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Bioventus Launches DUROLANE® in the US

Posted On March 5, 2018 By OrthoSpineNews In Biologics /  

March 05, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today launched DUROLANE, its single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA).DUROLANE joins three-injection HA GELSYN-3™ and the five-injection HA SUPARTZ FX™ in the company’s OA portfolio making Bioventus the only orthobiologics company in the US with a single, three and five-injection HA option for treatment of knee OA.

“Introducing DUROLANE to the US market gives patients, physicians and payers access to a proven pain reliever for knee OA that has improved the lives of more than 1 million people worldwide,” said Tony Bihl, CEO of Bioventus. “In addition, DUROLANE is very safe for patients and has more level-1 clinical studies than any other single-injection HA knee therapy on the market today.”

Hyaluronic acid is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues within the knee. DUROLANE has been proven to provide greater reduction in knee pain versus Synvisc-One®1* and longer lasting pain relief versus a steroid injection2. DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.2, 3

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. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3, is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corporation. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

* Some patients were treated with a three-injection Synvisc regimen. A three-injection Synvisc regimen is equivalent to one injection of Synvisc-One.

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.

References: 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. 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. 3. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.

Contacts

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

(Photo: Business Wire)

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Vivorté Continues Transformation with Announcement of Mark Wagner as Chief Executive Officer

Posted On March 5, 2018 By OrthoSpineNews In Biologics, Top Stories /  

LOUISVILLE, KY — (March 5, 2018) — Vivorté, Inc., a vertically-integrated manufacturer and marketer of Performance Biologics™ including TRABEXUS®, FORTERA™ and REGENTO™ announced today that Mark Wagner will assume the role of CEO to spur the company through its next phase of exponential growth.

Wagner has extensive experience leading commercial organizations within the orthopedics sector and broader medical device industry. Prior to joining Vivorté, Wagner was Senior Director of Sales and Marketing at DCI Donor Services, leading the commercialization of a diverse product line servicing the orthopedics, spine and wound care market segments.

“It is a critical time in Vivorté’s history and we are excited to announce this transition”, said Robert Saunders, Vivorté Chairman. “Over the last several months, Vivorté has been actively implementing a variety of strategic initiatives that are beginning to bear fruit. As we continue to focus on commercial execution, we look forward to continued progress and growth under Mark’s direction. Additionally, the board of directors would like to acknowledge Ruth Voor, whose wealth of contributions include leading the Vivorté organization through the product development and regulatory clearance of Trabexus and establishment of the Company’s current portfolio of products.”

Wagner joined Vivorté in October 2017 and has made a significant impact by implementing new branding / marketing initiatives and energizing the company’s sales channels. Prior experience includes leadership positions at AmerisourceBergen, Angiotech Pharmaceuticals and RTI Surgical. Wagner holds a Master of Business Administration from the Kellogg School of Management at Northwestern University and a Bachelor of Arts from Dartmouth College.

“I’m excited to become Vivorté’s CEO at this pivotal point in the company’s history,” said Wagner. “Vivorté already has the two most important ingredients for success – great products and great people. The company is focused on delivering our game-changing products to the orthopedic marketplace and sharing the clinical product efficacy results we are now seeing from our early adopters.”

Representatives from Vivorté will be attending the upcoming American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, held March 6-10, 2018 in New Orleans, Louisiana to address corporate inquiries.

About Vivorté, Inc. 

Vivorté, Inc., headquartered in Louisville, Kentucky is a privately-held, vertically-integrated manufacturer and marketer of Performance Biologics™. Vivorté is committed to developing innovative and cost-effective surgical products for the benefit of surgeons, hospitals and patients. The Company’s product portfolio includes Trabexus® Trabecular Osteoinductive Biocement, Fortera™ Fortifying Osteoconductive Biocement and Regento™ Regenerative Scaffold. To learn more, please visit our website at vivorte.com.

Media Contact: Therese Montano / 502-714-7234 / tmontano@vivorte.com

 

 

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Biomatlante Continues To Invest In Innovative Solutions For Active Healing Through Orthobiologics

Posted On March 1, 2018 By OrthoSpineNews In Biologics /  

NANTES, FRANCE (PRWEB) FEBRUARY 28, 2018

After the success of the European program REBORNE (FP7) focused on safety and efficacy of the Biomatlante matrix combined with autologous bone marrow expanded mesenchymal stem cells (MSC), MBCP+™*, made from our well-known MBCP Technology, was confirmed as the adapted matrix for tissue engineering and chosen for 2 new European research programs (H2020): MAXIBONE and ORTHOUNION.

The current challenge is to compare the clinical performances of this Advanced Therapy Medicinal Product (MBCP+™/MSC) with autograft, considered as the gold-standard for bone reconstruction: MAXIBONE (150 patients) for bone augmentation in maxillofacial surgery before dental implant placement and ORTHOUNION (about 100 patients) focused on non-union after long bone fractures.

BIOMATLANTE will showcase its technology at the American Academy of Orthopaedic Surgeons (AAOS) Congress, held 6-10 March 2018 in New Orleans, USA.

About BIOMATLANTE, experts in bone regeneration 
Based near Nantes, France, Biomatlante specializes in synthetic biomaterials for bone regeneration and is a world leader in bone graft technologies, selling its products in over 50 countries. Biomatlante’s products are routinely used in orthopedics and trauma surgery, in spine and dental surgery. BIOMATLANTE strives to integrate a strategy of strong innovation and product development required to meet and exceed the needs of today’s market. Our R&D collaborates closely with universities and research centers across the world, bringing together competences in innovation, technological transfers of new biomaterials, surgical technologies and providing the intellectual protection required to foster long-term projects.

About MBCP™ Technology*, worldwide reference in synthetic bone graft 
The unique manufacturing process developed by BIOMATLANTE confers its core MBCP biphasic HA/ ß-TCP technology unique properties for hard tissue regeneration. Its micro-macroporous structure mimics that of human bone and provides an ideal osteogenic matrix for bone regeneration in general and tissue engineering in particular.

About REBORNE, Regenerating Bone Defects using New biomedical Engineering approaches 
The objective of REBORNE is to develop new biomaterials that stimulate bone tissue formation with a view to correcting bone regeneration defects in orthopedic and maxillofacial surgery. Biomaterials, combined with the use of stem cells, are interesting alternatives to biological grafts.

About MAXIBONE, Personalized maxillofacial bone regeneration 
This European project aims at performing a multicenter clinical trial on 150 patients for bone augmentation in maxillofacial surgery prior to dental implants with autologous bone marrow expanded mesenchymal stem cells and biomaterials versus autologous bone grafting. Personalized 3D printed calcium phosphate biomaterials are also developed and in the R&D workpackage, a new optimized smart scaffold for cells and drugs combination will also be tested and developed.

About ORTHOUNION MBCP+™
The “ORTHOpaedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs” (ORTHOUNION) is a 5 years project funded with 6M EUR by the EU H2020 programme, in the topic SCI-PM-11-2016-17: Clinical research on regenerative medicine.

For further information about BIOMATLANTE and its technologies, please visit http://www.biomatlante.com

  • This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use
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Heraeus Medical to Introduce Medium Viscosity Bone Cement and Vacuum Mixing System Innovations at AAOS 2018 Annual Meeting

Posted On February 28, 2018 By OrthoSpineNews In Biologics /  

YARDLEY, Pa., Feb. 28, 2018 /PRNewswire/ — Heraeus Medical, a global leader in joint fixation and infection management announced today the introduction of innovations to its current PALACOS® product portfolio.  The exciting new products include the medium viscosity bone cement PALACOS MV variations, along with two mixing systems, PALAMIX® and PALABOWL®.

The innovative PALAMIX® and PALABOWL®, while created for use with PALACOS® bone cement, can be effectively used with other types of bone cements. These new products, along with the complete PALACOS® portfolio, will be displayed during the American Academy of Orthopedic Surgeons’ Annual Meeting, March 6-10, 2018 in New Orleans.  AAOS attendees wanting to learn more about the medium viscosity bone cement, versatile mixing options or view other ground-breaking products are encouraged to visit Heraeus Medical at booth 1713 and participate in demonstrations and discussions.

“The collaborative environment of AAOS provides an excellent opportunity to share our newest technologies with total joint arthroplasty surgeons and gain direct feedback,” said Devin Childers, Vice President and General Manager of Heraeus Medical LLC. “Heraeus is excited to share our rapidly growing portfolio with attendees.”

In January, the company announced it would provide PALACOS® customers with earlier access to its latest technologies by selling to them directly. PALACOS®, formerly sold exclusively through a distributor in the US, is now available directly through its pioneer and manufacturer, Heraeus Medical.

New and existing PALACOS® customers in the US are able to order products directly from Heraeus Medical by calling 1-833-PALACOS (725-2267). Heraeus Medical has successfully sold and supported PALACOS® customers directly in Europe, Australia, and several other countries through an integrated ordering process that is now also available to US customers.

For more information or to order PALACOS® in the US, please visit www.heraeus-medical-usa.com or call 1-833-PALACOS (725-2267).

For more information during AAOS, please visit Heraeus Medical at booth 1713.

About the Heraeus Medical Global Business Unit
Heraeus Medical is known as a global leader in joint fixation and infection management in orthopedics and trauma surgery. This enables the company to make an important contribution to supporting surgeons and the surgical team and to improve surgery outcomes. In the area of biomaterials, Heraeus Medical focuses on products for use in bone and joint surgery. The core product PALACOS® is considered the gold standard among bone cements and has repeatedly proven itself over five decades of clinical use.

About Heraeus
Heraeus, the technology group headquartered in Hanau, Germany, is a leading international family-owned company formed in 1851. With expertise, a focus on innovations, operational excellence and an entrepreneurial leadership, we strive to continuously improve the businesses of our customers around the world.

We create high-quality solutions for our customers and strengthen their long-term competitiveness by combining material expertise with technological know-how. Our ideas are focused on important issues such as the environment, energy, health, mobility, and industrial applications. Our portfolio ranges from components to coordinated material systems which are used in a wide variety of industries, including the steel, electronics, chemical, automotive, and telecommunications industries.

In the 2016 financial year, the FORTUNE Global 500 listed company-generated revenues without precious metals of US$2.2 bn and a total revenue of US$23.8 bn. With approximately 12,400 employees worldwide in more than 100 subsidiaries in 40 countries, Heraeus holds a leading position in its global markets. In 2016, the Foundation for Family Businesses named Heraeus as one of the “Top 10 Family Businesses” in Germany.

 

SOURCE Heraeus Medical

Related Links

http://www.heraeus-medical-usa.com

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Leader Biomedical announces acquisition of International Orthopaedics Holding GmbH

Posted On February 28, 2018 By OrthoSpineNews In Biologics /  

Amsterdam | Geisingen | 27 February 2018

Leader Biomedical is pleased to announce the phased acquisition of International Orthopaedics Holding GmbH (International Orthopaedics), a manufacturer and distributor of orthopaedic implants based in Geisingen, Germany. The companies have entered into a notarial deed on the 20th of February, 2018. This phased acquisition is in line with Leader Biomedical’s vision to expand its therapeutic solutions offering in Germany and to enhance its infrastructure for global operations.

“I am excited to partner with Leader Biomedical. We see that with the support of Leader Biomedical’s team, we will be able to increase our offerings of orthopaedic implants to our customers to include cements, bone grafts, and additional biomaterials for spine and sports. Leader Biomedical’s investments into International Orthopaedics will further help us strengthen our position on the German market in offering value-added services to our customers,” shares Marc Bittenbinder, Founder and Managing Director of International Orthopaedics Holding GmbH.

“We are eager to welcome International Orthopaedics to the Leader Biomedical Group,” says Mr. Leo Liyeung, Group Executive Director of Leader Biomedical Group. “International Orthopaedics has been a reliable partner for Leader Biomedical from the start. Their strengths are highly complementary to ours, and together, we can create myriad opportunities for further growth.”

Customers in Germany will benefit from International Orthopaedics’ infrastructure, complemented by Leader Biomedical’s solutions portfolio, next generation technologies, and dedicated customer service. International Orthopaedics’ current portfolio of orthopaedic implants will be supplemented with C-ment®, a high-quality line of PMMA bone cements with and without gentamycin, the X-Grip® system, a leading ACL reconstruction solution, eTiss® allografts processed with Leader Biomedical’s proprietary eCOO® Technology using supercritical carbon dioxide, as well as the Ossfinity® and OssGro® line of synthetic grafts produced with MBCP™ Technology, a proprietary method which combines 60% HA and 40% βTCP.

“The acquisition of International Orthopaedics is consistent with Leader Biomedical’s ambitions to expand our on-ground operations in Europe. We are pursuing strategic opportunities in catering to local healthcare establishments and in providing affordable healthcare services with International Orthopaedics. We shall be investing in the infrastructure of International Orthopaedics to integrate Leader Biomedical’s supply chain and after sales capabilities. Over the next years, we envision to further develop customer management in the DACH region through Geisingen“, adds Basil Babychan, Group Business Director Leader Biomedical Group.

This acquisition reaffirms Leader’s vision for the DACH region after the discontinuation of the partnership with aap Joints GmbH in 2017 and an increased investment into BioTiss GmbH in early 2018. The acquisition of International Orthopaedics is the latest investment by Leader Biomedical and follows its earlier expansions into India, Brazil, Russia, and Malaysia in 2016 and the U.S.A. in 2017.

About International Orthopaedics Holding GmbH: “Innovation in Orthopaedics”
International Orthopaedics Holding GmbH is dedicated to safety in procedures by providing innovation and performance to patients as well as offering education and great service support to healthcare professionals. IO Holding GmbH offers high performance implants and instruments from trusted, high-Quality German and other European manufacturers (www.io-holding.com)

About Leader Biomedical: “Extending Your Reach”
Leader Biomedical is committed to contributing to the betterment of the global healthcare community with proven solutions and continuous innovation, and extending the reach of patients and caregivers by improving global access to reliable, targeted therapeutic solutions and new technologies. Leader Biomedical’s portfolio offers therapeutic solutions; focusing on orthopaedic, dental, spine, trauma and sports medicine (www.leaderbiomedical.com)

Leader Biomedical Europe B.V.
Herikerbergweg 300, Diana Building
1101 CT Amsterdam
The Netherlands

Sandy Plat
Group Marketing & Communications Manager
+31 (0)6 2972 6530

This release was published on openPR.

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Collagen Matrix Launches OssiMend® Spine and DuraMatrix® Dural Repair Products in Asia

Posted On February 26, 2018 By OrthoSpineNews In Biologics /  

OAKLAND, N.J., Feb. 26, 2018 /PRNewswire/ — Collagen Matrix, Inc., a leader in regenerative medicine and a global manufacturer of collagen and mineral based medical devices announced today its first entrance into the India market with two product lines, OssiMend® bone graft matrices from its Spine Business Unit and DuraMatrix® membranes from its Dural Repair Business Unit.

OssiMend® bone graft matrices are designed to provide a scaffold for a patient to grow new bone and are typically used in spinal fusion surgeries. DuraMatrix® dural repair products are engineered to provide a scaffold for brain and spinal cord host dura to naturally regenerate resulting in the protection, closure and repair of dural defects as well as providing leak resistance of cerebrospinal fluid.

Both of these product lines as well as others from the Collagen Matrix five business units—Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair—have been developed with its six proprietary technologies. With a robust 20-year reputation of product innovation, the Collagen Matrix products have helped patients worldwide with over 7.5 million medical devices.

Collagen Matrix now has the opportunity to launch its innovative products into India with this recent Registration Certificate of approval from the Central Drugs Standard Control Organisation, Medical Device & Diagnostic Division of Government of India.

“This first approval in India, the seventh largest country in the world, establishes an opportunity for Collagen Matrix to grow in this market and extends the Collagen Matrix Spine and Dural Repair footprint into Asia. It is another strategic milestone that represents our company’s commitment to continuously advancing our international distribution capability,” said Bart J. Doedens, CEO. “These products are a premium addition to the spine and neurosurgical surgeons’ biologics toolboxes, and the India market aligns with our expansion strategy.”

Discover more about the Collagen Matrix Spine Solutions at www.CollagenMatrix.com/Products/Spine and Dural Repair Solutions at www.CollagenMatrix.com/Products/Dural-Repair.

About Collagen Matrix
Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery. The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth. Opportunities continue to exist for collaboration through Product Distribution, Product Development and Contract Manufacturing. More information about Collagen Matrix can be found at www.CollagenMatrix.com.

Contact: Margo Lane
201-405-1477
mlane@collagenmatrix.com

 

SOURCE Collagen Matrix, Inc.

Related Links

http://www.collagenmatrix.com

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Bioventus to Co-Develop Next Generation Bone Allograft with LifeLink

Posted On February 26, 2018 By OrthoSpineNews In Biologics /  

February 26, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into an agreement with LifeLink Tissue Bank, a division of LifeLink Foundation, Inc. headquartered in Tampa, FL, to co-develop a next generation bone allograft solution for use in spine and trauma surgery. Terms of the agreement were not disclosed.

“Orthobiologics will continue to evolve to meet the needs of patients, surgeons and payers and Bioventus is pleased to begin work on the next generation of bone graft solutions with LifeLink,” said Tony Bihl, CEO of Bioventus. “This approach is consistent with our strategy to grow sales of our existing products in the surgical orthobiologics space and expand our offering with new product innovations.”

“The gift of tissue donation is invaluable and offers the opportunity to benefit so many patients in need,” said Jean Davis, President and CEO of LifeLink Foundation, Inc. “Companies like Bioventus are helping to further enhance the immeasurable impact of tissue donations by investing in R&D to bring new solutions to the market and we are excited for our research teams to collaborate together on this development initiative.”

About LifeLink:

LifeLink Foundation, an independent, non-profit community service organization is dedicated to the recovery and transplantation of organs and tissue. The Foundation is made up of five divisions: LifeLink Tissue Bank, which recovers and processes tissue for patients in need; LifeLink of Florida, LifeLink of Georgia, and LifeLink of Puerto Rico, three federally-certified organ procurement organizations; and LifeLink Transplantation Immunology Laboratory, which supports 15 organ-specific transplant programs. Additionally, the LifeLink Legacy Fund supports the LifeLink Foundation mission through patient assistance, research and programmatic grants to improve organ and tissue donation, and transplantation. Learn more about LifeLink Foundation at www.LifeLinkFoundation.org or LifeLink Tissue Bank at www.LifeLinkTB.org.

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. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

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.

Contacts

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

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The biomaterial of next-gen spinal implants

Posted On February 21, 2018 By OrthoSpineNews In Biologics /  

19 February 2018 – Medical Plastics News

A wealth of research and clinical experience is confirming that the use of PEEK-Optima polymer-based spinal implants confers advantages that can, potentially, enhance the efficacy of spinal implants and improve patient outcomes. Combined data from three clinical studies that directly compared PEEK-Optima with titanium devices for cervical fusion showed fusion rates between 88-100% for PEEK-Optima versus 47-93% for titanium devices.1-3 The high-performing polymer was the first implantable PEEK and introduced by Invibio Biomaterial Solutions (Invibio) in 1999. Since that time the company has pioneered further innovations and supported its partner companies with pre-clinical study results and clinical outcome data to achieve regulatory clearances and to help educate the medical community.

One such recent PEEK-based innovation was Invibio´s PEEK-Optima HA Enhanced polymer. It combines PEEK-Optima polymer with hydroxyapatite (HA) for medical applications where bone on-growth is required.  Hydroxyapatite, a well-known osteoconductive material that enhances bone apposition and a constituent of human bone, is fully integrated, not coated, into the PEEK matrix, making it available on all surfaces of a finished device, which also eliminates the time and expense of applying coatings to the manufactured implant.

Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-Optima Natural, including a modulus close to that of human bone, reduced stress shielding, and artifact-free imaging, whether by X-ray, MRI or CT scanning, allowing clear visual assessment of the fusion mass.

Pre-clinical studies demonstrate the potential benefits of PEEK-Optima HA Enhanced

The performance of PEEK-Optima HA Enhanced has been studied in pre-clinical studies, and has demonstrated a greater amount of new bone formation and a higher quality of new bone bridging, within early stages of treatment, compared with the results obtained when using PEEK-Optima Natural.

Invibio commissioned an independent cervical fusion study in sheep, to compare outcomes between interbody fusion devices composed of PEEK- Optima HA Enhanced, PEEK- Optima Natural and allograft bone. Results indicate that PEEK- Optima HA Enhanced may provide several advantages4:

  • Greater new bone formation. PEEK- Optima HA Enhanced resulted in greater new bone formation at six weeks, compared with PEEK- Optima Natural.
  • Higher quality new bone bridging. PEEK- Optima HA Enhanced provided a more favorable environment, with higher quality local bone at six and 12 weeks compared with PEEK-OPTIMA Natural.
  • Enhanced mechanical performance. PEEK- Optima HA Enhanced devices outperformed allograft, with fracture of the allograft devices in 6/13 (46%) instances.

A previous study had evaluated and compared the bone ongrowth that resulted from the use of the two implantable polymers in a bone defect model in sheep, and revealed that PEEK- Optima HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation compared with PEEK- Optima Natural.5

 

 

READ THE REST HERE

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Histogenics Corporation to Present at Upcoming Investor Conferences

Posted On February 20, 2018 By OrthoSpineNews In Biologics /  

WALTHAM, Mass., Feb. 20, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that Company Management will be presenting at two upcoming healthcare investor conferences.

  • Canaccord Genuity 2018 Musculoskeletal Conference – New Orleans (March 6, 2018)

    Adam Gridley, Histogenics’ CEO, will present a corporate overview on Tuesday, March 6, 2018 at 8:00 a.m. CT / 9:00 a.m. ET.  The conference immediately precedes the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting and explores the current state of orthopedics, biologics, imaging, robotic surgery, tissue sculpting, and regenerative tissue companies.
  • Cowen and Company 38th Annual Health Care Conference – Boston, MA (March 12-14, 2018)

    Mr. Gridley will present a corporate overview on Wednesday, March 14, 2018 at 8:40 a.m. ET.

To access a live audio webcast of the presentations on the “Investor Relations” page of the Histogenics website, please click here.  The webcasts will be available for approximately 45 days following the respective conferences.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart®, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and may prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit www.histogenics.com.

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Bone Therapeutics SA completes patient recruitment for Phase IIA Spinal Fusion study with ALLOB®

Posted On February 19, 2018 By OrthoSpineNews In Biologics /  

Gosselies, Belgium, 19 February 2018, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it has completed the recruitment of its Phase IIA lumbar spinal fusion study with its allogeneic bone-cell therapy product, ALLOB®. Given this timing, efficacy and safety data for the full set of 32 patients are expected mid-2019, following a follow-up period of 12 months.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are pleased to announce recruitment of the last patient into our Phase IIA spinal fusion study with ALLOB®, on schedule. Our promising interim results showed bone formation in ALLOB®-treated patients, who also reported significant improvement in pain and day to day functional abilities. We look forward to reporting the full data set in mid-2019 as further positive results would continue to confirm the potential of our allogeneic cell therapy product to provide patients and physicians with improved treatment outcomes.“

The Phase IIA trial in lumbar spinal fusion is designed to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to achieve fusion of the lumbar vertebrae. Endpoints of the study include radiological assessments: the evaluation of fusion and intervertebral mobility; and clinical assessments: the improvement in functional disability and reduction in pain; and safety assessments. Positive interim safety and efficacy results were reported in September 2017.

About Spinal Fusion

Due to ageing populations and sedentary lifestyles, an increasing amount of people are suffering from degenerative spine disorders. Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, – placed into the intervertebral space – for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Over 500,000 lumbar spinal fusions are performed each year in Europe and the US and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-union and failure to relieve pain are still frequent and up to 35% of spinal fusion patients are not completely satisfied with their surgery.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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