Copy to clipboard 
SDIP Innovations was granted FDA 510(k) clearance to market the JAZBI™ Bone Void Filler, designed to support bone regeneration and healing. This marks the company’s entry into the U.S. bone graft substitute market and represents the first clearance of a device based on its proprietary JAZBI biomaterial.
JAZBI represents a novel biomaterial designed to resorb over time and be replaced by bone during the natural healing process. According to the company, the underlying JAZBI biomaterial has been engineered to enable the tailoring of its physical, mechanical, and biological characteristics to different clinical requirements, creating a foundation for a broader portfolio of regenerative products. The clearance represents the first commercial application of JAZBI, with potential future applications across orthopaedics, spine, craniofacial surgery, dental surgery, and soft-tissue reconstruction.
A distinguishing feature of SDIP’s strategy has been its investment in local manufacturing. The company has established comprehensive in-house manufacturing capabilities.
“JAZBI combines two primary components: an osteoconductive biphasic ceramic and our patented non-inflammatory polymer component, bringing them together in a composite structure with an optimised resorption rate and biological characteristics,” said Dr. Iman Manavitehrani, Chief Technology Officer and Co-founder. “We are scientifically and clinically investigating applications of the JAZBI platform across orthopaedics, spine, dental and craniofacial surgery, as well as next-generation biomaterial-based drug delivery systems,” he added.
Dr Maryam Parviz, Chief Executive Officer and Co-founder of SDIP Innovations, commented, “This FDA clearance is a major milestone for SDIP and an important validation of the proprietary JAZBI™ technology platform. It represents the first commercial application of a technology that has the potential to support multiple future products across a range of healthcare sectors.
“Our mission is to enable surgeons to innovate during surgery based on their patients’ unique needs, and the future vision for JAZBI™ is centred on supporting that goal.”
Source: SDIP Innovations Pty Ltd
SDIP Innovations was granted FDA 510(k) clearance to market the JAZBI™ Bone Void Filler, designed to support bone regeneration and healing. This marks the company’s entry into the U.S. bone graft substitute market and represents the first clearance of a device based on its proprietary JAZBI biomaterial.
JAZBI represents a novel biomaterial...
SDIP Innovations was granted FDA 510(k) clearance to market the JAZBI™ Bone Void Filler, designed to support bone regeneration and healing. This marks the company’s entry into the U.S. bone graft substitute market and represents the first clearance of a device based on its proprietary JAZBI biomaterial.
JAZBI represents a novel biomaterial designed to resorb over time and be replaced by bone during the natural healing process. According to the company, the underlying JAZBI biomaterial has been engineered to enable the tailoring of its physical, mechanical, and biological characteristics to different clinical requirements, creating a foundation for a broader portfolio of regenerative products. The clearance represents the first commercial application of JAZBI, with potential future applications across orthopaedics, spine, craniofacial surgery, dental surgery, and soft-tissue reconstruction.
A distinguishing feature of SDIP’s strategy has been its investment in local manufacturing. The company has established comprehensive in-house manufacturing capabilities.
“JAZBI combines two primary components: an osteoconductive biphasic ceramic and our patented non-inflammatory polymer component, bringing them together in a composite structure with an optimised resorption rate and biological characteristics,” said Dr. Iman Manavitehrani, Chief Technology Officer and Co-founder. “We are scientifically and clinically investigating applications of the JAZBI platform across orthopaedics, spine, dental and craniofacial surgery, as well as next-generation biomaterial-based drug delivery systems,” he added.
Dr Maryam Parviz, Chief Executive Officer and Co-founder of SDIP Innovations, commented, “This FDA clearance is a major milestone for SDIP and an important validation of the proprietary JAZBI™ technology platform. It represents the first commercial application of a technology that has the potential to support multiple future products across a range of healthcare sectors.
“Our mission is to enable surgeons to innovate during surgery based on their patients’ unique needs, and the future vision for JAZBI™ is centred on supporting that goal.”
Source: SDIP Innovations Pty Ltd
You’ve reached your limit.
We’re glad you’re finding value in our content — and we’d love for you to keep going.
Subscribe now for unlimited access to orthopedic business intelligence.
JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
