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Boston Scientific's (BSX) Wavewriter Alpha SCS Gets FDA's Nod
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Boston Scientific, Inc. (BSX - Free Report) recently received FDA approval for an expanded indication of the WaveWriter Alpha Spinal Cord Stimulator (“SCS”) Systems. With this approval, the system will be available for the treatment of painful diabetic peripheral neuropathy (DPN) — a complication of diabetes that can affect the lower extremities of the body.
The recent approval is set to boost the company’s Neuromodulation business, which develops and manufactures devices to treat various neurological movement disorders and manage chronic pain.
Significance of the News
Diabetic neuropathy is a type of nerve damage that can occur in people living with diabetes. With time, high blood sugar (glucose) can injure nerves throughout the body, often impacting nerves in the legs and feet. Depending on the affected nerves, diabetic neuropathy symptoms include pain and numbness in the legs, feet and hands. Per a published estimate, of the 37.3 million Americans who live with diabetes (11.3% of the U.S. population), diabetic neuropathy will affect nearly 50% of adults living with diabetes during their lifetime.
Image Source: Zacks Investment Research
The WaveWriter Alpha SCS Systems include a unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators to provide uncompromised personalization. The company’s proprietary FAST (Fast-Acting Sub-perception Therapy) included in SCS is designed to deliver profound paresthesia-free pain relief in a minute.
News in Detail
The WaveWriter Alpha SCS Systems were previously approved by the FDA in December 2020 for the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, complex regional pain syndrome types I and II intractable low back pain and leg pain. The latest approval expands the indications to include DPN of the lower extremities for paresthesia-based stimulation.
As a non-opioid treatment option, the system provides therapy for pain relief by sending mild electric pulses to the spinal cord to interrupt pain signals traveling to the brain. The use of SCS is an important advancement for Boston Scientific, which intends to support a subset of the diabetes population for one of the fastest-growing chronic conditions in the world.
According to Boston Scientific’s representative, the expanded indication underscores the company’s commitment to delivering a robust portfolio of interventional pain solutions that provide physicians with more treatment choices to help their patients find relief.
Industry Prospects
Per a report by Precedence Research, the global neuromodulation market was valued at $6.43 billion in 2022 and is expected to witness a CAGR of 12.2% by 2032.
Recent Highlights of the Neuromodulation Unit
In the last reported second quarter of 2023, BSX’s operational net sales growth across the Neuromodulation business was primarily driven by growth within the deep brain stimulation franchise, having seen continued momentum from new product launches in the United States and procedure recovery in Europe. Throughout the first half of the year, sales were driven by improved procedural volume growth within the SCS franchise, led by the WaveWriter Alpha SCS System, as well as growth within the deep brain stimulation franchise.
In July 2023, BSX received FDA approval for the Vercise Neural Navigator 5 software, which, combined with Vercise Genus Deep Brain Stimulation Systems, can help provide clinicians with data for efficient programming in the treatment of Parkinson's disease. Further, the company anticipates sales in the SCS franchise to improve in the second half of the year, with strong trialing in the second quarter, backed by the company’s recent presentation of clinical evidence at Aspen.
Price Performance
In the past six months, Boston Scientific shares have decreased 4.3% compared with the industry’s fall of 18.3%.
Zacks Rank and Other Key Picks
Boston Scientific currently carries a Zacks Rank #2 (Buy).
Cardinal Health stock has risen 36.7% in the past year. Earnings estimates for the company have increased from $6.65 to $6.66 in 2023 in the past 30 days and from $7.56 to $7.57 for 2024 in the past seven days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.03%. In the last reported quarter, it posted an earnings surprise of 4.73%.
Estimates for Haemonetics’ 2023 earnings per share have remained constant at $3.82 in the past 30 days. Shares of the company have increased 15.1% in the past year against the industry’s decline of 9.4%.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 25.8% in the past year compared with the industry’s growth of 20.6%.
ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it posted an earnings surprise of 9.90%.
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Boston Scientific's (BSX) Wavewriter Alpha SCS Gets FDA's Nod
Boston Scientific, Inc. (BSX - Free Report) recently received FDA approval for an expanded indication of the WaveWriter Alpha Spinal Cord Stimulator (“SCS”) Systems. With this approval, the system will be available for the treatment of painful diabetic peripheral neuropathy (DPN) — a complication of diabetes that can affect the lower extremities of the body.
The recent approval is set to boost the company’s Neuromodulation business, which develops and manufactures devices to treat various neurological movement disorders and manage chronic pain.
Significance of the News
Diabetic neuropathy is a type of nerve damage that can occur in people living with diabetes. With time, high blood sugar (glucose) can injure nerves throughout the body, often impacting nerves in the legs and feet. Depending on the affected nerves, diabetic neuropathy symptoms include pain and numbness in the legs, feet and hands. Per a published estimate, of the 37.3 million Americans who live with diabetes (11.3% of the U.S. population), diabetic neuropathy will affect nearly 50% of adults living with diabetes during their lifetime.
Image Source: Zacks Investment Research
The WaveWriter Alpha SCS Systems include a unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators to provide uncompromised personalization. The company’s proprietary FAST (Fast-Acting Sub-perception Therapy) included in SCS is designed to deliver profound paresthesia-free pain relief in a minute.
News in Detail
The WaveWriter Alpha SCS Systems were previously approved by the FDA in December 2020 for the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, complex regional pain syndrome types I and II intractable low back pain and leg pain. The latest approval expands the indications to include DPN of the lower extremities for paresthesia-based stimulation.
As a non-opioid treatment option, the system provides therapy for pain relief by sending mild electric pulses to the spinal cord to interrupt pain signals traveling to the brain. The use of SCS is an important advancement for Boston Scientific, which intends to support a subset of the diabetes population for one of the fastest-growing chronic conditions in the world.
According to Boston Scientific’s representative, the expanded indication underscores the company’s commitment to delivering a robust portfolio of interventional pain solutions that provide physicians with more treatment choices to help their patients find relief.
Industry Prospects
Per a report by Precedence Research, the global neuromodulation market was valued at $6.43 billion in 2022 and is expected to witness a CAGR of 12.2% by 2032.
Recent Highlights of the Neuromodulation Unit
In the last reported second quarter of 2023, BSX’s operational net sales growth across the Neuromodulation business was primarily driven by growth within the deep brain stimulation franchise, having seen continued momentum from new product launches in the United States and procedure recovery in Europe. Throughout the first half of the year, sales were driven by improved procedural volume growth within the SCS franchise, led by the WaveWriter Alpha SCS System, as well as growth within the deep brain stimulation franchise.
In July 2023, BSX received FDA approval for the Vercise Neural Navigator 5 software, which, combined with Vercise Genus Deep Brain Stimulation Systems, can help provide clinicians with data for efficient programming in the treatment of Parkinson's disease. Further, the company anticipates sales in the SCS franchise to improve in the second half of the year, with strong trialing in the second quarter, backed by the company’s recent presentation of clinical evidence at Aspen.
Price Performance
In the past six months, Boston Scientific shares have decreased 4.3% compared with the industry’s fall of 18.3%.
Zacks Rank and Other Key Picks
Boston Scientific currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are Cardinal Health (CAH - Free Report) , Haemonetics (HAE - Free Report) and Align Technology (ALGN - Free Report) , each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cardinal Health stock has risen 36.7% in the past year. Earnings estimates for the company have increased from $6.65 to $6.66 in 2023 in the past 30 days and from $7.56 to $7.57 for 2024 in the past seven days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.03%. In the last reported quarter, it posted an earnings surprise of 4.73%.
Estimates for Haemonetics’ 2023 earnings per share have remained constant at $3.82 in the past 30 days. Shares of the company have increased 15.1% in the past year against the industry’s decline of 9.4%.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 25.8% in the past year compared with the industry’s growth of 20.6%.
ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it posted an earnings surprise of 9.90%.