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Thursday, 26 January 2023 14:56

Presentations to Highlight the Success of BonoFill at the 42nd Annual Conference of the Israeli Orthopedic Association

Orthopedic Surgeons to Showcase Successful Treatment of Bone Deficiencies with BonoFill, a Live Human Bone Graft by Bonus Biogroup

Bonus BioGroup (TASE: BONS) is a clinical-stage Israeli biotechnology company, engaged in research and development of biomedical tissue-engineered and cell therapy products.

Bonus Biogroup is pleased to announce that orthopedic surgeons from various medical centers will present their successes in treating complex bone deficiencies using BonoFill, a live human bone graft developed by the Company [1]. BonoFill is undergoing two phase II clinical trials for the treatment of critical and complicated bone deficiencies in limbs and the jaw. The presentations will be held at the 42nd Annual Conference of the Israeli Orthopedic Association on January 25-26, 2023, in Tel Aviv.

Several case studies will be presented during the conference, showcasing the effective treatment of complex bone deficiencies using BonoFill in patients for whom other surgical treatments have failed.

Examples include:

Treatment of a critical bone defect over 5 cm long, accompanied by limited weight-bearing ability and pain: At the end of the follow-up period following BonoFill transplantation, complete fracture union, a return to normal function, and the absence of pain were observed.

Treatment of a critical bone defect with a volume exceeding 40 cc, accompanied by walking limitations, weight-bearing issues, and pain: Six months after BonoFill transplantation, normal functions were observed and no pain was reported.

Treatment of a complex fracture involving two forearm bones, accompanied by weight-bearing inability and pain: Following BonoFill transplantation, the union of both forearm bones were observed at the end of the follow-up period, and no pain was reported.

The annual conference of the Israel Orthopedic Association, founded by the Israel Medical Association, is expected to be attended by leading doctors and orthopedic surgeons in Israel. The Israel Orthopedic Association is an adjunct member of the European Association of Orthopedics and Traumatology.

Dr. Shai Meretzki, CEO of Bonus Biogroup, stated, "Presenting Bonus Biogroup's successes at this prestigious conference demonstrates the promise of BonoFill in treating a variety of bone deficiencies in challenging cases. We aim to inform doctors in both community and hospital settings about the potential benefits of BonoFill, a live human bone graft developed by our Company. We are committed to ensuring that this innovative treatment for large or complex bone deficiencies is available to patients who have exhausted standard treatment options without success."

The Company estimates that by 2030, the target market for a range of potential treatments using BonoFill will reach approximately 6.2 million patients per year in the US alone, with an estimated annual value of $70 billion. The global market is projected to be double that figure. Due to the COVID-19 pandemic, this market may experience further growth [2-4], as severe COVID-19 patients treated with steroid drugs can suffer decreased bone density. Additionally, the direct effects of the virus or the immune response against it may impair bone quality and increase the incidence of unhealed fractures in general.

Bonus Biogroup – the Company

Since its inception, Bonus BioGroup has been involved in cellular medicine and tissue engineering. To date, the Company has two products in clinical development: BonoFill - a viable human bone graft for the regeneration and reconstruction of bone tissue, and MesenCure - a cell therapy for acute inflammation, including acute respiratory distress in severe COVID patients. In addition, the Company has a variety of other technologies and products in preclinical development.

The main building block utilized to produce BonoFill bone graft is mesenchymal cells extracted from the patient's adipose tissue. Alongside the development of BonoFill, the Company developed a cell therapy based on mesenchymal cells isolated from adipose tissue of healthy donors that are professionalized to enhance their ability to counteract acute inflammation, including cytokine storms prevalent in COVID patients and other diseases. These efforts led to the development of the professionalized cell therapy product MesenCure.

In light of the Company's demonstration of the efficacy of MesenCure in treating severe COVID patients, the Company has expanded its efforts to examine the potential of MesenCure to treat other conditions involving systemic inflammations and multi-organ injuries. Such conditions include cytokine release syndrome caused by biological therapies or hematopoietic stem cell transplantation. In developing its drug products, Bonus BioGroup uses unique technologies and knowledge developed in-house. The Company's rich intellectual property, including seven families of patents and patent applications, encompasses thirty-eight (38) approved patents and seventeen (17) patent applications in many countries worldwide.

BonoFill – a viable human bone graft

Bone deficiencies can result from various causes, including aging, infections, arthritis accompanied by bone loss, trauma (accident or fall), and tumors. Bonus Biogroup develops viable human bone grafts based on cells sampled from the patient (autologous tissue). Growing bone grafts outside the patient's body allow their on-demand manufacturing to provide effective bone grafts for various medical conditions involving bone loss, including oral and maxillofacial surgery, cranial surgery, orthopedic surgery, and plastic surgery.

MesenCure cell therapy

The cell therapy MesenCure consists of professionalized mesenchymal cells. MesenCure is designed to treat acute inflammations and subsequent conditions. These conditions may include life-threatening pneumonia and respiratory distress, whether caused by the coronavirus, any other virus or bacterial infection, or whether caused by other conditions underlined by a hyperactive immune system. The efficacy of MesenCure, as demonstrated in the clinical trial for treating severe COVID patients, is presumably attributed to the professionalization of the mesenchymal cells comprising MesenCure. This professionalization enhances the cells' natural ability to attenuate the inflammation and cytokine storm, which, without MesenCure, could lead to life-threatening multi-organ damage. Furthermore, the cells comprising the drug product MesenCure affect inflammation and cytokine storm through various mechanisms. Therefore, MesenCure may have a broader and more robust effect on diverse populations of patients than drugs acting via a single mechanism.

Company estimations regarding forward-looking statements

Bonus BioGroup's assessments regarding the medical effect and/or commercial potential of its products and/or the resulting economic opportunities, and the Company's ability to continue the process of their development, including conducting studies, and arriving at a product that can be medically applied in humans, for the duration and expected dates to perform any stage in any experiment and publish its results and obtain regulatory approvals for marketing the product, are forward-looking statements, as defined by the Securities Law of 1968, which are based on the Company's estimates and on the information in its possession at the time of reporting.

There is no certainty that these estimates will materialize, in whole or in part, among others, due to dependence on the actions of third parties, which are not under the Company's control, on the development of future cancer therapies, on future studies results, if any, due to the possibility of delay in obtaining approval from relevant authorities and/or change in the relevant conditions and/or feasibility tests that the Company may conduct and/or delay in performing studies and/or need to perform further experiments and/or failure of experiments and/or technological changes and/or the development and/or marketing of similar and/or more efficient competing products and/or the lack of resources and/or the realization of any of the risk factors associated with the research and/or studies and/or its results.


Bonus Biogroup Ltd.

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

[1] For more information, see the immediate report dated April 11, 2022 (REF: 2022-01-038652) and the immediate report dated December 7, 2022 (REF: 2022-01-148102) included in this report by means of reference.

[2] Sapra, L., Saini, C., Garg, B. et al. Long-term implications of COVID-19 on bone health: pathophysiology and therapeutics. Inflamm. Res. 71, 1025–1040 (2022).

[3] Tang J. COVID-19 Pandemic and Osteoporosis in Elderly Patients. Aging Dis. 2022 Jul 11;13(4):960-969. doi: 10.14336/AD.2021.1201.

[4] Tang J. What can we learn about corticosteroid therapy as a treatment for COVID-19? Osteoporos Int. 2020 Aug;31(8):1595. doi: 10.1007/s00198-020-05487-w.

Last modified on Monday, 08 May 2023 04:41







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