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Teleflex Incorporated (TFX - Free Report) recently received the FDA’s 510(k) clearance to expand the Indications for Use of its Arrow EZ-IO Intraosseous (IO) Vascular Access System. With the expanded indication, the device can be used for up to 48 hours when alternate intravenous access is not available or reliably established in patients aged 12 years and above.
For investors’ note, the Arrow EZ-IO device can be used in cases where intravenous access is difficult or impossible to obtain in emergency, urgent or medically necessary cases for up to 24 hours. Further, per the expanded indication, the access can be extended for up to 48 hours.
With the expanded Indications for Use, Teleflex aims to strengthen its Vascular Access business across the globe.
Significance of the Clearance
Per management, one of the most basic but critical component of patient care is vascular access. The ability to use the Arrow EZ-IO system for a longer period (dwell time) enables clinicians to utilize the IO access for the entire period of therapy in patients with difficult vascular access for up to 48 hours.
The expanded indication provides additional time to physicians to choose the personalized device and optimal site for insertion to establish safe vascular access in patients. This is of utmost importance amid the current situation where the number of patients outweigh the available limited resources.
The management also confirmed that the FDA’s approval for an expanded indication was pursued based on the medical fraternity’s demand for a longer dwell time.
Industry Prospects
Per a report by Transparency Market Research, the global IO devices market was valued at more than $361 million in 2017 and is projected to reach $586.9 million by 2026, at a CAGR of approximately 5.5%. Factors like rising number of medical emergency situations, increasing incidence of various diseases and a growing elderly population are likely to drive the market.
Given the market potential, the expanded Indications for Use of the Arrow EZ-IO System is likely to significantly boost Teleflex’s business.
Recent Developments
Of late, Teleflex has witnessed a few developments across its businesses.
During the second-quarter earnings call in August, the company confirmed that growth in its EZ-IO products contributed to its top line. Further, Teleflex stated that its Vascular Access business remained strong due to demand driven by the pandemic.
In July, the company announced presenting data from three studies of the UroLift System at the European Association of Urology 2020 virtual congress, which demonstrated the safety and effectiveness of the minimally-invasive treatment for benign prostatic hyperplasia among broad patient groups.
Price Performance
Shares of the company have gained 2.3% in the past year compared with the industry and S&P 500’s 20.9% and 14.1% growth, respectively.
Zacks Rank & Stocks to Consider
Currently, Teleflex carries a Zacks Rank #4 (Sell).
A few better-ranked stocks from the broader medical space include QIAGEN N.V. (QGEN - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Globus Medical, Inc. (GMED - Free Report) .
Thermo Fisher’s long-term earnings growth rate is estimated at 15.5%. It currently carries a Zacks Rank #2 (Buy).
Globus Medical’s long-term earnings growth rate is estimated at 13%. The company presently carries a Zacks Rank #2.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Teleflex's (TFX) Arrow EZ-IO Gets FDA's Expanded Indications
Teleflex Incorporated (TFX - Free Report) recently received the FDA’s 510(k) clearance to expand the Indications for Use of its Arrow EZ-IO Intraosseous (IO) Vascular Access System. With the expanded indication, the device can be used for up to 48 hours when alternate intravenous access is not available or reliably established in patients aged 12 years and above.
For investors’ note, the Arrow EZ-IO device can be used in cases where intravenous access is difficult or impossible to obtain in emergency, urgent or medically necessary cases for up to 24 hours. Further, per the expanded indication, the access can be extended for up to 48 hours.
With the expanded Indications for Use, Teleflex aims to strengthen its Vascular Access business across the globe.
Significance of the Clearance
Per management, one of the most basic but critical component of patient care is vascular access. The ability to use the Arrow EZ-IO system for a longer period (dwell time) enables clinicians to utilize the IO access for the entire period of therapy in patients with difficult vascular access for up to 48 hours.
The expanded indication provides additional time to physicians to choose the personalized device and optimal site for insertion to establish safe vascular access in patients. This is of utmost importance amid the current situation where the number of patients outweigh the available limited resources.
The management also confirmed that the FDA’s approval for an expanded indication was pursued based on the medical fraternity’s demand for a longer dwell time.
Industry Prospects
Per a report by Transparency Market Research, the global IO devices market was valued at more than $361 million in 2017 and is projected to reach $586.9 million by 2026, at a CAGR of approximately 5.5%. Factors like rising number of medical emergency situations, increasing incidence of various diseases and a growing elderly population are likely to drive the market.
Given the market potential, the expanded Indications for Use of the Arrow EZ-IO System is likely to significantly boost Teleflex’s business.
Recent Developments
Of late, Teleflex has witnessed a few developments across its businesses.
During the second-quarter earnings call in August, the company confirmed that growth in its EZ-IO products contributed to its top line. Further, Teleflex stated that its Vascular Access business remained strong due to demand driven by the pandemic.
In July, the company announced presenting data from three studies of the UroLift System at the European Association of Urology 2020 virtual congress, which demonstrated the safety and effectiveness of the minimally-invasive treatment for benign prostatic hyperplasia among broad patient groups.
Price Performance
Shares of the company have gained 2.3% in the past year compared with the industry and S&P 500’s 20.9% and 14.1% growth, respectively.
Zacks Rank & Stocks to Consider
Currently, Teleflex carries a Zacks Rank #4 (Sell).
A few better-ranked stocks from the broader medical space include QIAGEN N.V. (QGEN - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Globus Medical, Inc. (GMED - Free Report) .
QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Thermo Fisher’s long-term earnings growth rate is estimated at 15.5%. It currently carries a Zacks Rank #2 (Buy).
Globus Medical’s long-term earnings growth rate is estimated at 13%. The company presently carries a Zacks Rank #2.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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