Success Reported in a Keynote Presentation at the World Orthopedics Conference 2023.

Bonus Biogroup proudly announces a global first: the successful fusion of ankle and foot joints using BonoFill™, a lab-grown human bone graft. This groundbreaking achievement was part of a Phase II clinical trial targeting the treatment of critical-sized bone defects in limbs.

Joint fusion, known medically as arthrodesis, is a procedure used to treat conditions like arthritis, congenital anomalies, and deformities stemming from illness or trauma. Such conditions can cause significant pain and hinder normal function, often resisting conservative treatments [1]. The goal of joint fusion is pain alleviation and the restoration of patient mobility. Annually, the U.S. sees approximately 70,000 ankle and foot joint fusion surgeries [2], with over 1.5 million joint fusion procedures across various joints [3], including the wrist, fingers, and spine.

In the U.S., over 300,000 joint fusion surgeries involve autologous bone grafting, where the bone is transplanted from another part of the patient's body [4]. BonoFill™ offers a revolutionary alternative. Cultivated in a lab from cells derived from the patient, BonoFill™ negates the need for invasive bone harvesting, simplifies the surgical implantation process, and has the potential to expedite patient recovery.

Prof. Nimrod Rozen, President of the Israeli Orthopedic Association and Director of the Orthopedics - Rehabilitation Division at HaEmek Medical Center, showcased BonoFill's success at the World Orthopedics Conference (ORTHO 2023) in London from August 24-26, 2023 [5], following an invitation from the conference organizers. In his Keynote Presentation, Prof. Rozen highlighted several case studies where patients, after enduring years of unsuccessful conventional treatments, achieved stable joint fusion using BonoFill™. These individuals can now walk in regular shoes without support and are pain-free.

Among the cases presented was that of a 74-year-old woman with multiple background diseases. She underwent fusion in three different joints (tibiotalar, subtalar, and talonavicular joints) using a single BonoFill™ transplant. Previously, she had suffered from severe bone deformity and swelling in her ankle due to an old fracture that led to Avascular Necrosis. This condition caused bone collapse and a significant bone deficiency in her ankle. Notably, even before completing her one-year follow-up, post-BonoFill™ implantation, she successfully achieved a stable fusion in all transplanted ankle joints, allowing her to walk pain-free in regular shoes without any support.

To the best of Bonus Biogroup's knowledge, this treatment represents the first of its kind, where multiple joints were fused using a live human bone graft grown outside the patient's body. Additionally, Prof. Nimrod Rozen shared Bonus Biogroup's accomplishments in two Phase II clinical trials addressing bone deficiencies in the face or limb bones using BonoFill™.

The company projects that by 2030, the potential U.S. market for BonoFill™ treatments for various bone deficiency indications could reach approximately 6.2 million patients annually [6]. This translates to an estimated market opportunity of $70 billion in the U.S. alone, with global figures potentially doubling.

Dr. Shai Meretzki, CEO of Bonus Biogroup, commented, "The World Orthopedics Conference, attended by esteemed orthopedists worldwide, highlighted the expertise of leading surgeons and thought leaders. We express our gratitude to the organizers for spotlighting our BonoFill™ product in a keynote lecture, underscoring its potential in joint fusion and other challenging treatments, including where traditional methods are inadequate. This event was a prime opportunity for us to emphasize Bonus Biogroup's technological prowess and our unwavering commitment to advancing human health through our pioneering products."

About Bonus Biogroup

Bonus Biogroup Ltd. is a clinical-stage biotechnology company dedicated to developing advanced therapies in tissue regeneration and biotech products using tissue engineering and cell therapy. The Company currently has two products in clinical development: BonoFill™, a live tissue-engineered human bone graft intended for bone tissue regeneration and rehabilitation, and MesenCure, a cell therapy designed to treat inflammation and tissue damage, including pneumonia and respiratory distress. Bonus Biogroup also maintains a variety of technologies and products in the preclinical development phase.

The development of these products involves the application of unique technologies and knowledge proprietary to Bonus Biogroup. The Company's robust intellectual property portfolio includes six families of patents and patent applications, comprised of twenty-eight approved patents and fifteen patent applications, spanning numerous countries worldwide.

About BonoFill™ – Living Human Bone Graft

Bonus Biogroup has announced results from twenty out of thirty bone grafts in Phase II clinical trial for treating facial bone deficiencies, following a six-month observation period after each transplantation. The Company has completed the recruitment of all participants and is conducting a multicenter Phase II clinical trial to treat critical-sized bone defects in limb, hand, or foot bones at five medical centers in Israel using BonoFill™.

Bone deficiencies can arise due to aging, infections, osteoarthritis, traumas, and tumors. To mitigate the risk of rejection, Bonus Biogroup developed a living human bone graft using cells sampled from the patient. This lab-grown bone ensures effective bone grafts are readily available for various medical needs, including oral and maxillofacial surgery, skull surgery, orthopedic surgery, and plastic surgery, where bone tissue is lacking.

About the drug MesenCure

Bonus Biogroup has completed a Phase II clinical trial for treating pneumonia and life-teetering respiratory distress in severe COVID-19 patients using the cell therapy drug MesenCure. Clinical trial results indicate that MesenCure reduced the mortality rate of severe COVID-19 patients by 68% compared to the control group, with the survival rate standing at 94% for the 50 severe patients treated with the drug.

MesenCure, comprised of professionalized mesenchymal cells, aims to treat inflammation and tissue damage, including pneumonia and respiratory distress caused by the coronavirus or other viruses, bacterial infections, or other sources of immune overactivity, inflammation, or tissue damage.

The drug's effectiveness is attributed to the professionalization of the comprising cells, which enhances their natural ability to heal inflammation and tissue damage. The cells constituting MesenCure also affect inflammation and promote tissue regeneration through various mechanisms, potentially offering a broader and superior effect on diverse populations suffering from inflammation and tissue damage from multiple causes compared to drugs with a single mechanism of action.

Given the successful demonstration of MesenCure's effectiveness in treating acute respiratory distress in severe COVID-19 patients, the Company has broadened its efforts to investigate the potential efficacy of the drug and its derivatives in treating other indications such as cytokine release syndrome resulting from immunotherapy treatments to activate the immune system against cancer or from hematopoietic stem cell transplantation, as well as in tissue rehabilitation and healing.

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)

References

1. The Journal of Bone & Joint Surgery. https://doi.org/10.2106/jbjs.18.01300
2. Based on a U.S. population of 334.2M and an incidence rate of 20.2 per 100K person-years for ankle and foot joint fusion surgeries. Source: The Journal of Foot and Ankle Surgery. https://doi.org/10.1053/j.jfas.2015.04.023
3. The estimated minimum annual rate of joint fusion procedures in the U.S. is based on the rate of vertebral fusion procedures alone, which exceeds 1.6 million procedures per year. Source: Becker's Spine Review. https://www.beckersspine.com/spine/45273-surgeons-perform-1-62m-instrumented-spinal-fusions-per-year-in-the-us-5-things-to-know.html
4. The estimated minimum annual rate of autologous bone grafts in joint fusion procedures in the U.S. is based on the rate of auto-bone transplants for vertebral fusion applications alone, projected to be about 307,000 transplants per year. Source: 2021 DRG Report on the U.S. Bone Grafts and Replacements Market.
5. World Orthopedics Conference (ORTHO 2023) Official Website. https://orthopedics.magnusconferences.com/
6. Potential U.S. market projections for BonoFill™ treatments by 2030, based on an analysis by McKinsey & Company.