Surgalign Archives - Medical Design Sourcing

Augmedics to acquire digital health assets from Surgalign auction

Augmedics announced today that it successfully bid for the digital health assets of Surgalign and Holo Surgical following an auction.

Surgalign conducted the court-supervised marketing and sale process following its Chapter 11 bankruptcy filing in June. It conducted the auction process in accordance with bidding procedures approved by the U.S. Bankruptcy Court for the Southern District of Texas, Houston Division.

According to Surgalign, Augmedics bid for the digital health assets with a cash purchase price of $900,000. It also includes the assumption of certain liabilities.

The Chicago-based augmented reality-based surgical navigation technology developer says the purchase strengthens its portfolio with IP and other digital health assets. Augmedics expects the sale to close pending Bankruptcy Court approval at a hearing set for Aug. 8.

This news follows last month’s announcement of an $82.5 million fundraising round for Augmedics.

“We…

Surgalign receives Nasdaq delisting notice following bankruptcy filing

Surgalign (Nasdaq:SRGA) announced today that it received a delisting notice from the Nasdaq market after filing for Chapter 11 bankruptcy.

Earlier this week, the company entered into an agreement to sell assets under a Chapter 11 bankruptcy. The asset purchase agreement enables Surgalign to sell substantially all U.S. hardware and biomaterial assets. It has a stalking horse bidder in place for those hardware and biomaterial assets.

Deerfield, Illinois-based Surgalign plans to conduct its business in an uninterrupted manner and fund the Chapter 11 proceedings.

According to a news release, Nasdaq determined that, due to the company’s voluntary Chapter 11 filing, its securities will be delisted. The company said it has no intentions to appeal the determination.

Surgalign said the Nasdaq intends to suspend trading at the opening of business on July 3, 2023. Once the delisting takes effect, it expects to begin trading on the OTC under the SRGAQ t…

Surgalign files Chapter 11 to sell global hardware, biologics business

Surgalign (Nasdaq:SRGA) announced today that it entered into an agreement to sell assets under the Chapter 11 Bankruptcy Code.

The asset purchase agreement enables Surgalign to sell substantially all U.S. hardware and biomaterial assets. It also intends to sell the equity interests in non-debtor entities related to the debtors’ hardware business outside the U.S. — Xtant Medical. That sale totals $5 million. Surgalign sold two product lines to Xtant Medical earlier this year.

Deerfield, Illinois-based Surgalign said it plans to effectuate the sale through Chapter 11 proceedings. The company and certain subsidiaries elected voluntary petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas, Houston Division.

As part of the proceedings, the company filed a motion seeking authorization to pursue an auction and sale process. Under this, Surgalign designates Xtant as the stalking horse bidder. It a…

Surgalign releases HOLO AI Insights for neurovascular research

Surgalign (Nasdaq:SRGA) announced today that it released its HOLO AI Insights for use in neurovascular research.

Deerfield, Illinois-based Surgalign initially launched HOLO AI Insights for spine imaging in March 2023. It enables customers, partners and clinical researchers to utilize the HOLO AI portfolio. The system features a secure, highly scalable cloud platform for the automated analysis of medical images.

HOLO AI utilizes convolutional neural network technology. It automatically segments medical images, measures anatomic structures, automates pedicle screw planning and performs other tasks.

The latest release brings HOLO AI to neurovascular research. The system can analyze large sets of cranial MRI images and automatically identify 16 different structures. It can also aggregate the data for the user into configurable graphical and file formats. Insights generated this way can provide multiple applications in population health, clinical research and…

Surgalign sells Coflex, Cofix product lines for $17M

The Coflex device. [Image from Surgalign]Surgalign (Nasdaq:SRGA) announced an agreement for Xtant Medical (NYSE:XTNT) to acquire two of its product lines for $17 million.

On Feb. 28, the two companies entered into a definitive agreement whereby Xtant acquired the Coflex and Cofix product lines from Surgalign. They subsequently closed on the deal for a total consideration of $17 million.

Surgalign designed Coflex as an interlaminar stabilization device used after an open decompression in various settings. It offers a non-fusion treatment option for lumbar spinal stenosis (LSS) patients. Coflex, the only implant with FDA premarket approval for treating LSS, is a supplemental fixation device.

More than 200,000 patients over 60 countries received Coflex implants, which also estalblished ambulatory surgical center reimbursement.

Cofix, a minimally invasive system, offers usability across all levels of the lumbar spine, Surgalign said in a news release. Read more

Layoffs in medtech: These companies recently reduced their workforce

[Image courtesy of Nastuh Abootalebi on Unsplash] The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs.

You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more.

For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply chain challenges and more.

Medtech has shown some resilience in the present environment. Some major medical device companies released positive earnings. However, others announced headcount reductions, citing macroeconomic headwinds. Others felt the weight of regulatory issues and restructuring efforts.

Here are a few companies across medtech that enacted layoffs over the past several months.

In 3M’s fourth-quarter earnings report, the company announced that it plans to reduce its global manufacturing workforc…

Surgalign announces 100th Cortera case

Surgalign Holdings (Nasdaq: SRGA) recently announced the 100th case completed with its recently launched Cortera spinal fixation system,

Deerfield, Illinois–based Surgalign engaged in a limited market release of Cotera shortly after FDA 510(k) clearance in August.

Surgalign has used the initial market release to collect clinical and design feedback on the system from a wide range of spine surgeons. The company is now seeking to secure additional products. It plans to develop additional implants and instruments to add to the Cortera system over the next three to four years. In addition, it is working to integrate Cortera with its Holo Portal surgical guidance system.

Surgalign’s plan is to ramp up commercialization in the first half of 2023. It looks to grow its market share in what it says is an estimated $2.2 billion U.S. posterior fixation market.

“Cortera represents the first organically developed product at Surgalign, and we believe hold…

Surgalign plans layoffs

Surgalign (Nasdaq:SRGA) today announced a board-approved corporate restructuring plan that includes layoffs.

The Deerfield, Illinois–based spine surgery tech company did not disclose how many jobs may be cut amid the planned streamlining and brand and product portfolio rationalization initiatives. As of Dec. 31, 2021, Surgalign had 231 employees — 70 of them outside the U.S., according to its most recent annual report.

The company estimates it will save roughly $30–35 million compared to 2022.

In addition to approving the restructuring plans yesterday, Surgalign’s board gave management the green light to explore other cost-saving avenues. Future moves could include paring down, selling or exiting certain aspects of its business, both domestically and abroad.

The goal is to refocus the company on R&D and commercializing products that align with its core strategy.

“We believe these programs will enable us to generate growth in…

Surgalign launches new family of interbody fusion devices

The Fortilink-C interbody fusion implant. [Image from Surgalign]Surgalign (Nasdaq:SRGA) announced today that it expanded its Fortilink product portfolio with a new family of interbody fusion devices.

Deerfield, Illinois-based Surgalign’s new devices feature TiPlus technology. The implants include Fortilink-A with TiPlus for anterior lumbar interbody fusion (ALIF) procedures.

Additionally, the product family includes Fortilink-TC and -TS with TiPlus for posterior lumbar interbody fusion (PLIF/TLIF). It also features Fortilink-C with TiPlus technology for anterior cervical discectomy and fusion (ACDF) procedures.

“TiPlus is a great new offering that significantly bolsters the interbody solutions I can offer to my patients, based on their specific clinical need,” said Dr. Jon White, an orthopaedic spine surgeon at Hoag Orthopedic Institute in Irvine, California. “The acid-etched surface and optimized pore size allows for both bone ongrowth and ingrowth, …

FDA clears Surgalign’s Cortera spinal fixation system

Surgalign (Nasdaq:SRGA) announced today that it received FDA 510(k) clearance for its Cortera spinal fixation system.

Deerfield, Illinois-based Surgalign said in a news release that the new flagship Cortera product represents a key piece to its portfolio in terms of driving the company’s future growth and ensuring market gains in the posterior fixation market.

“The Cortera system is a testament to the spine engineering talent and expertise we’ve assembled in very short order, as we moved from zero engineers in the United States following the RTI divestiture two years ago, to approximately 30 today,” said Terry Rich, president and CEO of Surgalign. “Thanks to our team and incredible surgeon partners, we progressed from company inception to FDA 510(k) clearance with a very polished system in approximately 16 months. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better…

Surgalign settles on OEM business sale, posts Q2 earnings miss

Surgalign (Nasdaq:SRGA) shares are down today on the news of its second-quarter financial results and a global settlement agreement.

Shares of SRGA were down 8.3% at $5.50 apiece before the market opened this morning. They sank even further after the market opened, with shares trading down 20.5% at $4.77 in the early hours. (MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was mostly unchanged.)

Effective Aug. 5, Surgalign entered into a global settlement agreement with Pioneer Surgical Technology, Resolve Surgical Technologies and RTI Surgical relating to the sale of its OEM business in 2020 and the continued relationship it has had with RTI since then.

Under the settlement agreement, the parties have amended various agreements, including distribution agreements for spinal implants and biologics. All parties have settled the litigation and released each other from potential claims, as well, according…

Surgalign settles with SEC for $2M over alleged misreported revenue numbers

Surgalign (Nasdaq:SRGA) announced that it reached a settlement with the U.S. Securities and Exchange Commission (SEC).

The settlement concludes and resolves in its entirety an SEC investigation related to activities including pulling sales forward from future quarters to address projected quarterly revenue shortfalls. Activities evaluated in the investigation occurred between 2015 and 2019, back when Surgalign operated under the RTI Surgical name.

Surgalign’s RTI OEM business was divested in 2020.

Deerfield, Illinois–based Surgalign agreed to pay a civil penalty of $2 million — recorded in full during the fourth quarter of 2021 — under the terms of the settlement.

According to a news release, as part of the settlement, Surgalign also agreed to refrain from future violations of specified provisions of federal securities laws and rules. The company is also expected to receive $600,000 from former executives related to recouped compensation. Read more