Draft:Ossio
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| Submission declined on 18 April 2025 by Greenman (talk). This draft's references do not show that the subject qualifies for a Wikipedia article. In summary, the draft needs multiple published sources that are: Declined by Greenman 21 days ago.
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| Company type | Private |
|---|---|
| Industry | Medical device |
| Founded | 2014 |
Key people | Brian Verrier (CEO) |
| Products | OSSIOfiber® Suture Anchors, OSSIOfiber® Compression Staples, OSSIOfiber® Compression Screws, OSSIOfiber® Trimmable Fixation Nails, OSSIOfiber® Hammertoe Fixation System |
| Website | ossio |
OSSIO Ltd is a privately held medical device company headquartered in Woburn, Massachusetts, United States. The company focuses on the development and commercialization of bio-integrative orthopedic fixation technology.
Overview
[edit]OSSIO was founded in 2014 with the goal of providing a credible replacement for metal implants in the orthopedic surgery market. The company's core technology, OSSIOfiber®, is a proprietary polymeric mineral fiber matrix designed to facilitate rapid bone in-growth, regeneration, and replacement. OSSIOfiber® implants are intended to provide the mechanical strength required for functional fixation while allowing for full integration into the patient's native anatomy without adverse biological response, ultimately leaving nothing permanent behind.
Technology
[edit]OSSIO's flagship technology, OSSIOfiber®, is a proprietary material that combines natural bone minerals with a bio-absorbable polymer matrix. This composite is engineered to provide mechanical strength for bone fixation while enabling natural bone healing and gradual integration into the patient's anatomy, eventually leaving no permanent hardware behind. Common procedures include uses in surgery in bunion correction and hammer toe implants.
Products
[edit]OSSIO's primary product line is based on its OSSIOfiber® Intelligent Bone Regeneration Technology. This technology is utilized in a range of orthopedic implants, including:
- OSSIOfiber® Suture Anchors: Used for soft tissue fixation to bone in procedures of the shoulder, foot/ankle, knee, hand/wrist, and elbow.
- OSSIOfiber® Compression Staples: Indicated for use in the hand and foot for maintaining alignment and fixation.
- OSSIOfiber® Compression Screws: Used for grafts in the upper extremity, fibula, knee, ankle, and foot.
- OSSIOfiber® Trimmable Fixation Nails: Applicable in various orthopedic surgeries of the hand and wrist, foot and ankle, sports medicine, and pediatrics.
- OSSIOfiber® Hammertoe Fixation System: Cleared for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in hammertoe repair.
The OSSIOfiber® material is designed to be stronger than cortical bone and bio-integrative, meaning it is gradually replaced by the patient's natural bone over time. This aims to eliminate the risks associated with permanent metal implants, such as the need for secondary removal surgeries and potential long-term complications[1, 2].
History
[edit]Established in 2014, OSSIO operates with development headquarters in Caesarea, Israel, and commercial headquarters in Woburn, Massachusetts, USA[3]. The company was founded with the goal of providing a credible replacement for metal implants in the orthopedic surgery market[4]. In March 2019, OSSIO secured $22 million in financing to accelerate its US commercialization and operational expansion[5]. In October 2022, the company completed a $38.5 million Series C financing round led by MVM Partners[6], aimed at strengthening awareness for the patient benefits of its OSSIOfiber® technology and accelerating new product platforms[7] In December 2024, OSSIO raised an additional $27.6 million in equity funding to further scale its commercial efforts [8].
Clinical Adoption
[edit]As of 2025, OSSIOfiber implants have been utilized by over 1,500 surgeons across the United States. The implants are designed to utilize existing surgical techniques and reimbursement codes, facilitating their integration into current medical practices.
Regulatory Approval
[edit]OSSIO's OSSIOfiber-based products have received 510(k) [9] from the U.S. Food and Drug Administration (FDA) for various applications in orthopedic surgery.[10] This includes FDA clearance for its OSSIOfiber Compression Screw Portfolio in 2020 [11], OSSIOfiber Suture Anchors in March 2022 16, and OSSIOfiber Compression Staples in January 2022 [12]. In December 2023, OSSIO received FDA clearance for its OSSIOfiber bio-integrative bone fixation technology for use in pediatric surgery [13].
References
[edit][1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26] [27]
- ^ "Ossio, Ltd. Completes $38.5 Million Series C Financing". England & Company Investment Banking. 5 April 2023.
- ^ "Single/multiple component metallic bone fixation appliances and accessories" (PDF). FDA. FDA.
- ^ "OSSIO's Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance". Businesswire. ].
- ^ "OSSIOfiber® Threaded Trimmable Fixation Nails Approval" (PDF). FDA.gov. FDA.
- ^ "OSSIOfiber® Compression Screw Approval" (PDF). FDA.gov. FDA.
- ^ "OSSIO's Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance". BioSpace. 2023-12-06. Retrieved 2025-05-05.
- ^ "Ossiofiber® Holistic Metal-Free Surgical Hardware". University Foot and Ankle Institute. Retrieved 2025-05-05.
- ^ "Ossio closes $38.5M Series C". MassDevice. 2022-10-17. Retrieved 2025-05-05.
- ^ "Ossio, Ltd. Completes $38.5 Million Series C Financing". England & Company Investment Banking. 2023-04-05. Retrieved 2025-05-05.
- ^ "OSSIO Closes Series C Financing of $38.5 Million". MVM Partners LLP. 2022-10-17. Retrieved 2025-05-05.
- ^ "OSSIO Closes Series C Financing of $38.5 Million". Ortho Spine News. 2022-10-18. Retrieved 2025-05-05.
- ^ "OSSIO Raises $27.6 Million to Accelerate Its Commercial Engine as High Demand for Bio-Integrative Fixation Technology Continues". BioSpace. 2024-12-02. Retrieved 2025-05-05.
- ^ "OSSIO Raises $27.6M Equity Financing to Speed Commercial Engine". ODT Magazine. 2024-12-04. Retrieved 2025-05-05.
- ^ "OSSIO Raises $27.6 Million in Funding". ORTHOWORLD. 2024-12-02. Retrieved 2025-05-05.
- ^ "Ossio Raises $27.6M in Equity Funding". FinSMEs. 2024-12-02. Retrieved 2025-05-05.
- ^ "OSSIO: Medical Device Company Closes $27.6 Million In Funding". Pulse 2.0. 2024-12-03. Retrieved 2025-05-05.
- ^ "Ossio announces US launch of Ossiofiber suture anchors". MassDevice. 2022-08-08. Retrieved 2025-05-05.
- ^ "U.S. Launch of OSSIOfiber Suture Anchors". ORTHOWORLD. 2022-08-08. Retrieved 2025-05-05.
- ^ "OSSIO Announces U.S. Launch and First Commercial Use of OSSIOfiber® Suture Anchors, Expanding Patient Access to Growing Portfolio of Bio-Integrative Orthopedic Fixation Technology". Ortho Spine News. 2022-08-08. Retrieved 2025-05-05.
- ^ "OSSIO Expands Portfolio of Highly Differentiated Bio-Integrative Fixation Implants with Small Compression Staples to Enhance Bunion Repair Patients' Satisfaction". BioSpace. 2024-06-19. Retrieved 2025-05-05.
- ^ "Ossio announces launch of Ossiofiber compression staples". MassDevice. 2023-02-07. Retrieved 2025-05-05.
- ^ "OSSIO Awarded FDA 510(k) Clearance for OSSIOfiber® Compression Screw Portfolio". BioSpace. 2020-10-19. Retrieved 2025-05-05.
- ^ "U.S. Launch of OSSIOfiber Compression Screw". ORTHOWORLD. 2020-10-20. Retrieved 2025-05-05.
- ^ "OSSIO Awarded FDA 510(k) Clearance for OSSIOfiber® Compression Screw Portfolio". Business Wire. 2020-10-19. Retrieved 2025-05-05.
- ^ "OSSIO's Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance". Business Wire. 2023-12-06. Retrieved 2025-05-05.
- ^ "OSSIO receives FDA clearance for bone fixation technology in pediatric surgery". Healio. 2023-12-08. Retrieved 2025-05-05.
- ^ "OSSIO's Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance". BioSpace. 2023-12-06. Retrieved 2025-05-05.
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