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Orthopedic US FDA 510(k) Clearances

One of the most anticipated FDA clearances of the month came from Zimmer Biomet, with the clearance of its Rosa One spine application. This clearance will allow the Rosa—which has recently been cle...

Ellex Appoints Gerald Wallace as CEO

Ellex Medical Lasers announced April 8 that it has appointed Gerard Wallace as chief executive officer. Wallace replaces Tom Spurling, the company’s CEO for eight years. Spurling resigned but will ...

Monthly Orthopedic 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 these fundrai...

Ocugen, Histogenics Agree to Reverse Merger

Privately held Ocugen will become a public company in a reverse merger with orthopedics company Histogenics, the two announced April 8. The combined entity will use Ocugen’s name and headquarters i...

Tranexamic Acid (TXA) Gains Clinical Support

Tranexamic acid (TXA) is now receiving attention in the US and Europe, nearly 50 years after its invention. TXA is a synthetic lysine analog that was invented in 1962 by Utako Okamoto and her husba...

NGM to Raise Potential $176.5 Million in IPO, Private Placement

NGM Biopharmaceuticals announced April 3 that it sold 6.7 million shares at $16, the top of its range, in its initial public offering. The South San Francisco, California, company’s pipeline includ...

Deepmind Officials Demonstrate AI-Powered Retinal Diagnostic Device Candidate

Google’s Deepmind artificial intelligence (AI) business unit gave a live demonstration of its candidate for a retinal diagnostic device in April at London’s Francis Crick Institute. Deepmind offici...

Bluejay Gains CE Marking for Allergic Conjunctivitis Test

Bluejay Diagnostics has gained CE marking for its Allereye Tear Total IgE Test, a point-of-care device designed to aid in the diagnosis of allergic conjunctivitis. The Acton, Massachusetts, company...

Clearside Appoints George Lasezkay as Interim CEO

Clearside Biomedical has appointed George Lasezkay, PharmD, JD, as interim CEO, the Alpharetta, Georgia, company announced April 8. Lasezkay replaces Daniel H. White, who resigned to pursue other o...

Roche Extends Deadline for Spark Tender Offer

Roche announced April 3 that it has extended the deadline for its tender offer for shares of Spark Therapeutics. The offer now runs through the end of May 2. It was set to expire April 3. Spark agr...

Nearly 15 Thousand Registrants Attend AAOS 2019

Nearly 15 thousand registrants attended the 2019 AAOS annual meeting in Las Vegas. The majority of attendees were AAOS members, and over 3,500 international surgeons attended. Thousands of exhibito...

FDA Chief Scott Gottlieb, MD, Announces Resignation

US FDA Chief Scott Gottlieb, MD, is resigning and will leave the agency in April, the Department of Health and Human Services announced March 5. Gottlieb, who has led the agency for nearly two year...

Improved Premium IOLs will Drive Growth in the Global IOL Market over the Next Five Years

Innovation in premium lens technology will fuel patient demand in the global intraocular (IOL) lens market over the next five years. The improved technology will provide better visual outcomes with...

Aura Closes $40 Million Series D Financing

Aura Biosciences has closed a $40 million Series D financing. The Cambridge, Massachusetts, company said April 2 that it would use the funding to support late-stage clinical development of its lead...

Bausch + Lomb Launches Lotemax SM for Post-surgery Inflammation, Pain

Bausch + Lomb reported April 2 that it has launched Lotemax SM, a new gel formulation for inflammation and pain following ocular surgery. The company, a division of Bausch Health, gained US FDA app...

Allergan’s Abicipar Shows Lower Inflammation Rate in New Wet AMD Study

Allergan reported April 2 that manufacturing changes have decreased inflammation in patients treated with abicipar. Incidence of intraocular inflammation in a new MAPLE study in wet age-related mac...

Fera Gains US FDA Approval for Avaclyr for Herpetic Keratitis

Fera Pharmaceuticals announced April 1 that the US FDA has approved Avaclyr for the treatment of herpetic keratitis. The New York company also gained orphan drug exclusivity, providing seven years ...

Outlook to Begin Enrolling US Patients in Study of Bevacizumab Formulation in Wet AMD

Outlook Therapeutics announced April 1 that the company will begin enrolling patients in the US portion of its Phase III trial of ONS-5010 after getting the green light from the US FDA. Enrollment ...

Aldeyra’s Reproxalap Meets Endpoints in Phase III Trial in Allergic Conjunctivitis

Aldeyra Therapeutics reported March 26 its Phase III trial of topical reproxalap in patients with allergic conjunctivitis met its primary endpoint and key secondary endpoint at two concentrations. ...

Polar3 Achieves Positive Results in Restrospective Study

On March 13, Smith & Nephew announced a retrospective analysis of the UK’s National Joint Registry (NJREW). The company analyzed the survivorship of its Polar3 total hip solution and found a 7-year...

Weber Is First Female President of AAOS

Kristy Weber, MD, became the first female president of the American Academy of Orthopaedic Surgeons (AAOS) on March 15 during the organization’s annual meeting in Las Vegas. She served as vice pres...

Corin Acquires OMNI

UK-based Corin Group acquired US-based OMNI Orthopaedics, the company announced March 13. OMNI produces the OMNIBotics imageless TKA system. The device combines a robotic cutting guide with a ligam...

HydroCision Appoints Tranchemontagne CEO

Announced March 15, HydroCision has appointed Alain Tranchemontagne as its new CEO. HydroCision manufactures bone and soft tissue cutting devices that use high-velocity water jets. Tranchmontagne h...

ReNu Outperforms Hyaluronic Acid in Study

Organogenesis announced March 12 the results of its clinical trial for ReNu, a human-derived amniotic for the treatment of knee osteoarthritis. The trial showed that ReNu was superior to hyaluronic...

Stryker Acquires Orthospace

Styker announced March 14 that it has acquired Israel-based OrthoSpace for up to $220 million; half of the payment will be made up front. The acquisition will complement Stryker’s sports medicine p...

Alcon Spin-off Set for April 9

Novartis has announced the date of its planned spin-off of Alcon, its eye care division. The move will happen April 9, the Swiss company said March 22. Alcon will be listed on the New York Stock Ex...

Allergan Agrees to Split Chairman, Executive Roles at Next Leadership Transition

Allergan has agreed to split its chairman and executive roles at the next leadership transition, according to an SEC filing March 22. Brent Saunders, 49, currently serves as chairman, president, an...

Promimic Partners With Onkos

Promimic, the Swedish maker of the HAnano orthopedic implant coating, announced March 15 that it is entering a partnership with New Jersey-based Onkos Surgical. Promimic’s coating will be applied t...

Revex Granted FDA Fast-Track Designation

The US FDA granted fast-track designation to Purdue Pharmaceutical’s Revex (injectable nalmefene) on March 13. Purdue is also the maker of OxyContin, a primary target in the opioid epidemic. Nalmef...

Smith & Nephew Acquires Brainlab’s Orthopedic Reconstruction, Brainlab Acquires Medineering

Smith & Nephew announced March 12 that it has entered a definitive agreement to acquire Brainlab’s orthopedic reconstruction business. This acquisition will include hip and knee navigation, augment...

Smith & Nephew Acquires Osiris

Smith & Nephew announced March 12 that it will acquire Osiris Therapeutics. The cash deal is expected to equal $660 million. Smith & Nephew will add some key biologic products to its portfolio from...

THINK Collaborates With United for TKA Marketing

THINK Surgical and United Orthopedic Corporation announced March 13 that they are going to collaboratively market total knee replacement products. THINK Surgical is the California-based manufacture...

EyePoint Announces Pricing of $20 Million Public Offering

EyePoint Pharmaceuticals has announced the pricing of a public offering of 10.5 million shares of its common stock at $1.90 per share. The gross proceeds are expected to total about $20 million. Th...

Optovue Launches AngioWellness Patient-Monitoring Technology at Vision Expo East

Optovue unveiled its new AngioWellness patient-monitoring software to optometrists in March at Vision Expo East in New York. AngioWellness is designed to provide one efficient report combining stru...

HSS Study Identifies Undiagnosed Osteoporosis, Osteopenia in Spine Fusion Candidates

The Hospital for Special Surgery in New York City conducted a study measuring bone quality in patients undergoing spine fusion surgery. Using quantitative computed tomography (QCT) prior to surgery...

FDA Addresses Metal-on-Metal Hip Safety Concerns

The FDA issued a statement March 15 that new guidance will soon be released to address adverse reactions to medical device materials. One of the main concerns is the use of metal-on-metal hip impla...

Pacira Acquires Myoscience for up to $220M

Myoscience reported March 5 that it will be acquired by Pacira Pharmaceuticals. Myoscience’s iovera° cryoneurolysis system will become part of Pacira’s non-opioid pain management portfolio. Per the...

Medacta, Geisinger Partner for Lifetime Guarantee on Knee Replacement

Medacta International and Geisinger announced March 13 that they are launching a pilot program for lifetime-guaranteed knee replacements, following the successful launch of a similar program for hi...

Humana Launches Bundled Payment for Spine Fusion and Expands Program for THA, TKA

Humana reported March 12 that it is expanding its value-based orthopedic specialty care for Medicare Advantage members. First, it is launching a spinal fusion episode-based model that offers additi...

Exactech Acquires XpandOrtho

Florida-based Exactech announced March 12 that it acquired XpandOrtho for an undisclosed amount. Exactech produces bone and joint devices and biologics, along with computer-assisted surgery technol...

Axolotl Research Points to Spinal Cord Regeneration Possibilities

Researchers from the Marine Biological Laboratory published results in Nature Communications Biology on March 6 on axolotl genes that control spinal cord regeneration. After trauma, the gene c-Fos ...

Yale Study Shows Conformis Custom Implants Save Money

Conformis, maker of the iTotal PS and iTotal CR knee implants, reported results of a study from the Yale School of Medicine and Baker Tilly Virchow Krause on Feb. 19. The researchers found that the...

SWORD Health Publishes Positive Results for AI-Driven PT

A pair of studies published in Nature Scientific Reports and Journal of Medical Internet Research within the last 12 months reported superior results for SWORD Health’s AI-driven physical therapy p...

Aerie Begins Phase II Study of AR-1105 for ME Associated with RVO

Aerie Pharmaceuticals has begun patient dosing in a Phase II clinical trial of AR-1105, its investigational dexamethasone implant, in patients with macular edema due to retinal vein occlusion, the ...

Coolief Trial Yields Positive Results

A prospective, randomized, multi-center trial with 177 patients was sponsored by Avanos Medical, the maker of Coolief, a cooled radiofrequency (RF) nerve ablation system. The study compared Coolief...

Aerpio’s Lead Candidate for Diabetic Retinopathy Fails in Phase IIb Study

Aerpio Pharmaceuticals’ lead candidate, AKB-9778, failed to meet its primary endpoint in a Phase IIb study for moderate to severe nonproliferative diabetic retinopathy (NPDR), the Cincinnati compan...

Bascom Palmer’s Wei Li Receives $9.12 Million NEI Grant to Develop Antibody for ROP

Wei Li, PhD, of the Bascom Palmer Eye Institute has received a $9.12 million National Eye Institute (NEI) grant to develop a drug to protect infants from retinopathy of prematurity (ROP), the Unive...

Laser Spine Institute Closes Permanently

Tampa-based Laser Spine Institute closed its doors March 1. The company provided minimally invasive decompression and stabilization spine surgery in Tampa, Cincinnati, Scottsdale, and St. Louis. Th...

Myoscience Updates iovera° System

Myoscience announced Feb. 26 that it is launching the iovera° Smart Tip 309. The iovera° cryoneurolysis system uses liquid nitrous oxide (N2O) to generate temperatures of -88°C and 55 to 90 mm need...

Seikagaku, Ono Publish Phase III Clinical Results for Knee OA Drug

Positive results were reported Feb. 19 from a Phase III clinical trial for the hyaluronic acid (HA) and NSAID combination drug ONO-5704/SI-613. The product was developed through a collaboration bet...

Ophthalmic Company Revenues Increase 4.7 Percent in Q4-2018

Public company reports are in for Q4-2018, and overall ophthalmic revenues totaled $8.9 billion, an increase of 4.7 percent over the same quarter last year. The total includes Market Scope estimate...

Surgeons Report 4.2 Percent Growth in US Ophthalmic Procedure Volume in Fourth Quarter

US ophthalmologists reported that ophthalmic procedures increased 4.2 percent in Q4-2018 compared with the same quarter last year, according to Market Scope’s latest surveys. Growth was sporadicall...

India Honors Ophthalmic Heritage, Unveils Ambitious New Goal in DR

The All India Ophthalmological Society (AIOS) celebrated 200 years of Indian ophthalmology at its 77th annual conference, which was held Feb. 14-17 in Indore, India. Prof. S. Natarajan, MD, the new...

Manual Small Incision Cataract Surgery Travels from India to America

Daniel Hutter, MD (US), told attendees at the All India Ophthalmological Conference (AIOC) in Indore how the Bascom Palmer Eye Institute started teaching manual small incision cataract surgery (MSI...

Roche to Acquire Spark Therapeutics for $4.8 Billion

Roche will acquire Spark Therapeutics for $4.8 billion, paying a price of $114.50 per share, in an all-cash transaction, the companies announced Feb. 25. The move build’s on Roche’s hemophilia prog...

China’s Crackdown on Health Agencies Opens Door for Global Ophthalmic Firms

China's massive overhaul of its health agencies is continuing the Communist Party's push to open the country to more health care therapies and technologies. The move is creating new opportu...

Alcon Acquires PowerVision for $285 Million, Plus Potential Milestone Payments

Alcon has acquired PowerVision for an upfront payment of $285 million, Novartis announced March 18. Alcon also agreed to make additional payments based on regulatory and commercial milestones start...

Eurazeo Acquires DORC from Montagu for €300 Million

Paris-based Eurazeo Capital has agreed to acquire Dutch Ophthalmic Research Center (DORC) from Montagu Private Equity, of London, for nearly €300 million ($339 million), the companies announced Mar...

FDA Approves Aerie’s Rocklatan for Open-Angle Glaucoma, Ocular Hypertension

The US FDA has approved Aerie Pharmaceuticals’ Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or o...

FDA Chief Scott Gottlieb, MD, Announces Resignation, Will Leave Post in April

US FDA Chief Scott Gottlieb, MD, has announced that he is resigning and will leave the agency in April, the Department of Health and Human Services announced March 5. Gottlieb, who has led the agen...

Oncologist Ned Sharpless, MD, to Serve as Acting FDA Commissioner

Oncologist Norman “Ned” Sharpless, MD, will serve as acting commissioner of the US FDA after Scott Gottlieb, MD, steps down in April, US health secretary Alex Azar announced March 12. Azar said the...

EyePoint Launches DEXYCU in the US for Postoperative Inflammation

EyePoint Pharmaceuticals announced March 12 that is has launched DEXYCU in the US for intraocular treatment of postoperative inflammation. DEXYCU (dexamethasone intraocular suspension) 9% is admini...

Ascendis Pharma Leads Latest Fundraising Efforts with $400 Million Financing

Ascendis Pharma led recent fundraising efforts by ophthalmic companies, recently raising $400 million. Other firms with financing deals included Oyster Point Pharma, which raised $93 million in a S...

University Claims Ex-Professor Stole Grad Student’s Ophthalmic Formulation

The University of Missouri alleges in a lawsuit filed Feb. 26 that a former pharmacy professor at its Kansas City campus stole a student’s ophthalmic drug research and sold it secretly to a drug co...

Market Scope Weekly Ophthalmic Surgeon Polls for March 2019

Market Scope Weekly Surgeon Poll for Feb.18-24, 2019

March 2019 Ophthalmic News Briefs

Ipsen to Acquire Clementia, Dry Eye Candidate, for $1 Billion Ipsen has agreed to acquire Clementia Pharmaceuticals, including its ophthalmic candidate for dry eye, for $1.04 billion, the companies...

FDA Approves Aerie’s Rocklatan for Open-Angle Glaucoma, Ocular Hypertension

EyePoint Launches DEXYCU in the US for Postoperative Inflammation

Carl Zeiss Meditec Gains US Clearance for CIRRUS HD-OCT Enhancement

Carl Zeiss Meditec announced March 7 that it has received US FDA 510(k) clearance for new software for its CIRRUS HD-OCT platform that adds epithelial thickness mapping capability to its Anterior S...

US Orders Guardian to Stop Compounding Drugs

The US FDA announced March 13 that a federal court has stopped Guardian Pharmacy Services of Dallas from compounding drugs. The government alleges that Guardian has been manufacturing drugs that ar...

Genentech-backed Study Found AI Can Detect DME Severity from Color Fundus Photos

Artificial Intelligence (AI) can detect the severity of diabetic macular edema (DME) through analysis of color fundus photographs, a Genentech-backed study found. Genentech said the study suggests ...

Harrow Health Reports 2018 Revenues of $41.4 Million

Harrow Health, formerly Imprimis Pharmaceuticals, announced March 12 that its total revenues for 2018 were $41.4 million, a 55 percent increase over the 2017 total of $26.8 million. The San Diego c...

Eurazeo Acquires DORC from Montagu for $339 Million

Paris-based Eurazeo Capital has agreed to acquire Dutch Ophthalmic Research Center (DORC) from Montagu Private Equity, of London, for $339 million (nearly €300 million), the companies announced Mar...

Q BioMed Licenses Biomarker for Glaucoma from Washington University

Q BioMed has agreed to exclusively license a biomarker for glaucoma from Washington University in St. Louis, the New York-based company announced March 11. The biomarker, growth differentiation fac...

ProQR Doses First Patient in Phase I/II Trial of QR-421a for Usher Syndrome Type 2

ProQR Therapeutics announced March 11 that is has dosed the first patient in STELLAR, its Phase I/II clinical trial of QR-421a for patients with Usher syndrome type 2 or non-syndromic retinitis pig...

Second Sight Reports 69 Argus II Implantations in 2018

Second Sight reported March 13 that ophthalmologists implanted 69 Argus II retinal prostheses in 2018. The implant is designed for patients with retinitis pigmentosa. Surgeons implanted 16 prosthes...

Three Companies Create Venture to Integrate Platforms

Rothman Orthopaedics, NueHealth, and Muve Health announced Feb. 19 that they have agreed to integrate their platforms and expand beyond the Philadelphia area. Rothman is an orthopedic group practic...

Implanet Partners With SeaSpine in US

French company Implanet announced Feb. 21 that its Jazz spine portfolio will be distributed in the US by SeaSpine. Under the Private Label Distribution Agreement, SeaSpine will have exclusive right...

PrinterPrezz Partners With SI-Bone

PrinterPrezz disclosed Feb. 12 that it has entered a customer agreement with SI-Bone to provide development services for 3D-printed devices and implants. SI-Bone is well known for its iFuse Implant...

Philips Releases Zenition

Philips announced Feb. 18 that it launched the Zenition mobile C-arm imaging platform, which will reach US, Austrian, German, and Swiss markets in Q1-2019. Zenition is smaller than other C-arm plat...

Biogen to Acquire Nightstar, Ophthalmic Gene Therapy Candidates for $877 Million

Biogen has agreed to acquire Nightstar Therapeutics and its ophthalmic gene therapy candidates for $877 million, Nightstar announced March 4. Biogen, a Massachusetts-based company focused on neurol...

Outlook Therapeutics Seeks to Raise $50 Million to Fund Phase III Trials for Ophthalmic Bevacizumab Candidate

Outlook Therapeutics (formerly Oncobiologics) has filed a prospectus for a $50 million common stock offering, according to SEC documents filed March 7. The offering is for 47.6 million shares price...

MacuLogix Raises $38.7 Million in Series D Round

MacuLogix announced March 4 that is has completed a $38.7 million Series D financing. The company’s AdaptDx automated dark adaptometer is designed to help doctors detect, monitor, and treat age-rel...

Ascendis Pharma Announces $400 Million Public Offering

Ascendis Pharma has started a public offering of $400 million American depositary shares (ADSs), each representing one Ascendis share, the company announced March 4. The Danish biopharmaceutical co...

FDA Chief Scott Gottlieb Announces Resignation, Will Leave Post in April

Retinal Scientist Vladimir Kefalov, PhD, Receives 2019 Bressler Prize

Retinal scientist Vladimir Kefalov, PhD, is the recipient of the 2019 Bressler Prize for outstanding advances in vision science research, Lighthouse Guild announced March 7. The annual award honors...

Omeros’ Revenues Reach $22 Million for Q4-2018

Omeros’ revenues for Q4-2018 totaled $22 million, the Seattle firm reported March 1. The fourth quarter was the company’s highest revenue quarter to date. Omeros recorded Q3-2018 revenues of $4.6 m...

Researchers Give Mice Infrared Vision

Scientists have generated infrared vision in mice without affecting their normal vision and with negligible side effects, according to research published Feb. 28 in the journal Cell. The work was l...

Horizon’s Phase III Trial of Teprotumumab in Active Thyroid Eye Disease Meets Primary Endpoint

Dublin-based Horizon Pharma announced Feb. 28 that its Phase III trial of teprotumumab for the treatment of active thyroid eye disease met its primary endpoint. Teprotumumab is a fully human monocl...

Xbrane to Use $6.37 Million in Proceeds from Rights Issue in Support of Lucentis Biosimilar

Xbrane Biopharma will use $6.37 million from a fully guaranteed rights issue to support Xlucane, a biosimilar candidate to Lucentis, the Swedish company announced Feb. 25. Xbrane reported it will c...

Neuromodulation Remains Fastest-Growing Spine Surgery Market

The concept of using electrical impulses to treat pain has existed for millennia. Modern neuromodulation—including spinal cord stimulation—got its clinical start in the 1960s and 1970s. Adoption of...

Global Demand for Spine Surgery Grows With Access to Care

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

Orthopedic US FDA 510(k) Clearances

This feature focuses on US FDA 510(k) clearances, but it is worth noting that Spinal Kinetics received premarket approval (PMA) for its M6-C cervical disc replacement on Feb. 6. Spinal Kinetics was...

APSS, APPOS Expect Over 600 Attendees

The Asia Pacific Spine Society (APSS) is the spine section of the Asia Pacific Orthopaedic Association (APOA). The APSS holds a joint meeting every other year with the Asia Pacific Paediatric Ortho...

Vegas to Host 2019 AAOS Annual Meeting

The 2019 annual meeting of the American Academy of Orthopedic Surgeons (AAOS) will take place March 12-16 in Las Vegas, Nevada. AAOS hosts the largest orthopedic meeting in the world; last year’s a...

Monthly Orthopedic Fundraising

Orthopedic Earnings Rise 2 Percent in Q4-2018

Most public company reports are available for Q4-2018. Overall orthopedic revenues, including Market Scope estimates for private companies, were up 2 percent to $11.4 billion compared to Q4-2017. T...

Knee Replacement Demand Is Growing Worldwide

Approximately 40 percent of the global population over age 55 experience chronic knee pain. This pain is often due to osteoarthritis (OA), a condition characterized by cartilage destruction, subcho...

Growth Factors Still Considered Effective

Biologic products are frequently used in orthopedic procedures to fill bone voids or aid fusion. They can be used in place of autograft, thus preventing the need for a second surgical site to harve...

Roche to Acquire Spark Therapeutics for $4.8 Billion

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