Liquidmetal® Passes Implant Study

Posted On March 29, 2017 By OrthoSpineNews In Biologics /

March 28, 2017

RANCHO SANTA MARGARITA, Calif.–(BUSINESS WIRE)–Liquidmetal® Technologies, Inc. (OTCQB: LQMT; the “Company”),announced today that it has passed additional pre-screening biocompatibility tests for use in medical implants and is now pursuing collaborations with medical implant companies.

In February of 2017, LQMT received long-term implantation results from parts 3, 10, 6 and 11 of the ISO 10993 (Biological Evaluation of Medical Devices) suite of tests, which include evaluation of genotoxicity, sub-chronic systemic toxicity, and pyrogenicity. LQMT alloy LM105 passed all of these tests well within the allowable limits. These results, combined with previously completed tests from ISO 10993 parts 10, 11, 4, and 5 which cover sensitization, irritation, acute systemic toxicity, hemocompatibility and cytotoxicity, indicate that the Liquidmetal process is compatible with a wide range of medical device requirements including long term implants.

“The results of these tests are very exciting and it positions the Company well to engage medical device customers in a broad range of implantable device applications including, cardiac rhythm, cochlear, spinal, and orthopedic implants among others. The Company will now focus on partnering with medical implant manufacturers to identify specific applications to further explore the use of Liquidmetal,” said Paul Hauck, Executive Vice President of Sales and Marketing at LQMT.

About Liquidmetal Technologies

Rancho Santa Margarita, California-based Liquidmetal Technologies, Inc. is the leading developer of bulk amorphous alloys. Amorphous alloys are unique materials that are distinguished by their ability to be injection molded and die cast into high performance applications for a broad range of markets. For more information, go to www.liquidmetal.com.

Contacts

Liquidmetal Technologies, Inc.
Otis Buchanan
Media Relations
949-635-2120
otis.buchanan@liquidmetal.com

Burst Biologics Initiates Prospective Multicenter Clinical Study in Spinal Fusion

Posted On March 28, 2017 By OrthoSpineNews In Biologics /

March 28, 2017

BOISE, Idaho–(BUSINESS WIRE)–Burst Biologics has received IRB approval to begin a multicenter prospective clinical study in spinal fusion patients. This study will be conducted using BioBurst Fluid, a cellular allograft derived from umbilical cord blood (UCB) which has shown very promising results in spinal fusion procedures. Fifteen clinical sites will participate throughout the US with a total enrollment of 450 patients.

Popularity of cellular allografts has increased over the last decade. Figures show that the global spine biologics market is valued at $1.6 billion and is expected to reach $2.2 billion by 2022.¹ This represents a significant opportunity for innovative biologic products.

Ira Fedder, MD, Towson, Maryland, explains, “As we continue to try to understand the mechanisms that lead toward successful fusion, it is critical that we consider the cellular content and activity that may contribute to positive outcomes. Patients that have compromised health and/or healing potential may stand to be the biggest benefactors of this type of technology. It is imperative that surgeons demand that companies demonstrate that their products have a positive impact on patient outcomes. A registry is a simple step in that direction.”

As Chris Jones, CEO of Burst Biologics, explains, “An open registry allows us to evaluate success rates in complex cases that would otherwise be excluded from studies. Stringent inclusion-exclusion criteria narrow the patient population and usually involve only single-level procedures, not allowing previous surgery or fusion attempts, and excluding other high-risk conditions. We want to demonstrate to spine surgeons and third-party payers that BioBurst Fluid can be successful in their more challenging patients.”

For more information on this prospective multicenter clinical study, please visit:

www.clinicaltrials.gov

www.burstbiologics.com/fluidclinicaltrial

About Burst Biologics

Burst Biologics is a rapidly growing Biotechnology Company and federally registered tissue bank located in Boise, Idaho. Burst Biologics is a developer of effective tissue processing methodologies, all of which is done at the company’s state-of-the-art research facility. For more information about Burst Biologics or its products, please visit its website at: www.BurstBiologics.com

1. Sandberg, J., Global Spine Biologics Market Expected to Reach $2,214 Million by 2022 – Allied Market Research. OrthoSpineNews, 2017. Available from: https://www.alliedmarketresearch.com/spine-biologics-market.

Contacts

Burst Biologics
Ryan Sciarrotta, 1-888-322-1191
Marketing Department
marketing@smart-surgical.com

Organogenesis Inc. Announces Acquisition of NuTech Medical

Posted On March 28, 2017 By OrthoSpineNews In Biologics, Top Stories /

CANTON, Mass. and BIRMINGHAM, Ala., March 28, 2017 /PRNewswire/ — Organogenesis Inc., a commercial leader in the field of regenerative medicine, is expanding beyond wound care with the acquisition of NuTech Medical. The newly-combined company will offer a portfolio of advanced and next generation products for the wound care and surgical biologics markets.

Based in Birmingham, AL, NuTech Medical is an emerging player, offering a diverse portfolio of amniotic products for a variety of surgical and wound care needs. NuTech Medical’s non-biologics product line will remain as a separate company, NuTech Spine.

“This is an important transaction for the regenerative medicine field. It unites two pioneering companies, each with decades of experience in bringing quality biologics products to patients around the world,” said Gary S. Gillheeney, Sr., President and CEO of Organogenesis. “This is a compelling, highly complementary combination of best-in-class, innovative products in both the regenerative wound and surgical biologics markets. Organogenesis is currently growing at 40% a year, and we have patiently waited to enter the amniotic tissue space. Specifically, we’ve been watching the development of next-generation amniotic products, and we’ve found in NuTech Medical what we believe is the field’s most promising product portfolio and pipeline, with a technology platform that’s really unparalleled in the field.”

NuTech Medical will continue existing operations as a new division of Organogenesis Inc., focused on the surgical biologics arena. It will continue to develop and distribute NuTech’s product line from its existing facilities in Birmingham, AL, with plans to grow its existing surgical sales network of approximately 150 representatives, significantly expanding Organogenesis’ sales capabilities. NuTech’s President & CEO Howard Walthall will join Organogenesis Inc. as President of the company’s Surgical Division, and as Senior Vice President for Strategy and Development for Organogenesis Inc.

“This is an exciting time for NuTech Medical, as we share with Organogenesis a commitment to regenerative product innovation, and a culture of scientific advancement and exceptional customer service,'” said Mr. Walthall. “Like NuTech, Organogenesis has decades of experience bringing ground-breaking technology to market, and building a large and loyal customer base. This acquisition enables us to drive significant growth in both the wound and surgical biologics markets together, through our combined R&D programs, and our strong and proven distribution networks.”

NuTech Medical’s portfolio includes an amniotic product line for both soft tissue and bone applications, utilized in multiple markets including wound healing and surgery. The product line includes Affinity, a novel, fresh amniotic allograft; NuShield, a dehydrated terminally-sterilized allograft that comprises both the amnion and chorion layers; and NuCel and ReNu, cryopreserved allografts derived from human amnion and amniotic fluid, as well as other complementary products. NuTech’s proprietary BioLoc™ process is the field’s state-of-the-art technology for preserving the native structure of the amnion and chorion membranes, optimized to provide excellent strength, flexibility, and handling. NuTech’s proprietary AlloFresh™ process allows for the fresh hypothermic storage of amniotic tissues while retaining their structural integrity, viability and native benefits.

About Organogenesis
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products for advanced wound care, orthopedics and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs.

Originally founded as a spin-off from technology developed at MIT in 1985, Organogenesis pioneered the advanced wound care space with the first-ever FDA approval of a mass-produced living cell-based therapy, Apligraf®, for the treatment of chronic venous leg ulcers. In 2014, Organogenesis acquired Dermagraft®, a living cell-based technology approved by the FDA for the treatment of chronic diabetic foot ulcers. In 2016, the company launched PuraPly Antimicrobial™, an FDA-cleared purified type 1 collagen + PHMB-antimicrobial device, designed to manage and prevent the reformation of biofilm in wounds.

CONTACT:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

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Safety and Efficacy of New Class of Orthopedic Implant for Intramedullary Biologic Stabilization of Fractured Long Bones Studied Out to 1 Year

Posted On March 24, 2017 By OrthoSpineNews In Biologics, Extremities /

March 23, 2017

LEXINGTON, Mass.–(BUSINESS WIRE)–CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today it has published safety and efficacy data at one year showing that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for open surgery. Results of this study have been published in the Journal of Orthopaedic Research.

“Our study further evaluates the percutaneous application of the IlluminOss System, which is a light-curable photodynamic bone stabilization device developed by IlluminOss Medical as a safe and biocompatible treatment for fracture stabilization and repair in load-bearing bones, such as the long bones of the leg,” said co-investigator Brett G. Zani, Ph.D., Director of Applied Sciences, CBSET.

“Local biocompatibility evaluations comparing the IlluminOss System to standard K-wire implants showed no significant long-term local tissue reactions associated with either implant, and good systemic biocompatibility of the IlluminOss System over the course of a year,” added co-investigator and CBSET scientist Amanda L. McSweeney.

The IlluminOss System is commercially available in international markets under a CE Mark for approved clinical applications through both a direct sales force and distribution networks. It combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. The implant begins as a liquid monomer that is completely contained within a Dacron or PET balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. Now, international surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures.

“CBSET’s high-quality preclinical evaluation continues to substantiate the application of our bone stabilization system and its potential to be a truly disruptive alternative to traditional fracture repair,” said Robert Rabiner, Chief Technical Officer & Founder of IlluminOss Medical.

“CBSET strives to help innovative companies such as IlluminOss to develop new and disruptive technologies that foster paradigm-shifting improvements in patient care. In this case, for patients requiring fracture-fixation in an orthopedic trauma care unit, access to a new solution that is metal-free and can be performed in a minimally invasive manner, and not open surgery, is exciting, and our organization is proud to have contributed,” said Peter Markham, President, CEO and a co-founder of CBSET.

To learn more about these results and the services provided by CBSET, please contact: Michael Naimark, Director, Business Development: +1-970-988-5273, mnaimark@cbset.org.

* The IluminOss™ System is approved for sale in Europe and for investigational use in the U.S.

About CBSET
CBSET Inc. — 500 Shire Way, Lexington, Mass. — is the preclinical research leader in therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. Learn more about CBSET’s expert biomedical research services.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Study points a way to better implantable medical devices

Posted On March 22, 2017 By OrthoSpineNews In Biologics /

Science Daily, Source: Massachusetts Institute of Technology – March 20, 2017

Medical devices implanted in the body for drug delivery, sensing, or tissue regeneration usually come under fire from the host’s immune system. Defense cells work to isolate material they consider foreign to the body, building up a wall of dense scar tissue around the devices, which eventually become unable to perform their functions.

Researchers at MIT and Boston Children’s Hospital have identified a signaling molecule that is key to this process of “fibrosis,” and they have shown that blocking the molecule prevents the scar tissue from forming. The findings, reported in the March 20 issue of Nature Materials, could help scientists extend the lifespan of many types of implantable medical devices.

“This gives us a better understanding of the biology behind fibrosis and potentially a way to modulate that response to prevent the formation of scar tissue around implants,” says Daniel Anderson, an associate professor in MIT’s Department of Chemical Engineering, a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES), an affiliate at Boston Children’s Hospital, and the senior author of the study.

The paper’s lead author is Koch Institute and JDRF postdoc Joshua Doloff.

Preventing fibrosis

Anderson’s lab has been working for several years on an implantable device that could mimic the function of the pancreas, potentially offering a long-term treatment for diabetes patients. The device encapsulates insulin-producing islet cells within a material called alginate, a polysaccharide naturally found in algae. Alginate provokes a lesser immune response than human-made materials such as metal, but it still induces fibrosis.

READ THE REST HERE

Bioventus to Invest in New Clinical Research for EXOGEN®

Posted On March 16, 2017 By OrthoSpineNews In Biologics /

March 15, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced it will commission an innovative series of real-world evidence, direct-to-patient studies to further validate the ability of its EXOGEN Ultrasound Bone Healing System to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.¹

Recent publications analyzing data from a large registry of almost 8,000 fractures treated with EXOGEN suggest that the device supports healing fractures in patients despite the presence of associated comorbidities or medication use.^2,3,4 This new clinical research, known as the Bioventus Observational Non-interventional EXOGEN Studies (BONES), will build on this evidence and supplement the product’s broad body of clinical knowledge in a prospective population-based innovative clinical development program.

The BONES studies will compare the incidence of fracture nonunions in patients utilizing the EXOGEN device with patients from a national health insurance claims database who received standard of care alone. The studies will include bones representative of long and small bones of upper and lower extremities. The unique design was discussed with FDA during its development.

“BONES represents a significant investment in developing epidemiologically grounded rigorous clinical evidence to support use of EXOGEN in fractures at risk, and to underscore the product’s clinical utility in mitigating the risk of nonunions, a highly debilitating and costly condition,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “It will build upon knowledge gained from extensive research conducted by Bioventus and recently published in JAMA Surgery, in over 700,000 fracture patients that has identified 40-plus factors which place a patient at an increased risk of progression to a nonunion.⁵”

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. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^® Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. 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, and EXOGEN are registered trademarks of Bioventus LLC.

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.
Nolte P, Anderson R, Strauss E, Hu L, J Jones, RG Steen. 2016. Heal rate of metatarsal fractures: A propensity-matching study of low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. 2017 47(11):2584-2590.
Zura R, G Della Rocca, S Mehta, A Harrison, C Brodie, J Jones, RG Steen. 2015. Treatment of chronic (> 1 year) fracture nonunion: Heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury 46:2036-2041.
Zura R, S Mehta, G Della Rocca, J Jones, RG Steen. 2015. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): Findings in the elderly versus all patients. BMC Musculoskel. Dis. 16:45.
Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones, JAMA Surgery. 2016: e162775. doi:10.1001/jamasurg.2016.2775.

EXOGEN – Summary of Indications for Use in the US

*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 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 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Soft Tissue Regeneration Raises Series C Financing and Rebrands to Biorez

Posted On March 16, 2017 By OrthoSpineNews In Biologics, Top Stories /

NEW HAVEN, CONN. (PRWEB) MARCH 14, 2017

Biorez, Inc., formerly known as Soft Tissue Regeneration, Inc., today announced the close of a $1.5 million investment following preliminary results of the first in-human study of its novel implant for anterior cruciate ligament (ACL) reconstruction.

The breakthrough approach makes use of a proprietary tissue-engineered scaffold that stabilizes the knee, facilitates the body to regrow new ACL tissue, and then fully resorbs, leaving only new, functional tissue.

Connecticut Innovations, Connecticut’s leading source of financing and ongoing support for Connecticut’s innovative, growing companies, led the investment round. Vertical Group and KLP Ventures, an affiliate of Launch Capital, also participated in the round.

“Biorez has learned a great deal through their early stages of development and testing,” said Dan Wagner, managing director at Connecticut Innovations, and a Biorez board member. “With a new CEO at the helm and a new path ahead, we look forward to supporting the progress of this company and technology in the future.”

“Typically, a torn ACL is surgically reconstructed using a tissue graft harvested from the patient or a cadaver,” said Kevin Rocco, CEO of Biorez. “Neither option is ideal for patients, but both biologic grafts remodel into new functional tissue over time. We have developed an off-the-shelf, synthetic scaffold constructed from biocompatible polymers that harnesses the same regenerative remodeling process.”

Biorez will be sharing the detailed results of the human trial in private meetings with key partners, surgeons, and researchers during the American Association of Orthopedic Surgeons (AAOS) meeting in San Diego, from March 14 through March 18, 2017. Biorez is the first company to clinically investigate a tissue-engineered scaffold for ACL reconstruction in a human trial.

“The clinical study has validated our unique approach, and given us a first-mover advantage to further optimize our technology,” said Rocco. “We look forward to publishing our results.”

About Biorez, Inc.
Biorez, Inc. is a privately-held, early-stage regenerative medicine company engaged in developing bioresorbable scaffold implants to regenerate functional tissue in vivo. Its lead product candidate is an off-the-shelf implant for ACL reconstruction that spares harvesting of patient donor-tissue, and provides a better alternative to cadaver-based materials. The company plans to commercialize its lead ACL technology, as well as expand its platform to develop new and innovative clinical solutions. To learn more, visit http://www.biorez.com.

BONESUPPORT™ Founder Lars Lidgren Receives the 2017 OREF Clinical Research Kappa Delta Award

Posted On March 16, 2017 By OrthoSpineNews In Biologics, Recon /

Lund, Sweden, 16 March, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that its founder Lars Lidgren, is a member of a group of Swedish and US Knee and Hip surgeons from Lund and Gothenburg, Sweden, Boston and Rochester U.S. that has received the 2017 OREF Clinical Research Kappa Delta Award. The award was made for the group’s outstanding research contribution leading to improved prosthetic survival and patient outcomes.

The OREF Clinical Research Kappa Delta recognizes outstanding clinical research related directly to musculoskeletal disease or injury. Henrik Malchau, MD, PhD, part of the Swedish and US group, will present the study “Arthroplasty Implant Registries Over The Past Five Decades: Development, Current and Future Impact” The award will be given at the AAOS meeting, San Diego, California on Thursday, March 16 at 11:00 am in the Ballroom 20.

Lars Lidgren, M.D., Ph.D. Hon. Member AAOS., founder of BONESUPPORT, said: “I’m delighted that clinical research on joint replacements, one of the most common surgical procedures today, has gained this very prestigious award. I am confident that our long term research based on arthroplasty registries will continue to help shape the development of new innovative technologies to provide patients with improved orthopaedic outcomes.”

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

Notes to Editor

About the OREF Clinical Research Kappa Delta Award

This award recognizes outstanding clinical research related directly to musculoskeletal disease or injury. Eligible applicants must be members of the American Academy of Orthopaedic Surgeons, the Orthopaedic Research Society, the Canadian Orthopaedic Association, and the Canadian Orthopaedic Research Society. The winning paper is presented by the author at the Orthopaedic Research Society’s annual meeting, and the award is presented to the recipient by an OREF representative at the Academy’s annual meeting during the Kappa Delta Award presentations.

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

BoneSupport TM extends U.S. Distribution agreement for Cerament TM Bone Void Filler

Posted On March 14, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 14 March, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has extended the term of its U.S. distribution agreement with Zimmer Biomet. Under the agreement, Zimmer Biomet will continue to have exclusive rights for BONESUPPORT’s proprietary CERAMENT BONE VOID FILLER product line for Orthopedics, Trauma and Foot and Ankle indications in the United States.

“We are extremely pleased to extend our distribution agreement with Zimmer Biomet,” said Richard Davies, CEO of BONESUPPORT™. “The partnership has been very successful and has resulted in the current rapid growth of our flagship product, CERAMENT in the world’s largest bone graft substitute market. This rapid growth is building an important platform from which we can launch product extensions into the US.”

In addition to commercialization of CERAMENT BONE VOID FILLER in the U.S. market, BONESUPPORT is currently enrolling patients into the FORTIFY Clinical Study, an FDA approved IDE randomized control pivotal study for the Company’s anti-biotic eluting product CERAMENT G. CERAMENT G is currently approved and commercialized in the EU and other markets outside the United States.

About BONESUPPORT™

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to improve the lives of patients suffering from bone disorders that cause bone voids, lead to injury, breakage, pain, and reduced quality of life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT and CERAMENT are registered trademarks.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

Bioventus Presents Bone Healing, Osteoarthritis Pain and Bone Graft Solutions at AAOS

Posted On March 13, 2017 By OrthoSpineNews In Biologics /

SAN DIEGO – March 14, 2017 – Bioventus, a leader in orthobiologic solutions, today announced its plans for the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) March 13-18 in the San Diego Convention Center. Among the products clinicians visiting Bioventus in booth #5223 can learn more about is GELSYN-3™ the company’s next generation, three-injection hyaluronic acid (HA).

GELSYN-3 helps relieve pain associated with knee osteoarthritis (OA) and is the company’s latest portfolio addition joining its five-injection knee OA solution called SUPARTZ FX^®, and its single-injection OA product known as DUROLANE^®.Both GELSYN-3 and SUPARTZ FX are available exclusively in the US while DUROLANE is available in OUS markets. Bioventus will also feature the EXOGEN^® Ultrasound Bone Healing System and the associated volume of clinical evidence for efficacy that underscores its position as the #1 prescribed bone healing system in the US.

In addition, Bioventus Surgical will highlight its suite of allograft, cell & marrow and synthetic bone graft solutions including: OSTEOAMP^®, a uniquely processed allograft bone graft substitute; CELLXTRACT^™, a novel cell and bone marrow extraction tool; and SIGNAFUSE^™ a bi-phasic mineral composite combined with a patented bioactive glass and resorbable polymer carrier.

“Since it was established in 2012, Bioventus has expanded its portfolio to include 13 offerings for bone healing, osteoarthritis and bone grafts,” said Tony Bihl, CEO, Bioventus. “Our singular and unique focus is on orthobiologics that provide positive outcomes to benefit patients, surgeons, hospitals and payers. We invite AAOS attendees to visit with us and learn more about our solutions which are not only effective, but are backed by clinical and technical data.”

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. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. 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.

Media Contact:
Thomas Hill, +1 919-474-6715, thomas.hill@bioventusglobal.com

Bioventus, the Bioventus logo, DUROLANE, OSTEOAMP and EXOGEN are registered trademarks and GELSYN-3, CELLXTRACT and SIGNAFUSE are trademarks of Bioventus LLC of Bioventus LLC. SUPARTZ FX is a registered trademark of Seikagaku Corp.

Summary of Indications for Use

OSTEOAMP may be used in situations where an autograft is appropriate. 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 at BioventusSurgical.com or by contacting customer service at 1-800-637-4391. 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 at BioventusSurgical.com or by contacting customer service at 1-800-637-4391. 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 at BioventusSurgical.com by contacting customer service at1-800-637-4391.

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 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. Full prescribing information can be found at www.GelSyn3.com or by contacting customer service at 1-800-836-4080.

EXOGEN

Summary of Indications for Use: In Canada, the EU, Australia and New Zealand

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

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

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

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.

Summary of Indications for Use in the US

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 1-800-836-4080.

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

DUROLANE

European Union and Chile:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved in the EU 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 in the presence of osteoarthritis within 3months of the procedure.

Full prescribing information can be found in product labeling, or at www.durolane.com.

Canada:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been licensed for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, fingers and toes.

DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, fingers and toes.

Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy in the presence of osteoarthritis within 3months 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 in product labeling, or at www.durolane.com.

Australia/New Zealand/Mexico:

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. Full prescribing information can be found in product labeling, or at www.durolane.com.

India, Indonesia, U.A.E., Saudi Arabia, Jordan, Hong Kong, Russia:

DUROLANE (3ml): Symptomatic treatment of mild to moderate knee and hip osteoarthritis.

Taiwan:

DUROLANE (3ml): Treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.