Osfirm to Launch Novel Implantable Whitlockite Biomaterial

By Julie A. Vetalice

Osfirm to Launch Novel Implantable Whitlockite Biomaterial

Osfirm is developing biodegradable plates and screws based on whitlockite, a form of magnesium tricalcium phosphate that has shown superior bioactive regenerative and reconstructive properties and excellent biocompatibility, making it an ideal biomaterial for implant use on sites of fracture or bone defects.

Whitlockite-based synthetic bone is an alternative to allograft bone from a human cadaver, and xenograft bone from animal recipients which presents risks of allograft rejection and infection. The medical devices being developed by Osfirm are expanding their product line by combining whitlockite with various materials such as polymers, titanium and hyaluronic acid as a basic material.

One of their products is a plate and screw to treat fractured bones. It is a product made by mixing whitlockite with a biodegradable polymer. "A biodegradable material implies that after the human tissue such as the bone is regenerated and fully reconstructed, the substance will naturally degrade and absorb into the human tissue over a period of 6 months to 2 years," said Chan Yeong Heo, CEO of Osfirm. He continued, "These plates and screws will stabilize and support the fractured bones until the break heals and will dissolve on its own within 2 years."

Osfirm is preparing to submit applications to the Korean Ministry of Food and Drug Safety by 2022 for approval of an IND on whitlockite-based bone implants, and if approved, is expecting to begin the clinical trials by year 2023.

Osfirm is preparing to enter the U.S. market at the same time as its entry into domestic clinical trials in 2023. The goal is to obtain six clinical trial approvals and three product approvals by 2026. Although the current primary pipelines are concentrated on medical equipment development, bone disease-related cell therapy is being prepared alongside.

3D printing technology has been incorporated to create "patient-specific bone implants" based on whitlockite synthetic material. In such cases, CT scans are used to model the bone structures. With a sufficiently accrued database for bone imaging, manufacturing time is expected to be curtailed. It may be possible to generate standard ready-made products at reduced cost and manufacturing time. The therapeutic effect of these implants is significantly influenced by accurate alignment and position of implants, operation time and recovery period of the patients. With the use of novel technologies, Osfirm expects to address drawbacks to currently available products in the market.

Source: Osfirm

Product Labels: Trauma Ankle/Foot/Toe, Upper Extremity, Lower Extremity

Tags: Product Launch