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The 10 largest orthopedic device companies in the world

[Image from Pixaby]

Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the w…

NuVasive wins FDA nod for disc replacement device

NuVasive (NSDQ:NUVA) announced today that it received FDA approval for its Simplify disc in two-level cervical total disc replacement (cTDR).

San Diego-based NuVasive’s Simplify cervical artificial disc, part of its NuVasive C360 portfolio, is comprised of PEEK on ceramic materials to allow for enhanced visualization through MRI postoperatively when compared to alternative devices, according to a news release.

Simplify is anatomically designed and includes 4mm, 5mm and 6mm options, while the proprietary design allows for a variable center of rotation for each treated level to closely mimic the motion dynamics of a natural spine segment.

The disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level FDA investigational device exemption (IDE) study. The device also delivered an overall success rate that was nearly 10% higher when compared to ACDF.

“This approval is an inc…

NuVasive reports mixed Q4 results

NuVasive (NASDAQ: NUVA) today reported Q4 earnings that beat the consensus forecast on Wall Street, but it came up short on revenue.

The San Diego–based spine tech company earned $1.7 million, or 3¢ per share, on sales of $291.8 million for the three months ended Dec. 31, 2020, for a bottom-line drop of –94% on a sales decline of –6% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were 59¢, 4¢ ahead of The Street, where analysts were looking for EPS of 55¢ on sales of $298.36 million.

“NuVasive continues to see significant impact from COVID-19 on elective surgical procedures and patient sentiment, particularly within the U.S. market, which increased late in the fourth quarter,” NuVasive CEO J. Christopher Barry said in a news release out this evening.

“Against a challenging 2020, we made key investments in infrastructure, talent, and innovation to unlock our ability to fulfill our long-term strategy…

NuVasive acquires Simplify Medical in $150M deal

NuVasive (NSDQ:NUVA) yesterday announced that it has acquired Simplify Medical for $150 million.

Through the deal, NuVasive made an upfront payment of $150 million at closing using cash on hand, subject to customary purchase price adjustments. The company agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales.

Simplify Medical develops the Simplify Cervical Artificial Disc for cervical total disc replacement (cTDR). The acquisition adds the cTDR technology to NuVasive’s cervical portfolio to address all key segments of the cervical spine.

The disc is anatomically designed and includes 4, 5 and 6 mm options. It has unique articulation to allow for a variable center of rotation for each treated level and is designed to mimic the motion dynamics of a natural spine segment.

“The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expandi…

Corza Medical set to take on “almost monopolistic” surgical giants

Corza Medical, a new venture backed by the financial firepower of private equity giant GTCR, is looking to build a surgical tool supplier that its executive chairman Greg Lucier says can compete with “almost monopolistic” leaders in the space.

To mount the challenge, Corza acquired Surgical Specialties Corp., a supplier of surgical sutures and ophthalmic knives. Corza will use this beachhead in Westwood, Mass., to build a pipeline of acquired assets including TachoSil, a surgical patch product line Corza acquired from Takeda Pharmaceuticals last year.

In an interview with the DeviceTalks Weekly podcast, Lucier, the former CEO of spinal company NuVasive (NSDQ:NUVA) and diagnostic company Life Technologies, said management believes “there is an opening for a pretty good-sized surgical tools and technologies company to compete against the Ethicons and the Medtronics of the world.”

Lucier said the two Goliaths have reached a size that makes them “almost mono…

Medtech and COVID-19: 7 things you need to know

[Photo by Sasha • Stories on Unsplash]

When COVID-19 set upon the U.S. in March, medtech executives only had a month at most to explain to analysts in quarterly calls how the pandemic was hitting their companies — not nearly enough time to understand the long-term impact.

Three more months have passed since those quarterly calls, and we’re now wrapping up a new earnings season. While no one can be 100% sure what the future will hold, medtech executives’ comments — and their companies’ actions — are shedding some light on changes coming to the medtech industry.

Here are seven insights we’ve gleaned at Medical Design & Outsourcing and MassDevice from the latest medtech earnings season.

Next>> Listen to us discuss all 10 points during our latest DeviceTalks Weekly podcast>>

Executive editor Chris Newmarker contributed to this report.

NuVasive dips despite Street-beating Q2

NuVasive (NSDQ:NUVA) shares closed today on the downturn despite second-quarter results that beat the consensus forecast.

The San Diego-based spine surgery technology developer posted losses of -$50 million, or -98¢ per share, on sales of $203.6 million for the three months ended June 30, 2020, for a bottom-line slide from profits of nearly $15 million year-over-year on a sales decline of 30.3%.

Adjusted to exclude one-time items, losses per share were -40¢, 7¢ ahead of Wall Street, where analysts were looking for sales of $175.8 million.

Last month, NuVasive announced preliminary results that revealed an operating loss of between -$35 million and -$40 million on a GAAP basis, with losses of between -$17 million and -$23 million on a non-GAAP basis.

Stay-at-home orders and elective surgical procedure delays as a result of COVID-19 were reflected in NuVasive’s net sales for the quarter, which it had expected to come in between $202 million and $205…

NuVasive projecting losses up to $40m for Q2

NuVasive (NSDQ:NUVA) announced that it anticipates losses for the second quarter to come in around -$40 million amid the COVID-19 pandemic.

The San Diego-based spine surgery technology developer said in a news release that preliminary results for the quarter, ended June 30, 2020, revealed an operating loss of between -$35 million and -$40 million on a GAAP basis, with losses of between -$17 million and -$23 million on a non-GAAP basis.

Stay-at-home orders and elective surgical procedure delays as a result of COVID-19 were reflected in NuVasive’s net sales for the quarter, which it expects to come in between $202 million and $205 million. That marks about a -30% decline from the $292.1 million in revenue the company posted in the same quarter last year.

Additionally, the pandemic is causing NuVasive to record incremental charges, including ones related to inventory and accounts receivable, totaling between $20 million and $25 million and contributin…

NuVasive launches pediatric spinal deformity device

NuVasive (NSDQ:NUVA) announced today that it launched its Reline 3D posterior fixation system for pediatric spinal deformities.

San Diego-based NuVasive’s latest addition to its spine portfolio is now commercially available around the globe for treating adolescent idiopathic scoliosis (AIS). The Reline 3D is designed to turn a multi-step technique into a holistic, single-plane correction to offer surgeons versatility, according to a news release.

Reline 3D is an extension of NuVasive’s fixation portfolio filled with Reline systems, including Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. The latest version of the platform is commercially available within the U.S. and European markets now, and NuVasive expects availability in other countries next year.

“Reline 3D represents a true procedural solution that increases efficiencies and supports a less invasive approach to addressing complex pathologies,” NuVasive pre…

Nuvasive announces $400m offering

NuVasive (NSDQ:NUVA) announced that it intends to offer $400 million aggregate principal amount of convertible senior notes in a private offering.

The San Diego-based spine technology company is offering the notes, due in 2023, as well as granting initial purchasers a 13-day option to purchase up to an additional $50 million in notes.

According to a news release, the notes will be paid semiannually in arrears on June 1 and Dec. 1 of each year, beginning on Dec. 1, 2020. The notes will mature on June 1, 2023, unless earlier repurchased or converted.

Prior to the close of business on the business day immediately before Feb. 1, 2023, the notes will be convertible at the option of the holders. After the close of business on the second scheduled trading day preceding maturity, they will be convertible at the option of the holders at any time. Interest rate, conversion rate and other terms will be determined at the time of the offering’s pricing.

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