Orthofix Archives - Page 5 of 5 - Medical Design Sourcing

Orthofix launches Fitbone limb lengthening system

[Image from Orthofix]Orthofix (NSDQ:OFIX) today said it launched its Fitbone intramedullary lengthening system in the U.S. and Europe.

The system is designed for limb lengthening and deformity correction of the femur and tibia bones. The lengthening nail is a fully implantable system for correcting leg length and deformity discrepancies.

“Orthofix is the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction and deformity correction,” president of global extremities Paul Gonsalves said in a news release. “We are pleased to now be able to broaden access to the Fitbone system by expanding availability in the U.S. and Europe, giving surgeons a choice in treating patients in need of deformity correction and limb lengthening.”

Fitbone is implanted through a minimally invasive procedure that consists of an implanted intramedullary nail, a subcutaneously implanted receiver and an exter…

Orthofix names new global extremities president

Orthofix (NSDQ:OFIX) announced that it appointed Paul Gonsalves as the president of its global extremities business.

Gonsalves joins Lewisville, Texas-based Orthofix after previously serving as chief commercial officer at Integra LifeSciences (NSDQ:IART). He also served as senior VP of enterprise sales and corporate marketing at the medtech company.

Before his roles at Integra, Gonsalves served as senior VP and chief transformation officer with AccentCare and held the role of VP and GM of primary care at Novartis (NYSE:NVS), among a series of other roles including a handful at General Electric Healthcare (NYSE:GE).

In his new role, Gonsalves will also serve on the company’s executive leadership team while reporting to Orthofix president and CEO Jon Serbousek.

“Paul brings to Orthofix more than 30 years of industry experience and proven leadership that will both complement and strengthen our exceptional extremities management team,” Serbousek…

MedTech 100 roundup: Another high as stocks tick up

For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from the 89.01-point total at the same time a week prior (July 31).

On Aug. 5, the index reached 90.45 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.37) coming last week.

The most recent high mark represents just a -2% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 2.5% increase from July 31 to Aug. 7, and the Dow Jones Index fared even better, positng a 3.8% rise over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13…

Orthofix down on Street-beating Q2 results

Orthofix (NSDQ:OFIX) posted second-quarter results today that beat the consensus on Wall Street.

The Lewisville, Texas-based company reported losses of -$18.4 million, or -96¢ per share, on sales of $73.1 million for the three months ended June 30, for a sales loss of -36.8% compared with Q2 2019.

Adjusted to exclude one-time items, earnings per share were -59¢, 49¢ ahead of The Street, where analysts were looking for sales of $50.7 million.

“Despite the significant impact of COVID-19 in the second quarter, we continued to execute successfully against our strategic initiatives,” president and CEO Jon Serbousek said in a news release. In particular, with the regulatory clearances of the Firebird SI Fusion System and the JuniOrtho Plating System, we believe we are making progress in creating a high-velocity new product innovation program.”

“After reaching a low point in April, revenues rebounded sequentially in both May and June in large part due to…

Orthofix wins FDA clearance for pediatric plating system

(Image courtesy of Orthofix)

Orthofix (NSDQ:OFIX) today said it received FDA clearance and CE Mark approval for its JuniOrtho plating system.

The device is designed specifically for pediatric patients and is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.

“The field of deformity correction is rapidly evolving with multiple technical and technological advances every year,” said Philip McClure, an orthopedic surgeon at the International Center for Limb Lengthening in Baltimore. “External fixators are an incredibly powerful tool in caring for deformities in children around the world. Improved designs of internal fixation devices have allowed us to provide complimentary options to external fixators to benefit our patients and their families. Our goal is to obtain the best possible outcome so children can enjoy their lives after deformity correction…

Orthofix wins FDA clearance for pediatric plating system

(Image courtesy of Orthofix)

Orthofix (NSDQ:OFIX) today said it received FDA clearance and CE Mark approval for its JuniOrtho plating system.

The device is designed specifically for pediatric patients and is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.

“The field of deformity correction is rapidly evolving with multiple technical and technological advances every year,” said Philip McClure, an orthopedic surgeon at the International Center for Limb Lengthening in Baltimore. “External fixators are an incredibly powerful tool in caring for deformities in children around the world. Improved designs of internal fixation devices have allowed us to provide complimentary options to external fixators to benefit our patients and their families. Our goal is to obtain the best possible outcome so children can enjoy their lives after deformity correction…

FDA clears Orthofix Firebird SI fusion system

Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium bone screw.

Lewisville, Texas-based Orthofix touts its Firebird SI as the first 3D-printed titanium bone screw to launch in the U.S. for treating sacroiliac (SI) joint dysfunction. The fusion system is designed to both compress and stabilize the SI joint, according to a news release.

The Firebird SI includes a porous mid-shaft region designed to allow bone to grow into its surface, creating a bond between the implant and the patient’s bone at the SI joint. With a cannulated screw design, surgeons can pack the device with autografts and/or allografts with viable cells to help ensure bone fusion.

Screws for the system are available at a variety of lengths and diameters and are implanted through a minimally invasive surgery that takes about one hour and may lead to less time at the hospital with faster recovery, Orthofix said.

The …