Outset Medical

[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 (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 (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…

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 (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 (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&#…

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 …

[Image from Outset Medical]Levi & Korsinksy notified Outset Medical (Nasdaq:OM) investors today of a class action securities lawsuit against the company.

In June, Outset announced that it was holding shipments of its Tablo hemodialysis system for home use as a result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance.

Last month, it was revealed that the company would face a shareholder lawsuit claiming that the company and its top executives made false and misleading positive statements leading up to the shipment hold announcement. In announcing its quarterly results earlier this week, though, the company said that it received the FDA 510(k) clearance and is resuming shipments of Tablo.

According to a news release from the law firm, the lawsuit seeks to recover losses on behalf of Outset Medical investors who were “adversely affected by alleged securities fraud.̶…