Drug solution for bone fracture nonunions

Introduction

Bone fracture nonunion (FNU) is one of the leading unmet orthopaedic clinical needs, resulting in billions of healthcare costs annually without any drug approved by regulatory agencies for this debilitating indication. Due to considerable shortcomings of the current best practices in treating bone FNUs, patients are facing increased risks and morbidity.

Current Treatment Landscape

The market has available only bone substitutes and enhancers with limited clinical efficiency, highlighting an essential need for more effective therapies. Genera Research is on its way to filling the gap with its globally patented OSTEOGROW-C product: a novel biological drug transforming patients’ blood into bone.

Project Overview

The proposed OSTEOforUNION project aims to develop and commercialize OSTEOGROW-C, an innovative drug for bone regeneration. OSTEOGROW-C is a novel treatment option for bone FNUs, an implant composed of:

1. An active substance - recombinant human bone morphogenetic protein 6 (rhBMP6)
2. Incorporated in an autologous blood coagulum (ABC)
3. Tricalcium phosphate (TCP) ceramics added as a compression resistant matrix (CRM)

This combination forms a personalized implant that catalyzes bone growth at the implantation site.

Advantages of OSTEOGROW-C

It is easily prepared in the operating room from the patient's blood without the need for a painful bone harvesting procedure, as in current treatment practices. This method reduces associated complications and morbidities such as:

• Donor site pain
• Infection
• Nerve injuries
• Blood loss
• Iliac wing fracture

These benefits also lead to reduced additional healthcare costs.

Market Potential

OSTEOGROW-C targets the global FNU market, which serves 6 million patients yearly. Key overlapping markets include:

• Fracture Fixation
• Orthobiologics
• Bone Grafts
• BMP

OSTEOGROW-C's unique stance promises to revolutionize the FNU market. The initial market entry will concentrate on the markets in the EU, with 180,000 diagnosed long bone FNUs in Europe annually. Simultaneously, OSTEOGROW-C will be launched in the US, addressing more than 120,000 bone FNUs.