<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=1000083763474443&amp;ev=PageView&amp;noscript=1">

SmartTRAK Life Sciences News and Analysis Blog

3 min read

SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement

By Jay Merkel on 6/19/24 11:55 AM

The proposed MAC LCDs for Skin Substitutes/CTPs was the hot topic of SAWC and will continue to be until the LCDs are finalized. In this article, SmartTRAK highlights new learnings from discussions at SAWC and the MAC open meetings.

The Symposium on Advanced Wound Care (SAWC) Spring 2024 meeting welcomed clinicians, researchers and industry to Orlando, FL, to learn, earn continuing education credits, share knowledge and network on the latest developments in advanced wound care. As is typical during SAWC, the Alliance of Wound Care Stakeholders also held a meeting of their members. With the Medicare Administrative Contractors (MACs) recently announced proposed changes in the Local Coverage Determination (LCD) governing Skin Substitutes/CTPs (cellular and/or tissue-based products), the Alliance pivoted and invited an expert to speak to the group about how the LCD process works and what laws govern what can be done at the MAC level versus the Center for Medicare & Medicaid Services (CMS) levels. Kudos go out to the team at the Alliance for bringing this meeting together. In addition to the Alliance meeting at SAWC, the MACs held open meetings for these LCDs from May 16 to May 29, and anyone, including manufacturers, could present comments, make a request and provide evidence. SmartTRAK participated in several of these meetings.

In this downloadable article, SmartTRAK gives an overview of LCDs, how they are drafted, the coverage limitations by wound type, issues surrounding evidence for inclusion on the covered list and an implementation timeline. For more information on what the proposed LCDs cover, see also “Medicare Administrative Contractors’ (MACs) LCD Changes: Impact on Skin Substitutes/CTPs.

The following subjects are covered in detail in this downloadable article:

  • The Process for Drafting LCDs
    As background, CMS governs the process for drafting the LCDs in their Medicare Program Integrity Manual (PIM) in Chapter 13, which was most recently updated in 2019 with almost every section re-written. These changes include ... (read more)

  • Coverage Limitations
    The LCD is a literal guide to what is allowed and, conversely, what is automatically denied within the limits written in the LCD. The LCDs for Skin Substitutes/CTPs are for ... (read more)

  • Missing or New Evidence and Reconsiderations
    One area that generated the most questions from manufacturers was how to address coverage decisions if the MAC working groups are missing recently published evidence or have evidence currently in development. The comment submission period was ... (read more)

  • Timeline for LCD Implementation
    During the MAC open meetings, participants had several questions regarding the timeline for LCD implementation, and some requested a delay in implementation. The following timeline applies to all LCDs ... (read more)

Just click the button below to download and read the complete " SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement " Perspective article by Jay Merkel, SmartTRAK Sr. Analyst.
Read the Article

Continue Reading
4 min read

INS 2024: The Past, Present and Future of Neuromodulation

By Anne Staylor on 6/17/24 12:16 PM

INS President Dr. Marc Russo and INS President-Elect Dr. Konstantin Slavin discuss the current “state of the union” in neuromodulation, how the field is evolving and the challenges and opportunities that lie ahead in an interview with SmartTRAK at INS 2024.

At the 16th International Neuromodulation Society World Congress (INS 2024) held in Vancouver, Canada, Dr. Marc Russo, INS president, and Dr. Konstantin Slavin, INS president-elect, discussed the current “state of the union” in neuromodulation, how the field is evolving, where it’s going and trends in research, technology and clinical practice in an interview with SmartTRAK. They also discussed challenges and opportunities in the field, how the INS is addressing recent criticisms about neuromodulation and the promise and potential of neuromodulation across a wide range of clinical applications. 

To find out more, including the promising indications and areas of growth for spinal cord stimulation (SCS) and deep brain stimulation (DBS), click on the following video to listen to the interview recorded live at INS 2024 (51:53 min). Click hereto download a complete transcript of the interview. Topics by timecode are provided below. 

Continue Reading
3 min read

Orthopedic Enabling Tech Trends at AAOS and Beyond

By Elise Wolf on 6/4/24 9:45 AM

SmartTRAK highlights four key trends to watch in orthopedic enabling tech displayed at the 2024 AAOS and Canaccord Genuity Musculoskeletal Conferences.

Enabling technology was a hot topic of discussion at the 2024 Canaccord Genuity (CG) Musculoskeletal Conference and was a big focus at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco, California.   SmartTRAK  highlights four key trends noted at the meetings and expected through 2024 and beyond in orthopedic enabling tech and reports on key news from 17 companies in this space, ranging from multinational strategics to start-ups.

SmartTRAK's four key trends to watch in orthopedic enabling tech, which are discussed in detail in this downloadable Market Outlook article, are: 

    • Continued Growth in Ortho Robotics 
      • Similar to the last several years, robotics continued to be a large focus of orthopedic enabling tech at this year’s meetings, with SmartTRAK projecting ... (read more)
    • Navigation Targeted to ASC
      • Newer navigation technologies are overcoming the hurdles of traditional navigation systems and are making headway into the ASCs with designs targeted specifically to ... (read more)
    • Augmented Reality Gaining Traction
      • Intraoperative augmented reality continued to be an area of interest at the AAOS and Canaccord meetings this year, and SmartTRAK noted an ever-expanding number of ... (read more)
    • Advances in Smart Implants
      • Smart implants will continue to advance in 2024 as companies launch new products and work toward expanded applications. In addition to next-generation knee robotics and partial cementless knees ... (read more).
Click the button below to download and read the complete "Orthopedic Enabling Tech Trends at AAOS and Beyond" Market Outlook article by Elise Wolf, GM & VP, SmartTRAK Orthopedics, Digital & Quality. Read the Article
Continue Reading
3 min read

Medicare Administrative Contractors' (MACs) LCD Changes: Impact on Skin Substitutes/CTPs

By Susan Paquette on 5/29/24 9:45 AM

All seven MACs, in a united front, released proposed changes to the LCDs, which govern Skin Substitute/CTP use for DFUs and VLUs. SmartTRAK lookat the potential impact on the market.

A long-awaited update to Medicare coverage for skin substitutes has arrived. On April 25, 2024, all seven MACs issued the same proposed Local Coverage Determination (LCD) governing the use of skin substitutes/CTPs for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). For seasoned SmartTRAK subscribers, the decision to release an updated LCD was not a surprise. Several of the MAC directors have openly discussed tackling the LCDs. In 2022, a few of the MACs issued a different proposal, and in August of 2023, three MACs issued a final LCD governing skin substitutes for implementation later in 2023, only to be rescinded days before the effective date. In August 2023,  SmartTRAK published an article, " Impact of Medicare Administrative Contractor LCD Changes on Skin Substitutes/CTP Changes," discussing the potential impact of those earlier attempts.

Since the article was published last year, SmartTRAK has identified explosive market growth in some new care sites and added a new category, Mobile+, for expanded coverage. 

In this downloadable article, SmartTRAK delves into Mobile+, the key provisions in the proposed LCDs, patients affected and the estimated financial impact on the market, including:

  • Key Policy Changes
    • One of the key limitations of these LCDs is the number of product applications. Previous LCDs often had a ... (read more)
  • Impact on Patients
    • With the united front from all the MACs, this LCD will impact all traditional Medicare patients across the US. Patients enrolled in Medicare Advantage plans are also impacted by ... read more)
  • Market Impact
    • By reviewing the LCD coverage changes and mapping them to the various sites of care that have varying payment models, SmartTRAK sees ... (read more)
  • Links to LCDs and Articles from the CMS Announcement
  • List of Covered Products with Companies and Ulcer Sizes
Just click the button below to download and read the complete "Medicare Administrative Contractors' (MACs) LCD Changes: Impact on Skin Substitutes/CTPs" Perspective article by Susan Paquette, SmartTRAK VP & General Manager, Wound and Jay Merkel, SmartTRAK Sr. Analyst, Wound.Read the Article
Continue Reading
3 min read

Key Trends in Neurovascular Intervention for 2024

By Shelly Caruso on 5/21/24 9:45 AM

SmartTRAK highlights market and technology trends that will help drive growth in neurovascular interventions in 2024.

The neurovascular intervention market is poised for another exciting year in 2024, with key trends driven by an expanding treatable population and innovative technologies addressing critical gaps in patient care. The percentage of eligible acute ischemic stroke (AIS) patients who receive endovascular therapy (EVT) is projected to increase from ~25% in 2022 to ~40% in 2027E. According to the SmartTRAK US Mechanical Thrombectomy Market Overview, the market will generate a 5-year CAGR of 11.1%. Amidst market growth driven by treatment time window expansions, direct-to-EVT protocols and increasing evidence supporting EVT to treat large core stroke patients, SmartTRAK predicts continued advancements in three key areas: aspiration thrombectomy for ischemic stroke, automated stroke detection software and novel devices for treating intracranial aneurysms.

#1: Innovations to Increase Aspiration Efficiency
Aspiration thrombectomy is a mainstay of stroke treatment. With the increasing adoption of A Direct Aspiration, First Pass Technique (ADAPT), companies are innovating to improve aspiration efficiency, effectiveness, procedure speed, reperfusion and patient functional outcomes. SmartTRAK sees ... (read more)

#2 Accelerating Adoption of Automated Stroke Detection Technologies
Early and accurate stroke diagnosis is critical for timely intervention. Automated stroke detection software is gaining traction, with companies like Brainomix, RapidAI and Viz.ai leading the charge. Studies have shown that ... (read more)

#3 Aneurysm Treatment Beyond Flow Diverters
 While flow-diverting stents (FDS) remain a mainstay in treating intracranial aneurysms, SmartTRAK has witnessed the development of more novel devices catering to a broader range of aneurysm types and sizes since MicroVention introduced the Woven EndoBridge (WEB) device in 2011, the first intrasaccular device developed specifically for the treatment of wide-neck bifurcation aneurysms. This trend towards tailored solutions based on ... (read more)

The neurovascular intervention market is on an exciting trajectory, driven by increasing patient populations, innovative technologies and a focus on improving patient outcomes. 2024 promises to be a year of significant advancements in ... (read more)

Just click the button below to download and read the complete "Key Trends in Neurovascular Intervention for 2024" Market Outlook article by  Shelly Caruso, SmartTRAK Market Analyst/Associate Editor. Read the Article

Topics: Neurovascular
Continue Reading
3 min read

ISASS: Approaching 25 Years of Advancing Techniques and Technologies for Treating Spinal Disorders

By Kris Jacques on 5/14/24 9:00 AM

ISASS’s Morgan Lorio, MD, president-elect, discusses the obstacles to adopting emerging technologies in spine surgery and the importance of advocating for policy changes to support innovative treatments and improve patient outcomes in an interview with SmartTRAK.

SmartTRAK recently interviewed Morgan Lorio, MD, the incoming president of the International Society for the Advancement of Spine Surgery (ISASS), to learn more about the society’s commitment and goals to spine advocacy and research as it approaches its 25th anniversary as a society.

Key topics discussed include ISASS’s successful efforts in addressing coding and reimbursement challenges to ensure access to innovative treatments for patients, the potential impact of artificial intelligence (AI) on reimbursement, the new ICD-10 codes for discogenic pain, regenerative spine treatments, future directions and initiatives for ISASS and fostering collaboration between industry stakeholders and surgeon societies.

Continue Reading
3 min read

SmartTRAK Launches New Site-of-Care Treatment Tracker for Wound Care Powered by Data Partnership with Intellicure Analytics

By Gabriele Nichols on 5/13/24 3:35 PM

New offering delivers wound care companies with actionable data and analytics on wound care treatments, products and brands by site of care.

IRVINE, Calif., May 13, 2024 /PRNewswire-PRWeb/ -- SmartTRAK, the leading Medtech market and business intelligence solution in Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapies, in partnership with Intellicure Analytics announces the release of SmartTRAK Treatment Tracker, an innovative tool that provides in-depth market data and trending analytics across wound care treatments by site of care. The first offering in the data solutions portfolio is available now and covers the usage of Skin Substitutes in the hospital outpatient department (HOPD).

Continue Reading
2 min read

Vaporox Company Spotlight

By Susan Paquette on 5/2/24 6:33 PM

New leadership at Vaporox to launch a second generation of vaporous hyperoxia therapy at SAWC Spring 2024.

With the upcoming launch of its second-generation Vaporous Hyperoxia Therapy (VHT-200), Denver, CO-based Vaporox is well positioned to treat a wide range of chronic, hard-to-heal wounds and expand the company’s presence in the almost five billion dollar US Market for Advanced Wound Care. SmartTRAK spotlights the company, its latest research and VHT, a breakthrough technology designed to accelerate wound healing when combined with standard or advanced wound care.

In this comprehensive SmartTRAK Perspective article, available for download, we delve deep into Vaporox, exploring a variety of detailed topics, including:

  • The Overview
    Vaporox CEO and President Alan Sage, a successful start-up entrepreneur, brings his decades of experience to the medical device industry to bring VHT-200 to market. The novel technology was developed as a result of work at UCLA Medical Center for children with debilitating bed sores ...
  • Technology/Key Differentiator
    VHT delivers a unique combination of elements that accelerate healing: ultrasonic mist and concentrated oxygen. Vaporox administers these elements in a patented, automated, dual-modality system ...
  • Market Potential  
    After starting in the diabetic foot ulcer (DFU) space, the company has quickly expanded into facilities treating all types of wounds, including venous leg ulcers (VLUs), dehisced post-surgical wounds, burns and pressure injuries ...
  • Business Model/Financing
    The Vaporox business model provides the device to the clinician at no cost and charges for the disposable and pay-per-use fees ...
  •  Clinical/Regulatory Status 
    Vaporox received FDA 510(k) clearance for the second-generation VHT-200 product in the spring of 2023 ...
  • Reimbursement
    VHT is a low-frequency, non-contact, non-thermal ultrasonic mist therapy. It is an FDA-cleared technology that has been clinically validated as a safe and effective adjunctive treatment for healing nine types of skin wounds ...
  • Goals
    The company just hired a new vice president of sales and marketing and is aggressively pursuing high-volume private-practice podiatric surgeons, medical doctors, and nursing facilities ...

To download and read the complete "Vaporox Company Spotlight" perspective article by Susan Paquette, SmartTRAK VP & General Manager, Wound, just click the button below. Read the Article

Topics: Wound Care
Continue Reading
3 min read

Inceptiv SCS: Offering Options in a Closed-Loop Device

By Anne Staylor on 4/26/24 11:56 AM

Medtronic’s David Carr, VP & GM, Pain Interventions, discusses Inceptiv closed-loop SCS in an interview with SmartTRAK.

Medtronic (MDT) announced FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS), the second closed-loop SCS device to reach the market using evoked compound action potentials (ECAPS). The company previously launched Inceptiv in Europe and Japan and plans to initiate Inceptiv’s US market launch in the coming weeks. 

SmartTRAK recently interviewed David Carr, MDT’s vice president and general manager of Pain Interventions, to learn more about Inceptiv, what differentiates it from other SCS devices and what it means for Medtronic and the SCS market. To listen to the interview, click on the following video (22:54 min). A link to download the complete transcript of the interview is also provided below. 

Anne Staylor here with BiomedGPS. Today, I am talking with David Carr, who is the vice president and general manager of Pain Interventions at Medtronic. Exciting news, David. Medtronic now has FDA approval for your Inceptiv SCS device, an ECAPs-based device. So David, tell me what does Inceptiv mean for Medtronic?

David Carr: Good afternoon, Anne, and thank you for your time today and your interest in this announcement for us. This is a big moment for Medtronic and especially for the pain team within Medtronic. This is technology that has taken many, many years to develop. If you think back to the pivotal RCT, we did ECHOMAC, which demonstrated the performance of closed-loop technology, the algorithm, many years ago. Six published manuscripts across many recognized journals. Twenty peer-reviewed abstracts and posters, data from over 200 patients and several million ECAPs. So this is not something that's just been developed in the last couple of years. There's been a tremendous amount of work invested in this platform. So this is a very big moment for Medtronic, finally getting approval with the FDA to launch the product in the US market. Because as you know, we've already launched this product in Europe and Japan, and we're already seeing the tremendous patient benefits that the product brings to the market.

Let's start by having you talk about the technology itself. What are the key differentiators for Inceptiv versus other ECAPs-based devices on the market?

DC: Well, there's only one other ECAP-based product on the market, and that product is essentially closed-loop paresthesia. Okay, what differentiates this product is ...

To download and read the complete interview "Inceptiv SCS: Offering Options in a Closed-Loop Device" with David Carr, VP and GM of Pain Interventions at Medtronic, just click the button below. Download the Transcript

Continue Reading
3 min read

Three Global Spine Robotics Start-ups to Watch in 2024

By Shelly Caruso on 4/23/24 9:45 AM

SmartTRAK highlights three innovative start-ups with next-gen spine robots in development: Cyber Surgery, LEM Surgical and SpinEM Robotics.

The landscape of spine robotics has undergone a remarkable transformation in recent years, with advancements in technology revolutionizing the approach to spinal surgeries. As we step into 2024, there’s a race in the Spine Enabling Technology Market among companies to develop state-of-the-art robotic systems. The demand for minimally invasive spinal surgeries has been a driving force in the evolution of spine-enabling technologies. 

In this article, available for download, SmartTRAK explores in detail three innovative start-ups with next-gen spine solutions in development. They are:

  • Cyber Surgery: A Modular System to Improve Minimally Invasive Spine Surgery
    Cyber Surgery, a Spain-based healthcare technology startup specializing in medical robotics, is developing ALAYA, a robotic navigation system that uses internally developed haptic technology, which Cyber Surgery says is more precise and user-friendly than optical navigation systems. The company touts the system as ... (read more)

  • LEM Surgical: A Unique Multi-armed Approach to Spine Robotics
    Founded in 2021 and based in Bern, Switzerland, LEM Surgical takes a unique approach to spine robotics. Although LEM Surgical has held its robotic project, Sapien, in stealth mode, the company is looking toward ... (read more)

  • SpinEM Robotics: A Tracking Solution for Precision in Robotic Spine Surgery
    SpinEM was founded in 2021 and is headquartered in France. The company is supported by local industrial partners and a start-up factory in Grenoble. In January 2024, Haventure, an international accelerator for digital surgery and robotics start-ups, announced that ... (read more)

As Cyber Surgery, LEM Surgical and SpinEM Robotics pave the way for next-gen spine robotics, the market is poised for a significant transformation. These companies bring a unique set of capabilities, from AI-enhanced surgical planning to modular adaptability and a focus on minimally invasive techniques. The potential impact on the market is ...

Click the button below to download and read the complete Market Outlook article "Three Global Spine Robotics Start-ups to Watch in 2024" by Shelly Caruso, SmartTRAK Market Analyst/Associate Editor.Read the Article

Continue Reading
  • There are no suggestions because the search field is empty.

Follow Us on Social Media

Recent Articles