RTI Surgical wins FDA IDE approval for Cortiva Allograft Dermis in breast reconstruction

RTI Surgical today announced it received investigational device exemption approval from the FDA to study its Cortiva Allograft Dermis.

The Alachua, Florida-based company plans to initiate a study to confirm the safety and effectiveness of Cortiva in implant-based breast reconstruction.

Cortiva is processed using the Tutoplast tissue sterilization process and the implants are currently regulated as Section 361 human cell and tissue products. They are restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue.

“This milestone marks a significant step towards obtaining FDA pre-market approval (PMA) for our Cortiva allograft implants. It reinforces our strategic objective of becoming a leading medical device company in regenerative medicine by offering a diverse portfolio that enables surgeons to better address the unique needs of their patients,” President and CEO Olivier Visa said in a news release.<…

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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…

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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

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How medtech fared in the first waves of the pandemic

[Photo by Martin Sanchez on Unsplash]Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry.

To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021.

Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre-pandemic years. The handful of companies that joined this yea…

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RTI Surgical, Exactech form partnership to develop biologic bone substitutes

The FDA-cleared Optecure demineralized bone matrix [Image courtesy of RTI Surgical] RTI Surgical announced a long-term agreement with Exactech for the development and supply of biologic bone substitutes.

The deal, announced today, includes RTI Surgical acquiring Exactech’s FDA-cleared Optecure demineralized bone matrix, used as a bone graft extender in the spine, pelvis, and extremities. RTI Surgical officials think Optecure will complement their portfolio of bone graft substitutes. RTI Surgical offers a portfolio of tissue-based, synthetic and metal implants to OEM customers.

The financial terms of the deal were not disclosed.

“Biologic materials that support joint replacement surgery are an important facet of Exactech’s business,” Exactech CEO Darin Johnson said in a news release.

“This collaboration with RTI allows each company to focus on our unique strengths,” Johnson said. “RTI has specialized expertise…

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MedTech 100 roundup: Stocks tick back up to open July

After a solid start to July, the medtech industry continues to experience a stock market roller coaster amid the COVID-19 pandemic.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 84.25 points at the end of last week (July 3). That total represents a 2.9% increase from the 81.88-point total at the same time a week prior (June 26), resulting in another significant direction change, following a -3.7% dip just one week before.

Meanwhile, the S&P 500 Index saw a 4% bump from June 26 to July 2 (market close before a holiday), and the Dow Jones Index fared similarly well, posting a 3.2% increase over the same period of time. Both indexes mirrored the medtech industry’s changes, having each posted decreases the week prior.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 35.6% growth in total. Stocks in the indu…

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RTI Surgical posts losses ahead of potential OEM business sale

RTI Surgical (NSDQ:RTIX) shares dipped today on first-quarter results that fell short of the consensus forecast.

The Deerfield, Ill.-based company posted losses of -$17.9 million, or -24¢ per share, on sales of $73.7 million for the three months ended March 31, 2020, for a 91% bottom-line slide on sales growth of 5.3%.

Adjusted to exclude one-time items, losses per share were also -24¢, 23¢ behind Wall Street, where analysts were looking for sales of $75.3 million.

“I am very proud of the actions taken by our entire organization over the last several months as we have navigated the COVID-19 pandemic while at the same time managing through the pending sale of the OEM business and a number of other headwinds,” RTI Surgical president & CEO Camille Farhat said in a news release. “The integrity, dedication, and talent of our people have enabled us to come out on the other side of this unique period in time ready to take advantage of the opportunities that…

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