U.S. Markets closed
  • S&P 500

    3,638.35
    +8.70 (+0.24%)
     
  • Dow 30

    29,910.37
    +37.90 (+0.13%)
     
  • Nasdaq

    12,205.85
    +111.44 (+0.92%)
     
  • Russell 2000

    1,855.27
    +10.25 (+0.56%)
     
  • Crude Oil

    45.53
    -0.18 (-0.39%)
     
  • Gold

    1,788.10
    -23.10 (-1.28%)
     
  • Silver

    22.64
    -0.81 (-3.44%)
     
  • EUR/USD

    1.1970
    +0.0057 (+0.4788%)
     
  • 10-Yr Bond

    0.8420
    -0.0360 (-4.10%)
     
  • Vix

    20.84
    -0.41 (-1.93%)
     
  • GBP/USD

    1.3314
    -0.0042 (-0.3169%)
     
  • USD/JPY

    104.0850
    -0.1650 (-0.1583%)
     
  • BTC-USD

    18,072.60
    +304.55 (+1.71%)
     
  • CMC Crypto 200

    333.27
    -4.23 (-1.25%)
     
  • FTSE 100

    6,367.58
    +4.65 (+0.07%)
     
  • Nikkei 225

    26,644.71
    +107.40 (+0.40%)
     

Baxter (BAX) Attains FDA De Novo Authorization for Theranova

Zacks Equity Research
·4 min read

Baxter International Inc. BAX recently announced that its novel dialysis membrane, Theranova has been granted the FDA De Novo application.

Notably, Theranova was developed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by aiming for efficient removal of conventional and large middle molecules. These middle molecules may be related to inflammation and cardiovascular disease in patients afflicted with kidney failure.

By granting a De Novo application, the FDA is paving the path for a new class of dialyzer technology with unique performance standards.

This regulatory clearance is expected to boost the company’s Renal Care business.

More on Theranova

HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane needed. Theranova dialyzer’s unique membrane design brings in a filtration profile that more closely imitates that of the natural kidney and can be utilized with existing hemodialysis machines.

Patients are currently treated with HDx enabled by Theranova in more than 40 countries. Baxter is taking every possible step in the United States to ensure that medical providers can also offer the new therapy efficiently to their patients who are already on HD.

Due to the novel nature of Theranova, Baxter conducted a randomized controlled clinical study in the United States that evaluated the safety and proficiency of HDx therapy enabled by Theranova. The study proved that the HDx therapy offered by Theranova is a promising alternative to what is currently available because it delivers a filtration profile that is closer to the natural kidney.

Recent Development

In August 2020, Baxter attained FDA Emergency Use Authorization (EUA) for Regiocit, the company’s replacement solution that contains citrate for regional citrate anticoagulation of the extracorporeal circuit. Under the EUA, Regiocit is cleared to be used as a replacement solution only in adult patients being treated with continuous renal replacement therapy (CRRT) and for whom regional citrate anticoagulation is suitable during the COVID-19 pandemic. This also boosted the company’s Renal Care business.

Market Prospects

Per a report by Allied Market Research, the global dialysis market size was valued at $86.62 billion in 2016, and is estimated to reach $118.51 billion by 2023, expanding at a CAGR of 4.5% from 2017 to 2023. Hence, this FDA clearance is well-timed.

Price Performance

Over the past six months, the stock has gained 0.1% compared with the broader industry’s growth of 10%.

Zacks Rank & Stocks Worth a Look

Baxter currently carries a Zacks Rank #5 (Strong Sell).

A few better-ranked stocks from the broader medical space include OPKO Health OPK, Surmodics SRDX and Merit Medical Systems MMSI.

OPKO Health’s long-term earnings growth rate is estimated at 12%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Surmodics’ long-term earnings growth rate is estimated at 10%. The company presently carries a Zacks Rank #2.

Merit Medical Systems’ long-term earnings growth rate is estimated at 11.9%. It currently carries a Zacks Rank #2.

Breakout Biotech Stocks with Triple-Digit Profit Potential

The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.

Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.

See these 7 breakthrough stocks now>>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Baxter International Inc. (BAX) : Free Stock Analysis Report
 
Surmodics, Inc. (SRDX) : Free Stock Analysis Report
 
Merit Medical Systems, Inc. (MMSI) : Free Stock Analysis Report
 
OPKO Health, Inc. (OPK) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research