FITM: The Full Conversation with ForCast Orthopedics

This is a deep-dive extended interview with the team behind ForCast Orthopedics — a company working to change how periprosthetic joint infection is treated. It's for orthopedic surgeons, arthroplasty specialists, and anyone interested in how a clinical idea becomes a medical device company.

The conversation brings together Dr. Jared Foran (CSO and co-founder), Dr. Leo Whiteside (the surgeon whose intraarticular infusion technique underlies the product), and Peter Noymer (CEO). Together they trace the origin of the idea from residency-era frustration with antibiotic elution curves, through multiple failed prototypes, to the current catheter-based system designed to make Whiteside's technique practical and scalable.

The discussion covers the pharmacokinetic rationale for intraarticular infusion, the clinical and economic case for tackling PJI more aggressively, the regulatory strategy including Orphan Drug and QIDP designations, what it takes to pitch early-stage med tech to investors, and what ForCast's scientific advisory board actually does for product strategy. If you're curious about what a surgeon-founded company looks like from the inside — the pivots, the regulatory burden, the reimbursement complexity, and the moment the team knew the idea was worth building — this is the conversation.

Learn more about ForCast Orthopedics: https://forcastortho.com

⏱️ Chapters:
00:00 Introductions
01:44 The clinical origin of the idea
02:57 Why intraarticular infusion works: the pharmacokinetic argument
06:00 What ForCast brought to Leo's technique
07:34 Peter's personal and professional motivation
08:46 The emotional spark that drove Jared to pursue it
10:35 Early questions and challenges developing the technique
13:30 Success rates and the evidence base
14:41 From good idea to viable company: the business case
16:49 Surprising early prototype results and what they revealed
19:15 Common mistakes new innovators make
20:00 How to approach investors before clinical proof exists
22:06 Orphan Drug and QIDP designations explained
25:21 FDA endpoints and what has to be proven
26:08 Balancing regulatory requirements with clinical reality
27:03 How the scientific advisory board shapes product strategy
28:53 What makes surgeons trust or resist a new technology
30:43 Feedback from early adopters
33:05 The kit that surgeons have been waiting for
33:25 The biggest barrier to hospital adoption
35:20 What true success looks like for ForCast
37:20 Timeline for widespread adoption
37:48 The hardest part of the journey
38:18 What "from idea to market" means after living it
39:14 Advice for the surgeon with an idea on a napkin
41:07 What has been most fulfilling
43:20 Closing thoughts

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This podcast is intended for educational and informational purposes only. The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #ForCastOrthopedics #PeriprostheticJointInfection #PJI #IntraArticularInfusion #MedicalDeviceInnovation #OrthopedicInfection #TotalHipArthroplasty #TotalKneeArthroplasty #ArthroplastyInfection #MedTechStartup #OrphanDrug

Transcript

Peter Noymer 0:26

Hi, my name is Peter Noymer. I'm the CEO of ForCast Orthopedics. I'm also a PhD in mechanical engineering. I've spent nearly 30 years, uh, working on, uh, developing novel drug delivery systems for improving treatments across a number of different therapeutic areas.

Leo Whiteside 0:43

Oh, I'm Leo Whiteside Uh, I'm an orthopedic surgeon. Just, uh, retired last January. Uh, engaged in hip and knee replacement, uh, sort of subspecializing in, in, uh, infected arthroplasty. I did my training, uh, in the University of Texas in Dallas, Parkland Hospital and, uh, Washington University in St. Louis. Spent some time as chairman of the Department of Washington University Orthopedic Department and, uh, and then, uh, built the Missouri Bone and Joint Center, uh, into a large group and, uh, now retired and, uh, working on some topics in involving general health and uh, cellular physiology.

Jared Foran 1:29

I'm Jared Foran. I'm an orthopedic surgeon in Denver, Colorado. I'm a hip and knee arthroplasty specialist. Um, I have an interest in, in infection, of course, I'm the Chief Scientific Officer of ForCast Orthopedics, and I'm one of the co-founders.

Joseph M. Schwab 1:44

can you describe the moment in your clinical practice when you first kind of thought about a better local therapy to move beyond systemic antibiotics, and what core problem were you trying to deal with that inspired your approach?

Jared Foran 1:59

Yeah, I was actually a resident going back 20, 25 years ago, and we were, uh, doing these cases and my attending was frustrated and I think we were, you know, we were putting in antibiotic static spacers with, with, you know, uh, you know, antibiotics in the cement. And we were doing some DAIR procedures. And I remember thinking back then, we had these elution curves that were coming out in the literature showing just how the, how the, how the antibiotic would ute highly for a couple days, then it would go to, to next to nothing within a week. And I was thinking back then, there's gotta be a better way, there's gotta be a better delivery way. And that's what started this whole process.

Joseph M. Schwab 2:35

And Dr. Whiteside, your early move to intraarticular infusion for periprosthetic joint infection was kind of the inspiration for what ForCast became. Um, is there a specific aspect of direct infusion into the joint that kind of convinced you this was a viable option?

Leo Whiteside 2:56

Um, ab absolutely. Um, back in the 1980s. I was involved in arthroplasty and doing the usual, um, thorough washout, clean out debridement, exchange arthroplasty, and then antibiotic spacer in, in most cases. And, uh, just as Jared said, the, the, uh, local levels were high with the antibiotic spacer. By high, I mean about a hundred micrograms per milliliter quickly, uh, down to two or one microgram per milliliter. And 72 hours. I mean, uh, it, it was, and, and back then we were starting to learn about how important biofilm is in arthroplasty infected arthroplasty. And the quick, the, the minimum biofilm eradication concentration. Uh, is in the thousands of micrograms per milliliter, not 10. And, and there's only one way to get that, and that's direct infusion into the joint. And also the killing power of, uh, of, a bacterocidal antibiotic is related to the area on the concentration versus time curve. Uh, and, and so you had this little spike that you get that where it's kind of effective but not really very effective if you have any type of resistance in your organism. So the only way to do that was to infuse for a long period of time. And a fellow named Clayton Perry back then was working with a, uh, an fusion pump that put in the abdominal subcutaneous tissue with a tube going down to the hip or knee that infused. And then you would weekly or may, sometimes daily, inject antibiotic into the pump. Through the, uh, uh, abdominal adipose tissue and to refresh the pump, we had all sorts of trouble with a pump. And, and I ran across the Hickman catheter from, uh, talking to a friend of mine who's involved in, in cancer surgery and used Hickman catheters to infuse directly into cancer to infuse, um, not a cancer drug directly into the cancer, uh, for a while. And, and it has a cuff around the, the, uh, tube that seals the cuff so you don't get infusion or, or, or I should say, leakage of material from the outside down the outside of the tube and into the joint, which is catastrophic. Uh, so that, that was the only reasonable way that I could find to, to do prolonged injections. And, and you could also leave the infusion module outside the patient. Just tape it down, uh, as opposed to. A big pump that's inside the patient in a big procedure and a mess when it fails. So we started with that and it worked, worked very well. And, and I've been doing that since the, uh, late 1980s or, uh, early 1990s. Uh, and, uh, it is, it's, it's good reasonable, uh, but there are some issues that make it tough for the surgeon, and that's what I've been looking for. And that's, that's what ForCast brought to me. Actually, when ForCast first came, they were, they had an implant that would go into the total knee and it would hold the antibiotics, and they had a very elegant little pump that would pump antibiotics into the knee joint. Uh, and, and I think working with that for a while and seeing how difficult it was. Finally, uh, accepted the idea that an infusion catheter would be better, and, and then, then brought me in lot, a lot more, uh, uh, thoroughly and in into their operations. If the surgeon doesn't feel real comfortable with it and doesn't have a lot of little fiddling to do, uh, they'll, you'll be much better off. And if they, if they can work out, walk outta the operating room feeling like, well, I, I solved a problem. And then turn most of the other management over to somebody else, uh, that they, you, you're gonna be successful. Surgeons are not good at fiddling with stuff every day. They just don't do that very well. They get it done and they. And they say, okay, team, here's, here's, here's the patient and let me know if it needs operating on again.

Joseph M. Schwab 7:36

Peter, that that leads me to ask you, because both Jared and Leo take care of these periprosthetic joint infections, but I understand you also have a. Personal perspective in this. Tell me a little bit about what's, what's your why for being part of ForCast?

Peter Noymer 7:53

Sure. Um, yeah, I mean I've got sort of a personal and professional overlap for me that's kind of interesting, um, professionally, right? I've spent nearly 30 years working on different drug delivery systems for various therapeutic areas, and so kind of have a bit of an expertise in that space. Um, but I also have two hip replacements myself. I had them done about five years ago. Um, so I had sort of a personal understanding of, you know, how transformational, um, the joint replacement procedures can be, right? I went from, um, having quite a bit of pain and limited limited activity levels to now being kind of back to where I was, I'd say even 20 years ago. Um, and I'm thrilled about that, right? And the idea of somebody suffering even more with an infection, um, it really compels me to want to do better for them and, and come up with a better way to, to treat these PJI patients.

Joseph M. Schwab 8:46

Jared, let me ask you, I want to talk a little bit about the moment that you kind of realized that this. Idea could work or that it could be something you could bring to market. Tell me a little bit about the sort of personal drive or maybe an emotional spark that made you pursue it. We all run into ideas, but there was something about this idea that you decided to take a whole extra, uh, distance, uh, further than most would Tell me a little bit about what drove that.

Jared Foran 9:16

Sure. Um, like I said, I, I'd been thinking about the problem for a while and, uh, as a relatively junior guy in my practice, I was getting a lot of infections. Uh, that I was taken care of and, you know, they were doing okay. But it just seemed like we hadn't done anything different in this space for decades. We were just doing the same thing over and over, trying to beat biofilm with this kind of funny method of, of, you know, IV antibiotics and, uh, and, and, and maybe, and maybe these, uh, an antibiotic alluding spacers. And then I just sort of had this idea of, you know, I love Leo's idea, but I was worried about its practicality because of the fiddle factor, because of it's not FDA approved and because of all the things we've talked about and hard to use for the patient and external tubes. And so I, I, I had this idea of, of making this, you know, hollowed out polyethylene that, uh, spacer that could hold antibiotics and elute them into the joint. And I actually started talking to some people about it. Some of my colleagues was like, that's a great idea. Do it. And then I sent out this letter like kinda looking for investors, and it was overwhelmingly positive, way more than I thought it would be. And so we started going down this road. Now we've pivoted a couple times. I think we've got to the right place with usually making Leo's technique, uh, very, very usable for the patient and the, and the physician. But that's kinda what got us there.

Joseph M. Schwab 10:34

So Leo, let's talk a little bit about that technique, because you did give some information upfront about what inspired it. What were some of the early questions that you had about how to use it or questions you needed to ask yourself, um, in developing this type of technique?

Leo Whiteside 10:52

Yeah. All sorts of things you have to look into. Uh, the pharmacokinetics are a big issue. Uh, how, how, how does the level get in the joint? What does that do to the peripheral level? Do you get a blood level? Uh, does it, does it last for a long time? And so those, we really delved into deeply and we found that we certainly did get thousands of micrograms per milliliter concentration in the joint. Uh, it, it had a dec decay rate, uh, halftime decay of, of, of about six hours, something like that, which meant. It needs to be refreshed daily. Uh, and um, we also found y'all's significant blood level and had to be careful with it. We had, you have to follow blood levels. Uh, if you don't, then you can overdose. You can get patients with a very high serum vancomycin level. Uh. Depending on the patient and the, the, the, the, um, the dosage and that sort of thing. So oftentimes you have to adjust the dose. Um, and then we had to find out ways to manage the tubes, what to do with the tube, because we caught a, got a couple of, um, fungal infections from invasion around the tube, down through the, um, the, the fibrous cuff. So we had to find that you found that you needed a, an antifungal and an antibiotic, uh, ointment that is very effective around the tube and has to be managed by somebody. Somebody has to look at that you do not dare let these tubes go and let the patient manage it completely unless you test them out. And so we had to have a whole. A group of people in my office who could help manage these tubes. And it's still, that's always gonna be a, an issue I think for us is management of the tooth. But what we did find was we could get huge doses of antibiotics, we could do it daily, we could do it for six weeks, and that outperformed everything. There's nothing that's, that's been as effective as that. And we've had success rates that were phenomenal with failed infected total knee replacement. I was getting 95% success rate with it. And, uh, there's no reason not to. If you have a meticulous surgical group, uh, very dedicated with an operating time to operate all day on a single patient if they have to, and, uh, then a dedicated team to take care of this patient afterward, uh, I think we've done the groundwork that showed that it's safe.

Peter Noymer 13:30

I wanted to tack on what, to one thing Leo said, like, he, he mentioned that he's seen an exceptionally high success rate in his own practice, um, with the intraarticular infusion approach. And we've also done sort of a meta analysis of what's published in the literature to kind of convince ourselves of the same, and I don't remember the exact numbers off the top of my head, but there's about a dozen or so, um, articles that we're easily able to find. And I think the composite success rate of those is on the order of like 98%, um, of all the cases reported. So it, it is quite high. It gives us a lot of confidence and very much supports what Leo says and what he's seen in his own practice.

Jared Foran 14:10

and I'd like to go back and, and comment too. Uh, Leo's correct. The efficacy is very high. It works, it's safe. The issue has been sort of secondary infections and tube management and patient compliance. So our thesis has been in this company, we, there is a product that exists. Let's make it. Usable. And so we've engineered it and been very thoughtful for making the, uh, the, the way the catheter hooks up. It's a proprietary catheter, the way it seals the skin. That's, that's the work we've been doing with this company.

Joseph M. Schwab 14:40

So it's one thing, and Peter, I'm gonna address this to you. It's one thing to talk about, um, the, you know, how reliable this product is, how the outcomes are, um, because there's lots of things that we can do that are quite, you know, have good efficacy. From a business standpoint, what convinced you that this was not only something that had good efficacy, but was a viable company worth building?

Peter Noymer 15:06

Sure, yeah. The, um, so to, to put it sort of bluntly, the health economics in the PJI space are, are pretty horrible, and that's driven largely by the failure rates that we see now. Um, the burden on the healthcare system on a, on a per patient basis, on easily gets into the six figure dollars, and, and often it is seven figures, um, for some of the worst cases. Um, so that's a huge strain on the healthcare system. And so obviously by moving the needle, you know, and coming up with something that's much, much more reliable than, you know, DAIR or revision procedures, right? You can get to something that has. Better outcomes for patients, um, you know, better for the bottom line for the hospitals and the insurers, and you can, you know, there's still room in there for reasonable profit margin for a company to sustain itself. I actually, um, before I joined ForCast as CEO, um, I, I did a consulting project for the company and, and, and it was exactly the, you know, is there a, there, there kind of question. Um, and to be honest, I I, I wasn't sure myself, right? But as I, as I plugged through, um, you know, the numbers that are out there, I did a little bit of market research. I dove through the literature. Um, I did a lot of different things and, and came up with the, oh, you know, you can actually get a product to market for. Probably, I think it was less money than I thought, less capital than I thought to begin with. And the, the return on investment or the, you know, especially the revenue potential was much, much stronger than I thought. And like I said, it was when you do the math on the failure rates and the. The dollars that patients are costing the system now, um, it's, it's, it's super compelling.

Joseph M. Schwab 16:49

Jared, you mentioned some of the early sort of prototypes or ideas for this, for this product. Um, as you were fiddling or working with those, was there anything that was, um, maybe a surprising result that you found early on? Either surprising, good or surprising bad?

Jared Foran 17:08

Well, I, it was interesting to see. You might have an idea that works, but is it practical? Is it practical economically? Is it practical for supply chain? For instance, the problem with the, the hollowed out polyethylene spacer that would elute, you can imagine if you're gonna make that work, you need to have a bunch of those polys on the shelf at every hospital waiting for the patient to come. And frankly, there's no, the economics there just don't work. Right. And then we, uh, shifted to this magnetically driven coupled, um, uh, subcutaneous pump that I had some merit to. But again, the problem there is no surgeons didn't wanna go back and take that pump out. Right. So it was interesting to see. The importance of ease of use became incredibly apparent to me.

Joseph M. Schwab 17:58

so Jared, let's talk about, you mentioned some of your earliest prototypes. Um, and what I wanna know is, were there surprising results that you got early on, either surprising, this is great or surprising? Gee, I, I'm, I'm really kind of concerned about this.

Jared Foran 18:15

Yeah, it, it was interesting, uh, I learned relatively early on the difference between a good idea and a practical idea, and one that was going to become a true product. So the initial idea was to have an antibiotic eluding polyethylene spacer, uh, sort of hollowed out, uh, spacer. We, we engineered it, it worked the problem with it, and people were interested in using it. The problem with it, you can imagine you'd have to have. An incredible number of polyethylene sizes on the shelf at every hospital. Were just waiting for the infected patient, which is economically not practical. So there was an issue there. And then we shifted to this, uh, uh, magnetically coupled subcutaneous pump that was also would work. We got the engineering there would, was gonna deliver antibiotics. The problem is there is surgeons didn't wanna go back and have to take something out. So I learned that you need essentially three things. You need a good idea and it has to be very usable for the surgeon. No fiddle factor or minimal, very usable for the, for the patient. And it has to be able to make money. And so you kinda learn that the hard way.

Joseph M. Schwab 19:14

Right. Uh, and so Dr. Whiteside talking about innovations. You've been involved in a number of innovations including. What, you know, the product here at ForCast, what are some of the common mistakes that you see new innovators, uh, making when they're trying to validate a new idea? Mm-hmm.

Leo Whiteside 19:34

Well, the, there are a couple of'em. The, the personal mistakes that most, uh, innovators in medicine make, uh, is to not protect their intellectual property early on. But the other, other big surprise, I think, to most guys new and medical innovation is the burden that regulatory puts on the entire process and the cost of regulatory.

Joseph M. Schwab 19:58

So you touched on two things that I actually find interesting'cause I want to ask Peter about this. And, and one is funding and the other is validation because these things, as you described, Leo, often happen in parallel. Um, you guys recently, um, just closed on, uh, an initial series A, I think it was this past August or last August. How do you approach investors for an idea like this before all the clinical proof is there and, and really what, what's your pitch to investors that gets them to say yes.

Peter Noymer 20:33

Yeah, that's a great question. Um, I mean, I think, I mean, I'll start with like you said, sort of like there's the validation and the investment thesis and those kind of go hand in hand. Um, you know, this is gonna be the engineer in me. Talking now. Right. But my approach has always been to sort of put together a ground game and then run it. Right. You know, there's, there, there's a lot of block and tackle stuff that's gonna get done. Right? Like Jared said, you've gotta come up with a technology that's got a good product market fit. Right. You know, great idea, but not usable isn't gonna fly. Right. So kind of finding the right technology, demonstrating proof of concept with that. Um, getting some early traction with the FDA, like we've done with our Orphan and QIDP designations. Um, and then doing the ROI analysis, the return on investment analysis, right. And kind of showing that there is, there is a business model here. Um. And, and, and to me that's kind of the, the, it all kind of wraps up that way, right? You know, the investors, I mean, there are some, I mean, the good news is right, there are some in investment groups that, you know, do have an appetite for early stage investment, some prefer later stage close to IPO, right? So we're obviously not for them. Um, but you know, some are willing to take a look at something that's preclinical, where you get in early on, you know, the, the, you know, the price per share of stock is relatively inexpensive. Um, so there's potentially good bang for the buck for them to be able to get in early, um, you know, and, and still get a significant return on their investment coming out the other end.

Joseph M. Schwab 22:05

And I wanna stay on this for just a minute with you, Peter, because you mentioned the the orphan drug and QIDP uh, designations. How do those designations specifically shape your strategy and your timeline?

Peter Noymer 22:19

Yeah, that's great. Um, uh, I don't wanna go all the way back to kind of like what they are and what they do. Right. But, um, you know, there's special designations for the FDA, the orphan drug designation relates to, you know, uh, diseases or conditions with, uh, patient population under 200,000 in the US and PJIs less than half of that. And then QIDP, which stands for Qualified Infectious Disease Product, is a special designation within the anti-infectives group for, um, things that, that, that serve a compelling unmet medical need. Um, so for me, I'd say, I mean, timeline perspective, I mean, early on, you know, when I joined the, the, those were like the, the two things at the top of my list to get done. Right. Just to get those in place. Um, but what they do for you is pretty, is pretty impressive. Right. So during your development program. Um, they provide sort of, I'll call it more rapid access to the FDA for meetings. So, I don't know if you guys know this or if the audience knows this, but when companies take products through, uh, development with the FDA, there's certain milestone meetings along the way where you meet and you check in, you kind of give them, Hey, this is what we're planning on doing. Do you agree that this is adequate? You know, then maybe later meet again and review some data and, and make agreements about how to move forward, right? So we can typically, um, have those meetings happen a little bit more quickly. Um, when we get to the stage when we're submitting a marketing application, um, we should be eligible for priority review, which would be. Sort of a six month review instead of a 10 to 12 month review. Um, and then when we go to market, this is where it's sort of like the, I'd say the most compelling, um, the, uh, orphan designation and the QIDP designations add up to provide, um, 12 years of market exclusivity for the product when it gets to market, which means that, um, the FDA, uh, will not let a, I'll call it like a knockoff product, go to market, right? This is, you see this in the generic space, right? The branded products have a certain amount of time, uh, to kind of recoup the investment for the companies and the investors. Um, and you know, this isn't just somebody puts a knockoff product in the market and we have to go sue them through the patent office. This is literally the FDA will not allow the knockoff product to, to go to market. Um, so we have that extra layer of protection for us. So it's kind of a, I mean, I call it like a little bit of a soup to nuts kind of thing in terms of economic and, and timing benefits, but it's, it's very helpful.

Joseph M. Schwab 24:48

Sounds like that's a big advantage for your company, those types of designations and that that type of protection.

Peter Noymer 24:54

Absolutely. I mean, it, it's, you know, it's smaller bits in the earlier days. It's, it's much bigger impact later on. And it's meaningful to investors when they hear about the, you know, you can run your development program more efficiently. They like the course, they like to hear that. Uh, and, you know, anything, you know, above and beyond just general patent protection that can get you, um, an advantage in the marketplace when you go commercial, that's, that's very big as well.

Joseph M. Schwab 25:20

So Jared, speaking of the process of going through this, the FDA review, clinically speaking, what were the key endpoints or safety markers that you had to prove to the FDA in order to get this product moving forward?

Jared Foran 25:34

Y Yeah, so we're still proving it. Uh, of course there's, uh, toxicology, uh, work that's being done. Uh, and there's, you know, uh, you know, local, local toxicity. Systemic toxicity, we have to, we have to, uh, prove that it's safe. Uh, and then for the, you know, endpoints, for the, for the, uh, uh, phase one, phase two studies, it's basically composite endpoints of infection. Uh, eradication, uh, re-operation, and of course, endpoints such as death. Uh, up to, uh, I believe 180 days is our, is our, uh, goal endpoint.

Joseph M. Schwab 26:07

Jared, how do you balance those sort of FDA or other regulatory requirements with what you just simply know matters to patients and surgeons?

Jared Foran 26:20

It is a great question. Uh, I mean, at the end of the day, we s we surgeons do things off label at times, right? We, we sort of have to, or sort of make the right decision for the patient. But I think systematically it's tough to ask surgeons to take personal risks off-label without some type of regulatory backing. So I think. Is a necessary to go through the FDA. The FDA actually is a, uh, consumer, you know, watchdog group. They have the back of the, of the American public, and I think it's, it's something we just have to do and go through the process. It's, is it perfect? No. Is it important? Yes.

Joseph M. Schwab 27:02

So Peter, I wanna shift gears for just a little bit and I want to talk about. ForCasts scientific advisory board and your board is, um, uh, I would say top tier. Um, how do you leverage that group, that scientific advisory board in shaping not just clinical validation of the product, but product strategy?

Peter Noymer 27:27

Yeah, no, I, I, I agree. The, uh, you know, this is like a pinch me moment sometimes, right? I think we've got a great group. Um, I'm, I'm somewhat odd by it. Um, I would say, you know, despite the, you know, the lofty names and reputations and all that, um, what I've found is that they're all. Um, you know, they're all very approachable. Uh, they, they like to roll up their sleeves, right. They've got the clinical experience like Jared and Leo have of dealing with this, you know, I'm not on a day-to-day basis. Exactly right. But they know, they know the problem. They know it's in need of a better solution. Um, right. They've joined on with us because they like what we're doing, and so it's been, you know, fairly easy to sort of tap into them and, and get their inputs and I mean, you know, we do it across the board, you know, for, you know, whatever it is. Right. So product design and configuration, FDA regulatory strategy, um, you know, maybe some bits and pieces of reimbursement strategy, um, and, and go to market strategy and stuff. So it, it's all across the board. Um. And Yeah, I, and even, I'm just trying to think of the latest thing we did we're, you know, we're gearing up for a clinical trial next year, right. So the, the, the trial design, we ran the synopsis by six or eight folks and got a lot of good inputs to help us tune that up as well. So yeah, it's been, it's been super helpful and meaningful for us.

Joseph M. Schwab 28:52

Leo, I want to ask you, because putting together a scientific advisory board like this requires you to engage with surgeons who have some trust in the product, and you mentioned that FDA designation is one way to get a surgeon to trust what a product offers. Are there other key factors that you see that make surgeons either trust a new product or technology, or on the other hand, other factors that might make surgeons resist a new technology?

Leo Whiteside 29:23

Well, the, there's a, a double edged sword and, uh, that is, um, the product champion that's gonna bring some on board, but it's gonna run some of'em away, and you just have to accept that. But I think, um, what Peter has done is gotten, gotten a, a broad group, uh, so that, uh, most people will feel at home with this group and, and not not, and, and be able to ignore their personal feelings about what was said at a microphone 15 years ago and, and, and get, get on board. And besides that, if it's a good idea. Most people, even with their greatest resistance, will come around'cause they'll see the surgeons, other surgeons being successful with a si situation that's been miserable. As Jared said, it's just been miserable, uh, trying to use intravenous antibiotics and a spacer for the last 50 years. I mean, it's time to do something. And then when, when we get to that point, then I think people e even the highly productive, uh, sought after surgeons, uh, come to you and want to get on board with you. I think that's where we'll.

Joseph M. Schwab 30:42

Yeah. Jared, what is some of the most compelling feedback that you're hearing from some of these early adopter surgeons, specifically ones on your scientific advisory board?

Jared Foran 30:55

Uh, the feed, I mean, essentially the feedback is they just can't wait to use it, right? That's the, the over and over. When can I get this in my hands? That's, I hear over and over. Even I hear it from, from non joinin versus spine, spine colleagues that I know that are using it when, and we start using it. So that kind of feedback is, and they've seen the data, they've seen, they know the, the, the elution curves. They know the, the, the biofilm eradication concentration numbers that we can get to, and it's exciting.

Peter Noymer 31:22

Yeah. Just to add to that, when we, um, you know, Jared and I, uh, gave a pitch at the, uh, AHF Shark Tank this past year in Nashville. Right. And, and thankfully we won. Uh, that was nice. But the, the funny thing was, I mean, I must have gotten about two, three dozen emails within a few days of the event from pe either surgeons, uh, or distributors. You know, when can I, where can I get it? When can I have it? And, you know, the response was, you know, virtually always the same. Like, I, I'm really sorry. We're still in development. It's not ft a cleared, da da da, you know? And then the response was, thank you. You know, just kind of let me know when it is. Right. That

Joseph M. Schwab 32:03

Right,

Jared Foran 32:04

I think a lot, a lot of these folks have known about Dr. Whiteside's technique and been reluctant to use it for all the things, all the reasons why we said, or tried to use it and got blocked by their system. So they're ready, right? They're waiting.

Leo Whiteside 32:16

Yeah. They, they seem, they seem to be, and, um, I, I, I'll tell you, having a kit that works is the key to success here. We got the intellectual backing, we got the literature behind us. Uh, there's a great need for this, but you gotta have something that is a kit that works. The surgeon ties the last knot on it, and it's done as far as he's concerned, except for looking it over. That, that, that's, that's where I've always had success in the past is when you get the surgeon walking outta the operating room feeling like, well, I finished with this. I'm, I'm done. Uh, and, and everybody is thinking, and the operating room is thinking, wow, this is great. Now, now we go. So I, I think, um, we're poised. That's, that's the way I feel about it.

Joseph M. Schwab 33:04

So, Peter, I want to ask you, beyond the clinical data that they're talking about and beyond Leo's idea of just having this kit that um, essentially is a, you know, all in one piece, what's the single biggest barrier, not to surgeons, but to hospitals adopting this technology and how are you addressing.

Peter Noymer 33:25

Yeah, so I think, you know, one of the, one of the bigger challenges relates to, um, the reimbursement pathway, or I'll call it reimbursement pathways, right? Because this is multifaceted, right? We have, you know, we're addressing, uh, an issue with a drug in a device, in a surgical procedure, right? So there's kind of part A, part B, part D all mixed in there. Um, and that that can make it complicated, as Leo said. So there's the kit to make it easy for the surgeon. We also want to make it easy for the, you know, for the back office stuff to make sure that everybody kind of gets what they need. Um. So I would say, you know, we, you know, and I've seen this with other companies I've worked with in the past, right? We decided early on to try to get a better read on this. Um, so even. Even before we completed our series A, actually, even before we started to talk to people about the Series A raise, um, we did a, a sort of a reimbursement landscaping escaping exercise. We engaged a third party consultancy that does this stuff all day long. Um, and we got some preliminary answers to the, you know, how much money can you make or, you know, per, per course of therapy and, and what are the channels by which you're gonna make that? So we had kind of early answers to that going into the series A investors discussions, and we've got a portion of our series A funding now allocated to continue that. Right? So it's not a build, necessarily build a full go to market strategy at this point, but it's to flesh it out even further understand, um, where the call points exactly what are the reimbursements look like, um, so that when we get to the next. Funding round. In the next stage of advancement of the company, we can sort, we can sort of start the commercial strategy ground game and start to hire a team and start to operationalize, um, all the groundwork we've been laying so far.

Joseph M. Schwab 35:21

So you've all been really generous with your time. I, I just have a few more questions to ask each of you. And I wanna start by talking about, just looking forward, um, from the perspective of ForCast. And I'm gonna start with you, Peter,'cause you kind of touched on this just a little bit. What is, I will say, true success look like for ForCast? Um, maybe in terms of the difference you'll make for patients, maybe in terms of, uh, revenues, maybe in terms of, uh, uh, market penetration. What does true success look like for you guys?

Peter Noymer 35:54

I mean, sure. Thanks. I'll give a, I mean, it's probably more of an altruistic answer, right? I think I'd like to see our product use as first line therapy, right? PJ patient presents with PJI and it's a no brainer. We're gonna give, you know, we're gonna do a DAIR procedure and this is the shot. I mean, granted, there's gonna be some patients that maybe aren't eligible for DAIR, right? They've got other comorbidities and all that, right? But, um, I'd like to see this be that and, you know, and then everything else you mentioned sort of flows from that, you know, patient adoption, patient outcomes, revenue, right? But if, if we can make this the go-to for the surgeons, um, I think that would be huge.

Jared Foran 36:32

If I could, if I could add onto that, I, I think that in the not too distant future that, you know, future generations of orthopedic surgeons are gonna be using this tech technique, intraarticular infusion, and they're not gonna imagine a world where we didn't use to use it. Like, what you guys didn't do this forever. And I think success to me is we, we bring that to the world and, uh, and get that ball rolling and really move the needle.

Joseph M. Schwab 36:55

Do you see that as your technology as, um, being standard arthroplasty practice within the next five years, within the next 10 years, 15 or sooner than that?

Jared Foran 37:06

Uh, I see that as practically, I see it in the next 10 years because the FDA, uh, issues, we'll, we'll be doing it sooner than that, but for the widespread adoption, it's gonna be a five to 10 year window.

Joseph M. Schwab 37:19

So Jared, where do you see this technology fitting within Standard Arthroplasty practice in say the next five years?

Jared Foran 37:26

Yeah, I think that we are going to see a shift from, uh, the morbid two stage procedures to one stage and DAIRs. If we can make, uh, those, those procedures, uh, as or more efficacious than a two stage, the world's going to go there. And I think this product allows that to happen.

Joseph M. Schwab 37:47

So what has been the hardest part of this journey for you, Jared?

Jared Foran 37:52

Yeah. The hardest, the hardest part's really been sort of not going into it, understanding the complexities of the regulatory landscape. Uh, it's, it's a big burden. It, it's expensive, it's timely. It just takes a lot, it takes a lot more time and effort and, uh, a much larger, robust team than I ever imagined. But on the, on the flip side, that's also, I guess, what makes it so satisfying and what's gonna make it so satisfying when we get to the finish line.

Joseph M. Schwab 38:18

And the last question for you, Jared. Our series is called From Idea to Market, and obviously, um, you know, your story really fits into what we think of as, um, you know, an idea being brought to market in this way in orthopedics. If you were to talk about what the phrase from idea to Market might mean to you, having gone through this journey, tell me a little bit about that.

Jared Foran 38:43

Yeah, that idea means to me if you have an idea and you believe in it, and I'm talking to, to the surgeon inventor or the whoever's, whoever's listening, you really gotta, you really have to commit. You have to be all in, and you have to know that, that what you're doing is gonna make the world a better place, and that it's worth it. It's worth your time. It's worth your effort. It's worth your money. It's worth it for the future. And if you believe that it'll work.

Joseph M. Schwab 39:13

So, Leo, a couple of questions for you. You've mentored a lot of innovators, and if you were to think about the most important piece of advice you would give to the next surgeon who has an idea is maybe scribbling it on the back of a napkin, uh, but doesn't know where to begin, what would be your best piece of advice?

Leo Whiteside 39:35

Well, uh, for, uh, the first thing is make sure you're totally behind it because most people don't realize it. It could be a lifetime of work to get it where you want it to be. And then, uh, the other is early into protection of intellectual property. And, uh, and then, uh, it, it's a, it's a very, uh, joyful thing to do. It's a lot of fun to see problems solved and to encounter new challenges. It's just a great thing. I, I recommend it for the right person, but most people are not willing to, to, to face the opposition. Opposition will come from all sides sometimes. It's amazing how, uh, well educated physicians will be so resistant to a new idea. Even with good data on your side. It's all it takes is another couple of guys on either side of them. And then there are consensus and, and you are by yourself. And the other thing is you better be ready to be by yourself on panels over, over again with everybody disagreeing. But then, um, you have to remember that if you believe what 95% of the people believe about any topic, you're wrong. It's the 5%. That's right.

Peter Noymer 41:07

Yeah, it, I was gonna just build on that, Joe, if you don't mind. Um, I'd say the, the glass half full version of the, the physicians I've worked with in, in different therapeutic areas, um. I think in a very good way. They all, they all care tremendously about their patients. And I've done a lot of work in other orphan disease spaces, right? So they're, they've got fragile patient, a fragile patient population that, that first and foremost, they wanna protect and they wanna do right by. Um, and, you know, but then with that comes the, well, I've been doing it this way for 20 years. Why this new thing? You know, why should I do this new thing? I don't, I don't want to take a risk, right? I, I know X, Y, Z works and, you know, I think that just requires, you know, sort of an extra, extra level of care, you know, empathy, handholding and, and all that type of stuff. But I, I, get where they're coming from and I'm sure there are gonna be stick in the muds who don't want to hear anything about new data. But I'd say by and large, what I see is mostly motivation to, to kind of protect the patients first and foremost.

Joseph M. Schwab 42:09

Peter, what has been the most fulfilling part of this journey for you personally?

Peter Noymer 42:16

Sure, sure. Uh, also a little bit what, what Leo said. Um. You know, I've, there's the altruistic part, like for me personally, you know, kind of getting up, waking up every morning and going to work on something that I know is gonna make people's lives better. That's huge. Um, but the other big part of it is the, you know, the people that we're surrounded by, I mean, Jared and Leo are top notch in their fields, right? We also have Charlie DeCook on board. Um, he's amazing and he is got an incredible entrepreneurial streak. Um, and then, you know, behind the scenes we've got people kind of covering, uh, clinical, regulatory, product development, formulation, uh, commercial strategy right in there. All, uh, top of their game. Most of them people I've worked with in the past. Um, and so there's a bit of, you know, when you work with people that bring, bring their A game to the, to the, um, to the operation every day, like, I feel like I have to as well, keeps me on my toes, keeps me focused and, you know, make sure, you know, I'm, I'm doing the best I can for everybody involved, right. Patients and docs and, and the team.

Joseph M. Schwab 43:21

Leo, how has the experience with ForCast specifically changed the way you think at all about surgery or innovation or leadership?

Leo Whiteside 43:32

It's fun to, to work with people who are also dedicated and find a way. And there's, there's always a way, you know, if you, there's so many different ways that you can find one. And, uh, that's, that, that the enjoyable, uh, part to me so far has been the process of getting this to the point where we're ready to fire.

Joseph M. Schwab 43:53

I am gonna, uh, give you both kind of the same prompt, uh, for the last question. And, and what I wanna say is if you could each finish this sentence, and Peter, we'll start with you, if you could finish the sentence, innovation in orthopedics means, what would you say? How

Peter Noymer 44:09

I think I'd say something that means, uh, great ideas coming outta clinical practice and eventually finding traction in the marketplace.

Joseph M. Schwab 44:17

about you, Leo?

Leo Whiteside 44:18

Find a, a, a, a great solution for patients who are in dire need. That's what we're doing here for sure.

Joseph M. Schwab 44:27

That's excellent. Um, I, I really appreciate the time that you gentlemen have taken with us today. I just wanted to give you both an opportunity to, uh, yeah, if there's anything you want to add, please take an opportunity now.

Peter Noymer 44:41

Yeah. So if you don't mind, Joe, I just, I wanted to, um, give a shout out to you and the folks at the Anterior Hip Foundation for, for, inviting us and for even just doing this podcast, right? Because I, in my experience, um, you know, getting a product to market is more than just hire engineers and work through the FDA and then off you go, right? Um, there's a lot of, um. People, players, entities, organizations in the ecosystem that helps make something become successful. So having a group like AHF that advocates for, um, you know, the arthroplasty procedures, the infection treatments, you know, gives ForCast the opportunity to pitch at the Shark Tank and win the Shark Tank and, and do this. I mean, that all, that all helps, right? Because I think it, it enables us to, you know, reach a broader audience, make people more aware about what we're doing and why we're doing it. Um, there may be some folks that maybe even, uh, aren't as aware of how bad the problem is right now with PJI. So I think all this stuff, um, you know, it's like a rising tide raises all ships kind of thing. So we really appreciate the effort that you, um, and the AHF folks are putting into doing things like this.