Scientia Vascular CEO Rick Randall discusses the company, its novel technology and plans for growth in an interview with SmartTRAK. 

Scientia Vascular CEO Rick Randall discusses the company’s recent leadership transition, his priorities and vision as CEO and what’s next for the company in a recent interview with SmartTRAK.

Click on the following video (36:39 min) to learn more about the company, its differentiated microfabrication technology, product portfolio, marketing strategies and growth plans. Interview topics by timecode are provided below, as is a link to download a complete transcript of the interview.

Interview Outline by Timecode:

00:06 Introduction to Scientia Vascular, CEO Rick Randall, the leadership transition and his priorities as CEO.
05:08 Innovative products, new technologies, market positioning and differentiating Scientia in a crowded market.
09:54 Leveraging microfabrication technology and expanding the product portfolio.
14:18 Future directions in neurovascular and peripheral vascular. Clinical research and product validation.
22:07 Company growth and market strategy. Leading products and revenue mix.
26:59 Market share and business evolution.
29:26 Financing strategies and future investments.
31:57 Long-term growth strategies and potential IPO.

Click the button below to download and read the complete transcript of SmartTRAK's interview with Scientia Vascular CEO Rick Randall conducted by Anne Staylor, SmartTRAK Executive Editor, VP & GM of Neuro Therapies.

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.

Caroline Fife, MD, CMO of Intellicure and Executive Director of the US Wound Registry, discusses real-world evidence in wound care and other topics in an interview with SmartTRAK. 

Caroline Fife, MD, discusses insights from the Intellicure database about what diabetic foot ulcer (DFU) and venous leg ulcer (VLU) patients look like, the role of real-world evidence in wound care and the challenges in treating wound care patients.

To find out more, including the challenges for manufacturers and the systemic issues in wound care and payment policies, click on the following video to listen to the interview (37:48 min). A link to download the complete transcript of the interview is provided below. Interview topics by timecode are also provided below. 

Interview Outline by Timecode: 

00:30 Overlap between diabetic foot ulcers and venous leg ulcers.
08:19 Challenges in wound classification and diagnosis.
14:02 Limitations of randomized controlled trials and the role of real-world evidence.
17:38 Potential for biomarkers and intermediate outcome measures.
21:57 Neglected wound types and nutritional deficiencies.
29:14 Barriers to wound care implementation.
32:50 Opportunities for change in wound care practices.
34:31 Local coverage determinations (LCDs) and manufacturer challenges.
35:16 Systemic issues in wound care and payment policies.

Click the button below to download and read the complete transcript of SmartTRAK's interview with Caroline Fife, MD, CMO of Intellicure, conducted by  Elizabeth Anderson, SmartTRAK Senior Analyst, Wound Biologics.

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.

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

Bryan Lord, CEO of Pristine Surgical, discussed the company’s Summit 4K, single-use arthroscopic camera in an interview with SmartTRAK at the Arthroscopy Association of North America (AANA) 2025 Meeting in Washington, D.C . 

Watch the following video to learn more about Pristine Surgical and its novel technology. (21:27 min.) A link to download a complete transcript of the interview is also provided below. 

Hey, everybody, it's Andy Knapik, Senior Analyst for SmartTRAK for all things sports medicine and arthroscopy. I'm here at the AANA meeting in Washington, D.C. We're at the Pristine Surgical booth. I'm joined by Bryan Lord, CEO of Pristine Surgical, and here just to talk about what they have going on. They have a single-use arthroscopic camera.

Bryan, I've known you now for probably a few years, we've talked about this quite a bit. When we look in the video capital world, we see a lot of different things going on right now. We have traditional capital systems like the Strykers, and Smith+Nephews, Arthrexes of the world, with a full tower. We have some wireless options out there now that are pretty intriguing. And then we have some single-use options. Arthrex has a nanoscope and then you guys have yours as well.

So, talk about how this got started, what benefits you initially saw, and how is that progressing now.

BL: Yes, so the genesis of the scope that we see here today actually was in a rather niche application. Some docs said, ‘Look, we think we could do some things different in visualization.’ And they were looking for ways to do some different angular types of views, 30, 70, in more of a pannable configuration. The early days of the development we did in partnership with a group called DECA Research in Manchester, New Hampshire, led by the noted medtech developer and entrepreneur engineer, Dean Kamen. In the conversation with those doctors and Dean, the concept came up (Dean's idea) to say, ‘Look, we think that we could do this single use. Would that be interesting?’

At that time, it was still early in the ways that people were understanding the proliferation of digital technologies, but everybody knew, including Dean, who's always been in the forefront, this was really a big idea. How could we take today's burgeoning areas of digital photography and bring that into the surgical suite? And it was early on that we knew that it was ...

Click the button below to download and read the complete transcript of SmartTRAK's interview with Bryan Lord, CEO of Pristine Surgical, conducted by  Andy Knapik, SmartTRAK Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies.