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Baxter (BAX) Attains FDA De Novo Authorization for Theranova
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Baxter International Inc. (BAX - Free Report) 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 - Free Report) , Surmodics (SRDX - Free Report) and Merit Medical Systems (MMSI - Free Report) .
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.
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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.
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Baxter (BAX) Attains FDA De Novo Authorization for Theranova
Baxter International Inc. (BAX - Free Report) 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 - Free Report) , Surmodics (SRDX - Free Report) and Merit Medical Systems (MMSI - Free Report) .
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.
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