SmartTRAK provides insights into the latest trends, research and consensus opinions in surgical Orthobiologic treatments and non-operative regenerative medicine from this year’s BA Summit and AANA meetings.
3 min read
Anika Therapeutics: Innovations in Early Orthopedic Interventions
Dr Cheryl Blanchard, president and CEO of Anika Therapeutics, discusses the company, technology and developments for future growth in an interview with SmartTRAK.
In a recent interview with SmartTRAK, Dr. Cheryl Blanchard, president and CEO of Anika Therapeutics, discussed the company’s strategic direction, proprietary technology and advancements in its next-generation osteoarthritis (OA) pain management and regenerative solutions.
To find out more about the company, its differentiated technologies, products and growth strategy, click on the following video (26:40 min).
Interview topics by timecode are provided below, as is a link to download a complete transcript of the interview.
Interview Outline by Timecode:
00:20 Introduction to Anika Therapeutics, president and CEO Dr. Cheryl Blanchard and the company’s strategy.
01:14 The US OA Injectables Market and Anika’s next-generation OA pain solution, Cingal.
02:52 Cingal’s advantages and how it fit in the treatment continuum.
04:56 Cingal’s positioning and clinical trials’ progress.
10:47 Marketing communication, commercial and pricing approach and beyond knee OA.
13:42 Hyalofast, Anika’s next-generation cartilage repair solution.
17:25 Anika’s regenerative platform and the Integrity Implant System.
19:54 Cheryl Blanchard’s take on the next major disruptive force.
22:42 Thoughts around healthcare policy changes, tariffs uncertainty and other macro trends.
Click the button below to download and read the complete transcript of SmartTRAK's interview with Dr. Cheryl Blanchard, president and CEO of Anika Therapeutics, conducted by Freddy Buntoum, SmartTRAK Senior Analyst, Orthobiologics and Regenerative Medicine.
Topics:
Regenerative Medicine
Orthobiologics
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2 min read
FDA Guidance Documents Could Seriously Impact Access to Allograft Tissue
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.
Topics:
Orthobiologics
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3 min read
AANA 2025: Spotlight On OSSIO
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.
3 min read
Aatru Medical: Next-Gen NPWT for Surgical Incisions
Thomas Lash, COO and co-founder of Aatru Medical, talks about the company’s innovative single-use negative pressure device, NP-Sims, a Negative Pressure Surgical Incision Management System.
Thomas Lash, chief operating officer and co-founder of Aatru Medical elaborates on the company’s strategy to mitigate the risk of surgical site infections through NP-SIMS, their single-use negative pressure surgical incision management system. To listen to the interview, please click on the following video (21:21 minutes). A link to download a complete transcript of the interview is provided below.
SmartTRAK: Hi, this is David Shepard, senior analyst with SmartTRAK. Today it's my pleasure to be joined by Tom Lash, COO and co-founder of Aatru. He's going to talk to us today about a product that he co-invented, called NPSims. Tom, tell us a little about your company and about the product.
Tom Lash: We started the business about eight years ago, a small research and commercialization team with the goal of developing an alternative solution for the single-use, disposable negative pressure wound therapy market. Kind of a mouthful to say that, but in essence, what we were trying to do is looking at the predicate devices that are on the market, we knew that if we were going to try and have a product that could make an impact on that market segment, it would be necessary for us to find an innovative mode of action to create the negative pressure without the current use of electromechanical pump which powers the leading products that are in use today. They have an electromechanical pump. They're battery-operated. They have software. Those products were primarily devised for the open or chronic wound market, and because of our focus on the surgical incision market, we were able to design something that was different. We believe the current products are probably over-engineered for the surgical incision market. So, our approach was to devise ...
Click the button below to download and read the complete transcript of SmartTRAK's interview with Aatru Medical's Co-Founder and COO Thomas Lash, conducted by David Shepard, SmartTRAK Lead Analyst, Orthobio & Regen.
3 min read
NASS Biologic Interventions 2025: Spotlight on Allumin8
Allumin8 CEO Alyssa Huffman discusses the company's novel therapeutic hardware during an interview with SmartTRAK at the 2025 NASS Biologic Interventions.
Alyssa Huffman, CEO of Allumin8, discussed the company and its efforts to create a new product category of therapeutic hardware in an interview with SmartTRAK on May 9, 2025, at the 2025 North American Spine Society (NASS) Biologics Interventions meeting in Chicago, Illinois. The company is focused on treating over 200 unique bone disorders and diseases, and its first product is focused on the Spinal Hardware Market.
Click on the following video (8:49 min) to learn more. A link to download a complete transcript of the interview is also provided below.
SmartTRAK: Hi, this is Erin Dorgan, senior analyst here at SmartTRAK. I'm here today with Alyssa Huffman, CEO of ALLUMIN8. Alyssa, thank you for joining me today. Can you share a little bit more about your background and your role at ALLUMIN8?
Alyssa Huffman: Absolutely, Erin. Thanks for being here. I started in the clinic, then worked in the OR, went into sales, distribution. I worked my way into an executive function and then decided I was going to bet on myself. I have 30 years of experience throughout orthopedic spine biologics regenerative therapies.
That's awesome.
AH: And computer navigation.
Well, that's quite extensive. So we're here today at the NASS Biologic Interventions for Spinal Pathologies meeting. Why are you here with ALLUMIN8? What's the purpose for ALLUMIN8 presenting?
AH: Dr. Zorica Buser, she asked me to come and talk to the researchers and physicians about how to design a product that will actually commercialize and can get funded. There's a very different issue that's going on right now where products that only are a little bit, 1% to 3%, better than what's currently available on the market. There's a plethora of those, and so we have ...
Click the button below to download the complete transcript of our interview with Allumin8 CEO Alyssa Huffman, conducted by Erin Dorgan, SmartTRAK Senior Analyst.
3 min read
CytexOrtho: Regenerative Medicine Solutions for Osteoarthritis
SmartTRAK spotlights CytexOrtho, the AAOS 2024 OrthoPitch winner, as it develops its biodegradable implant to address early joint degeneration.
In this interview with SmartTRAK, CytexOrtho CEO Brad Estes, PhD, discusses the company’s cartilage repair implant, ReNewHip, an engineered bicomponent implant used for cartilage regeneration.
To find out more about CytexOrtho and its technology, click the image below to watch the video (26:37 min). A link to download a transcript of the interview is also provided below.
SmartTRAK: Hi, this is Emily Meng with SmartTrak. Today I'm here with CytexOrtho CEO Brad Estes. Thanks, Brad, for joining me today.
Bradley Estes: Yeah, I'm happy to be here. Thanks for having me.
So, we'll just jump in and start asking you some questions. Let’s start with can you tell me about yourself and your background and how you got started with CytexOrtho.
BE: Yeah, it was kind of a circuitous route to get here. I started my career in the Medtech industry with Sofamor Danek, which was eventually acquired by Medtronic, and kind of did a lot of R&D in the heyday of spine, I like to say it, and was even on the team that did BMP-2. So that was a lot of fun seeing the role of a biologic in orthopedics and what that could really do to change the way patients are treated. And so I spent about eight years in Medtronic and then I left industry, came to academia, did a PhD at Duke and kind of retooled and learned the molecular biology, the stem cell biology, the tissue engineering and just kind of gained a whole new skill set. I got to work with some really great people and that kind of set us off on our journey of where we are today and kind of tie in some product development experience with science and having the right time and the right people and the right funding to push forward with CytexOrtho. And I'm sure I caused more questions in that response than answered, but I'm happy to fill in the gaps, too.
Can you tell us a little bit about CytexOrtho and what you guys are doing, and specifically, I guess, for ReNew Hip, since that's your product that is under development.
BE: So, our goal from the beginning has been to treat that patient that currently has no solutions. I'm talking the patient in their 30s, 40s or 50s that have early-stage hip disease, but they have no solutions right now. Their plight is kind of sad if you think about it. They go see their doctor, they have some hip pain, they're starting to not be able to do the things they want to do. And so, they take some ibuprofen, do some PT, and let's come back and see me in a year and that progresses for about seven or eight years typically. That's what our data tells us. That patient is just living with more chronic pain and increasing disability over that eight years until finally they can't take it anymore and then they replace their hip. And so, our technology is ...
Click the button below to download the complete transcript of our interview with Brad Estes, CEO of CytexOrtho, conducted by SmartTRAK analyst Emily Meng.
Topics:
Orthopedics
Orthobiologics
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2 min read
Clinical Evidence Poised to Redefine the Bone Replacement Market in 2025 and Beyond
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.
Topics:
Orthopedics
Orthobiologics
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3 min read
Innovation On Display at the 2nd Annual AAOS OrthoPitch
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.
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.
Topics:
Orthopedics
Orthobiologics
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3 min read
Joint Restoration and Preservation: The CG MSK & AAOS 2025 Playbill
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.
