Bioventus Introduces New Products for Spine Surgery, Osteoarthritis at AAOS
ORLANDO – March 2, 2016 – Bioventus, a leader in orthobiologic solutions, today announced it will introduce several new products in booth #1851 at the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) March 1-5 in the Orange County Convention Center. These include GELSYN-3™, a three-injection, hyaluronic acid (HA) based product for pain relief associated with osteoarthritis (OA) of the knee. HA is a naturally occurring molecule that provides for lubrication and cushioning in a normal joint.
This week Bioventus will also introduce CellXtract™ a novel cell and bone marrow extraction tool; and SIGNAFUSE™ Bioactive Bonegraft Putty, which is comprised of a bi-phasic mineral composite combined with a patented bioactive glass and resorbable polymer carrier providing surgeons with exceptional handling properties.
“Bioventus is very pleased to introduce a full portfolio of bone grafting solutions backed by clinical and technical data to benefit patients, surgeons, and hospitals this week at AAOS,” said Tony Bihl, CEO, Bioventus. “We are also excited to speak with attendees about GELSYN-3, our newest HA as well as the rest of our active healing therapies product portfolio. It’s our goal to provide customers with leading orthobiologic products that heal patients quickly and safely while helping them resume and enjoy active lives.”
Also on display in the Bioventus booth will be EXOGEN® Ultrasound Bone Healing System – indicated for the treatment of established non-unions and indicated fresh fractures; SUPARTZ FX® – a five-injection HA for treatment of pain in the knee due to OA; DUROLANE® – a single-injection stabilized HA based upon a natural, safe and proven technology called NASHA®, and indicated for the treatment of mild to moderate OA pain in a variety of joints; OsteoAMP® Allogeneic Morphogenetic Proteins – a uniquely processed allograft bone graft substitute and a suite of additional synthetic and allograft bone graft solutions added with the recent BioStructures acquisition.
About Bioventus
Bioventus LLC is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.
For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal
Bioventus, the Bioventus logo, EXOGEN and OsteoAMP are registered trademarks and GELSYN-3, CellXtract and SIGNAFUSE are trademarks of Bioventus LLC. SUPARTZ FX is a registered trademark of Seikagaku Corp. DUROLANE and NASHA are registered trademarks of Galderma S.A.
Summary of Indications for Use
The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at www.exogen.com or by calling customer service at 1-800-836-4080. A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found at www.SupartzFX.com or by contacting customer service at 800-836-4080.
DUROLANE (3ml)-Europe: Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers and toes. DUROLANE SJ (1ml)-Europe: Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers and toes. Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3 months of the procedure. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site. Clinical effectiveness has been demonstrated out to 6 months but results may vary depending on various patient factors. DUROLANE is not approved for sale in the United States. Indications presented are those approved in the European Union; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest.
OsteoAMP may be used in situations where an autograft is appropriate, such as spinal fusion procedures. It should be restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects. Please see OsteoAMP instructions for use for complete list of contraindications, warnings, and precautions. Full prescribing information can be found in product labeling by contacting customer service at 1-800-836-4080. It is available in the US only.
SIGNAFUSE is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). SIGNAFUSE can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process. Full prescribing information can be found in product labeling by contacting customer service at 1-949-553-1717. It is available in the US only.
CellXtract is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. Full prescribing information can be found in product labeling by contacting customer service at 1-800-836-4080.
GELSYN-3 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). GELSYN-3 is not to be administered to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations and should not be injected into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site.
