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SmartTRAK Life Sciences News and Analysis Blog

Susan Paquette

Susan Paquette, MS, MBA | Vice President and General Manager, Wound. 25+ years' experience in new business development, R&D, international and marketing. Director, New Business Development & Commercialization, 3M Health Care; Technical Director, 3M Medical.

Recent Posts

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August of 2023, three MACs issued a final LCD governing skin substitutes for implementation later in 2023, only to be rescinded days before the effective date.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

Desert Foot 2023: Caring for Patients with DFUs

By Susan Paquette on 3/12/24 9:30 AM

Established and innovative new biologic products share space at Desert Foot 2023.

The diabetic population in the US continues to rise, with the Centers for Disease Control and Prevention (CDC) estimating that ~11.3% of US adults will be diagnosed with diabetes in 2021, the vast majority having Type II. The number of diabetics is even higher in the Veterans Health Administration (VHA), where one in four (25%) has diabetes, according to recent statistics published in VA News.

According to the Mayo Clinic, Type II diabetes can eventually lead to high blood sugar levels, which can cause disorders of the circulatory, nervous and immune systems. One ailment that often arises with diabetes is the occurrence of a diabetic foot ulcer (DFU) due to poor blood flow and neuropathy that many of these patients experience. The prevalence of a DFU varies with age, ranging from two percent in younger adults to eight percent in adults 65 and older.

In this article, which can be downloaded here, SmartTRAK reports on:

  • Skin Substitute Market Leaders at Desert Foot
    • Four of the top five US skin substitute/ CTP companies had a strong presence at the meeting. They were ... (read more)

  • Companies and innovations that caught SmartTRAK’s attention, including:
    • MicroVascular Tissues (MVT) - Featured mVASC, an off-the-shelf human tissue allograft consisting of ... (read more)
    • Fidia US - Showcased its newly launched Wound Care line of products, including ... (read more)
    • Merakris Therapeutics - Provides Dermacyte Amniotic Wound Care Matrix (Dermacyte Matrix) to the market as a skin substitute. However, at Desert Foot, the company discussed its ongoing clinical trial to investigate ... (read more)
    • Omeza - Presented its unique Omeza Complete Matrix (OCM) product and started the presentation by stating, “Omeza is not a Collagen Dressing or Product!! OCM is not a Dressing.” The company described OCM as ... (read more)

      To download and read the complete "Desert Foot 2024" article by Susan Paquette, SmartTRAK VP & General Manager, Wound, just click the button below.
      Read the Article
Topics: Wound Care
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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

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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2 min read

Kerecis and the Road to Success: An Interview with CEO Fertram Sigurjonsson

By Susan Paquette on 10/6/23 2:56 PM

Fertram Sigurjonsson, CEO of Kerecis, discusses the recent acquisition, how the Company has evolved over the last decade and key milestones along its “Road to Success” in an interview with SmartTRAK.

Topics: Wound Care
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2 min read

Spotlight on the Skin Substitute Market: SAWC Spring 2023

By Susan Paquette on 6/27/23 9:30 AM

SmartTRAK highlights the latest news from SAWC Spring 2023 for the ever-changing, continually growing skin substitute/CTP segment.

The skin substitute/CTP segment has seen double-digit growth year after year. Although the category has been known as the skin substitute or CTP (cellular and/or tissue-based products) market and has been dominated in recent years with amniotic tissue and xenograft products, it has recently grown to include non-biologic or synthetic-based products such as those based on polyurethane, polylactic acid, and bioabsorbable glass. The Journal of Wound Care recently published an international consensus document on “best practice for wound repair and regeneration,” with the clinical panel concluding CTPs weren’t the best terminology for the category. The panel suggested a more accurate name is “cellular, acellular and matrix‑like products (CAMPs),” expanding the definition to include "A broad category of biomaterials, synthetic materials or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action."
 

This SAWC Spring 2023 perspective article extensively covers a wide range of topics pertaining to skin substitutes and Cellular and Tissue-based Products (CTPs), offering in-depth insights and analysis, and highlights a multitude of areas for discussion. Some of the key topics explored in this article include:

  • CAMP Companies and Products Dominate
    • Spring SAWC was dominated by companies showcasing their CAMPs, with nearly 30 companies exhibiting this year. The market is currently led by ...
  • Reimbursement: It’s Complicated
    • Skin substitute utilization is heavily influenced by reimbursement and setting of care. The physician office currently captures the largest share of the skin substitutes market. This is primarily driven by ...
  • Emerging Sites of Care
    • In its Site of Care module, SmartTRAK currently tracks the use of CTP or CAMP products in the surgical suite, HOPD, physician office, VA Health system and burn center. In discussions at SAWC, SmartTRAK learned ...
  • Future Growth
    • Despite reimbursement hurdles, SmartTRAK projects strong growth for this segment in the coming years, primarily due to ...

To download and read the complete "SAWC Spring 2023: Spotlight on the Skin Substitute Market" market perspective article by Susan Paquette, SmartTRAK's VP & General Manager, Wound, just click the button below.Download the Article

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2 min read

A Whopping Quarter for Biologics: Q123 Advanced Wound Care Market Recap

By Susan Paquette on 6/23/23 12:30 PM

Biologics had a whopping quarter, Advanced Dressings saw strong gains and External Devices continue to show minimal gains due to traditional NPWT holding down the segment.

The global AWC market is split geographically, with the US accounting for just over half, followed by Europe and then ROW, due to the US using higher technology products and their allowed reimbursement. SmartTRAK has noted shifts in market share, largely driven by currency movements. In Q123, there was less of an impact. From Q221 to Q123, the US went from 52.6% share to 53.1%, Europe from 27.9% to 28.6% and ROW from 19.5% to 18.2%.

Among the many topics covered in detail in SmartTRAK's comprehensive Q123 Advanced Wound Care Market Recap* are:

  • Complete Q123 Advanced Wound Care Market Overview
  • SmartTRAK's Expert Market Analysis and Insights
  • All AWC Companies' News, Revenues, Data, Charts and Market Shares
  • WW Advanced Dressings: Acceleration of Continued Solid Growth
  • Biologics: An Impressive Quarter
    • Skin Substitutes/CTPs
    • Topical Delivery/Drug
    • Collagen/Active Dressings
  • External Devices: Single-use NPWT and Topical Oxygen Therapy Drive Growth
  • Growth Analysis – Currency Having a Less Strong Impact
    • Growth Details for Key Companies in Q123
  • Other Notable Q123 AWC Events

3M remained the global revenue leader in the Q123 WW AWC market, with Smith+Nephew (SNN) is in second place and Mölnlycke rounding out the top three,  with revenues of ...

Read the entire Q123 AWC Market Recap, including SmartTRAK's expert analysis, news, data, charts, company revenues and shares*

*These links and the complete unedited article can only be viewed by SmartTRAK subscribers to this module. For more information on SmartTRAK, including how to receive a demo and subscribe, please click the button below.Learn More about Subscribing to SmartTRAK

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2 min read

Healthy Gains: Q422/FY22 AWC Market Recap

By Susan Paquette on 5/1/23 9:30 AM

Advanced Dressings and Biologics added healthy gains to the WW Advanced Wound Care market, while External Devices showed minimal growth.

The global Advanced Wound Care market is split geographically, with the US accounting for just over half, followed by Europe and then ROW, due to the US using higher technology products and their allowed reimbursement. SmartTRAK noted a sizeable shift in market share from Q122 to Q422.
 

Among the many topics covered in detail in SmartTRAK's comprehensive Q422/FY22 AWC Market Recap* are:

  • Complete Q422/FY22 AWC Market Overview and Highlights
  • SmartTRAK's Expert Market Analysis and Insights
  • All Company News, Revenues, Data, Charts and Shares
  • WW Advanced Dressings: Continued Solid Growth
  • Biologics: Growth Remains Healthy but Dips Slightly in Q422
    • Skin Substitutes/CTPs
    • Topical Delivery/Drug
    • Collagen/Active Dressings
    • Traditional NPWT Performance
    • Single-use NPWT Performance 
    • Topical Oxygen and Debridement
  • Growth Analysis – Currency Having a Strong Impact Throughout 2022

The US went from 51.9% share market to 55.3% of the global AWC market, Europe from 29.5% to 26.4% and ROW from 18.6% to 18.3%. The primary reason is ...

Read the entire Q422/FY22 AWC Market Recap, including SmartTRAK's expert analysis, news, data, charts, company revenues and shares.*

*These links and the complete unedited article can only be viewed by SmartTRAK subscribers to this module. For more information on SmartTRAK, including how to receive a demo and subscribe, please click the button below.Learn More about Subscribing to SmartTRAK


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2 min read

The Past, Present and Future of 3M Health Care

By Susan Paquette on 1/17/23 9:18 AM

With the recent announcement that 3M is spinning off its Health Care division, SmartTRAK looks back at the evolution of 3M Health Care, its businesses today, the entry into Advanced Wound Care (AWC) and potential new opportunities for the new Health Care business.

3M, a large, diversified company with annual sales of $35.4B in 2021 announced earlier this year plans to spin-off its Health Care business into a new public company. Today, 3M markets thousands of products through four business groups: Safety and Industrial, Transportation and Electronics, Health Care and Consumer. Post-spin-off, 3M will continue as a leading global material science innovator, while the new stand-alone business will seek to become a global diversified healthcare company focused on wound care, healthcare IT, oral care and biopharma filtration.

Download "The Past, Present and Future of 3M Health Care" Article
Among the many topics covered in this fascinating article are:

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