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Fixes 4 Kids, Inc. will launch its E-Fix Supracondylar Humerus Fracture Reduction and Pinning System (E-Fix) and E-Thotic perioperative orthosis (E-Thotic), the first system designed to treat supracondylar (distal humerus) fractures in children, at the upcoming American Academy of Orthopedic Surgeons (AAOS) Annual Meeting in March in Chicago, Ill.

“Supracondylar fractures, commonly known as a broken elbow, are the most common fracture in children ages three to 12 years old,” said Kurt Vedder, President, CEO and Founder of Fixes 4 Kids. “Approximately 65,000 children in the United States each year are treated for supracondylar fractures. The E-Fix eliminates the current treatment procedure of pulling on a child’s arm when managing complex fractures, which may lead to misalignment and revision procedures.”

The E-Fix device provides six degrees of freedom in three planes of motion to allow for precise alignment of the fracture. A specially designed pin guidance system allows the surgeon to pin the fractured bone fragment with more control and precision than standard freehand pinning techniques. The E-Thotic, a highly functional and custom orthosis, is used in conjunction with the E-Fix. It supports the upper arm and forearm during the procedure and replaces a traditional cast used to immobilize the arm after reduction.

“The Fixes 4 Kids fracture reduction and pinning system allows the surgeon to provide a consistent and precise reduction for this type of fracture,” said Dr. Mohammad Diab, Chief of Pediatric Orthopedics at University of California, San Francisco. “The E-Fix and E-Thotic will change the way orthopedists treat elbow supracondylar fractures.”

The current approach to treating supracondylar fractures involves a process called manual reduction; forceful manipulation of the arm to bring together two broken pieces of bone. This technique carries inherent risks, including impingement of the neurovascular structure (blood vessels and nerves) and possible damage to collateral tissues. The E-Fix system is designed to minimize such risks and reduces further complications such as Cubitus Varus (gunstock elbow), a condition caused by malunion of the broken fragments.

Rich Ferrari, General Partner of De Novo Ventures (Menlo Park, Calif.), said, “Fixes 4 Kids has developed novel technology to replace a traditional surgical procedure that has not changed in 50 years. Surgeons will see the value in not only standardizing how fractures are repaired by using the E-Fix jig, but also in adopting an entirely new method to replace the archaic procedure of casting to immobilize the arm.”

Mizuho OSI, based in Union City, Calif., a leading orthopedic surgical device manufacturer and distributor, will distribute the E-Fix and E-Thotic worldwide. As part of the distribution arrangement, Mizuho OSI has also invested in Fixes 4 Kids.

“We are pleased to be partnering with Mizuho OSI to bring this innovative and valuable technology to the market,” Vedder said. “Mizuho OSI has a reputation for delivering the best-in-class products and services. With Mizuho OSI as a partner we intend make the E-Fix and E-Thotic products the standard-of-care for the medical community and within the pediatric orthopedic industry in general.”

Steve Lamb, President and COO of Mizuho OSI, Inc., stated, “We are very excited to partner with Fixes 4 Kids and distribute the E-Fix and E-Thotic to the orthopedic industry. We feel these products will bring innovation and standardization to the current treatment methods for supracondylar humerus fractures. Both the E-Fix and the E-Thotic are real game-changers that will definitely enhance patient outcomes.”

Vedder teamed with renowned medical innovators, surgeons and engineers to develop the E-Fix and E-Thotic. The company has also assembled a strong surgeon advisory board with many highly recognized members of the orthopedic community. Vedder added, “The industry has been primarily focused on adults. Fixes 4 Kids represents a new opportunity to focus on the niche pediatric segment of the orthopedic sector.”

Fixes 4 Kids was represented by Gravitas Healthcare, LLC.

About Fixes 4 Kids

Fixes 4 Kids Inc. is developing a family of innovative products to address a range of complex pediatric orthopedic fractures. These solutions seek to improve clinical outcomes while reducing cost, procedure risk and time. The E-Fix/E-Thotic, designed for treating supracondylar fractures, are the first products in the family to be commercialized.

For more information, visit www.fixes4kids.com.

About Mizuho OSI

Mizuho OSI was founded in 1978 as Orthopedics Systems, Inc., and is now a subsidiary of the Mizuho Ikakogyo Co., Ltd., in Tokyo, Japan. Mizuho Ikakogyo was founded in 1919 and is the leading general surgical table manufacturer in Japan and Asia. Mizuho OSI is the leading orthopedic and spinal surgical table manufacturer worldwide. Mizuho OSI’s products are sold in the U.S. through direct sales representative and worldwide through authorized international distributors.

For more information, visit www.mizuhosi.com.