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Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Modulim Announces CE Mark of Clarifi Imaging System for Microvascular Assessment

Modulim can now expand its marketing and distribution throughout Europe and apply for registration in other international markets that recognize the CE Mark.

Genius AI Detection Receives FDA Clearance

Hologic notes the new technology which the company has now made commercially available represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam.

OSSIOfiber Trimmable Fixation Nail System Launches in the U.S.

July 22, 2020

OSSIOfiber Trimmable Fixation Nail System official US launch and first commercial use, to securely fixate bone fractures, osteotomies and arthrodeses for healing, ultimately leaving the patient’s bone restored with no permanent hardware left behind was announced today by Ossio, Inc. The first commercial cases were bunion and MTP fusion procedures performed successfully by Chris Hyer, DPM, Foot and Ankle Surgeon at Polaris Surgery Center in Westerville, Ohio.

Part of the OSSIOfiber Bone Pin Product Family, which received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) in 2019, the OSSIOfiber® Trimmable Fixation Nail System includes strong, biointegrative Trimmable Fixation Nails in 2.4mm and 4.0mm diameters packaged with corresponding sterile, disposable instrumentation. These trimmable nails rival the performance of metal compression screws, combining the necessary strength for bone fixation with the ability to provide rapid bone in-growth, regeneration, and replacement without adverse inflammation, therefore avoiding the costs, pain, and complications often seen with permanent hardware.

Additionally, the ability to trim the implants to any desired length enables customization to any patient anatomy and adaptability for a wide range of surgical indications including forefoot, midfoot, hindfoot, and an array of hand/wrist applications.

“Having successfully utilized this new biointegrative option in my own clinical practice, it is clear that the OSSIOfiber® Trimmable Fixation Nails have real potential to replace metal compression screws and pins in numerous orthopedic procedures, with the ability to optimize bone healing while avoiding permanent implant-related post-operative complications,” said Dr. Hyer. “This novel trimmable nail system is exceptionally strong and well-designed, providing both the stability needed for solid fixation, natural healing and integration into the surrounding anatomy. The ease-of-use of the pre-sterilized, disposable instrumentation is excellent, and I like how the tapered ends of the nail allow for straightforward insertion into the bone tunnel and that it can be easily trimmed for broad procedural utility.”

OSSIO’s proprietary OSSIOfiber technology is engineered from a high performing matrix of reinforcing mineral fibers yielding strength that is 1.5 times greater than cortical bone. The design features of the OSSIOfiber® Trimmable Fixation Nail System contribute to the ability to maintain compression, stability and fixation strength and strong pull-out strength. Additionally, the hexagonal shape of the trimmable nails resist rotation, which prevents loosening that often results in screw back-out.

Additional procedures utilizing the OSSIOfiber® Trimmable Fixation Nail System are planned across the United States in the coming weeks.

“We are pleased to bring our next biointegrative fixation system to market, providing surgeons and their patients with an alternative to metal screws and pins that deliver strength, stability and utility for multiple surgical applications – all while fully integrating into the patient’s bone and leaving nothing permanent behind,” said Brian Verrier, CEO, OSSIO. “Adoption of our OSSIOfiber® Bone Pin Family has been strong to date, with substantial customer utilization across the U.S. We look forward to bringing additional breakthrough technology platforms to market that utilize our proprietary OSSIOfiber® technology and deliver a new standard of care in orthopedic fixation.”

Earlier this year, the company received FDA 510(k) Clearance for its OSSIOfiber® Hammertoe Fixation System. Approximately 700 hammertoe repairs have been conducted to date utilizing the implant.

“OSSIO continues to add promising, innovative solutions that offer an alternative to metal implants to our surgical toolbox,” said Erik Carlson, MD, Hand and Upper Extremity Specialist, Active Orthopaedics PC, and Chief of Orthopaedic Surgery, St. Mary’s Hospital, Waterbury CT. “OSSIOfiber® technology has a strong performance track-record and continues to demonstrate excellent clinical outcomes in the foot and ankle space, with high surgeon and patient satisfaction across the board. I look forward to actively utilizing the customizable OSSIOfiber Trimmable Fixation Nail System in applicable hand and wrist procedures.”

OSSIOfiber® Intelligent Bone Regeneration Technology can address many surgical applications through the manufacturing of endless implant designs, including nails, screws, anchors and plates. The company intends to pursue multiple applications in the distal extremity, trauma, sports, reconstruction, pediatrics and spine segments.

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Fusion Antibodies and Queen’s University Belfast Awarded a £453,000 Grant from Invest Northern Ireland

The two organisations will use the funds to accelerate the discovery of novel therapeutic and diagnostic antibodies with validated anti-infective properties against COVID-19. Building on strong scientific knowhow, a new antibody development platform will be created that will help realise the vision of producing a breakthrough therapeutic that directly targets SARS-CoV-2.

Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Kayentis, a global provider of digital data capture systems for clinical trials, today announces it has raised €7M (approx. $8.3M) in growth capital.

Kayentis is active in the global electronic Clinical Outcome Assessment (eCOA) market, which is expected to reach $2.6 billion by 2027. Market growth in eCOA – a method of capturing outcomes data electronically in clinical trials – is driven by the clinical trials industry.

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Stoke Therapeutics Announces Proposed Public Offering

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