Episode #121| Absorbable Biomaterials with Dr. Rao Bezwada

Absorbable biomaterials have transformed modern medicine, enabling implants, sutures, and drug-delivery systems that safely degrade once their function is complete. Dr. Rao S. Bezwada has helped shape the field of bioresorbable polymers for more than three decades. As the inventor of Monocryl®, the absorbable suture that has generated more than $2 billion in worldwide sales, and the holder of more than 150 U.S. patents, his innovations have influenced everything from surgical sutures to next-generation biomaterials. In this episode of The Lattice, Dr. Bezwada joins Dr. Jenny Chen to discuss the science behind bioresorbable polymers, the chemistry that controls how materials degrade, and what the next generation of resorbable biomaterials could make possible.

⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.

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Show notes: https://3dheals.com/episode-121-absorbable-biomaterials-with-dr-rao-bezwada/

Transcript

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FDA Approvals And Vanishing Materials

SPEAKER_04 0:00

That's how we convinced FDA that whatever put in is safe, and when they hydrolyze, they come out safe. So that's how we got 15 FITNK approvals. Airbrex got 15 FITA NK approvals. Matter of 18 months, they were able to develop a product. Now they have over 10 products for all orthopedic applications.

SPEAKER_00 0:30

Please listen to the disclaimer at the end of this podcast.

SPEAKER_01 0:34

Hello, hello. Welcome to the pot, everyone. Most of the stuff in healthcare, we put medical devices into the body to last. But today's guest, his main inventions, are to build things that last in the body but then vanish. From dissolving sutures to printable tissues to even biodegradable plastics. Our guest today, Dr. Ra Biswata, is the scientist behind a whole slew of products of these bioabsorbable polymers. Welcome to the podcast. So, Ra, you're a chemist who made almost 150 inventions in your lifetime. But I know that you've been in the industry for more than 40 years, is that right? Right. So tell us, what was that like in the you started in the 1990s, you know, some of our audience wasn't even born. Tell us what was the journey like back then as a material scientist. Okay.

SPEAKER_04 1:35

Let me give you a little background. Thank you, Jenny, for uh uh the podcast, and thank you for your introduction. I I came to the United States after my graduation from India Medical School and I've joined Steve Institute of Technology, Hoboken, did my master's and PhD in polymer science, actually polyurethane science. And I was fortunate enough to get a job in Athakon Medical Device Company. The leading medical device

Building Better Absorbable Sutures

SPEAKER_04 2:10

company. And the timing was so perfect. Before that, we used the cat gut suture, which is a collagen-derived suture material, which is not very good. So they got the assignment of this project for me, and we developed the monocle suture, which is far better than cat gut suture, which is two, three times stronger, more flexible, good tie-down. This is a terminology, tie-down strength as terminology for sutures. Surgeons understand that. So they we we developed it and uh introduced the product. It's a great success for the company. And it was um annual sales is now $100 million, cumulative sales is $3 billion of the product. It's a successful product. When I was working on this product, I realized there's a lot of opportunities to make all kinds of absorber polymers, liquid polymers, elastomers for drug delivery. I'll explain more on the other polymers stuff later.

SPEAKER_01 3:30

So was Ethicom part of Johnson Johnson, uh or it was bought by Johnson Johnson?

SPEAKER_04 3:35

It's a part of Johnson and Johnson. They started as it didn't, it was not purchased or anything, it was developed in-house. It was a leading 85% market share at the company. It's still a leading company. It's the number one um company. It's a great company to work.

SPEAKER_01 3:57

So you decided to study bioabsorbable. Did you have the vision that a lot of things in healthcare wasn't perfect because it's not absorbable by the body at the beginning? How did you decide to focus on this field?

SPEAKER_04 4:11

So fortunately, I worked on ethical and unabsorbable polymers, and I realized there are a lot of potential for absorbable. So the applications are enormous applications. Can you imagine have a polymer which does the job and go away from without doing any harm to the body so we can save the um so many pol I mean um for the polymers. So what I what I did was that what I did was that um uh find out uh what the polymers were developed. Let me explain to you before I go too far with this stuff. Let me give you example of uh what is absorber polymer. And a little bit of history. It's a great history with this stuff. It was discovered the product was discovered accidentally by DuPont. DuPont was DuPont was working on fabrics in the 60s and 70s, and polyglycolic acid is one of the products. They made the fabric and test for this washing cycles, go through the cycles, and they found out that nothing came out. And then they realized the this polymer is not stable under moisture and heat. Then DuPont decided they don't have any use for it, license the technology to Yatacon. So Yatacon gained their product. It's a six billion dollar business, absorber polymer business. So amazing. Amazing. So over the years, it was only 50 years history in the whole absorber polymer. Over the years, first they developed a suture material from DuPont chemistry. That was the PLGA polymers, polyglycolic polylactic acids. They are developed a monofilament suture for PDS polymer. And I developed a monoclonal suture after this because the PGA, PLGA polymers are too stiff, very high melting, processing is going to be difficult. Making sutures, especially monofilaments, is going to be difficult. So they asked me to work on most best handling properties of suture stuff. That's why they took monochrome. So I discovered this polymer by making a segmented copolymer. First time, they can make a segmented copolymer of polycapillactoin and glycolite. So use the the polymers we have earlier was a homopolymer and a copolymer. Uh PDS is homopolymer, PLGA is a copolymer. And very hard to process them. So when I introduced the monoclonal it's a big hit, and then it replaced the catgirl suture. It was mainly used for most gynecological procedures under plastic surgery.

SPEAKER_01 7:35

Why is that?

SPEAKER_04 7:36

Because it's more internal? Because it's the plastic surgery, which it goes away very quick and also very easy to handle. Tie down, because the tie down is very important, good strength when you're using it in the earlier stages of the stuff. And go away from absorption cycle, very fast cycles, and also BSR, strength goes away. So plastic surgery is easy, very good. Gynacological procedures.

SPEAKER_01 8:07

So back then, uh, when you were doing just pure science, and this still fascinates me for the work that chemists do. He seems to be alchemist in a way, like you just decided how to mix

The Chemistry Behind Controlled Hydrolysis

SPEAKER_01 8:20

this and that together, and suddenly things happen. But what was your, I don't know if you can tell us, what was the process of discovery, this uh monoclonal based polymer?

SPEAKER_04 8:30

That's an excellent question. So what happened with the the we are making all kinds of subsutures, absorber sutures, and I came, it came to my mind, what is the cause for hydrolysis breakdown? Why one polymer hydrolyzed faster than the other? So I looked very carefully, analyzed it, and found out that glycolic acid, the very short chain of the CH2COO, that's a short link of the polyglycolic acid, hydrolyzes very fast in the presence of moisture. I said, and then I reviewed all the commercial sutures materials and found out the only power products which are absorbable, faster absorbable, are the ones containing glycolic acid. So I thought, if I can find a way to take this glycolic acid, incorporate it into the backbone of the polymer chain, if we could do it, it will control the rate of hydrolysis of the polymer, thereby by putting the glycolic acid in the chain, which will increase the hydrolysis if we get closer to it, if they are far away from it, also neighboring groove effect of the stuff. That started my discovery process of making a novel new absorbal polymers. That was the so from from that technology, I developed all these uh polyurethane, tissue adhesives, montage, everything, and it's still going on now. But you even have bioconjugated drugs, we're making it with this stuff.

SPEAKER_01 10:24

Absolutely. It's kind of amazing because in the software industry, we always hear founders pitch platform technology, and very rarely people would understand that chemistry can be also a platform technology as well. And it seems like you have discovered the beginning of a platform technology in the chemistry side, which is kind of amazing because the number of polymers you could modify using this discovery is probably infinite. Unbelievable, unbelievable. Um so so back then when Ethicon was hitting the lottery,

Why He Left Big Medtech

SPEAKER_01 11:00

got the jackpot, you could have read your career successfully there forever, probably till today in Johnson Johnson and Ethicon. What made you decide that you're gonna just give out all that and start your own company, which is not an easy life, I would say?

SPEAKER_04 11:18

Oh, I agree with you 100%. A thought came to my mind so many times. Why did I do this stuff? One of the main reasons actually I I have nothing but good words about Ethacon and Johnson and Johnson company. So when I started working in Ethacon, they have most of the companies have exploratory research groups. I I I don't know whether it may be too young for this stuff. So every DuPont, AT ⁇ T, generally, all the companies have a 3M is number one exploratory group. I happen to work an exploratory group, a lot of freedom. We can work anything I want with as long as they get a boss permission. So you're able to do the stuff. That's why I was able to be very successful. I got an average of three patents per year every year. There's a history in uh in Athakan. I think um Athakan, I was the I was the only guy who got this so many patents for this stuff. So what happened over the years? Research changed, project management changed, and they put lead on on the explorer research, actually eliminated explorer research work, and the projects are run, research run by project leaders. So the direction goes in a different way, very limited flexibility. So I wanted to explore all my technologies for I have developed. So I took a chance to come out and do this stuff. And I think again, Stethacon, which was a good company, but I had the opportunity and the freedom to develop more products. That's why my own company had 55 patents, because nobody stopped me to do the patent. Um so even though it cost me money, was I was able to accomplish a lot of technology with our patents.

SPEAKER_01 13:26

So after almost 20 years' career at the large MedTech company, you decided to quit all that and start your own company. What was the first one or two years was like? And back then, you know, VC was not a thing. You you probably have to be on your own.

SPEAKER_04 13:43

Actually, you are asking me very good questions. Um what happened is that at the time, stent business was big, booming. I don't know whether you recall that in 2000 to 2005 timeframe, um stent business was booming. And there was a

Surviving Early Funding And Finding Revenue

SPEAKER_04 14:05

lot of need for new polymers. And if you make a new polymers for stent coatings, uh absorbable stents, uh, people are paying, giving money millions of dollars of research work. By the time I decided to quit and do the stuff, and the stent business had problems, so their money was ran out of the money with the stuff. But fortunately, I contacted one of the polyurethane company guys in California, met him in ACS meeting. He was supportive for two, three years to develop the absorbable polyurethane work. With his funding, I was able to do initial work uh which was very helpful to me. Unfortunately, the the person was company sold, he sold the company and left. So I left out with problems, the financial problems with the stuff. But it was not too long. Within a few months, I was able to get funding. So I also do the contact research work, custom synthesis work, absorb polymers while I was developing it. It's not like one product company. My company is a platform technology stuff. So I was able to always generate some money, keep me going. So I never had a and uh never had a problem. And I polyurethane technology, a licensed reabrics, so I get a constant stream of um uh licensing and uh royalty payments. That is helping me to develop new stuff.

SPEAKER_01 15:42

Yeah, no, I think your business strategy is very interesting as well, which we we'll cover a little bit later. And but every time I talk to you now, I feel like I'm getting a chemistry lesson, except I'm not a very good student and I I spend too little time on this. So we I want to get some professor lecture from you about this um whole beyond PLGA bioabsorbable polymer lecture. Um so

Beyond PLGA Toward New Polymers

SPEAKER_01 16:10

you already talked a little bit about about PLGA as the foundational bioabsorbable polymer that that was discovered, like you said, a wonderful history of DuPont. But then there was a lot of problem with that. What was the problem with it for healthcare reasons?

SPEAKER_02 16:27

Problem with the PLGA polymers?

SPEAKER_01 16:29

Yes. Like just yeah, without your polymers, what if we just just use that? What's the problem?

SPEAKER_04 16:36

What's the problem with the PLG of polymers? That's whatever. Okay. PLG polymers is the number one problem. It's very difficult to make it, uh, very difficult to process them. PLGA polymers. Uh and uh the there's a lot of acid dumping when they have been hydrolyzed too fast. So the acid dumping which kills the cells, so it cannot be used for drug delivery polymers stuff. So having a copolymers reduce the the acidity of the uh glycolide uh polymer. That's why capalactone copoly capalactone is very, very good polymer to work with. It's an excellent, excellent bio ink for 3D bioprinting stuff. Copolymers with a capalactone are easy to work with, and having a copolymer of a capalactone in a polyurethane backbone is a great asset for biocompatibility. Great asset biocompatibility. So over the years, um after uh copolymers were done, because there was an added crying demand for new suture materials, uh ethacon and metronic, they were not doing any new material stuff. Um so after after 25E, and my my product was released in 1993, over 30 years, Metronic just released a competition, just released a couple of weeks ago, competition for monocle suture. So all these years there was no competition. Nobody is working on this stuff. That's one of the reasons, uh Jenny, that I wanted to develop other polymers from the knowledge I did I gained from commercial absorbable materials. I gained the knowledge of using these hydrolyzable links which were in the absorbable polymer. So I take the link and put it in wherever I can, develop a novel class of polymers. I give you a simple example. Suppose you want to make an amino acid-based polyester emits. You have an amine group, uh amino acid, amine group and carboxyl group. Glycolic acid, a hydroxyl group, and carboxyl group. So I can functionalize them. That means I react them with an amino acid like a glycine and then make a polymer out of it. It'll become a polyester amide. So glycolic acid link in the chain creates an absorber polymers. I have over 15 patents on polyamino acid-based polyester emides. So so I can I can take a biostable polymer, I can convert into biodegradable polymer. I give you when when I talk about absorbable polyurethane polyurethane, I can explain to you more. So I give you before I go there, I want to show you we come we compiled we compiled polyester amides, polyoxide polyoxy esters, and polyurethane, and you any any polymer like if you have an aromatic molecule, if a drug, let's say we have a drug, which has a dihydrox dihydroxy compound, dicarbox dicarboxylic acid compound. Like antiinflammatory drugs have all uh dicarboxyl groups and hydroxyl groups. I take that product and functionalize with the glycolic lactic acids or a capalactone or PDO, and that's become a new entity and make a polymer out of it. So what happens? You incorporate the glycolic acid in the polymer backbone of the stuff. So you you you make an extrudable product or a drug delivery polymer, whichever, and in the presence of hydrogen, in the presence of moisture in the body, it starts breaking up the glycolic acid links. Okay? That's the same thing I used it in polyurethane, absorbable polyurethane. Nobody ever made an absorbable polyurethane except me. I'm the only one, if you go look co-pilot, I'm the only Baswater Biometer is the only company have an absorbable polyurethane, control degradation profile polyurethane. Use that technology for developing products like tissue bond and montage and all this stuff. If you have time, I can explain to you basic chemistry of polyurethane. I don't think you ever heard before. Can I explain that?

SPEAKER_01 21:42

Yes. Um, I just want to um uh uh add that we're gonna have some graphic presentation of these compounds. So the listeners uh can go onto our YouTube channel to see the graphic demonstration of what Ron is about to say, because I understand the concept, maybe complex. Without any kind of visual explanation. So yes, go ahead and talk about polyurethrine, because I know that is a main product from your company and your inventions.

SPEAKER_04 22:12

Right, right, right. So, as

Making Fully Degradable Polyurethane Safely

SPEAKER_04 22:15

I mentioned to you before, from the knowledge we gained from absorbable polymers, glycolic acid, lactic acid. So absorbal polymers degrade anywhere from 70 days to three years. So if I have a polylactide polymer, it takes two to three years for absorption. If I use a glycolic acid polymer, it goes to 90 to 100 days. So using that hydrolyzable links into the putting into the backbone of polyurethane creates a bioabsorbable polyurethane. Let me go back and briefly explain polyurethane. Absorbable polyurethane is a very polyurethane, biostable polyurethane is very useful, very unique, amazing polymer. But the problem with absorbed polyurethane is it is the ingredients we put in like a tolyune diasocyanate or MDI, which is a metaphenylin diasocyanate. Toluendiacin is a carcinogenic. I know, I've heard cyanide. That's that's not good. Yeah. And the MDI is toxic. I mean, there's byproducts are toxic. Right. So no medical device uses toluene diesocyanide. People use MDI, metaphylline diastroase. It's a beautiful product, except that minor impurity of the toxicity. Polyurtens have rate of reaction is very important. If it doesn't react fast enough, it's not going to be good for a lot of applications, like a tissue adhesives, the bone application product for bone application. So we took this MDI is the key component for a biostable polyurethane. My goal is to take a molecule, similar, make a molecule very similar to MDI. MDI is actually two aromatic rings with connected with a methylene group and diazocyanase on both sides. It's a simple molecule. So compounds I use are very safe compounds to make that. So you take these molecules combined together with the glycolic lactic acid, which is a pre the first step, literally a first step of the suture metri polymer, diathylene glycol with glycolic acid on both sides. Link that in into this MDI middle, take the methylene group out and put that linker, hydrozebo linker in the middle. So what happens is that molecule has a control degradation profile with no toxic materials coming up. That's how we convinced FDA that whatever put in is safe and when they hydrolyze, they come out safe. So that's how we got 15 phi 10k approvals. Airbrex got 15 phi 10k approvals. Matter of 18 months, they were able to develop a product. Now they have over 10 products for all orthopedic applications. So we are that's the key. So the polyurethane are made with hot segment and soft segment. Hard segment contains MDI, soft segment contains polyester. Whatever everybody doing absorbable polyurethane is that hydrolysis of the polyester, soft segment. Nobody touches the hot segment of MDI. They have a partial hydrolysis, never get a full complete hydrolysis. There, if I that that's where I use this technology to make a bio-based biodegradable polyurethane where everything degrades to the starting material.

SPEAKER_01 27:20

I have a couple of uh layman questions about this um this polyurethrase product is what how do you know the bioproduct it's gonna be at the end of the degradation? How do you know how do you how do you measure it to see if there's something toxic to the cells? Okay, okay, you know.

SPEAKER_04 27:41

So what happens is that if you look at the structure, you have uh if you be if it goes down to amino benzoic acid, so you got a ureth, worst can come only link of ureth urethane, one link of urethane linkage in the chain. But they essentially what we did, uh Niti participated in making this stuff is what we did is that we synthesize the molecule and do the NMR, high NMR interpretation while we're doing the stuff. So they we break down to the starting materials.

SPEAKER_01 28:20

Okay. There's no bypassing that's clarifying, yeah.

SPEAKER_04 28:24

Then the major trouble is that they have a aromatic diamonds are the cause cancer, not cancer, the toxicity coming from. But besides that, everything else is okay. That's why when they use MDI for the medical products, they extract the product out with the hexane solvent to remove all the impurities from there. So they would never use it as such. They use make sure this all the extractables are coming out before they can use it.

SPEAKER_01 29:02

And you you mentioned that you have a partnership with APREX and you had rapid FDA clearance. And I think

Abyrx Orthopedic Putty Applications

SPEAKER_01 29:10

our listener will be interested in knowing what these products are and what are the major applications of this kind of polyurethane polymer.

SPEAKER_04 29:19

Okay. So the ABREX is interested only for orthopedic applications, and I licensed the technology only for orthopedic applications. The main quality for this Abrex products are they're supposed to react very fast. We can harden because they they use the calcium phosphate, hydroxyapatite, it it's like a putty. So when you apply the putty, apply on the on the bone, it has to be spreadable. And also you can combine them as a the adhesive because I it'll become, if I use only for a hemostat, it'll stay as a hemostat react and become this. If I use the two bones to stick together within 45 seconds to one minute, they can start adhering together, become very hard like a bone-like material. So they have approvals for all kinds of applications: bone hemostat, bone cement, bone wide filler, uh now when antibiotics, they have the antibiotic stuff, and have a thoracic surgery. It's a big hit on thoracic surgery because when you cut it open, the ribs are bleeding. So when you have apply this one before the surgery, and then remove after the surgery, remove it and before they close it, you apply again this uh it will give, according to the literature, it gives about 30% strength, especially older people after surgery. My understanding is a big hit on thoracic surgery with this stuff.

SPEAKER_01 31:08

Yeah, I I I see um so do they still use wires to because I read chest sector every day and I see a lot of people have these wires on their sternum because they had open chests. Do you put this uh putty on top of the wire or do you still need the wire?

SPEAKER_04 31:25

When you cut the rib, ribs out, in the extern, what do you call sternum in the middle? Yeah, sternum, yeah, in the middle. I think that that's where um they they use that. And the rib. Right? So they can take it out and when when it's done, the because they it will prevent um it will prevent the bleeding and also give us strength because it is already adhered to the stuff.

SPEAKER_01 31:53

That's amazing. And have they gotten any um post-market analysis of bone regeneration or absorption for for this kind of thing?

SPEAKER_04 32:03

Yeah, but publishing it. So my understanding is that because we are using a particular monomer stuff, you can control the if for some applications you go, want to go slow absorption, so the bone can grow in with the stuff. It could go up to two years. As the party goes absorbable, then the bone will grow into the stuff. That is a neat thing about this fabric stuff. That's amazing.

SPEAKER_03 32:33

Yeah.

SPEAKER_04 32:34

Yeah.

SPEAKER_01 32:35

I would love to know more about it, especially how the clinical outcome for these patients. It's a very successful company. So now we're talking

How Licensing Partnerships Actually Work

SPEAKER_01 32:45

about an external company that you work with. It seems like you work with many different companies through partnerships and licensing. How do people work with you um as a partner? How do you find these partners?

SPEAKER_04 32:57

So mostly um mostly um I get the calls from for somebody recommended somebody, or we we s we talk to, you know, the the um uh website, people see in the website, they would they would uh they will come and say, we have this issue um with the product, and we will talk to them, and then Neeti will be there who is a quality person with the stuff. Talk to them what the issue is, and then we go back and make a prototype of the sample, and we put uh after that we go and explain the stuff to them uh and make the samples, prototype samples, and they evaluate it. They come back and say we this is good, but this is not good. The strength is good, but absorption is too fast. So you fix this information. We go back again, do the stuff, track the points and go, and then once they approve it, the sample, we'll have a scale-up capacity. ISO 9001 13485 um approval stuff. As a team, we look into this and we'll work on the project stuff.

SPEAKER_01 34:15

That's how uh so not only do you design the polymers, you also help them with manufacturing. Is that right?

SPEAKER_04 34:22

Yes, yes, yes, yes, yes. We do. Um well we are working with a customer now on uh the electrostatic spinning uh tissue scaffold stuff. So we uh they look very promising with the stuff. We have done, we have done with the small scale in university tissue scaffold stuff. Then we have a commercial customer um came to us to work on tissue in scaffold. And that's what we're doing. We submitted two polymers for tissue scaffolding, and they they came back and said electrospinning problem, and they said one is good, one is not good. We've got to talk to them and find out what the difference is about. So it's a constant communication back and forth with Zoom calls and presentations, stuff like that.

SPEAKER_01 35:11

Yeah, but it's a it's a universal, a lot of people don't know that's happening in the background. We met each other many years ago, probably starting in 2020, is that right, Rol? Was it 2020? Right. And we our journeys intersected because of 3D printing and bioprinting.

SPEAKER_03 35:30

Right.

SPEAKER_01 35:30

And I know you have a very strong interest in this field as well. Right. Right. What is different about our bioabsorbable polymers for biomanufacturing in particular? You you mentioned electro spinning, which is very interesting, by the way, because we just had a podcast with Professor Paul Dalton, who is the inventor of MELT Electro Writing, which is like a modified version of electro, it's like a more controlled way of 3D printing using electro spinning foundational information. So I'm I'm just curious, like, how did you become interested in 3D printing? And what are your takes on polymers

PEG Bioinks And 3D Bioprinting Needs

SPEAKER_01 36:15

in bioprinting and biofabrication?

SPEAKER_04 36:18

Yeah. Very interesting question. It's a very good question, too. So our participation in 3D printing is accidental. So what happened, a friend of mine who is working on uh 3D printing about 2000, um they're they're interested in peg accolates. So we we have no experience on making peg accolades. We know how to make it, but he never made it. So my friend came and said, I need it bad, I need large quantities of the peg accolades. I have nobody to make the product for me, you've got to help me out. So we ended up making for her, and we were happy with the stuff, they're very happy, and we work with a big customer, very big customer, on making over 200 kilos peg accolades and 6,000, 3,400, all kinds of pegolates. And they were very happy with the service, and they wanted us to make other pegacolades, petacolates, peg all this stuff. So that's how we got into this peg business stuff.

SPEAKER_01 37:33

One might be curious, um, one might be curious what they're making that they need so much.

SPEAKER_04 37:38

Yeah.

SPEAKER_01 37:39

If you're allowed to tell us.

SPEAKER_04 37:41

We don't know. It's a big company, we don't know what they're making with this stuff. So we've we've found out there's a lot of need for this stuff. So we have a whole new peg polymers, and we work with the two sm two or three small uh companies working on breast implants, uh organ replacement stuff. So we work with them and they say peg is weak, I don't have elasticity, no strength. Can you help me out? So we develop new polymers, excluding glycolide. We glycolide is a bad actor with the PEG copolymers. So we go with polycaprolactone, um, peg copolymers, caprolactone, trimethylene carbonate, lactite. So we buy diblacopolymers, triglycopolymers, gives enough strength with the stuff. Some of the customers, we know they are working on breast implants to improve the strength and the stuff like that. That's how we got into. Now we are we are almost equivalent to some of the peg suppliers. We have more peg polymers than some of the supplier stuff. Where we are getting only, not for any other medical pharmaceutical products, we're getting only for 3D bioprinting work. Our peg polymers we are making with this stuff right now. And we have, I would say we have at least 50 to 80 peg-based polymers in stock. We are supplying companies like the Sigmall Rich and distributor stuff, but we are working on also small companies who need this product stuff. And if you know anyone who wants to peg accolates with a good price, we are here.

SPEAKER_01 39:45

Um what do you think is the challenging when you were developing these polymers uh specifically for bioprinting applications?

SPEAKER_04 39:52

So I give you an example of um pegs. Peg is one example, and I give you another example to PLGA polymers. Peg polymers, we are really mastered peg polymers. Actually, we're going to have a couple of patents on incorporation of the polyurethane to the peg polymers to give an extraordinary strength, and also we can we have discovered that you can make a sealance, peg-based sealants with the with the beautiful strength, the adhesion, all this stuff. So we talk to the customer and we see what is happening, and we develop based on the customer say, I am working on this. I have a problem of solubilizing it. How could I make a dye block copolymer with a good solubility in water? Polyoxyester is another example. Polyoxyester containing glycolic acid moieties in the stuff, but it behaves like a peg, but it has polyester strength. So I can make if somebody wants only a peg, nothing else, with a strength with the stuff. So I can use polyoxyesters and the backbone of the chain, and then we create a have pendant hydroxyl groups and convert them into acrylic groups and photocurable with the stuff. So a polyester backbone with hydrolyzable links like pegs and have a pendant groups with the stuff and the crosslink, either crosslink with the pegacy, acrylate groups, or attach is add the react to our react to isocyanate, hydrolyzable reactive isocyanate into this stuff. So you can cure them while you are at room temperature, you can cure them the with the with uh peggy pegylation bioinks, bioprint, bioprinting. That's the that's where we are going, our direction is going with this stuff. So another other sorry, other example I want to give you quickly and PLGA. Customer is looking for a polymer, have a specific requirement, availability, viscosity, hydrolysis, and coating properties of one polymer. So we're working back and forth with the customer, is a big is a big company, customer, develop one piece at a time, work with the customer back and forth. It's going on very well. That's where we work with the coordination with the customers, develop products. A lot of time a customer has an issue, we're able to solve them.

SPEAKER_02 42:58

That's how we build the relationships.

Future Bets And The Funding Problem

SPEAKER_01 43:02

Thank you so much. I learned so much from this episode. Now we're reaching the end of this conversation, although I do hope it can last longer. So I want to hear some of your uh vision for the future. Where do you think Biswara Technologies, or sorry, Bizwara biomedical is going to play a role in the future of healthcare and drug delivery, biofabrication, and maybe even sustainability, which is one topic we haven't really focused on. So just kind of want to see, you know, where do you see your company is going to do to change the landscape for the industries?

SPEAKER_04 43:44

I I to be honest with the Jenning, I thought it would have happened five years ago. Uh you could have been a completely different company. Uh, but it's very difficult to get the funding, and it's very difficult for the Companies to aggressively go after our tissue adhesive. We have met all the requirements for the tissue adhesive properties, and it is safe and biocompatible and good tensor property, good properties, but the funding is the difficult one. But we are struggling to get more funding to develop the stuff. What I see is I see a lot of opportunity 3D prior 3D bioprinting, even though it is a little bit slower now right now. We feel the technology we have, especially with the polyurethane into the system is so we can make tissue at room temperature without heating, no heating, with very quick reaction stuff, biocompatible polymers. That's with for 3D bioprinting. And I also see biodegradable polyurethane. We have tested it, it's it's which is biodegradable in the soil testing. We proved that we can make a biodegradable biobased polyurethane. We have done extensive work. But there is no big money in there, but I'm committed to do at least if I reduce the polyurethane waste from 25 million tons of polyurethane waste, even if I reduce one ton or two tons of the polyurethane waste, I think I I I make I make it there for me. It's going to be fantastic. That's one. And I I'm going to, other thing I'm struggling for years. I thought this is going to be a great thing, is that bioconjugated drugs. So my technology has so many patterns on biotechnology, drugs containing hydroxyl group, carboxyl group, amine group. I can react them, make a polymer chain, and have this drug in the chain, and then you want to trigger by moisture in the presence of moisture, breaks down in a comp in a controlled fashion. If I use glycolic acid, it'll go very fast. If I use lactic acid, it goes slow. Caprolacton, very slow. I can control the degradation profile. I'm working very hard now trying to get a funding. It's so difficult. I've been trying actually for many years, and nobody wants to hear it. Everybody wants a ready-made product. They're going to take it and sell it. Nobody wants to invest time to develop the technology. I think that's one of the unfortunate things you have for my business, not able to get funding together with this stuff. But I feel that with 3D bioprinting, I have a lot of hopes on that.

SPEAKER_01 47:10

Well, I certainly do as well, since I'm heavily invested in this industry. And I hear you, uh Ra, and have to say your perspectives are very unique and it's definitely a chemist perspective. You know, nobody else is gonna measure their legacy with a ton of polyurethane waste uh as a legacy metrics. You know, you're the only one I've ever heard of.

SPEAKER_04 47:33

I I wrote to all the big companies. Nobody doesn't want to, everybody thinks the cost is a problem. They don't want, they don't want to touch it. Because now the regulations are really relaxed on the polymer waste. Um, so it it is difficult.

SPEAKER_01 47:52

Yeah, I I I I understand where you're coming from. A lot of things depend on what you work in day in, day out, what you're seeing, the world that you're in, like our perspectives are different. And I actually recently wrote an article about why are we spending so much money in AI and not not enough in biofabrication and science, basically. And you know, it's it's a much deeper question. I think you and I constantly are thinking about this. And it's a combination of culture, policies, politics, and humanity. What do we prioritize? And unfortunately, at the moment, I feel science has taken a step back and a lot of other things are more prioritized.

SPEAKER_03 48:42

Right.

SPEAKER_01 48:43

I uh you know, I don't know. I mean, for for me, for you, this probably is a bit of misjudgment, but for many other people, AI is probably the number one. And uh I'm not saying I'm right, I'm just I just don't know. I think time would tell. Um and I I am also convinced that we need to invest more in material science, in biotech in general. Um, so yeah, I I'm on the same page, but

Advice For The Next Generation

SPEAKER_01 49:15

I understand your frustration as well. Now, for the final question I have for you, um, what I love about you is you have this entrepreneur spirit all the time. I mean, you have 40 years in this and you're still not, you're still as enthusiastic as you were 40 years ago. And I don't I don't think that this has diminished over time. What are your some advice for the next generation of scientists and entrepreneurs in medtech in particular? Uh, what do you have uh in terms of advice for them?

SPEAKER_04 49:50

Yeah, I think um don't go don't lose hope on uh the science, even though it took a back seat now. Um I have a couple of uh uh uh co-op students worked with me. Uh with my my advice to them is to have a deep understanding. I think what's happening now, they everybody come in, they want to learn quick some things and get a promotion, move on. It is not unlike old days, nobody is interested why it's working, why it's not working, what makes it the product successful, not successful. Um my advice is to learn, understand what you're doing, have a logical thinking. Because most of the most of the people work now, college kids, they don't care about this. They come in or go home and work on other stuff more than the work. That's what I noticed from biomedical engineering students worked with me, co-op students, master's graduates with this stuff.

SPEAKER_01 51:02

Well, we're we're definitely a lot more distractible

Closing And Disclaimer

SPEAKER_01 51:05

these days. You are a focused person, that's for sure.

SPEAKER_03 51:08

Yeah.

SPEAKER_01 51:09

Thank you so much, Rol. Uh, this is a wonderful conversation. I hope to see you again. Okay. Talk soon. Okay. Yeah, bye.

SPEAKER_00 51:20

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