OSSIO's Bio-Integrative Bone Fixation Implants Receive FDA Clearance for Pediatric and Adolescent Use

Dec 08, 2023 16:30 CST Updated 16:30

Ossio

Orthopedic Medical Device R&D Manufacturer

Source: Bone Future; Editor:Liu Xinyi

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On December 6, 2023, OSSIO, a company specializing in bio-integrative materials for orthopedic fixation implants, announced that its compression screws and customizable fixation pins made with OSSIOfiber® bio-integrative material received FDA approval.Can be used clinically for children and adolescents aged 2 to 21。

OSSIOfiber®PressurizationScrews andOSSIOfiber®Possible裁Cut Fixation Nail

# Approval Details

The FDA's approval this time is based on clinical data published at the 2023 International Pediatric Orthopedic Symposium (IPOS 2023), which showed that,Because OSSIOfiber® bio-integration material was used, children do not need to undergo a second surgery to remove metal implants.。

Article Title

The FDA's detailed explanation of this approval is as follows:

“OSSIOfiber® Compression Screw SeriesNow, with the simultaneous use of appropriate stents and/or fixation devices, as long as the patient's epiphyseal plate has stopped developing, or the surgery will not affect the epiphyseal plate that has not yet fully developed, thenCan be used to align and fix fractures, comminuted fractures, bone fragments, osteotomies, arthrodesis, and bone grafts in the upper limbs, tibia, knee, ankle, and foot of adults, children (2-12 years old), and adolescents (12-21 years old).”

“OSSIOfiber® Fixation Nail SeriesIn cases where additional fixation measures (e.g., rigid internal fixation devices, plaster casts, braces) are used simultaneously, as long as the patient’s epiphyseal plate has ceased development or the surgery will not affect an immature epiphyseal plate, thenCan be used to align and fix fractures, osteotomies, arthrodesis, and bone grafts in children (2-12 years old) and adolescents (12-21 years old).。”

OSSIO CEO Brian Verrier said, "This approval has been long-awaited, and with it, OSSIO has now entered a significant area in orthopedic surgery. Our...OSSIOfiber®The implant product portfolio has also been expanded with new additions, which can be used to fix fractures and soft tissue injuries throughout the body in various clinical scenarios, and can now treat fractures in children as young as two years old.Our innovation is expected to become a new option for clinicians, children, and parents in addressing fracture repair.。”

Brian Verrier

# What is OSSIOfiber® Bio-integration Material?

OSSIOfiber® Bio-integrative MaterialFive times stronger than traditional absorbable biomaterials, the internal structure canPromote bone tissue attachment and osseointegration, and a two-year preclinical study also demonstrated thatThis material-guided bone integration is progressively controllable, thus does not trigger inflammatory responses.. After guiding bone integration,The material will also be absorbed by the body, leaving no residual structure and avoiding secondary surgery.. The promotional video for the material is as follows:

Material Composition:This material is a polymer-based composite material, whereinNaturally Degradable Polymers(PLDLA, where the L:DL ratio is 70:30) andReinforced Natural Mineral Fibers(Composed of SiO2, Na2O, CaO, MgO, B2O3, and P2O5, mimicking natural bone) The proportions are roughly equal, ensuring both strength and absorbability.

Microstructure:This material contains thousands of continuous natural mineral fibers inside.Fibers are bundled into strands and formed into layers, suspended in a polymer resin.。

Internal Structure Adjustable:The uniqueness of this material lies in the implants made from it, whichThe internal structure can be adjusted according to design requirements to provide optimal biomechanics.This adjustment can be achieved because the structure of thousands of natural mineral fibers can be fine-tuned. These fibers are first integrated into fiber bundles, then formed into fiber layers, with each layer of fibers oriented to provide mechanical properties along different mechanical axes. Finally, these layers form a customizable matrix structure.

Mild degradation process:The polymer in OSSIOfiber® bio-integrative material can hydrolyze into methoxy acid compounds metabolizable by the human body in vivo. These acidic compounds and the alkaline degradation products of mineral fibers achieve acid-base neutralization.Ensures pH Balance During the Degradation ProcessAt the same time, mineral fibers and the polymer matrix form interconnected pores.Facilitates the excretion of degradation products and the ingress of body fluids into the implant., promoting the regeneration of bone tissue.

Degradation and Healing Synchronization:This materialProgressive Degradation in Synchronization with Bone Healing, as the bone heals, the newly formed bone gradually shares the load, further supporting the natural healing process. This materialCan be fully integrated in approximately 18-24 months.。

# About OSSIO Ltd.

OSSIO Ltd. was founded in 2014, with its R&D and manufacturing headquarters located in Caesarea, Israel, and its commercial headquarters in Boston, Massachusetts, USA. The company has developed OSSIOfiber®, a high-strength bio-integrative material.Hope to become a company that uses this material to manufacture more orthopedic fixation implants to replace metal implants.(The company estimates that the global orthopedic fixation market is worth billions of dollars).

The company's current products includeSuture Anchor, Compression Pin, Compression Screw, Trimable Fixation Pin, Hammertoe Deformity Fixation Implant, these implants are all made of OSSIOfiber® bio-integration material.

It is known that the company has currently undergone three rounds of financing, with an amount reaching$60.5 million, detailed information is as follows:

On October 17, 2022, the company announced that it had secured funding in its Series C round.$38.5 million`, led by MVM Life Science Partners.`

On March 11, 2019, the company announced that it had secured funding in its Series A round.$22 million, led by OCV, with participation from OurCrowd, Secocha Ventures, and Ortho Vision.

On May 1, 2016, the company announced that it had received an undisclosed amount of financing in its seed round, led by Secocha Ventures.

International Orthopedic Enterprises:

Stryker｜Johnson & Johnson

Zimmer Biomet ｜Medtronic

Smith+Nephew｜Enovis ｜NuVasive

Globus Medical｜Orthofix｜CONMED

Chinese Orthopedic Enterprises:

Chunli Medical｜Sanyou Medical ｜WEGO Orthopaedics ｜Dabo Medical

Kailite Medical｜Ossio Medical ｜Haohai Bio-Tech ｜AK Medical