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SmartTRAK Life Sciences News and Analysis Blog

4 min read

AWC Summit EU 2023: European and US Growth Explored in London

By Kris Flinn on 1/15/24 3:40 PM

SmartTRAK joined industry colleagues in London to explore new technologies at an exciting time in wound care.

SmartTRAK has determined the 2022 European Advanced Wound Care (AWC) Market grew at a +4.4% rate compared to 2021. AWC in Europe is dominated by Advanced Dressings, with Wound Biologics and External Devices only accounting for 18.6% of total revenue. This is in stark comparison with the US AWC Market in which highly-priced treatments such as Wound Biologics (44.4% share in US) and External Devices (28.4%) have favorable reimbursement levels. SmartTRAK forecasts both markets to benefit from healthy growth in the next five years despite some looming reimbursement challenges. In the US, Medicare Administrative Contractor LCD changes to skin substitutes (as featured in this article) could lead to reduced usage of the products in the hospital outpatient and physician office sites of care, and in Germany reimbursement on silver products is due to end in late 2024.
 
At the event in London, contributors discussed areas as varied as adapting to home care and remote monitoring, launching products in the US and keeping up with the changing European regulatory landscape as the Medical Device Regulation (MDR) replaces the old Medical Device Directive (MDD). SmartTRAK was present and Lennart Stadler, SmartTRAK GM and OUS Sr. Analyst, Wound, presented the latest market insights from the global AWC space, including an overview of the recent corporate activity (Figure 1).

The session that generated the greatest discussion was titled  “Investment 101.”   Asif Shahinsha from PharmaVentures , Pierre Socha from  Amadeus Capital Partners  and Gabor Heltovics from   NLC Health Ventures  discussed the best approaches toward fundraising and which companies have been successful. 

A regular feature of the AWC Summit is the Innovation Showcase. At the event in London, six companies took turns pitching their technologies, with the delegates voting to award one company as the winner.  The companies were:
 

The Innovation Showcase

At the event in London, six companies took turns pitching their technologies, with the delegates voting to award one company as the winner. The companies were:

  • Amferia– a Swedish company that is developing antimicrobial peptides for use in a variety of applications and carriers. The Company has made an FDA submission and is currently operating within the veterinary market.
  • Healthy.io– an Israeli digital organization that has launched Minuteful for Wound. The app is being used widely in the UK and has shown positive impacts on treatment, such as a 33% reduction in antimicrobial usage.
  • Hybrisan– a Welsh medtech product development company that has an antibiofilm technology called WoundSan. The solution can be used alongside existing antimicrobials such as silver and the company is in discussions with potential commercial partners.
  • Plasma4– a British cold plasma company spun out from the University of Lancaster. The product applies the treatment through a dressing.
  • SmartWound– a British biophysical chemistry company that has developed infection-sensing technologies within dressings or via a swab. The Company believes the test can be undertaken for around $6, making it less expensive than other alternatives.
  • SolasCure– this UK-based business has been visible on the market for a few years with its enzymatic debridement technology, Aurase. The product is moving towards its IIb clinical study and is unlikely to reach the market before 2028.
Following the vote, the winning organization was announced as Hybrisan. SmartTRAK talked with Hybrisan CEO Dr. Chris Mortimer to discuss the challenge of biofilms and the company’s journey to bring its WoundSan technology to market.

That interview, titled "Combating Biofilms at Every Stage of Wound Care," is featured in this post on the SmartTRAK blog.

To download and read the "AWC Summit EU 2023: European and US Growth Explored in London" article by Kris Flinn, SmartTRAK Sr. Analyst, Wound, just click the button below. Read the Article
 
Topics: Wound Care
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2 min read

Reimagine Wound Care Possibilities at CAMPS 2024

By SmartTRAK on 1/12/24 9:30 AM



MIAMI, FLORIDA — We are thrilled to announce that SmartTRAK's Susan Paquette, VP of Wound Care, will be speaking at the inaugural Cellular, Acellular and Matrix-like Products (CAMPs) Wound Care Summit 2024, set to take place on March 13-14 in the vibrant city of Miami. This two-day clinical and scientific summit aims to empower physicians and wound care professionals to achieve optimal outcomes, strategize for regulatory approval, and navigate reimbursement processes for CAMPs.

Topics: Wound Care
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7 min read

What’s New in Neuromodulation? News to Know Before NANS 2024

By Anne Staylor on 1/9/24 9:30 AM

The North American Neuromodulation Society (NANS) is celebrating its 30th anniversary in 2024 and is once again bringing together the leading clinicians, researchers and manufacturers to Caesar’s Palace in Las Vegas for the NANS 2024 Annual Meeting, to be held January 18-21. To get you up to speed before the meeting, SmartTRAK has put together highlights of recent neuromodulation news. The following is just a small sampling of recent Neuromodulation-related news and updates from around the world compiled, reviewed and posted in real-time every day by the expert analysts at SmartTRAK.

SmartTRAK will be attending NANS 2024 from January 18-21. If you'd like to meet with us in person, please reach out to Anne Staylor, SmartTRAK’s Executive Editor and VP & GM, Neuro Therapies, at anne.staylor@smarttrak.com, or just click the button below. Meet with SmartTRAK

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2 min read

Sports Medicine and Extremities Start-Ups to Watch

By Sharon O'Reilly on 1/3/24 9:30 AM

SmartTRAK highlights start-ups developing innovative products for joint resurfacing, soft tissue fixation, ligament and tendon augmentation at the 2023 MNVC.

Sports medicine and extremities were prominent themes at the 21st Annual Musculoskeletal New Ventures Conference (MNVC) held in Memphis in November 2023. Approximately one-third of the 38 presenting companies debuted new and innovative technologies for treating sports-related injuries of the knee, shoulder, hand, foot & ankle ranging from soft tissue fixation, ligament and tendon augmentation and cartilage resurfacing. Now that investment in robotics and surgical navigation craze has peaked, major orthopedic manufacturers are directing research and development (R&D) dollars toward restoring joint function using biological approaches and a variety of less invasive techniques. 

Among the topics covered in this market outlook article are:

  • Promising Knee and Shoulder Start-Ups
  • Extremity Fixation: An Emerging Market
  • Resurgence in Joint Resurfacing

A fertile ground for strategic negotiations and deal-making, several of the major players have broadened their range of products through strategic tuck-in acquisitions in the past year. Also, several start-ups are targeting the multi-billion dollar Soft Tissue Fixation market.  This landscape reflects a dynamic and competitive environment where established players seek to strengthen their positions through ...

To download and read the complete "Sports Medicine and Extremities Start-Ups to Watch" market outlook article by Sharon O'Reilly, SmartTRAK's Founder and CEO, just click the button below. Read the Article

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2 min read

Plastic Surgery: The Meeting 2023 in Austin, TX

By Doug Devens on 12/19/23 9:30 AM

SmartTRAK attended key sessions on ADM use and reports on the latest trends impacting the US Breast Matrices Market.

The American Society of Plastic Surgeons (ASPS) and various manufacturers continue to pursue IDEs to gain an indication to use an acellular dermal matrix (ADM) in breast reconstruction. At Plastic Surgery: The Meeting 2023 (PSTM2023), held in Austin, TX, SmartTRAK attended key sessions on ADM use and reports on the latest trends affecting the market for ADMs.

In this article, SmartTRAK discusses the evolution and growth of ADMs and shares observations from the meeting across primarily two sessions covering breast reconstruction: They are:

  • “Support Group: A Mesh For Each Patient and Getting Away Without It”
  • “Back to the Future: Moving Forward or Going Back with Pre and Subpectoral Reconstruction.”

Just click the button below to download and read the complete detailed "Plastic Surgery: The Meeting 2023" article by Doug Devens, SmartTRAK's IT Product Director and Sr Analyst, Wound. Read the Article

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2 min read

SAWC Fall 2023: Skin Substitutes Reign Again

By Susan Paquette on 12/12/23 9:30 AM

Over the last 10+ years, the market for skin substitutes has been turbulent with new technologies and products being launched and reimbursement changes occurring for the various sites of care. SmartTRAK highlights a few of these based on the recent SAWC Fall meeting.

Skin substitutes, also referred to as CTPs (cellular and/or tissue-based products) or CAMPs (cellular, acellular and matrix‑like products), remained front and center at the Symposium on Advanced Wound Care (SAWC) Fall meeting held in Las Vegas on November 2-5, 2023. The strong presence of these products mirrors a similar trend in the overall US Advanced Wound Care (AWC) market. For Q323, skin substitutes alone account for 37% of the US AWC market, more than Negative Pressure Wound Therapy (NPWT) or Advanced Dressings, according to an analysis of SmartTRAK Financial Dashboard.

In this article, SmartTRAK discusses in detail:

  • The Migration of Skin Substitutes Over the Years
  • Which Synthetics are Gaining Attention
  • New Companies–Unique Technology and Innovations
  • Health Policy Dynamics–Reimbursement and Advocacy
  • The Future of US-Based AWC Companies
  • The Potential for Acquisitions on the Horizon

To download and read the complete detailed "SAWC Fall 2023: Skin Substitutes Reign Again" article by SmartTRAK's Susan Paquette, VP & General Manager, Wound and Terry Hayslett, Sr. Analyst, Wound, just click the button below. Read the Article

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2 min read

Trends, Advancing Technologies and New Deals Shaping the Future of Spine: NASS 2023

By Kris Jacques on 12/5/23 9:45 AM

SmartTRAK was on-site at NASS 2023 covering the latest spine trends including hosting the hottest reception in town, “Targeting the ASC, What Spine Companies Need to Know."

Shifting hospital-based procedures to the ambulatory surgery center (ASC) is one of the biggest opportunities for healthcare savings and the opportunity is especially great for spine given its high acuity procedures like lateral lumbar fusions, 360 fusions and total disc replacements (TDRs) according to the results of SmartTRAK’s recent survey of 30 ortho, spine and neurosurgeons. At this year’s North American Society (NASS) Annual Meeting held in Los Angeles, CA October 18-21, SmartTRAK hosted a standing-room-only reception for industry on the migration of spine procedures into the ASC titled “Targeting the ASC: What Manufacturers Need to Know,” which included panel discussions and presentations focused on the spine market and practice trends. In this article, SmartTRAK highlights the top takeaways from the reception and identifies the latest trends and innovations at NASS affecting growth in the US Spine Market. Topics covered in the article include:

  • New Care Models Optimizing Outpatient Spine
  • The Motion Preservation “Renaissance” was Hard to Miss
  • MIS SI Joint Fusion Systems – A Plethora of Systems, New Devices Launching Ahead of 2024 Reimbursement Changes.
  • Will New Interbody Technologies Displace the Need for Biologics?
  • Deals Abound: Several Biologics Deals Announced at NASS and After

To download and read the complete "NASS 2023: Trends, Advancing Technologies and New Deals Shaping the Future of Spine" article by Kris Jacques,  SmartTRAK's GM, Spine, just click the button below. Read the Article

Topics: Spine
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2 min read

BREAKING NEWS - Nevro Acquires VYRSA Technologies

By Anne Staylor on 12/1/23 1:49 PM

Nevro* (NVRO) announced it acquired VYRSA Technologies*, a privately held company focused on the minimally invasive treatment of chronic sacroiliac joint (SI Joint) pain. According to the Company, VYRSA is the only SI joint company that manufactures and supports a complete portfolio of FDA-cleared, state-of-the-art SI joint fusion devices. The acquisition was signed and closed on Nov 30, 2023. 

NVRO paid $40MM at closing and agreed to pay up to an additional $35MM in cash or stock tied to milestones. NVRO CEO Kevin Thornal said VYRSA offers differentiated implants to the Company’s current call point of physicians and will help drive company growth, adding that the technology will help bring long-term pain relief to the 15-30% of people suffering with chronic low back pain associated with the SI joint.

The US MIS SI Joint Fusion Market is the fastest-growing segment in the US Spine Market and a growing number of pain physicians are performing these procedures. According to SmartTRAK’s recently published 2023 US MIS SI Joint Market Report, this market is projected to grow at +18% CAGR over the next five years and 53+ MIS SI Joint Fusion systems are now commercially available in the US. See 2023 MIS SI Joint Fusion Market Report*.

The Company also announced the closing of a six-year, $200MM term loan credit facility to be used to repurchase the majority of its 2025 Convertible Notes and for working capital and other corporate purposes. NVRO CFO Rod MacLeod noted that the Company was pleased to refinance a majority of its debt and push the maturity out to 2029 while limiting equity dilution to 2.6MM warrant shares. 

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2 min read

US MIS SI Joint Fusion Market: Unlocking the Future of Spine

By Kris Jacques on 11/28/23 9:49 AM

Ready to dive into one of the most rapidly expanding markets in the world of Spine? Welcome to the realm of SI Joint Fusion, a market poised for remarkable growth with a projected 5-year CAGR of +18%. At SmartTRAK, we’re excited to introduce you to this thriving sector and give you a sneak peek of our forthcoming in-depth market segment solution subscription.

Outlined below is a brief list highlighting some of the key insights awaiting you upon subscribing to SmartTRAK's innovative solution and the valuable knowledge it delivers:

  • Market Overview (US only/MIS market only):
    - Incidence and Prevalence: Understand the scale of SI Joint Fusion cases.
    - Market Size: Explore the market's current size and potential.
    - Revenue/Procedure Forecast through 2027: Take a look at expected future growth by market segments; transfixing and non-transfixing.
    - Growth Trends: Stay ahead with insights into emerging trends.
  • Competitive Landscape:
    - By System Type: Discover the differences between Transfixing and Non-transfixing.
    - 2022 ASP Data Summary: Gain access to crucial pricing information.
  • National/Regional Site of Service Procedure Volume Data:
    - HOPD vs ASC vs. Inpatient: Know where these procedures are performed.     - Annual Trends from 2017: Track the historical data for insights. 
  • Coding & Reimbursement - 2024 Outlook:
    - Anticipate changes in coding and reimbursement for the coming year.
  • Why MIS SIJ Fusion Matters:
    Within the vast Spine landscape, the Minimally Invasive Surgery (MIS) SI Joint Fusion procedure category is the star of the show. Here's why:
    - Growing Awareness and Diagnosis: More individuals are recognizing SI joint pain as a significant issue.
    - Robust Clinical Data: The body of clinical evidence is expanding.
    - Increasing Reimbursement Coding: Hospitals, HOPDs, ASCs and Physician's offices.
  • The Future of MIS SI Joint Fusion:
    Acceptance of the posterior/dorsal non-transfixing MIS SI fusion approach is on the rise. This process is set to drive procedural growth and popularity, particularly among interventional pain physicians at Ambulatory Surgical Centers (ASCs).

So are you ready to dive into one of the most rapidly expanding markets in the world of Spine? Don’t miss your chance to stay ahead of the curve in the booming world of SI Joint Fusion and Be The Expert! Just click the button below to find out more. Be The Expert!

Topics: Top Story Spine
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2 min read

Impact of Medicare Administrative Contractor LCD Changes on Skin Substitute/CTP Market

By Susan Paquette on 11/21/23 9:30 AM

Three MACs rocked the Skin Substitute/CTP market with changes in coverage in their final LCDs implemented in September. SmartTRAK takes a look at the overall impact on the market.

SmartTRAK has covered the highly active, ever-growing Skin Substitute/CTP market for over ten years. During that time, the market has grown at a CAGR of over +13%. Most years it experienced strong double-digit growth except those years impacted by reimbursement changes, Department of Justice (DOJ) investigations or the COVID-19 pandemic. Skin Substitute/CTPs are primarily used on Medicare patients with non-healing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The Center for Medicare & Medicaid Services (CMS) primarily pays for health care services for people aged 65 and older. Individuals can receive health care benefits via traditional Medicare or Medicare Advantage, which is run by private health insurance plans. Traditional Medicare contracts with Medicare Administrative Contractors (MACs) to process claims for reimbursement and write local coverage determinations (LCDs). Currently, there are twelve regions in the US managed by seven MACs.

Among the topics covered in this extensive article are:

  • Key Policy Changes
  • Impact on Patients
  • Market Impact

On August 3, 2023, three MACs issued final LCDs governing the use of Skin Substitutes/CTPs in treating DFUs and VLUs. The release of the final LCDs, which are effective September 17, 2023, was not surprising to the market, given that the proposed LCDs were issued in 2022. The proposed LCDs allowed ...

To download and read the complete "Impact of Medicare Administrative Contractor LCD Changes on Skin Substitute/CTP Market" article by Susan Paquette, SmartTRAK's VP & General Manager, Wound and Terry Hayslett, Sr. Analyst, Wound just click the button below.Be The Expert!

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