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.

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.

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. 

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.

SmartTRAK highlights key trends and happenings in sports medicine and arthroscopy at AAOS 2024.

The American Academy of Orthopaedic Surgeons (AAOS) convened this year in San Francisco, California, from February 12-16. Following several years of subdued participation due to the COVID-19 pandemic, last year's strong showing at AAOS in Las Vegas fostered expectations for a continuation of momentum this year. Despite lower-than-projected attendance from medical professionals, the event featured a robust presence of large and small companies presenting their products and services. So, what was the buzz at the meeting?

In this Perspective article, which can be downloaded here, SmartTRAK highlights key takeaways from AAOS for companies competing in the Sports Medicine Market, including the following topics:

• Continued Interest in Biologic-driven Soft Tissue Fixation
  Companies are still helping drive soft tissue fixation sales through the use of biologics, which now are key advancements in technology at the forefront of sports medicine surgical procedures. Smith+Nephew continues to drive its Sports Medicine business with ... (read more)
  
  
• Ongoing Focus on the ASC Market
  Companies at AAOS had a prominent focus on the Ambulatory Surgery Center (ASC) Market. According to the SmartTRAK US Ortho ASC Market Overview, as of 2022, there were over ... (read more)
  
  
• Developments in Arthroscopic Technologies
  Another common theme on display across the AAOS 2024 exhibit floor was the showcasing of surgical video technologies. All the big players in sports medicine had their video systems on display, and some notable systems stood out. Stryker highlighted its newest ... (read more)

To download and read the complete "Highlights in Sports Medicine and Arthroscopy from AAOS 2024" Perspective article by Andy Knapik, SmartTRAK Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies, just click the button below.