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SmartTRAK Life Sciences News and Analysis Blog

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August of 2023, three MACs issued a final LCD governing skin substitutes for implementation later in 2023, only to be rescinded days before the effective date.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
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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
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3 min read

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

By Kris Jacques on 5/14/24 9:45 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.

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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).

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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
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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

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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

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3 min read

Polaroid Therapeutics: Start-Up Spotlight

By Kris Flinn on 4/12/24 10:42 AM

Antimicrobial resistance (AMR) was directly responsible for 1.27 million deaths worldwide in 2019, according to the World Health Organization. With AMR now seen as a top global health concern and COVID-19 still in recent memory, the challenge of overcoming infections appropriately and effectively exists in all areas of healthcare and beyond. This includes wound care, with SmartTRAK forecasting that the WW antimicrobial market will exceed $1.00B for the first time in 2024.

One company aiming to tackle the challenge in antimicrobial therapies is Swiss-based Polaroid Therapeutics. The company has developed a proprietary advanced polymer technology that is designed to reduce bio-burden in a variety of settings, including in wound management. SmartTRAK recently caught up with CEO and co-founder Ran Frenkel to discuss the journey that the company has been on. Click on the video below to listen to the interview (15:01 min). A link to download the transcript of the interview is also provided below.

Download the Transcript

SmartTRAK: This is Kris Flinn with SmartTRAK. Today, I'm joined by Ran Frenkel, CEO and co-founder of Polaroid Therapeutics. Polaroid Therapeutics is a Swiss-based biotech startup focused on the development of innovative antimicrobial technology. The company has developed a proprietary advanced polymer technology that is designed to reduce bio-burden in a variety of settings, including in wound management. Ran, thank you for joining us today. Could you please start by giving me some background on yourself?

Ran Frenkel: Hi, Kris. Thanks. Happy to be here. I'm a pharmacist by training. For the last 25 years, I have been working in the pharmaceutical industry in different kinds of management positions in drug discovery and drug development. For the last 11 years, I was the Chief Development Officer of an oncology company here in the US, where we developed a first-in-class new drug for blood cancers, which was approved in over 50 countries. For the last two years, nearly two years, I joined Polaroid Therapeutics, moving from the oncology space into more of the antibacterials and wound management space.

Fantastic. So, Polaroid is a name that many people will recognize, but could you tell me a little about Polaroid Therapeutics specifically and the journey that the company's been on?

RF: Yeah, and it's a very nice story because everyone is familiar with ...

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3 min read

Spine Market Movers to Watch in 2024

By Kris Jacques on 4/9/24 9:30 AM

SmartTRAK highlights companies to watch as they continue their double-digit growth train with multiple catalysts for expansion in 2024.

Overall, the US Spine Market had a remarkable year in 2023 with the completion of the Globus/NuVasive (GMED) merger creating a new #2 in Spine, displacing the incumbent DePuy Synthes (JNJ). SmartTRAK estimates the US Spine Hardware Market grew ~5.5% in 2023. However, many pure-play spine companies exceeded industry growth with exceptional, double-digit growth rates in 2023, while others approached the $100MM revenue milestone. In this article, SmartTRAK highlights five pure-play spine companies to watch and the catalysts driving their expansion in 2024.

Continued Double-Digit Growth in 2024

SmartTRAK  expects three spine companies to see continued double-digit growth in 2024, particularly based on competitive moats developing and the ability to execute in their respective purviews, They are:
  • Alphatec Spine: Expanding Its Competitive Moat in Lateral Procedures
    • Alphatec has grown double digits yearly over the last five years. ATEC is now the #1 pure-play Spine Market leader and #5 in the overall Spine Market. These market share gains can be attributed to ... (read more)
  • SI-Bone: Competition Will Test the SI Fusion Market Leader in 2024
    • SI-Bone has grown double digits over the past three years. SIBN is the market leader in minimally invasive spine (MIS) SI Fusion with over 55% market share in the SI Fusion Market and more than ... (read more)
  • Centinel Spine: Fastest Growing Spine Company in 2023
    • In 2023, Centinel Spine was the fastest-growing spine company in one of the fastest-growing areas in spine, motion preservation. Centinel Spine reported record worldwide total disc replacement (TDR) revenue of nearly ... (read more)

Companies Closing in on $100MM in 2024

Both Spinal Elements and Xtant Medical came close to reaching the $100MM revenue mark in 2023 and SmartTRAK expects both to reach that lofty milestone in 2024. 

  • Spinal Elements: Focus on MIS Innovation, the Aging Spine and ASCs
    • Spinal Elements was just shy of $100MM in revenues in 2023. The company is focused on some of the fastest-growing trends in spine including ... (read more)
  • Xtant Medical:  Integrated Hardware, Biologics and More Acquisitions
    • Xtant Medical (XTNT) is also closing in on the $100MM revenue mark, growing +54.5% over 2022. XTNT had an exciting year of acquisition activity, including ... (read more)

To download the complete "Spine Market Movers to Watch in 2024" article by SmartTRAK's  Kris Jacques, please just click the button below. Read the Article

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4 min read

Swedish Wound Care Companies – You Win Some, You Lose Some

By Lennart Stadler on 4/2/24 9:30 AM

It is difficult to make it as a small to midsize company in the Global Wound Care Market, which was painfully evident for a few Swedish companies in the fall of 2023. SmartTRAK looks at lessons learned and explains why the future is still bright.

Sweden is traditionally a great place to start a wound care company. Several established global leaders are based there, like Mölnlycke*, Essity* and Arjo*. They fund early-stage companies and act as a source of skilled personnel. Strong universities and leading pharma and medical device companies also contribute to a dynamic market.

In the fall of 2023, not one, not two, but three Swedish companies found themselves in deep trouble. RLS Global filed for bankruptcy, Promore Pharma was liquidated and S2Medical was under reconstruction. In this article, SmartTRAK looks deeper at those companies, what went wrong, and highlights a few startups embarking on the journey. Lessons learned are not limited to the Swedish market but apply everywhere.

The companies covered in detail in this comprehensive Market Perspective article, which can be downloaded in its entiretyhere, are:

Although the fall of 2023 was challenging for a few companies, the future looks bright for Sweden to maintain its position as a strong generator of ...

* These links can only be accessed by SmartTRAK subscribers. To learn more            about SmartTRAK and how to subscribe, scroll down.

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