Electrophysiology Devices: Key Players In A Fast-Growing Market

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Includes: ABT, ATRC, BSGM, BSX, HNSN, JNJ, MDT, STXS
by: Hedged Equity

Summary

EP Ablation Catheter is the largest and fastest growing segment.

Medtronic's AF Solutions business has been growing at a rate twice the market growth, driven by global acceptance of the Arctic Front CryoAblation System and PVAC Gold Phased RF system.

Biosense Webster, a subsidiary of Johnson & Johnson Ltd., is the market leader in the global electrophysiology devices market.

Abbott, with its most recent acquisition of St. Jude Medical (SJM) closed on January 2017; the combined business of SJM and Abbott has created a premier medical device leader.

Electrophysiology Devices - Companies Research Report Introduction

Arrhythmia refers to abnormal heart rhythms due to any change from the normal sequence of electrical impulses in the heart. It is more prevalent in people over 65 years of age who suffer from heart damage caused by heart attack, cardiac surgery or any other heart condition. Atrial fibrillation, which is the most common of arrhythmia, has one of the highest incidence and prevalence rates globally. Around 65% of patients with arrhythmia suffer from AF. According to American Heart Association (AHA) estimates, AF affects between 2.7 and 6.1 million people in the US, and its prevalence is expected to double by 2050.

Electrophysiology (EP) is the study of the mechanism, function and performance of electrical signaling pathways that guide the functioning of the heart. EP study is a procedure that is performed to diagnose arrhythmias by locating areas of heart tissue that interrupt the normal functioning of the heart's electrical system. During an EP study, the electrophysiologist inserts several long, flexible tubes with wires, called catheters, into the heart to record electrical activity within the heart chambers and to detect abnormal electrical pathways. The second part of the test involves electrical stimulation of various parts of the heart to induce an abnormal heart rhythm. This helps the electrophysiologist in treatment mapping, which could involve surgical removal of the abnormal tissue in the heart using a catheter.

Electrophysiology is a specialty area within the cardiovascular market that is witnessing rapid growth. Electrophysiology devices are intended for use in the diagnosis and treatment of atrial fibrillations and other abnormal rhythms of the heart. The electrophysiology devices market can majorly be categorized into three segments: Electrophysiology Ablation Catheters, Electrophysiology Diagnostic Catheters, and Electrophysiology Lab Systems.

Electrophysiology Devices Market Sizing: Global Market was Valued at $4bn in 2016

Table: Global Electrophysiology Devices Market, Revenue ($bn), 2016 - 2021

2015

2016

2017

2018

2019

2020

2021

CAGR 2016 - 2021

Electrophysiology Devices

3.4

3.8

4.2

4.6

5.2

5.7

6.4

11%

The global electrophysiology devices market was valued at $4 billion in 2016 and is forecast to grow at a compound annual growth rate (CAGR) of 11% over the next five years (St. Jude Medical Analyst and Investor Meeting, 2016). The increasing incidence of arrhythmia worldwide coupled with the limited long-term success of drug therapy and its potential undesirable side-effects in patients with arrhythmia has transformed the cardiac arrhythmia market into a lucrative market for electrophysiology device manufacturers globally.

Electrophysiology Market Segments: EP Ablation Catheter is the Largest and Fastest Growing Segment

The electrophysiology devices market can majorly be categorized into three segments: Electrophysiology Ablation Catheters, Electrophysiology Diagnostic Catheters, and Electrophysiology Lab Systems.

Figure: Global Electrophysiology Devices Market, Market Segmentation (%), 2016

Source: St. Jude Medical 2016 Analyst and Investor Meeting (February 2016)

Note: Others include ICE and LAA closure devices

The EP ablation catheter is the largest segment, accounting for 31% of the global EP devices market. The EP ablation catheter market was valued at $1.2 billion in 2016. The EP ablation catheter market is primarily driven by the increase in the use of the ablation procedure for the treatment of AF, a highly prevalent heart rhythm disorder affecting around 12 million people worldwide, and the most common cause of stroke.

The recognition of catheter ablation as class I recommendation for AF in drug refractory patients and class II recommendation as a front-line treatment for AF has facilitated rapid increase in procedural volumes. Worldwide ablation procedures were estimated to be around 950,000 in 2016, growing at a rate of 10% annually. As a result, manufacturers are increasingly directing their product development efforts towards designing ablation catheters specifically indicated for AF treatment.

At present, the AF treatment (ablation) market is only around 2% penetrated, making it a highly attractive market for medtech players.

Global Electrophysiology Devices Market - Competitive Landscape

The global EP devices market is dominated by four major players and has experienced some minor changes in the past several years due to M&A activity.

Biosense Webster, a subsidiary of Johnson & Johnson Ltd. (NYSE:JNJ), is the market leader in the global electrophysiology devices market. The company accounted for ~44% market share in 2015. Biosense Webster's broad product offerings, including ablation catheters, an ablation generator, guiding sheaths, the 3D CARTO navigation system, and diagnostic catheters, as well as the compatibility of its catheters with the Stereotaxis (NASDAQ:STXS) magnetic navigation system, places the company in a strong position. Collaborations with Stereotaxis, Siemens Healthcare (OTCPK:SIEGY), and GE Healthcare (NYSE:GE) also enabled the company to maintain a substantial market share.

Abbott Laboratories (NYSE:ABT), Medtronic (NYSE:MDT), and Boston Scientific Corporation (NYSE:BSX) are other leading competitors in the market. Abbott entered and took over the EP market with a series of acquisitions and investments. With its most recent acquisition of St. Jude Medical (SJM) closed on January 2017, the combined business of SJM and Abbott has created a premier medical device leader securing second position in the AF EP marketplace.

Medtronic's AF Solutions business has been growing at a rate twice the market growth, driven by global acceptance of the Arctic Front CryoAblation System and PVAC Gold Phased RF system.

Boston Scientific strives to strengthen its foothold in the global EP devices market through innovations and acquisitions. The company's EP business was significantly boosted following the acquisition of Bard EP in 2013. Boston Scientific garnered net sales of $233 million for the year ended December 31, 2015, (Boston Scientific 2015 Annual Report and 10-K). Additionally, the company's leading product lines - the RHYTHMIA Mapping System and IntellaMap Orion Mapping Catheter entered full global commercialization in 2015.

Table: Global Electrophysiology Devices Market, Company Ranking

Company Name

Market Ranking

Biosense Webster, Inc.

#1

Abbott Laboratories (includes SJM)

#2

Medtronic, Inc.

#3

Boston Scientific Corporation (includes Bard EP)

#4

Sources:

JNJ Medical Devices & Diagnostics Presentation (2013)

Abbott Presentation - Creating A Premier Medical Device Leader (April 2016)

Medtronic Annual Report and Form 10-K (2016)

Boston Scientific Corporation Investor Day (2015)

Key Market Players

Biosense Webster, Inc. (Biosense Webster), a subsidiary of Johnson & Johnson, is a medical device company engaged in the design and manufacturing of diagnostic and therapeutic products for the diagnosis and treatment of cardiac arrhythmias. The company's comprehensive product portfolio ranges from diagnostic and therapeutic catheters to navigation systems that enable electrophysiologists to map the pathways of complex arrhythmias with accuracy and to offer patients a cure through advanced cardiac ablation techniques.

In 2009, the company received US FDA approval for the marketing of its CARTO 3 System, which is the most advanced 3D imaging technology for use by electrophysiologists for the treatment of cardiac arrhythmias. Some of the innovative proprietary products of the company include the CARTO XP System, the CARTOSOUND Image Integration Software Module, the THERMOCOOL Irrigated Tip Catheter, and the LASSO Circular Variable Mapping Catheter.

In August 2016, Biosense Webster was granted FDA premarket approval for its THERMOCOOL SmartTouch SF catheter. The catheter is designed to be integrated into the company's flagship CARTO 3 system during cardiac ablation procedures to treat AF.

Table: Biosense Webster Inc., EP Devices Portfolio, 2016

Diagnostic Catheters

ISMUS Catheter

HALO XP Tricuspid Mapping Catheter

CRISTACATHCatheter

PENTARAY® NAV Eco Catheter

LASSO® NAV Eco Catheter

DECANAV™ Catheter

SOUNDSTAR® Catheter

Ablation Catheters

NAVISTAR Catheter

THERMOCOOL SF Catheter

THERMOCOOL Catheter

THERMOCOOL SF Bi-Directional Catheter

THERMOCOOL SMARTTOUCH Catheter

EP Lab Systems (Navigation Systems)

CARTO 3 System

Generator

SMARTABLATE™ SYSTEM

Sources:

JnJ Website (Biosense Webster Products)

Biosense Webster Website (Products)

Boston Scientific Corporation

Boston Scientific Corporation (Boston Scientific) is a leading provider of minimally invasive treatment for cardiac arrhythmias. The company provides a wide array of diagnostic catheters for performing diagnostic EP study, along with therapeutic ablation catheters and RF ablation systems. The addition of Bard Electrophysiology's robust portfolio, including catheter and recording device technologies, almost doubled the size of the Boston Scientific's Electrophysiology business.

The company's leading product lines include the Blaze line of ablation catheters designed to deliver enhanced performance and responsiveness, and the RHYTHMIA Mapping System, a catheter-based, 3-D cardiac mapping and navigation solution designed to help diagnose and treat a variety of arrhythmias.

Table: Boston Scientific Corporation, EP Devices Portfolio, 2016

Product Type

Product Name

Diagnostic Catheters

Blazer Dx-20 Bidirectional Duodecapolar Diagnostic Catheter

SteeroCath-Dx™ Steerable Diagnostic Catheter

Polaris X™ Steerable Diagnostic Catheter

Constellation® Diagnostic Mapping Catheter

Ultra ICE™ Imaging Catheter

IntellaMap Orion™ High-Res Mapping Catheter

WovenFlexie™ Fixed Curve Diagnostic Catheter

Woven Diagnostic Catheter

Viking™ Fixed-Curve Diagnostic Catheter

Tango® Stabilene™ Fixed-Curve Diagnostic Catheter

Dynamic Tip™ CS Steerable Diagnostic Catheter

Dynamic XT™ CS Steerable Diagnostic Catheter

Radia™ Steerable Mapping Catheter

EP•XT™ CS Steerable Diagnostic Catheter

Orbiter™ PV Advanced Mapping Catheter

Orbiter™ ST Steerable Mapping Catheter

CONFORMA™ Bidirectional Diagnostic Catheter

EP Lab Systems

LabSystem™ PRO EP Recording System

EPLogix™ Mapping and Analysis Suite

EPLink™ H.I.S. Interface

MicroPace StimLab™ Bedside Interface

CLEARSIGN™ Amplifier

Rhythmia Mapping System

Ablation Catheters

Blazer™ II Temperature Ablation Catheter

Blazer™ II HTD Temperature Ablation Catheter

Blazer Prime™ Temperature Ablation Catheter Family

Blazer™ II XP Temperature Ablation Catheter

Blazer Prime™ XP Temperature Ablation Catheter Family

Blazer™ Open-Irrigated Ablation Catheter

Chilli II Cooled Ablation Catheters

IntellaTip MiFi™ XP Catheter

RF Generator

Maestro 3000™ Cardiac Ablation Generator

Source: Boston Scientific Corporation - Electrophysiology Products Corporate Overview (January 2014)

Medtronic, Inc.

Medtronic, Inc. (Medtronic) is a medical technology company that offers a comprehensive range of radiofrequency and cryoablation catheters for the treatment of cardiac arrhythmias.

The company's portfolio of AF solutions includes the Arctic Front Advance System, which encompasses the US FDA approved Aortic Front Advance ST CryoAblation Catheter, indicated for pulmonary vein isolation in the treatment of patients with drug refractory paroxysmal AF. Medtronic received the US FDA approval for its Aortic Front Advance ST CryoAblation Catheter in the first quarter of 2016.

Table: Medtronic Inc., EP Devices Portfolio, 2016

Product Type

Product Name

Diagnostic Catheters

5F Torqr Coronary Sinus Series Diagnostic Catheters

Marinr Coronary Sinus Series Diagnostic Catheters

Marinr (Multi-Curve) and MCXL Series Diagnostic Catheters

Marinr (Single-Curve) Series Diagnostic Catheters

Soloist Series Diagnostic Catheters

Torqr Series Diagnostic Catheters

Stablemapr SM Series Diagnostic Catheters

RF Ablation Catheters

4mm RF Conductr (Multi-Curve) Series

5mm RF Conductr (Multi-Curve) Series

5F RF Marinr (Single-Curve) Series

RF Contactr (Dual-Curve) Series

RF Enhancr II (Single-Curve) Series

RF Marinr (Multi-Curve) Series

Cryoablation Catheters and

Systems

Freezor Cardiac CryoAblation Catheter

Freezor Xtra Surgical Cardiac CryoAblation Device

Freezor MAX Surgical Cardiac CryoAblation Device

Arctic Front Advance CryoAblation Catheter

Achieve Mapping Catheter

CryoConsole Cardiac CryoAblation System

Sources:

Medtronic Website (Cardiac Ablation Products)

Medtronic Annual Report and Form 10-K (2016)

Abbott Laboratories

Abbott Laboratories is a global healthcare company. Abbott electrophysiology business is among the fastest growing segments within the company's broader device portfolio. The Abbott EP product portfolio offers diagnostic, access, mapping and therapy solutions for diagnosis and treatment of heart arrhythmias.

Table: Abbott Laboratories, EP Devices New Portfolio, 2016

St. Jude Medical Products

Abbott Products

TactiCath Quartz Contact Force Ablation Catheter

Topera Rotor Mapping Solution

FlexAbility Irrigated Ablation Catheter

EnSite Precision cardiac mapping system

WorkMate Claris™ Recording System

MediGuide™ Technology

Ampere RF Ablation Generator

Advisor FL Circular Mapping Catheter, Sensor Enabled

Agilis NxT Steerable Introducer

Sources:

Abbott Presentation - Creating A Premier Medical Device Leader (April 2016)

SJM website (Electrophysiology Products)

Independent and Emerging Players

Despite the fact that the EP market is characterized by intense competition and is currently governed by four large companies that account for majority of the EP device market share, a number of independent players with breakthrough technologies are emerging in the rapidly growing $4 billion EP marketplace.

Table: Independent Companies in the EP Market

Company

Location

Year Founded

Key Product

Developmental Stage

Sales ($mn)

Stereotaxis

St. Louis, Missouri

1990

Epoch Solution (Niobe ES Remote Magnetic Navigation System, Odyssey Solution, the Vdrive Robotic Navigation System)

Marketed

37.7 (year ended December 31, 2015)

AtriCure (NASDAQ:ATRC)

Mason, Ohio

2000

Isolator Synergy Ablation System; AtriClip

Marketed

1297 (year ended December 31, 2015)

Hansen Medical (NASDAQ:HNSN)

Mountain View, California

2002

Sensei Robotic System

Marketed

BioSig (OTCQB:BSGM)

Minneapolis, Minnesota

2009

PURE EP System

510(k)

CardioFocus

Marlborough, Massachusetts

1990

HeartLight Endoscopic Ablation System

Pre-Market Approval (NYSEARCA:PMA) in April 2016

Received CE mark in July 2009

Stereotaxis is a leading healthcare technology company engaged in the development of robotic navigation systems for the treatment of cardiac arrhythmias and coronary disease.

The company's proprietary Epoch Solution is an advanced remote robotic navigation system for use in a hospital's interventional surgical suite for the treatment of arrhythmias and coronary artery disease. The Epoch Solution comprises of the Niobe ES Remote Magnetic Navigation System, Odyssey Solution, the Vdrive Robotic Navigation System, and related devices.

The company has entered into strategic alliances with leading technology companies including Siemens, Philips, and Biosense Webster to commercialize its Niobe system. The company integrates its Niobe system with Siemens' and Philips' cath lab imaging systems (NYSE:PHG) and Biosense Webster's 3D catheter location sensing technology.

Table: Stereotaxis Inc., EP Marketed Products

Company

Product Type

Product Name

Product Description

Stereotaxis Inc.

EP Navigation System

Niobe ES Remote Magnetic Navigation System

Provides the physician with remote instrument control.

Advantages of the system include:

- Precise control of diagnostic and therapeutic devices;

- reduction in x-ray exposure to physicians, staff and patients; and

- soft and consistent tissue contact along with efficient and successful procedures due to computer control and digital automations.

Information Management Solution

Odyssey Solution

Offers a fully integrated, real-time information solution to manage, control, record and share procedures across networks or around the world, enabling doctors to focus on the patient for optimal procedure efficiency

Also features a remote viewing and recording capability called Odyssey Cinema, which is an innovative solution delivering synchronized content for optimized workflow, advanced care and improved productivity

EP Navigation System

Vdrive Robotic Navigation System

- Provides remote, robotic control of diagnostic devices

- Provides precise movement of devices

- Maintains stability of devices

Sources:

Stereotaxis Inc. Website (Products)

Stereotaxis Annual Report and Form 10-K (2016)

AtriCure, Inc. is a leading provider of AF solutions. The company's product lines include RF ablation devices, cryoablation devices, and left atrial appendage (LAA) management devices.

Table: AtriCure Inc., EP Marketed Products

Company

Product Type

Product Name

Product Description

AtriCure Inc.

Radio Frequency Ablation Device

Isolator Synergy Ablation System

Only FDA-approved surgical device for the treatment of persistent atrial fibrillation and longstanding persistent atrial fibrillation

Cryoablation Device

cryoICE Cryoablation System

Used to ablate cardiac tissue for the treatment of cardiac arrhythmias and to provide temporary pain relief to thoracic surgery patients via ablation of peripheral nerves

LAA Management Device

AtriClip System

Designed to exclude the left atrial appendage by mechanically clamping the appendage from the outside, eliminating blood flow between the left atrial appendage and the atrium while avoiding contact with circulating blood

Sources:

AtriCure Inc. Website (Products)

AtriCure Inc. Annual Report and Form 10-K (2016)

Hansen Medical is a global leader in advanced medical robotic solutions intended for use in electrophysiology procedures and peripheral vascular interventions. The company's EP product offerings include the Sensei System (Sensei X and Sensei X2 generations of systems) and the Artisan Extend catheter.

Table: Hansen Medical, EP Marketed Products

Company

Product Type

Product Name

Product Description

Hansen Medical

EP Navigation system

Sensei Robotic System

- Facilitates manipulation and stable control of catheter and catheter-based technologies during EP procedures

- Provides navigation of flexible catheters, resulting in stability, and control in interventional procedures

Robotic Catheter

Artisan Extend Control Catheter

Designed to offer advanced navigational capabilities and the flexibility required to reach difficult-to-access cardiac anatomy while maintaining stability during complex cardiac arrhythmia procedures

Sources:

Hansen Medical Website (Cardiac Arrhythmia Products)

Hansen Medical Annual Report and Form 10-K (2015)

CardioFocus, Inc. is a manufacturer of advance ablation treatment for AF. The company received PMA from the US FDA for its HeartLight Endoscopic Ablation System, a novel catheter ablation technology for the treatment of patients with paroxysmal AF. The HeartLight System consists of the HeartLight Catheter, the Endoscope, Balloon Fill Media and the HeartLight Console.

Table: CardioFocus, Inc., Key Marketed Products

Company

Product Type

Product Name

Product Description

CardioFocus, Inc.

EP Ablation System

HeartLight Endoscopic Ablation System

Incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation

Source: CardioFocus Inc. Website (Technology)

BioSig Technologies, Inc. is an emerging player engaged in development of a proprietary technology platform for cardiac electrophysiology procedures.

The company is currently seeking FDA 510(k) clearance for its first product, PURE EP System, which is a surface electrocardiogram and intracardiac multichannel recording and analysis system. BioSig has partnered with some of the leading cardiac centers, including the Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, U.H. Case Medical Center in Cleveland, William Beaumont Hospital in Michigan, Mount Sinai Medical Center in New York, and the Mayo Clinic in Minnesota on the development and preclinical/clinical testing of the PURE EP system.

In February 2016, BioSig signed an agreement with Minnetronix to initiate development of its PURE EP system. The product is expected to be launched in second quarter of 2017.

Table: BioSig Technologies, Inc., EP Pipeline Product

Company

Product Type

Product Name

Key Features

Estimated Cost

BioSig Technologies, Inc.

EP recording and mapping system

Precise Uninterrupted Real-time evaluation of Electrograms PURE EP System

- Improved resolution

- Clearer cardiac recordings

- Longer dynamic range

- Intuitive and flexible display

- Designed to run alongside existing systems

$175,000per install

Source: BioSig Website

BioSig's PURE EP System versus Standard EP Systems

High-quality information provided by the EP recording system is essential for an electrophysiologist to determine ablation strategies during the termination of arrhythmias. However, the EP recording systems currently available on market are hampered by high signal-to-noise ratio outputs, limited dynamic range, and low sampling rates. The limitations of these standard EP systems make it difficult for the electrophysiologist to find and treat arrhythmias such as atrial fibrillation and ventricular tachycardia. Also, it leads to longer surgery times and lower success rate for cardiac ablation procedures, thereby adding significant cost to the hospitals and potential adverse effects on the patient.

BioSig's proprietary system has been developed to overcome these challenges. The PURE EP System is designed to be superior to traditional EP recording systems owing to its unique features such as very low noise, longer dynamic range, and its ability to provide critical information that is unobtainable from any other EP device. Most importantly, PURE EP is designed to be used in conjunction with existing EP recording systems.

Some of the benefits of the PURE EP System are:

  • Facilitates real-time clinical decision-making
  • Maximizes ablation efficiency and improve procedural outcomes
  • Reduces procedure times

Thus, BioSig through its PURE EP System is poised to capture a significant portion of the rapidly growing EP market by bringing a new product category to the market, an EP Information System, which makes interpretation and visualization of challenging signals possible.

Global Electrophysiology Devices Market - Mergers & Acquisitions (M&A)

The EP devices market is characterized by a high degree of M&A activity and consolidation, with major players acquiring small and niche companies. The major reason for the acquisition spree in the electrophysiology devices market is that small players are technologically sound with strong product pipelines, which allows major players to further expand their product portfolio, improve their market share and provide opportunities to be the first entrant into a niche market segment.

For instance, Abbott entered into the high-growth EP market in 2014 through acquisition of Topera Medical, developer of a 3-D rotor mapping system to improve AF diagnosis and treatment. Abbott also secured an option to buy Advanced Cardiac Therapeutics (NASDAQ:ACT), which was developing an ablation catheter designed to improve the safety and effectiveness of ablation procedures. To further expand its presence in the EP market, Abbott acquired Kalila Medical, a private medical device company developing access technologies used in electrophysiology procedures. With its recent acquisition of St. Jude Medical, the company has become a contender as global leader of the EP devices market.

There was a marked increase in the number of deals over past years in the electrophysiology devices market. The high-value deals are indicative of the ambitious expansion plans of companies in this segment. This is evident from the table below:

Table: EP Devices Market, M&A Activity

Acquirer

Target

Deal Value

Year of Acquisition

Deal Rationale

Abbott

St. Jude Medical

$25 billion

April 2016 (Announced)

January 2017 (Closed)

The combined business will hold leadership position across large and high-growth cardiovascular device markets, along with a powerful pipeline that is expected to bring numerous new medical device products to key markets

Abbott

Kalila Medical

Undisclosed

February 2016

To expand and strengthen its presence in AF market

AtriCure

nContact

$99 million

October 2015

To expand and strengthen its presence in AF market

Medtronic

CardioInsight

$93 million

June 2015

CardioInsight's ecVUE system will complement

Medtronic's atrial fibrillation solutions business in its cardiac rhythm and heart failure division. ecVUE system is a noninvasive cardiac system that maps electrical disorders of the heart. The device received FDA 510(k) clearance in November 2014.

Abbott

Advanced Cardiac Therapeutics

NA

October, 014

Option to acquire this ablation catheter company. Ablation catheter will complement the mapping system from Topera deal

Abbott

Topera Medical

$250 million

December 2014

To gain foundational entry into EP devices market

Boston Scientific

Bard EP

$275 million

November 2013

Strengthen Boston Scientific's presence in the EP market and help compete with bigger players

Source: Company Press Releases

Key Sources:

American Heart Association (October 2016).

St. Jude Medical 2016 Analyst and Investor Meeting (February 2016).

JNJ Presentation: Medical Devices & Diagnostics.

Boston Scientific 2015 Annual Report and 10-K.

Disclosure: I am/we are long STXS, BSGM.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: www.HedgedEquity.com has a long position in STXS and BSGM in its model portfolios at the time of this publication.


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