Outset Medical Archives - Medical Design Sourcing

FDA labels Outset Medical recall of Tablo hemodialysis system as Class I

[Image from Outset Medical]The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind.

The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA.

Outset Medical (Nasdaq: OM) + recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching was identified at levels above allowable safety limits. Peroxide-cured silicone tubing in the machines’ hydraulics and dialysate lines caused the unsafe NDL-PCBAs levels.

The dialysate solution may expose patients to higher than allowable limits. According to the FDA, Outset Medical determined that leaching NDL-PCBAs decreases over time and will reduce to an acceptable safety level after 336 hours of console operational use.

Exposure to NDL-PCBAs and NDL-PCBA-related comp…

Outset Medical pauses shipments for Tablo accessory as it awaits FDA clearance, stock sinks

[Image from Outset Medical]Outset Medical (Nasdaq: OM) + shares took a hit after hours today after the company announced a shipment hold within its second-quarter results.

Shares of OM fell 12.7% at $16.91 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 1.1%.

San Jose, California-based Outset Medical paused shipments for its TabloCart with Prefiltration, an accessory for Tablo. The company said the shipment hold is pending FDA clearance, for which Outset plans to submit later this month.

News of the shipment hold follows last month’s announcement of an FDA warning letter for Tablo. That included an observation asserting that TabloCart with Prefiltration requires prior 510(k) clearance for marketing authorization. TabloCart, a Tablo accessory, launched in the third quarter of 2022. S…

Outset Medical receives FDA warning letter

Outset Medical (Nasdaq: OM) + announced that it received a warning letter from the FDA listing observations related to its Tablo system.

San Jose, California-based Outset previously disclosed an FDA form-483 on its annual report in February. That FDA form identified four inspectional observations resulting from an inspection concluded on Feb. 10, 2023. From there, Outset provided a response plan on March 3 and completed remediation workstreams to address the observations.

A new warning, dated July 5, raises two additional observations. Outset issued a press release outlining the new warning on July 7. As the markets opened today (July 10), shares of OM fell 14% at $17.60 apiece.

First, the FDA asserts that certain materials it reviewed (found on Outset’s website) promote continuous renal replacement therapy (CRRT). That modality falls outside the current indications for the Tablo hemodialysis system. Outse…

Outset Medical upgrades full-year guidance after strong Q1 performance

Outset Medical (Nasdaq: OM) + this week posted first-quarter results that beat the overall consensus on Wall Street.

The San Jose, California-based dialysis company reported profit losses of $43.97 million, or 90¢ per share, on sales of $33.5 million, for the three months ended March 31, for a sales gain of 9.55% compared to Q1 2022. It had a bottom-line less compared to the same time last year when it reported $36.9 million in losses.

Adjusted to exclude one-time items, earnings per share were -72¢, 2¢ ahead of The Street, where analysts were looking for sales of $31.76 million.

“We had a strong start to 2023, with revenue growth ahead of our expectations and gross margins expanding for the 8th consecutive quarter,” CEO Leslie Trigg said in a news release. “The momentum we had exiting 2022 carried through the first quarter of 2023 with the benefits of Tablo continuing to resonate with acute-care and home provid…

Outset Medical beats The Street in Q4, reaffirms guidance

Outset Medical (Nasdaq:OM) shares remained unchanged after hours today on fourth-quarter results that topped the consensus forecast.

Shares of OM sat still at $28.43 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 10.7%.

The San Jose, California-based at-home hemodialysis technology developer posted losses of $41.4 million. That amounts to losses of 86¢ per share on sales of $32 million for the three months ended Dec. 31, 2022.

Outset recorded a slight bottom-line slide deeper into the red on sales growth of 13.7%.

Adjusted to exclude one-time items, losses per share came in at 71¢. That registers 15¢ ahead of expectations on Wall Street. Outset also beat on revenues as analysts projected sales of $30.9 million.

Among the highlights was a 54% year-over-year increase in the year-end installed base of its Tablo home h…

The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4%

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

Axonics, Outset lead medtech space on Deloitte’s list of fastest growing companies

Deloitte today released its “North America Technology Fast 500” list of growing companies, including a handful of medtech firms.

The list, which ranking of the fastest-growing North American companies across a range of sectors, included several “Life Sciences” outfits. Immunology company Vir Biotechnology led the way in first place on the list.

Axonics (Nasdaq:AXNX) represented the highest-ranked medical device company at No. 4. According to Deloitte, the company registered 25,401% growth over a three-year period. Axonics reported $180.3 million in revenue in fiscal 2021, compared to $707,000 in fiscal 2018.

The company topped last year’s version of the list. Axonics develops novel products for adults with bladder and bowel dysfunction. Its sacral neuromodulation (SNM) systems provide adults suffering from overactive bladder and/or fecal incontinence with long-lived, easy-to-use, safe, clinically effective therapy. The compa…

Outset Medical skyrockets on Q3 revenue beat, raises full-year guidance

Outset Medical (Nasdaq:OM) this week posted third-quarter results that were in line with earnings estimates and beat the revenue consensus on Wall Street.

The San Jose, California-based home hemodialysis device maker reported net losses of $40.8 million, or -85¢ per share, on sales of $27.8 million for the three months ended Sept. 30, for a sales growth of 5.48% compared to Q3 2021. Comparatively, Outset Medical reported net losses of $30.5 million.

Adjusted to exclude one-time items, earnings per share were 70¢, in line with The Street, where analysts were looking for sales of $25.23 million.

“Our third quarter results reflect the value Tablo is delivering in both the acute and home settings, with console shipments exceeding our initial expectations,” CEO Leslie Trigg said in a news release. “While we have seen staffing and inflationary pressures persist for our provider customers, we believe our continued expansion in the acute setting and our strong s…

Outset Medical secures debt financing of up to $300M

Outset Medical (Nasdaq: OM) today announced two senior secured credit facilities with investment affiliates managed by SLR Capital Partners.

Collectively, the facilities provide for up to $300 million in borrowing for the maker of the Tablo Hemodialysis System. The facilities include an up-to-$250-million term loan facility and an up-to-$50-million asset-based revolving credit facility.

Outset drew $100 million under the term loan facility at closing. It has another $100 million available to borrow under the credit facilities as of closing. With the new credit facilities from SLR, Outset retired its existing, cash-secured debt facility from Silicon Valley Bank.

“We are pleased to have entered into this non-dilutive debt financing with favorable terms, enabling us to further strengthen our balance sheet,” Outset Medical CEO Leslie Trigg said in a news release. “This agreement provides additional support and flexibility as we advance our mission to bring a…

Outset Medical unveils TabloCart for Tablo hemodialysis system

Outset Medical (Nasdaq:OM) this week launched the newest accessory for its Tablo Hemodialysis System, the TabloCart.

The San Jose, California-based company designed TabloCart to help medical professionals easily move anywhere around the hospital. It provides added maneuverability and optional prefiltration or storage.

[Hear more from Outset Medical CEO Leslie Trigg at DeviceTalks West on October 20]

TabloCart has 360º rotating wheels and directional locking rear wheels to enhance mobility and maneuverability. Hospital staff can easily transport Table across elevator thresholds, turn around in tight areas or maneuver quickly into a small bedside or ICU.

The new accessory’s prefiltration system simplifies prefiltration, enhances filter volume and withstands tough water conditions. According to Outset Medical, water represents more than 90% of the total composition of a standard dialysate prescription, so TabloCart&#…

10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

Outset Medical wins national VA contract

Outset Medical (Nasdaq:OM) announced today that it has won a national contract with the U.S. Department of Veterans Affairs to sell its Tablo hemodialysis system into the department’s 106 VA hospitals.

San Jose, California–based Outset already has Tablo deployed at some VA hospitals, which overall provide dialysis for 35,000 U.S. veterans. But the new five-year contract allows VA centers to acquire consoles to send veterans home. It also expands usage in the acute setting.

The contract covers an indefinite quantity of services and goods.

“Our honored veterans deserve to have the most advanced dialysis care possible, and it is our great privilege to support them through the SAC contract for hemodialysis care,” Outset Medical CEO Leslie Trigg said in a news release. “This partnership with the VA will further our mission to bring a technology-enabled, patient-centered approach to dialysis both in the acute and home setting.”

The news of the VA …