Bone Solutions said today that it entered into a private label licensing agreement with Onkos Surgical for its OsteoCrete bone void-filling technology. Colleyville, Texas-based BSI’s OsteoCrete is an FDA 510(k)-cleared magnesium-based injectable, moldable solution designed to attaching ligaments and tendons to bone and bone to bone. Parsippany, N.J.-based Onkos Surgical intends to market OsteoCrete under the […]
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WishBone Medical inks deal to distribute Bone Solutions OsteoCrete
WishBone Medical confirmed a private label distribution agreement with Bone Solutions, Inc. (BSI) for worldwide rights within pediatric orthopedics to license and sell OsteoCrete. OsteoCrete, a magnesium-based bone void filler, is designed to assist with bone repair and regeneration. It is the first device of its kind in the orthopedic market with 510(k) approval from […]
Si-Bone grows sales 45% in Q1, raises full-year guidance
Si-Bone this week posted first-quarter results that beat the overall consensus on Wall Street. The Santa Clara, California-based orthopedic company reported profit losses of $11.1 million, or 32¢ per share, on sales of $32.7 million for the three months ended March 31, for a bottom-line gain of 36.1% on sales growth of 45.76% compared with […]
ZimVie announces new dental bone graft products
ZimVie (Nasdaq: ZIMV) recently launched two biomaterials that add to its dental bone grafts portfolio. The RegenerOss CC Allograft particulate naturally blends cortical and cancellous bone particles. It’s for use in filling bony voids in a variety of dental applications. Meanwhile, ZimVie describes the RegenerOss bone graft plug as an easy-to-use grafting solution for filling […]
Orthofix hits 5,000 mark for Fitbone implantations
Orthofix Medical (Nasdaq:OFIX) announced today that it surpassed 5,000 device implants for its Fitbone TAA intramedullary limb-lengthening system. Lewisville, Texas-based Orthofix said the system features more than 20 years of clinical history. Over that time, the device demonstrated safety and effectiveness in limb lengthening and deformity correction in adults and children. Orthofix acquired the Fitbone […]
FDA committee unanimously votes in favor of over-the-counter Narcan from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) announced today that its over-the-counter Narcan (naloxone HCl) nasal spray received unanimous approval from governing bodies. The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk profile for Narcan. The voters support […]
Si-Bone wins expanded FDA clearance for iFuse Bedrock Granite implant
Si-Bone (Nasdaq:SIBN) announced today that it received additional FDA clearance for its iFuse Bedrock Granite implant. New indications for the implant include its use with a range of commercially available pedicle screw systems. Santa Clara, California-based Si-Bone received FDA 510(k) clearance for iFuse Bedrock Granite for spinal procedures in May. It designed the implant to […]
Data backs Orthofix cellular bone allograft for lumbar fusion
Orthofix (Nasdaq:OFIX) today announced positive results from a clinical study evaluating its Trinity Elite cellular bone allograft (CBA). The prospective, multicenter study evaluates the Orthofix Trinity Elite in lumbar spinal fusion procedures. It demonstrated fusion rates of 98.6%, measured by bridging bone at 12 months follow-up. Investigators published the study results in Neurology International. “The […]
Si-Bone grows sales 15% in Q2
Si-Bone (NSDQ:SIBN) this week posted second-quarter results that beat the revenue consensus on Wall Street and missed earnings estimates. The Santa Clara, California-based company reported losses of $18.5 million, or -54¢ per share, on sales of $25.6 million for the three months ended June 30, for a bottom-line loss of 32.4% on sales growth of 15.28% […]
Orthofix wins FDA PMA for bone growth stimulation device
Orthofix (Nasdaq:OFIX) announced today that it received FDA premarket approval (PMA) for its AccelStim bone healing therapy device. Lewisville, Texas-based Orthofix designed the AccelStim device to provide a safe and effective nonsurgical treatment for indicated fresh fractures and for fractures that have not healed (nonunions). According to a news release, the device generates a low-intensity […]
Si-Bone posts mixed bag Q4 results
Si-Bone (NSDQ:SIBN) this week posted fourth-quarter results that beat revenue consensus on Wall Street but miss earnings estimates. The Santa Clara, California-based musculoskeletal treatment device company reported losses of -$14.5 million, or -43¢ per share, on sales of $25.2 million for the three months ended Dec. 31, 2021 for a sales growth of 13.94% compared […]
