Bioventus Reaches Milestone with 2 Million DUROLANE® Treatments Worldwide

DURHAM, NC – September 22, 2020 – Bioventus, a global leader in Innovations For Active Healing, is celebrating a milestone and recognizing more than 2 million treatments worldwide with DUROLANE, its single-injection, hyaluronic acid (HA) product used in the treatment of pain associated with osteoarthritis (OA). DUROLANE is the original single injection hyaluronic acid therapy, has helped patients in nearly 30 countries and is a trusted therapy for clinicians in the management of OA.

Proven safe and effective, DUROLANE has more clinical studies than any other US single-injection HA, and has also been proven to provide greater reduction in OA knee pain versus Synvisc-One®.1,2 It has longer lasting pain relief versus a steroid injection, is safe and repeated use of DUROLANE does not increase the incidence of adverse events.3,4 

DUROLANE is available in its original 3ml syringe for treatment of large joints and in a 1ml syringe, known as DUROLANE SJ, to enable treatment of small joints.* Both are produced using a natural, safe and proven technology called NASHA®. This process yields a high molecular weight stabilized HA, which is a naturally occurring molecule that provides lubrication and cushioning in a normal joint.

“The US launch of DUROLANE in 2018 boosted our growth to more than 2 million treatments and we are very proud of this milestone. Still, there are many more patients to reach,” said John Nosenzo, Chief Commercial Officer, Bioventus. “In the US, more than 14 million people are afflicted with knee OA and osteoarthritis overall affects more than 240 million globally.5,6 Returning people to active lifestyles is our commitment to the market and we are pleased that DUROLANE is serving the needs of clinicians and the OA patients they treat.”

About Bioventus
Bioventus 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. The Innovations For Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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.bioventus.com and follow the company on LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

*DUROLANE SJ is not available in the US.

Summary of Indication for Use: DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. Do not inject DUROLANE in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Full prescribing information can be found in product labeling, at www.DUROLANE.com, or by contacting Bioventus Customer Service at 1-800-836-4080.

NOTE: The above indications presented are for the US market; indications may vary by country. Contact your local Bioventus representative or visit www.durolane.com/uk/selection for prescribing information specific to your market.

  1. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 2. DOF RPT-001111 3. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 4. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017. 5. Arthritis Foundation. What is osteoarthritis? Accessed February 9, 2019. www.arthritis.org/about-arthritis/types/osteoarthritis/what-is-osteoarthritis.php 6. Hawker GA. Osteoarthritis is a serious disease. Clin Exp Rheumatol. 2019;37 Suppl 120(5):3-6.

Bioventus Reports First Use of its SIGNAFUSE Bioactive Bone Graft in Strip Format

DURHAM, NC – September 2, 2020 – Bioventus is sharing results of the first in-patient use of its new SIGNAFUSE Bioactive Bone Graft strips. Rick Placide, M.D. of VCU Health in Richmond, VA, performed a posterolateral lumbar fusion (PLF) and placed the SIGNAFUSE strips in the posterolateral gutters of the patient’s spine.

“Since the recent release of the SIGNAFUSE strip, we have used it as a bone graft extender in several cases and found it easy to use,” remarked Dr. Placide. “We have already been impressed by its ability to absorb bone marrow aspirate while maintaining its form, flexibility and toughness. These properties make SIGNAFUSE strips ideal for a variety of cases, including spanning large defects. We look forward to following the clinical outcomes.”

SIGNAFUSE strips were designed with the patient in mind. They come in multiple sizes ranging from 25 to 200 millimeters in length, allowing utilization over multiple levels like we saw in Dr. Placide’s deformity application case,” said Lawrence Boyd PhD, Vice President, Product Development, Bioventus. “There are benefits for the surgeon as well: these strips hydrate rapidly and provide exceptional handling properties for intraoperative flexibility.”

100mm-SIGNAFUSE-Strips-used-on-each-side-of-a-4-level-posterolateral-lumbar-fusion.

The new strip format of SIGNAFUSE is available now from Bioventus distributors nationwide.

About Bioventus

Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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.bioventus.com and follow the company on LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus, the Bioventus logo and SIGNAFUSE are registered trademarks of Bioventus LLC.

Summary of Indications for Use
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.


Bioventus Appoints Katrina Church Chief Compliance Officer

DURHAM, NC – August 24, 2020 – Bioventus, a global leader in orthobiologic solutions, has appointed Katrina Church as its Chief Compliance Officer, effective August 24, 2020. Church brings more than 20 years of experience counseling public and private companies to ensure the highest compliance with industry standards, reporting and controls. She will be responsible for all ethics and compliance functions at Bioventus, joins the company’s executive leadership team and will report directly to its CEO Ken Reali.

“I am very pleased to welcome Katrina as our new Chief Compliance Officer,” said Reali. “High ethics and compliance standards are paramount to our success and also important to our culture at Bioventus. I expect Katrina to build on the great foundation we have at this company as we continue to expand and grow to meet the needs of patients, physicians and payers.”

Church joins Bioventus after nearly 11 years with the Merz Group of companies where she served in several corporate counsel and compliance roles, most recently as Global Compliance Officer for Merz Pharma GmbH & Co KGaA. In 2020, Church was nominated for several industry awards for compliance training, and won the 2020 Women in Compliance Award for “Most Impactful Compliance Training Programme of the Year.”

Prior to Merz, Church served as a legal consultant to Stiefel Laboratories and in general counsel and corporate counsel roles with Connetics Corporation and VISX, Inc. She began her career as an attorney at Hopkins & Carley, a San Jose-based law firm. Church received her Juris Doctor from New York University School of Law and an AB magna cum laude from Duke University.

About Bioventus
Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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.bioventus.com and follow the company on LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.


Hyaluronic Acid Provides Knee OA Pain Relief with Lower Costs, Fewer Adverse Outcomes vs. Corticosteroids or Knee Arthroplasty

DURHAM, NC – August 13, 2020Intra-articular hyaluronic acid (IHA) knee osteoarthritis (OA) pain relief treatments had lower total medical care costs vs. patients treated with intra-articular corticosteroids (ICS) or total knee arthroplasty (TKA). This according to a retrospective study, published in Seminars in Arthritis and Rheumatism.

The study involved an analysis of an insurance claims database whose eligible members were diagnosed with knee OA, followed for a four-year observation period and allocated to three cohorts: patients who received IHA only, those who received ICS only, and those who received TKA only. The analysis also found that patients in the IHA cohort had fewer adverse outcomes vs. patients in the ICS and TKA cohorts and had lower use/costs of opioids and prescription analgesics vs. patients in the ICS and TKA cohorts.

“Knee osteoarthritis is a lead cause of chronic pain and disability that affects more than 14 million Americans1. The treatment options available to these patients are limited and many are associated with complications. We have long known that introducing HA treatments earlier in the continuum of care of knee OA patients provides pain relief and safely allows them to enjoy a more active lifestyle,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus.

“Now we know that with the efficacy and safety of HA treatments also come reduced total medical costs, fewer adverse events and a minimization of opioids and analgesics use. These findings should be very relevant to clinicians and payers working with these patients to improve treatment algorithms and minimize healthcare costs,” she added.

The study was funded by Bioventus and its authors include John Mackowiak, Ph.D., Center for Surgical Quality and Outcomes Research; John Jones, M.A., M.S., Bioventus; and Vinod Dasa, M.D., Louisiana State University.

To learn more this study, visit OAKneePainRelief.com/Healthcare-Provider/Haste/

About Bioventus

Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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 LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

  1. Deshpande BR, et al. Number of persons with symptomatic knee osteoarthritis in the US: impact of race and ethnicity, age, sex, and obesity. Arthritis Care Res 2016;68:1743-50

 


Bioventus Makes $15 Million Equity Investment in CartiHeal with an Agreed Option Structure to Acquire Company Upon Milestone Achievements

KFAR SABA, ISRAEL and DURHAM, NC– July 16, 2020CartiHeal, developer of the proprietary Agili™-C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints, has secured an additional $15 million equity investment from Bioventus, a global leader in orthobiologics. The investment follows the recently completed enrollment and outcome of interim analysis in CartilHeal’s investigational device exemption (IDE) multinational pivotal study. An additional $5 million can be secured by CartiHeal from Bioventus, if needed, for IDE study completion.

This new round of funding is expected to enable CartiHeal to complete all patient follow-up in the study and submit a first application for premarket approval (PMA) to the FDA. Bioventus made an initial $2.5 million investment in the Agili-C IDE study in January 2018, as part of a previous financing round.

Bioventus and CartiHeal have agreed on an option structure under which Bioventus will acquire the company shortly after FDA approval of the Agili-C implant. Terms of that option structure are not disclosed.

“We are pleased Bioventus continues to see value in the Agili-C implant and is making a greater investment to support the completion of the IDE study,” said Nir Altschuler, founder & CEO, CartiHeal. “We look forward to the work ahead and a successful application for PMA approval.”

“The successful enrollment and outcome at the interim analysis of CartiHeal’s pivotal study for Agili-C implant is an important milestone,” said Ken Reali, CEO, Bioventus. “It is a testament to the strength of its continuing development program and more importantly the future potential of the Agili-C technology in addressing the large unmet need in patients with joint surface lesions. This investment underscores our belief in the novel technology and we look forward to working with the team at CartiHeal in the years to come.”

Credit Suisse is acting as financial advisor to CartiHeal.

About CartiHeal
CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

About the Agili-C implant IDE multinational pivotal study
The trial’s objective is to demonstrate the superiority of the Agili-C implant over the surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both osteoarthritic knees and knees without degenerative changes. It includes more than 250 patients in centers in the US, Europe and Israel.

About Bioventus
Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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.bioventus.com and follow the company on LinkedIn and Twitter.

For Bioventus Contact: Thomas Hill, 919-474-6715, [email protected]

For CartiHeal Contact: [email protected]

Bioventus and the Bioventus logo are registered trademarks of Bioventus, LLC.


Bioventus Receives FDA Clearance of Strip Format of its SIGNAFUSE Bioactive Bone Graft

DURHAM, NC – June 25, 2020 – Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format. The strips consist of 55% bioglass by weight and have been shown to induce higher levels of osteoblast differentiation compared to other synthetic bone graft strips.1

SIGNAFUSE has been available as a putty since 2014; the new strips hydrate rapidly and provide exceptional handling properties for intraoperative flexibility.  They come in multiple sizes ranging from 25 to 200 millimeters in length, with the longer strips providing a great option for large, multilevel procedures.

The biphasic mineral in SIGNAFUSE is composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate; a ratio supported by multiple prospective2 and randomized controlled trials.3-5

“We are excited to expand our portfolio of bone graft solutions with the SIGNAFUSE Bioactive Bone Graft strip,” said Megan Osorio, Vice President, Marketing, Bioventus. “Apart from the ideal combination of biomaterials that contribute to healing, and best-in-class handling, this product is unique in that it offers a great solution for patients that require more significant interventions such as spinal deformity correction.”

“We also believe SIGNAFUSE in the strip format will provide efficiencies for the hospital, either by opening fewer packages or cost savings opportunities vs. alternative grafts,” added John Nosenzo, Chief Commercial Officer, Bioventus.

The new strip format of SIGNAFUSE will be available in Q3 from our distributor partners across the country.

About Bioventus

Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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.bioventus.com and follow the company on LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus, the Bioventus logo and SIGNAFUSE are registered trademarks of Bioventus LLC.

Summary of Indications for Use
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

  1. Data on file. RPT-000962. Osteoblast Differentiation Study. 2. Cavagna R, Daculsi G, Bouler JM. Macroporous calcium phosphate ceramic: a prospective study of 106 cases in lumbar spinal fusion. J Long-Term Effects Med Implants, 1999;9:403-12. 3. Ransford AO, Morley T, Edgar MA, et al. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br. 1998;80-B:13-8. doi: 10.1302/0301-620x.80b1.7276 4. Delécrin J, Takahashi S, Gouin F, Passuti N. A synthetic porous ceramic as a bone graft substitute in the surgical management of scoliosis: a prospective, randomized study. Spine (Phila Pa 1976). 2000;25(5):563-9. doi: 10.1097/00007632-200003010-00006 5. Pascal-Moussellard H, Catonné Y, Robert R, Daculsi G. Anterior cervical fusion with PEEK cages: clinical results of a prospective, comparative, multicenter and randomized study comparing iliac graft and a macroporous biphasic calcium phosphate. Spine J. 2006;6(suppl 5):136S. Abstract P109. doi: 10.1016/j.spinee.2006.06.318

Bioventus Selects Bazis NN as Distributor of DUROLANE in Russia

HOOFDDORP, THE NETHERLANDS – June 15, 2020 – Bioventus, a global leader in orthobiologic solutions, has selected Bazis NN as its authorized distributor for DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment. OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues.

According to official statistics, patients with OA make up one quarter of all patients with musculoskeletal system diseases and OA is detected in 4% of the entire adult population.1 Hyaluronic acid (HA)-based products like DUROLANE and DUROLANE SJ help manage pain in the knees, hips, wrists, elbows, ankles, finger and toe joints of patients with OA.

“We believe the OA market in Russia is underserved and the patients there will benefit greatly from DUROLANE,” said John Nosenzo, Chief Commercial Officer, Bioventus. “Bazis has a terrific track record in marketing and selling orthopaedic solutions in Russia and we are pleased they are helping Bioventus reach more patients and physicians with our proven pain reliever for osteoarthritis.”

“Bazis has been serving patients and physicians in Russia for more than 16 years,” said Aleksandr Alekseev, Director, Bazis NN. “We are excited to offer DUROLANE for knee and hip and DUROLANE SJ for small joints. Both are safe, single injection options for patients that provide powerful and long-lasting OA pain relief.”

DUROLANE and DUROLANE SJ are produced using a natural, safe and proven process called NASHA®. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. It has been proven to provide greater reduction in OA knee pain versus Synvisc-One®2* and longer lasting pain relief versus a steroid injection3. DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.4

About Bioventus

Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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 LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

Summary of Indication for Use: DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, and toes. DUROLANE SJ is also indicated for pain following joint arthroscopy in the presence of osteoarthritis within three 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 and breastfeeding women, and in children. Risks can include transient pain, swelling and/or stiffness at the injection site. Indications presented are those approved in Russia; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.durolane.com.(1mL / 3mL).

References: 1. Kabalyk M.A. Prevalence of Osteoarthritis in Russia: Regional Aspects of Trends in Statistical Parameters During 2011–2016 Rheumatology Science and Practice. 2018;56(4):416-422. (In Russ.) doi:10.14412/1995-4484-2018-416-422. 2. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 3. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 4. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2018.


Bioventus Announces Change in Chief Executive Officer, Ken Reali Appointed to Succeed Tony Bihl Who Will Retire

DURHAM, NC - March 25, 2020 – Tony Bihl, CEO of Bioventus, a global leader in orthobiologic solutions, is electing to retire on April 30, 2020. As a result, the Bioventus Board of Managers has unanimously appointed Ken Reali, former President and CEO of Clinical Innovations, LLC, to assume the role of CEO of Bioventus. Reali will also become a member of the Company’s Board of Managers, effective April 20, 2020.

Reali served as President and CEO of Clinical Innovations, a medical device company focused in woman’s healthcare, from June 2015 until its successful sale on February 12, 2020. He started his career at Biomet and worked at Stryker, Smith & Nephew and Baxano Surgical where he held positions of increasing responsibility, including CEO over the past ten years. Reali also worked within the Clinical Therapies business of Smith & Nephew over a decade ago which was later spun out to become Bioventus. He currently serves on the boards of Ossio Integrative Orthopedics, AdvaMed and AdvaMed Accel and is Chairman of the Ethics and Compliance Committee for AdvaMed.

“I am honored to have the opportunity to lead Bioventus,” said Reali. “The Company’s broad product portfolio, global presence and solid growth have it well positioned to serve the needs of patients and physicians. Even more successes lie ahead and I’m excited to work with the talented Bioventus team to drive strong value for all stakeholders.”

“Tony has been an outstanding CEO and Leader of Bioventus and we will miss him, though at the same time, the Board and I are pleased to welcome Ken Reali as the incoming CEO of Bioventus,” said William Hawkins, retired Chairman and CEO of Medtronic, Senior Advisor to EW Healthcare and Bioventus Board Chairman. “Ken’s experience in business development, driving top and bottom line growth while building a compliant culture, global product commercialization and sales of medical devices, combined with strong background in ethics and compliance, market analysis, experience as a CEO in both public and private companies is just the right fit to lead Bioventus.”

“Today I feel great satisfaction with the progress we have made toward achieving our mission and growing Bioventus. We have broadened our product offering, built a talented team, grown revenue and profit each year, and woven together a positive culture focused on the patients we serve,” said Bihl. “I want to thank the Board and my colleagues at this great company and I know Ken Reali will bring new ideas and energy for the next growth phase of Bioventus.”

About Bioventus
Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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 LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

 


Bioventus Recognizes 25 Years of Bone Healing from Exogen

DURHAM, NC – February 24, 2020 – Bioventus, a global leader in orthobiologic solutions, is recognizing 25 years of proven bone healing with its EXOGEN Ultrasound Bone Healing System. EXOGEN uses low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural bone healing process and promote fracture healing. It has an 86% heal rate for fractures not healing on their own1and provides 38% faster healing of indicated fresh fractures.2, 3

Since its launch in 1995, EXOGEN has been used to treat more than 1 million patients worldwide. Today it is prescribed by over 10,000 physicians annually4 and is sold in 15 countries. Backed by 16 Level 1 studies proving its safety and efficacy, 5-20* EXOGEN is used by patients at home and at their convenience for just 20 minutes a day.

“The numbers tell such a compelling story and represent an incredible milestone for Bioventus and EXOGEN,” said Tony Bihl, CEO, Bioventus. “It’s a great product with proven outcomes and for the last 25 years, it has healed nonunion and acute fractures for patients worldwide. This level of success and longevity was made possible by the tireless efforts of our employees and treating clinicians.”

About Bioventus
Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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 LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

Summary of Indications for Use
EXOGEN is indicated for the non-invasive treatment of established nonunions† excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions† in patients:

  • With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
  • Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
  • Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.

EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures. 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 exogen.com or by calling Bioventus Customer Service at 800-836-4080. † A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

1.     Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low-intensity pulsed ultrasound in the treatment of non-unions. J Trauma. 2001; 51(4):693−703.
2.     Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of tibial fracture-healing by non-invasive, low intensity pulsed ultrasound. J Bone Joint Surge [Am].1994; 76(1):26−34.
3.     Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo controlled study. J Bone Joint Surg [Am]. 1997; 79(7):961−973.
4.     Bioventus, Data on File, RPT-000965 [A].

*The Journal of Bone & Joint Surgery Level of Evidence 2015 Ratings Table was used to define the level of each clinical study. Levels of Evidence for Primary Research Question, J Bone Joint Surg Am. 2015;97(1)1-2. These studies, which reflect the body of evidence for EXOGEN, include evaluations of applications outside the approved labeling.

  1. Dudda M, Hauser J, Muhr G, Esenwein SA. J Trauma. 2011;71(5):1376-80.
  2. El-Mowaf H, Mohsen M. Int Orthop. 2005;29(2):121-4.
  3. Emami A,Petrén-Mallmin M, Larsson S. J Orthop Trauma. 1999;13(4):252-7.
  4. Handolin L, Kiljunen V, Arnala l, et al. J Orthop Sci. 2005;10(4):391-5.
  5. Handolin L, Kiljunen V, Arnala I, Pajarinen J, Partio EK, Rokkanen P. Arch Orthop Trauma Surg. 2005;125(5):317-21.
  6. Heckman JD, Ryaby JP, McCabe J, Frey JJ,Kilcoyne RF. J Bone Joint Surg Am. 1994;76(1):26-34.
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Bioventus Updates US Label for EXOGEN Ultrasound Bone Healing System

DURHAM, NC – February 10, 2020 – Bioventus, a global leader in orthobiologic solutions, has updated the indications for use for its EXOGEN Ultrasound Bone Healing System. EXOGEN uses low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural bone healing process and promote fracture healing. It has an 86% heal rate for fractures not healing on their ownand provides 38% faster healing of indicated fresh fractures.2, 3

The updated label now prominently features indications for using EXOGEN as an adjunctive non-invasive treatment of established nonunions in patients:

  • With internal or external fracture fixation hardware present
  • Undergoing treatment for infection at the fracture site
  • Believed to have diminished bone quality

“This label update underscores important usage scenarios where fracture management protocol may have limited consideration. Now, EXOGEN may be confidently prescribed in these indications,” said Peter Shaw, MBBS DRCOG, Chief Medical Officer, Bioventus. “Patients with comorbidities such as osteoporosis and bone infection can benefit from use of EXOGEN by helping to progress fracture healing and resolve nonunion. In addition, EXOGEN will heal fractures in the presence of infection at the fracture site and also serve as an important adjunctive therapy when stabilizing fractures with instrumented fixation.”

About Bioventus

Bioventus 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. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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 LinkedIn and Twitter.

Media Contact: Thomas Hill, 919-474-6715, [email protected]

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

Summary of Indications for Use
EXOGEN is indicated for the non-invasive treatment of established nonunions† excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions† in patients:

  • With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
  • Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
  • Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.

EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures. 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 exogen.com or by calling Bioventus Customer Service at 800-836-4080.

† A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

1. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low-intensity pulsed ultrasound in the treatment of non-unions. J Trauma. 2001; 51(4):693−703.
2. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of tibial fracture-healing by non-invasive, low intensity pulsed ultrasound. J Bone Joint Surge [Am].1994; 76(1):26−34.
3. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo controlled study. J Bone Joint Surg [Am]. 1997; 79(7):961−973.