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February 2-4, 2017
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FinancialRegulatoryTop Stories

Stryker awarded $248.7 million in patent case against Zimmer

July 13, 2017 OrthoSpineNews

Nate Raymond / July 13, 2017

(Reuters) – A U.S. judge has increased the amount medical device maker Zimmer Biomet Holdings Inc must pay Stryker Corp for infringing patents on a surgical cleaning wand to $248.7 million following a ruling by the U.S. Supreme Court.

The ruling by U.S. District Judge Robert Jonker in Grand Rapids, Michigan, on Wednesday came after the Supreme Court in June 2016 ruled for Stryker in finding that judges should have more discretion to boost penalties in patent infringement cases.

Stryker declined to comment on Thursday. Zimmer did not immediately respond to a request for comment.

The ruling came in a lawsuit filed in 2010 by Kalamazoo, Michigan-based Stryker that claimed its competitor’s Pulsavac Plus device for cleaning wounds during orthopedic surgical procedures infringed three of its patents.

In 2013, a federal jury awarded Stryker $70 million in lost profits and found Warsaw, Indiana-based Zimmer’s conduct to have been willful.

Jonker later that year ruled Stryker deserved triple damages based on the “flagrancy and scope of Zimmer’s infringement.” With other fees, the award came to $228 million.

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Regulatory

MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy

July 11, 2017 OrthoSpineNews

NEW YORK, July 11, 2017 /PRNewswire-USNewswire/ — In an address given in Paris, France to delegates attending the 13th annual IMPLANTS conference on orthopedic innovation, U.S. executive David W. Lown advised that companies will be left behind in a crowded orthopedic market unless they adopt an integrated and compliant research,  development, and commercial access strategy.

Mr. Lown, General Manager of Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), noted that the complexity of clinical, regulatory and reimbursement dynamics can present many unforeseen business challenges to even the most experienced industry veterans. “Every phase of the technology lifecycle is becoming more interwoven and multifaceted,” he said.  “Given the substantial size of the device industry and the increasing concerns of rising healthcare costs, the Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and numerous other governmental and private stakeholders all have a seat at the table in influencing whether industry has proved safety, efficacy, and cost effectiveness over existing treatments. Although governmental and private constituents act individually for the most part, industry must execute their business strategies in an integrated fashion so that marketing claims are consistent with regulatory claims which are consistent with reimbursement coding and coverage, in order to compliantly adhere to the multiple U.S. laws of these constituents. Lastly, clinical evidence requirements are increasing on most technologies, both new and existing, thereby increasing the investment required for successful commercialization, which is putting additional strain on both companies and private investors to further invest in advancements.”

MCRA was founded in 2004 and has partnered with nearly 500 clients globally to design and execute integrated product development strategies.  “Since the 1960’s, the orthopedic industry was focused on bringing innovation accessible to surgeons in a quick and cost efficient manner. Device companies must realize today that industry-wide evidence requirements are quickly becoming analogous to the pharmaceutical industry and for those who invest properly both value creation and risk mitigation will be the reward.” Mr. Lown advised.

Full details of the proceedings of IMPLANTS 2017 are available at www.implants-event.com. For more information about MCRA go to: www.mcra.com.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.

Contact
David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

 

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Related Links

http://www.mcra.com

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RegulatorySpineTop Stories

K2M Receives FDA Clearance & CE Mark for NILE® Proximal Fixation Spinal System

July 6, 2017 OrthoSpineNews

LEESBURG, Va., July 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark for its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation. NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for NILE Proximal Fixation also includes the use of anchors, which are not cleared for use in the United States.

“I have used many band technologies for proximal construct augmentation from different companies and NILE Proximal is a huge leap forward in simplifying the design to achieve this goal,” said Greg Mundis, MD, a surgeon specializing in pediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, California. “K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion.”

I am excited about this addition to the NILE product family,” said John Ferguson, MD, an orthopedic spine surgeon in Auckland, New Zealand. “The implants are straightforward and easy to use. I think this product will be a very useful addition to many of my complex procedures.”

NILE Proximal Fixation has a versatile application in complex procedures, from scoliosis to adult degenerative. The NILE bands are manufactured from polyethylene terephthalate and can be used to provide additional fixation in a MESA® , MESA 2, EVEREST®, or DENALI® Spinal System construct through sublaminar passage or attachment to an anchor (OUS only). The band can then be integrated into the construct using the NILE transverse or medial offset connectors.

“Similar to our recent announcements around MOJAVE™ PL 3D Expandable, SAHARA® AL Expandable, and CAPRI™ Small 3D Static, we are incredibly proud to announce yet another innovative technology in NILE Proximal Fixation,” stated K2M President and CEO Eric Major. “This regulatory milestone—coupled with the recent launch of our Balance ACS™ platform— further emphasizes our focus on achieving three-dimensional spinal balance, and ultimately Total Body Balance, for patients.”

Balance ACS (BACS™) provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the NILE Proximal Fixation Spinal System and K2M, visit www.K2M.com. For more information about Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving threedimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forwardlooking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com

Investor Contact:

Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com

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RegulatorySports MedicineTop Stories

Regenerating Knee Cartilage with Stem Cells: Groundbreaking Clinical Trial Underway at Andrews Institute

July 6, 2017 OrthoSpineNews

GULF BREEZE, Fla., July 6, 2017 /PRNewswire/ — A groundbreaking randomized clinical trial (RCT) evaluating the use of a patient’s own stem cells to regenerate knee cartilage is underway at Andrews Institute for Orthopaedics & Sports Medicine in Gulf Breeze, Florida. The study, led by Adam Anz, M.D., an orthopaedic surgeon at Andrews Institute, is the first multicenter Phase II United States Food and Drug Administration (FDA) observed RCT of its kind.

While early regenerative medicine treatment options utilizing stem cells are currently being used and studied at Andrews Institute to facilitate healing of ligaments and tendons, this is the first time stem cells will be evaluated in a clinical trial to regenerate cartilage in massive knee cartilage injuries.

“In the United States, there are currently no proven treatment options that utilize stem cells to regenerate a patient’s knee cartilage once it has deteriorated,” said Dr. Anz. “This clinical trial is a monumental step to get FDA approved stem cell technology to our patients.”

The study is being conducted in conjunction with the Kuala Lumpur Sports Medicine Center (KLSMC) in Kuala Lumpur, Malaysia, and will be funded in part by the Malaysian government. It will attempt to replicate outcomes from clinical treatments currently available to patients in Malaysia using a cartilage regeneration technology developed by Dr. Khay-Yong Saw, an orthopaedic surgeon who practices at KLSMC.

“The whole concept of regenerating cartilage is totally different from what’s being used now to treat damaged cartilage,” said Dr. Saw. “We are hoping this study will help the FDA evaluate the safety and the effectiveness of this clinical application.”

The RCT will be facilitated through the Andrews Research & Education Foundation, an independent 501(c)(3) not-for-profit entity that serves as the research and education wing of Andrews Institute. The study could take up to six years; however, there may be a possibility to stop the RCT earlier if results show statistical significance.

Baptist Health Care opened the Andrews Institute in 2007. Named for internationally renowned orthopaedic surgeon James R. Andrews, M.D., the Andrews Institute has secured northwest Florida as a cradle for musculoskeletal treatments and research.

SOURCE Andrews Institute for Orthopaedics & Sports Medicine

Related Links

http://www.theandrewsinstitute.com

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RegulatoryTop Stories

MHRA Updates Alert on Metal-on-Metal Hip Implants

June 30, 2017 OrthoSpineNews

Posted 29 June 2017 – By Michael Mezher

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued an alert to healthcare professionals with updated recommendations for long-term follow-up for patients with metal-on-metal hip replacements.

Safety and durability concerns about metal-on-metal hip replacements, along with a scandal involving faulty breast implants, were a driving factor in the EU’s decision to overhaul its medical device and in vitro diagnostics regulations.

Previously, MHRA’s recommendations focused on larger metal-on-metal hip replacements (≥36mm) and certain implants made by Johnson & Johnson subsidiary DePuy Synthes, which were thought to be riskier than other types of metal-on-metal hips.

In August 2010, DePuy recalled two models of its ASR hip replacement systems, and in 2013 the UK’s National Health Service (NHS) stopped performing most metal-on-metal hip replacements, citing high failure rates. However, tens of thousands of patients in the UK still have the devices implanted.

 

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RegulatorySpineTop Stories

Meditech Spine Releases CURE LP System and Talos® HA Peek Spacers as Comprehensive Solution for Surgeons

June 30, 2017 OrthoSpineNews

ATLANTA, June 29, 2017 /PRNewswire/ — Meditech Spine, LLC, announced today it has received 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP allows surgeons to utilize the lumbar plating system along with Meditech’s innovative lumbar Talos® fusion devices, which are manufactured with PEEK-OPTIMA™ HA Enhanced polymer offered by Invibio Biomaterial Solutions. These devices are essential in the market, as an estimated 25 percent of thoraco-lumbar interbody fusions are performed via the anterior and lateral approaches.

The CURE LP is:

  • A low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent bone screws anchored on the spine from loosening and backing out.
  • Designed with a large graft window for viewing the interbody space.
  • Pre-lordosed for lumbar sacral applications.
  • Available for both anterior and lateral procedures as four-hole or two-hole plates.

“As the anterior and lateral surgical approaches continue to grow, especially as they relate to global sagittal balance and alignment of the spine, we are pleased to receive this clearance so quickly after the clearance for our ALIF and LLIF Talos® HA Peek spacers earlier this month,” says Eric Flickinger, co-founder of Meditech Spine. “This accomplishment is really a testament to our team for their focused efforts in achieving two major milestones this year, and we are privileged to add value to our implant solutions for surgeons and their patients.”

The CURE LP and Talos®-A (HA) Lumbar IBF device will be combined in one tray with streamlined instruments to make it easier for hospital and surgery centers to process the system. Both systems will be provided sterile and pre-packaged to reduce implant related infections and help with implant tracking.

Meditech began its partnership with CURE International, an organization that serves children with physical disabilities in underserved areas of the world, during the development of its CURE Anterior Cervical Plate (ACP), introduced last year. “We are excited to continue building upon our relationship with CURE International and inspired to see how they work tirelessly around the world, bringing healing and hope to those who are less fortunate,” says Flickinger. A portion of proceeds from the sale of every CURE LP plate will help CURE International treat patients in underserved areas who are in need of surgical care.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

Caption & Copyright:

Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved.

INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are registered trademarks of Invibio, Ltd. All rights reserved.

 

SOURCE Meditech Spine, LLC

Related Links

http://www.meditechspine.com/

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RegulatoryTop Stories

Medovex Corporation Schedules First Human Case for DenerveX™ System

June 28, 2017 OrthoSpineNews

ATLANTA, GA–(Marketwired – Jun 27, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), a developer of medical technology products, today announced that it has scheduled its first human cases for its DenerveX™ System in the EU to commence during mid-July, followed by other cases throughout the balance of the month and in August. Dr. Martin Deeg, an Orthopedic Surgeon from Stuttgart, Germany will be the first surgeon to utilize the new device.

The Company previously announced that it had received its first three commercial orders for its DenerveX System on the heels of receiving CE Mark approval for the system allowing it to be marketed in Europe. The first commercial orders of the DenerveX System included both the DenerveX Kit containing the DenerveX Device and the DenerveX Pro-40 Generators for Germany, UK and Italy.

Manny Sablowski, Sr. Vice President of Sales and Marketing, stated, “We are pleased to be building atop recent momentum having established near term dates for the first human cases in the EU. The first human cases follow the recent receipt of stocking orders from our distributors EDGE Medical of Manchester England, TCB Ortho Division of Germany, and AlfaMed of Porto San Giorgio, Italy.”

Sablowski continued, “In recent weeks, we also received additional positive feedback holding a successful DenerveX training session with our Italian distributor. I have high hopes that all our other distributors are equally excited like the AlfaMed team. Their twelve sales representatives are all specialists in the Spinal field and clearly understand Facet Joint Syndrome.”

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem affecting millions each year in the United States, the EU, and rest of the world. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is differentiated from radiofrequency ablation technologies by denervating and removing capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

Published studies indicate that lower back pain is the fifth most common reason for U.S. doctor office visits, the most common cause for activity limitations in persons under the age of 45, and a driver of physician opioid prescribing patterns. Additionally, research indicates that total health care expenditure for LBP in the U.S. exceeds $100 billion dollars annually. The DenerveX System was specifically designed to address long term lower back pain management seeking to alleviate, and/or mitigate pain, in addition to potentially reducing dependence on pharmaceutical based remedies.

The DenerveX System consists of the DenerveX Device Kit, containing a single use medical device and the DenerveX Pro-40 Power Generator. The DenerveX system is not yet FDA cleared.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

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RegulatoryTop Stories

Oklahoma doctor charged in opioid deaths of 5 patients

June 27, 2017 OrthoSpineNews

June 27, 2017 – Justin Juozapavicius

An Oklahoma doctor was charged Friday with second–degree murder in the overdose deaths of at least five patients from the powerful painkillers and other drugs she prescribed, often in combinations that made up an addict’s “holy trinity” of pills, state investigators said.

Oklahoma’s attorney general announced five second–degree murder counts against Regan Nichols, whose patients died while she worked at a Midwest City clinic. An Oklahoma County judge also issued a warrant for her arrest.

Nichols is among several doctors who have been criminally charged or sentenced to prison in the overdose deaths of their patients as the country desperately tries to curb its opioid epidemic. Opioids—primarily prescription painkillers and heroin—were factors in more than 33,000 deaths across the US in 2015, and opioid overdoses have more than quadrupled since 2000, according to the US Centers for Disease Control and Prevention.

“Nichols prescribed patients, who entrusted their well–being to her, a horrifyingly excessive amount of opioid medications,” Oklahoma Attorney General Mike Hunter said Friday. “Nichols’ blatant disregard for the lives of her patients is unconscionable.”

 

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RegulatorySpineTop Stories

Spineology® Announces FDA Clearance of Rampart One™ Anterior Lumbar Interbody Fusion System

June 27, 2017 OrthoSpineNews

June 27, 2017

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in anatomy-conserving surgery™, is excited to announce FDA clearance of the Rampart One Anterior Lumbar Interbody Fusion System.

Rampart One is designed to minimize the exposure and vascular retraction requirements associated with traditional anterior spinal fusion procedures. The system includes both standard and oblique interbody device footprints each with integrated fixation screws.

“Minimizing exposure and retraction are cornerstone elements of all Spineology anatomy conserving designs. We are very excited about this approval and look forward to entering the anterior market in the near future,” said John Booth CEO of Spineology.

“Variable angle instrumentation and integrated guides are colinear with the access, providing the surgeon the ability to keep the incision to a minimum,” said Dr. Jeremy Shore of Boston, Massachusetts.

“For instances where there is limited to no vessel mobility, the Rampart One Oblique footprint is an excellent option,” adds Dr. Clifford Tribus of Madison, Wisconsin.

Rampart One is manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material. This provides an improved osteoconductive surface for bone on-growth while preserving the traditional benefits of PEEK-OPTIMA Natural including a modulus similar to bone, reduced stress shielding and artifact-free imaging.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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BiologicsRegulatoryTop Stories

Bone Therapeutics receives Intent to Grant Notice from European Patent Office for allogeneic bone cell therapy platform

June 26, 2017 OrthoSpineNews

Gosselies, Belgium, 26 June 2017; 7am CEST – 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 the European Patent Office (EPO) has notified the Company of its intention to grant a key patent covering its first-in-class allogeneic cell therapy technology.

Once granted, the patent titled, “Osteogenic differentiation of bone marrow stem cells and mesenchymal stem cells using a combination of growth factors”, will provide legal protection to Bone Therapeutics both for the manufacturing methods and for the distinct cell type used in its allogeneic cell therapy technology. Specifically, the patent covers methods to manufacture differentiated and biologically active osteoblastic (bone-forming) cells from bone marrow stem cells, using a specific combination of growth factors, and also covers a new class of osteoblastic cells suitable for allogeneic administration to the patient.

Bone Therapeutics will now validate the patent in several countries in the European Union, potentially allowing IP protection for its allogeneic bone cell therapy platform until 2029. Patents from the same patent family have already been granted in Japan, Australia and Singapore and applications are pending in the USA, Canada, India and South Korea. ALLOB®, Bone Therapeutics’ most advanced allogeneic bone cell therapy product, is currently being evaluated in Phase I/IIA clinical trials for delayed-union fractures and spinal fusion, for which interim results are expected in the third quarter this year.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “This notice from the European Patent Office confirms our allogeneic bone cell therapy technology is both innovative and distinctive. When granted, this European patent will significantly strengthen our IP position in the field of bone cell therapy, giving us further validation for the scientific and commercial development of our cell therapy products whilst also enhancing our position with respect to new partnerships.”

Dr. Miguel Forte, Chief Medical Officer of Bone Therapeutics, further noted: “Obtaining this patent is an important step in the development of our allogeneic bone cell therapy technology. It will provide a solid IP protection for our current work and for future technological advances, allowing us to continue our efforts to create patient-centric and commercially interesting bone cell therapy solutions.”

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 non-union fractures.

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.

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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