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BD's (BDX) PeritX System Gets FDA's Expanded 510(k) Clearance

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Becton, Dickinson and Company (BDX - Free Report) , popularly known as BD, recently announced receipt of the FDA’s 510(k) clearance for its PeritX Peritoneal Catheter System. The system is to be used for the drainage of symptomatic, recurrent non-malignant ascites.

For investors’ note, ascites is a debilitating condition which leads to the build-up of fluid in the abdomen, and can make ordinary daily activities very challenging. Further, the fluid may also reach the chest and surround the lungs, thereby leading to breathing difficulties.

With the latest expanded indication, BD will be aiming to solidify its position in the global Peripheral Intervention space. Notably, the Peripheral Intervention business is a component of the company’s broader BD Interventional arm.

Few Words on PeritX

The PleurX Peritoneal Catheter System, which was launched in 2005 for the drainage of malignant ascites, has been rebranded as the PeritX Peritoneal Catheter System following the new, expanded indication. This is expected to make it easier for physicians to navigate BD's portfolio of at-home drainage products.

Further, the PeritX Peritoneal Catheter System is the first and only FDA-indicated tunneled catheter for the drainage of malignant and non-malignant ascites, as well as for the palliation of symptoms associated with recurrent ascites.

Significance of the Expanded Indication

Per management, the new expanded indication for the PeritX System is expected to aid more patients with ascites resulting from liver disease or other non-cancer-related origins. Further, recurrent ascites being a debilitating condition requiring frequent hospital visits for fluid removal from the peritoneum (the membrane lining the abdominal cavity and covering abdominal organs), the system is likely to help keep patients out of the hospital.

Industry Prospects

Per a report by Market Reports World, the global ascites market is expected to reach $3710.4 million by 2023 from $2806.1 million in 2016, at a CAGR of 4%. Factors like rising prevalence of cirrhosis and its related complications, and increasing occurrence of cancer are likely to drive the market.

Given the market potential, the latest expansion of indication for the PeritX System is expected to significantly boost BD’s business across the world.

Recent Developments

Of late, BD has witnessed a few notable developments across its businesses.

The company, in June, announced that it has been authorized as a Common Vulnerability and Exposures (“CVE”) Numbering Authority via the CVE Program. BD is the first medical technology company with such an authorization.

BD, in May, announced the U.S. launch of a Urine Culture Application for use with the BD Kiestra lab automation incubation and imaging system.

Also in May, the company launched the BD Surgiphor Sterile Wound Irrigation System. It is the first and only ready-to-use aqueous povidone-iodine (PVP-I) irrigation solution currently available in the market which mechanically loosens and removes wound debris.

Price Performance

Shares of BD have gained 4.9% in the past year compared with the industry’s 31% growth and the S&P 500's 39.6% rise.

Zacks Investment ResearchImage Source: Zacks Investment Research

Zacks Rank & Stocks to Consider

Currently, BD carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Veeva Systems Inc. (VEEV - Free Report) , AMN Healthcare Services Inc (AMN - Free Report) and National Vision Holdings, Inc. (EYE - Free Report) .

Veeva Systems’ long-term earnings growth rate is estimated at 15.8%. 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.

AMN Healthcare’s long-term earnings growth rate is estimated at 6.5%. It currently carries a Zacks Rank #2.

National Vision’s long-term earnings growth rate is estimated at 23%. It currently sports a Zacks Rank #1.

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