NeuroOne begins shipping 30-day sEEG electrodes to Zimmer Biomet

The NeuroOne Evo sEEG [Photo courtesy of NeuroOne]NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that shipped its first commercial order in an agreement with Zimmer Biomet (NYSE:ZBH).

Zimmer Biomet holds an exclusive development and distribution agreement with NeuroOne for its thin film technology. It already sells NeuroOne’s earlier cortical strip and grid electrode devices. Over a year ago, Zimmer Biomet placed initial stocking orders with NeuroOne to sell the Evo sEEG device to neurosurgeons.

Zimmer paid $3.5 million to NeuroOne under the deal in August. That came after an up-front payment of $2 million in 2020.

“This shipment represents a monumental accomplishment for the company,” said NeuroOne CEO Dave Rosa. “Without the persistence of our staff and manufacturing partners, we could not have reached this point. We look forward to commercialization of this exciting technology in the future in partnership with Zimmer Biomet…

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Zimmer Biomet’s 3D-printed tibia receives FDA clearance

The Persona OsseoTi Keel Tibia. [Image from Zimmer Biomet]Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for the Persona OsseoTi Keel Tibia.

Warsaw, Indiana-based Zimmer Biomet designed the system for cementless knee replacement. It represents the latest addition to the Persona Knee system platform.

Persona OsseoTi features a new porous version of the Persona anatomic tibia. It includes the Zimmer Biomet OsseoTi porous medical technology. That uses anatomical data with 3D printing technology.

The technology helps to build a structure that directly mimics the architecture of human cancellous (spongey) bone. Combined with a keeled design, it delivers stable initial and biological fixation, according to Zimmer Biomet.

Clearance helps Zimmer Biomet “close out the year” strong

“With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-lea…

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Zimmer Biomet stock ticks up on Street-beating Q3, increased guidance

Zimmer Biomet (NYSE:ZBH) shares rose this morning on third-quarter results that topped the consensus forecast.

Shares of ZBH ticked up 1.3% at $113.25 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — increased by 1.4%.

The Warsaw, Indiana-based orthopedic device maker posted profits of $194 million for the quarter. That amounts to 92¢ per share on sales of $1.67 billion for the three months ended Sept. 30, 2022.

Zimmer Biomet recorded a 33.2% bottom-line gain on a sales decline of 0.9%. The company’s knee and hip businesses both saw marginal sales increases (1.4% and 3.1%, respectively).

Meanwhile, sports medicine, extremities, trauma, craniomaxillofacial and thoracic (S.E.T.) sales decreased 6.4%, and the “other” category dropped 7.2%, contributing to the overall sales dip.

Adjusted to exclude one-time items, earnings pe…

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FDA clears NeuroOne’s Evo sEEG electrode for 30-day use

The Evo sEEG uses NeuroOne’s hi-definition thin-film electrodes technology. [Photo courtesy of NeuroOne]NeuroOne today announced it received expanded FDA 510(k) clearance to market its Evo sEEG Electrode technology for temporary use with brain recording, monitoring and stimulation equipment.

Eden Prairie, Minnesota-based NeuroOne previously announced it resubmitted its 510(k) application for up to 30-day use. The resubmission included additional biocompatibility testing as requested by the FDA.

The new FDA clearance covers temporary use for up to 30 days with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

“I am extremely proud of the entire NeuroOne team and their relentless pursuit of this clearance. Despite the challenges we faced, our team remained focused and persistent in driving this successful conclusion. This is clearly our most exc…

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Zimmer Biomet wins FDA clearance for shoulder replacement system

Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for its Identity shoulder system.

Warsaw, Indiana-based Zimmer Biomet designed Identity for anatomic, reverse and revision shoulder replacement.

Identity is a convertible system that uses proprietary technologies, the company said. It aligns each surgeon’s approach to individual patient anatomy to alleviate pain and optimize range of motion. Zimmer Biomet said it designed Identity to allow surgeons to devise and execute patient-specific plans precisely.

“The FDA clearance of the Identity Shoulder System is exciting because it offers surgeons a highly adaptable solution for anatomic, reverse and revision procedures to help patients optimize natural shoulder movement,” said Ivan Tornos, COO at Zimmer Biomet. “This significant milestone adds to progress in our growing sports medicine, extremities and trauma (S.E.T.) portfolio, a critical area of focus as w…

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Zimmer Biomet, Surgical Planning partner on total hip replacement

[Image from Surgical Planning]Zimmer Biomet (NYSE:ZBH) announced today that it signed an exclusive, multi-year co-marketing agreement with Surgical Planning.

Warsaw, Indiana-based Zimmer Biomet’s agreement with Surgical planning centers around the commercialization of Surgical Planning’s HipInsight.

HipInsight is the first FDA-cleared, mixed-reality navigation system for total hip replacement. It is customized for Zimmer Biomet’s hip implant portfolio, according to a news release. It allows surgeons to use Microsoft HoloLens 2 glasses to visualize a hologram of the patient’s pelvic anatomy during surgery.

Zimmer Biomet said that HipInsight expands the capabilities of its ZBEdge suite of integrated smart, digital and robotic technologies. The company added HipInsight to its OptiVu mixed reality portfolio of applications.

“The addition of HipInsight to our mixed reality portfolio advances our commitment to transform the su…

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Zimmer Biomet loses appeal on $3.5M hip implant suit verdict

[Image from Unsplash]A U.S. Court of Appeals denied an appeal from Zimmer Biomet (NYSE:ZBH) to move to a new trial after a $3.5 million hip implant lawsuit verdict.

In 2020, a federal jury in Iowa awarded $3.55 million to Lori Nicholson and her husband Willis for injuries sustained as a result of the company’s much-litigated M2a Magnum metal-on-metal hip implant. The jury found  in Nicholson’s favor following the conclusion that the M2a Magnum was defectively designed. Around the same time as the Iowa lawsuit, a federal judge in Missouri signed off on a $21 million judgment regarding the M2A Magnum.

Zimmer Biomet moved for a new trial and renewed its motion for judgment as a matter of law, but the district court denied these motions and, in a decision filed Aug. 24, the U.S. Court of Appeals for the Eight Circuit affirmed that denial.

The appeals court found that the district court did not err in denying Zimmer Biomet’s motion for judgment as a …

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10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

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16 surgical robotics companies you need to know

Intuitive remains the dominant surgical robotics company, but corporations ranging from Medtronic to Vicarious Surgical look to compete. The Da Vinci Xi robotic surgery system. Intuitive continues to dominate the space. [Image courtesy of Intuitive]Robotic-assisted surgery remains one of the hottest spaces in medtech. Intuitive, which pioneered the field in the 1990s and early 2000s, continues to innovate. At the same time, a host of other companies are looking to compete.

Companies making headlines in the robotic surgery space over the past year include:

Company Robotic system(s) Intuitive Surgical Da Vinci Xi, Da Vinci X, Da Vinci SP, Ion Medtronic Hugo Johnson & Johnson Monarch, Velys, Ottava Stryker Mako Siemens Healthineers’ Corindus CorPath GRX Vicarious Surgical Beta 2 Titan Medical Enos Asensus Surgical Senhance Moon Surgical Maestro Momentus Surgical Anovo Virtual Incision MIRA Stereotaxis Genesis RMN, Vdrive, Niobe Monteris …
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Zimmer Biomet speeds up investments in NeuroOne

NeuroOne Medical Technologies (Nasdaq: NMTC) announced today that it will receive an accelerated $3.5 million milestone payment from Zimmer Biomet.

The milestone payment is related to Eden Prairie, Minnesota–based NeuroOne’s Evo sEEG electrode technology, which last year received FDA 510(k) clearance for temporary (less than 24 hours) recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Under an agreement inked in July 2020, Zimmer Biomet (NYSE: ZBH) has exclusive rights to distribute the NeuroOne’s cortical and sEEG diagnostic electrode technology worldwide. The agreement amendments announced today also gave ZB a warrant to purchase 350,000 shares of NeuroOne’s common stock at an exercise price of $3.00 per share. (NMTC shares are up by about a third to $1.56 apiece this morning; MassDevice‘s MedTech 100 Index is up slightly.)

“This agreement accomplishes multiple objectives for …

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Zimmer Biomet scores a big earnings beat in Q2

Zimmer Biomet (NYSE and SIX: ZBH) today reported second-quarter results that handily beat the consensus forecast on Wall Street, upping its full-year forecast for 2022.

The good news comes as a host of U.S. companies in medtech and other industries are reporting macroeconomic headwinds related to foreign exchange rates, inflation, supply chain challenges and more. ZB officials, however, are betting that they can innovate their way out of rough economic seas. In May, the company introduced new AI capabilities for its Omni Suite intelligent operating room — part of its ZBEdge connected intelligence suite for orthopedic surgery that also includes surgical robotics. It’s also the first to offer smart knee implants.

“We believe our focus on innovation and the transformation of our business continues to position us well for long-term growth and continued delivery for our shareholders,” Zimmer Biomet CEO Bryan Hanson said in a news release.

Th…

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The 10 largest orthopedic device companies in the world

Stryker, Johnson & Johnson’s DePuy Synthes and Zimmer Biomet top the list of largest orthopedic device companies. [Adobe Stock image]With elective procedure numbers rebounded after the darkest days of the COVID-19 pandemic, most of the world’s largest orthopedic device companies saw their revenues increase by double-digit percentages during their most recent fiscal years.

Here are the world’s 10 largest orthopedic device companies, ranked by ortho business revenue pulled from their most recent annual reports:

Largest orthopedic device companies Annual revenue (% change) Headquarters 1 Stryker $17.1 billion (+19.2%) Kalamazoo, Michigan 2 Johnson & Johnson – DePuy Synthes $8.6 billion (+10.6%) Locations: Raynham, Massachusetts.; West Chester, Pennsylvania; Warsaw, Indiana; Palm Beach Gardens, Florida 3 Zimmer Biomet (minus ZimVie spinoff) $6.8 billion (+11.6%) Warsaw, Indiana 4 Medtronic – Cranial & Spinal Technologies $4.5 billion (+3.9%) Locat…
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