Jeffery A. Acuff Named New Bioventus Vice President of Sales
Jeffery A. Acuff Named New Bioventus Vice President of Sales
DURHAM, N.C. – July 16, 2014 – Bioventus, a leader in active orthopaedic healing, today announced that Jeffery A. Acuff will join the company on July 15, 2014 as its new Vice President, US Sales. Acuff, an experienced healthcare executive known for achieving exceptional sales results and building high-performing teams, will become a member of the Bioventus Executive Team and report directly to Tony Bihl, Chief Executive Officer. In this role, Acuff will be responsible for providing strategic sales direction and delivering profitable sales growth for the US business. He will play a key role with the Executive Team, helping to guide the growth of our existing business and to develop new sales channels in line with our Orthobiologics strategy.
“Jeff joins us with a breadth of sales leadership experience and experience in Biologics,” Bihl said. “This experience will be an important part in furthering our strategy to be a global leader in Orthobiologics.” Acuff previously served as Senior Vice President of Commercial Operations at BioD where he developed and executed the commercial strategy at the biotechnology company. Prior to BioD, Acuff was Vice President of Sales, Americas at Varian Medical Systems where he developed and led the commercial strategy and implementation for its Radiation Oncology business.
Previous to Varian, Acuff was Vice President of Sales in various roles at Medtronic. During his thirteen years with the company, Jeff led both mature and fast growing sales organizations in multiple markets, built a new sales organization for the Biologics business and drove transformation within the businesses that he led.
He holds a Bachelor of Business Administration from University of Memphis.
About Bioventus
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics 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 or follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal or www.twitter.com/BioventusGlobal).
Bioventus Names Alessandra Pavesio New Chief Science Officer
Bioventus Names Alessandra Pavesio New Chief Science Officer
DURHAM, N.C. – July 11, 2013 – Bioventus, a leader in active orthopaedic healing, today announced that Alessandra Pavesio will join the company Aug. 5 as its new Chief Science Officer. Pavesio will be based in the company’s Durham headquarters and will report directly to Bioventus CEO Mark Augusti.
In the role, Pavesio, 46, will be responsible for providing critical strategic and operational leadership for the further growth of Bioventus products from early-stage development to commercial launch. She will lead various functional areas for the company including Research, Product Development, Clinical Affairs, Clinical Development, Project Management and Regulatory Affairs.
“As we work to expand our product portfolio and firmly establish our company as a leader in biologics, we knew it was crucial to have strong, experienced leadership in the CSO role,” Augusti said. “Alessandra’s technical knowledge, industry accomplishments and unwavering drive make her the ideal choice for the position. I’m excited to have her on our leadership team.”
During Pavesio’s 20-year career, she has developed – from concept to bedside – more than 25 Class-III innovative medical devices/biologics, designed for regeneration of soft and hard tissues, licensed to market leaders worldwide. A recognized opinion leader in regenerative medicine, Pavesio revolutionized cartilage regeneration by conceiving and developing the first third-generation autologous chondrocyte implantation technology to reach the market. She has also served as chairperson of international technology innovation platforms and government advisory councils.
Prior to joining Bioventus, Pavesio managed the Boston University Coulter Translational Partnership, a foundation-sponsored research program designed to enhance clinical impact and wealth creation through the development and transfer of innovative intellectual properties from university laboratories to commercial practice. She also held Vice President of Research & Development positions at two biomedical companies – Anika Therapeutics, a publicly-traded Massachusetts-based company that manufactures and markets products based on hyaluronic acid – and Fidia Advanced Biopolymers (FAB), a leading-edge European firm acquired by Anika that specialized in hyaluronic acid-based regenerative medicine products for use in bio-orthopaedics, wound healing and specialty surgery.
Pavesio is the co-author of 25 peer reviewed publications and more than 15 patented inventions. She holds a Master’s degree in Medicinal Chemistry from the University of Turin in Italy.
About Bioventus
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics 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 or follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal or www.twitter.com/BioventusGlobal).
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Bioventus Announces European Launch of Next Generation EXOGEN Device
Bioventus Announces European Launch of Next Generation EXOGEN Device
HOOFDDORP, THE NETHERLANDS – (July 4, 2013) – Bioventus, a global leader in active orthopaedic healing, today unveiled the next generation of its market-leading1 EXOGEN® Ultrasound Bone Healing System. The new EXOGEN has begun shipping in Europe and will be released in the United States, Canada and Australia later this year.
EXOGEN – the clinically proven treatment for indicated* bone fractures – is a medical device that helps fractured bones heal. The device:
• uses safe, effective low-intensity pulsed ultrasound to help stimulate the body’s natural healing process2
• has an 86% heal rate for fractures not healing on their own3
• offers 38% faster healing of indicated fresh fractures4
• received guidance from the UK’s National Institute for Health and Care Excellence (NICE) supporting the use of the cost-effective device (guidance MTG12) as an alternative to surgery for nonunions
The new version of EXOGEN introduces new compliance capabilities – such as a log and patient treatment history – to help physicians ensure that patients are appropriately using and benefiting from the device.
“The value of EXOGEN and how it helps fracture patients has long been known and documented,” explained Duncan Fatkin, Vice President of Global Marketing and Reimbursement for Bioventus. “However, patients may not see results unless they adhere to their physician’s prescribed treatment regimen. That’s a theme we heard over and over again as we partnered with physicians, payers and patients to develop the next generation EXOGEN. Achieving better healing outcomes for patients was something they asked us to focus on, and our new features including the reminder calendar address this.”
"The acceleration and promotion of bone healing continues to be an important goal in the treatment of fractures, non-unions and limb reconstruction. Research continues but progress is slow and demanding,” said Gavin De Kiewiet, Director of Trauma for Limb Reconstruction for Sunderland Royal Hospital in the UK. “The EXOGEN device with low-intensity pulsed ultrasound has greatly contributed to our ability to help these patients. Backed by sound basic science research, level 1 studies and published successful treatment trials, EXOGEN has significantly enhanced treatment modalities available to all clinicians. Patient friendly, doctor successful, and importantly today, cost effective, it is a treatment that has significantly aided our treatment of fractures and non-unions."
Prescribed by thousands of physicians around the world, EXOGEN is a portable, lightweight device that features an ultrasound probe that patients place on their skin at the site of the bone break for 20 minutes a day. Patients can easily perform the treatment at home, and EXOGEN has no known contraindications.
The new EXOGEN replaces the previous models available in Europe – EXOGEN 4000+ and EXOGEN Express. The new device is more portable and user friendly, with its new color LCD screen, splash-proof casing, and sleeker, lightweight design; more environmentally friendly, with its removable, rechargeable battery; and more adaptable with an SD card that determines the number of treatments for the device.
For more information about EXOGEN, visit www.exogen.com.
About Bioventus
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics 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 or follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal / www.twitter.com/BioventusGlobal).
EXOGEN and the Bioventus logo are registered trademarks of Bioventus LLC.
*A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
1. Based on company reports for global sales Jan-Dec 2011
2. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001;16(4):671-680.
3. Nolte PA, van der Krans A, Patka P, Janssen JMC, Ryaby JP, Albers GHR. Low-intensity ultrasound in the treatment of nonunions. J Trauma 2001;51:693–703.
4. 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 Surg Am. 1994;76(1):26-34.
EXOGEN summary of indications for use in the EU, Canada and Australia:
EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes: Treatment of delayed union and non-unions, accelerating the time to heal of fresh fractures, treatment of stress fractures, accelerating repair following osteotomy, accelerating repair in bone transport procedures, accelerating repair in distraction osteogenesis procedures, treatment of joint fusion. There are no known contraindications for the EXOGEN device. Safety and effectiveness has 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 at www.exogen.com.
EXOGEN Summary of Indications for use in the US:
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 has 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 contacting customer service at 1-800-396-4325.
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Bioventus Launches Company in Australia and Poland
Bioventus Launches Company in Australia and Poland
HOOFDDORP, THE NETHERLANDS – (July 1, 2013) – Bioventus, a global leader in active orthopaedic healing, has expanded its operations by launching its business in Australia and Poland.
Bioventus, which delivers clinically proven, cost-effective solutions that help people recover and heal quickly and safely, was formed last year as a strategic partnership between the company’s owners – Smith & Nephew, the global medical technology business, and an Essex Woodlands-led investor syndicate. Since that time, the company has launched in several countries where it has transitioned the existing Smith & Nephew biologics and clinical therapies business – the employees and the products – to Bioventus.
“The launch of Bioventus should be fairly transparent for our customers in Poland and Australia,” said Mark Augusti, CEO of Bioventus. “Their contacts within our company remain the same, as does our product set. However, they will receive an added level of support and product expertise through our European and Australian dedicated customer support teams.”
Augusti explained that Poland customers will have access to Bioventus’ International customer care center, the multi-lingual facility that opened late last year in the Netherlands. Australian customers will be supported by a new customer care team located in Bioventus’ Australian office.
Bioventus will also rebrand its products from the previous Smith & Nephew packaging to Bioventus. (Exact timing varies by market and product.) The products themselves will not change and will remain the same clinically proven, safe, effective solutions that physicians and patients know and trust. This includes:
• EXOGEN® Ultrasound Bone Healing System – a product indicated in Europe and Australia to accelerate the healing of recent fractures and to heal bones that have either delayed healing (delayed unions) or stopped healing completely (non-unions). EXOGEN has been shown to heal 86 percent of non-unions fractures* and accelerate the healing of fresh fractures up to 38 percent faster**. EXOGEN is developed and marketed by Bioventus in countries around the world. (See the EU and Australian indications statement below.)
• DUROLANE® – a single-injection, 3ml, joint-fluid treatment to relieve mild to moderate osteoarthritis (OA) pain of all sizes of synovial joints. A 1ml version of the product, DUROLANE SJ, is also available in Europe and indicated for treatment of OA pain in small joints. DUROLANE is developed/manufactured by Q-Med AB and marketed by Bioventus in many countries outside the U.S. (See the EU and Australian indications statement below.)
About Bioventus
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics 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 or follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal / www.twitter.com/BioventusGlobal).
EXOGEN and the Bioventus logo are registered trademarks of Bioventus LLC. DUROLANE is a registered trademark of Q-Med AB.
* Nolte et al (2001) Low Intensity Pulsed Ultrasound in the Treatment of Nonunions, J. Trauma 51 (4) 693-703
** Kristiansen et al (1997) J. Bone Joint Surg. 79A 961-973 Accelerated Healing of Distal Radial Fractures with the Use of Specific, Low-Intensity Ultrasound A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Study; Heckman JD, Ryaby JP, McCabe J et al. (1994) Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. Journal of Bone & Joint Surgery - American Volume 76:26-34.
EXOGEN summary of indications for use in the EU and Australia:
EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes: Treatment of delayed union and non-unions, accelerating the time to heal of fresh fractures, treatment of stress fractures, accelerating repair following osteotomy, accelerating repair in bone transport procedures, accelerating repair in distraction osteogenesis procedures, treatment of joint fusion. There are no known contraindications for the EXOGEN device. Safety and effectiveness has 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 at www.healmybone.com.
DUROLANE summary of indications for use in the EU:
DUROLANE (3ml): 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): 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 either in the presence of osteoarthritis or subsequent to general surgical repair 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. Full prescribing information can be found at www.durolane.com.
DUROLANE summary of indications for use in Australia:
For the symptomatic treatment of mild to moderate osteoarthritis of the knee.
DUROLANE (3ml): Symptomatic treatment of mild to moderate knee osteoarthritis.
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.
For full prescribing information, please refer to the Instructions for Use
Bioventus Acquires Exclusive Rights to Pfizer's BMP Portfolio
Bioventus Acquires Exclusive Rights to Pfizer's BMP Portfolio
DURHAM, N.C. – July 1, 2013 – Bioventus, a leader in active orthopaedic healing, today announced agreement with Pfizer Inc. for an exclusive, worldwide license to Pfizer’s bone morphogenetic protein (BMP) portfolio of development programs and associated intellectual property. The portfolio includes a next-generation BMP in development, designed to offer additional options to currently-marketed BMP products, and the rights to rhBMP-2 in indications and fields previously reserved to Pfizer. Bioventus has also acquired an exclusive option to a BMP program for soft tissue indications.
Pfizer has agreed to transfer to Bioventus all existing development work for the BMP assets and to undertake certain early-development activities relating to the next-generation BMP. Pfizer will also manufacture rhBMP-2 and supply it to Bioventus.
To lead the BMP programs, Bioventus has retained the services of distinguished BMP scientists Dr. John Wozney and Dr. Howard Seeherman. Bioventus is opening a research laboratory in Boston, MA to pursue development and commercialization of the BMP assets.
Under the terms of the license agreement, Pfizer received an upfront payment and will be eligible to receive milestone payments and royalties on any sales.
Martin Sutter, founding partner and Managing Director of Essex Woodlands, the lead investor in Bioventus, said “This licensing agreement demonstrates the viability of the investment thesis underlying our participation in Bioventus. Developing the next-generation BMP will enable Bioventus to become a recognized leader in orthobiologics.”
“As Pfizer continues to prioritize and actively manage our dynamic pipeline, we have looked for strong partners who are best suited to advance programs outside our core focus areas,” said Jose Carlos Gutierrez-Ramos, Ph.D., Group Senior Vice President and Head of Biotherapeutics R&D at Pfizer. “Given Bioventus’ expertise and commitment to orthopaedic healing, we believe it is well positioned to advance important new options to orthopaedic patients.”
“This transaction strengthens our vision of Bioventus being a recognized global leader in active orthopedic healing. BMPs are a class of demonstrably potent biologics that will benefit from Bioventus' commitment to developing clinically efficacious technologies in partnership with world class physicians and the appropriate regulatory agencies. The BMP programs will expand and complement Bioventus’ ongoing development in bone stimulation and injectable hyaluronic acid therapies,” said Mark Augusti, CEO of Bioventus.
About Bioventus
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics 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 or follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal or www.twitter.com/BioventusGlobal).
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NTAC Releases Adoption Pack to Assist Implementation of NICE Guidelines Supporting the Use of EXOGEN
NTAC Releases Adoption Pack to Assist Implementation of NICE Guidelines Supporting the Use of EXOGEN
HOOFDDORP, THE NETHERLANDS – (May 13, 2013) – The NHS Technology Adoption Centre (NTAC), the implementation arm of the National Institute for Health and Care Excellence (NICE), recently launched a new Adoption Pack regarding the EXOGEN Ultrasound Bone Healing System.
The new adoption pack is designed to help NHS Trusts correctly implement guidelines NICE released (guidance MTG12) supporting the use of EXOGEN as an alternative to surgery for thousands of patients with long bone non-union fractures. The pack includes information about the benefits of EXOGEN to patients/physicians/healthcare systems, the national and local opportunities available, the drivers for adoption, detailed case studies of where EXOGEN has already been successfully used in the NHS, and the costs and potential savings.
NTAC’s experience of working with NHS clinicians, managers and commissioners ensures the information and advice contained within the Adoption Pack is accurate and useful for the NHS.
EXOGEN, which is manufactured and distributed worldwide by Bioventus LLC, uses a unique low-intensity pulsed ultrasound signal to stimulate broken bones to heal naturally, in comparison to surgical management. Patients using EXOGEN place an ultrasound probe on the skin for 20 minutes a day and the treatment, done at home, is entirely pain free with no known side effects. Clinical studies have shown EXOGEN to have an equivalent 86% success rate as surgery1.
The device is used by physicians around the world including many of the UK’s leading surgeons, a number of which have been interviewed for the Adoption Pack. One of these is Angus MacLean, Senior Orthopaedic Consultant at Glasgow Royal Infirmary, who said: “By accelerating health there is significant potential for this technology to save money for the NHS by reducing the need for surgery and returning patients to work more quickly than before. Cost savings and clinical effectiveness therefore make a potential ‘win-win’ situation for the NHS and the patient.”
About Bioventus
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics that make it a global leader of active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behaviour, Bioventus is a trusted partner for physicians worldwide.
For more information, visit www.BioventusGlobal.com.
References:
1. Nolte PA, van der Krans A, Patka P, Janssen JMC, Ryaby JP, Albers GHR. Low-intensity ultrasound in the treatment of nonunions. J Trauma 2001;51:693–703.
EXOGEN is a registered trademark of Bioventus LLC
EXOGEN summary of indications for use in the EU:
EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes: Treatment of delayed union and non-unions, accelerating the time to heal of fresh fractures, treatment of stress fractures, accelerating repair following osteotomy, accelerating repair in bone transport procedures, accelerating repair in distraction osteogenesis procedures, treatment of joint fusion. There are no known contraindications for the EXOGEN device. Safety and effectiveness has 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 at www.healmybone.com.
