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FITM: The Full Conversation with ForCast Orthopedics · AHF Podcast

0:26
Peter Noymer: Hi, my name is Peter Noymer.
0:28
Peter Noymer: I'm the CEO of ForCast Orthopedics.
0:30
Peter Noymer: I'm also a PhD in mechanical engineering.
0:32
Peter Noymer: 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.
0:43
Leo Whiteside: Oh, I'm Leo Whiteside Uh, I'm an orthopedic surgeon.
0:47
Leo Whiteside: Just, uh, retired last January.
0:49
Leo Whiteside: Uh, engaged in hip and knee replacement, uh, sort of subspecializing in, in, uh, infected arthroplasty.
0:58
Leo Whiteside: I did my training, uh, in the University of Texas in Dallas, Parkland Hospital and, uh, Washington University in St.
1:06
Leo Whiteside: Louis.
1:07
Leo Whiteside: 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.
1:29
Jared Foran: I'm Jared Foran.
1:30
Jared Foran: I'm an orthopedic surgeon in Denver, Colorado.
1:32
Jared Foran: I'm a hip and knee arthroplasty specialist.
1:35
Jared Foran: 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.
1:44
Joseph M. Schwab: 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?
1:59
Jared Foran: 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.
2:15
Jared Foran: And we were doing some DAIR procedures.
2:17
Jared Foran: 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.
2:28
Jared Foran: And I was thinking back then, there's gotta be a better way, there's gotta be a better delivery way.
2:32
Jared Foran: And that's what started this whole process.
2:35
Joseph M. Schwab: And Dr.
2:36
Joseph M. Schwab: Whiteside, your early move to intraarticular infusion for periprosthetic joint infection was kind of the inspiration for what ForCast became.
2:46
Joseph M. Schwab: Um, is there a specific aspect of direct infusion into the joint that kind of convinced you this was a viable option?
2:56
Leo Whiteside: Um, ab absolutely.
2:58
Leo Whiteside: Um, back in the 1980s.
3:02
Leo Whiteside: 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.
3:18
Leo Whiteside: And, uh, just as Jared said, the, the, uh, local levels were high with the antibiotic spacer.
3:26
Leo Whiteside: By high, I mean about a hundred micrograms per milliliter quickly, uh, down to two or one microgram per milliliter.
3:36
Leo Whiteside: And 72 hours.
3:37
Leo Whiteside: I mean, uh, it, it was, and, and back then we were starting to learn about how important biofilm is in arthroplasty infected arthroplasty.
3:48
Leo Whiteside: And the quick, the, the minimum biofilm eradication concentration.
3:57
Leo Whiteside: Uh, is in the thousands of micrograms per milliliter, not 10.
4:02
Leo Whiteside: And, and there's only one way to get that, and that's direct infusion into the joint.
4:08
Leo Whiteside: And also the killing power of, uh, of, a bacterocidal antibiotic is related to the area on the concentration versus time curve.
4:20
Leo Whiteside: 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.
4:32
Leo Whiteside: So the only way to do that was to infuse for a long period of time.
4:36
Leo Whiteside: 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.
4:50
Leo Whiteside: And then you would weekly or may, sometimes daily, inject antibiotic into the pump.
4:56
Leo Whiteside: Through the, uh, uh, abdominal adipose tissue and to refresh the pump, we had all sorts of trouble with a pump.
5:05
Leo Whiteside: 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.
5:22
Leo Whiteside: 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.
5:39
Leo Whiteside: Uh, so that, that was the only reasonable way that I could find to, to do prolonged injections.
5:45
Leo Whiteside: And, and you could also leave the infusion module outside the patient.
5:50
Leo Whiteside: Just tape it down, uh, as opposed to.
5:54
Leo Whiteside: A big pump that's inside the patient in a big procedure and a mess when it fails.
5:59
Leo Whiteside: So we started with that and it worked, worked very well.
6:03
Leo Whiteside: And, and I've been doing that since the, uh, late 1980s or, uh, early 1990s.
6:09
Leo Whiteside: 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.
6:20
Leo Whiteside: And that's, that's what ForCast brought to me.
6:22
Leo Whiteside: 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.
6:38
Leo Whiteside: Uh, and, and I think working with that for a while and seeing how difficult it was.
6:43
Leo Whiteside: 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.
6:56
Leo Whiteside: 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.
7:05
Leo Whiteside: And if they, if they can work out, walk outta the operating room feeling like, well, I, I solved a problem.
7:11
Leo Whiteside: And then turn most of the other management over to somebody else, uh, that they, you, you're gonna be successful.
7:18
Leo Whiteside: Surgeons are not good at fiddling with stuff every day.
7:22
Leo Whiteside: They just don't do that very well.
7:24
Leo Whiteside: They get it done and they.
7:26
Leo Whiteside: And they say, okay, team, here's, here's, here's the patient and let me know if it needs operating on again.
7:36
Joseph M. Schwab: 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.
7:45
Joseph M. Schwab: Personal perspective in this.
7:47
Joseph M. Schwab: Tell me a little bit about what's, what's your why for being part of ForCast?
7:53
Peter Noymer: Sure.
7:53
Peter Noymer: Um, yeah, I mean I've got sort of a personal and professional overlap for me that's kind of interesting, um, professionally, right?
8:00
Peter Noymer: 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.
8:09
Peter Noymer: Um, but I also have two hip replacements myself.
8:11
Peter Noymer: I had them done about five years ago.
8:13
Peter Noymer: Um, so I had sort of a personal understanding of, you know, how transformational, um, the joint replacement procedures can be, right?
8:21
Peter Noymer: 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.
8:30
Peter Noymer: Um, and I'm thrilled about that, right?
8:32
Peter Noymer: 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.
8:46
Joseph M. Schwab: Jared, let me ask you, I want to talk a little bit about the moment that you kind of realized that this.
8:52
Joseph M. Schwab: Idea could work or that it could be something you could bring to market.
8:56
Joseph M. Schwab: Tell me a little bit about the sort of personal drive or maybe an emotional spark that made you pursue it.
9:03
Joseph M. Schwab: 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.
9:16
Jared Foran: Sure.
9:16
Jared Foran: 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.
9:25
Jared Foran: Uh, that I was taken care of and, you know, they were doing okay.
9:29
Jared Foran: But it just seemed like we hadn't done anything different in this space for decades.
9:33
Jared Foran: 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.
9:48
Jared Foran: 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.
10:01
Jared Foran: 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.
10:10
Jared Foran: And I actually started talking to some people about it.
10:12
Jared Foran: Some of my colleagues was like, that's a great idea.
10:15
Jared Foran: Do it.
10:16
Jared Foran: 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.
10:21
Jared Foran: And so we started going down this road.
10:23
Jared Foran: Now we've pivoted a couple times.
10:25
Jared Foran: 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.
10:32
Jared Foran: But that's kinda what got us there.
10:34
Joseph M. Schwab: So Leo, let's talk a little bit about that technique, because you did give some information upfront about what inspired it.
10:42
Joseph M. Schwab: 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?
10:52
Leo Whiteside: Yeah.
10:52
Leo Whiteside: All sorts of things you have to look into.
10:54
Leo Whiteside: Uh, the pharmacokinetics are a big issue.
10:58
Leo Whiteside: Uh, how, how, how does the level get in the joint?
11:02
Leo Whiteside: What does that do to the peripheral level?
11:04
Leo Whiteside: Do you get a blood level?
11:06
Leo Whiteside: Uh, does it, does it last for a long time?
11:09
Leo Whiteside: 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.
11:19
Leo Whiteside: Uh, it, it had a dec decay rate, uh, halftime decay of, of, of about six hours, something like that, which meant.
11:28
Leo Whiteside: It needs to be refreshed daily.
11:31
Leo Whiteside: Uh, and um, we also found y'all's significant blood level and had to be careful with it.
11:36
Leo Whiteside: We had, you have to follow blood levels.
11:38
Leo Whiteside: Uh, if you don't, then you can overdose.
11:40
Leo Whiteside: You can get patients with a very high serum vancomycin level.
11:44
Leo Whiteside: Uh.
11:46
Leo Whiteside: Depending on the patient and the, the, the, the, um, the dosage and that sort of thing.
11:52
Leo Whiteside: So oftentimes you have to adjust the dose.
11:56
Leo Whiteside: 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.
12:11
Leo Whiteside: 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.
12:24
Leo Whiteside: 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.
12:32
Leo Whiteside: And so we had to have a whole.
12:33
Leo Whiteside: A group of people in my office who could help manage these tubes.
12:39
Leo Whiteside: And it's still, that's always gonna be a, an issue I think for us is management of the tooth.
12:44
Leo Whiteside: 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.
12:54
Leo Whiteside: There's nothing that's, that's been as effective as that.
12:58
Leo Whiteside: And we've had success rates that were phenomenal with failed infected total knee replacement.
13:05
Leo Whiteside: I was getting 95% success rate with it.
13:08
Leo Whiteside: And, uh, there's no reason not to.
13:11
Leo Whiteside: 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.
13:30
Peter Noymer: 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.
13:41
Peter Noymer: 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.
13:55
Peter Noymer: And I think the composite success rate of those is on the order of like 98%, um, of all the cases reported.
14:03
Peter Noymer: So it, it is quite high.
14:04
Peter Noymer: It gives us a lot of confidence and very much supports what Leo says and what he's seen in his own practice.
14:10
Jared Foran: and I'd like to go back and, and comment too.
14:12
Jared Foran: Uh, Leo's correct.
14:14
Jared Foran: The efficacy is very high.
14:15
Jared Foran: It works, it's safe.
14:17
Jared Foran: The issue has been sort of secondary infections and tube management and patient compliance.
14:23
Jared Foran: So our thesis has been in this company, we, there is a product that exists.
14:27
Jared Foran: Let's make it.
14:29
Jared Foran: Usable.
14:30
Jared Foran: And so we've engineered it and been very thoughtful for making the, uh, the, the way the catheter hooks up.
14:35
Jared Foran: It's a proprietary catheter, the way it seals the skin.
14:38
Jared Foran: That's, that's the work we've been doing with this company.
14:40
Joseph M. Schwab: So it's one thing, and Peter, I'm gonna address this to you.
14:43
Joseph M. Schwab: 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.
14:57
Joseph M. Schwab: From a business standpoint, what convinced you that this was not only something that had good efficacy, but was a viable company worth building?
15:06
Peter Noymer: Sure, yeah.
15:07
Peter Noymer: 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.
15:18
Peter Noymer: 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.
15:30
Peter Noymer: Um, so that's a huge strain on the healthcare system.
15:33
Peter Noymer: 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?
15:41
Peter Noymer: You can get to something that has.
15:43
Peter Noymer: 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.
15:56
Peter Noymer: 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.
16:07
Peter Noymer: Um, and to be honest, I I, I wasn't sure myself, right?
16:11
Peter Noymer: But as I, as I plugged through, um, you know, the numbers that are out there, I did a little bit of market research.
16:17
Peter Noymer: I dove through the literature.
16:19
Peter Noymer: 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.
16:26
Peter Noymer: Probably, I think it was less money than I thought, less capital than I thought to begin with.
16:31
Peter Noymer: And the, the return on investment or the, you know, especially the revenue potential was much, much stronger than I thought.
16:37
Peter Noymer: And like I said, it was when you do the math on the failure rates and the.
16:42
Peter Noymer: The dollars that patients are costing the system now, um, it's, it's, it's super compelling.
16:49
Joseph M. Schwab: Jared, you mentioned some of the early sort of prototypes or ideas for this, for this product.
16:55
Joseph M. Schwab: Um, as you were fiddling or working with those, was there anything that was, um, maybe a surprising result that you found early on?
17:04
Joseph M. Schwab: Either surprising, good or surprising bad?
17:08
Jared Foran: Well, I, it was interesting to see.
17:10
Jared Foran: You might have an idea that works, but is it practical?
17:14
Jared Foran: Is it practical economically?
17:15
Jared Foran: Is it practical for supply chain?
17:17
Jared Foran: 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.
17:31
Jared Foran: And frankly, there's no, the economics there just don't work.
17:34
Jared Foran: Right.
17:35
Jared Foran: And then we, uh, shifted to this magnetically driven coupled, um, uh, subcutaneous pump that I had some merit to.
17:44
Jared Foran: But again, the problem there is no surgeons didn't wanna go back and take that pump out.
17:49
Jared Foran: Right.
17:50
Jared Foran: So it was interesting to see.
17:53
Jared Foran: The importance of ease of use became incredibly apparent to me.
17:58
Joseph M. Schwab: so Jared, let's talk about, you mentioned some of your earliest prototypes.
18:01
Joseph M. Schwab: Um, and what I wanna know is, were there surprising results that you got early on, either surprising, this is great or surprising?
18:11
Joseph M. Schwab: Gee, I, I'm, I'm really kind of concerned about this.
18:15
Jared Foran: 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.
18:24
Jared Foran: So the initial idea was to have an antibiotic eluding polyethylene spacer, uh, sort of hollowed out, uh, spacer.
18:30
Jared Foran: We, we engineered it, it worked the problem with it, and people were interested in using it.
18:35
Jared Foran: The problem with it, you can imagine you'd have to have.
18:37
Jared Foran: An incredible number of polyethylene sizes on the shelf at every hospital.
18:42
Jared Foran: Were just waiting for the infected patient, which is economically not practical.
18:46
Jared Foran: So there was an issue there.
18:47
Jared Foran: And then we shifted to this, uh, uh, magnetically coupled subcutaneous pump that was also would work.
18:53
Jared Foran: We got the engineering there would, was gonna deliver antibiotics.
18:56
Jared Foran: The problem is there is surgeons didn't wanna go back and have to take something out.
18:59
Jared Foran: So I learned that you need essentially three things.
19:02
Jared Foran: You need a good idea and it has to be very usable for the surgeon.
19:06
Jared Foran: No fiddle factor or minimal, very usable for the, for the patient.
19:10
Jared Foran: And it has to be able to make money.
19:12
Jared Foran: And so you kinda learn that the hard way.
19:14
Joseph M. Schwab: Right.
19:15
Joseph M. Schwab: Uh, and so Dr.
19:17
Joseph M. Schwab: Whiteside talking about innovations.
19:19
Joseph M. Schwab: You've been involved in a number of innovations including.
19:23
Joseph M. Schwab: 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?
19:32
Joseph M. Schwab: Mm-hmm.
19:34
Leo Whiteside: Well, the, there are a couple of'em.
19:35
Leo Whiteside: The, the personal mistakes that most, uh, innovators in medicine make, uh, is to not protect their intellectual property early on.
19:44
Leo Whiteside: 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.
19:58
Joseph M. Schwab: So you touched on two things that I actually find interesting'cause I want to ask Peter about this.
20:03
Joseph M. Schwab: And, and one is funding and the other is validation because these things, as you described, Leo, often happen in parallel.
20:11
Joseph M. Schwab: Um, you guys recently, um, just closed on, uh, an initial series A, I think it was this past August or last August.
20:20
Joseph M. Schwab: 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.
20:33
Peter Noymer: Yeah, that's a great question.
20:35
Peter Noymer: 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.
20:43
Peter Noymer: Um, you know, this is gonna be the engineer in me.
20:46
Peter Noymer: Talking now.
20:47
Peter Noymer: Right.
20:47
Peter Noymer: But my approach has always been to sort of put together a ground game and then run it.
20:51
Peter Noymer: Right.
20:52
Peter Noymer: You know, there's, there, there's a lot of block and tackle stuff that's gonna get done.
20:55
Peter Noymer: Right?
20:56
Peter Noymer: Like Jared said, you've gotta come up with a technology that's got a good product market fit.
21:00
Peter Noymer: Right.
21:00
Peter Noymer: You know, great idea, but not usable isn't gonna fly.
21:04
Peter Noymer: Right.
21:05
Peter Noymer: So kind of finding the right technology, demonstrating proof of concept with that.
21:09
Peter Noymer: Um, getting some early traction with the FDA, like we've done with our Orphan and QIDP designations.
21:16
Peter Noymer: Um, and then doing the ROI analysis, the return on investment analysis, right.
21:19
Peter Noymer: And kind of showing that there is, there is a business model here.
21:22
Peter Noymer: Um.
21:24
Peter Noymer: And, and, and to me that's kind of the, the, it all kind of wraps up that way, right?
21:30
Peter Noymer: 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?
21:41
Peter Noymer: So we're obviously not for them.
21:43
Peter Noymer: 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.
21:53
Peter Noymer: 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.
22:05
Joseph M. Schwab: And I wanna stay on this for just a minute with you, Peter, because you mentioned the the orphan drug and QIDP uh, designations.
22:13
Joseph M. Schwab: How do those designations specifically shape your strategy and your timeline?
22:19
Peter Noymer: Yeah, that's great.
22:20
Peter Noymer: Um, uh, I don't wanna go all the way back to kind of like what they are and what they do.
22:25
Peter Noymer: Right.
22:26
Peter Noymer: 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.
22:40
Peter Noymer: 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.
22:53
Peter Noymer: 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.
23:03
Peter Noymer: Right.
23:03
Peter Noymer: Just to get those in place.
23:05
Peter Noymer: Um, but what they do for you is pretty, is pretty impressive.
23:08
Peter Noymer: Right.
23:08
Peter Noymer: So during your development program.
23:10
Peter Noymer: Um, they provide sort of, I'll call it more rapid access to the FDA for meetings.
23:14
Peter Noymer: 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.
23:28
Peter Noymer: Do you agree that this is adequate?
23:30
Peter Noymer: You know, then maybe later meet again and review some data and, and make agreements about how to move forward, right?
23:36
Peter Noymer: So we can typically, um, have those meetings happen a little bit more quickly.
23:41
Peter Noymer: 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.
23:48
Peter Noymer: Sort of a six month review instead of a 10 to 12 month review.
23:52
Peter Noymer: 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?
24:16
Peter Noymer: This is, you see this in the generic space, right?
24:18
Peter Noymer: The branded products have a certain amount of time, uh, to kind of recoup the investment for the companies and the investors.
24:25
Peter Noymer: 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.
24:32
Peter Noymer: This is literally the FDA will not allow the knockoff product to, to go to market.
24:37
Peter Noymer: Um, so we have that extra layer of protection for us.
24:39
Peter Noymer: 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.
24:48
Joseph M. Schwab: Sounds like that's a big advantage for your company, those types of designations and that that type of protection.
24:54
Peter Noymer: Absolutely.
24:55
Peter Noymer: I mean, it, it's, you know, it's smaller bits in the earlier days.
24:58
Peter Noymer: It's, it's much bigger impact later on.
25:01
Peter Noymer: And it's meaningful to investors when they hear about the, you know, you can run your development program more efficiently.
25:07
Peter Noymer: They like the course, they like to hear that.
25:09
Peter Noymer: 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.
25:20
Joseph M. Schwab: 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?
25:34
Jared Foran: Y Yeah, so we're still proving it.
25:36
Jared Foran: Uh, of course there's, uh, toxicology, uh, work that's being done.
25:40
Jared Foran: Uh, and there's, you know, uh, you know, local, local toxicity.
25:43
Jared Foran: Systemic toxicity, we have to, we have to, uh, prove that it's safe.
25:48
Jared Foran: 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.
25:57
Jared Foran: Uh, eradication, uh, re-operation, and of course, endpoints such as death.
26:03
Jared Foran: Uh, up to, uh, I believe 180 days is our, is our, uh, goal endpoint.
26:07
Joseph M. Schwab: Jared, how do you balance those sort of FDA or other regulatory requirements with what you just simply know matters to patients and surgeons?
26:20
Jared Foran: It is a great question.
26:21
Jared Foran: Uh, I mean, at the end of the day, we s we surgeons do things off label at times, right?
26:28
Jared Foran: We, we sort of have to, or sort of make the right decision for the patient.
26:32
Jared Foran: But I think systematically it's tough to ask surgeons to take personal risks off-label without some type of regulatory backing.
26:42
Jared Foran: So I think.
26:44
Jared Foran: Is a necessary to go through the FDA.
26:46
Jared Foran: The FDA actually is a, uh, consumer, you know, watchdog group.
26:50
Jared Foran: 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.
26:57
Jared Foran: It's, is it perfect?
26:58
Jared Foran: No.
26:58
Jared Foran: Is it important?
27:00
Jared Foran: Yes.
27:02
Joseph M. Schwab: So Peter, I wanna shift gears for just a little bit and I want to talk about.
27:07
Joseph M. Schwab: ForCasts scientific advisory board and your board is, um, uh, I would say top tier.
27:16
Joseph M. Schwab: Um, how do you leverage that group, that scientific advisory board in shaping not just clinical validation of the product, but product strategy?
27:27
Peter Noymer: Yeah, no, I, I, I agree.
27:29
Peter Noymer: The, uh, you know, this is like a pinch me moment sometimes, right?
27:32
Peter Noymer: I think we've got a great group.
27:34
Peter Noymer: Um, I'm, I'm somewhat odd by it.
27:37
Peter Noymer: 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.
27:46
Peter Noymer: Um, you know, they're all very approachable.
27:49
Peter Noymer: Uh, they, they like to roll up their sleeves, right.
27:52
Peter Noymer: 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.
27:58
Peter Noymer: Exactly right.
27:59
Peter Noymer: But they know, they know the problem.
28:00
Peter Noymer: They know it's in need of a better solution.
28:03
Peter Noymer: Um, right.
28:04
Peter Noymer: 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.
28:17
Peter Noymer: Right.
28:18
Peter Noymer: 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.
28:30
Peter Noymer: So it, it's all across the board.
28:32
Peter Noymer: Um.
28:33
Peter Noymer: 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.
28:40
Peter Noymer: 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.
28:48
Peter Noymer: So yeah, it's been, it's been super helpful and meaningful for us.
28:52
Joseph M. Schwab: 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.
29:10
Joseph M. Schwab: 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?
29:23
Leo Whiteside: 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.
29:36
Leo Whiteside: 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.
30:00
Leo Whiteside: And besides that, if it's a good idea.
30:03
Leo Whiteside: 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.
30:17
Leo Whiteside: As Jared said, it's just been miserable, uh, trying to use intravenous antibiotics and a spacer for the last 50 years.
30:27
Leo Whiteside: I mean, it's time to do something.
30:29
Leo Whiteside: 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.
30:40
Leo Whiteside: I think that's where we'll.
30:42
Joseph M. Schwab: Yeah.
30:43
Joseph M. Schwab: 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?
30:55
Jared Foran: Uh, the feed, I mean, essentially the feedback is they just can't wait to use it, right?
31:01
Jared Foran: That's the, the over and over.
31:03
Jared Foran: When can I get this in my hands?
31:05
Jared Foran: That's, I hear over and over.
31:06
Jared Foran: 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.
31:12
Jared Foran: So that kind of feedback is, and they've seen the data, they've seen, they know the, the, the elution curves.
31:16
Jared Foran: They know the, the, the biofilm eradication concentration numbers that we can get to, and it's exciting.
31:22
Peter Noymer: Yeah.
31:23
Peter Noymer: 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.
31:32
Peter Noymer: Right.
31:32
Peter Noymer: And, and thankfully we won.
31:35
Peter Noymer: Uh, that was nice.
31:36
Peter Noymer: 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.
31:48
Peter Noymer: You know, when can I, where can I get it?
31:50
Peter Noymer: When can I have it?
31:51
Peter Noymer: And, you know, the response was, you know, virtually always the same.
31:54
Peter Noymer: Like, I, I'm really sorry.
31:55
Peter Noymer: We're still in development.
31:56
Peter Noymer: It's not ft a cleared, da da da, you know?
31:59
Peter Noymer: And then the response was, thank you.
32:00
Peter Noymer: You know, just kind of let me know when it is.
32:02
Peter Noymer: Right.
32:02
Peter Noymer: That
32:03
Joseph M. Schwab: Right,
32:04
Jared Foran: I think a lot, a lot of these folks have known about Dr.
32:06
Jared Foran: 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.
32:13
Jared Foran: So they're ready, right?
32:15
Jared Foran: They're waiting.
32:16
Leo Whiteside: Yeah.
32:16
Leo Whiteside: 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.
32:26
Leo Whiteside: We got the intellectual backing, we got the literature behind us.
32:30
Leo Whiteside: Uh, there's a great need for this, but you gotta have something that is a kit that works.
32:36
Leo Whiteside: The surgeon ties the last knot on it, and it's done as far as he's concerned, except for looking it over.
32:43
Leo Whiteside: 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.
32:52
Leo Whiteside: I'm, I'm done.
32:54
Leo Whiteside: Uh, and, and everybody is thinking, and the operating room is thinking, wow, this is great.
32:58
Leo Whiteside: Now, now we go.
32:59
Leo Whiteside: So I, I think, um, we're poised.
33:02
Leo Whiteside: That's, that's the way I feel about it.
33:04
Joseph M. Schwab: 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.
33:25
Peter Noymer: 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?
33:35
Peter Noymer: Because this is multifaceted, right?
33:37
Peter Noymer: We have, you know, we're addressing, uh, an issue with a drug in a device, in a surgical procedure, right?
33:42
Peter Noymer: So there's kind of part A, part B, part D all mixed in there.
33:46
Peter Noymer: Um, and that that can make it complicated, as Leo said.
33:50
Peter Noymer: So there's the kit to make it easy for the surgeon.
33:52
Peter Noymer: 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.
34:00
Peter Noymer: Um.
34:02
Peter Noymer: 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?
34:09
Peter Noymer: We decided early on to try to get a better read on this.
34:12
Peter Noymer: Um, so even.
34:15
Peter Noymer: 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.
34:26
Peter Noymer: We engaged a third party consultancy that does this stuff all day long.
34:30
Peter Noymer: 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?
34:42
Peter Noymer: 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.
34:53
Peter Noymer: Right?
34:53
Peter Noymer: 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.
35:07
Peter Noymer: Funding round.
35:08
Peter Noymer: 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.
35:21
Joseph M. Schwab: So you've all been really generous with your time.
35:23
Joseph M. Schwab: I, I just have a few more questions to ask each of you.
35:26
Joseph M. Schwab: And I wanna start by talking about, just looking forward, um, from the perspective of ForCast.
35:33
Joseph M. Schwab: And I'm gonna start with you, Peter,'cause you kind of touched on this just a little bit.
35:37
Joseph M. Schwab: What is, I will say, true success look like for ForCast?
35:42
Joseph M. Schwab: 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.
35:51
Joseph M. Schwab: What does true success look like for you guys?
35:54
Peter Noymer: I mean, sure.
35:55
Peter Noymer: Thanks.
35:55
Peter Noymer: I'll give a, I mean, it's probably more of an altruistic answer, right?
35:58
Peter Noymer: I think I'd like to see our product use as first line therapy, right?
36:02
Peter Noymer: PJ patient presents with PJI and it's a no brainer.
36:05
Peter Noymer: We're gonna give, you know, we're gonna do a DAIR procedure and this is the shot.
36:08
Peter Noymer: I mean, granted, there's gonna be some patients that maybe aren't eligible for DAIR, right?
36:12
Peter Noymer: They've got other comorbidities and all that, right?
36:15
Peter Noymer: 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?
36:25
Peter Noymer: But if, if we can make this the go-to for the surgeons, um, I think that would be huge.
36:32
Jared Foran: 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.
36:45
Jared Foran: Like, what you guys didn't do this forever.
36:47
Jared Foran: 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.
36:55
Joseph M. Schwab: 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?
37:06
Jared Foran: 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.
37:19
Joseph M. Schwab: So Jared, where do you see this technology fitting within Standard Arthroplasty practice in say the next five years?
37:26
Jared Foran: Yeah, I think that we are going to see a shift from, uh, the morbid two stage procedures to one stage and DAIRs.
37:34
Jared Foran: If we can make, uh, those, those procedures, uh, as or more efficacious than a two stage, the world's going to go there.
37:42
Jared Foran: And I think this product allows that to happen.
37:47
Joseph M. Schwab: So what has been the hardest part of this journey for you, Jared?
37:52
Jared Foran: Yeah.
37:52
Jared Foran: The hardest, the hardest part's really been sort of not going into it, understanding the complexities of the regulatory landscape.
38:00
Jared Foran: Uh, it's, it's a big burden.
38:01
Jared Foran: It, it's expensive, it's timely.
38:04
Jared Foran: It just takes a lot, it takes a lot more time and effort and, uh, a much larger, robust team than I ever imagined.
38:11
Jared Foran: 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.
38:18
Joseph M. Schwab: And the last question for you, Jared.
38:21
Joseph M. Schwab: 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.
38:35
Joseph M. Schwab: 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.
38:43
Jared Foran: 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.
38:58
Jared Foran: 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.
39:04
Jared Foran: It's worth your time.
39:05
Jared Foran: It's worth your effort.
39:06
Jared Foran: It's worth your money.
39:07
Jared Foran: It's worth it for the future.
39:09
Jared Foran: And if you believe that it'll work.
39:13
Joseph M. Schwab: So, Leo, a couple of questions for you.
39:16
Joseph M. Schwab: 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?
39:35
Leo Whiteside: Well, uh, for, uh, the first thing is make sure you're totally behind it because most people don't realize it.
39:44
Leo Whiteside: It could be a lifetime of work to get it where you want it to be.
39:50
Leo Whiteside: And then, uh, the other is early into protection of intellectual property.
39:57
Leo Whiteside: And, uh, and then, uh, it, it's a, it's a very, uh, joyful thing to do.
40:02
Leo Whiteside: It's a lot of fun to see problems solved and to encounter new challenges.
40:08
Leo Whiteside: It's just a great thing.
40:09
Leo Whiteside: I, I recommend it for the right person, but most people are not willing to, to, to face the opposition.
40:19
Leo Whiteside: Opposition will come from all sides sometimes.
40:23
Leo Whiteside: It's amazing how, uh, well educated physicians will be so resistant to a new idea.
40:31
Leo Whiteside: Even with good data on your side.
40:33
Leo Whiteside: It's all it takes is another couple of guys on either side of them.
40:37
Leo Whiteside: And then there are consensus and, and you are by yourself.
40:41
Leo Whiteside: And the other thing is you better be ready to be by yourself on panels over, over again with everybody disagreeing.
40:50
Leo Whiteside: But then, um, you have to remember that if you believe what 95% of the people believe about any topic, you're wrong.
41:04
Leo Whiteside: It's the 5%.
41:05
Leo Whiteside: That's right.
41:07
Peter Noymer: Yeah, it, I was gonna just build on that, Joe, if you don't mind.
41:10
Peter Noymer: Um, I'd say the, the glass half full version of the, the physicians I've worked with in, in different therapeutic areas, um.
41:22
Peter Noymer: I think in a very good way.
41:23
Peter Noymer: They all, they all care tremendously about their patients.
41:26
Peter Noymer: And I've done a lot of work in other orphan disease spaces, right?
41:29
Peter Noymer: 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.
41:37
Peter Noymer: Um, and, you know, but then with that comes the, well, I've been doing it this way for 20 years.
41:41
Peter Noymer: Why this new thing?
41:43
Peter Noymer: You know, why should I do this new thing?
41:44
Peter Noymer: I don't, I don't want to take a risk, right?
41:46
Peter Noymer: 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.
41:57
Peter Noymer: 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.
42:02
Peter Noymer: But I'd say by and large, what I see is mostly motivation to, to kind of protect the patients first and foremost.
42:09
Joseph M. Schwab: Peter, what has been the most fulfilling part of this journey for you personally?
42:16
Peter Noymer: Sure, sure.
42:17
Peter Noymer: Uh, also a little bit what, what Leo said.
42:19
Peter Noymer: Um.
42:21
Peter Noymer: 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.
42:30
Peter Noymer: That's huge.
42:32
Peter Noymer: 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?
42:39
Peter Noymer: We also have Charlie DeCook on board.
42:41
Peter Noymer: Um, he's amazing and he is got an incredible entrepreneurial streak.
42:45
Peter Noymer: 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.
42:55
Peter Noymer: All, uh, top of their game.
42:57
Peter Noymer: Most of them people I've worked with in the past.
42:59
Peter Noymer: 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.
43:16
Peter Noymer: Patients and docs and, and the team.
43:21
Joseph M. Schwab: Leo, how has the experience with ForCast specifically changed the way you think at all about surgery or innovation or leadership?
43:32
Leo Whiteside: It's fun to, to work with people who are also dedicated and find a way.
43:37
Leo Whiteside: And there's, there's always a way, you know, if you, there's so many different ways that you can find one.
43:42
Leo Whiteside: 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.
43:53
Joseph M. Schwab: I am gonna, uh, give you both kind of the same prompt, uh, for the last question.
43:57
Joseph M. Schwab: 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?
44:08
Joseph M. Schwab: How
44:09
Peter Noymer: I think I'd say something that means, uh, great ideas coming outta clinical practice and eventually finding traction in the marketplace.
44:17
Joseph M. Schwab: about you, Leo?
44:18
Leo Whiteside: Find a, a, a, a great solution for patients who are in dire need.
44:24
Leo Whiteside: That's what we're doing here for sure.
44:27
Joseph M. Schwab: That's excellent.
44:28
Joseph M. Schwab: Um, I, I really appreciate the time that you gentlemen have taken with us today.
44:32
Joseph M. Schwab: 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.
44:41
Peter Noymer: Yeah.
44:41
Peter Noymer: 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?
44:52
Peter Noymer: 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?
45:03
Peter Noymer: Um, there's a lot of, um.
45:06
Peter Noymer: People, players, entities, organizations in the ecosystem that helps make something become successful.
45:12
Peter Noymer: 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.
45:27
Peter Noymer: I mean, that all, that all helps, right?
45:28
Peter Noymer: 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.
45:36
Peter Noymer: Um, there may be some folks that maybe even, uh, aren't as aware of how bad the problem is right now with PJI.
45:43
Peter Noymer: So I think all this stuff, um, you know, it's like a rising tide raises all ships kind of thing.
45:48
Peter Noymer: So we really appreciate the effort that you, um, and the AHF folks are putting into doing things like this.