Paris High Court Rules in Favor of CoorsTek in Lawsuit Claiming Trademark Infringement of Ceramic Orthopaedic Hip Componets

Posted On March 12, 2018 By OrthoSpineNews In Regulatory /

March 07 2018

Paris, France – CoorsTek today announced that the Paris High Court has ruled in its favor in a lawsuit brought by CeramTec GmbH attempting to block the manufacture and sale of CoorsTek’s CeraSurf®-p “pink” ceramic hip components.

In its ruling, the Paris High Court stated that CeramTec sought to “indefinitely perpetuate the technical effect” of its patent covering its Biolox Delta materials—which expired at the same time CeramTec was filing for its “pink” trademarks—in order to prevent its competitors from selling products using the once patented composition. The court found that CeramTec’s actions at the time of filing the trademarks were done in bad faith. The results of this judgement are that CeramTec’s European Union trademark registrations related to the color pink as applied to ceramic implants are invalid and unenforceable throughout the European Union, and that CeramTec’s infringement action against CoorsTek was dismissed.

“CoorsTek is pleased with this decision as it supports CoorsTek’s efforts to be able to provide medical device manufacturers with additional access to high-quality, substantially equivalent implantable ceramic components,” said Jonathan Coors, Co-CEO of CoorsTek. “This ruling is one more step in opening up the implantable device market to further competition, benefitting patients and enabling CoorsTek to achieve its mission of making the world measurably better.”

The inherent pink color of CoorsTek CeraSurf®-p ceramic material is a natural result of the chromium oxide dopant used in the ceramic matrix to provide a combination of hardness and toughness. CeraSurf®-p ceramic hip implant femoral heads (hip balls) and acetabular liners (cups) demonstrate extreme durability and longevity in applications due to a combination of high-performance ceramics, metals and polymers. CeraSurf®-p ceramic femoral heads and acetabular liners have received regulatory approvals and have been distributed for clinical use as bearing surfaces for hip implant systems in South America since 2011 and Europe since 2012, and received FDA 510(k) clearance in the U.S. in 2016.

CeramTec originally brought the suit against CoorsTek in 2013, claiming the development and marketing of the pink CoorsTek acetabular liners and femoral heads was in direct violation of its now invalid European Union trademark registrations.

The Paris High Court decision follows a similar ruling in January 2017, when the U.S. District Court for the District of Colorado ruled in favor of CoorsTek in its lawsuit challenging CeramTec’s claims to the color pink for implantable ceramic components. In that ruling, the U.S. District Court stated that CeramTec does not own any trademark or trade dress rights in the color pink in the U.S. and enjoined CeramTec from interfering with the rights of CoorsTek Medical to market CeraSurf®-p ceramic components in the United States.

Kuros Biosciences obtains European patent covering osteoinductive materials

Posted On March 12, 2018 By OrthoSpineNews In Regulatory /

Schlieren (Zurich), Switzerland, March 12, 2018

Kuros announced today that its Dutch subsidiary, Kuros Biosciences BV, has been granted the European patent, EP3021878, entitled “Method for producing an osteoinductive calcium phosphate and products thus obtained” by the European Patent Office (EPO).

The patent covers Kuros’ technology for osteoinductive calcium phosphates and their methods of production. The resulting unique surface topography instructs the body’s own stem cells and osteoprogenitor cells to differentiate into bone forming cells. It forms part of the portfolio of patents and patent applications that Kuros is putting in place to protect its MagnetOs product family. The MagnetOs family of bone graft substitutes are based on biphasic calcium phosphate materials with a novel submicron surface structure designed to regenerate bone in the implanted site in the body. These highly sophisticated materials have been demonstrated to perform equivalently to autograft in clinically-relevant preclinical models.

“The grant of this patent by the EPO broadens the intellectual property estate around our advanced bone graft substitute materials and reinforces Kuros’ leadership in the field of bone graft substitutes.”, said Joost de Bruijn, CEO of Kuros.

About MagnetOs

MagnetOs Granules have CE Mark approval in the EU as a bone void filler for craniomaxillofacial, orthopedic and dental applications with an osteoinductive claim. MagnetOs Granules and MagnetOs Putty both have US 510k clearance with an osteoconductive claim for use with autograft as a bone graft extender in the posterolateral spine.

For further information, please contact:

Hans Herklots

Lifesci Advisors

hherklots@lifesciadvisors.com

+41 79 598 7149

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

Exactech Receives 510(k) Clearance for Equinoxe® Stemless Shoulder

Posted On March 12, 2018 By OrthoSpineNews In Regulatory /

March 12, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the Equinoxe® Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe® Shoulder System. The Stemless Shoulder is the latest addition to the company’s extremities product line.

“Our world-class design team and engineers deserve a lot of praise for this new product, and in particular, for an efficient product development process. Their ingenuity, coupled with their passion for clinical outcomes, allowed them to navigate this product to market very quickly, and is emblematic of our mission to help patients,” said Darin Johnson, Exactech vice president of marketing for extremities.

Designed for anatomic total shoulder arthroplasty, the Stemless Shoulder features a single tray of instruments for operating room efficiency. It uses a three-dimensional porous structure with optimized pore size, count and porosity. In addition, the Stemless Shoulder incorporates a bone cage for bone through-growth to enhance the probability of biologic fixation.

“The Stemless Shoulder’s innovative combination of three-dimensional porous material and bone cage technology help differentiate it from others on the market,” said design team member Buddy Savoie III, MD, of Tulane University. “Exactech’s ability to convert design team concepts and ideas into a reality is quite impressive, and I am certain surgeons will be eager to learn more about this meaningful technology.”

Joining Dr. Savoie on the design team were Pierre-Henri Flurin, MD, of Clinique du Sport in Bordeaux-Mérginac, France; Curtis Noel, MD, of Crystal Clinic Orthopaedic Center in Akron, Ohio; Ryan Simovitch, MD, of Palm Beach Orthopaedic Institute in Palm Beach Gardens, Fla.; Thomas Wright, MD, of the University of Florida; and Joseph Zuckerman, MD, of NYU Langone Orthopaedic Hospital.

Exactech plans to initiate targeted clinical evaluation of the Stemless Shoulder immediately, and will aggressively expand the release throughout the second half of the year.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President Corporate & Marketing Communication
media@exac.com

DeGen Medical Receives E3 MIS™ System FDA Clearance

Posted On March 9, 2018 By OrthoSpineNews In Regulatory /

Florence, S.C., March 09, 2018 (GLOBE NEWSWIRE) — DeGen Medical announced the FDA clearance of E3 MIS™ Modular Pedicle Screw System for thoraco-lumbar spine. E3 MIS™system addresses a wide range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods. It allows the surgeon intra-operative flexibility for bone grafting and screw placement. The screw thread is specifically engineered to combine the option for standard or cortical screw placement.

E3 MIS™ System allows surgeons three different MIS towers to choose from inter-operatively in a two-tray configuration.

The E3 MIS™ System features:

Modular tulip heads and screws compatible with the current F1 MPS™ system and 5.5mm rod offerings.
Several titanium alloy and cobalt-chrome modular screw head options, including MIS and Spondy.
A complement of surgical instruments to facilitate MIS and Open approaches.
Screw sizes starting at 4.0mm diameter (solid) and 4.5mm diameter (cannulated) through 10mm diameter.
Cortical-cancellous thread design or F1 MPS™ thread design.
Four different options for percutaneous rod insertion.
MIS towers range from 11mm to 16mm in diameter.

DeGen Medical would like to thank the following doctors for their contributions to this innovative and versatile system: Dr. Rakesh Chokshi, Dr. P. Douglas deHoll, Dr. Gene Massey, and Dr. Daniel Williams.

About DeGen Medical, Inc.

DeGen Medical, Inc. is a medical-device development company dedicated to providing surgeons with innovative products engineered to improve quality of life for patients with complex spinal disorders. World-class implants, coupled with intuitively-designed instrumentation, provide a complete package to promote superior surgical outcomes. Our passion to advance spine-care solutions is driven by clinical insights, sound research, and science-based design. DeGen Medical maintains the highest quality standards to provide reliable products and safeguard patient health.

For more information, please contact:

Jessica McCracken
DeGen Medical, Inc.
843-407-0538
jessica@degenmedical.com

Attachment:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2ed524a9-c64f-4c18-9ba2-985de87ecff0

AmnioFix® Injectable Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA for the Treatment of Osteoarthritis of the Knee

Posted On March 9, 2018 By OrthoSpineNews In Regulatory /

MARIETTA, Ga., March 9, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that the U.S. Food and Drug Administration (FDA) has granted MiMedx’s micronized amniotic tissue, AmnioFix® Injectable, the Regenerative Medicine Advanced Therapy (RMAT) designation for use in the treatment of Osteoarthritis (OA) of the knee.

In its letter to the Company, the FDA confirmed its determination that MiMedx Allogeneic Micronized Dehydrated Human Amnion/Chorion Membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for RMAT designation. The FDA further stated that MiMedx has provided clinical information to demonstrate preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for this condition.

In granting the RMAT designation to MiMedx AmnioFix Injectable for use in the treatment of OA of the knee, the FDA committed to a multidisciplinary comprehensive discussion with MiMedx regarding the Company’s development program, including planned clinical trials and plans for expediting the manufacturing development strategy.

“The FDA’s RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need. We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA,” said Parker H. “Pete” Petit, Chairman and Chief Executive Officer.

“AmnioFix Injectable has been shown to have the potential to reduce pain and improve function in patients with OA of the knee. Given the lack of treatment options for patients with this condition, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new front-line therapy,” added Bill Taylor, President and COO. “In addition, we believe AmnioFix Injectable has the potential to become a blockbuster therapeutic biologic, with long-term peak revenue potentially exceeding $4 billion for musculoskeletal pain management within the more than $12 billionaddressable U.S. joint pain injection market.”

An investigational regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious condition, and if preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition.

“Our clinical, scientific and regulatory team has done a superb job in the development of this product, and we are very fortunate to have such a talented and dedicated team in our organization,” noted Taylor.

The FDA will also provide MiMedx with intensive guidance on efficient drug development, as well as an organizational commitment to involve senior management in facilitating the product’s development program. The RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interaction with sponsors, which may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About Osteoarthritis of the Knee

Osteoarthritis of the knee is an irreversible and persistent condition, prevalent in adult populations and even more so in older populations, associated with pain, restricted mobility, swelling and ultimately joint instability that can significantly limit day-to-day functioning. Osteoarthritis affects an estimated 31 million Americans and is the leading cause of disability in American adults. Prevalence increases with age ranging from about 2% among persons under age 45 and more than 80% among those over 75. Symptomatic OA of the knee presents in 14 million Americans including 2 million under the age of 45, and more than 6 million between the ages of 45 and 64.

The disorder occurs when the joint surface cartilage (also called hyaline cartilage or articular cartilage) becomes worn away leaving the raw bone beneath exposed. The cartilage normally serves as a “pad” or a bearing in the joint. When the bearing wears away, the result is a roughed joint surface that causes the pain and stiffness associated with osteoarthritis.

Knee osteoarthritis is the leading cause of limitations in activities of daily living such as walking and climbing stairs. Knee osteoarthritis symptoms often develop slowly and may become markedly worse over time or with specific activities. Characteristic signs and symptoms of osteoarthritis include stiffness, pain, soreness, inflexibility, swelling, grating/creaking, bone spurs and deformity. While knee osteoarthritis is often a progressive and irreversible degenerative process, functional improvement and pain control are the most common treatments used to treat this condition.

About MiMedx

MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements that may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

InVivo Therapeutics Receives FDA Approval for Pivotal, Randomized, Controlled Trial of the Neuro-Spinal Scaffold™ in Patients with Acute Spinal Cord Injury

Posted On March 8, 2018 By OrthoSpineNews In Regulatory /

March 08, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the company has received supplemental Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for a second pivotal clinical study of the company’s Neuro-Spinal Scaffold™ in patients with acute spinal cord injury (SCI). The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the company’s single-arm INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury). The definition of study success is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on AIS assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%.

InVivo recently reported that seven of 16 (43.8%) evaluable patients in the INSPIRE study experienced an improvement in AIS grade from baseline at six months compared to the Objective Performance Criterion (study success definition) of 25% of patients. Of these seven patients, three of five individuals who had converted from AIS A SCI (complete) to AIS B SCI (sensory incomplete) in the first six-month period of follow-up subsequently further improved to AIS C SCI (motor incomplete) within 12 to 24 months, including a recent patient who converted from AIS B to AIS C at the 12-month exam in January 2018.

Richard Toselli, M.D., President and Chief Executive Officer of InVivo, commented, “We are pleased to announce the FDA’s approval of this randomized, controlled trial and appreciate the agency’s collaboration with us on the development of a protocol to address the substantial unmet needs in this patient population. We believe this now sets us in a direction towards a clear and efficient path to approval under the HDE regulatory program, and we are focused on engaging with the investment community and exploring financing mechanisms to support this approved randomized study. We look forward to providing further updates as we obtain clarity on financing and the timing for our second pivotal trial.”

“InVivo has achieved important milestones with the FDA over the past seven months under Dr. Toselli’s leadership,” stated Ann Merrifield, InVivo’s Chair of the Board of Directors. “I wish to commend Rich and his team in their continuing interactions with the FDA and their strategy for advancing this important program in the clinic.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the status of the company’s clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s discussions and engagement with the FDA; the company’s ability to initiate, conduct and complete clinical trials; the expected benefits and potential efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical trials and future product commercialization; and other risks associated with the company’s business, research, product development, attainment of regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended September 30, 2017 and its other filings with the SEC, including the company’s most recent Form 10-K, its Form 10-Qs and its current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Amedica announces FDA Clearance of the Valeo C+CSC with Lumen Interbody Fusion Device

Posted On March 7, 2018 By OrthoSpineNews In Regulatory /

SALT LAKE CITY, UT, March 06, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride as a platform for biomedical applications, is pleased to announce the U.S. Food and Drug Administration (FDA) clearance of the Valeo C+CsC with Lumen Interbody Fusion Device.

The Valeo C+CsC with Lumen Interbody Fusion Device is a composite spinal fusion implant that combines different densities of Amedica’s proprietary medical grade silicon nitride ceramic. An outer shell of solid silicon nitride is manufactured around a porous core, called CsC (Cancellous structured Ceramic). The Valeo C+CsC device is already used in Europe, and the Valeo C+CsC with Lumen is the introduction of this porous technology in the USA.

“This FDA clearance of CsC is a significant milestone for Amedica. CsC reflects a truly unique technology. In addition to being the first structural porous bioceramic available in a medical implant, our published clinical data from the CASCADE clinical trial have shown that CsC can achieve spinal fusion sua sponte, i.e., in the absence of added bone grafts, and with success rates at least as favorable as bone autograft, i.e., the gold standard in bone fusion. The European device design was submitted earlier to the FDA, and the approved version is a design modification of the same material, based on feedback provided by the FDA.” stated Dr. Sonny Bal, Chairman and Chief Executive Officer for Amedica.

“Since developing silicon nitride for spinal fusion, Amedica has investigated this highly-differentiated biomaterial platform extensively, and its most recent scientific data show that under appropriate experimental conditions, silicon nitride induces the expression of hydroxyapatite and collagen, the key constituents of bone, even in the absence of living cells. Medical-grade titanium, and polymers like PEEK, which are widely used in spinal fusion, do not exhibit this osteoinductive property” added Dr. Bal.

“In addition to attracting new surgeon users and investigators, approval of the Valeo C+CsC with Lumen Interbody Fusion Device in the U.S. market opens the door to new designs of spinal fusion devices that may reduce or eliminate the need for added bone grafts. In the value-based economic climate of health care today, the ability of CsC to achieve bone healing without the added expense and complexity of bone grafts is a practical advantage. When combined with the other well-established attributes of silicon nitride, i.e., ease of viewing on every radiographic imaging modality available today, and bacteriostatic properties against a variety of bacterial species, CsC is truly without parallel among biomaterials”

Dr. Bal further stated that “beyond CsC, Amedica will continue its commitment to a strong R&D program that remains focused on developing additional key technologies related to silicon nitride.”

The Valeo C+CsC with Lumen Interbody Fusion Device is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. Additional information about Amedica’s complete line of products can be found at www.amedica.com.

About Amedica Corporation

Amedica is focused on the development and application of interbody implants manufactured with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty as well as dental applications. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM and private label partnerships.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward looking statements include: the statement that approval of the Valeo C+CsC with Lumen Interbody Fusion Device CsC in the U.S. market opens the door to new designs of spinal fusion devices; that when combined with the other well-established attributes of silicon nitride, CsC is truly without parallel among biomaterials. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K/A, filed with the Securities and Exchange Commission (SEC) on December 27, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:

Amedica IR
801-839-3502
IR@amedica.com

Synergy Biomedical Announces Regulatory Clearance and Launch of BIOSPHERE PUTTY in Australia

Posted On March 6, 2018 By OrthoSpineNews In Regulatory /

March 06, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of orthobiologic and biomaterial products, announced that it has received Therapeutic Goods Administration (TGA) clearance in Australia for its bioactive bone graft, BIOSPHERE PUTTY. BIOSPHERE PUTTY is an advanced synthetic bone graft product that has previously received FDA and CE Mark clearances, and has been on the market since 2013.

“We are very pleased with our TGA clearance and are excited to launch this innovative, synthetic bone graft in Australia,” indicated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “This clearance enables more surgeons worldwide access to our next-generation bone graft technology.”

“The launch of BioSphere Putty in Australia represents a significant milestone in expanding our distribution across the globe,” stated Kevin Booth, VP of Sales. “The Australian market provides Synergy with a sizable opportunity to grow our BioSphere Putty sales.”

BIOSPHERE PUTTY is a synthetic bone graft that utilizes a unique, spherical form of bioactive glass in combination with a resorbable carrier. The product provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass. The use of spherical particles allows for precise control over the properties of bioactive glass, and results in an optimal bone healing response. BIOSPHERE PUTTY is the first of several bioactive glass products being developed by Synergy Biomedical.

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing, and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com

Simplify Medical Announces 50th U.S. Patent for Innovative Cervical Disc Replacement Portfolio

Posted On February 27, 2018 By OrthoSpineNews In Regulatory, Spine /

February 27, 2018

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced receipt of the company’s 50^th U.S. patent for its innovative cervical motion preservation intellectual property (IP) portfolio. The Simplify Disc is designed to minimize patient risk associated with radiation, optimize long-term durability, simplify implantation and increase access to cervical disc replacement for patients with smaller anatomies.

The company’s 50^th patent, U.S. Patent No. 9,883,945, is entitled “Artificial Intervertebral Disc with Lower Height” and relates to the unique low-profile and more anatomically-shaped disc design. Other recent patents include U.S. Patent No. 9,839,532, covering Simplify Medical’s proprietary methods for inserting intervertebral discs in a less traumatic manner, and U.S. Patent No. 9,839,525, relating to implanting intervertebral discs with a movable core and a protrusion for holding the core captive between endplates.

“Simplify Medical is committed to innovation that improves clinical outcomes for patients with degenerative disc disease,” said Simplify Medical CEO David Hovda. “We believe Simplify Medical has the largest and most impactful IP portfolio in the spine motion preservation space, and we continue to invest in technology to further optimize patient outcomes and surgical ease of use.”

The Simplify Disc is anatomically designed with low height implant options, as low as four millimeters, to treat a broad range of patients, including patients with smaller cervical disc spaces.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on magnetic resonance imaging (MRI) in order to minimize post-operative patient exposure to radiation from computed tomography (CT) scans currently necessary to view metal discs. While MRI is widely used pre-operatively for surgical planning, spine surgeons often switch to CT scans post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

The Simplify Disc is being studied in two U.S. pivotal trials. The one-level, prospective trial comparing Simplify Disc with cervical fusion surgery at one level between C3 to C7 has completed enrollment. Use of the Simplify Disc in two levels of the spine is being studied in a second IDE trial in the U.S., which is approximately 40 percent enrolled, and enrollment is expected to be completed by the end of 2018. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. For information about eligibility or enrollment in the two-level pivotal trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA XP Expandable Spacer System

Posted On February 6, 2018 By OrthoSpineNews In Regulatory, Top Stories /

February 06, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ: OFIX), a global medical device company focused on musculoskeletal healing products, today announced the 510(k) clearance and U.S. limited market launch of the FORZA® XP Expandable Spacer System.

Designed to restore normal disc height in patients suffering from degenerative disc disease, the FORZA XP Expandable Spacer System can be expanded after insertion into the disc space in order to fit the patient’s anatomy. Made primarily of titanium alloy, these expandable interbodies are used for PLIF (Posterior Lumbar Interbody Fusion) and TLIF (Transforaminal Lumbar Interbody Fusion) procedures. Unlike the incremental expansion offered by some expandable interbody devices, the Orthofix System allows for a continuous controlled expansion and a custom fit to the disc space. Once the desired expansion is achieved the device features automatic locking which further adds to its ease of use.

“The FORZA XP Expandable Spacer System is a strong addition to our robust portfolio and makes Orthofix competitive in one of the fastest growing segments in spine,” said Ray Fujikawa, President of Orthofix Spine Fixation. “This new system offers an industry-leading 6.5mm starting height and also enables surgeons to place bone graft material inside the device after implantation. The ability to pack our new expandable device with bone graft post expansion is extremely important to ensure proper contact of the material with the vertebral endplates.”

The FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine. The FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation such as the Orthofix Trinity ELITE® allograft tissue and the Firebird® Spinal Fixation System.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix, International N.V.
Investor Relations:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

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