Founded in 2008 by Dr. Shai Meretzki and a multidisciplinary team of experts, Bonus Biogroup is committed to advancing regenerative medicine by developing cell therapy and tissue engineering solutions, each of which are currently undergoing clinical evaluation.

In 2013, Bonus Biogroup established a dedicated manufacturing center to support its research and development efforts.

Between 2016 and 2017 the Company initiated clinical trials evaluating BonoFill for facial and limb bone defects. The Phase II clinical trial for maxillofacial bone defects, including sinus augmentation and bone void filling, was completed in 2024. BonoFill demonstrated no treatment-related severe adverse events. The primary efficacy endpoint achieving a reconstructed bone height sufficient for dental implant placement was met in 90% of transplants.

Further clinical development is planned to evaluate BonoFill in patients with jaw bone defects, including a Phase III study in the United States planned for 2026, subject to regulatory approval. A Phase II study for limb bone defects remains ongoing, and further clinical development is planned.

MesenCure, an allogeneic cell therapy product candidate, was initially developed to address inflammation and tissue damage in severe COVID-19 patients. A first-in-human study was initiated in 2021, followed by a Phase II clinical trial to evaluate MesenCure for treating patients with severe respiratory distress due to COVID-19 pneumonia. The study enrolled 50 patients who received MesenCure in addition to standard-of-care (SOC) treatment.

The trial reported a 68% reduction in 30-day mortality risk for the MesenCure group compared to a retrospective control group of 150 matching patients (6% vs. 18.7%). Additionally, patients receiving MesenCure had a 57% lower risk of progressing to invasive ventilation compared to the control group receiving SOC alone. MesenCure was well-tolerated in this trial, with no immediate or delayed treatment-related adverse events reported.

In February 2025, the FDA permitted the Company to proceed with a Phase III trial to evaluate MesenCure for treating severely ill patients affected by respiratory distress due to COVID-19 pneumonia. The Company is working on an amended clinical protocol to broaden the scope of the Phase III trial to include patients with respiratory distress from all causes, including ARDS, pending FDA clearance.

In 2022, Bonus Biogroup expanded its operations with a new facility in Haifa, Israel, designed to comply with GMP standards for clinical manufacturing. This facility supports ongoing research, development, and production of the two lead candidate products.

In 2024, the Israeli Ministry of Health certified that BonoFill and MesenCure are manufactured under cGMP standards for Phase III clinical trials. Additionally, the Ministry issued a certificate of accreditation confirming that the Company’s production facilities meet regulatory requirements under Israeli law and the cGMP guidelines recommended by the World Health Organization.

Bonus Biogroup collaborates with leading academic and research institutions. Recent partnerships included the Israel Institute for Biological Research, The Jackson Laboratory USA, and St. Catherine's Hospital in Croatia, supporting ongoing research and clinical development.

Bonus Biogroup’s journey reflects its dedication to advancing regenerative medicine through scientific research and technological innovation. The Company continues to focus on the clinical development of its leading cell therapy and tissue engineering product candidates to address unmet medical needs. Looking ahead, Bonus Biogroup remains steadfast in its mission to empower patients worldwide to live healthier and longer lives.

The product candidates mentioned on this website are in the investigational stage and have not been approved by the FDA or any other regulatory authority for commercial use.

Clinical trials are ongoing to evaluate their safety and efficacy.