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Monday, January 11, 2021

Abbott blood test to evaluate mild concussions wins FDA OK

 Doctors soon will have a new way to evaluate patients with concussions: a rapid blood test made by Abbott Laboratories that has been cleared by the U.S. Food and Drug Administration.

It’s an advancement that could eliminate the need for some patients to get costly CT scans and the radiation exposure that accompanies them.

The test works by measuring proteins that can be present in the blood after a traumatic brain injury. It uses blood drawn from the arm and can be performed on a handheld device. It can produce results in 15 minutes, after plasma is extracted from the blood, which typically takes place in a lab. The test has been approved for use in people ages 18 years and older.

The FDA approved the test as a way for doctors to rule out the need for a CT scan, which is often necessary to figure out whether there’s brain tissue damage after an injury, Abbott announced Monday. If the blood test doesn’t detect the proteins or detects very low levels of them, it’s unlikely the patient has tissue damage.

“If it comes out negative, then it gives clinicians and patients a sense of certainty that they can go home,” said Dr. Beth McQuiston, medical director of Abbott’s diagnostics arm. “You don’t have to wait for a CT. You can get them home and give them peace of mind.”


Patients who test positive will still likely need CT scans. The test is approved for patients with suspected mild traumatic brain injuries, not those exhibiting severe symptoms.

Nearly 3 million people in the U.S. went to emergency rooms, were hospitalized or died from traumatic brain injuries in 2014, according to the Centers for Disease Control and Prevention. The injuries are typically caused by bumps, blows or jolts to the head because of falls, being struck by objects or motor vehicle accidents.

https://www.chicagotribune.com/business/ct-biz-abbott-blood-test-concussions-fda-approval-20210111-5qddey336fdnjeuiwopcioykty-story.html

Halozyme Provides 2020 Guidance Highlighted By Strong Revenue, EPS Growth

 - 2021 Revenue Guidance of $375 to $395 Million Representing 40%-45% Growth over Expected 2020 Revenue -

- 2021 Royalties Projected to Double versus Expected 2020 Royalties -

- 2021 EPS Guidance of $1.40 to $1.55 Representing 55%-70% Growth over Expected 2020 EPS -

Anticipated 2021 Key Events :

  • Strong subcutaneous DARZALEX® (daratumumab) royalty revenue growth driven by continued US and international market uptake;
  • Potential Ministry of Health, Labour and Welfare approval in Japan for Janssen's subcutaneous DARZALEX® utilizing ENHANZE®;
  • Potential U.S. FDA approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in light chain amyloidosis;
  • Strong Phesgo® (pertuzumab, trastuzumab and hyaluronidase) royalty revenue growth driven by adoption in US and Europe;
  • Two new products entering Phase 3 development, resulting in a total of 4 products in Phase 3, including Roche's TECENTRIQ® (atezolizumab) and argenx's efgartigimod;
  • Five new Phase 1 trial starts for ENHANZE® partner programs resulting in a total of 13 Phase 1 studies completed or ongoing by end of 2021;
  • Continued commitment to capital return with up to $125 million in share repurchases anticipated in 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme's board of directors in November 2019.

DexCom 2020 prelim revenue up 30%

 -DexCom, Inc. (Nasdaq: DXCM), the leader in continuous glucose monitoring (“CGM”), today reported that it expects preliminary, unaudited revenue for the fourth quarter ended December 31, 2020 to meet or exceed $567 million, an increase of 23% over the fourth quarter of 2019. U.S. revenue is expected to be approximately $451 million, representing growth of 20% over the fourth quarter of 2019. International revenue is expected to be approximately $116 million, an increase of 33% over the fourth quarter of 2019.

For fiscal 2020, total preliminary, unaudited revenue is expected to meet or exceed $1.925 billion, an increase of more than 30% over 2019.

“Dexcom demonstrated its resilience in the face of the unique challenges of 2020, delivering revenue growth of nearly $450 million over 2019 and making several significant steps to extend our growth opportunity well into the future. I am incredibly proud of the work of our teams and want to express my gratitude to our employees for prioritizing the care of our customers and service to our communities throughout the year,” said Kevin Sayer, Dexcom’s Chairman, President and CEO. “2021 is shaping up to be an exciting year for Dexcom and we look forward to updating you on our continued progress.”

2021 Outlook

For 2021, Dexcom currently anticipates total revenue of approximately $2.21 billion to $2.31 billion, representing expected growth of approximately 15% to 20% over 2020. This growth outlook considers sensor volume growth driven by increasing CGM awareness for people with Type 1 and Type 2 diabetes, continued international expansion, shifting channel mix and overall market dynamics.

https://www.businesswire.com/news/home/20210111005292/en/Dexcom-Reports-Preliminary-Unaudited-Revenue-for-the-Fourth-Quarter-and-Fiscal-Year-2020-and-Provides-Initial-2021-Outlook

Atricure prelims disappoint

 AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, announced preliminary financial results for the fourth quarter and full year 2020.

Preliminary, unaudited revenue for fourth quarter 2020 is expected to be approximately $57.7 million, reflecting a decrease of approximately 6% over the fourth quarter of 2019 (-7% on a constant currency basis). Preliminary revenue for full year 2020 is expected to be $206.5 million, reflecting a decline of approximately 11% over full year 2019 (-11% on a constant currency basis). Fourth quarter and full year 2020 revenue was impacted by the global decline in surgical procedures as a result of the COVID-19 pandemic.

https://www.businesswire.com/news/home/20210111005139/en/AtriCure-Reports-Preliminary-Results-for-Fourth-Quarter-and-Full-Year-2020

Nevro Prelim Q4, 2020 Revenue

 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced its preliminary, unaudited revenue for the fourth quarter and full-year ended December 31, 2020.

Fourth Quarter 2020

Preliminary, unaudited fourth quarter 2020 worldwide revenue is expected to be $109.7 million, compared to $114.4 million in the fourth quarter in the prior year period. Preliminary, unaudited fourth quarter 2020 U.S. revenue is expected to be $94.6 million, compared to $97.9 million in the prior year period. Preliminary, unaudited fourth quarter 2020 international revenue is expected to be $15.1 million, compared to $16.5 million in the prior year period. Fourth quarter U.S. trial procedures were down approximately 8% versus prior year. 

Full-Year 2020

Nevro's preliminary, unaudited full year 2020 worldwide revenue is expected to be $362.0 million, compared to $390.3 million in the prior year period. Preliminary, unaudited full year U.S. revenue is expected to be $311.9 million, compared to $326.0 million in the prior year period. Preliminary, unaudited full year international revenue is expected to be $50.2 million, compared to $64.3 million in the prior year period.

"Despite the challenges created by the COVID-19 pandemic in 2020, I am extremely proud of the significant efforts of the Nevro team to serve our customers and patients, and execute on our plans for the future," said D. Keith Grossman, Chairman, CEO and President of Nevro.  "In the second half of the fourth quarter, the increase in COVID activity negatively affected both trial and permanent implant volumes.  Even with the pandemic challenges throughout the year, we continued to capture share in the core lower back and leg pain market with our best-in-class SCS technology, superior clinical data and sharpened execution.  I believe we are well positioned for attractive growth when the pressure of COVID on our business subsides.  In addition, we are excited about expanded growth opportunities to treat Painful Diabetic Neuropathy and Non-Surgical Refractory Back Pain, which will bring our HF10 therapy to the many patients who are unable to find relief with currently available treatment options."

Nevro plans to report its full financial results and provide more detail for its fourth quarter and full-year 2020 financial results after the market closes on Wednesday, February 24, 2021, to be followed by its quarterly conference call at 1:30 pm Pacific Time that day.

Nevro to Present at J.P. Morgan Healthcare Conference

D. Keith Grossman, Chairman, CEO and President of Nevro, will present at the J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 4:30 pm Eastern Time / 1:30 pm Pacific Time.  A live webcast of this event, as well as an archived recording, will be available in the Investors section of Nevro's website at www.nevro.com

https://www.thepress.net/news/state/nevro-announces-preliminary-unaudited-fourth-quarter-and-full-year-2020-revenue/article_bbdc598b-14b6-5e04-b467-0e8bf075dfaf.html

Jaguar Eyes Conditional Marketing Authorization, Initially for Covid 'Long Haulers'

 New COVID-19 strain estimated to have tripled number of infections in England during November 2020 lockdown


Investor webcast scheduled for Thursday, January 14 at 11:30 A.M. Eastern Time. 

When: Thursday, January 14 at 11:30 a.m. Eastern Time

Participant Registration & Access Link: Click Here

https://finance.yahoo.com/news/jaguar-health-exploring-possibility-conditional-133000284.html

Vertex JPMorgan presentation

 

39th Annual J.P. Morgan Healthcare Conference