SeaSpine Archives - Medical Design Sourcing

Could 2023 be a boom year for orthopedic devices?

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]The orthopedic devices market is expected to reach nearly $50 billion this year as procedures bounce back from COVID-19, according to GlobalData.

GlobalData predicts the orthopedic surgical robotics space will be even hotter this year, growing 25.6% year-over-year to $984 million.

“Boosted by artificial intelligence (AI) and machine learning, new generations of orthopedic robots are expected to further improve clinical outcomes. Unlike the general surgery robotics market — which is dominated by only one company, Intuitive Surgical — all major orthopedic manufacturers are competing in the orthopedic robotics market,” Tina Deng, principal medical devices analyst at GlobalData, said in a news release posted Feb. 1.

In addition, Global Data noted that the pandemic has accelerated the shift of procedures to outpatient or ambulat…

Orthofix launches Mariner deformity pedicle screw system

The Mariner system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq:OFIX) announced that it initiated the full commercial launch of its Mariner deformity pedicle screw.

Lewisville, Texas-based Orthofix also announced the first patient cases with Mariner. It marks the first product launched since the merger between Orthifix and SeaSpine earlier this month. SeaSpine developed the Mariner screw system.

In a news release, Orthofix said the foundational Mariner system addresses complex adult deformity spine cases. The full commercial launch adds reduction and correction instrumentation, as well as specialized implant technologies. It also features robust osteotomy tools to deliver efficient and powerful surgical intervention.

“The Mariner deformity system represents an innovative collaboration between surgical minds and a cutting-edge product development team,” said Dennis Cirino, SeaSpine SVP, global spinal systems. “Combined with our market-leading biolog…

Orthofix, SeaSpine complete merger

Orthofix and SeaSpine today completed its previously announced merger of equals to create a global spine and orthopedics company.

Under the terms of the agreement, Orthofix will merge with SeaSpine and SeaSpine will continue as the surviving company and a wholly-owned subsidiary of Orthofix. SeaSpine shares also ceased trading on the Nasdaq global market this morning.

Holders of SeaSpine common stock will receive 0.4163 shares of Orthofix common stock for each share of SeaSpine common stock owned. The combined companies will continue to trade on the Nasdaq under the symbol OFIX.

The two companies plan to rename the merged company at a later date, but it will be Orthofix Medical until then. The combined company will market spine and orthopedics with a complementary portfolio of biologics, spinal hardware solutions, market-leading bone growth therapies, specialized orthopedic solutions and a surgical navigation system.

“The completion of this merger…

SeaSpine places 100th 7D Flash navigation system

SeaSpine Holdings (Nasdaq: SPNE) today announced the 100th worldwide placement of its 7D Flash navigation system.

7D Flash uses visible light to create a three-dimensional image for surgical navigation in just seconds. SeaSpine says the fast 3D imaging results in shorter and more efficient spinal procedures with less radiation exposure. Novel and proprietary camera-based technology and machine-vision algorithms have enabled the 7D Flash’s features.

Inova Fairfax Hospital in Virginia purchased the 100th system.

“Their unique segmental referencing method and Flash navigation system will protect patients and providers from the cumulative effects of radiation while allowing for more accurate placement of spinal fixation. We can virtually eliminate use of X-ray during the surgery and overall reduce radiation for the patient and save time compared to other navigation systems,” orthopedic surgeon Dr. Laurel Bla…

Orthofix, SeaSpine announce CFO post-merger

SeaSpine CFO John Bostjancic [Image courtesy of SeaSpine]SeaSpine CFO John Bostjancic will continue as the top financial officer of the to-be-named orthopedic device giant created through a merger with Orthofix.

When the two companies announced their plans to merge last month, they said that Bostjancic’s present boss, SeaSpine CEO Keith Valentine, would be CEO.

“John has been a key leader of SeaSpine dating back to the successful spin-out of the organization in 2015. I am confident his background and experience in the medical device industry, coupled with his cultural influence, will benefit the newly combined company as we continue to grow,” Valentine said in today’s news release.

“I believe John is well positioned to help lead us through the successful integration of the two companies, ensuring accountability across all levels of the organization, as we focus on the key initiatives that will drive growth, scalability and shareholder value.” Read more

SeaSpine launches Mariner MIS Wayfinder

SeaSpine (Nasdaq:SPNE) this week announced it launched its Mariner MIS Wayfinder system commercially.

Mariner MIS Wayfinder is a one-step, k-wireless screw delivery system for pedicle screw fixation. It eliminates the reliance on traditional guidewires for percutaneous screw placement by providing a fully-integrated, surgeon-led solution that uses the company’s Mariner modular pedicle screw technology.

“Thoughtful and efficient instrumentation design in Mariner MIS Wayfinder delivers the capability to significantly reduce the number of steps associated with fixation placement,” said Dr. Azam Basheer, a neurosurgeon at Henry Ford Health in Jackson, Michigan. “Combined with the outstanding functionality of Mariner MIS and Flash Navigation’s recently-launched percutaneous module, SeaSpine now offers a market-leading procedural solution.”

Mariner MIS Wayfinder is integrated with SeaSpine’s 7D Flash Navigation system and the Flash Percutaneous mod…

Orthofix, SeaSpine plan all-stock merger to create global spine and orthopedic company

Orthofix (Nasdaq:OFIX) and SeaSpine (Nasdaq:SPNE) today announced a definitive agreement to combine companies in an all-stock merger of equals.

Under the terms of the agreement, SeaSpine shareholders will receive 0.4163 shares of Orthofix common stock for each share of SeaSpine common stock owned. Once the transaction closes, Orthofix shareholders will own approximately 56.5% of the combined companies. SeaSpine shareholders will own approximately 43.5% of the combined company on a diluted basis, according to an SEC filing.

Both companies’ boards have unanimously approved the merger. They plan to close the transaction in the first quarter of 2023, naming the new combined company beforehand.

Shares in OFIX were down more than 21% to $14.49 apiece, and SPNE was up more than 5% to $5.90 apiece in premarket trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down more than 3%. Read more

SeaSpine launches WaveForm TA interbody system

[Image from SeaSpine]SeaSpine (Nasdaq:SPNE) announced that it fully launched the WaveForm TA (TLIF articulating) interbody system.

Carlsbad, California-based SeaSpinedesigned the WaveForm TA interbody system to deliver an interbody to the anterior portion of the disc space. The aim is to optimize sagittal alignment and endplate support.

According to a news release, surgeons can use WaveForm TA to address specific anatomical needs intraoperatively. With a range of footprint and lordotic options, surgeons don’t see adverse impacts to their surgical workflow.

“WaveForm TA is an exciting addition to our interbody portfolio and provides a best-in-class offering in what we estimate is the $175 million U.S. [transforaminal lumbar interbody fusion] market for 3D-printed and solid titanium products,” said Dennis Cirino, SeaSpine SVP of global spinal systems. “This system provides a versatile and reproducible lumbar interbody solution while providing efficiency…

SeaSpine posts mixed-bag Q2 results, raises guidance for fiscal 2022

SeaSpine (NSDQ:SPNE) posted second-quarter results that beat the revenue consensus on Wall Street and missed earnings estimates.

The Carlsbad, California-based company reported losses of $13.9 million, or -38¢ per share, on sales of $56.3 million for the three months ended June 30, for a sales growth of $56.3 million compared with Q2 2021.

Earnings per share were 3¢ behind the street, where analysts were looking for sales of $53.34 million.

“Our first quarter’s strong revenue momentum sustained through the second quarter,” President and CEO Keith Valentine said in a news release. “The success we’ve had in attracting and onboarding distributors from our larger competitors, as well as additional transformational distributors we expect to transition in the near-term, is due in large part to our consistent execution in the commercial launch of industry-leading, new and enhanced products and systems. Our expectation for continued sales traction and visibility…

SeaSpine rises on Q1 earnings, increased 2022 revenue outlook

SeaSpine (Nasdaq:SPNE) shares rose this morning on first-quarter results that were mixed compared to the consensus forecast.

The Carlsbad, California-based company posted losses of $16.6 million, or 45¢ per share, on sales of $50.7 million for the three months ended March 31, 2022, for a 30% bottom-line slide further into the red on sales growth of 20.8%.

SeaSpine’s losses per share of 45¢ came in 9¢ behind projections on Wall Street, where analysts were looking for sales of $49 million.

“We were pleased to see revenue acceleration throughout the quarter,” SeaSpine President and CEO Keith Valentine said in a news release. “Despite significant omicron headwinds throughout January, we exceeded our own internal expectations as the quarter progressed with strong results across all portfolios as hospital staffing and OR capacity quickly recovered. On the heels of recent product introductions, we gained further momentum and energy in the field among our sur…

SeaSpine posts Q4 sales beat, projects 20% revenue growth in 2022

SeaSpine (Nasdaq:SPNE) this morning reported fourth-quarter results that were mixed compared to the consensus forecast.

The Carlsbad, California-based company posted losses of $18.8 million, or 52¢ per share, on sales of $55.6 million for the three months ended Dec. 31, 2021, for a bottom-line slide deeper into the red on sales growth of 19.7%.

SeaSpine’s losses per share of 52¢ came in 17¢ behind expectations on Wall Street, where analysts were looking for sales of $54.9 million.

“We are pleased with our revenue performance in the fourth quarter, despite the impact of the pandemic on surgery volumes in December,” SeaSpine President and CEO Keith Valentine said in a news release. “As we enter the new year, we are encouraged with the steady improvements we have seen in operating room capacity and hospital staffing levels since early February.

“Those improvements, coupled with the strength of our comprehensive spinal implants and advance…

SeaSpine launches new orthobiologic products

SeaSpine (NSDQ:SPNE) announced the launches of the NorthStar cervical facet fusion and Flash navigation lumbar facet fusion.

Carlsbad, California-based SeaSpine designed what they tout as first-of-their-kind orthobiologic systems to streamline reproducible procedural workflow while maximizing the area for fusion with OsteoStrand DBM fibers contained within the facet joint.

According to a news release, the company has initiated the full commercial launch of the NorthStar facet fusion, an all-in-one solution for combining OsteoStrand DBM fiber cervical pellets and disposable facet prep instrumentation. All of this is optimized for use with SeaSpine’s posterior cervical fixation system, the NorthStar OCT.

SeaSpine designed its Flash navigation lumbar facet fusion — which will have a limited commercial launch — with instruments for targeting and delivering OsteoStrand Plus DBM fiber pellets within the facet joint during minimally invasive spine procedu…