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Wright Medical’s Stock Drops When Early Adopters of Cartiva Retreat
After RBC analyst Brandon Henry alerted stockholders in early July that doctors are reducing their use of a Cartiva toe cartilage implant sold by Wright Medical, Wright’s shares dropped 7 percent. ...
Tendon and Nerve Transfer Study Yields Promising Results for Tetraplegic Patients
Results of a prospective study published in The Lancet on July 4 assessed the result of nerve transfers in 16 tetraplegic patients with traumatic spinal cord injuries. Ten of the patients also rece...
AlloSource Partners With Advanced Regenerative Manufacturing Institute
AlloSource announced June 18 that it has joined the Advanced Regenerative Manufacturing Institute (ARMI). ARMI’s BioFabUSA is a public-private research and manufacturing institute within the Manufa...
Booming Demand, Surgical Planning Integration Drive Growth in Ophthalmic Diagnostic Market
Incremental improvements in technology will find their way into more mid-range models—making them more affordable. The diagnostic market is one of the most dynamic spaces within ophthalmology, with...
White House Pivots on Drug Price Strategy, Drops Proposed Rebate Ban
The Trump administration is now focused on lowering US drug prices by tying those prices to the lowest prices paid elsewhere, after scrapping plans to eliminate hidden rebates. Health Secretary Ale...
Pfizer Gains US Approval for Avastin Biosimilar
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Drugmaker Pfizer has gained US approval for Zirabev, a biosimilar to Avastin (bevacizumab), for five types of cancer. The New York company announced the milestone June 28. Avastin is used off-label...
Studies Provide Conflicting Picture of Eye Screening for Diabetics in US
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Two studies published in 2019 provide conflicting eye screening rates for diabetics in the US. Stephen Benoit and colleagues analyzed insurance claims data from IBM Watson Health for those with dia...
IDx Announces New CPT Code for Automated Point-of-Care Retinal Imaging
IDx Technologies announced June 25 that the American Medical Association has accepted a new category 1 CPT code for automated point-of-care retinal imaging, which will cover exams with the IDx-DR s...
BioTime Initiates Dosing in Phase I/IIa Study of OpRegen for Dry AMD Using Orbit Subretinal Delivery System
BioTime announced July 11 that it had dosed its first patient with the Orbit Subretinal Delivery System—as well as with a new “thaw-and-inject” formulation of OpRegen, the company’s retinal pigment...
BioTime Sells Shares in OncoCyte to Fund Cell Therapy Candidates, Including OpRegen
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BioTime announced July 2 that it planned to raise $4.5 million to advance its cell therapy candidates, including OpRegen, through the sale of 2.25 million shares of common stock in OncoCyte Corp. a...
Clearside, Aura Enter Licensing Deal for Microinjector to Deliver Ocular Oncology Drugs to SCS
Clearside Biomedical announced June 9 that it had reached a worldwide licensing agreement with Aura Biosciences for the use of Clearside’s Suprachoroidal Space (SCS) Microinjector to deliver Aura’s...
Eyenovia Hopes to Raise $12.2 Million in Public Offering to Advance MicroProst, MicroPine
Eyenovia priced an underwritten public offering of 4,388,490 shares of its common stock at $2.78 per share. The New York company said July 11 that it intends to use the net proceeds and other avail...
Past News Stories
Horizon Therapeutics Submits BLA for Teprotumumab to Treat Active Thyroid Eye Disease
Horizon Therapeutics, of Ireland, announced July 10 that it had submitted a biologics license application (BLA) to the US FDA for teprotumumab for the treatment of active thyroid eye disease. Tepro...
Hoya Obtains CE Marking for Nanex MultiSert+ IOL Delivery System
Hoya Surgical Optics announced July 1 that it had obtained CE marking for its Nanex multiSert+, a new IOL delivered in a first-of-its kind preloaded delivery system. The company says the 1.62 mm in...
Nicox Receives $3 Million Milestone Payment from Eyevance for Zerviate in the US
Nicox, of France, announced July 9 that it had received a $3 million milestone payment from partner Eyevance Pharmaceuticals, triggered by the completion of regulatory and manufacturing activities ...
Oxurion Reports Positive Topline Phase I Trial Results for THR-149 in DME
Oxurion NV reported on July 1 positive topline data from a Phase I study of THR-149, its plasma kallikrein (PKal) inhibitor, as a treatment for diabetic macular edema (DME). THR-149 is being develo...
SparingVision Awarded $2.8 Million by EIC Accelerator Program
SparingVision, of France, announced July 9 that it has been awarded $2.8 million (€2.5 million) through the European EIC Accelerator program. SparingVision, a spinoff of the Paris Vision Institute,...
Zeiss Receives FDA Clearance for Clarus 700 Ultra-Widefield Imaging Device
Carl Zeiss Meditec announced July 8 that it had received US FDA 510(k) clearance for the Clarus 700 high-definition, ultra-widefield imaging system. The company said this enhanced version of the 50...
Orthopedic US FDA 510(k) Clearances
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During the past month, 44 orthopedic devices have received FDA clearance. Roughly one-third of the devices were spine implants. Six of the spine devices cleared were for fixation. Lifespine receive...
Knee Surgeons Rate Availability of Revision Model as Most Important Implant Feature
In a Q1-2019 survey, Market Scope asked knee surgeons to rate the importance of several knee implant features on a scale of 1 to 5, with 5 being most important. Seventy-five percent of surgeon part...
Monthly Deals
Between May 15 and June 15, there were three notable acquisitions and one extended Series D financing round that took place. Two companies completed acquisitions to round out foot and ankle offerin...
Judge Rules in Favor of US FDA in Bid to Crack Down on Stem Cell Clinics
Judge Ursula Ungaro ruled in favor of the US FDA on June 3 in a lawsuit against a Florida-based stem cell clinic whose treatments have blinded at least three patients. Ungaro agreed that the FDA ha...
Spine Biologics Market Growing 4.9 Percent Through 2024
The current spine biologics market will average nearly 5 percent annual growth over the next five years, and the landscape of products is continually shifting. Autograft and allograft bone—bone har...
New EU Regulations Spark Debate at EFORT 2019
More than 6 thousand orthopedic surgeons assembled at the European Federation of National Associations of Orthopaedics and Traumatology’s (EFORT) 20th Annual Congress June 4-8 in Lisbon, Portugal. ...
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