30 Nov

Carmel spine surgeon wins $112M verdict in royalty battle with Medtronic

November 30, 2018 / John Russell Dr. Rick C. Sasso, an Indiana spine surgeon and inventor, has won a sweeping, five-year legal battle against medical-device giant Medtronic, with a jury this week awarding him $112 million in damages. Sasso, 58, president of Carmel-based Indiana Spine Group, had claimed that Medtronic had violated a contract by not paying royalties he was due for spinal implants and screw-implant systems he had invented and sold to the company more than a decade ago. The systems became one of the company’s largest product lines, with annual sales of more than $200 million. Along the way, Medtronic paid Sasso more than $20 million in royalties, but he contended the company shortchanged him, breaching its obligations and acting in bad faith. A six-person jury in Marshall County Circuit Court returned the verdict in favor of Sasso on Wednesday, wrapping up a nearly month-long trial. Medtronic—based in suburban Minneapolis with operations in Warsaw, Indiana—had acknowledged that Sasso played a role in inventing several products. But the company argued Sasso was seeking payment “far in excess of the value of his contributions.” In a regulatory filing Thursday, the company said it has “strong arguments to appeal the verdict” and will file post-trial motions with appellate courts. But Sasso’s attorney, Frederick Emhardt of Plews Shadley Racher & Braun, said the jury—which included two science teachers--spoke loudly with their verdict, sifting through a complicated set of facts and circumstances. “After a month of evidence, they learned much about spine surgery and the business of medical device sales and the need to honor contractual commitments, even if they were made by persons no longer with a company," he said in an email. "In a period of six hours, they unanimously rendered a verdict awarding to a dollar what Dr. Sasso requested—$112,452,269. The jury system is a bedrock of our way of life. It worked exactly the way intended by our founders.” Inventive surgeon For more than a decade, Sasso appeared to have a model business relationship with Medtronic, one of the nation's largest makers of spinal devices. Court papers show Sasso considered himself a key member of the invention and engineering team at Medtronic. In one filing, he pointed out that he “attended several retreats with executives and engineers of Medtronic Spine and other inventors/surgeons like himself.” He added that he “contributed know-how and technical information to all phases of Medtronic Spine’s product designs.” In addition to being an inventor, Sasso "is a world-class—and that’s not exaggeration—spine surgeon,” Plymouth-based attorney Jere L. Humphrey, who served as local counsel in the case, told the Pilot News in Plymouth, Indiana, where the trial was held. “He goes all over the world and gives instructions on how to do spine surgery." Sasso in recent weeks did not respond to several requests from IBJ to comment on the dispute. But in voluminous court filings and interviews with other outlets over the years, a picture emerges of a focused surgeon interested in finding new ways to do things. He grew up in Warsaw, a city nicknamed the orthopedic capital of the world for the prevalence of medical-device companies focusing on the spine and joints. Sasso’s father was a veterinarian, and as a boy, Sasso wanted to become one too. He was accepted into Purdue University, but on his father’s advice, he changed his sights to human medicine and entered Wabash University, according to a 2007 profile story in the college magazine. After getting his bachelor’s degree in 1982, Sasso entered the Indiana University School of Medicine, and later did his residency in orthopedic surgery at the University of Texas Medical School in Houston. During a fellowship at Northwestern University in Chicago, Sasso noticed that surgeons had a difficult time tending certain spinal fractures and were still using primitive methods, such as wires, rods and big hooks. “Nothing made sense,” Sasso told Wabash magazine. “Nothing worked. I’m training with these world experts and they say, ‘Oh yeah, this is the way we do things.’ I think, ‘This is the most ridiculous way.’” So he soon began experimenting with a new system of his own. In 1994, Sasso and an engineer, Dan Justin, filed a patent application for a spine-implant device, involving screws and rods that would provide stability in the upper neck. Around the same time, Sasso formed a start-up company, See LLC, with his brother and father-in-law, to manage his intellectual property. He and Justin were issued a patent in 1997. They initially had trouble getting medical device companies interested in the invention because there were no similar surgical systems on the market, according to court papers filed by Sasso. But Sasso finally had a breakthrough after being introduced to Robert Compton, an Indiana venture capitalist who was president of Sofamor Danek Group, a maker of spinal instruments based in Memphis, Tennessee, that had operations in Warsaw. Compton is well-known in Indiana as one of the early financial backers of the email-marketing firm ExactTarget, which was cofounded by Sasso’s brothers-in-law, Scott Dorsey and Chris Baggott. See LLC transferred its intellectual property rights to Sofamor Danek in return for $100,000 in cash, 1,500 shares of stock, and royalties. Just a year later, Sofamor Danek Group was acquired by Medtronic for $3.3 billion, and in the ensuing years, Sasso entered into several agreements with Medtronic for a series of medical devices related to spinal stabilization.

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30 Nov

Global Hip & Knee Reconstruction Devices Market Outlook to 2027 – Computer-assisted Total Hip Replacement Surgery is One of the Hottest Revolutions – ResearchAndMarkets.com

November 30, 2018

DUBLIN--(BUSINESS WIRE)--The "Global Hip & Knee Reconstruction Devices Market Analysis & Trends - Industry Forecast to 2027" report has been added to ResearchAndMarkets.com's offering. The Global Hip & Knee Reconstruction Devices Market is poised to grow strong during the forecast period 2017 to 2027. Some of the prominent trends that the market is witnessing include rising gap between hospital costs and reimbursements, computer-assisted total hip replacement surgery is one of the hottest revolutions and latest technological developments of hip & knee reconstruction devices. This industry report analyzes the market estimates and forecasts of all the given segments on global as well as regional levels presented in the research scope. The study provides historical market data for 2015, 2016 revenue estimations are presented for 2017 and forecasts from 2018 till 2027. The study focuses on market trends, leading players, supply chain trends, technological innovations, key developments, and future strategies. With comprehensive market assessment across the major geographies such as North America, Europe, Asia Pacific, Middle East, Latin America and Rest of the world the report is a valuable asset for the existing players, new entrants and the future investors. The study presents detailed market analysis with inputs derived from industry professionals across the value chain. A special focus has been made on 23 countries such as U.S., Canada, Mexico, U.K., Germany, Spain, France, Italy, China, Brazil, Saudi Arabia, South Africa, etc. The market data is gathered from extensive primary interviews and secondary research. The market size is calculated based on the revenue generated through sales from all the given segments and sub segments in the research scope. The market sizing analysis includes both top-down and bottom-up approaches for data validation and accuracy measures. Report Highlights
  • The report provides a detailed analysis on current and future market trends to identify the investment opportunities
  • Market forecasts till 2027, using estimated market values as the base numbers
  • Key market trends across the business segments, Regions and Countries
  • Key developments and strategies observed in the market
  • Market Dynamics such as Drivers, Restraints, Opportunities and other trends
  • In-depth company profiles of key players and upcoming prominent players
  • Growth prospects among the emerging nations through 2027
  • Market opportunities and recommendations for new investments
Key Topics Covered 1 Market Outline 1.1 Research Methodology 1.1.1 Research Approach & Sources 1.2 Market Trends 1.3 Regulatory Factors 1.4 Product Analysis 1.5 Strategic Benchmarking 1.6 Opportunity Analysis 2 Executive Summary 3 Market Overview 3.1 Current Trends 3.1.1 Rising gap between hospital costs and reimbursements 3.1.2 Computer-assisted total hip replacement surgery is one of the hottest revolutions 3.1.3 Latest Technological Developments of Hip & Knee Reconstruction Devices 3.1.4 Growth Opportunities/Investment Opportunities 3.2 Drivers 3.3 Constraints 3.4 Industry Attractiveness 3.4.1 Bargaining power of suppliers 3.4.2 Bargaining power of buyers 3.4.3 Threat of substitutes 3.4.4 Threat of new entrants 3.4.5 Competitive rivalry 4 Hip & Knee Reconstruction Devices Market, By Product 4.1 Knee Reconstruction Devices 4.1.1 Partial Knee Reconstruction Devices 4.1.2 Primary Cemented Knee Reconstruction Devices 4.1.3 Revision Knee Reconstruction Devices 4.1.4 Primary Knee Reconstruction Devices 4.1.5 Primary Cementless Knee Reconstruction Devices 4.2 Hip Reconstruction Devices 4.2.1 Partial Hip Reconstruction Devices 4.2.2 Hip Resurfacing Devices 4.2.3 Primary Hip Reconstruction Devices 4.2.4 Revision Hip Reconstruction Devices 5 Hip & Knee Reconstruction Devices Market, By Geography 5.1 North America 5.2 Europe 5.3 Asia Pacific 5.4 Middle East 5.5 Latin America 5.6 Rest of the World (RoW) 6 Key Player Activities 6.1 Acquisitions & Mergers 6.2 Agreements, Partnerships, Collaborations and Joint Ventures 6.3 Product Launch & Expansions 6.4 Other Activities 7 Leading Companies 7.1 Stryker Corporation 7.2 Corentec 7.3 Zimmer Biomet 7.4 Smith & Nephew PLC 7.5 Arthrex, Inc. 7.6 United Orthopedics Corporation 7.7 Baumer S.A. 7.8 Beijing Chunlizhengda Medical Instruments Co. Ltd. 7.9 DJO Global 7.10 Exactech, Inc. 7.11 Tornier, Inc 7.12 Allegra Orthopaedics Limited 7.13 Corin Group PLC 7.14 Japan MDM, Inc. 7.15 DePuy Synthes For more information about this report visit https://www.researchandmarkets.com/research/2rknvs/global_hip_and?w=4

Contacts

ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 Related Topics: Orthopedic Devices

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30 Nov

LimaCorporate Celebrates the Launch of the SMR TT Hybrid Glenoid, Expanding the Shoulder Portfolio

UDINE, ItalyNovember 30, 2018 /PRNewswire/ -- LimaCorporate is pleased to announce the launch of the SMR TT Hybrid Glenoid, the latest addition to the SMR Shoulder System. The SMR Shoulder System is a total shoulder replacement designed to provide surgeons a wide range of options to address the different patients' pathologies. There have been over 150,000 implants performed worldwide. SMR TT Hybrid Glenoid is the first glenoid component with hybrid fixation convertible from anatomic to reverse. Being part of the SMR Shoulder System, SMR TT Hybrid Glenoid has been designed to provide an innovative solution for glenoid replacement allowing for proper soft tissues management thanks to an optimal range of sizes, mismatch options, and a reliable fixation supported by a combination of polyethylene and Trabecular Titanium, LimaCorporate's proprietary 3D printed technology. After a limited release phase, the SMR TT Hybrid Glenoid has been launched in the USA and New Zealand. SMR TT Hybrid Glenoid has also received the CE mark and will be officially launched next year in February during the Paris Shoulder Course. This important accomplishment has been reached thanks to the contribution of a panel of experienced shoulder surgeons coming from all over the world. This year, the SMR Shoulder System has been awarded by the Orthopaedic Data Evaluation Panel (ODEP) in the UK, two ratings (ODEP ratings can be found on odep.org.uk) a 10A rating for the SMR Reverse with Uncemented Fixation (Metal Glenosphere / Polyethylene Liner Combination), making it the only Reverse with a 10A rating available on the market and a 5A ODEP Rating - SMR Reverse HP with Uncemented Fixation (Polyethylene Glenosphere / Metal Liner Combination). "We are very excited about the introduction of this innovative device on the market, which allows LimaCorporate to further complete the Shoulder portfolio, keeping its outstanding clinical heritage and approaching a new fixation philosophy," said Luigi Ferrari, CEO of LimaCorporate. About LimaCorporate LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate's product range includes large joint revision and primary implants and complete extremities solutions including fixation. For additional information on the Company, please visit: limacorporate.com Limacorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine - Italy
T: +39-0432-945511
E: info@limacorporate.com SOURCE Limacorporate S.p.A. (Logo: https://mma.prnewswire.com/media/637371/Lima_Corporate_Logo.jpg )

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29 Nov

Jackson hospital first in nation to get next-gen spinal surgery technology

Nov 28, 2018 / By Taylor DesOrmeau JACKSON, MI - It looks like a tablet but instead of connecting to headphones, the wires protruding from this new device at Henry Ford Allegiance Health connects to stickers - which are attached to the arms and legs of patients undergoing surgery. The new device is called a Sentio generation 2 neuromonitoring system and Jackson's hospital is the first in the nation to use it. The minimally-invasive technology can offer patients a faster recovery, less blood loss and a shorter hospital stay, according to a HFAH press release. Surgeons began using it in Jackson in October. "While we're placing our instrumentation, we're able to better assess that we're in the correct place," said Dr. Amritraj Loganathan, a neurosurgeon at HFAH. The Sentio is primarily used during spine surgeries to decompress nerves. Accelerometers in the stickers can detect subtle muscle twitches - which are then shown on the screen. This shows which nerves are firing and what they're specific functions are, Loganathan said. What excites Loganathan is the hospital's plan to lead studies, in expectation of finding ways to expand the tool's usage. Loganathan believes it could help surgeons assess how healthy a nerve is. Right now, they must rely on a patient's pain assessment to determine if the nerve was successfully decompressed during surgery.   READ THE REST HERE   Photo: Courtesy of Henry Ford Allegiance Health

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29 Nov

Histogenics and FDA Continue to Discuss NeoCart® Phase 3 Clinical Trial Data and Potential Regulatory Pathway

WALTHAM, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on its ongoing dialogue with the U.S. Food and Drug Administration (the FDA).  Since the initial Type C meeting in October 2018, Histogenics and the FDA have continued their discussions on the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the NeoCart Biologics License Application (BLA).  The FDA has not yet made a final decision regarding a potential BLA submission.  Histogenics intends to provide a further update by the end of 2018 or early 2019 based on additional feedback from the FDA, once available.

“We very much appreciate the FDA’s consideration and active review of our request to evaluate the existing Phase 3 clinical data for a potential NeoCart BLA submission.  We continue to work very closely with the FDA to review the data from the NeoCart development program.  Our discussions have covered many areas including the clinical data, patient population and related statistics from the NeoCart Phase 3 clinical trial, potential alternative pathways for the BLA as well as the current treatment paradigms for knee cartilage defects in relation to the design of the NeoCart Phase 3 clinical trial,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We continue to believe, based on the totality of the data, that NeoCart, if the BLA were accepted and approved by the FDA, may offer patients a treatment alternative that provides a more rapid recovery from pain and return to daily activity than other currently available options to treat damaged knee cartilage.”

About Histogenics Corporation

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

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  expectations regarding the timing and success of ongoing discussions with the FDA regarding the potential submission or acceptance of a BLA for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.  Histogenics has not yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the information contained in the official meeting minutes or any subsequent meetings that may be held with the FDA.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

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28 Nov

WishBone Medical, Inc. acquires Response Ortho

WARSAW, Ind., Nov. 28, 2018 (GLOBE NEWSWIRE) -- WishBone Medical, Inc. announces the acquisition of Response Ortho. Response Ortho has a complete pediatric line of external and internal fixation and deformity correction products. Response Ortho has been in business for fourteen years and has built a modern, high-tech manufacturing facility with access to an experienced engineering and technical labor force. Because of this, product development and launch activities have been dramatically accelerated for WishBone Medical with the Response Ortho offering of over thirty developed pediatric orthopedic systems, with multiple patents, including the award winning “Smart Correction” Hexapod Fixator and “Click2Correct” surgical preoperative planning software.  Eighteen of the current product systems can be sold in the US now and we are working on FDA clearance for the remaining products. Our commitment is to provide global access to anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits for children. Nick Deeter, Chairman of the Board and CEO at WishBone Medical, said, “With the acquisition of Response Ortho, we are thrilled about our pediatric orthopedic product offerings. The combination of Response Ortho’s thirty product systems and WishBone’s eight product systems will give WishBone Medical the broadest product portfolio in pediatric orthopedics worldwide.”  Mr. Deeter added, “These pediatric orthopedic products can be delivered in sterile packed, procedural kits anywhere in the world, next day, to the surgeons that care for children.” Sehmuz Isin, CEO of Response Ortho said, “We are excited that Response Ortho is now part of WishBone Medical.  Our primary focus has been outside the US, and we will now be able to offer these innovative orthopedic product systems everywhere.  Having more than 50 years of combined experience, Nick and I understand the unmet needs and will provide global solutions to children with orthopedic issues.” About WishBone Medical, Inc. WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing. About Response Ortho Response Ortho is a vertically integrated, ISO 13485 certified, CE Mark lean company that is focused on the orthopedic industry with modern equipment and scalable technology. Response Ortho is located in Istanbul, Turkey. For further information, visit www.WishBoneMedical.com or call Andrew Miclot, Vice-Chairman and President at 574-306-4006.

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28 Nov

FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain

November 28, 2018

HOUSTON--(BUSINESS WIRE)--SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced the FDA has cleared its Investigational New Drug (IND) protocol for human trials in the U.S., considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses. The clearance allows SpinalCyte to begin recruiting and screening patients for the study. The trial is to be initiated after the first production run is tested for quality and safety to meet the FDA stated criteria. “The clearance of the IND for our fibroblast-based therapy, CybroCell™, in the treatment of degenerative disc disease validates our clinical science and is our biggest step toward commercialization,” said SpinalCyte Chief Executive Officer, Pete O’Heeron. “After the extremely positive results from our Phase 1/Phase 2 clinical trial, this clearance by the FDA will allow us to continue testing CybroCell™ and will further our mission of bringing back pain relief to the millions of Americans who suffer from it every year. The applications of CybroCell™ go beyond degenerative disc disease and hold promise in other disease pathways including cancer, diabetes, osteoarthritis, liver failure and heart failure.” The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index (ODI), 100% had improvement in Visual Analogue Scale (VAS) and over 84% had an increase or no change in disc height. “CybroCell’s pain and MRI data show clear superiority to all other cell therapy treatments for degenerative disc disease,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “This IND clearance allows us to continue our research and application of CybroCell™. This treatment which targets the source of chronic pain in degenerative disc disease is a medical breakthrough. The persistent structural and functional improvements we have observed in patients demonstrate that CybroCell™ has the potential to help combat the opioid epidemic by eliminating chronic pain.” About Degenerative Disc Disease Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration. About CybroCell™ CybroCell™ is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell™ had sustained improvement in pain relief and increased back mobility. About SpinalCyte Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 35 U.S. and international issued patents and has filed for an additional 41 patents pending. SpinalCyte holds 116 U.S. and International Patents pending and issued across a variety of disease pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

David Schull or Ned Berkowitz Russo Partners LLC 858-717-2310 646-942-5629 david.schull@russopartnersllc.com ned.berkowitz@russopartnersllc.com SpinalCyte, LLC info@spinalcyte.com

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28 Nov

In2Bones Commercializes CoLink® View “See-Through” Plating System

Memphis, Tenn., (November 27, 2018) – In2Bones Global, Inc. today announces the commercial launch of the CoLink® View Plating System. CoLink® View Bone Plates, marketed under the CoLink® View brand name, incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK). The CoLink® View Plates offer transverse joint compression through an X-ray transparent PEEK hub. This allows the surgeon to watch the patient’s bone fusion site during the post-surgical healing process. Traditional metal plates cannot do this because metal absorbs X-rays and blocks the image underneath. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company. In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing. The CoLink® View is the sixth In2Bones PEEK-related implant system to reach commercialization. It demonstrates In2Bones’ commitment to expanding the extremities market by launching innovative technological advancements to improve surgical outcomes and patient care. For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com. About In2Bones Headquartered in Memphis, Tennessee, In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-usa.com. Safe-Harbor Statement: This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks. Media Contacts: Jon Simon | Sr. Vice President of Marketing In2Bones USA 6000 Poplar Ave, Suite 115 Memphis, TN 38119 M: 512.739.5793 • O: 901.260.7931 • F: 844-712-6637 Email: jsimon@i2b-usa.com https://www.linkedin.com/company/22344175/ Bob Reed Element-R Partners 630.579.1770 bob@rurelevant.com
 

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28 Nov

United Orthopedic Corporation Announces FDA Clearance for Vitamin E Highly Cross-Linked Polyethylene Hip Liner

IRVINE, Calif.Nov. 27, 2018 /PRNewswire/ -- United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration has cleared its vitamin E highly cross-linked polyethylene (E-XPETM) hip liner. The E-XPE™ is the new generation of highly cross-linked polyethylene blended with vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties. "Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements," said Calvin Lin, President of United Orthopedic Corporation USA. "Clearance of our E-XPETM, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry." Vitamin E is an effective biological antioxidant which helps prevent the oxidative degradation of cell membrane phospholipids. When added to ultra-high molecular weight polyethylene ("UHMWPE"), vitamin E performs a similar role by helping to prevent oxidation of the polyethylene chains.1 Vitamin E -stabilized UHMWPE is a biocompatible material with good mechanical, wear, and oxidative proprieties. Results from accelerated aging tests show that E-XPE inserts and liners exhibited a 60 percent and 75 percent reduction, respectively, in gravimetric wear2.  E-XPE material provides greater strength in comparison to re-melted highly crosslinked polyethylene while maintaining oxidation resistance as demonstrated in mechanical tests. An estimated 4.7 million Americans have undergone total knee arthroplasty ("TKA") and 2.5 million have undergone total hip arthroplasty ("THA").The prevalence of THA rises to nearly 6 percent by 80 years of age. The prevalence of TKA rises to nearly 10 percent by 80 years of age.3 About United Orthopedic Corporation United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instrument sets. The company offers clinically proven solutions used in primary and revision total hip/knee replacement in addition to oncology applications. The company has implemented and maintains Quality Management Systems compliant with ISO 13485, FDA and CE requirements. To learn more visit www.uocusa.com. Media Contact
Erich Sandoval
Lazar Partners Ltd. 
Phone: +1 917-497-2867
esandoval@lazarpartners.com _____________________________
Gigante A, Bottegoni C, Ragone V, Banci L. Effectiveness of Vitamin-E-Doped Polyethylene in Joint Replacement: A Literature Review. J Funct Biomater 2015; 6(3):889-900. Chang TW, Cheng YW, Lu CK, Liau JJ. Is Highly Cross Linked UHMWPE Blended with Vitamin E a Viable Reduction Wear in TKA? Presented at Orthopaedic Research Society, 2017, San Diego, CA. Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA et al. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am 2015; 97(17):1386-97. SOURCE United Orthopedic Corporation

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28 Nov

FloSpine announces the commercial launch of its CANAVERAL®Minimally Invasive Pedicle Screw System

BOCA RATON, FL --- FloSpine, a medical device company that designs, develops and manufactures spinal implants and instruments for the surgical treatment of spinal disorders, announced today the commercial launch of its CANAVERAL®Minimally Invasive Pedicle Screw System. The Canaveral Minimally Invasive Screw (MIS) System is a thoracolumbar posterior stabilization system featuring extended modular screw heads. This allows the surgeon to select the various modular screw head options to a wide range of screw offerings. This includes the option of 30mm reduction and a selection of closed or open style headbodys. The CANAVERAL® MIS system is an extensive and customizable solution for all surgical cases. Two surgery’s using the FloSpine CANAVERAL®  MIS Pedicle Screw System were performed by Texas Back Institute surgeons Dr. Richard Guyer, MD and Dr. Jack Zigler, MD at the Presbyterian Plano Center for Diagnostics & Surgery in Plano TX. Both surgeons were impressed with the instruments and the various implant options available. “I was very impressed by the ease of insertion, and also gratified to see how many of our recommendations that were used in the progressive refinement of the system” said Jack Zigler, MD, Orthopedic Spine Surgeon at Texas Back Institute and Co-Director of the Center for Disc Replacement. Richard Guyer, M.D.  the Co-founder of the Texas Back Institute and Director of their Spine Fellowship Program said “FloSpine a great job engineering a very slick, surgeon-friendly system. It is also a scrub tech friendly system and they felt it was one of the easiest systems to put together” Dr. Guyer is also Co-Director for the Center for Disc Replacement at Texas Back Institute. “The CANAVERAL®  Minimally Invasive System also reduces the number of implants that need to be present in the operating room and thereby reduces unnecessary clutter in the surgical area. _____________________________________________ About FloSpine FloSpine, LLC is a privately held US medical device company offering products for addressing complex deformity spine problems, minimally invasive spine surgery and thoracolumbar degenerative conditions. For more information please visit FloSpine at http://www.flospine.com About Texas Back Institute Texas Back Institute is one of the largest multidisciplinary spine centers in the world. Using the latest technology and medical advances, Texas Back Institute is dedicated to helping patients get back to life. For more information please visit Texas Back Institute at  https://www.texasback.com  

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