Medical Device and Wound Care News and Analysis Blog

3 min read

Impact of the OPPS Reimbursement Rules on the US Advanced Wound Care Market

By Kris Flinn on 11/26/25 2:22 PM

Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of the final OPPS rules on the US Advanced Wound Care Market.

Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the Centers for Medicare & Medicaid Services’ (CMS) final rules on Outpatient Prospective Payment System reimbursement, and the potential impact on the US Advanced Wound Care Market.

To listen to the interview, click on the following video (21:35 min). A link to download the complete transcript of the discussion is also provided below.

Topics: Wound Care

3 min read

Cartilage Repair and Regeneration: Innovative Use of Hydrogel

By David Shepard on 11/25/25 9:30 AM

Leo Smit, CEO of Hy2Care, discusses the company's innovative hydrogel platform for articular cartilage repair in an interview with SmartTRAK at ICRS World Congress 2025.

In this interview with SmartTRAK, Hy2Care CEO Leo Smit discusses the company's innovative technology. Hy2Care, a Dutch spin-off from the University of Twente, is developing a new hydrogel platform to address focal cartilage defects. Smit explains their "joint-mimicking" hydrogel, which is applied arthroscopically as a liquid, enzymatically cross-links in place within one minute, and bonds strongly to surrounding tissue. The product could represent a new generation of acellular, off-the-shelf scaffolds that aim to close this gap by offering a simpler procedure that regenerates high-quality, durable tissue.

To find out more about the Hy2Care procedure and what makes it so revolutionary, click on the following video (12:43 min). A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is David Shepard with SmartTRAK. And I'm here with Leo Smit, the CEO for Hy2Care. Thank you for taking the time.

Leo Smit: Pleasure.

Excellent. So, if you could, tell me a little bit about your technology and your interest in getting into the cartilage space.

LS: Sure. Well, first, maybe a little bit about Hy2Care, we are a Dutch spin-off from the University of Twente. The group of Professor Marcel Karperien, he is a decades-old, experienced professor in the field of osteoarthritis and cartilage research. He came up together with a bunch of his co-workers with a new technology to repair cartilage. And that's a really unique technique. It's a hydrogel platform. It's a platform that is based on what we call joint mimicking composition, joint mimicking polymers. We use dextran and hyaluronic acid in a somewhat modified way and then make them... Allow them to be cross-linked during the surgery.

So, what we do is we take...

Want to learn more about Hy2Care and its unique hydrogel platform that addresses focal cartilage defects? Click the button below to download and read the complete transcript of our interview with Leo Smit, CEO of Hy2Care, conducted by David Shepard, SmartTRAK GM/Sr Analyst, Orthobio & Regen.

Topics: Regenerative Medicine Orthopedics Orthobiologics

3 min read

OSET 2025: Spotlight on Conmed and BioBrace

By Andy Knapik on 11/13/25 6:06 PM

Conmed’s Lisa Donnelly, VP of Marketing for US Orthopedics, and Jeff Ott, Director of R&D, discuss their BioBrace technology in an interview with SmartTRAK at OSET 2025 in Las Vegas.

Conmed’s Lisa Donnelly, VP of Marketing for US Orthopedics, and Jeff Ott, Director of R&D, sat down with SmartTRAK at the Orthopaedic Summit (OSET) 2025 Annual Meeting in Las Vegas (September 18–25, 2025) to discuss BioBrace and how its bioinductive technology sets it apart from the competition.

To find out more about Conmed and BioBrace, click on the following video (16:30 min). A link to download a complete transcript of the interview is also provided below.

Hey everybody, it's Andy Knapik with SmartTRAK, here at Ortho Summit in Las Vegas, and I'm happy to be here at the ConMed booth, and joined by a good friend of mine, Lisa Donnelly, who's VP of Marketing for US Ortho for ConMed, and then also Jeff Ott, who is a director of R&D. Why don't you just start by talking to us about how you started with the company? I'm just going to let you go with the intro part.

Jeff Ott: Yes, happy to do that. I joined a small company called Biorez about six or seven years ago as a small startup. We were focused on trying to find ways to help with tendon and ligament healing, and we developed a product called the BioBrace, which now is a part of ConMed.

So, when was that acquired? That was about a year…

Lisa Donnelly: August of 2022.

Okay. So a few years now. Wow. It's flown.

JO: Yes, time has flown by. So the BioBrace, which we developed, we designed a product that is a bioinductive scaffold with strength. What we did is we created a product that can both reinforce a tendon or ligament repair, and it also can ...

Want to learn more about the BioBrace technology? Click the button below to download and read the complete transcript of our exclusive interview with Conmed’s Lisa Donnelly, VP of Marketing for US Orthopedics, and Jeff Ott, Director of R&D, conducted by Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Topics: Orthopedics Arthroscopic Technologies Soft Tissue Fixation Arthroscopy

3 min read

Impact of Final Physician Fee Schedule on US Skin Substitutes in 2026

By Kris Flinn on 11/7/25 11:22 AM

Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of the final physician fee schedule on US Skin Substitutes in 2026.

SmartTRAK Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the Centers for Medicare & Medicaid Services’ ( CMS) policy announced on October 31 on the final Physician Fee Schedule for US Skin Substitutes in 2026 and the overall impact on the market.

To listen to the interview, click on the following video (19:37 min). A link to download the complete transcript of the discussion is also provided below.

Transcript:

Kris Flinn: This is Kris Flinn with SmartTRAK. I'm joined today by our senior analysts, Elizabeth Anderson and Jay Merkel. On Friday the 31st of October, CMS published the final physician fee schedule reimbursement rules for 2026. These rules are likely to have a significant impact on the US skin sub market. SmartTRAK values the 2024 skin sub market at just under $8 billion, with the sites of care affected by the physician fee schedule, such as physician office and mobile plus, accounting for over 3/4 of that number. This year's number could be even higher.

Today, during this call, we're going to look to discuss the rules that have been finalized and the impact they could have on the US advanced wound care market. Jay, Elizabeth, thank you for joining me today. Jay, if I could just start with you. Could you please talk about the rules that have been finalized, and particularly the changes from the original proposals?

Jay Merkel: Yeah, I'm just going to share a screen to help me go through all of the steps, but TLDR is that everything that was proposed was essentially adopted. So the first thing that we talk about is ...

To download and read a complete transcript of SmartTRAK's Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discussing the impact that the final physician fee schedule will have on US Skin Substitutes in 2026, just click the button below.

Topics: Wound Care Skin Substitute/CTP

2 min read

A Unique Perspective on Orthopedics/Sports Medicine: An Interview with ESPN Writer/Analyst Stephania Bell

By Andy Knapik on 11/6/25 9:00 AM

Stephania Bell, a licensed physical therapist, ESPN senior writer, and renowned sports injury analyst, brings together her clinical expertise and media experience, exploring how sports injuries in professional athletes intersect with those seen in the general population.

In a recent interview with SmartTRAK, Stephania Bell, a licensed physical therapist, ESPN senior writer and renowned sports injury analyst, brings together her clinical expertise and media experience, exploring how sports injuries in professional athletes intersect with those seen in the general population.

Click on the following video to watch the interview (43:14 min). For more details, interview topics by timecode and a link to download a complete transcript of the interview are provided below.

Interview Topics By Timecode:

02:00 Stephania’s background.

11:15 Work with Arthrex on the education side.

18:50 Where do med device companies fit in with prevention?

21:51 Patient insistance on being treated like the pros.

29:24 Public perception of sports injuries.

The connection between sports injuries in professionals and those in the broader population offers valuable insight into treatment and recovery trends. Click the button below to download and read the complete transcript of our interview with Stephania Bell, ESPN senior writer and renowned sports injury analyst, conducted by Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Topics: Orthopedics Trauma Soft Tissue Fixation

3 min read

Decoding the Future of Cartilage: Biologics, AI and the New Standard of Care

By Andy Knapik on 11/4/25 9:30 AM

Incoming ICRS President Dr. Christian Lattermann discusses the future of cartilage repair in an interview with SmartTRAK at the 2025 ICRS Global Congress in Boston.

In this interview, SmartTRAK speaks with Christian Lattermann, MD, the incoming president of the International Cartilage Regeneration and Joint Preservation Society (ICRS), about the future of joint repair. He shares insights on emerging technologies, highlighting advances in mechanical correction, AI and biologics. Dr. Lattermann explains how AI helps clinicians understand causes of degeneration that were previously overlooked. He emphasizes the excitement surrounding orthobiologics, especially extracellular vesicles, as a novel approach to guiding biological responses.

To find out more, click on the following video (22:22 min). Interview topics, organized by timecode, and a link to download a complete transcript of the interview are provided below.

Interview Outline by Timecode:

00:22 The three pillars of revolution: AI, biology, and mechanics.

06:36 Orthobiologics and extracellular vesicles: From "voodoo" to validated science.

10:25 Rethinking inflammation: fixing the "leak."

13:53 The collaborative alliance: industry, clinicians and researchers.

16:46: Finding the niche: comparing the roles of MACI, Agili-C, and other technologies.

21:29: Conclusion: the future of individualized patient care.

Curious about the future of cartilage repair? Click the button below to download and read the complete transcript of our interview with the incoming ICRS president, Dr. Christian Lattermann, conducted by Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Topics: Orthobiologics Soft Tissue Fixation

3 min read

Super-Bore Catheters 2025: An Interview with Raul Nogueira, MD

By Anne Staylor on 10/28/25 9:39 AM

Raul Nogueira, MD, discusses the latest research and innovation in super-bore catheters for the treatment of AIS and the preliminary results from the MARRS pivotal trial in an interview with SmartTRAK.

In an interview with SmartTRAK, Raul Nogueira, MD, interventional and stroke neurologist at the University of Pittsburgh and chief of cerebrovascular medicine at the UPMC Stroke Institute, discusses the latest research and innovation in super-bore catheters for the treatment of acute ischemic stroke (AIS), including preliminary results from the MARRS pivotal trial that he recently presented at the Society of NeuroInterventional Surgery (SNIS) 2025 Annual Meeting in Nashville, TN.

Dr. Nogueira highlights key results from the MARRS pivotal trial, which is evaluating Perfuze Medical’s Millipede super-bore 088 catheter, how the results compare to other super-bore pivotal trials and what factors contributed to MARRS’ high first-pass effect rate.

Listen to the interview below (43:20 min) to learn more, including how Millipede performed in different parts of the brain and the status of research and innovation that is helping to drive growth in the US Market for Mechanical Thrombectomy. A link to download a full transcript of the interview is also provided below.

Interview by Timecode

00:06 Introduction, background about stroke thrombectomy and the evolution of technology and research in mechanical thrombectomy devices.

10:27 Discussion about the MARRS pivotal trial vs other trials and what contributed to the the high, first-pass effect rate.

18:44 Different studies use different definitions of first-pass effect and good reperfusion. Where does the MARRS study definition fit and compare to how other studies define good reperfusion?

21:47 Discussion about safety data for super-bore catheters vs the Millipede catheter, device designs and comparison to other types of thrombectomy devices.

Topics: Neuro Therapies Neurovascular

3 min read

What's Next in Orthopedic Trauma?

By Nick Fitzpatrick on 10/21/25 9:45 AM

SmartTRAK reviews the evolving trauma startup landscape in 2025, spotlighting five innovators, followed by a comparative chart mapping 19 emerging companies.

The Trauma Market is undergoing a subtle but significant evolution. Amid growing pressure on hospitals to improve outcomes, reduce costs, and avoid complications like surgical site infections, a wave of early-stage companies is rethinking the fundamentals of fracture care. From infection-mitigating implants to ultra-low-profile nails and percutaneous plating systems, these startups are betting that innovation in surgical efficiency, implant design, and value-based care will ultimately reshape the trauma landscape.

Historically seen as a commoditized space dominated by legacy original equipment manufacturers (OEMs), trauma is now attracting mission-driven founders, surgeons and academic engineers building platforms with real clinical intent, whether to reduce the burden of open fractures, address fragility fracture under-treatment, or to simplify procedures that have seen little change in decades. While most remain pre-commercial, several are advancing toward regulatory milestones, clinical validation, or meaningful early traction.

In this article, SmartTRAK highlights 19 companies with trauma-specific implants and technologies, categorized by platform/product, commercial stage, latest funding round, regulatory status and relevant activity callouts. Of these, SmartTRAK also provides a deep dive on five companies to watch in the Trauma Market in 2025 and beyond.

Company Spotlights: Five to Watch in Trauma

CURVAFIX
Curvafix is redefining pelvic fracture fixation with a novel intramedullary (IM) implant system designed specifically for curved bone anatomy. The company’s flagship device, the CurvaFix IM Implant, is the first and only FDA-cleared implant that ... (read more)
Endeavor Orthopedics
Endeavor Orthopaedics is a trauma-focused medical device company pioneering implant systems for complex avulsion fractures. Its flagship product, the Summit Patella Plating System, addresses a critical need in the treatment of ... (read more)
Meduloc
Meduloc is an early-stage orthopedic startup advancing intramedullary fixation solutions for small, long-bone fractures. The company’s proprietary system combines ... (read more)
OrthoXel
OrthoXel is an orthopedic trauma company developing advanced intramedullary nailing systems designed to optimize healing biomechanics and surgical workflow. Based in Cork, Ireland, the company has commercialized two flagship platforms ... (read more)
Reselute Medical
Reselute Medical is a pre-commercial orthopedic startup developing a novel class of intramedullary implants capable of localized antibiotic delivery for the treatment of severe traumatic long bone fractures. The company’s lead product is ... (read more)

Curious about what's next in Orthopedic trauma and the companies that are rethinking the fundamentals of fracture care? Click the button to get the full article by Nick Fitzpatrick, SmartTRAK Associate Market Analyst – Orthopedics.

Topics: Orthopedics Trauma

2 min read

Advancing Orthobiologic Care: Charting a New Course at TOBI 2025

By David Shepard on 10/14/25 9:29 AM

TOBI President Michael Khadavi, MD, shares his thoughts on the institute's future, key insights from this year’s conference, and exciting new techniques and technologies in the orthobiologics field.

Dr. Michael Khadavi, a triple-boarded physician in physical medicine and rehab (PM&R), sports medicine, and ultrasound, and the current president of the Orthobiologic Institute (TOBI), discusses the organization's future plans, including expanding its educational programs, research initiatives and strengthening partnerships with industry in an interview with SmartTRAK. Dr. Khadavi also reviews the use of musculoskeletal ultrasound in orthobiologics and highlights the promising results of intraosseous subchondral injections for joint treatments, citing encouraging data from recent studies. Click on the following video (08:22 min) to learn more. A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is David Shepard with SmartTRAK. It's my pleasure to be joined by the president of TOBI. This is Dr. Michael Khadavi, triple-boarded physician in PM&R, sports and ultrasound. Thank you very much for joining us.

Michael Khadavi, MD: It is an honor.

Thanks a bunch. So, we're just wrapping up with TOBI, fantastic presentations throughout the week. It's been really, really great. What's your take-home message to all the people that couldn't make it? What are the things that you learned from these last two days? What's the summary of what you learned here?

MK: This was a strong conference, if I've ever been to a good conference. My biggest take-homes are ...

Click the button below to download the full transcript of our exclusive interview with TOBI President Michael Khadavi, MD, conducted by David Shepard, SmartTRAK GM/Sr Analyst, Orthobio & Regen.

Topics: Orthobiologics

3 min read

OSET 2025: Spotlight on OSSIO Kneebar Procedure

By Andy Knapik on 10/2/25 9:53 AM

Dr. Brian Cole discusses the novel OSSIO Kneebar procedure in an interview with SmartTRAK at OSET 2025 in Las Vegas.

Brian Cole, MD, orthopedic surgeon and sports medicine specialist at Rush Health System, discussed the OSSIO Kneebar procedure for the management of subchondral insufficiency fracture of the femur and tibia, utilizing the bio-integrative OSSIOFiber 4.0mm Cannulated Trimmable Fixation Nail, in an interview with SmartTRAK at the Orthopaedic Summit (OSET) 2025 Annual Meeting held September 18-25, 2025 in Las Vegas, NV.

To find out more about the OSSIO Kneebar procedure and what makes it so revolutionary, click on the following video (11:49 min). A link to download a complete transcript of the interview is also provided below.

Interview Transcript

Hi everybody, it's Andy Knapik with SmartTRAK. I'm here at the OSET meeting in Las Vegas and I'm joined with Dr. Brian Cole. Thanks for joining me today.

Dr. Brian Cole: Thanks for having me, Andy.

Yes. I've talked a lot in the past about OSSIO. They have some really great products and one of the products that's out now, it's called KneeBar. It's a very unique product. So I thought it'd be great if you, being so involved with the product, you could walk through it and tell us about it.

BC: Yes, so for clarity, KneeBar is probably what we would say the procedure, I guess is a KneeBar procedure.

Okay.

BC: The device itself is OSSIO fiber, so it's their core technology, which is I'd say bio-talented, bio-replaceable and gets replaced and/or turns into bone over time. So we know that's the construct for OSSIO fiber, and the device itself is a cannulated trimmable fixation nail.

So the KneeBar procedure basically is a procedure that will address ...

Want to learn more about the novel OSSIO Kneebar procedure? Click the button below to download and read the complete transcript of SmartTRAK's interview with Brian Cole, MD, conducted by Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Topics: Orthopedics

SmartTRAK Life Sciences News and Analysis Blog

3 min read

Impact of the OPPS Reimbursement Rules on the US Advanced Wound Care Market

3 min read

Cartilage Repair and Regeneration: Innovative Use of Hydrogel

3 min read

OSET 2025: Spotlight on Conmed and BioBrace

3 min read