graft products are available:

Injectable bone graft:

BonoFillTM injectable bone graft is provided in a pre-filled syringe and intended for well-defined bone repair applications, such as bone void filling required due to the removal of cyst from the jaw bone, as well as for purposes of sinus augmentation to enable stable dental implants placement. In the orthopedic field BonoFillTM is suitable for the filling of bone gaps in adequately confined long bone deficiencies.

 

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Generation of injectable bone graft 

View: Lower Jaw Bone | Mandible Bone  | Long Bone

Anatomically pre-designed bone graft:

The tailor-made bone graft is constructed to precisely fit the patient's defect, shaped according to the deficiency’s 3D Computed Tomography (CT) image. This bone graft product is specifically designed to repair large and segmental bone defects.

 

 

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 Generation of anatomically pre-designed bone graft

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