Tag: Medical Devices

Medtech Industry Heats Up as KARL STORZ Acquires Surgical Robotics Firm Asensus

Posted on by slightbourne@noblecapitalmarkets.com

The medtech deal landscape just got a major shake-up with medical technology giant KARL STORZ announcing it will acquire surgical robotics company Asensus Surgical for $0.35 per share in cash. The $775 million transaction represents a significant premium for Asensus shareholders and will create a new leader in robotic surgery systems within KARL STORZ’s vast product portfolio.

The acquisition highlights the intense interest and competition around next-generation surgical robotics platforms. KARL STORZ is doubling down on the space by bringing Asensus and its augmented intelligence technologies in-house to enhance its robotic surgery offerings, particularly the promising LUNA system Asensus had in development.

For the medtech sector and investors, this high-profile deal carries several implications:

Robotic Surgery Becomes Key Priority
KARL STORZ’s major bet on Asensus signals just how strategically important robotic-assisted surgery has become for medtech companies. The ability to market cutting-edge robotic platforms that improve precision and outcomes is now table stakes in many areas of surgery.

Medtechs involved in supporting technologies like visualization, data integration, and procedural automation should see increased interest and investment from larger players looking to beef up their surgical robotics capabilities. KARL STORZ’s acquisition also puts increased pressure on peers like Intuitive Surgical and Stryker to stay ahead of the innovation curve.

More Consolidation Could Follow
Billion-dollar acquisitions often beget more deals as competitors look to keep pace and buttress their own product portfolios. This could kick off another wave of M&A in the surgical robotics space specifically, with smaller innovative companies becoming prime targets for medtech incumbents.

But beyond just robotics, KARL STORZ’s aggressive move may spur more consolidation across the broader medtech landscape. Major strategic buyers have been a bit apprehensive on M&A recently. This deal could provide a catalyzing force for other medtechs, pharmaceuticals, and life science companies to start getting more acquisitive, especially with several cutting-edge names trading at more attractive valuations.

Public Listing Exits Will Continue
By taking Asensus private, KARL STORZ adds another data point to the growing trend of medtech companies going private or getting acquired by larger players. With the IPO markets effectively shuttered and sustaining a public listing increasingly difficult for many small-to-mid-sized medtechs, a lucrative exit via acquisition could become the preferred route.

Investors may need to adjust expectations and position accordingly. Rather than holding out for the “next big IPO,” top-performing private medtech holdings may deliver the biggest windfall by positioning to get scooped up via M&A premium valuations down the road.

Capital Allocation Will Be Key
The KARL STORZ-Asensus transaction underscores how critically important prudent capital allocation and portfolio management will be for medtech investors. The 67% premium paid by the German firm highlights the potential upside for backing innovative, promising names before they get acquired.

But it also serves as a reminder of the downside risks – making the wrong medtech bets can lead to significant impairment if firms struggle to remain viable acquisition targets or get their technologies to market successfully. Having robust processes to separate the wheat from the chaff across the medtech universe will be paramount moving forward.

KARL STORZ’s acquisition of Asensus represents both an ambitious strategic move for the medical device titan and an intriguing data point for medtech investors to digest. As the broader life science space continues rapidly evolving, this landmark M&A deal provides some insight into the developing landscape that savvy medtech investors will need to navigate adeptly.

GTCR to Take Surmodics Private in $627 Million Medical Tech Deal

Posted on by slightbourne@noblecapitalmarkets.com

One of the medical technology industry’s leading providers of coating systems and surface modification is being taken private by private equity firm GTCR in a $627 million deal. Surmodics (SRDX) announced Monday that it has entered into a definitive agreement to be acquired by GTCR in an all-cash transaction valuing the company at $43 per share.

The acquisition price represents a premium of over 41% to Surmodics’ average trading price over the past 30 days. It comes amid a broader push by private equity to double down on investments in the healthcare technology space as medical device innovation accelerates.

Surmodics has been a pioneer in the delivery of surface modification solutions that enhance the biocompatibility of medical products. The Eden Prairie, Minnesota-based company’s technologies are used by blue-chip medical device manufacturers to enable products to interact more safely and effectively with the human body.

Its proprietary coating and treatment platforms are integrated into thousands of devices including vascular intervention technologies, minimally invasive surgical tools, in vitro diagnostics, and ophthalmic products. Surface treatments from Surmodics can improve device thromboresistance, lubricity, durability, adhesion, and biocompatibility.

Those differentiated capabilities caught the eye of GTCR, which has significant experience investing in healthcare companies. The Chicago-based private equity firm currently manages over $25 billion in equity capital across multiple investment strategies.

For Surmodics shareholders, the $43 per share cash deal represents an attractive exit price. In addition to the 41% premium to the recent trading average, the buyout price is 26% higher than where the stock closed on Friday. The company’s shares soared 25% on Monday following news of the transaction.

Surmodics’ Board of Directors unanimously approved the merger agreement and recommends shareholders vote in favor of the deal. The transaction is expected to close in the second half of 2024, subject to shareholder approval, regulatory clearances, and other customary closing conditions.

Upon completion of the acquisition, Surmodics will become a privately held company and its shares will cease trading on the Nasdaq exchange.

The medical coatings and surface technology space has seen heightened M&A activity in recent years as major medical product companies seek to enhance their product pipelines. Private equity investors like GTCR have ample dry powder to deploy into healthcare sectors positioned for durable growth driven by demographic tailwinds and innovation.

While going private will provide Surmodics with flexibility to invest for the long-term, the $627 million price tag validates the company’s tools and know-how as essential for next-generation medical device engineering. As healthcare investors compete to back enablers of cutting-edge medical products, GTCR’s bet on Surmodics’ coating capabilities could pay off handsomely.

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Noble Capital Markets Emerging Growth Virtual Healthcare Conference Presentation Replays

Posted on by slightbourne@noblecapitalmarkets.com
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  • Emerging Growth Public Healthcare Company Executive Presentations
  • Q&A Sessions Moderated by Noble’s Analysts and Bankers
  • Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17th and 18th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.

Part of Noble’s Robust 2024 Events Calendar

The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

Sign up to receive more information on Noble’s other virtual conferences here.

What to Expect

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

The emerging growth healthcare space may be poised for a breakout year.  The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in the healthcare space can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.

Healthcare Investment Ideas on Display at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

Posted on by cpatches

Get the Virtual Conference eBook

Watch the Presentation and Q&A Replays

  • Emerging Growth Public Healthcare Company Executive Presentations
  • Q&A Sessions Moderated by Noble’s Analysts and Bankers
  • Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17th and 18th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.

Part of Noble’s Robust 2024 Events Calendar

The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

Sign up to receive more information on Noble’s other virtual conferences here.

What to Expect

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

The emerging growth healthcare space may be poised for a breakout year.  The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in the healthcare space can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.

Medical Device Company Laborie Acquires Urotronic for Innovative Prostate Treatment Technology

Posted on by slightbourne@noblecapitalmarkets.com

Portsmouth, New Hampshire-based medical device manufacturer Laborie Medical Technologies announced it has acquired Minnesota company Urotronic in a deal worth up to $600 million. The acquisition provides Laborie entry into the interventional urology market and adds Urotronic’s novel Optilume drug-coated balloon technology to its product portfolio.

The definitive agreement was signed on September 6, 2023 with an upfront payment of $255 million in cash to close the deal. Up to $345 million more is payable based on certain commercial and reimbursement milestones being achieved.

Optilume is a minimally invasive surgical therapy (MIST) that combines mechanical dilation with delivery of the chemotherapy drug paclitaxel to treat urinary tract conditions like urethral strictures and benign prostatic hyperplasia (BPH), also known as enlarged prostate.

BPH affects over 40 million men in the United States alone and the global market for BPH treatment is valued at over $4 billion. Current surgical interventions for BPH like transurethral resection of the prostate (TURP) or laser procedures can have side effects and long recovery times.

Optilume has already gained FDA approval and CE Mark in Europe for treating BPH. This regulatory clearance, along with positive clinical data showing good safety and efficacy, were key factors in Laborie’s decision to acquire Urotronic.

The Optilume technology represents a paradigm shift in how urologists can treat patients suffering from BPH and urethral strictures. Rather than invasive surgery or permanent implants, the drug-coated balloon can be inserted cystoscopically and then inflated to dilate the urethra and deliver the paclitaxel to the tissue. The minimally invasive approach leads to fast patient recovery compared to other options.

Take a moment to take a look at Noble Capital Markets’ Medical Device Research Analyst Gregory Aurand’s coverage list.

According to Laborie Medical President and CEO Michael Frazzette, “There has never been a minimally invasive, combination drug-device therapy like Optilume before, leading to a highly disruptive, paradigm change for physicians treating urethral strictures and BPH.”

Urotronic CEO David Perry likewise noted that “Backed by positive clinical data, the Optilume BPH therapy is truly groundbreaking as the only MIST option that doesn’t require cutting, burning, steaming or a permanent implant.”

The Urotronic acquisition represents a strategic move for Laborie Medical Technologies to push further into the global urology market. Laborie is focused on high-growth segments including urology, gastroenterology, gynecology, and obstetrics.

According to Patricia Industries, which owns Laborie, the deal furthers Laborie’s long-term growth strategy by adding an innovative product with strong potential to its portfolio. Urotronic’s employees and assets will be fully integrated into Laborie Medical after the acquisition.

Laborie itself was acquired by Patricia Industries in 2017 for an estimated $2.4 billion and has gone through a period of rapid growth since then. The company manufactures a range of diagnostic equipment like urodynamic systems as well as therapy products such as electrodes for pelvic floor stimulation.

The global medical device market has seen a surge of M&A activity in recent years. Strategic mergers and acquisitions allow companies to expand their product lines, access new technology, enter new geographic markets, and consolidate to gain economies of scale.

Medtech titan Boston Scientific for example has made 10 acquisitions in the past 5 years totaling over $10 billion to become a leading player in less invasive device treatments. Teleflex likewise acquired Neotract and its novel UroLift system for treating BPH in a $1 billion purchase in 2017.

The closing of the Urotronic acquisition provides another growth milestone for Laborie Medical as it executes its strategy of providing innovative therapeutic solutions to physicians and hospitals involved in urological procedures. Adding Optilume’s promising technology gives it a differentiated offering in the nonsurgical treatment of enlarged prostate and strengthens Laborie’s portfolio for continued expansion in the urology device sector.

Boston Scientific to Acquire Relievant Medsystems for $850 Million

Posted on by slightbourne@noblecapitalmarkets.com

Medical device maker Boston Scientific announced Monday it will acquire Relievant Medsystems for $850 million upfront and additional contingent payments. Relievant has developed a minimally invasive technology to treat chronic low back pain.

The deal aims to expand Boston Scientific’s portfolio in neuromodulation, the use of devices to modulate nerve activity. Relievant’s Intracept system uses targeted radiofrequency energy to ablate the basivertebral nerve, stopping pain signals from reaching the brain. It is the only FDA-cleared device specifically for vertebrogenic pain, a type of chronic back pain originating in the vertebrae.

Relievant’s system is designed to provide long-term pain relief and improve function through an outpatient procedure. It targets an estimated 5.3 million patients in the U.S. with vertebrogenic pain from degenerative disc disease or vertebral compression fractures. Boston Scientific cited Relievant’s novel technology and strong clinical data from multiple randomized controlled trials in deciding to acquire the company.

The Intracept procedure is implant-free, sparing patients from potential complications associated with implants. It also avoids destroying the intervertebral disc. The system has been used to treat over 2,000 patients since receiving FDA clearance in 2018 based on Level 1 clinical evidence.

The deal expected to close in the first half of 2024 pending approvals. Boston Scientific said Relievant is projected to generate over $70 million in sales this year with 50%+ growth in 2024. The acquisition is forecasted to be neutral or slightly accretive to Boston Scientific’s adjusted earnings per share.

“We look forward to working with the Relievant team to expand access to care for those with chronic back pain,” said Jim Cassidy, president of Neuromodulation at Boston Scientific. Both companies aim to transform the diagnosis and treatment of vertebrogenic pain through a minimally invasive approach.

Take a moment to take a look at Noble Capital Markets Senior Research Analyst Gregory Aurand’s coverage list.

Why Small Medical Device Stocks Could Become Very Rewarding this Year

Posted on by phoffman@channelchek.com

JNJ Admits M&A Appetite in Medtech Space

While pharmaceuticals and biotech get much of the attention in the life sciences field, investors in medical device manufacturers got confirmation last week that the high growth projections in sales is on track. Of added interest to those invested in smaller companies in the medtech space, large key players are looking to increase market share through mergers and acquisitions (M&A). This was emphasized in Johnson and Johnson’s (JNJ) Q2 reporting released last week.

Consumer health giant Johnson & Johnson said it has a “pretty voracious” appetite for medical device M&A going forward, as it expects further rebounds in surgery volume, post-pandemic, to continue funneling cash into the company for the rest of the 2023. Projections for the global medical device market size, according to Fortune Business Insights, was valued at $512.29 billion in 2022 & is projected to grow from $536.12 billion in 2023 to $799.67 billion by 2030.

Even after the demand from patients who put off procedures, while labor shortages in hospitals became less of a problem, device sales that are helping fulfill delayed procedures have a much brighter future even after the pandemic-related surge in needs.

Driving demand is an aging and sedentary population, with a growing prevalence of chronic disorders like diabetes, cancer, heart disease, etc. There is also an increased demand for ophthalmic and orthopedic procedures as the population experiences more joint fractures and debilitating vision issues.  

Source: Fortune Business Insights

Johnson and Johnson’s admitted during its quarterly reporting that it will continue actively looking for situations to acquire medtech companies. The company’s medtech businesses produced $7.79 billion in global revenue during the second quarter, totaling 14.7% growth compared to the $6.90 billion brought in during the same three-month period in 2022.

Last year JNJ bought a miniature heart pump maker Abiomed, for $16.6 billion. Business from this acquisition accounted for 4.8%, or nearly a third of the Q2 gains, with $331 million in worldwide revenue for the quarter. JNJ’s acquiring Abiomed was one of the largest medtech deals of 2022; as of the end of the second quarter, it has added $655 million to J&J MedTech’s bottom line since the acquisition was closed last December.

Source: JNJ, July 20, 2023

“Everything is moving well and according to plan in Abiomed’s integration, and we are increasingly convinced that this is going to be a key component in our medtech strategy of becoming a leader in heart recovery,” J&J CEO Joaquin Duato said on the company’s investor call.

“When it comes to M&A, we continue to look for opportunities,” Duato said. “And when it comes to medtech … we look forward to growing in areas that are close to where we are today: vision, cardiovascular, surgery, and also high-growth segments in orthopedics.”

Abiomed wasn’t the only contributor in JNJ’s growing medtech businesses. Much of the growth was driven by a 25.9% year-over-year boost in electrophysiology sales, pushing the segment past the billion-dollar mark. The company also saw increases in trauma orthopedics, wound closure kits and biosurgery products, as well as in contact lenses.

Take Away

Medical device companies are helping to fulfill a need as the population ages and new technology, including AI and robotics, are able to provide new solutions to old problems. The announcement by JNJ that they are hungry for medtech companies that fit their criteria ought to cause life sciences investors to pay even more attention to the space.

Late in 2022 Channelchek asked our Med Device & Services analyst to discuss his “shopping list” in the medical device arena, the video is helpful for investors to discover more about this space.

Paul Hoffman

Managing Editor, Channelchek

Release – BioSig Executes Agreement with Bellin Health for the Acquisition of its PURE EP™ Technology

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BSGM

January 10, 2023

Westport, CT, Jan. 10, 2023 (GLOBE NEWSWIRE) —

  • Leading Midwest healthcare system reports significant cost savings and noise reduction following evaluation of the PURE EP™ System
  • Medical center signs agreement to acquire the Company’s digital signal processing technology for arrhythmia care

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that Bellin Health System in Green Bay, Wisconsin has signed an agreement to acquire the Company’s PURE EP™ System.

The agreement follows a 60-day formal evaluation of the PURE EP™ System at Bellin Health. The hospital reported that the PURE EP™ demonstrated a significant cost savings per case as well as a substantial reduction in noise and signal interference compared to the use of conventional systems only.

The agreement grants Bellin Health full autonomy with respect to its operation of the PURE EP™ System, and BioSig will not be required to provide an on-site clinical account manager following the new system install.

The PURE EP™ System is a combination of hardware and software that enables the real-time acquisition of raw signal data—absent of unnecessary noise or interference—allowing physicians to make informed clinical decisions based on clear and precise data. With the heightened visualization of active signals, the PURE EP™ System is facilitating personalized patient care and innovations in the field of electrophysiology.

“Bellin has observed, first-hand, that clear cardiac signals provide more information that can impact procedural efficiency without driving up procedural costs,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies. “The terms of this agreement represent a new milestone for the PURE EP™ System—expanding the accessibility and automaticity of our novel digital signal processing technology.”

Bellin Health recently announced plans to combine operations with Gundersen Health System, a physician-led, nonprofit, integrated healthcare network headquartered in La Crosse, Wisconsin. The hospital serves 22 counties in western Wisconsin, southeastern Minnesota, and northeast Iowa. The merger allows the health systems to offer access to more resources and a broader network of top-tier clinical services, shared provider expertise, state-of-the-art technology and digital healthcare tools that bring virtual care options into homes and workplaces.1

About Bellin Health
Bellin Health’s Heart and Vascular Team brings more than 50 years of experience in all facets of cardiac care, making the medical center the most experienced program in the region. The physicians at Bellin are board-certified specialists with experience in all areas of cardiovascular care including echocardiography, nuclear cardiology, interventional cardiology, electrophysiology, and endovascular medicine. As the largest group of cardiovascular specialists in Green Bay, Bellin Health is renowned for its comprehensive cardiovascular care centers across the Midwest and its surrounding regions. (www.bellin.org).

About BioSig Technologies 
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives. 

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. 

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating. 

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.2

  


Forward-looking Statements 
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds; (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed; (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

1 https://www.gundersenhealth.org/news/gundersen-bellin-anticipate-merger-closing-nov-30-start-of-operations-dec-1

2Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

Release – BioSig’s PURE EP™ System Demonstrates Potential Time and Cost Savings at the 15th APHRS Scientific Session in Singapore

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BSGM

December 14, 2022

Abstract highlights promising results from PURE EP™ study at premier Asia-Pacific Heart Rhythm Society Conference

Westport, CT, Dec. 14, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that its PURE EP™ System was featured in an abstract presentation during the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore.

Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations. The study enrolled 29 patients with non-paroxysmal AF with post-ablation arrhythmia recurrence (“redo AF”). The primary objective was to determine the difference in procedural times when comparing ablations guided by PURE EP™’s electrocardiogram (EGM) visualization to the conventional ECG recording system. Study results demonstrated that the PURE EP™ System led to a mean procedure time reduction of 11.3 minutes. Given that the mean cost of operating room time is approximately $37 per minute1, the procedural time savings demonstrated by the PURE EP™ System suggest potential cost savings of approximately $418.10 per procedure. While this suggests that PURE EP™ might promote shorter procedural times, further studies are underway. 

The abstract titled, “Reduced Time of Redo Atrial Fibrillation Ablation Procedures with PURE EP™ Recording System for ECG/EGM Visualization: A Randomized Study,” was presented as a poster presentation by Dr. G. Joseph Gallinghouse, Cardiac Electrophysiologist at St. David’s Medical Center in Austin, TX.

 “With over 75,000 AF ablations performed in the US each year2 the ability to demonstrate that PURE EP™ may reduce procedure times resulting in potential healthcare cost savings is a landmark milestone for the overarching value proposition of our technology,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “We believe a hospital can generate a meaningful return on investment in the first year of ownership of a PURE EP™ System. Additional studies demonstrating compelling clinical and economic value of the PURE EP™ System are in motion and we are looking forward to sharing these insights with the EP and healthcare community in the near future.”  

APHRS 2022 represents the Company’s first abstract presentation at an international conference. It also marks the first physician-sponsored presentation unveiling clinical data from the Company’s REDO AF Sub Study, initiated in July 2021. [ClinicalTrials.gov Identifier: NCT04964440]. 

About APHRS  
The APHRS is a leading non-profit organization that represents medical, allied health, and science professionals specializing in cardiac rhythm disorders in the Asia-Pacific region. The annual Asia Pacific Heart Rhythm Society (APHRS) is a premier event featuring industry workshops and a core scientific program delivered by international and regional speakers.  

About BioSig Technologies 
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives. 
The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. 
The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating. 
The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.3 


  
Forward-looking Statements 
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds; (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed; (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

1. Kawasaki K. Megan, Cleary J. David, Correa de Sa D. Daniel, Calame R. Susan, Dillon M. Christopher, Tsai H. Mitchell, (2019) Abstract 9552: Understanding the Costs Associated with Cardiac Ablations. Circulation, 2019;140:A9552. www.ahajournals.org/doi/10.1161/circ.140.suppl_1.9552

2. “Late-Breaking Clinical Trials II: Innovation Boulevard: Pulsed AF: First Human Experience and Acute Procedural Outcomes Using A Novel Pulsed Field Ablation System” [Friday, May 8, 2020 at 11:00 a.m. EST]

3.  Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 

Source: BioSig Technologies, Inc.

Released December 14, 2022

Release – BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BSGM

December 06, 2022

Clinical abstract focuses on value of PURE EP™’s and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation

Westport, CT, Dec. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that a peer-reviewed case report titled, “Confirmation of Acute Pulmonary Vein Reconnection with The Utilization of PURE EP’s High-Frequency Algorithm (HFA)” has been published in the Journal of Atrial Fibrillation & Electrophysiology. The publication is available electronically via the JAFIB-EP open access digital journal.

Co-authored by Roy Chung, MD, Clinical Cardiac Electrophysiologist at Cleveland Clinic and Zachary Koch, CCDS, CEPS, Clinical Director at BioSig Technologies, Inc., the case report describes a 65-year-old patient with a medical history of symptomatic and persistent atrial fibrillation undergoing pulmonary vein isolation (PVI). PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logotation produced by a 3D mapping system. PURE EP™’s real-time HFA identified early local activation, providing a clear and precise location that served as the primary target for ablation therapy during the procedure. Results from the case study support the efficacy of PURE EP™’s HFA in identification of the pulmonary vein gap compared to the inferior annotation produced by the 3D mapping system.1 

“This case study adds to the growing pipeline of clinical evidence validating the PURE EP™ System as an essential and valuable technology for today’s EP lab—particularly for challenging cases,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that these findings, along with other clinical applications we continue to explore in collaboration with the Cleveland Clinic, demonstrate PURE EP™’s ability to set new standards in the field of electrophysiology.”

In October, the Company signed a master research agreement with Cleveland Clinic to explore expanded applications for its digital signal processing technology.

The proprietary High Frequency Algorithm (HFA)—a proprietary feature found only in the PURE EP™ System—reclaims the specificity lost within the blended data of the traditional bipolar wave. HFA enables electrophysiologists to apply specific near-field frequency data to the treatment of even the most complex arrhythmias. By removing unnecessary distractions, the PURE EP™ System with HFA preserves the value of cardiac signals and delivers clear, actionable insights to today’s electrophysiologist.

About BioSig Technologies
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.2

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

1 Koch W. Zachary; Chung, Roy (2022), Confirmation of Acute Pulmonary Vein Reconnection with Case Report: The Utilization of PURE EP’s High-Frequency Algorithm (HFA), Journal of Atrial Fibrillation & Electrophysiology, Volume 15, Issue 6, Nov 2022. https://jafib-ep.com/journal/volume-15-issue-6-nov-2022/confirmation-of-acute-pulmonary-vein-reconnection-with-the-utilization-of-pure-eps-high-frequency-algorithm-hfa/

2 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 
 

Source: BioSig Technologies, Inc.

Released December 6, 2022

BioSig Technologies (BSGM) – BioSig reports 3Q 2022; Lots of Activity; Target Price Reduced

Posted on by cpereira@noblefcm.com


Wednesday, November 16, 2022

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com). The Company’s first product, PURE EP(TM) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

BioSig reported 3Q 2022 results.  The Company reported $135,000 of revenues in the quarter that recognized $127,000 in product sales and $8,000 in service revenue.  We were looking for $980,000 in product revenues and $49,000 in service revenue.  The third quarter EPS loss of $0.14 matched our expected loss per share.

Marketing activities are ramping up.  PURE EP technology was featured in a physician presentation at the Kansas City Heart Rhythm Symposium held August 20-21, 2022.  In late September 2022, the Company released its most advanced software, known as PURE EP Software Version 6 with ACCUVIZ Module. The new Version 6 software was introduced at the Cleveland Clinic Global EP Summit held September 23-24, 2022.  In addition, the Company was invited to attend and sponsor the Venice Arrhythmias 2022 Congress that met October 13-15 in Venice Italy.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Medical Device Improves Muscle Rehab Accuracy by 15%

Posted on by phoffman@channelchek.com
Image Credit: MIT CSAIL

MIT System “Sees” the Inner Structure of the Body During Physical Rehab

Rachel Gordon | MIT CSAIL

A growing number of people are living with conditions that could benefit from physical rehabilitation — but there aren’t enough physical therapists (PTs) to go around. The growing need for PTs is racing alongside population growth, and aging, as well as higher rates of severe ailments, are contributing to the problem.

An upsurge in sensor-based techniques, such as on-body motion sensors, has provided some autonomy and precision for patients who could benefit from robotic systems to supplement human therapists. Still, the minimalist watches and rings that are currently available largely rely on motion data, which lack more holistic data a physical therapist pieces together, including muscle engagement and tension, in addition to movement.

This muscle-motion language barrier recently prompted the creation of an unsupervised physical rehabilitation system, MuscleRehab, by researchers from MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and Massachusetts General Hospital. There are three ingredients: motion tracking that captures motion activity, an imaging technique called electrical impedance tomography (EIT) that measures what the muscles are up to, and a virtual reality (VR) headset and tracking suit that lets a patient watch themselves perform alongside a physical therapist.

Patients put on the sleek ninja-esque all-black tracking suit and then perform various exercises such as lunges, knee bends, dead lifts, leg raises, knee extensions, squats, fire hydrants, and bridges that measure activity of quadriceps, sartorius, hamstrings, and abductors. VR captures 3D movement data.

In the virtual environment, patients are given two conditions. In both cases, their avatar performs alongside a physical therapist. In the first situation, just the motion tracking data is overlaid onto their patient avatar. In the second situation, the patient puts on the EIT sensing straps, and then they have all the information of the motion and muscle engagement.

With these two conditions, the team compared the exercise accuracy and handed the results to a professional therapist, who explained which muscle groups were supposed to be engaged during each of the exercises. By visualizing both muscle engagement and motion data during these unsupervised exercises instead of just motion alone, the overall accuracy of exercises improved by 15 percent.

The team then did a cross-comparison of how much time during the exercises the correct muscle group got triggered between the two conditions. In the condition where they show the muscle engagement data in real-time, that’s the feedback. By monitoring and recording the most engagement data, the PTs reported a much better understanding of the quality of the patient’s exercise, and that it helped to better evaluate their current regime and exercise based on those stats.

“We wanted our sensing scenario to not be limited to a clinical setting, to better enable data-driven unsupervised rehabilitation for athletes in injury recovery, patients currently in physical therapy, or those with physical limiting ailments, to ultimately see if we can assist with not only recovery, but perhaps prevention,” says Junyi Zhu, MIT PhD student in electrical engineering and computer science, CSAIL affiliate, and lead author on a new paper about MuscleRehab. “By actively measuring deep muscle engagement, we can observe if the data is abnormal compared to a patient’s baseline, to provide insight into the potential muscle trajectory.”

Current sensing technologies focus mostly on tracking behaviors and heart rates, but Zhu was interested in finding a better way than electromyography (EMG) to sense the engagement (blood flow, stretching, contracting) of different layers of the muscles. EMG only captures muscle activity right beneath the skin, unless it’s done invasively.

Zhu has been digging into the realm of personal health-sensing devices for some time now. He’d been inspired by using EIT, which measures electrical conductivity of muscles, for his project in 2021 that used the noninvasive imaging technique to create a toolkit for designing and fabricating health and motion sensing devices. To his knowledge, EIT, which is usually used for monitoring lung function, detecting chest tumors, and diagnosing pulmonary embolism, hadn’t been done before.

With MuscleRehab, the EIT sensing board serves as the “brains” behind the system. It’s accompanied by two straps filled with electrodes that are slipped onto a user’s upper thigh to capture 3D volumetric data. The motion capturing process uses 39 markers and a number of cameras that sense very high frame rates per second. The EIT sensing data shows actively triggered muscles highlighted on the display, and a given muscle becomes darker with more engagement.

Currently, MuscleRehab focuses on the upper thigh and the major muscle groups inside, but down the line they’d like to expand to the glutes. The team is also exploring potential avenues in using EIT in radiotherapy in collaboration with Piotr Zygmanski, medical physicist at the Brigham and Women’s Hospital and Dana-Farber Cancer Institute and Associate Professor of Radiation at Harvard Medical School.

“We are exploring utilization of electrical fields and currents for detection of radiation as well as for imaging of the of dielectric properties of patient anatomy during radiotherapy treatment, or as a result of the treatment,” says Zygmanski. “Radiation induces currents inside tissues and cells and other media — for instance, detectors — in addition to making direct damage at the molecular level (DNA damage). We have found the EIT instrumentation developed by the MIT team to be particularly suitable for exploring such novel applications of EIT in radiotherapy. We are hoping that with the customization of the electronic parameters of the EIT system we can achieve these goals.”

MuscleRehab Video

“This work advances EIT, a sensing approach conventionally used in clinical settings, with an ingenious and unique combination with virtual reality,” says Yang Zhang, assistant professor in electrical and computer engineering at the UCLA Samueli School of Engineering, who was not involved in the paper. “The enabled application that facilitates rehabilitation potentially has a wide impact across society to help patients conduct physical rehabilitation safely and effectively at home. Such tools to eliminate the need for clinical resources and personnel have long been needed for the lack of workforce in healthcare.”

Reprinted with permission of MIT News” (http://news.mit.edu/)