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Wednesday, 07 December 2022 14:42

In a world first: A severe knee deformity was successfully treated with viable human bone graft -BonoFill- manufactured by Bonus Biogroup, as part of a clinical trial for the treatment of bone deficiencies in limb bones.

 

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 a successful knee repair was achieved following the required one-year follow-up period for treating a severe knee deformity (Valgus Knee or Knocked Knee [1]) using BonoFill, for the first time in the world. BonoFill is a viable human bone graft manufactured by the Company and tested as part of phase II clinical trial for the treatment of critical bone defects in the limbs.

Valgus knee is a severe leg deformity manifested in an abnormal curvature that inclines inward. Subsequently, an excessive separation between the feet forms, and the knees touch each other. Such deformities may be congenital, developmental, or caused by trauma. Valgus knee condition is common in about 7% [2] of children and adolescents and also in overweight people. In severe cases, the excess pressure on the knee joint leading to its erosion, and the pressure on the ankle and the foot, may progress to degenerative arthritis and disability, manifested by great difficulties during prolonged standing, walking, and other functions.

The results of the first treatment of the valgus knee were presented at an international conference on innovation in healthcare – The Future Health Matrix – that took place on December 7-9, 2022, in Tel Aviv [3]. Results were presented by Prof. Nimrod Rosen, president of the Israeli Orthopedic Association and director of the Orthopedics-Rehabilitation Department, at the Emek Medical Center, Afula, at the invitation of the Israel Medicine Association (IMA),

At this conference, Prof. Rosen presented a case study of a thirty-year-old male patient from Haifa, who, following a trauma about two years ago, suffered from a very severe deformity of the knee, diagnosed as valgus knee, which significantly impaired his ability to stand and walk.

Before transplantation with the viable human bone graft produced by the Company, the patient underwent several procedures, including fixation and autologous bone grafting, constituting the current recommended standard of care, all of which have failed. After the failed operations, the patient was left with a deformed knee, severe pain, and considerable difficulties in walking and daily functioning.

As part of the surgery conducted at the Carmel Medical Center in Haifa, an acute correction of the deformity was first performed, which involved the resection of a large volume of approximately 40 cc of bone, creating a large bone cavity or void. The surgeon then filled this cavity with the viable human bone graft BonoFill, produced from the patient's cells using tissue engineering technology unique to Bonus Biogroup.

About three months after the transplantation of BonoFill, a union was observed between the viable bone graft and the patient's original bone, as well as the return of the knee to a normal position (axis). Also, the patient reported a significant reduction in pain, a considerable improvement in his functioning, and returning to routine life and occupation as a mechanic.

To the best of the Company's knowledge, this is the first account in the world for treating severe knee deformity, a valgus knee, using a bone grown outside the patient's body.

In addition, Prof. Nimrod Rozen presented the Company's achievements in the two Phase II clinical trials testing BonoFill in the treatment of craniomaxillofacial and limb bone deficiencies. According to the Company's estimation, the target market for BonoFill treatment of a variety of bone deficiencies is estimated in 2030 at approximately 6.2 million patients per year in the US alone and is expected to amount to approximately USD 70 billion per year in the US alone and twice as much worldwide.

Dr. Shay Meretzki, CEO of Bonus Biogroup, stated, "The impact of innovation in science and technology on the future of health care was widely discussed during The Future Health Matrix conference bringing together leaders of Israeli health care systems and medical organizations and associations from around the world. We thank Prof. Rozen, President of the Israeli Orthopedic Association, for focusing his lecture on innovation in bone regeneration using Bonus Biogroups's BonoFill. Presenting the Company's progress to some of the most important decision-makers in the world and BonoFill performance in particularly challenging indications and patients who have already exhausted the standard treatment options to no avail is an important milestone for us. It is also an opportunity to continue promoting the technology and the Company's products to benefit human health."

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 allows 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.

Sincerely,

Bonus Biogroup Ltd.

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


[1] Further information: https://www.physio-pedia.com/Valgus_Knee

[2] Further reading: https://doi.org/10.1590/1984-0462/;2017;35;4;00002

[3] Event information: https://december2022.ima-events.co.il

Last modified on Monday, 08 May 2023 04:43

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