Outset Medical announced today that it appointed Renee Gaeta as its chief financial officer (CFO), effective immediately. In addition to leading finance, Gaeta’s responsibilities include the San Jose, California-based company’s IT and HR organizations. She succeeds Nabeel Ahmed, who departed the home hemodialysis company to pursue other opportunities. “Renee brings deep financial and leadership experience […]
Outset Medical
Outset Medical announces reverse stock split
Outset Medical today announced a 1-for-15 reverse stock split, going into effect on Thursday, March 20, 2025. The company’s common stock will continue to trade on the Nasdaq market under the existing OM ticker on a split-adjusted basis. San Jose, California-based Outset said in a news release that its stockholders approved the split at a […]
Outset Medical stock rises on Street-beating Q4, 2025 guidance
Outset Medical shares got a boost today on fourth-quarter results that topped the consensus forecast on Wall Street. Shares of OM rose 10% to $1.03 apiece in mid-morning trading today. The San Jose, California-based home dialysis company reported losses of $25.6 million. That equals 49¢ per share on sales of $29.5 million for the three […]
Outset Medical resolves FDA warning letter
Outset Medical announced today that the FDA says it addressed all issues cited in a 2023 warning letter. Shares of OM rose nearly 4% to 85¢ apiece after hours shortly after the company made its announcement. In July 2023, the company announced that it received a warning letter from the FDA related to its Tablo […]
Outset Medical announces $169M financing
Outset Medical announced today that it entered into a definitive securities purchase agreement worth proceeds of $168.8 million. The agreement features a private placement of 843,908 shares of Series A non-voting convertible preferred stock at $200 per share. Subject to stockholder approval, each share automatically converts into 250 shares of common stock. That brings the […]
Outset Medical board member resigns due to affiliation with Baxter Kidney Care unit sale
Outset Medical today filed with the SEC to confirm that board member Jim Hinrichs resigned due to his affiliation with another kidney care company. Hinrichs resigned in connection with a significant affiliation with Vantive, the new standalone kidney care company separating from Baxter. He also resigned from his post as audit committee chair for the […]
Outset Medical stock falls on Q2 misses, slashed guidance as Tablo placements miss expectations
Outset Medical stock has lost more than half its value today — a day after a disappointing Q2 report. OM shares were down more than 60% to $1.33 apiece by midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up slightly. The San Jose, […]
Outset Medical stock sinks on workforce reduction, Q1 misses
Outset Medical shares fell this morning on first-quarter misses and restructuring resulting in headcount reductions. Chair and CEO Leslie Trigg noted cost-reduction steps taken by the company, although the company did not specify how many workers were affected. Shares of OM fell to more than 14% to $3.53 apiece in mid-morning trading today. MassDevice’s MedTech […]
Outset Medical begins selling TabloCart with Prefiltration again after FDA nod, stock soars
Outset Medical announced today that the FDA granted 510(k) clearance for its TabloCart with Prefiltration. Shares of OM rose more than 24% to $3.90 apiece in midday trading today after the announcement. MassDevice‘s MedTech 100 Index was down slightly. With clearance for the new optional accessory for the Tablo hemodialysis system, Outset resumed distribution of […]
FDA labels Outset Medical recall of Tablo hemodialysis system as Class I
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 recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching […]
Outset Medical inks deal to expand home hemodialysis in the U.S.
Outset Medical announced today that it partnered with U.S. Renal Care to accelerate home hemodialysis in the U.S. The company entered into a multi-year agreement with U.S. Renal Care, the country’s largest privately held kidney care provider. They aim to utilize the Outset Tablo hemodialysis system as a home dialysis option in the 33 states […]
