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Industry        Surgeon

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Trauma Market Focuses on New Solutions, Shifts in Care Delivery - Page 2

Posted in Research to Reality | Nov 2015 | Comments (0)

Tags: medical device developmentfracturemedical device innovationambulatory surgery centersdesign & developmentbundled paymentepisode of care

ORTHOPRENEUR: What recent products have you launched or developed in response to surgeons’ requests?

Avila: Our company is founded on an orthopaedic implant that’s designed to be minimally invasive. It’s a deflated balloon that fits into the intramedullary canal, and then infused with monomer and cured in place. Our solution is one that doesn’t require any additional patient trauma. To treat a fracture, we go in through a small incision and introduce the implant. It’s customized to the patient, then cures and provides immediate stability versus having to dissect soft tissue and muscle. We don’t move nerves and tendons around.

That’s the only product we have right now. We have different versions that fit different bone fracture locations, but it’s the same product. We’re currently in U.S. clinical trials to get approval to sell in the U.S. Our goal is to get through clinical trials and commercialize in the U.S. in 2017.

Dickson: We’re developing our complete line of trauma screws. We are going to come out with some headed and snap off screws with a wide range of sizes, which will be added to our line of headless screws. These products, as well as others will be available in the near future with our surface modification nanotechnology. We believe this technology will prevent infections of biofilm attaching to a foreign body. You’re not going to have another foreign body attaching to a foreign body that’s already implanted – it is difficult to fight an infection that’s already attached to a foreign body that’s already in your body.

Duffy: Our surgeons are requesting high quality implants at a reduced cost. In addition to our standard $15 3.5mm cortex screw, our most requested product is our $90 cannulated screw. Our aggressive pricing allows us to bring our $90 cannulated screw to the marketplace; it has been proven to fundamentally reduce the cost to care providers anywhere from 30 to 80 percent. The result allows the ASC/hospital to keep overhead much lower than their competition while still offering high quality products – a win/win for the patient, surgeon and facility.

Matityahu: Hip fracture is the most common fracture that is surgically treated in the world. The nails to treat this are static Cephalomedullary nails. These nails can fail ten to 20 percent of the time. That is more than 10,000 cases per year. A lag screw goes through a cannulated rod, up into the femoral head, then fixes the fracture. Realigning the bone into an anatomical location out of varus and placing the lag screw that goes up in the femoral head in the right position are the most important things you need to do to have a successful outcome. No implant, to date, has the ability to help the surgeon as an implant and a reduction tool. In 2007, we conceived the idea to solve these two problems. We designed a variable angle nail (VAN) implant that does two things. First, the surgeon can place the screw in the femoral head and dial in exactly where that screw needs to be without the implant constraining him/her. Secondly, the VAN is an implant and a reduction device. The surgeon can insert the implant into the femur and if the bone is not exactly where you want it to be, it takes three seconds to move the bone to the correct position.

It’s FDA cleared, but not on the market yet. It will be on the market in1Q16.

This product is the first of its kind. It is a smarter implant that we think is going to be differentiating because the majority of implants in our space are “me-too” products. They have little bells and whistles that are different from manufacturer to manufacturer, but basically they’re all the same.



Patrick Sweeney, M.D., Owner and CEO of Flow-FX, weighed in on the emergence of orthobiologics in the fracture repair market. His insight follows.

“I think the future is clearly centered on the increasing sophistication of biologics and their delivery.

“Most fixation concerns have been addressed by many brilliant doctors and engineers over the last 70 years. The bulk of remaining orthopaedic trauma concerns focus on osteoporosis, chronic infections, complex fractures and non-unions. We believe that the delivery of biologics, stem cell products, antibiotics and pain medication through implants is the most efficacious way to address these issues.

“Toward that goal, our first 510(k) cleared products, the Flow-Nail and Flow-Screw, are indicated for delivery of certain bone void fillers in addition to their primary function as fixation devices. In the near future, we plan to fund research regarding intraosseous delivery of antibiotics to chronic infections, as well as growth factor micro infusion to non-unions through our patented implants.”


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