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January 5, 2015 Issue

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Implant and Insertion Process for Percutaneous Treatment of Weak and Compromised Bone

 

 

Don Kennedy

President

 

Element Orthopedics, Inc.

www.elementorthopedics.com

  

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 5, 2015

 

CEOCFO: Mr. Kennedy, your website indicates Elements Orthopedics is a pioneer in orthopedic medical devices. How so?

Mr. Kennedy: We are the first orthopedic device company to offer an innovative and unique implant and insertion process for percutaneous treatment of two different conditions in weak and compromised bone. The primary implant will be used as a treatment for chronic subchondral bone marrow lesions associated with early stage osteoarthritis of the knee & ankle. Our treatment has the ability relieve the unrelenting pain associated with the lesion and quickly heal that bony area. This will be very appealing to the patient and physician as an early interventional treatment and therapy. Our corollary implant is used for the treatment of vertebral body compression fractures, a well known, established and rapidly growing market.

 

CEOCFO: What is available now; what have you created to improve the outcome?

Mr. Kennedy: Today the treatment options for bone marrow lesions are generally fairly conservative such as aspirin, bracing, bed rest, cortisone or viscosupplementation injections into the joint. One device company is using a liquid bone void filler to fill the lesion. We think this makes the best sense as the lesion has been shown to be a main pain generator. The technology we have developed significantly improves upon the mechanical and biological capabilities of any liquid filler. The simple insertion method gives the physician complete control over the injection process. 

 

CEOCFO: How can you do this?

Mr. Kennedy: We utilize very small solid beads that are connected one to another using a monofilament; this creates the flexibility between the solids and spacing where a liquid (fluent) can reside. The solid implant is predisposed into a cartridge, sterilized and packaged. During a procedure, a fluent material is injected into the cartridge that penetrates and surrounds the entire implant. Simultaneously, the combined solid + liquid is injected using constant velocity. The implant combination flows into the void and provides immediate structural characteristics. The fluent material addresses the healing requirement for that specific location and patient need.

 

CEOCFO: Do you need to pinpoint exactly when it gets inside?

Mr. Kennedy: The physician does pinpoint the precise location they would like to fill. A truly beneficial characteristic of our technology is the implant driver we use. It incorporates the use of velocity. So that once the target area is pinpointed, the physician may specifically guide, direct and build an implant in-situ (live, in place). 

 

CEOCFO: What type of training does a physician need?

Mr. Kennedy: They physician who would use this type of product is already trained and skilled in the art of injecting liquids into weak or compromised bone. There would be no other specific training or education requirement on how to operate our system; it is intuitive. One luminary physician has commented that we “iphoned” the injection. The injection is caused by a very simple pull of a handle; this advances two beads at a time with an aliquot of fluent material. The implant driver provides tactile feedback that corresponds visually on x-ray to how the implant is filling the bone area. Compared to using pressure, today’s standard for injecting liquids; our system which uses constant velocity, affords the ability advance, retract, rotate and cut the implant upon the pull of a handle and use of a  thumb button.  

 

CEOCFO: Where are you in the development and commercialization?

Mr. Kennedy: Already fully designed, the spine fracture implant is ready to take into final testing, validation and verification and then begin manufacturing. We plan to obtain a CE mark very early in 2016 and then launch in summer. The bone marrow lesion implant will require six months to complete. We already have determined the implant will consist of allograft beads flexibly tethered by a tested, cleared and clinically accepted suture. The fluent material used with the allograft implant will be bone marrow aspirate – from the patient. That aspirate contains stem cells that initiate and accelerate healing. Upon completion of that implant, we will be ready to begin the steps to gain regulatory clearance, both in the EU and the US.

 

CEOCFO: How have you decided what to work on first?

Mr. Kennedy: The two implants we are working on address a combined $3.0b market opportunity.  Because of the ability to address an unmet clinical need in the treatment of chronic subchondral bone marrow lesions and provide patients, physicians and payors with an all around winning scenario; we have selected the bone marrow lesion product to be our primary focus. However, we do see the spine fracture product as our first product to market.  Importantly that use will validate the functionality of our entire technology platform and should offer an ability to form early strategic partnerships that would benefit the entire enterprise.          

 

CEOCFO: What has been the reaction so far from the medical community or are they aware?

Mr. Kennedy: Candidly, we are often asked when the products and system will be available.  While our implants are appealing, the compelling characteristic physicians comment most about is our ability to simplify a procedure, making it consistent, reliable and reproducible. Pertaining to the BML implant, the ability to use a solid allograft bead and stem cell loaded fluent combination has every physician we have met, interested to use it.     

 

CEOCFO: What, if any downside could there be?

Mr. Kennedy: Clinically we really do not see any downsides to the implants nor delivery system.  Mainly because our implant materials are clinically proven, tested and cleared for use. However, delays in product development, regulatory clearances and resource limitations do have our attention.   

 

CEOCFO: How do you get around that?

Mr. Kennedy: We work with very experienced people, successful in developing and obtaining clearances for products in resource efficient environments. Equally, we have sought out global regulatory experts and obtained multiple viewpoints, guidance and advice. As President, I am constantly seeking appropriate relationships and resources.

 

CEOCFO: Would you tell us why this product is superior?

Mr. Kennedy: The essence of our innovation is the unique ability to make a solid flow like a liquid and simultaneously deliver a flowable material, without using pressure. This yields exceptional volumetric and directional control for the physician. Compared to any other treatment, we afford a far simpler procedure that creates dual benefits for the patient and physician through our unique mechanical and biological capabilities. Economically, we intend to invest in independent clinical research projects to demonstrate and validate cost reduction and cost prevention in direct association with our technical and clinical advantages.          

 

CEOCFO: That is exciting new ground!

Mr. Kennedy: Yes it is!  We serve two significant healthcare challenges in orthopedics, early stage osteoarthritis and osteoporosis with our two implants. Bone marrow lesions are often undetected until after damage has already occurred in the adjacent joint cartilage. If these lesions are detected earlier, our product has the ability to diminish the pain and heal the compromised bone. Quite possibly this could delay more invasive and much more costly procedures.  

 

CEOCFO: What changed in your focus along the way?

Mr. Kennedy: Initially the company was focused on design, development and IP creation. We had two preliminary inquiries about our main patent. However the as the main patent was in its final stages of work with the USPTO, the company decided it would commercialization the technology.  

 

CEOCFO: You are so near the end!

Mr. Kennedy: We are poised to take our two products to market during the next 18 months. The markets we address are large, growing and represent significant healthcare challenges. We believe our innovative technology will offer and yield physicians, patients and payors results that will be compelling, clinically relevant and economically sustainable.



 

“The essence of our innovation is the unique ability to make a solid flow like a liquid and simultaneously deliver a flowable material, without using pressure. This yields exceptional volumetric and directional control for the physician.”
- Don Kennedy


 

Element Orthopedics, Inc.

www.elementorthopedics.com

 

Contact:

Don Kennedy

952 500 3990

donkennedy@elementorthopedics.com


 

 



 

 


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