Companies breathe a temporary sigh of relief as the FDA reissues its guidance documents that could reduce allograft availability.

Manufacturers of allograft tissue and the medical device companies that market these products felt more at ease as the FDA reissued guidance set to take effect on May 4, with a new deadline for public comment on July 7. According to the American Association of Tissue Banks (AATB), the recommendations in their current form could reduce the availability of allograft tissues by 40%. The FDA’s recommendations aim to mitigate the risk of sepsis and Mycobacterium tuberculosis (Mtb) transmission when screening potential donors.

The tissue and blood banking industries have urged the agency to withdraw its current guidance and engage in a dialogue to review the actions already taken to mitigate the risk of disease transmission related to sepsis and Mtb. In this article, SmartTRAK examines new FDA recommendations, the concerns raised by these associations and their potential impact on the more than 2.5MM tissue transplants and over 15MM blood transfusions performed annually.

The topics covered in this downloadable SmartTRAK Perspective article are:

• Background to the Release of the Guidance Document 
• Origin of the Issue
• Guidelines Published by the FDA 
• Coordinated Response and Concerns from Trade Organizations
• Companies and Products Potentially Impacted
• Next Steps 

Click the button below to download and read the complete "FDA Guidance Documents Could Seriously Impact Access to Allograft Tissue" article by  David Shepard, SmartTRAK Lead Analyst, Orthobio & Regen.

SmartTRAK spotlights OSSIO in an interview at AANA 2025 in Washington, DC. 

Bryan Jones, vice president of marketing and medical education at OSSIO, discusses the company’s novel bio-integrative OSSIOfiber implants in an interview with SmartTRAK at the Arthroscopy Association of North America (AANA) 2025 Meeting in Washington DC. 

Watch the following video to learn more about OSSIO and its novel technology. (17:50 min.) A link to download a complete transcript of the interview is also provided below. 

 

Hey everybody, it's Andy Knapik, senior analyst with SmartTRAK covering sports medicine arthroscopy. I'm here at the AANA meeting in Washington, DC, and right now I'm joined by Bryan Jones, an old friend of mine who is now what, VP of marketing, right?

Bryan Jones: Yes.

For OSSIO. And OSSIO is really this great up-and-coming company. We've profiled them in the past, and I think their products are really incredible and the things that they're doing are really amazing. When you first joined OSSIO you came to me and said ‘Hey, you need to come check this out. This stuff's really cool.’ So I went and looked at it and the first thing I see is these kind of bioabsorbable pins, which 25 years ago I started my career by selling Bionix, which is absorbable pins and screws and stuff. Back then you could bend the pins. They were never all that sturdy. So, when you first talked to me about this I was a little dubious, and then I put my hands on one and you couldn't bend it, couldn't bend it at all. And I thought ‘Well, that's really interesting.’ And then you guys came out with a compression staple, which is completely amazing.

BJ: Yeah, right.

The only one on the market, right?

BJ: Only one in the world. Yes, the only non-permanent compression staple ever.

So talk to me about just about OSSIO, about the product. What makes OSSIO products as good as they are?

BJ: Yes. I'll touch on where you started when you said you and I first met probably what, six years ago now? And your initial reaction is probably like 10,000 other reactions that we got back then. The hardest thing we ever had to do was convince people that this was not a typical biocomposite or bioabsorbable implant. That was the hardest hurdle. To do that, we had to really tell them about ...

Click the button below to download and read the complete transcript of SmartTRAK's interview with Bryan Jones, Ossio's VP of Marketing & Medical Education, conducted by  Andy Knapik, SmartTRAK Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies.

Allumin8 CEO Alyssa Huffman discusses the company's novel therapeutic hardware during an interview with SmartTRAK at the 2025 NASS Biologic Interventions.

Click the button below to download the complete transcript of our interview with Allumin8 CEO Alyssa Huffman, conducted by Erin Dorgan, SmartTRAK Senior Analyst.

Click the button below to download the complete transcript of our interview with Brad Estes, CEO of CytexOrtho, conducted by  SmartTRAK analyst Emily Meng.

SmartTRAK discusses key products and compelling clinical evidence that may impact the Bone Replacement Market in 2025 and beyond.

SmartTRAK looks at what’s on the horizon in 2025 and beyond and highlights the innovation and product advances that could shake up the US Market for Bone Replacement, which is projected to reach a 5-year CAGR of +3.8% by 2028. In this article, SmartTRAK details the recent growth factors/peptides bone grafts that received the FDA’s Breakthrough Device Designation (BDD) and significant milestones in product development in 2024. It also discusses new clinical evidence challenging the belief that autologous bone is the most efficacious graft material.

Curious which companies and products are making waves? This downloadable market outlook article covers, among others:

• Cerapedics' investigational P-15 Peptide Enhanced Bone Graft
• Medtronic’s Infuse bone graft
• Theradaptive's OsteoAdapt SP bone graft
• Bone Biologics' NB1 bone graft
• Locate Bio's LDGraft bone graft 
• Renovos' Renovite BMP-2 bone graft 
• CBBio's NOVOSIS Putty
• Amphix Bio's  drug-device combination product for bone regeneration
• Kuros Biosciences' MagnetOs Granules bone graft

With new growth factor/peptides bone grafts progressing with their timelines to the market and clinical data demonstrating superiority over autograft, the Bone Replacement market is primed to grow in 2025 and the coming years.

Click the button below to download and read the complete "Clinical Evidence Poised to Redefine the Bone Replacement Market in 2025 and Beyond" Market Outlook article by SmartTRAK Erin Dorgan, Sr Analyst.

SmartTRAK highlights AAOS’ OrthoPitch 2025 finalists.

Innovation has always been a key growth driver in orthopedics and startups have been responsible for some of the most novel and innovative orthopedic products ever to reach the market. At the American Academy of Orthopaedic Surgeons (AAOS) 2025 Annual Meeting in San Diego, orthopedic startups were in the spotlight in the second annual OrthoPitch event, a Shark Tank-like competition sponsored, in part, by SmartTRAK.

Forty companies applied, but only four reached the finals and made their pitches at the event. In this article, SmartTRAK highlights the companies and technologies that made it to the OrthoPitch finals and announces the winner of the competition.

The finalists were:

• VISIE
  • VISIE, formerly known as Advanced Scanners, is a medtech startup located in Austin, TX. The company has developed proprietary hardware and software that ... (read more)
• 16 Bit
  • 16 Bit is a radiologist-founded medical technology company, located in Toronto, Ontario, focused on creating ... (read more)
• Auctus Surgical
  • California-based Auctus Surgical has developed a flexible tether implant designed for ... (read more)
• SentryX
  • SentryX, a clinical-stage biopharmaceutical company founded as a spin-out of the University Medical Center Utrecht in The Netherlands, has developed ... (read more)

SmartTRAK is proud to sponsor events such as OrthoPitch that foster an environment of innovation in orthopedics. We congratulate Visie, 16 Bit, Auctus Surgical and SentryX on making it to the final round.

AND THE WINNER IS ...

Click the button below to read more about each company's innovation and to find out who won the second annual OrthoPitch at AAOS 2025.

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SmartTRAK is the Medtech industry’s only global Insights-as-a-Service solution for the Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapy markets.  SmartTRAK’s propriety methodology turns disparate data from hundreds of sources into powerful insights customers can rely on as the trusted source for strategic decision-making. The  SmartTRAK enterprise platform includes rich daily updates, comprehensive market coverage and simple-to-use tools and dashboards for market, product and financial analysis. Customers leveraging the  SmartTRAK platform also have direct access to market experts for inquiries and advisory services. If you would like a demo of what  SmartTRAK has to offer and see how we can help increase proficiency, improve productivity and reduce costs for your company, just click  here. 

 

Soft tissue and cartilage repair trends and innovations take center stage.

Joint restoration and preservation continued to gain attention at this year’s Canaccord Genuity (CG) Musculoskeletal (MSK) Healthcare Conference and at the American Academy of Orthopaedic Surgeons' (AAOS) 2025 Annual Meeting, both in San Diego. From start-ups reporting early results and seeking investors to large companies showcasing recently acquired assets or newly launched products, the meetings were abuzz with companies and healthcare providers aspiring to help patients heal more naturally, restore an active lifestyle and delay joint replacement surgery.

In this market perspective article, SmartTRAK covers everyone from powerhouse names like Smith+Nephew and Stryker to dynamic start-ups, like CytexOrtho, Nanochon and Hyalex Orthopaedics. Their focus was clear: help the body heal naturally and preserve movement for as long as possible.

Below is a preview of the full article. The complete Market Perspective is available for download.

      

SmartTRAK spotlights Tetrous in an interview at AAOS 2025 in San Diego. 

Andy Carter, Chief Technology Officer and Founder of Tetrous, discusses the company’s novel approach to addressing Enthesis Failure Syndrome in an interview with SmartTRAK at the American Academy of Orthopaedic Surgeons (AAOS) 2025 Annual Meeting in San Diego. 

To learn more about Tetrous and its novel technology, listen to the following video. (21:42 min.) A link to download the transcript of the interview is also provided below. 

 

Hey everybody, it's Andy Knapik, live here at AAOS 2025 in San Diego. Today I'm joined here with a friend, colleague, and someone I've known now for, I guess a couple years, Andy Carter, Founder, Chief Technology Officer of a company called Tetrous, which is really some exciting biologic technology. So I just brought him along. We're going to chat a little bit about it. So Andy, why don't you just tell everybody what it is about Tetrous and what you guys do and why it's so great.

Andy Carter: Thanks for the opportunity. It's a great topic to talk about and I really, really love it. So we started Tetrous a couple of years ago. We spun it out of Theracell, the company that we sold to, ISTO Biologics. They're doing great and taking the technology in the spine and doing various things. But along the way, I read quite a few papers about how demineralized bone matrix materials could influence enthesis repair. And that's getting back to sports medicine, which is my roots and well, my real passion. I looked at these papers and they basically showed that demineralized bone matrix materials could influence the enthesis to heal. A tendon, the enthesis, is the bit between the tendon and the bone. It's the junction. It's how you get load transfer between rigid bone and flexible tendon. It's a biological structure that's very exquisite and unique. You look at the histology and the biologists go into raptures and "wows" about it and whatever.

The fundamentals are that you've got collagen fibers going from the bone through into the tendon. That's what gives you the strength. You see them in the histology with Sharpey's fibers. If you just reattach tendon to bone, you just get scar tissue. Scar tissue is not as strong. Basically, it pulls out and thins and fails with time. So part of the reason that we see so many problems with rotator cuff repair is that nobody's doing anything to heal the enthesis. There was this literature out there saying, ‘Hey, you can use DBM for this,’ but none of the papers showed it in any way that was something that you could see a surgeon being able to use-

Right, a practical form.

AC: There's one group, guys I know very well had used DBM powder. Now DBM powder, you can do it in a rat study and show that it works, but that's not a product. So what we were able to do, one of the clever things about the technology that we developed at Theracell, the fiber technology is, it allows us to ....

Click the button below to download and read the complete transcript of SmartTRAK's interview with Andy Carter, founder and CTO of Tetrous, conducted by Andy Knapik, SmartTRAK Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies.

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SmartTRAK is the Medtech industry’s only global Insights-as-a-Service solution for the Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapy markets. SmartTRAK’s propriety methodology turns disparate data from hundreds of sources into powerful insights customers can rely on as the trusted source for strategic decision-making. The SmartTRAK enterprise platform includes rich daily updates, comprehensive market coverage and simple-to-use tools and dashboards for market, product and financial analysis. Customers leveraging the SmartTRAK platform also have direct access to market experts for inquiries and advisory services. If you would like a demo of what SmartTRAK has to offer and see how we can help increase proficiency, improve productivity and reduce costs for your company, just click here.

SmartTRAK spotlights Doron Therapeutics in an interview with CEO Alessandra Pavesio at CG 2025 Musculoskeletal Conference in San Diego. 

Alessandra Pavesio, CEO of Doron Therapeutics, discusses the company, recent milestones and MOTYS, the company’s placental-derived injectable therapeutic for osteoarthritis, in an interview with   SmartTRAK  at the Canaccord Genuity (CG) 2025 Musculoskeletal Conference in San Diego, March 10, 2025.