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.Read More
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
- 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
ContactsResearchAndMarkets.com Laura Wood, Senior Press Manager firstname.lastname@example.org 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
UDINE, Italy, November 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.
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
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine - Italy
E: email@example.com SOURCE Limacorporate S.p.A. (Logo: https://mma.prnewswire.com/media/637371/Lima_Corporate_Logo.jpg )
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 HealthRead More
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.
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.Read More
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.Read More
November 28, 2018
ContactsDavid Schull or Ned Berkowitz Russo Partners LLC 858-717-2310 646-942-5629 firstname.lastname@example.org email@example.com SpinalCyte, LLC firstname.lastname@example.org
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.
Lazar Partners Ltd.
Phone: +1 917-497-2867
1 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. 2 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. 3 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
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.comRead More