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Boston Scientific's (BSX) SCS Systems Receives FDA's Nod
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Boston Scientific Corporation (BSX - Free Report) recently announced the receipt of the FDA’s approval for its WaveWriter Alpha portfolio of Spinal Cord Stimulator (“SCS”) Systems. The U.S. commercial launch of the SCS Systems is expected to commence during the first half of 2021.
Notably, the European launch of the WaveWriter Alpha SCS Systems was announced in September 2020.
With the latest regulatory clearance, Boston Scientific aims to strengthen its Neuromodulation business across the globe. Notably, the Neuromodulation business is a component of the company’s broader Rhythm and Neuro arm.
Significance of the Launch
Per management, this earlier-than-expected FDA approval for the WaveWriter Alpha SCS Systems will provide patients with multiple therapy options for chronic pain. However, further details about the functioning of the portfolio of SCS devices and how it can personalize the treatment of chronic pain will be provided during the North American Neuromodulation Society annual meeting.
Notably, chronic pain currently impacts millions of people in the United States and is the principal cause of disability in American adults. SCS therapies deliver pulses of mild electric current to the spinal cord and interrupt pain signals traveling to the brain in order to provide pain relief.
Further, the portfolio, which consists of four MRI conditional Bluetooth-enabled implantable pulse generators, offers expanded personalization suiting patients’ needs.
Industry Prospects
Per a report by Grand View Research, the global SCS devices market was valued at $1.83 billion in 2018 and is projected to reach $3.58 billion by 2026 at a CAGR of 8.7%. Factors like growing incidents of failed back syndrome and complex regional pain syndrome are expected to boost the market.
Given the market potential, the regulatory approval is expected to significantly boost Boston Scientific’s Neuromodulation business.
Notable Developments in Rhythm and Neuro Arm
Boston Scientific has witnessed some important developments in its Rhythm and Neuro segment over the past few months.
The company, in September, signed an investment agreement with an exclusive option to acquire Farapulse, Inc, a privately held company developing a pulsed field ablation system. The same month, Boston Scientific announced the receipt of the CE Mark and the subsequent limited-market launch of its fourth-generation Vercise Genus Deep Brain Stimulation System in Europe.
In June, Boston Scientific received the FDA 510(k) clearance for its LUX-Dx Insertable Cardiac Monitor System.
Price Performance
Shares of the company have lost 21.3% in the past year against the industry’s 4.8% growth and the S&P 500’s 18.3% rise.
Zacks Rank & Key Picks
Currently, Boston Scientific carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Hologic, Inc. (HOLX - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and ResMed Inc. (RMD - Free Report) .
Thermo Fisher’s long-term earnings growth rate is estimated at 18%. It currently carries a Zacks Rank #2 (Buy).
ResMed’s long-term earnings growth rate is estimated at 14.5%. The company presently carries a Zacks Rank #2.
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Boston Scientific's (BSX) SCS Systems Receives FDA's Nod
Boston Scientific Corporation (BSX - Free Report) recently announced the receipt of the FDA’s approval for its WaveWriter Alpha portfolio of Spinal Cord Stimulator (“SCS”) Systems. The U.S. commercial launch of the SCS Systems is expected to commence during the first half of 2021.
Notably, the European launch of the WaveWriter Alpha SCS Systems was announced in September 2020.
With the latest regulatory clearance, Boston Scientific aims to strengthen its Neuromodulation business across the globe. Notably, the Neuromodulation business is a component of the company’s broader Rhythm and Neuro arm.
Significance of the Launch
Per management, this earlier-than-expected FDA approval for the WaveWriter Alpha SCS Systems will provide patients with multiple therapy options for chronic pain. However, further details about the functioning of the portfolio of SCS devices and how it can personalize the treatment of chronic pain will be provided during the North American Neuromodulation Society annual meeting.
Notably, chronic pain currently impacts millions of people in the United States and is the principal cause of disability in American adults. SCS therapies deliver pulses of mild electric current to the spinal cord and interrupt pain signals traveling to the brain in order to provide pain relief.
Further, the portfolio, which consists of four MRI conditional Bluetooth-enabled implantable pulse generators, offers expanded personalization suiting patients’ needs.
Industry Prospects
Per a report by Grand View Research, the global SCS devices market was valued at $1.83 billion in 2018 and is projected to reach $3.58 billion by 2026 at a CAGR of 8.7%. Factors like growing incidents of failed back syndrome and complex regional pain syndrome are expected to boost the market.
Given the market potential, the regulatory approval is expected to significantly boost Boston Scientific’s Neuromodulation business.
Notable Developments in Rhythm and Neuro Arm
Boston Scientific has witnessed some important developments in its Rhythm and Neuro segment over the past few months.
The company, in September, signed an investment agreement with an exclusive option to acquire Farapulse, Inc, a privately held company developing a pulsed field ablation system. The same month, Boston Scientific announced the receipt of the CE Mark and the subsequent limited-market launch of its fourth-generation Vercise Genus Deep Brain Stimulation System in Europe.
In June, Boston Scientific received the FDA 510(k) clearance for its LUX-Dx Insertable Cardiac Monitor System.
Price Performance
Shares of the company have lost 21.3% in the past year against the industry’s 4.8% growth and the S&P 500’s 18.3% rise.
Zacks Rank & Key Picks
Currently, Boston Scientific carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Hologic, Inc. (HOLX - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and ResMed Inc. (RMD - Free Report) .
Hologic’s long-term earnings growth rate is estimated at 17.4%. The company presently sports 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 18%. It currently carries a Zacks Rank #2 (Buy).
ResMed’s long-term earnings growth rate is estimated at 14.5%. The company presently 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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