23-Apr-2017 Private Offering Investment

Bonus BioGroup Raises 9 Million NIS in Private Offering Investment at 0.70 NIS Per Share

Bonus BioGroup is pleased to announce an entry into an investment agreement in response to a private offering (immaterial and unexceptional) of Company shares with two investors who, to the best of the Company's knowledge, have no connection with the Company's stakeholders and/or functionaries.

        

According to conditions of the Investment Agreement, the Company, in a private allocation, will allocate 12,857,143 ordinary shares, registered and with no nominal value, and transfer them to the Investors against cash payment of 9,000,000 NIS.

 

This investment completes the raising of an overall total of 35.24 million NIS in private offerings from December 2014 – April 2017, at a share price that is an average of 16% higher than the closing price upon the date of approval of the relevant Investment Agreement.

13-Dec-2016 Revolutionary Medical Breakthrough

Bonus BioGroup Announces Revolutionary Medical Breakthrough

Successful Outcome in First Clinical Trial: Safe, Rapid and Efficient Reconstruction of Maxillofacial Bone by the Company's Injectable Live Human Bone Graft was Achieved in All Subjects

Bonus BioGroup is proud to announce that Dr. Ephraim Tzur, former head of the Oral and Maxillofacial Surgery Department of Assaf Harofeh Medical Center, who served as principal investigator in the trial and performed all procedures of the trial, presented during the 18th International Conference on Oral and Maxillofacial Surgery in Madrid, Spain, the overwhelming success achieved by the Company's unique graft in reconstructing missing bone tissues in all participating subjects.

 

The injectable bone graft is produced in the Company's manufacturing facility in Haifa, Israel, and is based on various cell types isolated from a fat sample collected from each subject. This population of cell types is cultivated in controlled sterile conditions on a three-dimensional scaffold. The cells and the scaffold create a construct capable of generating live human bone graft.

 

The first clinical trial for the reconstruction of maxillofacial bone was conducted in Israel as a Phase I/II study. Its purpose was to evaluate the safety and efficacy of the Company's first generation injectable graft in two clinical indications: (1) reconstruction and elevation of bone tissue in the maxillary sinus of the upper jawbone, and (2) void filling of bone tissue following the removal of cyst in the upper or lower jawbone.

 

In the first clinical trial 11 subjects underwent transplantation of the first-generation injectable live human bone graft. Subjects were 57 years old on average. The women weighed an average of 58 Kg while the men weighed an average of 82 Kg.

 

In terms of safety of the first-generation injectable bone graft - Full safety has been demonstrated. None of the subjects experienced adverse events nor reported any unusual symptoms.

 

In terms of efficacy of the first-generation injectable bone graft - Within three weeks of transplantation, all bone voids were filled with newly formed bone mass. The three-week time point marked the peak of bone height, which was subsequently maintained.

 

The average baseline bone height was measured 4 mm before transplantation, and approximately 19 mm on average post transplantation, which reflects a five-fold increase of the original bone height. In some cases, bone height reached up to about 25 mm following the transplantation. Two to three months post transplantation, bone tissues solidified and acquired the bone strength characteristic of natural bone.

 

The average volume of the injectable human bone graft utilized in the study's transplantations was 15ml, and in some cases reached up to 19ml. This compares favourably with the prevalent few ml bone cavities whose current conventional treatments are often unsuccessful.

 

Starting 6 months following the transplantation, metal dental implants were inserted into the subjects' jaws at the transplantation site as support to dental prosthetics. The insertion of the implants requires a minimal bone height of 10 mm. During the insertion process, bone biopsies were collected from the new bones in order to evaluate their quality. Results of all biopsies indicated that the newly emergent bone tissues were rigid, strong and fully capable of supporting the placement of metal implants.

 

Efficacy of the first-generation injectable bone graft was confirmed with statistical significance of >0.05, reflecting a confidence level of over 95%. This exceptionally high confidence level in the face of the small sample size of 11 subjects demonstrates that results are non-accidental, robust and repeatable in larger populations. The existing jaw bone bonded with the newly formed bone which reached a height of 15-23 mm, reflecting an average of 15 mm increase in bone height resulting from the transplantation and little statistical variance. Coupled with the high confidence level, results show that treatment with the first generation injectable human bone graft is applicable to all potential subjects requiring dental rehabilitation by dental implants regardless of age, sex and medical history.

 

As per the clinical protocol of the study, each subject underwent blood tests, X rays and CT scans. Results obtained were consistently normal. Long-term clinical follow-up on months 21-31 following the transplantation was carried out by the principal investigator. All subjects reported good health and complete satisfaction from the treatment.

 

Pending completion of the clinical trials and obtainment of required regulatory approvals, Bonus BioGroup may introduce to the multi-million worldwide bone market, a first-of-its-kind safe, rapid and efficient bone restoration modality based on a single injection of a lab-grown live human bone graft generated from subjects' own cells.

 

R&D efforts made alongside the conduct of the first clinical trial culminated in the second-generation injectable bone graft. Compared to its first-generation counterpart, the second-generation injectable graft exhibits enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production.

 

On September 8, 2016, Bonus BioGroup announced successful transplantation for the first subject in the Company's second clinical trial for the repair of maxillofacial bone deficiencies employing its second-generation injectable live human bone graft. The transplantation was performed a fortnight following collection of the subject's fat sample.

 

Both the first and the second clinical trials for maxillofacial bone reconstruction utilize the injectable live human bone graft.

 

Bonus BioGroup estimates that subsequent clinical trials may be carried out over a time period shorter than that of its first clinical trial. The approval by the Israeli Ministry of Health to carry out the Company's second clinical trial for the repair of jawbone deficiencies may facilitate future approvals of the Company's pipeline clinical trials, including a study aimed at repairing orthopaedic critical gaps in the extremities.

 

The Company intends to register its shares for trading on a Stock Exchange in the United States in addition to being registered in the Tel Aviv Stock Exchange.

 

15-Sep-2016 Successful First Transplantation of Second-Generation Injectable Live Human Bone Graft

Bonus BioGroup Announces Successful First Transplantation of Second-Generation Injectable Live Human Bone Graft in Clinical Trial for Maxillofacial Bone Repair

Bonus BioGroup announces today successful transplantation for the first patient in the Company's second clinical trial for the repair of maxillofacial bone deficiencies. The transplantation was performed a fortnight following collection of the patient's fat sample, and several weeks following the enrolment of the first three subjects.

 

The entire procedure, which lasted 40 minutes from local anaesthesia through to the end of the transplantation, was performed smoothly, without complications.

 

This second clinical trial is a Phase I/II study designed to evaluate the safety and efficacy of the Company's second-generation injectable graft in the treatment of lower and upper jawbone loss. The study is being conducted in Israel and will include up to 20 participants, men and women aged 18-70. Participants will be followed for 6 months post treatment, although the Company may prolong this period.

 

Bonus BioGroup developed two types of bone grafts which share common features: both are manufactured ex vivo (outside the human body), are grown on biodegradable scaffold carrier, consist of various cell types isolated from the patient's own fat sample, and are three-dimensional. However, they differ from one another in size and consistency:
1. The single-unit live bone graft is a predesigned and simply-shaped bone graft which matches the missing bone tissue;
2. The injectable single-unit micron-sized live bone graft consists of hundreds to thousands of micro-grafts which integrate into fills confined bone voids to restore the bone's integrity, albeit possible shape complexities. The injectability of this graft and its ability to carry an unlimited number of micro-grafts facilitate the surgical intervention.

 

The injectable bone graft is transported from the Company's manufacturing facility to the medical center performing the transplantation in a ready-to-use syringe. The injectable modality may prove a great benefit to the medical system as well as to the patient as the simplified intervention requires fewer medical staff and equipment and the rehabilitation process experienced by the patient is significantly hastened.

 

The injectable bone graft is manufactured in the Company's manufacturing facility as live autologous human bone tissue; both comprise of various cell types, and do not consist of non-living bone granules. Bonus BioGroup estimates that its live human bone grafts demonstrate qualities superior to any other non-living bone graft. Since the manufactured grafts originate from and return to the same patients, the Company believes that they will be fully integrated and immunologically tolerated by patients. Upon introduction of Bonus BioGroup’s grafts into patients’ bodies, the biological identity of the transplants is expected to be recognized by the patients’ immune system. Thus the common immunological response and rejection typical of foreign donor tissue transplantation are anticipated to be prevented.

 

Compared to its first generation counterpart, the second-generation injectable graft exhibits enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production.
Of note, both types of bone grafts, the solid and the injectable, are manufactured in the Company's manufacturing facility as live autologous human bone tissue; both comprise of various cell types, and do not consist of non-living bone granules. Bonus BioGroup estimates that its live human bone grafts demonstrate qualities superior to any other non-living bone graft. Since the manufactured grafts originate from and return to the same patients, the Company believes that they will be fully integrated and immunologically tolerated by patients. Upon introduction of Bonus BioGroup’s grafts into patients’ bodies, the biological identity of the transplants is expected to be recognized by the patients’ immune system. Thus the common immunological response and rejection typical of foreign donor tissue transplantation are anticipated to be prevented.

 

The Company's first clinical trial, which utilized its first generation injectable bone graft, is in final stages of clinical data processing and statistical analyses.
The Company performed preclinical testing of both types of bone grafts. However its first clinical trial was performed solely with the injectable bone graft, and so will its second. Bonus BioGroup estimates that the current clinical trial may be carried out over a time period shorter than that of its first clinical trial.
The approval by the Ministry of Health to carry out the Company's second clinical trial for the repair of jawbone deficiencies may facilitate future approvals by the Israeli Ministry of Health of the Company's pipeline clinical trials, including a study aimed at repairing orthopaedic critical gaps in the extremities, with the second generation injectable bone graft.

 

01-Aug-2016 Enrolment of First Three Subjects in Second Clinical Trial

One Week Following Receipt of Required Approvals for Second Clinical Trial

Bonus BioGroup Enrols First Three Subjects in Clinical Trial with Second Generation Live Injectable Bone Graft for Repair of Maxillofacial Deficiencies

Bonus BioGroup announces today enrolment of three subjects in its second clinical trial for the repair of maxillofacial bone loss. Upon completion of all preliminary tests confirming the subjects' eligibility to participate in the trial, fat samples will be collected and transferred to the manufacturing facility. Approximately one month later, the first transplantation of the Company's second generation live injectable bone graft will be performed.


This second clinical trial is a Phase I/II study designed to evaluate the safety and efficacy of the Company's second-generation injectable graft in the treatment of lower and upper jawbone loss. The study will take place in Israel and will include up to 20 participants, men and women aged 18-70. As per the Ministry's instructions, the clinical follow up for each participant will last 6 months from treatment, although the Company may prolong this period.


Bonus BioGroup developed two types of bone grafts which share common features: both are manufactured ex vivo (outside the human body), are grown on biodegradable scaffold carrier, consist of various cell types isolated from the patient's own fat sample, and are three-dimensional. However, they

 

differ from one another in size and consistency:
1. The solid single-unit live bone graft is predesigned in shape and size to precisely match the missing bone tissue;
2. The injectable single-unit live bone graft consists of thousands of micro-grafts which integrate into and augment the patient's natural bone tissue, albeit possible shape complexities. The injectability of this graft and its ability to carry an unlimited number of micro-grafts facilitate the surgical intervention.


The injectable bone graft is transported from the Company's manufacturing facility to the medical center performing the transplantation in a ready-to-use syringe. The injectable modality may prove a great benefit to the medical system as well as to the patient as the simplified intervention requires fewer medical staff and equipment and the rehabilitation process experienced by the patient is significantly hastened.


Compared to its first generation counterpart, the second-generation injectable graft exhibits enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production.


Of note, both types of bone grafts, the solid and the injectable, are manufactured in the Company's manufacturing facility as live autologous human bone tissue; both comprise of various cell types, and do not consist of non-living bone granules. Bonus BioGroup estimates that its live human bone grafts demonstrate qualities superior to any other non-living bone graft. Since the manufactured grafts originate from and return to the same patients, the Company believes that they will be fully integrated and immunologically tolerated by patients. Upon introduction of Bonus BioGroup’s grafts into patients’ bodies, the biological identity of the transplants is expected to be recognized by the patients’ immune system. Thus the common immunological response and rejection typical of foreign donor tissue transplantation are anticipated to be prevented.


The Company's first clinical trial, which utilized its first generation injectable bone graft, is in final stages of clinical data processing and statistical analyses.


The Company performed preclinical testing of both types of bone grafts. However its first clinical trial was performed solely with the injectable bone graft, and so will its second. Bonus BioGroup estimates that the current clinical trial may be carried out over a time period shorter than that of its first clinical trial.
The approval by the Ministry of Health to carry out the Company's second clinical trial for the repair of jawbone deficiencies may facilitate future approvals by the Israeli Ministry of Health of the Company's pipeline clinical trials, including a study aimed at repairing orthopaedic critical gaps in the extremities, with the second generation injectable bone graft.

 

 

27-Jul-2016 Bonus BioGroup Expands Prospective Product Line

Bonus BioGroup Expands Prospective Product Line

Successful Proof-Of-Concept Preclinical Study on the Development of Large Vascularized Human Bone Graft

Bonus BioGroup announces today successful results of a preclinical feasibility study on developing a large single-unit vascularized (blood vessel-containing) live human bone graft that can be attached to patients’ large blood vessels by microsurgical suturing.


The vascularized bone graft is composed of a multicellular culture originating from fat tissue obtained from the patient and other biodegradable components. It is manufactured ex vivo (outside the human body) within one to four weeks, and is intended to encourage the incorporation of the graft with the host tissue by provision of improved blood flow and nutrients.


Over recent months, Bonus BioGroup performed a series of preclinical trials to evaluate the incorporation and performance of its manufactured blood vessels. Following anastomosis (surgical connection) of the artificial vessels to native vessels in an animal limb model, the newly anastomosed vessels displayed the desired biocompatible properties and maintained the animal’s normal motor activity. Follow-up revealed normal blood flow with no leakage at the anastomosis site. Next, the Company plans to evaluate the ability of its manufactured blood vessels to provide blood supply to large bone grafts upon transplantation and until the manufactured blood vessels are naturally absorbed and replaced by endogenous ones.


This study is inapplicable to clinical trials with the Company’s injectable bone graft, as the latter consists of a large number of micron-sized bone grafts and does not require attachment to a major blood vessel for integration with the existing bone tissue.


The study takes place at the Company’s R&D center in MATAM Advanced Technology Park in Haifa and at the Surgical Wing of the Western Galilee Medical Center in Nahariya. It was awarded a grant by the Chief Scientist of the National Authority for Innovation, who reviewed its first year activities and approved support for its second year. This support will not be contingent upon payment of royalties and will be provided in addition to the Chief Scientist’s support of the Company’s R&D program.

 

Bonus BioGroup holds exclusive global rights to develop, manufacture and market large vascularized human bone grafts based on the aforementioned study, against payment of royalties to Technion Research and Development Foundation and the research institute at a rate totaling less than 3% of this product’s sales revenue.


Bonus BioGroup has so far developed two types of human live autologous bone grafts, which share common features: both are manufactured ex vivo, are grown on biodegradable scaffold carriers, consist of various cell types isolated from the patient's own fat sample, and are three-dimensional. However, they differ from one another in size and consistency:
1. The single-unit live bone graft is predesigned in shape and size to precisely match the missing bone tissue;
2. The injectable single-unit live bone graft consists of thousands of micro-grafts which integrate into and augment the patient's natural bone tissue, albeit possible shape complexities of the injection site. The injectability of this graft and its ability to carry an unlimited number of micro-grafts facilitate the surgical intervention.


The injectable bone graft is transported from the Company's manufacturing facility to the medical center performing the transplantation in a ready-to-use syringe. The injectable modality may prove a great benefit to the medical system as well as to patients since the simplified intervention requires fewer medical staff and equipment and the rehabilitation process experienced by patients is significantly hastened.

 

 

10-Jul-2016 Bonus BioGroup Raises 4 Million NIS at 70 Agorot per Share

Bonus BioGroup Raises 4 Million NIS at 70 Agorot per Share
Fundraised a total of 18 million NIS at a price 18% higher than the average stock exchange and intends to register all of its shares for trade in the US, at the NASDAQ or NYSE.

Bonus BioGroup announces today a capital investment by private allocation of 5.7 million common shares against cash payment of 4 million NIS.


This amount is priced at 70 agorot per share, which reflects a premium of approximately 18.5% over the closing price on the last trading date of signing the investment agreement.


This investment supplements a total of 18 million NIS raised between December 2014 and July 2016 in private offerings at a price-per-share higher by approximately 18% on average than the closing price on the Investment Agreement date.


The Company intends to register its shares for trading on the US stock exchange, initially with no public offerings in the United States. Highlighted by the Company's technological achievements, this milestone is estimated to boost the Company's share trade and facilitate raising additional capital.


The proceeds will be utilized, inter alia, for financing the Company's clinical trials in repairing bone deficiencies in various indications by transplantation of its live bone graft.


Bonus BioGroup estimates that its live human bone graft demonstrates qualities superior to any other non-living bone graft. Since the manufactured graft originates from and returns to the same patient, the Company believes that upon introduction of the graft into patients’ bodies, the biological identity of the transplant will be recognized by the patients’ immune system. Thus the common immunological response and rejection typical of foreign donor tissue transplantation are anticipated to be prevented.

07-Jun-2016 Bonus BioGroup Receives Israeli Ministry of Health Approval for Clinical Trial Testing Second Generation ...

Bonus BioGroup Receives Israeli Ministry of Health Approval for Clinical Trial Testing Second Generation Injectable Human Bone Graft for Maxillofacial Repair

Bonus BioGroup announces Israeli Ministry of Health approval to carry out a clinical trial with its second-generation injectable human bone graft for the repair of maxillofacial bone loss.
The approved clinical trial, the second to be held by Bonus BioGroup, is a Phase I/II study designed to evaluate the safety and efficacy of the Company's second-generation graft in the treatment of lower and upper jawbone deficiencies. The study will take place in Israel and will include up to 20 participants, men and women aged 18-70. As per the Ministry's instructions, the clinical follow up for each participant will last 6 months from treatment.
The Company's first clinical trial, which utilized its first generation product, is in final stages of clinical data processing and statistical analyses.
The current approval is believed to facilitate future approvals by the Israeli Ministry of Health of the Company's forthcoming clinical studies, which may be carried out over a time period shorter than that of the first clinical trial. One such study for the repair of critical gaps in the extremities – hands, feet, arms and legs – is now being prepared and is planned to employ the second-generation graft.
Compared to its first generation counterpart, the second-generation graft was developed to exhibit enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production. Representing yet another innovative product developed by Bonus, the second-generation graft, now syringeable and injectable, includes a large amount of autologous living cells in the quantities required for the augmentation of each patient's bone deficiency. The graft is transported from the Company's manufacturing facility to the medical center performing the transplantation in a ready-to-use syringe. The new injectable modality may prove a great benefit to the medical system as well as to the patient as the reduced complexity of the intervention requires fewer medical staff and equipment and the rehabilitation process experienced by the patient is significantly hastened.
The Company estimates that its live human bone graft demonstrates qualities superior to any other non-living bone graft. Since the manufactured grafts originate from and return to the same patients, the Company believes that they will be fully integrated and immunologically tolerated by patients. Upon introduction of Bonus BioGroup’s grafts into patients’ bodies, the biological identity of the transplants is expected to be recognized by the patients’ immune system. Thus the common immunological response and rejection typical of foreign donor tissue transplantation are anticipated to be prevented.

 

06-Dec-2015 Bonus BioGroup Enters Into an Exclusive Agreement for the Use of Engineered Nanoparticle Technology ...

Bonus BioGroup Enters Into an Exclusive Agreement for the Use of Engineered Nanoparticle Technology to Enhance Bone Regeneration

Bonus BioGroup announces today that on December 3, 2015, Bonus Therapeutics Ltd, a wholly owned subsidiary of the Company, signed an agreement with the Bar-Ilan Research and Development Company Ltd. (BIRAD), a subsidiary of Bar-Ilan University, Ramat Gan, for the development and exclusive use of innovative engineered nanoparticle technology, which may be incorporated, inter alia, into the Company’s live injectable human bone graft.

 

The live injectable human bone graft represents another innovation developed by Bonus; Researchers at the Company successfully minimized the graft's structure, which also contains its scaffold. The injectable graft includes a large amount of autologous living cells in the quantities required for the augmentation of each patient's bone deficiency.


The composition, size and unique properties of the engineered nanoparticles allow their integration into the Company’s live injectable human bone graft as an active ingredient in various ways: in-between the graft’s particles, as supporting layer over the live human cells or as a supporting layer over the scaffold.


Bonus BioGroup may exploit other attributes of the engineered nanoparticles to promote expedited biomaterial-driven bone regeneration in areas of scarce bone tissue. These attributes include the ability to identify specifically target areas of calcium withdrawal, to bind and deliver into the treated bone area biological factors involved in the generation of blood and bone cells, and the capability to prolong the lifespan of these biological factors so as to extend their activation period.


The Bonus BioGroup-Bar Ilan agreement stipulates that research teams of both parties will conduct joint research for further development of the engineered nanoparticles for a variety of applications. The research will be carried out mostly at the Company's R&D headquarters in MATAM Advanced Technology Park, Haifa.

 

17-Nov-2015 Bonus BioGroup to Hold Pre-IND Meeting with FDA Focused on Proposed Clinical Trial in the US

Bonus BioGroup to Hold Pre-IND Meeting with FDA Focused on Proposed Clinical Trial in the US

Bonus BioGroup reports a Pre-IND (Preliminary Investigational New Drug) meeting to be held in December 2015 with the Food and Drug Administration (FDA) in order to discuss the development of the Company’s live human bone graft as treatment for craniomaxillofacial bone deficiencies. This meeting precedes submission of a full IND (Investigational New Drug) application.
As preparation for the meeting, Bonus BioGroup provided the FDA with a briefing package containing information on the biological properties and quality of the Company's product. Following the meeting, a comprehensive application will be submitted to the FDA to allow Bonus BioGroup to conduct a clinical trial for the repair of craniomaxillofacial bone deficiencies in the US.
In April 2014, Bonus BioGroup commenced a clinical trial designed to test the safety and efficacy of its product in the repair of upper and lower jawbone defects by the Company's live human bone graft.
The clinical trial for the repair of craniomaxillofacial bone deficiencies is aimed at evaluating the safety and efficacy of Bonus BioGroup's live human bone graft across all craniomaxillofacial bone lacks, and will not be limited to the upper or lower jawbone. Broadening the array of clinical indications may expand the treatment options available to potential patients and cover more complex medical conditions.
Within the clinical trial for the repair of upper and lower jawbone defects, the Company utilized for the first time its injectable graft. This modality facilitates the surgical procedure by reducing the number and complexity of the required intervention and also hastens the rehabilitation process experienced by the patient.
Within the clinical trial for the repair of craniomaxillofacial bone deficiencies, the Company plans to employ its second generation injectable graft, which was developed to exhibit enhanced properties, including shorter manufacturing period, reduced manual processing, lower manufacturing costs and suitability for mass production.

 

08-Nov-2015 Bonus BioGroup Raises Investment of 5.2 Million NIS through Private Offering at 60 Cents per Share

Bonus BioGroup Raises Investment of 5.2 Million NIS through Private Offering at 60 Cents per Share

On November 6, 2015, Bonus BioGroup entered into investment agreements with two foreign investors.
Under the terms of the investment agreements, the Company will issue, in a private allocation, a joint total of 8,710,000 common shares without nominal value, registered to the Company, against cash payment of 1.34 million USD.
After their issuance, the shares allocated to the investors shall constitute approximately 3.81% of the Company's share capital and voting rights and approximately 3.07% of the Company's fully diluted share capital and voting rights, based on the Company's share capital at the date of this immediate report.
This investment supplements a total of 13.35 million NIS raised so far at a price-per-share higher by approximately 18% on average than the closing price on the Investment Agreement date, in private offerings during December 2014 - November 2015.
The proceeds will be utilized, inter alia, for financing the Company's operating activities, including the conduct of clinical trials aimed at repairing bone deficiencies in various indications by transplantation of Bonus BioGroup's live bone graft, and completion of the clinical trial for the treatment of upper and lower jawbone deficiencies.

 

12-Jul-2015 Bonus BioGroup Announces Chief Scientist Support of R&D Program Totalling 6.4 Million NIS

Bonus BioGroup Announces Chief Scientist Support of R&D Program Totalling 6.4 Million NIS

Bonus BioGroup announces that on July 12, 2015, Bonus Therapeutics Ltd., a fully-owned subsidiary of the Company, was approved a grant by the Israeli Chief Scientist to support its R&D program for 2015. The support amounts to 6.4 million NIS - and reflects a 60% increase in the company’s annual R&D budget over the previous year.


The R&D program for 2015 includes continuation of the clinical trial for the repair of lower and upper jawbone deficits by implantation of living human bone transplants manufactured in the Company’s production facility at MATAM Advanced Technology Park in Haifa, as well as development of treatments for additional deficient bone sites.


The clinical trial for the repair of jawbone deficiencies is designed to evaluate the safety and efficacy of Bonus BioGroup's living human bone transplants. 

 

The manufactured transplants, which originate from patients' own fat tissue, are predicted to fully integrate and be immunologically tolerated. The Company estimates that upon their introduction into patients’ bodies, the biological identity of the transplants will be recognized by the patients’ immune system, deflecting the rejection reaction typical of foreign donor tissue transplantation. The living bone transplants manufactured by Bonus BioGroup are therefore considered by the Company to be superior to other non-living bone grafts.


The support granted by the Chief Scientist constitutes 40% of the approved budget, and is contingent upon payment of royalties from all income generated by Bonus Therapeutics Ltd.
The Company strives to enhance its technological expertise by rigorous R&D activities carried out in its R&D Center and through collaborations with other entities aimed at joint development or purchasing and/or obtaining exclusive rights to relevant technologies.


On May 20, 2015, Bonus Therapeutics Ltd. was notified of being awarded its first EU grant, together with European research collaborators. The grant will support a pre-clinical study and will take place under EU's Horizon 2020 framework - the largest support program for research and innovation worldwide. 


On April 15, 2015, Bonus Therapeutics Ltd. was notified that it has been selected as a finalist for the 2015 edition of Red Herring’s Top 100 Europe Award. The editorial team of Red Herring, a company which performs daily and periodical analytic reviews of technology companies around the world, has selected the 100 technology companies which, to the best of their judgement, demonstrate the greatest business opportunities across Europe. The nominees are evaluated on 20 quantitative and qualitative criteria, including proof of concept, disruptive impact, market size, business strategy, management strength and financial performance. 


Bonus estimations regarding its jawbone deficiency repair clinical trial, the outcome of this clinical trial and/or establishment of collaborations with third parties include forward-looking statements as defined under the Securities Laws of 1968. These estimations are based on information presently available at the date of this announcement. Whether actual results will conform, partially or fully, with the Company's predictions is subject to various factors, including feasibility tests and/or delays in the clinical trial and/or difficulty in recruiting participating subjects and/or an arising need to carry out additional trials and/or unsuccessful stage/s in the trial and/or technological changes and/or development and marketing of competitive/ore efficient product/s and/or materialization of any of the risk factors associated with the clinical trial and/or its outcomes.

 

20-May-2015 Bonus BioGroup Receives EU Grant for Joint Development of New Method for Graft Tracking In Vivo

 Bonus BioGroup Receives EU Grant for Joint Development of New Method for Graft Tracking In Vivo


Bonus BioGroup announces that its subsidiary, Bonus Therapeutics Ltd, will receive its first EU grant, together with European research collaborators, to develop a non-invasive method for tracking in vivo (in the living body) the biological activity of its proprietary human live bone graft following transplantation. 
The research will take place under EU's Horizon 2020 framework - the largest support program for research and innovation worldwide. The program aims to mobilize collaborations within the EU, in the areas of scientific research and industrial R&D, and to foster innovation and job creation.
The research entails a preclinical study in which transplanted grafts will be monitored in vivo by magnetic resonance imaging techniques without needing to biopsy the grafted site. January 1st marks the start date of this research which will last four years. The innovative method is anticipated to decrease the number of animals used in preclinical studies, to shorten the period of the clinical trial and to reduce its cost.
Horizon 2020 offers €77 billion of funding available over 7 years (2014 to 2020) with an average annual financial support of over €10 billion. Israel joined Horizon 2020 in 1996 as an Associated Country under the same conditions as legal entities from the EU Member States. Bonus BioGroup will have right of use of any intellectual property arising from the research.

 

Bonus Therapeutics Ltd, a wholly owned subsidiary of the Company, has been recently selected as a finalist for the 2015 edition of Red Herring’s Top 100 Europe Award for most promising start-ups in Europe. The editorial team of Red Herring, a company which performs daily and periodical analytic reviews of technology companies around the world, has selected the 100 technology companies which, to the best of their judgement, demonstrate the greatest business opportunities across Europe. The nominees are evaluated on 20 quantitative and qualitative criteria, including proof of concept, technological innovation, market size, business strategy, management strength and financial performance.
Bonus BioGroup's unique technology combines disciplines such as biology, tissue and material engineering and personalized medicine. The Company strives to enhance its technological expertise by rigorous R&D activities and through collaborations with other entities aimed at purchasing and/or obtaining exclusive rights to relevant technologies.

 

13-May-2015 Bonus BioGroup Announces Agreement to Develop Innovative Biological Components

 Bonus BioGroup Announces Agreement to Develop Innovative Biological Components

 

The agreement allows Bonus to receive FDA approval for innovative biological components which will be integrated into its manufactured transplants. These will be submitted to the FDA at no cost for Bonus. 


Bonus BioGroup announces that it has entered into an agreement with LifeNet Health Inc., headquartered in Virginia, USA, to carry out joint research and development of innovative biological components, including those which may be uniquely adapted to incorporation into Bonus BioGroup’s human living transplants.

 

Biological components in line with Bonus BioGroup’s development pipeline and commercialization strategy and whose safety and efficacy are confirmed by clinical studies held by Bonus, may be submitted by LifeNet Health to regulatory authorities, including the FDA (Food and Drug Administration US) and the EMA (European Medicines Agency), to obtain approvals required for their transplantation in humans, in clinical trials and/or commercially.
Bonus BioGroup will own any intellectual property arising from the joint research without having to pay royalties to LifeNet Health and/or third parties.
LifeNet Health is the world's largest provider of biological components in the field of restorative and rehabilitative medicine. It supplies to medical centers and research institutes, and partners with over 400,000 physicians worldwide in the various disciplines, including orthopedics, neurology and cardiology.
Within the collaboration, Bonus BioGroup will be able to purchase advanced biological components at a cost significantly lower than market price, to characterize them and to then co-develop innovative ones exclusively for Bonus BioGroup’s applications. The collaboration will be facilitated by LifeNet Health’s financial and scientific resources and its experience in applying for FDA approvals.
Under the terms of the agreement, LifeNet Health will be granted Right of First Offer to supply Bonus BioGroup with the biological components developed within the research, for a period of at least two years, provided that commercial terms remain on a par with other vendors.

 

Dr. Shai Meretzki, CEO of Bonus BioGroup, commented, “We thank the management of LifeNet Health for trusting Bonus BioGroup’s experienced scientific team with advanced biological components never before marketed. The collaboration with LifeNet Health – the largest provider worldwide of human biological components, demonstrates and strengthens Bonus BioGroup's position in the scientific community as a leading biological material and tissue engineering company which works to advance the commercialization of rehabilitative medical products. Bonus BioGroup will continue to develop human living grafts and to establish collaborations with other leading entities both in Israel and abroad".

 

Bonus BioGroup's unique technology combines disciplines such as biology, tissue and material engineering and personalized medicine. The Company strives to enhance its technological expertise by rigorous R&D activities and through collaborations with other entities aimed at purchasing and/or obtaining exclusive rights to relevant technologies.

 

15-Apr-2015 Bonus Therapeutics Selected Amongst 100 Most Promising Innovative Technology Companies in Europe

Bonus Therapeutics Selected Amongst 100 Most Promising Innovative Technology Companies in Europe 

Bonus BioGroup is proud to announce that it was notified that Bonus Therapeutics Ltd., a wholly owned subsidiary of the Company, has been selected as a finalist for the 2015 edition of Red Herring’s Top 100 Europe Award.

 

The editorial team of Red Herring, a company which performs daily and periodical analytic reviews of technology companies around the world, has selected the 100 technology companies which, to the best of their judgement, demonstrate the greatest business opportunities across Europe. The nominees are evaluated on 20 quantitative and qualitative criteria, including proof of concept, technological innovation, market size, business strategy, management strength and financial performance.


Over the years, Red Herring’s experts have identified promising tech ventures which later reached leading positions in the area of their activities. Google, Yahoo!, Facebook, Twitter, Skype, YouTube, eBay and Mobileye, to name a few.


Bonus BioGroup is currently in the midst of a clinical trial designed to repair facial bone deficiencies, including upper and lower jawbone, through viable human bone transplants based on cells extracted from patients’ own fat tissue. The transplants are produced in the Company’s manufacturing facility at MATAM Advanced Technology Park in Haifa.
Bonus BioGroup’s unique technology combines various scientific disciplines such as biology, tissue engineering, material engineering and tailored medicine.

 

14-Jan-2015 Bonus BioGroup Announces Completion of Recruitment of 20 Patients for Clinical Trial to Repair Human ...

Bonus BioGroup Announces Completion of Recruitment of 20 Patients for Clinical Trial to Repair Human Facial Bone Deficiency 

Bonus BioGroup announced today that it was notified by the investigator at the medical center of the accomplishment of 20 patients recruitment. This is the maximal number approved for the human facial bone deficiency treatment clinical trial, using live human bone grafts.

 

The bone grafts are produced by Bonus BioGroup in its production facility, in Matam Industrial Park, Haifa. The clinical trial to repair facial bone deficiencies is designed to test the safety and efficacy of live human bone grafts produced by Bonus BioGroup.

According to the company's estimations, the live human bone graft, grown from cells extracted from the patient's fat tissue, is likely to be fully accepted, without any rejection, by the body of the patient whose sample was taken. When the bone graft is introduced, the patient's immune system is expected to recognize the biological identity between the patient's body and the bone graft grown by Bonus BioGroup. Therefore, the immune response and graft rejection, typical in treatments using foreign donor cells or tissue, rather than the patient's own, will be prevented.

 

Bonus BioGroup produces live human bone grafts, based on cells extracted from the patient's fat tissue, using the company's unique technology, which combines biology, tissue and material engineering, and a structured procedure of tailored medicine.

Bonus BioGroup recently announced that the company and its facilities are GMP certified, according to European standards, as well as ISO-9001 certified, in aspects of development, production, quality control and supply of its products to clinical trials. 

 

 

04-Jan-2015 Bonus BioGroup Announces Receipt of European GMP and International ISO-9001 Certification

Bonus BioGroup Announces Receipt of European GMP and International ISO-9001 Certification

 

Bonus is pleased to announce today that SWINET – Swiss Institute for Inspection, Education and Training – an EMA (European Medicines Agency)-recognized Institute for inspection and accreditation, certified Bonus BioGroup and its facilities to meet the European Good Manufacturing Practice (GMP) standard and the international ISO-9001 standard in development, production, quality assurance and supply of the Company's products for clinical trials in humans.

The Company's 1,000sqm facilities at MATAM Advanced Technology Park in Haifa comprise clean room production facilities designed for the manufacture of live human bone transplants, quality assurance laboratories and research and development laboratories.

Dr. Shai Meretzki, CEO of Bonus BioGroup, commented, "Bonus BioGroup is proud to announce international recognition of regulatory compliance in all its areas of operation, starting with the development of live human bone based on cells originating from patient's own fat tissue, through production in the Company's clean rooms and quality control measures, to supply of the final products for use in clinical trials. The Company's compliance with quality standards is another milestone towards commercialization of the Company's products".

Bonus BioGroup is currently holding a clinical trial for the repair of human facial bone deficiencies, including upper or lower jawbone deficiencies, by human bone transplants.

Bonus BioGroup’s transplants are individually manufactured for each patient from their own fat tissue. For this reason, no one graft is biologically similar to another, yet all are estimated by the Company to be histocompatible and induce full immunological tolerance by their recipient patient's body. This biological tailoring precludes the frequent phenomenon of foreign tissue rejection, typical of foreign donor tissue transplantation.

21-Dec-2014 Bonus BioGroup Announces Agreement to Develop Large Vascularized Living Transplants of Human Tissue

Bonus BioGroup Announces Agreement to Develop Large Vascularized Living Transplants of Human Tissue

Bonus BioGroup announces that it has entered into agreements to develop a large vascularized (blood vessel-containing) living transplants of human tissue. The Chief Scientist confirmed compliance of the Company with all conditions precedent thereby approving the support, with a budget of up to 1.3 million NIS in 2015. The joint research will be performed by Bonus Therapeutics Ltd, a wholly owned subsidiary of the Company, and the Western Galilee Hospital in Nahariya, affiliated with the Bar-Ilan University School of Medicine in Safed.


Bonus is currently developing a large living transplant of vascularized human bone to provide accelerated regeneration in the affected area. Composed of autologous (originating from the patient) cells and biodegradable materials, the blood vessels within the transplant will form new vasculature at the transplantation site.
Bonus entered into three agreements pertaining to this joint development: The first with the medical center, where development of the large vascularized living transplants of human tissue will continue; the second with the Technion to stipulate Bonus’ exclusive rights in the pre-existing intellectual property; and a third between the medical center and the TEchnion to secure Bonus’ exclusive marketing rights.

 

The research agreement, along with a licensing agreement, grant Bonus exclusive global rights to develop, manufacture and market large vascularized human-tissue transplants based on the aforementioned research.
At the beginning of this week the Company reported the raising of capital through private placement. Under the terms of the investment agreement the Company will allocate 4 million common shares for cash payment in the amount of 2 million NIS. This amount reflects a price of 50 agorot per share.

 

This capital raise took place several days following the selection of Bonus Therapeutics Ltd., a wholly-owned subsidiary of Bonus BioGroup, as a finalist for the 2015 edition of Red Herring’s Top 100 Europe Award for most promising start-ups in Europe. The editorial team of Red Herring, a company which performs daily and periodical analytic reviews of technology companies around the world, has selected the 100 technology companies which, to the best of their judgment, demonstrate the greatest business opportunities across Europe. The nominees are evaluated on 20 quantitative and qualitative criteria.
Over the years, Red Herring’s experts were amongst the first to identify the disruptive potential of notable companies such as Google, Yahoo!, Facebook, Twitter, Skype, YouTube, eBay and Mobileye.
Bonus BioGroup's unique technology combines disciplines such as biology, tissue and material engineering and personalized medicine. The Company strives to enhance its technological expertise by rigorous R&D activities and through collaborations with other entities aimed at purchasing and/or obtaining exclusive rights to relevant technologies.

 

 

02-Jul-2014 Bonus BioGroup Proud Recipient of BIRD Foundation Grant Totaling 2.8 Million NIS

 

Bonus BioGroup Proud Recipient of BIRD Foundation Grant Totaling 2.8 Million NIS

 

Bonus BioGroup announces today that on July 2, 2014, an agreement was signed for BIRD support of a joint Bonus BioGroup and Cellora LLC project for the development of innovative personalized regenerative medical technologies.

Cellora is a company incorporated under the laws of Delaware, USA. Upon finalization of the agreement BIRD Foundation forwarded support for the first period of the joint project.   

The joint project will focus on synergizing material science and tissue engineering. The development will take place in Cellora LLC, Harvard-MIT Biomedical Engineering Center (BMEC) under the Division of Health Sciences and Technology (HST), and at the Research and Development headquarters of Bonus BioGroup in Matam Advanced Technology Park, Haifa.

The BIRD Foundation - Israel-U.S. Binational Industrial Research and Development Foundation promotes collaboration between Israeli and American companies in various technological fields for the purpose of joint product development and fruition.

Dr. Shai Meretzki, CEO of Bonus BioGroup commented, “In light of the abundance of applications submitted to BIRD by US-Israeli industrial R&D companies and BIRD's comprehensive and competitive review processes, we are thrilled to be awarded this grant, which reflects an acknowledgment of Bonus BioGroup’s scientific uniqueness and proficiency. Bonus continuously seeks to expand its product offering by development of innovative technologies in the fields of tissue and material engineering”.

Under the agreement, the joint project is entitled to support in the amount of 2.8 million NIS (800 thousand dollars), provided that the sum of BIRD's support will not exceed 50% of the actual expenditure (“conditional grant”). The grant amount will be made in four installments for a period of 18 months, which began on November 1, 2013. The amount of support payments will be refunded BIRD Foundation, subject to achievement of defined goals of the joint project, and regardless of income, if and to the extent incurred for, the joint project.

BIRD will be repaid the conditional grant received subject to achievement of the goals defined for the joint project, and regardless of any income the project may generate. Bonus BioGroup is entitled to 137 thousand dollars, which reflects 70% of the total amount for the first period of the joint project, and Bonus’ relative share in all three future payments.

Projects submitted to the BIRD Foundation are thoroughly reviewed by evaluators appointed by the National Institute of Standard and Technologies (NIST) and by evaluators appointed by the Chief Scientist’s Office in the Israeli Ministry of Economy. The project was examined for its scientific merit - innovation and development potential of the technology and the product; operational feasibility – transfer to manufacture at industrial scale; regulatory challenges – required path to FDA approval of an innovative product, and ; marketability -  size of the global market and feasibility of product introduction.

The the best of the Company’s knowledge, BIRD Foundation is considered one of the leading expert foundations across all technological fields. Over its 36 year history, BIRD’s total investment in these projects has been over 300 million USD, helping to generate direct and indirect sales of more than 10 billion USD.

Bonus BioGroup is currently manufacturing live transplants of human bone based on cells originating in the patient, in a pre-designed shape to precisely fit the patient’s deficient anatomical site. Current applications include orthopaedics and dental surgery. The joint project may expand Bonus BioGroup’s range of cellular therapy products to include genetically personalized new innovative solutions and shelf products that will not require the extraction of cell sample and the culture of biological tissue ex-vivo (outside the body) in a production facility.           

The joint project constitutes another milestone in Bonus BioGroup’s R&D pipeline, according to which the Company strives to enhance its technological expertise by rigorous R&D activities and through collaborations with other entities aimed at purchasing and/or obtaining exclusive rights to relevant technologies.   

18-Apr-2014 Bonus BioGroup Announces Support by Chief Scientist of R&D Activities Including A Clinical Trial

Bonus BioGroup Announces Support by Chief Scientist of R&D Activities Including A Clinical Trial

 

Bonus BioGroup announces that on May 18, 2014, the Office of the Israeli Chief Scientist approved R&D support for year 2014 in the amount of 2 million NIS for Bonus Therapeutics Ltd., a wholly-owned subsidiary of Bonus BioGroup.

The R&D activities will include a clinical trial for the repair of human facial bone deficiencies, including upper or lower jawbone cavitation, by transplantation of live human bone grafts manufactured in the Company's production facility at MATAM Advanced Technology Park in Haifa.

On April 28, 2014, the first transplantation took place in the framework of the clinical trial. The Company estimates that interim results regarding the integration of the grafts will become available approximately 4 months following each transplantation. The clinical trial is intended to conclude within one year of the graft transplantations, see Immediate Report of April 29, 2014, Ref: 2014-01-052269.

Support offered by the Chief Scientist constitutes 40% of the approved budget, subject to payment of royalties from all income generated by Bonus Therapeutics Ltd. and submission of complementary documents.

The Company strives to enhance its technological expertise by rigorous R&D activities and through collaborations with other entities aimed at purchasing and/or obtaining exclusive rights to relevant technologies.

Bonus BioGroup's assessments regarding the set-up of the clinical trial, the number of participants, dates of clinical trial stages, trial completion and proof of safety and efficacy include forward-looking statements based on information available at the time of this report, as defined in the Securities Law – 1968. Whether actual results will conform, partially or fully, with the Company's predictions is subject to various factors, including feasibility tests and/or delays in the clinical trial and/or difficulty in recruiting participating subjects and/or an arising need to carry out additional trials and/or unsuccessful stage/s in the trial and/or technological changes and/or development and marketing of competitive/ore efficient product/s and/or materialization of any of the risk factors associated with the clinical trial and/or its outcomes.  

06-Apr-2014 Bonus BioGroup Has Commenced a Clinical Trial to Transplant Live Bone Grafts ...

A Human Bone Grown in a Lab to Be Transplanted in Humans:

Bonus BioGroup Has Commenced a Clinical Trial to Transplant Live Bone Grafts in Human Facial Bones

Bonus BioGroup announces it has commenced a clinical trial for the repairing of human facial bone deficiency, including upper or lower jaw bone deficiency, using a live human bone graft, produced in the company's production facility, in Matam Industrial Park, Haifa.

Bonus BioGroup produces live human bone grafts, based on cells extracted from the patient's own fat tissue, using the company's state-of-the-art technology, which combines biology, materials engineering, tissue engineering and personal medicine.

The first stages of the clinical trial have been successfully accomplished for the first patient recruited: obtaining fat tissue sample, transporting the sample safely to Bonus BioGroup's production facility and there, extracting the cells required for the generation of a live human bone graft.

The manufacturing process of the human bone graft began outside the production facility, when a fat tissue sample was obtained from the first patient enrolled in the live human bone graft transplant clinical trial. The sample was then transported, within a few hours, to the company's production facility, where the required cells for bone generation were extracted and the bone growing procedure has begun.

The production of the live bone graft is expected to be completed in approximately a month, and result in a bone graft ready for transplant in the patient whose sample was used to grow it. Approaching the scheduled date of the transplantation procedure, the graft will be transferred to the transplant site.

The first live human bone graft produced by Bonus BioGroup is expected to be fully accepted by the patient's body; as the patient's own tissue was used to produce it, the immune system, when facing the autologous graft, is expected to identify it is biologically similar, thereby preventing the immune system's reaction towards rejection, common in allografts (transplantations using tissue from a foreign donor).

In the upcoming weeks, Bonus will complete the fat tissue sample collection from all 20 patients expected to participate in the clinical trial to fill varying bone deficits in the facial bones.

First interim results are expected 4 months after the first bone graft transplantation in each patient.

The facial bone deficit repair clinical trial's goal is to test the safety and efficacy of Bonus BioGroup's live human bone grafts, and it is intended to conclude within one year of the last graft transplantation.

Bonus BioGroup's production facility was designed, established and qualified in compliance with the European Good Manufacturing Practice standards (GMP), required for producing cellular medicine products of the quality matching clinical application in humans. The facility allows Bonus BioGroup full control over the entire bone graft growing process, independently of any substantial collaboration or other parties.

26-Jan-2014 Harvard-MIT Director of Biomedical Engineering Center to Join Bonus BioGroup's Scientific Team

Harvard-MIT Director of Biomedical Engineering Center to Join Bonus BioGroup's Scientific Team 

Bonus BioGroup announces today the establishment of an agreement with Professor Elazer Edelman, M.D., Ph.D., according to which he will join the worldly renowned scientific team advising the company on product development and promoting its clinical goals.

Professor Edelman is a Professor of Health Sciences and Technology at MIT, Professor of Medicine at Harvard Medical School and Senior Attending Physician in the coronary care unit at the Brigham and Women's Hospital in Boston. Prof. Edelman directs the Harvard-MIT Biomedical Engineering Center (BMEC), operating under the Harvard-MIT Health Sciences and Technology Department, and the Edelman Lab.

Additionally, Prof. Edelman is an advisor to major American investment bodies and multinational companies, and has vast connections in the American Biotech industry.

Prof. Edelman and his laboratory have an international reputation in leading breakthrough medicine and vascular biology discoveries, from research and development to regulatory and production, including cell-based products, while applying tissue engineering, controlled drug delivery and biotechnology principals. His work has left a significant mark on biotechnology research and industry.

Dr. Shai Meretzki, CEO of Bonus BioGroup, says: "the joining of such an internationally renowned expert is an acknowledgment of the breakthrough achieved by Bonus' innovative technology, and is a vote of confidence in the company's development and commercial capabilities. We are certain Prof. Edelman's contribution to the company will be significant".

Professor Edelman's joining Bonus' leading scientific team further expands the collaboration with him, which began in a research agreement between Bonus Cellora Ltd., a fully owned subsidiary of Bonus BioGroup, and MIT, for the development of a new shelf product in the field of cellular medicine. The new product is designated for regeneration and renewal of damaged human tissue, in a combined tissue- and material engineering technology, and is simultaneously developed at MIT and Bonus BioGroup's development center in Haifa based on shared expertise and collaboration between MIT and the company.

To the company's best knowledge, in 2004, Prof. Edelman had established, along with Prof. Langer, the regenerative medicine company Pervasis Therapeutics, which had developed VascuGel, a gel-based treatment for blood vessels repair and improvement in patients with end-stage renal disease. Pervasis Therapeutics was acquired, in April 2012, while in Phase II clinical trial, by Irish biopharmaceutical company Shire PLC (LSE: SHP, NASDAQ: SHPGY), in a deal reportedly worth up to $200 million.

Bonus BioGroup seeks to further establish its technological foundation by leveraging the abilities the scientists employed at its R&D center, and further expand it by acquiring new technologies and/or exclusive rights for existing technology usage, as well as joint R&D collaboration with leading researchers in tissue engineering and overlapping fields.

16-Jan-2014 Bonus BioGroup to Commence Clinical Trial

Bonus BioGroup to Commence Clinical Trial

Received Approval for Live Human Bone Graft Transplant

Bonus BioGroup announces today it has received approval for clinical trial, in cases of facial bone deficiency, including upper or lower jaw bone deficiency. The repair of the facial bone deficiency will be performed by using a live human bone graft, produced in Bonus BioGroup's production facility, in Matam Industrial Park, Haifa.

The manufacturing process of human bone grafts starts outside the production facility, in a clinic, by obtaining the patient's blood sample and liposuction. The samples are then transported to the production center, where the stem cells required for growing the graft are produced from the fat tissue.About a month later, a live human bone graft is formed, customized for the patient whose samples were used and ready to be transplanted. The bone graft is then transferred from the production center to the medical center where the transplant is performed.

Bonus BioGroup's production facility was designed, established and qualified in compliance with the European Good Manufacturing Practice standards (GMP), required for producing cellular medicine products of the quality matching clinical application in humans. The facility allows Bonus BioGroup full control over the entire bone graft growing process, independently of any substantial collaboration or other parties.

Dr. Shai Meretzki, Bonus BioGroup's CEO, noted "engaging in clinical trials of the company's products transplantations in humans is an important milestone for the company, not only in realizing its independent production capacity but also in the news it presents to millions worldwide, who may achieve a complete cure thanks to Bonus BioGroup's innovative technology.

The clinical trial of completing facial bone deficiency is designated to test the safety and efficacy of the company's live human bone grafts. We estimate the initial patient recruitment for the clinical trial, which is expected to last a year after transplants, will begin in the upcoming few weeks".

31-Jul-2013 Bonus BioGroup Has Completed the Establishment of the First Facility Worldwide for Growing Human Bone Grafts

Bonus BioGroup Has Completed the Establishment of the First Facility Worldwide for Growing Human Bone Grafts

The new and innovative facility will provide the company in its clinical trials, expected to commence in the second half of 2013.

Bonus BioGroup announces today the completion of a first-of-its-kind facility for growing human bone grafts, with an approximate area of 750 square meters within a complex of new facilities in Matam Industrial Park in Haifa.

 

The new production facility includes a set of Grade-B cleanrooms (of the standard required for producing live human bone grafts), as well as quality control and assurance labs, to ensure the compliance of the production process with Good Manufacturing Practice (GMP), required by regulators. Generally, the set of cleanroom required for producing human bone grafts is of a higher standard than that required for Medicines or Medical Devices (Grade C-D).

 

By establishing the first facility in the world for growing live human grafts, Bonus has achieved the independent production capacity of growing bone grafts of the quality and mass required for its clinical trials, scheduled to commence in the second half of the year (subject to regulatory approvals).

After three to four months from the transplant of human bone grafts in the patients participating in the first clinical trial, first significant interim results can be achieved.

 

The facility allows Bonus BioGroup full control over the entire bone graft growing process, independently of any collaboration or other parties. Moreover, the successful initiation of the facility stands as proof to Bonus BioGroup's ability to establish and operate a worldwide network of bone graft growing facilities.

 

After concluding the clinical trials and receiving the approval for marketing live human bone grafts, Bonus BioGroup will be able to use the production facility to supply grafts for commercial use, by producing tailored bone grafts, pre-designed to accommodate the patient's bone deficiency.

19-Mar-2013 Bonus BioGroup Announces Chief Scientist Support of Joint Research with Technion Totaling 1.4 Million NIS

Bonus BioGroup Announces Chief Scientist Support of Joint Research with Technion Totaling 1.4 Million NIS

Bonus BioGroup announces today (Tuesday) approval by the Israeli Chief Scientist of a 1.4 million NIS joint program with the Technion. The research may enhance the attachment of mesenchymal and stem cells to the personalized pre-designed scaffold onto which they are seeded during transplant manufacture.

The research will take place at the Company’s R&D center at MATAM Advanced Technology Park in Haifa and at the National Institute of Stem Cell Technologies headed by Prof. Joseph Itskovitz-Eldor – Director of the Department of Obstetrics and Gynecology at Rambam Health Care Campus and full professor at the Faculty of Medicine of the Technion. Prof. Itskovitz-Eldor will lead the Technion’s scientific team who will carry out the joint project together with the Company’s researchers.

Prof. Itskovitz-Eldor is known for initiating the collaboration with James Thomson of the University of Wisconsin which has brought about the first production of human embryonic stem cells in the world, which is considered one of the most important scientific breakthroughs in medical history, alongside the human genome project DNA cloning. Prof. Itskovitz-Eldor derived the first human embryonic stem cells in Israel and these were approved for federal funding by the US and Germany.  

Dr. Shai Meretzki, CEO of Bonus BioGroup commented, “We are pleased to receive this support for the development of our Company’s unique technologies. This is the second award Bonus receives from the Chief Scientist, and this underlines the high value and confidence shown towards the Company’s continual technological development. Establishing collaborations with acclaimed leaders is a company strategy and indeed Prof. Itskovitz-Eldor is a pioneer and a world leader in the fields of stem cell and tissue engineering research. We believe his contribution towards further development of our pipeline will be significant.”     

Support provided by the Office of the Chief Scientist will amount to 910 thousand NIS out of the total approved budget for this research of 1.4 million NIS. Bonus BioGroup’s share will be in the amount of 516 thousand NIS.  

The Company announced several weeks ago that it had started establishing a first-of-its-kind human bone graft manufacturing facility in the Company’s 750sqm complex at MATAM Advanced Technology Park in Haifa. The facility will consist of three divisions: a manufacturing facility for producing human bone grafts to be utilized within the company's clinical trials planned to commence within several months, an R&D center, committed to ongoing pursuit of performance excellence and exploration of additional applications of the Company's human bone grafts, and headquarters for Bonus BioGroup's management, from which it will also supervise its projected R&D activities in the United States.