OrthoPediatrics Corp.

OrthoPediatrics (NSDQ:KIDS) today said it received FDA 510(k) clearance and launched its first sterile-packed implants for the Pediatric Nailing Platform Femur.

The system is designed for use in pediatric patients to address femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions, malunions and fixation of femurs that have been prepared for deformity correction.

“The introduction of sterile implants represents an important addition to our portfolio of sterile implant offerings,” VP of trauma and deformity correction Joe Hauser said in a news release. “We are committed to adding sterile implants to the systems that can provide real value to our customers. We are strategically aligned with our customers to decrease the overall footprint of all our systems while balancing and ensuring intraoperative efficiency.”

OrthoPediatrics’…

OrthoPediatrics (NSDQ:KIDS) announced earlier this week that it commenced an underwritten public offering of its common stock.

The Warsaw, Ind.-based pediatric orthopedics company intends to grant underwriters a 30-day option to purchase additional shares of common stock at the public offering price. According to a news release, there is no assurance as to whether or not the offering may be completed, or the actual size or terms of the offering.

OrthoPediatrics said it intends to use the net proceeds to invest in implant and instrument sets for consignment to its customers, to fund research and development activities and to expand its sales and marketing programs, along with working capital and other general corporate purposes.

Piper Sandler and Stifel are acting as joint book-running managers of the proposed offering.

OrthoPediatrics this week said it launched its ApiFix spinal deformity correction system in the U.S.

The ApiFix Minimally Invasive Deformity Correction (MID-C) system is a posterior dynamic deformity correction system for use in adolescent idiopathic scoliosis (AIS) patients. It is approved for use in adolescents with Lenke type 1 and Lenke type 5 curves of 40° to 60° and acts as an internal brace that is implanted unilaterally on the concave aspect of the curvature.

“ApiFix’s novel approach to correcting spinal deformity is a welcome medical advancement that has the ability to disrupt the continuum of care for scoliosis treatment in certain pediatric patients. Its elegant design and biomechanical considerations combined with the simplistic posterior approach is unmatched and provides superior technology for treating AIS. Now that the pause of elective surgeries due to COVID-19 is lifting, we look forward to initiating the commercial availability of the procedu…