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Outset Medical stock skyrockets on resumed Tablo shipments

[Image from Outset Medical]Outset Medical (Nasdaq:OM) shares are up big today on the news that people needing dialysis will once again be able to receive Tablo systems for home use.

The news of the shipment hold’s end was enough to counteract Q2 earnings misses, sending OM shares up 21.5% at $18.77 per share in midday trading. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.6%.

In June, the company 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.

However, in announcing its s…

Outset Medical faces shareholder lawsuit after shipment hold

Outset Medical (Nasdaq: OM) is facing a shareholder lawsuit in federal court, a month after it announced a shipping hold on its Tablo hemodialysis system for home use.

The company said on June 13 that it was holding off shipments amid a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance. The shipment hold news caused OM shares to lose more than a third of their value the next day. The company’s stock is down by nearly two-thirds over the past year, presently trading at around $16 per share.

Lawyers at Saxena White P.A. filed a lawsuit on July 8 in U.S. District Court in Northern California on behalf of the Plaintiff Plymouth County Retirement Association in Massachusetts and other Outset Medical shareholders. The lawsuit claims that the company and its top executives made false and misleading positive statements leading up to the shipment hold announcement.

Other law firms …

Outset Medical stock down on shipment hold news

Outset Medical (Nasdaq: OM) stock lost about a third of its value today — a day after the company said it was holding shipments of its Tablo hemodialysis system for home use.

OM shares were down more than 31% to $13.88 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

The San Jose, California–based company said the shipment hold was the 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.

Outset Medical said it has not identified any safety issues with Tablo — and will continue to ship the device for use in chronic and acute healthcare settings. The company has not removed already distributed devices from home, and current users can continue to work with their healthcare providers on appropriate treatment.

As a result of the shipment hold, Outset Medical susp…

MDMA elects Outset CEO Leslie Trigg as chair

Outset Medical Chair and CEO Leslie Trigg [Photo courtesy of Outset Medical]The Medical Device Manufacturers Association (MDMA) has elected Outset Medical Chair and CEO Leslie Trigg as chair of the trade group’s board of directors.

MDMA announced the leadership change today, following the Washington, D.C.-based industry association’s annual meeting last week.

“Medical technology innovators are at the forefront of improving patient outcomes and reducing the cost of care, and I am honored to lead MDMA as they continue their tremendous work as the leading voice of our industry,” Trigg said in a news release. “Modern technology is impacting when, where and how healthcare can be delivered. Together, we have the privilege of imagining what the future of healthcare could look like, and turning invention into reality.”

Get the full story at our sister site, Medical Design & Outsourcing.

Outset Medical rises on Street-beating Q4 revenues, high growth projections for 2022

Outset Medical (NSDQ:OM) shares shot up this morning on fourth-quarter revenues that beat the consensus forecast.

OM shares were up 9.6% at $37.50 per share in pre-market trading today.

The San Jose, California-based dialysis technology developer posted losses of $41.2 million, or 87¢ per share, on sales of $28.2 million for the three months ended Dec. 31, 2021, seeing its bottom line slide further into the red despite sales growth of 63.2%.

Adjusted to exclude one-time items, losses per share were 77¢, 10¢ behind Wall Street, where analysts were looking for sales of $26.4 million.

“Our entire team contributed to an exceptional 2021, driving record revenue growth, meaningful progress toward our long-term gross margin goal and excellent visibility into 2022,” Outset Medical Chair and CEO Leslie Trigg said in a news release. “Our established relationships with seven of the eight largest national health systems and one-third of the largest 100 …

Outset Medical hemodialysis system cartridge wins FDA clearance

[Image from Outset Medical]Outset Medical (NSDQ:OM) announced that a new sterilization method for its Tablo hemodialysis system received FDA 510(k) clearance.

San Jose, California-based Outset’s new sterilization method for the cartridge utilized in the Tablo system includes starting cartridge production through a manufacturing partner in Mexico, facilitating the localization of the cartridge in addition to the Tablo console, in North America.

According to a news release, FDA clearance allows for the new location to reduce the need for expensive and capacity-constrained air freight delivery of the cartridges, simplifying distribution and logistics for Outset, its customers and its patients.

Outset said another benefit to the FDA clearance is the ability to start using an eco-friendly cartridge sterilization method through E-beam non-ionizing technology. E-beam can be produced on-demand and does not involve toxic or potentially explosive chemicals, the…

Outset Medical achieves landmark Medicare approval for home dialysis system

[Image from Outset Medical]Outset Medical (NSDQ:OM) announced today that it received CMS approval for a payment adjustment on its Tablo hemodialysis system.

San Jose, California-based Outset said in a news release that it received the first-ever CMS approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). The decision helps encourage healthcare providers to embrace new technology that allows for patients to dialyze at home, according to Outset.

CMS recently enacted the TPNIES program to increase access to new and innovative medical technologies for end-stage renal disease (ESRD) patients. The add-on payment addresses barriers in the ESRD bundled payment system that can discourage providers from adopting new technologies on themarket.

As part of the TPNIES approval, providers will have access to supplemental reimbursement over the next two years to support patients’ use of Tablo at home.

Tablo…

Outset Medical beats the Street in Q2, names new chief financial officer

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

The San Jose, Calif.-based company reported losses of -$30.2 million, or -66¢ per share, on sales of $25.2 million for the three months ended June 30 for a sales growth of 114.75% compared with Q2 2020.

Adjusted to exclude one-time items, earnings per share were -57¢, 12¢ ahead of The Street, where analysts were looking for sales of $23.49 million.

“In the first half of 2021, we delivered best-in-class revenue growth and steady gross margin improvement driven by a team that is dedicated to, and united around, transforming the dialysis experience for patients and providers,” president and CEO Leslie Trigg said in a news release. “With new home console bookings up substantially in the second quarter, and both current and new customers purchasing Tablo for acute use, our integrated commercial strategy is working as expected. We remain confident i…

MedTech 100 roundup: New all-time best reached

Once again, the medtech industry has soared to new heights, eclipsing its all-time best performance by the tiniest of margins.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (July 2) at 114.59 points, coming in just 0.01 points ahead of the 114.58-point mark set in April — previously the industry’s all-time best performance.

The new high mark also represents a 1% rise from the 113.42-point total reached last week (June 25). The industry took a strong June into July, rising nearly 7% over the past four weeks.

Having overcome some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 24.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The positive movement in medtech …

Outset Medical CFO to leave, interim replacement named

Outset Medical (NSDQ:OM) announced that CFO Rebecca Chambers will step down and Nabeel Ahmed will take over in an interim capacity.

San Jose, Calif.-based Outset said in a news release that Chambers will depart to pursue other opportunities, effective on July 16, 2021. Ahmed, current VP of finance at the company, will assume the role once Chambers leaves.

Outset also announced that preliminary unaudited net revenue for the second quarter of 2021 is expected to be in the range of $24.5 million to $25 million, marking growth of 109% to 113% over the second quarter of 2020.

“On behalf of myself and the board of directors, we want to thank Rebecca for her contributions to Outset. She has been a key contributor to our success to date, and we wish her the best in her future endeavors,” Outset president & CEO Leslie Trigg said in the release. “Today, Outset is in a stronger position both financially and operationally than ever before. We are very pleased wi…

Outset Medical hires Amazon’s top health AI engineer as its CTO

Outset Medical (NSDQ:OM) announced today that it appointed Jean-Olivier Racine as its new chief technology officer.

Racine, a veteran of more than two decades in the technology industry, previously worked as the head of engineering and science for Amazon Web Services (AWS) Health AI, where he managed Amazon Comprehend Medical, Amazon HealthLake and more health services in development, according to a news release.

San Jose, Calif.-based Outset said Racine’s new role will have him oversee the strategic advancement of the company’s product technology, amplify the company’s data-driven innovation engine to elevate the patient care experience and drive operating efficiencies for providers.

“Jean-Olivier’s knowledge of the development of high-scale and high-availability services for the storage of health data, such as HealthLake, is critical to the innovation initiatives we intend to pursue in order to empower patients and healthcare provider…

Outset Medical appoints Edwards Lifesciences exec Katie Szyman to board of directors

Outset Medical (NSDQ:OM) announced that it appointed Edwards Lifesciences executive Katie Szyman to its board of directors.

Szyman currently serves as corporate VP & GM of critical care at Edwards, having spent more than 30 years in leadership roles in the medtech space, according to a news release. Much of her experience came in 23 years at medtech giant Medtronic.

She held finance roles before becoming CFO of Medtronic’s coronary stent business, then working with mergers and acquisitions before moving into general management work. Her final role at Medtronic was president of its diabetes business.

“Katie’s impressive track record of ushering medical device companies through market expansion and high growth is ideally suited to Outset,” Outset Medical CEO Leslie Trigg said in the release. “Her commercial growth acumen both in the critical care and consumer diabetes space reflects our focus on transforming the dialysis experience for patients and pro…