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10/11/2018
orthopedicpress release
Market Scope Announces Launch of New Website and Entry into Orthopedics

Market Scope, an industry leader for ophthalmic market research, announced today the launch of its new website and the firm’s entry into orthopedics, its second medical vertical. The new Market-Sco...

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1/18/2019
breakingophthalmic
US FDA Accepts IND Application for Aerie’s AR-1105, a Dexamethasone Intravitreal Implant

The US FDA has approved Aerie Pharmaceuticals’ investigational new drug (IND) Application for AR-1105 (dexamethasone intravitreal implant) for macular edema due to retinal vein occlusion (RVO), the...

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1/18/2019
breakingophthalmic
Glaukos Moving to Aliso Viejo from San Clemente

Glaukos will move its headquarters in May to Aliso Viejo, California, from San Clemente, California, according to an SEC filing. The company will lease three existing office buildings in Aliso Viej...

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1/18/2019
breakingophthalmic
Ocular Therapeutix Seeks to Expand Dextenza’s Indication

Ocular Therapeutix has submitted a supplemental new drug application (sNDA) to the US FDA for Dextenza, the Bedford, Massachusetts, company announced Jan. 10. The sNDA seeks to expand the product’s...

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1/18/2019
breakingophthalmic
Aerpio Completes Patient Dosing in Phase IIb Study for Diabetic Retinopathy Candidate

Aerpio Pharmaceuticals has completed patient dosing in its Phase IIb clinical trial of AKB-9778 for severe nonproliferative diabetic retinopathy (NPDR), the Cincinnati company announced Jan. 17. AK...

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1/18/2019
breakingophthalmic
FDA Accepts Xbrane’s Application to Begin Study of Xlucane, a Biosimilar of Lucentis

Xbrane reported Jan. 18 that the US FDA accepted the company’s application for a pivotal Phase III trial of Xlucane as a biosimilar to Lucentis in patients with wet age-related macular degeneration...

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1/18/2019
breakingophthalmic
Akorn Receives US FDA Warning Letter Citing Plant Violations

Akorn has received a warning letter from the US FDA after an inspection of its Decatur, Illinois, manufacturing plant, the Lake Forest, Illinois, company announced Jan. 9. The warning letter lists ...

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1/18/2019
newsletterorthopedic
Flexion Announces Positive Results for Phase II Trial of Zilretta

Massachusetts-based Flexion Therapeutics announced Jan. 2 that its Phase II pharmacokinetic study of Zilretta for OA of the shoulder and hip achieved positive results. Zilretta is the only extended...

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1/18/2019
newsletterorthopedic
Thirty-year Data for Lumbar Fusion With Silicon Nitride

SINTX Technologies announced Jan. 3 that independent research indicated positive 30-year results for silicon nitride implants used for lumbar fusion. The study was led by Ralph Mobbs, MD, and resul...

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1/18/2019
newsletterorthopedic
Miach Appoints Shadan President and CEO

Miach Orthopedics, based in Massachusetts, announced Martha Shadan as its new president and CEO on Jan. 3. Shadan has served as executive chairwoman since September 2018. Before joining Miach, Shad...

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1/18/2019
newsletterorthopedic
Factory-CRO Group and Boston Biomedical Merge

Netherlands-based Factory-CRO Group and Boston Biomedical Associates announced their merger on Jan. 7. Factory-CRO Group recently completed acquisitions of MileStone Research Organization, Five Cor...

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1/18/2019
newsletterorthopedic
Study Compares InSpace Balloon to Superior Capsular Reconstruction

A recent cadaveric study compared OrthoSpace Ltd’s InSpace balloon spacer to superior capsular reconstruction for massive rotator cuff tears (RCTs). Israel-based OrthoSpace announced Dec. 19 that t...

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Past News Stories

1/15/2019
newsletterorthopedic
Orthopedic US 510(k) Clearances

There were 66 US FDA regulatory clearances in the past 30 days. Forty-five percent of these clearances were for spinal implants. Spine fixation devices included three cervical plates from Atlas Spi...

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1/15/2019
orthopedic
Global Demand for Spine Surgery Growing With Access to Care

Global demand for spine surgery is expected to grow at a compound annual rate of 9.7 percent from 2018 to 2023, with annual surgical volume increasing from 3.6 million to 4.3 million procedures. De...

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1/15/2019
newsletterorthopedic
Double-Network Hydrogel Shows Promise for Meniscus Repair

Doctors have long sought a solution for meniscal tears. A new compound may solve issues faced by current treatment methods. The fibrocartilage of the meniscus is crucial for shock absorption and st...

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1/15/2019
newsletterorthopedic
Monthly Fundraising

The overall value of the orthopedic market increases when companies obtain money from outside sources such as public market fundraising or grants. The goal of this feature is to track the influx of...

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1/14/2019
newsletterorthopedic
Chinese Policy Changes

Made in China 2025 is a strategic, 10-year plan that began in 2015 with the goal of increasing the Chinese-made content of certain domestic products to 40 percent by 2020 and 70 percent by 2025. Th...

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1/14/2019
newsletterorthopedic
Overhaul of 510(k) Pathway Aims to Support Modern Technology and Patient Safety

Scott Gottlieb, MD, and the director of the Center for Devices and Radiological Health (CDRH), Jeff Shuren, MD, announced plans on Nov. 26 to revise the 510(k) process, which is part of the FDA’s M...

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1/14/2019
newsletterorthopedic
Neurostimulation for Spinal Fusion

A relatively common cause of spinal fusion failure is non-union, or pseudarthrosis. Approximately half of fusion revisions are due to pseudarthrosis. Electrostimulation may be an appropriate treatm...

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1/14/2019
newsletterorthopedic
Trends in Pediatric Opioid Use

Opioids are effective analgesics, but they are also highly addictive and have resale value, which invites abuse. One segment of opioid users that is not commonly evaluated is the pediatric populati...

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1/14/2019
newsletterorthopedic
Is Outpatient Joint Replacement Surgery More Than an Aspiration?

The US Centers for Medicare and Medicaid Services (CMS) removed total knee replacement surgery from its inpatient-only list in 2018 to encourage outpatient surgery. A similar ruling for total hip a...

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1/11/2019
breakingophthalmic
Oculis Raises $15.8 Million in Series B Extension, Licenses Ophthalmic Candidate from Novartis

Oculis announced Jan. 4 that it has raised CHF15.5 million ($15.8 million) in an extension of its Series B financing—bringing the total raised in the round to CHF35.5 million ($36.2 million). Oculi...

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1/11/2019
newsletterorthopedic
Smith & Nephew Acquires Ceterix

London-based Smith & Nephew announced Dec. 18 that it has acquired Ceterix Orthopaedics for up to $105 million ($50 million up front and $55 million installments based on performance). Ceterix deve...

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1/11/2019
breakingophthalmic
Kala Launches Inveltys, Hires Ophthalmology Sales Organization

Kala Pharmaceuticals has launched Inveltys, a twice-daily ocular corticosteroid indicated for the treatment of postoperative inflammation and pain, the Waltham, Massachusetts company announced Jan....

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