PR Newswire04.30.20
BONESUPPORT, an emerging leader in orthobiologics for the management of bone injuries, has announced a change in its leadership team that will take place June 1. Michael Roth will become the company's general manager and executive vice president of Commercial Operations, North America. Roth has more than 20 years of experience within the orthopedic sector with both direct and distributor-based sales management. He has a solid leadership experience from both sales and marketing and from small as well as large companies, amongst them Wright Medical Technology, Microport Orthopedics, and Howmedica.
"Michael Roth is the leader we need on the American market in order to take BONESUPPORT to the next level. His experience together with his leadership and capability to develop high performing, dynamic teams will be a contributing factor to our continued success on the important U.S. market and with the coming launch of CERAMENT G," said Emil Billbäck, CEO at BONESUPPORT.
Roth's appointment comes just two weeks after the company submitted a de novo application to the U.S. Food and Drug Administration (FDA) to obtain market approval for the company's antibiotic-releasing product CERAMENT G. The application is specified for the indication osteomyelitis (bone infection) and can potentially result in an approval at the latter end of 2020.
New preclinical data1 has been published that support BONESUPPORT's ambition to develop a combination product of the company's platform technology CERAMENT and bisphosphonate, a pharmaceutical that counteracts osteoporosis.
In a pre-clinical long-term study D.B. Raina et al. investigated different bone active pharmaceutical combinations in order to enhance long-term bone formation in the femoral neck of osteoporotic rats. Bone formation was measured six months after local treatment and showed that CERAMENT as a carrier of bisphosphonate indicated significantly higher bone volumes than the other treatment groups.
The evidence from this long-term study validates and confirms that local delivery of a bisphosphonate in combination with CERAMENT can regenerate cancellous bone in the femoral neck canal and has clear implications for enhancing implant integration and fixation in fragile bone. Osteoporosis often leads to fragility fractures of the hip resulting in impaired quality of life and increased mortality. Augmenting the proximal femur could be an attractive treatment option to decrease the risk of fracture fixation failure and reoperation.
"The long-term preclinical results of D.B. Raina et al. confirm our previous decision to focus our research efforts on developing a combination product of CERAMENT and bisphosphonate, that could potentially reduce the risk of fracture related complications and thereby improve and prolong the lives of patients suffering from hip fractures," said Billbäck.
Reference
1 Long Term Response to a Bioactive Biphasic Biomaterial in the Femoral Neck of Osteoporotic Rats was published in Tissue Eng Part A. 2020 Apr 3.
"Michael Roth is the leader we need on the American market in order to take BONESUPPORT to the next level. His experience together with his leadership and capability to develop high performing, dynamic teams will be a contributing factor to our continued success on the important U.S. market and with the coming launch of CERAMENT G," said Emil Billbäck, CEO at BONESUPPORT.
Roth's appointment comes just two weeks after the company submitted a de novo application to the U.S. Food and Drug Administration (FDA) to obtain market approval for the company's antibiotic-releasing product CERAMENT G. The application is specified for the indication osteomyelitis (bone infection) and can potentially result in an approval at the latter end of 2020.
New preclinical data1 has been published that support BONESUPPORT's ambition to develop a combination product of the company's platform technology CERAMENT and bisphosphonate, a pharmaceutical that counteracts osteoporosis.
In a pre-clinical long-term study D.B. Raina et al. investigated different bone active pharmaceutical combinations in order to enhance long-term bone formation in the femoral neck of osteoporotic rats. Bone formation was measured six months after local treatment and showed that CERAMENT as a carrier of bisphosphonate indicated significantly higher bone volumes than the other treatment groups.
The evidence from this long-term study validates and confirms that local delivery of a bisphosphonate in combination with CERAMENT can regenerate cancellous bone in the femoral neck canal and has clear implications for enhancing implant integration and fixation in fragile bone. Osteoporosis often leads to fragility fractures of the hip resulting in impaired quality of life and increased mortality. Augmenting the proximal femur could be an attractive treatment option to decrease the risk of fracture fixation failure and reoperation.
"The long-term preclinical results of D.B. Raina et al. confirm our previous decision to focus our research efforts on developing a combination product of CERAMENT and bisphosphonate, that could potentially reduce the risk of fracture related complications and thereby improve and prolong the lives of patients suffering from hip fractures," said Billbäck.
Reference
1 Long Term Response to a Bioactive Biphasic Biomaterial in the Femoral Neck of Osteoporotic Rats was published in Tissue Eng Part A. 2020 Apr 3.