steris Archives - Medical Design Sourcing

FDA accepts Steris as first contract sterilizer in Radiation Sterilization Master File Pilot to reduce ethylene oxide use

The FDA has accepted Steris as the first contract sterilizer for its Radiation Sterilization Master File Pilot Program.

That program is part of the agency’s initiative to promote new and existing alternatives to ethylene oxide (EtO). EtO is the most commonly used sterilization method for medical devices due to its ability to permeate packaging in bulk quantities. But the medtech industry faces EtO sterilization capacity limits and new regulations that could increase sterilization costs or wait times.

Steris Applied Sterilization Technologies (AST) customers can now use the contract sterilizer’s master file with the FDA to change the way their devices are sterilized, making it easier for them to move from EtO sterilization to gamma radiation.

The master file would also simplify sterilization site changes or processing redudancy additions, moves to non-gamma radiation medthods such as X-ray or electron beam sterilization, and reduced ga…

Steris completes acquisition of surgical instrumentation assets from BD

Steris (NYSE:STE) announced today that it completed its acquisition of surgical instrumentation assets from BD (NYSE: BD) + .

The companies announced in June that they agreed on a deal for the assets worth $540 million. BD’s divestiture includes V. Mueller, Snowden-Pencer and Genesis branded products. BD reports its surgical instrumentation platform as part of its Surgery unit within its Interventional segment.

Steris said the assets range across surgical instrumentation, laparoscopic instrumentation and sterilization containers.

In the deal, the company also received three manufacturing facilities in St. Louis, Cleveland, and Tuttlingen, Germany. The acquisition includes approximately 360 employees across the unit set to transfer to Steris.

According to the companies, the projected annual revenue for the acquired businesses totals approximately $170 million. Adjusted earnings before interest and tax…

Steris reports strong Q1 on big gains in healthcare

Steris (NYSE: STE) + today reported first-quarter results that exceeded Wall Street’s expectations while upping guidance for the year ahead due to a recently announced acquisition.

The Dublin, Ireland-based provider of sterilization services and other infection prevention tech posted profits of $123.6 million in the quarter ended June 30, 2023. That amounts to $1.25 per share on sales of $1.28 billion.

Steris reported top- and bottom-line gains of 11%.

Adjusted to exclude one-time items, earnings per share (EPS) totaled $2.00. Wall Street analysts were expecting adjusted EPS of $1.87 on sales of $1.21 billion.

“We are pleased to start the year with strong performance,” Steris President and CEO Dan Carestio said in a news release. “Our first quarter results benefited from continued improvement in procedure volumes and supply chain challenges easing. In addition to those factors, our ability to reduce…

BD sells surgical instrumentation assets to Steris for $540M

BD (NYSE: BD) + announced today that it signed a definitive agreement to sell its surgical instrumentation platform to Steris (NYSE:STE) for $540 million.

The divestiture includes V. Mueller, Snowden-Pencer and Genesis branded products. BD reports its surgical instrumentation platform as part of its Surgery unit within its Interventional segment.

In the deal, Steris also gets three manufacturing facilities in St. Louis, Cleveland, and Tuttlingen, Germany. Approximately 360 employees across the unit are set to transfer to Steris upon completion of the transaction.

BD and Steris expect the divestiture to close within the former’s fiscal year, ending Sept. 30, 2023. It remains subject to customary closing conditions and U.S. Federal Trade Commission (FTC) approval.

The BD view

BD said this divestiture “advances the ‘Simplify’ pillar of the BD 2025 strategy.” It marks an importan…

New ethylene oxide rules could trigger sterilization consolidation — and new options

Firefighters training on a simulated ethylene oxide leak [Photo via Adobe Stock]

The largest commercial sterilizers will likely absorb the costs of new ethylene oxide (EtO) regulations — and could consolidate smaller competitors, according to a new analysis from Moody’s Investors Services.

Tighter controls on EtO emissions would increase capital spending and operating costs for all commercial sterilizers who use the toxic gas, which is the most commonly used method for eliminating infection-causing microbes from medical devices.

“Large companies have enough liquidity to fund the significant increase in spending without incremental debt,” Moody’s said in a subscribers-only report this week. “But the higher costs and compliance requirements could make the business less attractive for some small companies.”

The largest commercial sterilizers can absorb the cost of new…

Sterilization startup Phiex adds ex-Medtronic chief medical and scientific officer as advisor

Phiex advisor Dr. Rick Kuntz was formerly Medtronic’s chief medical and scientific officer. [Photo courtesy o Kuntz]

Retired Medtronic Chief Medical and Scientific Officer Dr. Rick Kuntz has joined Phiex as an advisor as the medical device sterilization startup works toward commercialization.

Phiex is developing a new method for medical device sterilization using dry powder that generates chlorine dioxide gas inside product packaging.

The company sees a big opportunity to offer an alternative to ethylene oxide (EtO) sterilization, which is the most commonly used method in medtech but faces new safety regulations over health risk concerns.

“It’s clear that EtO’s going to have to go away. It’s just not going to be tolerated … and I just think this is the best alternative,” Kuntz said today in an interview with Medical Design & Outsourcing.

Kuntz j…

MedAccred joins The Irradiation Panel

NEWS RELEASE: MedAccred Program Joins Influential Irradiation Industry Association

MedAccred Sterilization Staff Engineer and Auditor Kim Patton [Photo courtesy of MedAccred]

The MedAccred program has become a member of The Irradiation Panel, a renowned not-for-profit industry association representing global and diverse interests in radiation processing.

The panel is comprised of suppliers and users of irradiated products and irradiation services, regulatory bodies, and consultants. Membership currently consists of 46 companies and nine individual members, including Steris, Sterigenics, BD, Smith & Nephew, NPL, Nelson, IBA, Mevex, and Astra Zeneca.

Established in 1966 and based in the UK, it has members from across Europe and beyond, and provides a forum for discussing the advancement, development, promotion, regulation and practice of radiation processing using electron beam, gamma, and X-ray techno…

Steris beats the Street on Q4 earnings and increases guidance

Steris (NYSE:STE) today reported fourth-quarter results that exceeded Wall Street’s expectations while upping guidance for the year ahead.

Shares of STE climbed 4% t0 $197 apiece in after-hours trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was flat on the day.

The Dublin, Ireland-based provider of sterilization services and other infection prevention tech posted profits of $187.2 million in the quarter ended March 31, 2023. That amounts to $1.89 per share on sales of $1.38 billion.

Steris recorded a 259% bottom-line gain on sales growth of 14.3%.

Adjusted to exclude one-time items, earnings per share (EPS) totaled $2.30. Wall Street analysts were expecting adjusted EPS of $2.15 on sales of $1.27 billion.

“We are pleased to end the year with strong performance,” Steris President and CEO Dan Carestio said in a news release. “Our teams worked diligently to meet customer de…

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

Steris stock dives on Q4 misses, slashed 2023 guidance

Steris (NYSE:STE) shares took a hit before hours today on third-quarter results that missed the consensus forecast on Wall Street.

Shares of STE dipped 9.2% at $196.01 before the market opened today.

The Dublin, Ireland-based provider of sterilization services and other infection prevention tech posted profits of $123.8 million in the quarter. That amounts to $1.24 per share on sales of $1.215 billion for the three months ended Dec. 31, 2022.

Steris recorded a 13.8% bottom-line slide on sales growth of 0.6%.

Adjusted to exclude one-time items, earnings per share totaled $2.02. That fell 17¢ shy of expectations on Wall Street. Sales fell just short too as analysts anticipated revenues of $1.27 billion.

Dan Carestio, Steris president and CEO, pointed to 7% constant currency organic revenue growth “in a challenging environment.” He said supply chain conditions improved despite remaining constraints for electronic components. Those …

Steris sticks by EPS guidance amid additional currency headwinds

Steris (NYSE: STE) reported mixed third-quarter results, but it held the line on EPS guidance amid additional foreign currency headwinds.

The provider of sterilization services and other infection prevention tech lost $315.2 million, or $3.15 per share, off $1.20 billion in revenue for the quarter ended Sept. 30, 2022. Steris swung to a loss versus Q3 2021, when it earned $69.8 million, or 69¢ per share. Revenue was up 0.3%.

Adjusted to exclude one-time items, Steris had earnings per share of $1.99. The result was a penny ahead of The Street, where analysts expected EPS of 98¢. However, revenue was slightly down from analysts’ $1.22 billion prediction.

Some supply chain relief for Steris

“We are pleased with our operational performance in the quarter, which reflected solid constant currency organic revenue growth in a challenging environment,” CEO Dan Carestio said in a news release out yesterday evening.

“As anticipated, we saw some relief …

Steris plans to build a new medical device testing facility

Steris released this rendering of the medical device testing facility it plans to open in Leipzig, Germany. [Image courtesy of Steris]

Steris (NYSE: STE) plans to build a new packaging and microbiological testing facility for medical devices in Leipzig, Germany.

The facility will offer packaging testing services such as accelerated and real-time aging, transportation and integrity testing. The new location will also offer microbiological testing in collaboration with the medical device manufacturer and sterilizer’s laboratory in Radeberg.

Steris said the Leipzig packaging testing services will complement existing services offered in Galway, Ireland, and Brooklyn Park, Minnesota.

RELATED: Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuits

“This investment furthers our commitment to supporting medical device manufacturers throughout all stages …