Diamond Orthopedic, LLC

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January 1, 2018 Issue



Q&A with Roy Bivens, CEO and Jonathan Crumpler, CFO of Diamond Orthopedic, LLC creating a New Fixation Standard in Orthopedics with a Faceted Threadform Bone Screw Technology that is the First True Thread Innovation in Orthopedics in Decades



Roy Bivens

Chief Executive Officer


Diamond Orthopedic, LLC

Interview with Roy Bivens, CEO and Jonathan Crumpler, CFO conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published January 1, 2018


CEOCFO: Mr. Bivens, what is the vision behind Diamond Orthopedic, LLC?

Mr. Bivens: Our vision is to be recognized as the new fixation standard in orthopedics. Our faceted threadform is the first true thread innovation in orthopedics in decades. We believe that, based on our testing and what we hear from clinicians who have had a chance to work with this product, that we have something very special something that is very unique and revolutionary in orthopedics.


CEOCFO: What is in use today and how does what you developed differ?

Mr. Bivens: We have applied this faceted threadform to bone screws across five product classes. The best way to explain how our product can be used is that different injuries require certain kinds of screws. Depending on what the injury is and where it is located in the body, we have a product for that. For example, there are screws that are used in foot and ankle injuries that may differ in size and shape from screws used in the hand and wrist or the hip, and so on. We have product offers across all of those areas. What we offer in the market today are faceted bone screws for use in orthopedic applications. We are very excited about all of the potential applications for this innovation.


CEOCFO: Are you replacing a technology that is used now? What is wrong with what is being used now?

Mr. Bivens: That is a great question. Today, for example, if a patient has a foot injury of a certain type that requires a bone screw, that surgery is performed with either a stainless steel or titanium bone screw. There are companies in the market today who do that; companies that provide those bone screws. There are five major companies who do that, for example Synthes and Stryker are two big players in that market. There are hundreds and thousands of bone screws put into the human body every year. We believe our faceted bone screw has a distinct advantage because our testing has shown better fixation vs conventional screws. For example, we have shown in our in vitro testing that pull out strength, which is a very basic measure that bone screws are evaluated by, is twenty to thirty percent better with our product. Better fixation is the ultimate goal. The faceted bone screw is a better product for patients because it provides better fixation.


CEOCFO: What is happening with the product that makes it a better choice? 

Mr. Bivens: There are several benefits, but I would point to a couple of things. One is that it takes about half the torque to insert our faceted bone screw vs the conventional orthopedic threadform.  That may sound complicated, but it basically means that the bone screw goes in easier with about half the effort to turn it. The reason that is important is that it reduces the chance for micro fractures in surrounding bone during insertion. That is important because if you can reduce the potential damage to bone when a bone screw is going into the body you have more healthy bone to engage the threadform. The second advantage is that there is less compressive stress. The best example I can give here us that if you have ever taken a screw and put it into a piece of wood at the house or if you are screwing something into the wall, you know that as you turn it it gets harder and harder and harder to turn. The reason is that you are building compressive stress in between the threads as you turn it. The faceted bone screw builds much less compressive stress. The value of that clinically is that a fracture closes sooner when using a facteted bone screw with less stress transfer to the bone. This is particularly important when you are talking about compromised bone. In the United States, ten thousand people turn sixty five every day. As a country we are getting older. We believe that, because of the way the facets work to close a fracture, that is a distinct advantage, in particular for people with compromised bone. Conversely, people with very healthy bone, such as athletes, often want the best product available to address their injuries. For fixation, the facteted bone screw is that best product.


CEOCFO: Has the orthopedic community been looking for a better way?

Mr. Bivens: That is an interesting question. I think the standard that is out there today has been around for so long th0p0p`pdxpPp@Ppt realize there was a better cell phone until Apple showed us. When we talk to clinicians and allow them to experience the tactile feel of putting one of these screws in they often have what we call a V8 moment, where they become convinced about the idea that it is easier to insert. They accept the idea that it builds less compressive stress and they slap their heads in that V8 moment saying, Why did I not think of this. That is one of the reasons that we like this so much. It is a very simple idea that has tremendous reach and potential value across a multitude of clinical applications.


CEOCFO: Is there a learning curve for usage?

Mr. Bivens: That is another great question. We were talking with a clinician three weeks ago and we took him through our demo. After he asked a few questions and got pretty excited about the potential to use it he said that one of the things he loved about it was that he did not have to change his practice or do something different than what he is already doing. This is a basic replacement, one for one, going from a traditional threadform that is in use today to using a faceted threadform. It doesnt require a change in practice, its just a better performing product.


CEOCFO: How can you tell how it will hold up over time?

Mr. Bivens: There are two answers to that. One is that we have done extensive testing on this product and we have subjected it to a litany of situations. We have tremendous biomechanical data that tells us that it will perform better. Secondly, though, we plan to compliment that biomechanical test data with an animal study in the first part of next year, and we are expecting great results from that study. With the in vitro work we have done and the in vivo work we will do with the upcoming study, we think that we will have that much more of a compelling value proposition for the clinical community.


CEOCFO: I know you had a seed funding raise recently. Will that take you through that segment of testing?

Mr. Bivens: It will. We have a good amount of runway to get through that study and get through the things that we want to do in the coming year, which includes a new product that we are planning on introducing in the second quarter. We are excited about where we are heading with the testing that we are doing and with the new product that we are building for release next year.


CEOCFO: What can you tell us about the new product?

Mr. Crumpler: The one thing we can say about it is that in the inaugural offering and then subsequent offerings, we are targeting single-use products. It is a trend that has been gaining traction in the market, and our intention is to deliver products in that same category. We will follow up with what the exact kit, so to speak, will be in this first launch. However, it will be a single use kit focused on particular procedures.


CEOCFO: How will the cost compare to what is available today? If it is so much better does cost really matter? 

Mr. Bivens: One of the things that we are keenly aware of is that, as an industry, healthcare has a keen eye on managing costs. We believe that part of the value proposition that we bring is not only a clinical value proposition, because it is a better performing product, but we are keenly aware that we have to have an administrative or business value proposition. Therefore, we plan to be very cost competitive with the market and to offer a compelling value proposition to the providers who would be buying this product to achieve better patient outcomes at a lower total cost.


CEOCFO: What do you and the team at Diamond Orthopedic understand about bringing a product to market? What did you learn from past experience that has helped you so far and will continue? 

Mr. Bivens: That is another great question. There are several things that go into developing a new product, as I am sure that you are aware. One of them is to make sure that you are developing a quality product, and that is top of mind for us. We have a lot of focus on making sure that what we bring to market is something that is high quality and that will meet the needs of our clinicians and patients. That is one component. I think that making sure that have the right design is another component. By that, I mean that we need and rely on our scientific advisory board and other advisors to help us define the right product for the right market. We have tremendous capability on our team. We have Robert Anderson, MD, who is one of the most recognized foot and ankle physicians in the country. We have David Helfet, MD, who is one of the foremost traumatologists in the United States at the Hospital for Special Surgery. We have Andy Koman, MD, who is our Chief Medical Officer. He runs the orthopedic department at Wake Forest University and is a hand and wrist specialist. That kind of competency and capability is very important to us in bringing a new product to market. We also have a partnership with a marketing firm who has helped us with making good choices about how we launch this product to clinicians and providers. That is another component; making sure that people would communicate the right things to the potential buyers of this product. The technology itself is an important part. We are not launching a me too product here. This is a tremendous, game changing innovation that the industry has not seen in a long time.

Mr. Crumpler: The other thing I would add to that is that you have to have an adept manufacturing capability to deliver the product in a timely and cost-effective way. We are excited about the manufacturing partners that we have aligned with. They are sophisticated and steeped in the medical device arena, so we feel very fortunate to have partners to help deliver the type of quality product that we are going to bring to market.    


CEOCFO: What have you learned so far that differs from the original idea? What have learned through the early testing?
Mr. Bivens:
We are in the middle of it right now. Therefore, it may be a little early to reflect on lessons learned. What I will say is that when you are bringing any product to market, yet you have some sense of how it is going to go and then there are always things you did not anticipate. I would say that we have not had an oh gosh moment yet. I think we have had some pleasant surprises in terms of the partners who we have been able to align with, the way that we will go about getting this project completed and the innovation that it is going to end up being to the market. We have had some of those nice developments. If you were to come back and talk to us in a year we would probably have a better answer to that question.


CEOCFO: Why is Diamond Orthopedic noteworthy?

Mr. Bivens: The best answer I can give to that is that we believe we are the new fixation standard in orthopedics. The reason that is important is you could take this simple idea of a new, faceted threadform and it can be applied to a myriad of applications in the human body. Therefore, because it is such a simple idea and because it is so ubiquitous, we believe it has tremendous reach across the industry and it has got the potential to redefine some long held beliefs in orthopedics. We have to prove that and we are in the middle of doing that. However, we believe that because of the improved fixation that can be achieved with this product we may be able to do some things that change long held beliefs in the industry.

Mr. Crumpler: Another thing I would add is that Roy had mentioned that our story and our strategy is centered around threadform, not just a threadform applied to a bone screw. There are many potential applications within orthopedics that will span beyond titanium and stainless steel, which is important because it defines a much bigger market opportunity for Diamond Orthopedic. That is what I think gets our investors and other constituents within healthcare excited.

Mr. Bivens: The last thing I would say is that it all reduces down to a better product that delivers better fixation, with the potential to achieve better patient outcomes at a lower total cost. At the end of the day that is what you want as a clinician.


Our vision is to be recognized as the new fixation standard in orthopedics. Our faceted threadform is the first true thread innovation in orthopedics in decades.- Roy Bivens


Diamond Orthopedic, LLC

Roy Bivens







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