DermaPace Technology Suggests Promising Outcomes of Acoustic Pressure Shockwave Treatment for Venous Leg Ulcers (VLU)

SUWANEE, GA, March 08, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, announces the publication of research that investigated the use of the dermaPACE® System in the treatment of Venous Leg Ulcers (VLU) in a case study series.  The study, titled “Treating venous leg ulcers with Extracorporeal Shockwave Technology (ESWT)” by Charne Miller (LaTrobe University), Suzanne Kapp (University of Melbourne), Jade Green (LaTrobe University), William McGuiness (LaTrobe Alfred Health Clinical School), and Michael Woodward (Austin Health/University of Melbourne), appeared in Wounds International 2017, Volume 8 Issue 3.  The case series was implemented at a medical professional lead, multidisciplinary outpatient wound clinic in Melbourne, Australia.

The case study series consisted of 6 patients, meeting eligibility criteria, presenting with venous leg ulcers (VLU) and who agreed to receive the dermaPACE treatment.  In order to better understand wound response to dose and energy, treatment selection used the two highest energy settings on the dermaPACE System, delivered at a frequency of 240 pulses/min. The shockwave pulse count was a function of wound area (cm2) with larger wounds requiring more shockwaves for treatment and thus longer time per therapy session than smaller wounds. The protocol used recommended one treatment delivered each week for 10 weeks.

Positive wound healing effects were observed for the majority of patients receiving ESWT.  At the conclusion of the case series the majority of wounds were either healed or healing was anticipated in a subsequent visit.

  • Patient 1 received 5 treatments over the course of 5 weeks, the wound reduced in size from 7 cm2 to 1 cm2 at the final treatment.
  • Patient 2 received 8 treatments over the course of 11 weeks, the wound, with an initial area of 2.5 cm2 at the time of the first treatment, was completely closed by week 16.
  • Patient 3 received 4 treatments over approximately 2 months.  Within 2 weeks of the first treatment, the wound had new areas of epithelialization tissue.  By the end of two months, the wound had epithelialized 100%.
  • Patient 4 received 4 treatments over a 6 week period.  By seven weeks post-initial treatment, the wound was documented as near-closure.
  • Patient 5 received only 1 treatment but continued to receive alternative modalities for treatment over a 5 week period.  In this time, the wound reduced in size from 2.5 cm2 to 1.5 cm2.
  • Patient 6 received a total of 3 treatments over a 3 week period.  The wound size at the first treatment was 1.5 cm2 and increased to 2.5 cm2 in the first two weeks.  By the last treatment, the wound presented with a reduction in the extent of hypergranulation and healthier wound margin.

The purpose of this case series was to expand evidence regarding the viability and the concurrent healing outcomes when using ESWT to treat venous leg ulcers.  The capacity to deliver the scheduled weekly treatments was not, however, achieved in any instance. Participants did find the treatment to be acceptable. Pain was reported only twice and was concurrent to reports of wound pain.

The active treatment itself would typically last for only 2-3 minutes with preparation and clean up also requiring only approximately additional five minutes of time, making ESWT an extremely practical therapy to implement in a busy clinic environment. However, the capacity to see patients weekly was difficult to realize for a variety of reasons.  This case study series is one of the first to document the use of dermaPACE in “real-life” conditions and not under the controlled settings seen in typical clinical investigations.  This study represents a low level of evidence regarding the viability and effect of ESWT in treating venous leg ulcers. The method which is characterized by a small sample and the absence of a comparison group represent limitations in comparison to more rigorous research methodologies. However, the case series is an appropriate research design for a burgeoning area of clinical enquiry, where questions regarding feasibility, acceptability, and effectiveness remain.

Suzanne Kapp (Visiting Academic, The University of Melbourne/ Honorary Clinical Study Coordinator, Wound Clinic Austin Health) commented, “The treatment can be easily implemented for clinicians, and was generally acceptable for patients.  We were pleased to see positive wound healing outcomes for the majority of participants.  We see the results from this small sample study as the first step in an evolving program of scientific study that will refine the treatment regimen and adopt more rigorous research designs.”  Adds Charne Miller, Senior Lecturer, LaTrobe University, “The results from this small sample are very encouraging.  It is one of the most promising case series we’ve conducted in terms of wound progress and feasibility. dermaPACE certainly warrants further investigation.”

Kevin A. Richardson II, CEO of SANUWAVE, stated, “We initiated this small case series study to attempt to better understand the response of VLUs to varied energy and shock count delivery.  The results were much better than anticipated, especially where adherence to the defined protocol was limited.  This small example is the first to document the vast series of issues clinicians face in real-life clinical settings.  This furthers our strong belief that dermaPACE will fill an unmet need in the wound care community to provide safe, effective, and fast treatment of wounds.  Enhancing wound management will help to improve the patient’s quality of life, reduce the medical risks associated with uncontrolled wounds, and also reduce health management costs.  SANWUAVE is excited to work with Dr. Kapp and the rest of the team in Melbourne to determine the next steps in developing a full treatment regimen.”

The dermaPACE System received US FDA clearance in late December for the treatment of Diabetic Foot Ulcers (DFU).  The DFU market is 1.5 million cases per year in the US.  The VLU market is larger at 2.5 million cases per year, but the overall costs are similar to the market size of DFU.  This is a natural extension as SANUWAVE expands its indications in the wound category.  This is a first step in preparing clinical work to expand our indication into VLU’s.  We are looking forward to expanding our clinical work with the folks in Australia and launching some work in the US later this year.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. ( is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, received US FDA clearance in December 2017 for the treatment of Diabetic Foot Ulcers.  dermaPACE is the only Extracorporeal Shockwave Technology (ESWT) device cleared or approved in the US for the treatment of DFUs.  Internationally, dermaPACE is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand, and South Korea.  SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/PacificIn addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

For additional information about the Company, visit


Millennium Park Capital LLC
Christopher Wynne

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board

CellRight Technologies Signs Multi-Year Distribution Agreement With Arthrex, Inc.

March 06, 2018

SAN ANTONIO–(BUSINESS WIRE)–Tissue Regenix Group (AIM:TRX) (“Tissue Regenix” or “The Group”) the regenerative medical devices company today announces subsidiary CellRight Technologies (“CellRight”) has signed a long-term, multi-year distribution agreement with Arthrex, Inc., a premier innovator of orthopaedic surgical solutions.

CellRight, which produces industry leading verified osteobiologics for use in orthopaedic, spine and foot and ankle procedures, enhances the healing opportunities of defects caused by trauma and disease.

The multi-year commitment will give surgeons access to verified osteobiologics and advanced surgical instrumentation and techniques to help influence better patient outcomes.

“This long-term distribution agreement will allow physicans and patients better access to CellRight’s innovative orthobiologics through the Arthrex network,” said Jesus Hernandez, CEO for CellRight Technologies. Our shared vision of offering surgeons total solutions which can positively impact patient outcomes solidifies the decision of both companies to work together.”

Steve Couldwell, CEO Tissue Regenix Group plc commented: “This is a flagship distribution agreement for CellRight and the wider Tissue Regenix Group. It highlights the value of strategic partnerships with prestigious companies in this space. We look forward to working with Arthrex to bring the CellRight product portfolio to an extended network of healthcare professionals.”

CellRight Technologies and TRX Orthopedics, will be exhibiting at the American Academy of Orthopaedic Surgeons in New Orleans, March 7-10 and can be found at booth #5413.

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company’s patented decellularisation (‘dCELL®‘) technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, rebranded TRX BioSurgery in February 2018. January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight’s human osteobiologics may be used in spine, trauma, general orthopedic, foot & ankle, dental, and sports medicine surgical procedures.


Tissue Regenix Group plc
Caitlin Pearson Head of Communications
Tel: (+44) 330 430 3073 / 07920272 441
FTI Consulting
Brett Pollard / Mo Noonan/ Rob Winder
Tel: 0203 727 1000

Bioventus Launches DUROLANE® in the US

March 05, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today launched DUROLANEits 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 injection2DUROLANE 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 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, 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.


Thomas Hill, 919-474-6715

(Photo: Business Wire)

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

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

Media Contact: Therese Montano / 502-714-7234 /



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

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.

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

  • 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

Heraeus Medical to Introduce Medium Viscosity Bone Cement and Vacuum Mixing System Innovations at AAOS 2018 Annual Meeting

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 EuropeAustralia, 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 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

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Leader Biomedical announces acquisition of International Orthopaedics Holding GmbH

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 (

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 (

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.

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

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 and Dural Repair Solutions at

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

Contact: Margo Lane


SOURCE Collagen Matrix, Inc.

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Bioventus to Co-Develop Next Generation Bone Allograft with LifeLink

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 or LifeLink Tissue Bank at

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 and follow the company on Twitter @Bioventusglobal.

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Bioventus LLC
Thomas Hill, 919-474-6715

The biomaterial of next-gen spinal implants

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