Startup wins an FDA clearance for a 3D-Printed Digital Fusion Implant

Startup wins an FDA clearance for a 3D-Printed Digital Fusion Implant

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510(k) Clearance of 3D-Printed Digital Fusion Implant (press release)
website… http://www.additiveortho.com/
Additive Orthopaedics, LLC, an early stage orthopedic device company, has received FDA 510(k) clearance for its 3D-printed titanium digital fusion implant, to address the over 1.1 million U.S. fusion procedures annually.
“Additive manufacturing allows us to develop complex geometries at reasonable manufacturing costs not possible before now with traditional manufacturing,” said Greg Kowalczyk, president and founder of Additive Orthopaedics. “Design teams really need to think outside the box when considering this innovative manufacturing process. And where better to do that then the global U.S. extremity market valued at $1.3 billion and growing at over 10 percent per year. We are confident that the market will respond well to this, our patient specific products in development, and our other devices currently being reviewed by the FDA.”
According to Dr. Selene Parekh, professor of surgery in the Department of Orthopaedic Surgery at Duke Orthopaedics and North Carolina Orthopaedic Clinic, “3D printing has a major role in the future of orthopedics. In today’s cost sensitive healthcare environment, 3D printing allows us to bring highly complex, lower cost technologies to the market very quickly, with patient specific features that will potentially improve patient outcomes.”
Additive Orthopaedics has closed its initial seed rounds and recently announced the start of its second round of financing.
 

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Priceline for orthopedics is here – patients can now put their joint surgery out to bid

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MEDIBID ALLOWS DOCTORS TO BID ON SURGERIES (Orthopedics This Week)
website… https://www.medibid.com/
MediBid, Inc. is a start-up company that allows patients to describe the procedure they want done and put it out for doctors to bid on. “Our mission is to give better quality health care at a better price with more choice and more access,” says Ralph Weber, a Katy, Texas, businessman and CEO of MediBid. According to investigative reporter Bill Spencer, doctors from all over the country (and even the world) can bid on the job, giving the patient the best price for that particular procedure.
Weber claims that patient customers, by putting their surgical needs out for bid, can save from 35% to 75% on most procedures. “And,” he said, “each bid comes with a rating on that doctor and a brief history of his work.” Among the most common surgeries advertised for are hip and knee replacements.
Spencer explains that to use MediBid, a customer logs onto the website, registers his name, writes a brief history of the medical condition he wants treated and asks for bids. MediBid claims that doctors from all over the country bid on the job, giving the patient their price for that particular procedure. MediBid charges its customers $50 for each inquiry put out for bid.
Spencer tells the story of Perry Hunt, a 53-year-old construction consultant, who needed a hip replacement. Perry had health insurance but his insurance company, for some reason, refused to pay for the surgery he needed, and the out-of-pocket cost was going to be over $100,000. “I went on the MediBid website” Hunt said, “and I ended up finding a fantastic doctor in San Antonio, one of the best in the country, and I paid just $21,000.”
Another case was Regina Warner, an administrative court clerk in Dallas, who needed gallbladder surgery. Even with health insurance her out-of-pocket expenses for the deductible and the co-pay were going to top $10,000. Then she found out her company had a contract with MediBid.
She went on the MediBid website and found a doctor in Nacogdoches who charged her $4,600 for the surgery. Warner’s health insurance paid the bill and she walked away without paying anything. Instead, Spencer reports that Warner was paid $1,000 for travel expenses.

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Nextremity's 2-piece hammertoe implant is shown to improve fusion rates

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84% FUSION RATE VS 16% – NEW JFAS HAMMERTOE STUDY (Orthopedics This Week)
A new study published in The Journal of Foot and Ankle Surgery, “Dual-Component Intramedullary Implant Versus Kirchner Wire for Proximal Interphalangeal Joint Fusion: A Randomized Controlled Clinical Trial,” compared using the Nextra implant to K-wires. Nextra crushed K-wires in terms of fusion rates.
The study, which was a randomized treatment group vs control group trial, found clear advantages to the Nextra Hammertoe Correction System to treat hammertoe deformity. K-wires are considered to be the traditional treatment for Hammertoe correction.
Nextra is a two-piece implant developed by Nextremity Solutions, Inc., located in Warsaw, Indiana. In the study it achieved a five times higher rate of bone fusion than did the K-wires—84% fusion rate with Nextra versus 16% with K-wires.
Mike Coon, Executive Director of Sales & Marketing for Nextremity Solutions, Inc., said, “Some of the issues with the utilization of K-wires in hammertoe surgery are a lack of fusion, lack of rotational stability, risk of infection with post-operative K-Wire exposure, and poor patient satisfaction. According to the study, patients with the Nextra implant not only had drastic improvements in fusion rates but also experienced greater pain relief, a decrease in disability and an increase in activity levels.”

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VIDEO: Spare The Scalpel: A Surgeon's Perspective on the Future of Orthopedics

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Spare The Scalpel: A Surgeon’s Perspective on the Future of Orthopedic Medicine (A TEDx Talk)
Watch the TED talk here…  https://youtu.be/CQ7vYksUiVU
Dr. Brian Cole from Midwest Orthopaedics at Rush discusses the evolution of orthopedic/sports medicine and the role of regenerative medicine and medical technology…past, present and future. Presented on April 30, 2016 at the TEDxRushU Event, Rush University Medical Center.
TED is an annual event where innovative, interesting, and motivated individuals are invited to share their insights and passions. TED stands for Technology, Entertainment, Design — three broad subject areas that are collectively shaping our future. Attendees have called it “the ultimate brain spa” and a “journey into the future.”
Brian J. Cole, MD, MBA, is a Professor in the Department of Orthopedics with an appointment in the Department of Anatomy and Cell Biology at Rush University Medical Center in Chicago, Illinois; Chairman of Surgery at Rush Oak Park Hospital and head of the world’s most active Cartilage Research and Restoration Center specializing in alternatives to joint replacement for arthritis. A team physician for the Chicago Bulls, Chicago White Sox and DePaul University.
www.briancolemd.com

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DePuy Synthes joins forces with HP for the future of 3D Printing

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J&J AND HP TEAM UP 3D PRINTING FOR ORTHO (Orthopedics This Week)
The biggest health care and printer companies in the world are now collaborating to create new 3D medical devices and other health care solutions.
On May 17, 2016, Johnson & Johnson, parent company of DePuy Synthes, and HP Inc. announced the collaboration to develop 3D printing technologies to “create better health care outcomes at reduced costs. Working together, the companies plan to combine their scientific, clinical, material science and technological expertise, and deep insights to develop products and solutions which can be manufactured quickly and customized to the needs of an individual patient or consumer,” stated the announcement.
The collaboration is focusing on personalization of instrumentation and software for patient-specific healthcare devices. The two companies anticipate that 3D printing technology will lead to innovation in areas such as orthopedics, eye health and consumer products, among others.
Sandra Peterson, Group Worldwide Chairman, Johnson & Johnson, said, “The intersection of technology and health care is spurring innovation that will have a profound impact on patients and consumers all over the world. Combined with advances in data mining and software, 3D printing could enable distributed manufacturing models and patient-specific products, therapies and solutions that deliver better outcomes, better economics and improved global accessibility. This collaboration with HP Inc. exemplifies our commitment to harnessing new technology to improve outcomes and reduce costs across the health continuum.”
Stephen Nigro, president of HP’s 3D printing business, said, “Advances in 3D printing technology have the potential to break historical paradigms of health care delivery in ways that are not feasible in traditional manufacturing processes. Together with Johnson & Johnson we have the potential to create opportunities and innovations in health care to improve patients’ lives that neither company could develop alone.”
U.S., Europe and China
A group of 3D printing-based patient-specific osteotomy instruments, orthopedic implants, and dental implants have been cleared by the FDA and CE marked in Europe for clinical use. According to a 2015 article in The Annals of Translational Medicine, orthopedics in China does not lag behind the U.S. and Europe in terms of patient number, operation volume, and surgical skills. “However, continued the article, “the Western countries have much advanced orthopedic devices, in particular the implants, than China. The 3D printing technology may provide a chance for the Chinese orthopedists and technicians to independently develop innovative medical devices to catch up with their Western counterparts.”

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