Clinical trials

Clinical Trials

Bonus Biogroup is conducting clinical trials to evaluate the safety and efficacy of its product candidates

Orthopedic Bone Regeneration

Bonus Biogroup is conducting a Phase II clinical trial to evaluate the safety and efficacy of BonoFill in treating critical bone defects in the limbs.

This open-label single-arm study assesses BonoFill for treating large limb fractures and large bone defects incapable of self-healing.

The trial includes patients with (1) Long- and short-bone extra-articular comminuted fractures and (2) Long- and short-bone nonunion or intra-articular bone gaps or nonunion, incapable of self-regeneration.

The efficacy endpoints for this study include union, as measured radiographically by bone bridging, and clinical evaluation of weight-bearing ability. Safety endpoints include no bone growth due to the treatment outside the transplant site, no excessive bone growth or abnormalities in the surgical site, and no blood test abnormalities. Data is still being collected in this trial.

This open-label single-arm study assesses BonoFill for treating large limb fractures and large bone defects incapable of self-healing.

The trial includes patients with (1) Long- and short-bone extra-articular comminuted fractures and (2) Long- and short-bone nonunion or intra-articular bone gaps or nonunion, incapable of self-regeneration.

The efficacy endpoints for this study include union, as measured radiographically by bone bridging, and clinical evaluation of weight-bearing ability. Safety endpoints include no bone growth due to the treatment outside the transplant site, no excessive bone growth or abnormalities in the surgical site, and no blood test abnormalities. Data is still being collected in this trial.

Maxillofacial Bone Regeneration

Bonus Biogroup has completed a Phase II clinical trial evaluating the safety and efficacy of BonoFill for the treatment of facial bone deficiencies, specifically for sinus augmentation and bone void filling in the jaw.

Efficacy endpoints of the trial include:

Radiological evidence of jawbone regeneration six months post-transplantation.
Enabling follow-up rehabilitation procedures, such as the placement of dental implants.

The primary safety endpoint was the absence of treatment-related adverse events.

Based on radiological assessments conducted six months after transplantation, 90% of transplants met the bone reconstruction criteria as defined in the study protocol. No severe adverse events were reported during the trial¹.

Pending FDA clearance, Bonus Biogroup plans to advance the program to a Phase III clinical trial based on the results of this Phase II study.

¹Tzur E., et al., Cytotherapy, Volume 26, Issue 6, Supplement, 2024, Pages S20-S21.

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Respiratory Distress Treatment

Bonus Biogroup has completed a Phase II clinical trial evaluating the safety and efficacy of MesenCure for the treatment of severely ill patients with respiratory distress due to COVID-19 pneumonia.

The primary endpoint of the trial was to assess the safety of intravenous (IV) administration of MesenCure, defined as the absence of treatment-related adverse reactions. The secondary endpoints included assessment of potential efficacy using a range of clinical parameters, including 30-day all-cause mortality.

In this trial, patients receiving MesenCure, in addition to the standard-of-care (SOC), were observed to experience:

A 68% lower mortality rate compared to patients receiving SOC alone.
A 57% reduction in the need for invasive ventilation compared to the SOC group.
A 38% shorter average hospital stay compared to SOC patients for patients with a hospital length of stay longer than seven days.

In February 2025, the U.S. Food and Drug Administration (FDA) authorized the Company to proceed with a Phase III clinical trial to evaluate MesenCure in patients with COVID-19-related respiratory distress.

The Company is working to 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, pending FDA clearance.

Bonus Biogroup is advancing clinical research to evaluate the safety and potential therapeutic use of its cell therapy and tissue-engineered product candidates. Ongoing and planned trials aim to assess their role in bone regeneration and inflammatory conditions.