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Drug solution for bone fracture nonunions

Project description

Personalised treatment for bone fracture non-union

Non-union of bone after fracture occurs in some patients and there is currently no approved drug or other treatment that is effective. It results in significant challenges, increased risks and even death to patients and it costs healthcare systems billions of euros annually. The EIC-funded OSTEOforUNION project aims to develop and commercialise OSTEOGROW-C, a globally patented drug for bone regeneration developed by the Croatian SME Genera Research. OSTEOGROW-C, based on recombinant human morphogenetic protein 6, transforms patients’ blood into bone. Surgeons can use OSTEOGROW-C to prepare a personalised implant in the operating room during surgery, eliminating the need for bone harvesting which is currently required to prepare conventional therapies.

Objective

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. 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.
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 an active substance - recombinant human bone morphogenetic protein 6 (rhBMP6) incorporated in an autologous blood coagulum (ABC) where tricalcium phosphate (TCP) ceramics is added as a compression resistant matrix (CRM). This combination forms a personalized implant that catalyzes bone growth at the implantation site. 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, with associated complications and morbidities (donor site pain, infection, nerve injuries, blood loss or iliac wing fracture etc.) and related additional healthcare costs.
OSTEOGROW-C targets the global FNU market, which serves 6M patients yearly. Key overlapping markets are Fracture Fixation, Orthobiologics, Bone Grafts, and 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.

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-EIC-ACC - HORIZON EIC Accelerator

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-EIC-2024-ACCELERATOR-02

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Coordinator

GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 2 499 999,00
Address
SVETONEDJELJSKA 2
10436 Kalinovica
Croatia

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Hrvatska Sjeverna Hrvatska Zagrebačka županija
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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