Outset Medical, Inc. - OM STOCK NEWS

Outset Medical, Inc. (NASDAQ: OM) has received FDA clearance for a new sterilization method of the Tablo Hemodialysis System cartridge. This advancement allows production to shift to North America, particularly Mexico, which is expected to reduce costs and enhance supply chain reliability. The new method is eco-friendly, utilizing e-beam technology. CEO Leslie Trigg highlighted that this milestone aims to improve gross margins while addressing manufacturing challenges and logistics.

Outset Medical, Inc. (NASDAQ: OM) has been named in Fast Company’s inaugural Next Big Things in Tech list, recognizing its groundbreaking Tablo® Hemodialysis System.

This innovative dialysis solution simplifies treatment and reduces costs, making it easier for patients and providers. Tablo combines advanced features like wireless connectivity and integrated water purification into a single unit. CEO Leslie Trigg emphasizes the importance of consumer-centric design in improving the dialysis experience. This recognition reflects Outset's commitment to revolutionizing dialysis care.

Outset Medical reported Q3 2021 net revenue of $26.3 million, a 91.3% increase from $13.8 million in Q3 2020. The gross margin improved to 11.2%, up from (37.3%) year-over-year. Full year 2021 revenue guidance was raised to $99 million to $101 million, indicating 98% to 102% growth over 2020. The company recorded a net loss of ($30.5 million), or ($0.65) per share, significantly better than the previous year’s loss. Cash stood at $406.4 million as of September 30, 2021.

Outset Medical, Inc. (Nasdaq: OM) announced management's participation in a fireside chat at the Stifel 2021 Virtual Health Care Conference on November 16, 2021, at 1:40 PM PT. The event will be available via a live and archived webcast on Outset's Investors section. Outset Medical is revolutionizing dialysis with the Tablo Hemodialysis System, making it easier and more cost-effective for patients and providers. This innovative technology enables dialysis to be administered anywhere, incorporating advanced data analytics and operational simplicity.

Outset Medical, Inc. (Nasdaq: OM) has received approval for its Tablo® Hemodialysis System from the Centers for Medicare & Medicaid Services for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). This approval aims to enhance home dialysis accessibility for patients with end-stage renal disease. Over the next two years, healthcare providers can receive supplemental reimbursements, promoting wider adoption of Tablo. The approval follows strong support from healthcare providers and patients, emphasizing the system’s ease of use and potential for better patient outcomes.

Outset Medical, Inc. (NASDAQ: OM) will release its third-quarter 2021 financial results after the market closes on November 3, 2021. A conference call hosted by CEO Leslie Trigg and CFO Nabeel Ahmed will take place at 2:00 PM PT to discuss these results. The Tablo® Hemodialysis System, which simplifies and reduces costs associated with dialysis, exemplifies Outset's innovation in improving patient care. The system enables dialysis to be provided anywhere with integrated technology for data analytics and water purification.

Outset Medical, Inc. (NASDAQ: OM) announced its participation in two virtual investor conferences. The 2021 Virtual Wells Fargo Healthcare Conference is scheduled for September 9, 2021 at 10:20 a.m. PT, while the Morgan Stanley 19th Annual Global Healthcare Conference will take place on September 13, 2021 at 2:00 p.m. PT. Outset's Tablo® Hemodialysis System simplifies dialysis and is FDA-cleared for use in various settings. Live webcasts will be accessible on the Outset website.

Outset Medical, Inc. (Nasdaq: OM) reported a significant financial performance in Q2 2021, with net revenue increasing by 115% to $25.2 million compared to Q2 2020. The company's gross margin improved to 4.2% from (40.6%). Product revenue also surged by 113% to $20.6 million. Operating expenses rose to $31.0 million, and the net loss for the quarter was ($30.2 million), or ($0.66) per share. Outset raised its full-year 2021 revenue guidance to a range of $97 million to $100 million, a projected growth of 94% to 100%.