SUWANEE, GA, July 11, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce a partnership with HyperMed in Memphis, TN to sponsor a continuing clinical investigation on Diabetic Foot Ulcers (DFUs). This investigational work is expected to begin in August 2018. An initial case series will be conducted at two sites, the primary site being the Vascular and Wound Care Center at University Hospital, Rutgers NJMS in Newark, NJ with Dr. Oscar Alvarez as the Principal Investigator, and the second site at Olive View-UCLA Medical Center with Dr. Aksone Nouvong leading the efforts. The intent of this trial is to quantify the level of increased perfusion and oxygenation during and after treatment with the dermaPACE® System.
Previous animal studies and clinical work using the dermaPACE® System has shown that treated tissue exhibits increased perfusion to the area, as measured by doppler imaging, and an increase in venule and arteriole diameters, indicating increased red blood cell velocity. This case series will utilize HyperMed’s Hyperview spectral imaging device to measure oxygen saturation, oxyhemoglobin level, and deoxyhemoglobin level in superficial tissue and using TcPO2 values as a control.
As a result of Dr. Alvarez’s leadership and case work, he will be able to provide SANWUAVE with valuable, measurable data to continue to expand our understanding of the dermaPACE® System’s mechanism of action. Dr. Nouvong has already performed and published extensive research using the HyperView spectral imaging device. These two renowned investigators and practitioners in wound care, with their combined expertise, will expand the already extensive clinical data associated with dermaPACE®. Both researchers participated in previous dermaPACE® DFU trials.
Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board and Chief Executive Officer, said, “We are very excited about this next opportunity to investigate the effects that the dermaPACE® System has on improving perfusion and oxygenation in treated tissue. This case series will enable us to quantify the increases and help us to better understand how dermaPACE® improves patients’ quality of life, leading to future research and improvement of clinical protocols for the treatment of Diabetic Foot Ulcers and other skin conditions. We are another step closer to Healing Today, Curing Tomorrow.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
For additional information about the Company, visit www.SANUWAVE.com.
CONTACT INFORMATION
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com
SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
AUDUBON, Pa., July 11, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, will showcase its advanced technologies at the Scoliosis Research Society’s (SRS) 25th Annual International Meeting on Advanced Spine Techniques (IMAST) being held July 11-14, 2018, in Los Angeles, California. The company will also highlight its robotics platform technology through an industry workshop at IMAST, ExcelsiusGPS® First Clinical Experiences, featuring its revolutionary robotic guidance and navigation system on July 13 from 12:00-1:00 pm led by Dr. Jeffrey A. Goldstein, Chief of Spine Service for Education and Director of the Spine Fellowship at NYU Langone Orthopedic Hospital.
“We recognize SRS as one of the world’s premier spine societies whose mission is critical to improving the lives of patients with spinal deformities,” said Andrew Iott, Senior Vice President Global Product Development. “As leaders in the musculoskeletal device industry, we are committed to supporting the research, education, and development of medical advancements in the field of spinal deformity. We are particularly proud to be a sponsor of IMAST as well as support the continued mission of SRS.”
With over 180 products launched to date, Globus Medical has one of the most comprehensive portfolios of expandable technology in the industry. With over 12 years of experience developing expandable interbody spacer systems, combined with a track record of success, Globus has developed next generation implants that provide innovative solutions to maximize lordosis and address sagittal imbalance.
About Globus Medical, Inc. Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com
BETHLEHEM, Pa., July 11, 2018 /PRNewswire/ — Tyber Medical, LLC, a privately held company focusing on developing innovative medical devices for rapid commercialization and advancing the science of bioengineered surfaces, announces the allowance for US Patent Application (No. 15/213,935) of TyFix™, an all-in-one extremity joint fixation system.
The TyFix™ sterile system delivers increased operating room efficiency and serial procedural flow by combining an intramedullary implant to the driver, drill, and broach instruments. The all-in-one instrument/implant design, combined with the recently released Sterile Handle Kit, is designed to reduce procedure steps and total operative time, while delivering an implant construct capable of maintaining the holding power of a 3.0 Screw.
“The notice of allowance granted to Tyber Medical highlights the Company’s growing strategy of building innovative products backed by science and intellectual property,” commented Jeff Tyber, CEO and President of Tyber Medical. Mr. Tyber added, “Tyber Medical recently targeted the Ambulatory Surgical Center (ASC) market with the limited release of the Forefoot Procedure Kit. The resultant patent family aims to be the foundation for future system solutions that enhances the economic value to both hospitals and ASC’s by eliminating redundant processing costs, simplifying instrumentation, and increasing the operating room cadence through instrumentation integration.”
The TyFix™ Patent is the eighth patent issued to the Company with an additional 10 patents pending for approval. Joseph Maenner, J.D., Tyber Medical Intellectual Property Counsel commented, “Tyber Medical’s patent strategy is centered around building innovation platforms backed by intellectual property. These platforms can be combined or rearranged to meet multiple products and customers needs. Additionally, the breadth of these IP fillings locks innovative design dates and allows the patent families to morph as product systems are developed or block competitive entry to the market.”
The TyFix™ system received FDA clearance in July 2017 for the innovative system that reduces the need for ancillary instrumentation for a wide range of bone fixation procedures. The TyFix™ combines a highly-optimized bone thread with a barbed head to maximize intramedullary bone purchase and compression in both the proximal and distal phalanges. The system delivers intraoperative flexibility by offering solid and cannulated implants with diameters ranging from Ø1.5 – 4.0mm in multiple lengths as well as a straight and an angled 10o option.
Visit Tyber Medical’s Booth #627, at AOFAS in Boston, MA where the Company will showcase the TyFix™ System as well as other innovative products available for private labeling.
About Tyber Medical, LLC.
Tyber Medical, LLC is an orthopedic device manufacturer providing rapid access to portfolio enhancing, regulatory approved, orthopedic implants within the spine and extremity/trauma markets. While focusing on rapid product commercialization, the Company distributes products via private labeling; releasing 14 spine and 25 extremity/trauma systems since its founding in 2012. Tyber Medical utilizes the differentiated, bioengineered technology such as TyPEEK® osteoconductive coatings and BioTy™, a new antimicrobial nano-textured surface modification to enhance the Company’s growing portfolio.
MAHWAH, N.J., July 11, 2018 /PRNewswire/ — Stryker announced today plans to activate The Mobility Zone® at the Constellation SENIOR PLAYERS Championship taking place in Highland Park, Illinois at Exmoor Country Club. Stryker will continue its commitment to educating golf fans about joint health through the interactive destination, where tournament-goers can speak with orthopaedic surgeons about potential treatment options and Stryker’s Mako Technology. In addition, Stryker will demonstrate its support for veterans during a ceremony in the Patriots’ Outpost on Friday, where Stuart Simpson, President, Stryker’s Joint Replacement Division, will present a donation to K9s For Warriors.
Marking the company’s nineteenth sponsored dog with the organization since 2015, Stryker’s donation Friday will allow K9s For Warriors to find, train and match a service dog with a veteran suffering from Post-Traumatic Stress Disability, traumatic brain injury or other military trauma as a result of military service post 9/11, giving the veteran a new leash on life.
“K9s For Warriors is a fantastic organization, which Stryker is very proud to have a relationship with,” said Simpson. “I’m honored to present this donation on behalf of Stryker. We are extremely passionate about supporting veterans and sponsoring a service dog that will provide them the support they need is a truly rewarding feeling.”
The ceremony, which begins at 11 a.m., will also include Marine veteran, and K9s For Warriors graduate, Tyler Leonard. Leonard will share his personal story of living with PTSD and the incredible support his service dog, Bella, has given him.
During the tournament, fans are invited to visit The Mobility Zone to learn about joint health and Mako Robotic-Arm Assisted Surgery –the latest advancement in joint replacement technology. A destination designed to engage and educate fans, The Mobility Zone offers a unique opportunity for tournament-goers to speak with local orthopaedic surgeons.
A premier feature of The Mobility Zone, the Accuracy Challenge allows fans to gain a better understanding of joint replacement and Stryker’s Mako Technology. This interactive experience challenges fans to remove arthritic bones from a life-size model named Art H. Ritis and replace them with Stryker implants.
Stryker will also be present throughout the course with its 1.7-mile health walk featuring interactive signs designed to educate fans about joint health and challenge them with golf trivia.
For additional information on the Stryker Accuracy Challenge as well as K9s For Warriors involvement, please visit: patients.stryker.com.
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at stryker.com.
About PGA TOUR
By showcasing golf’s greatest players, the PGA TOUR engages, inspires and positively impacts our fans, partners and communities worldwide.
The PGA TOUR co-sanctions more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR Series-China. Members on the PGA TOUR represent the world’s best players, hailing from 27 countries (88 members are from outside the United States). Worldwide, PGA TOUR tournaments are broadcast to more than 1 billion households in 226 countries and territories in 23 languages. Virtually all tournaments are organized as non-profit organizations to maximize charitable giving. In 2017, tournaments across all Tours generated a record of more than $180 million for local and national charitable organizations, bringing the all-time total to $2.65 billion.
The PGA TOUR’s web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, Florida.
SAN DIEGO, July 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company will officially unveil its XLIF® Lordotic Expandable (XLX) Interbody System, which just received 510(k) clearance from the U.S. Food and Drug Administration (FDA), at the 25th International Meeting on Advanced Spine Techniques (IMAST) in Los Angeles, July 11-14, 2018. NuVasive is a Double Diamond Sponsor of the conference, reflecting its continued support of advancing spine care.
Through controlled lordotic expansion and multifunctional instrumentation, the XLIF anterior column realignment (ACR) technique offers an efficient and minimally disruptive alternative to traditional open procedures. Leveraging the clinical advantages of the XLIF ACR procedure, the XLX ACR system allows the surgeon to address sagittal alignment from the anterior column while reducing blood loss and hospital stays. Scheduled to launch in July 2018, the XLX implant will be offered in a comprehensive range of lengths and heights with up to 30° of customizable lordosis to address varying patient anatomy.
Leveraging Surgical Intelligence™, the Company’s ecosystem for better surgery, XLX ACR has the ability to improve ACR procedures overall. The Integrated Global Alignment (iGA®) software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap®, and can intraoperatively evaluate correction using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.
“The XLX ACR implant adds the first expandable implant to the portfolio of pathology-specific XLIF interbody options,” said Dr. Ivan Cheng, spine surgeon and Associate Professor of Orthopedic Surgery and, by courtesy, Associate Professor of Neurosurgery at Stanford University. “We are now better able to achieve correction of alignment and save patients significant morbidity in comparison with traditional approaches of open posterior spinal fusion with osteotomy—procedures which many of our patients may not tolerate or even survive. XLX ACR provides us the ability to maximize lordosis segmentally and customize the optimal amount of overall lordosis based on patient-specific alignment goals using iGA through a minimally disruptive approach.”
The NuVasive XLX Interbody System is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation. It can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
“With the FDA 510(k) clearance of XLX ACR, we broaden our expandable portfolio to the lateral market,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “This clearance highlights our continued investment in innovation and Lateral Single-Position Surgery to transform clinical outcomes by developing and evolving spine’s leading solutions and systems to give surgeons the tools they need to best serve their patients.”
The XLX ACR implant will join the existing expandable interbody portfolio of TLX™ and MLX® as NuVasive’s first lateral expandable. TLX and MLX provide customizable correction with streamlined instrumentation from a TLIF approach.
During IMAST 2018, NuVasive is also showcasing LessRay® within its spine solutions portfolio, a foundational technology within Surgical Intelligence. LessRay offers the surgeon and hospital system the opportunity to use significantly reduced radiation imaging in the operating room, while providing unique Image Stitching for surgeons to quickly stitch together fluoroscopic images of any spine segment.
NuVasive will be holding two hands-on workshops at this year’s IMAST that tie in with its innovation in Lateral Single-Position Surgery and LessRay.
NuVasive Hands-on Workshops
Thursday, July 12 from 12:30—1:30 p.m. PST in Diamond Salon 7, JW Marriott L.A. LIVEProtect yourself and your patients with LessRay: A novel technology to reduce radiation and increase OR efficiency. Presented by Stephen I. Ryu, M.D. and Amer Samdani, M.D.
Friday, July 13 from 12:00—1:00 p.m. PST in Diamond Salon 7, JW Marriott L.A. LIVELeading. Expanding. Advancing. Insights to Lateral Procedural Solutions. Presented by Christopher R. Brown, M.D. and Jeff Lehmen, M.D.
IMAST 2018 attendees are encouraged to stop by NuVasive booth #32 to learn more about XLX ACR, LessRay and the Company’s comprehensive, industry-leading solutions for creating better clinical outcomes for spine procedures.
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
Kalamazoo, Michigan – July 10, 2018 – Stryker Corporation (NYSE:SYK) announced today that David K. Floyd, Group President, Orthopaedics has notified the Company of his intent to retire on June 30, 2019. Until this date, Mr. Floyd will serve as Group President and Advisor to the CEO and will assist with transitioning his responsibilities to our newly appointed leaders while also contributing to strategic growth projects.
Mr. Floyd joined Stryker in 2012 after 25 successful years in the medical technology industry. David has served as a key member of Stryker’s leadership team and enjoyed terrific success leading our Orthopaedics group.
“We are grateful for David’s leadership and his many contributions to Stryker’s success. His businesses consistently outgrew the market and David spearheaded several key acquisitions, including Mako. I wish David and his family all the very best in retirement,” said Kevin A. Lobo, Chairman and Chief Executive Officer.
We are now shifting responsibility for all of our operating businesses and regions under Timothy J. Scannell who will be appointed President and Chief Operating Officer effective August 1, 2018. In his new role, Tim will drive growth and operating leverage across all of Stryker’s businesses while promoting globalization and collaboration across our commercial units.
“Over his 28 years at Stryker, Tim has built an excellent track record of high performance and people development. I look forward to working closely with him and the rest of the Stryker leadership team to take Stryker to new heights,” said Mr. Lobo.
Mr. Scannell began his career with Stryker’s Endoscopy business in 1990 where he served in sales and marketing leadership roles. He then took on roles of increased responsibility spanning many of our businesses and has served as a Group President for nearly a decade, most recently overseeing MedSurg & Neurotechnology.
Within the new commercial leadership structure, Stryker will have two new Group Presidents. J. Andrew Pierce has been appointed Group President of MedSurg and Spencer S. Stiles has been appointed Group President of Instruments, Neurotechnology, and Spine. Mr. Pierce and Mr. Stiles have delivered strong performance over time in their lengthy Stryker careers and will now be accountable for leading multiple businesses.
Forward-looking statements
This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; potential supply disruptions; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.
Contacts
For investor inquiries please contact: Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com
For media inquiries please contact: Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Stryker Corporation via Globenewswire
Investor Contacts
Katherine A. Owen
Vice President, Strategy & Investor Relations
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
269-385-2600
MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants LLC, a company that develops orthopedic implant solutions, today announced that the final patient was treated in the two clinical trials evaluating the NUsurface® Meniscus Implant for the treatment of persistent knee pain caused by injured or deteriorated meniscus tissue. The trials are being conducted to evaluate the safety and effectiveness of the NUsurface Meniscus Implant in support of U.S. Food and Drug Administration (FDA) De Novo 510(k) clearance.
“We are now one step closer to filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement, which is a large unmet need in the orthopedic market,” said Ted Davis, president and CEO of Active Implants. “With enrollment complete, we will continue to work closely with the FDA and now focus our efforts on collecting the data required for the U.S. regulatory submission. We thank our investigator surgeons and patients for making this day possible.”
The two clinical trials enrolled a combined 243 patients, 176 of which received the NUsurface Meniscus Implant. The VENUS (Verification of the Effectiveness of the NUsurface System) trial is a randomized, multi-centered, prospective, controlled study comparing the NUsurface Meniscus Implant to the non-surgical standard of care and enrolled 128 patients at 10 U.S. study sites. The SUN (Safety Using NUsurface) trial is a single-arm study assessing the safety and probable benefit of the NUsurface Meniscus Implant in restoring function similar to that of a natural, healthy meniscus and enrolled 115 patients at 13 U.S. study sites. Active Implants conducted the two different types of studies concurrently in order to bring the NUsurface Meniscus Implant to market as quickly as possible while the company worked with the FDA to finalize the regulatory clearance for marketing in the U.S.
“The NUsurface Implant is being studied in patients who still have persistent knee pain following a meniscus surgery, have exhausted other treatment options, and are too old for repair and too young for total knee replacement,” said Elliott Hershman, MD, orthopedic surgeon at Lenox Hill Hospital in New York City and medical director for the studies.
If approved by the U.S. Food & Drug Administration, the NUsurface Implant would be the first “artificial meniscus.” The meniscus is a tissue pad between the thigh and shin bones, and once damaged, the meniscus in middle aged patients has a very limited ability to heal itself. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, recent studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.
About the NUsurface® Meniscus Implant
The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011.
About Active Implants LLC
Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.
CAUTION Investigational device. Limited by United States law to investigational use.
LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that the Company has signed a joint-venture agreement with the Spine division of National Surgical Pty Ltd (“National Surgical”) to introduce the Group’s innovative products and patient-specific technologies in Australia and New Zealand. Other divisions of the National Surgical Businesses will remain unchanged.
Prior to the establishment of the joint-venture, National Surgical was a leading distributor for Medtronic Spine and Biologics in Australia and New Zealand and has developed and maintained excellent relationships for over 14 years with key accounts throughout the territory, which represents the world’s third largest spine market after the United States and Japan and is valued at more than €170 million annually.
Jon Mills, Managing Director of National Surgical, will remain to lead the newly-formed subsidiary with his existing team of highly-trained representatives covering all states and territories of Australia and New Zealand. Mr. Mills stated, “Our history of exceptional service to customers will continue to ensure successful outcomes for patients benefiting from the technology we have supplied since 1997. Moreover, Medicrea’s proprietary UNiD ASI™ (Adaptive Spine Intelligence) technology is especially suited to the Australian market, where surgeons are particularly forward-looking and the healthcare system affords the financial freedom and flexibility to revolutionize spinal surgery. We expect to do nothing less with Medicrea Australia.”
Denys Sournac, President and Chief Executive Officer of Medicrea, added, “We are extremely pleased to have formed this joint venture with National Surgical and to enter Australia’s robust and growing spine market with such a capable partner. Mr. Mills and his team’s experience and long-standing relationships with healthcare professionals at all levels, including key spinal surgeons, hospital administration decision-makers and regulatory contacts, will allow us to rapidly capitalize on a direct sales model and generate new revenue for the Group.”
Medicrea International has been awarded its initial product registrations and holds a 51% majority stake in the Medicrea Australia joint-venture. All revenue generated through the sale of Medicrea products in Australia and New Zealand will be aggregated in Medicrea’s group consolidated numbers.
Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.
Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 185 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.
For further information, please visit: Medicrea.com.
As announced on 13 June 2018, SPINEWAY, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), finalized a new strategic plan aiming to reposition Spineway on its markets via targeted actions:
– refocus its activities on the most promising areas;
– reorganize its US subsidiary and reinforce R&D to adapt its instruments/implants in order to access additional markets;
– reinforce its innovation strategy via targeted acquisitions;
– refinance growth.
This transformation should allow Spineway to change its scope and set itself on a new path toward profitable growth in the coming years.
To accelerate the implementation of this roadmap, Spineway announces that it has set up financing with Alpha Blue Ocean, Inc.
This financing, representing a maximum of €14.50M, will allow it to carry out this ambitious plan while covering its day-to-day operating needs.
Legal framework
In accordance with the power granted to the Board of Directors and approved by the Ordinary and Extraordinary General Meeting held by the shareholders of Spineway (the “Company“) on 25 June 2018, on 4 July 2018, Spineway’s Board of Directors approved the principle of an issue of 200 tranche warrants (the “Tranche Warrants“) that, upon exercise, results in the issue of 200 bonds convertible into new or existing shares (the “OCEANE“) with attached warrants to subscribe shares (the “Warrants“), representing a bond issue with a total par value of €2M in favor of the European High Growth Opportunities Securitization Fund (the “Investor“), an investment fund managed by European High Growth Opportunities Manco SA, a Luxembourg asset-management company, and empowered the CEO to launch this transaction, approve its final terms and conditions, and issue said Tranche Warrants.
Pursuant to the issuance agreement entered into on this day between the Investor and Spineway (the “Issuance Agreement“), the Investor has agreed to subscribe, within a maximum period of 36 months:
first, through 15 September 2018, up to 200 OCEANE with attached Warrants, representing a total par value of €2M, in two successive €1M tranches (each referred to as a “Tranche“) (the “Initial Commitment“);
second, in accordance with the Issuance Agreement, and subject to approval by an Extraordinary General Meeting to be held by Spineway’s shareholders by 30 October 2018 at the latest of a power in favor of the Board of Directors allowing the pursuit of said financing program to its completion, the Investor has agreed to subscribe, pursuant to the exercise of 800 Tranche Warrants, as from said Extraordinary General Meeting, 800 OCEANE with attached Warrants, representing a total par value of €8M, in two successive €1M Tranches, and then twelve €0.5M Tranches (the “Additional Commitment“).
For its part, the Company has agreed not to initiate the exercise of any tranche warrants issued pursuant to the agreement for the issuance of Notes with attached Warrants entered into with the YA II PN, LTD investment fund on 28 July 2017 until the expiration of the Issuance Agreement. In the event that tranche warrants are exercised at YA II PN, LTD’s initiative before the end of the Issuance Contract, the Company undertakes to implement a Rest Period (as defined below) of 80 trading days, which will have the effect of postponing the Company’s ability to request that the Investor exercise any Tranche Warrants during the term of said Period.
In any event, the Investor shall not remain a long-term shareholder in Spineway’s capital.
Purpose of the transaction
The purpose of the issuance of these OCEANE with Warrants is to provide Spineway with the financial means necessary to carry out its new strategic plan and finance its 2018 operating costs. The transaction (Initial Commitment and Additional Commitment together) could result in a maximum capital investment of approximately €14.50M, broken down as follows:
– €9.5M corresponding to the subscription of all the 1,000 OCEANE to be issued pursuant to the financing program, at a unit subscription price equal to 95% of their par value; and
– €5M corresponding to the exercise of all the attached Warrants.
In 2018, close to €2M will be allocated to the financing of the first steps in the strategic plan, which include the reorganization of the US subsidiary, strengthening the Group’s sales and studying external-growth options. The balance of this new financing will, over the next years, be applied to reinforcing the innovation strategy, financing the WCR and adapting instruments/implants for the redeployment of sales in the United States and China.
Stéphane Le Roux, CEO of the Spineway Group, commented on this potential contribution of €14.50M in additional financial resources: “This transaction will allow us to significantly strengthen the Group’s financial structure and give us the means to carry out our development plan. It was important that we be able to acquire significant resources in order to implement our redeployment and reorganize our subsidiary in the US, as this is an area of strong growth potential for us. Moreover, this financing will allow us to take advantage of any and all external-growth opportunities with respect to the strategic targets we have already identified.”
Pierre Vannineuse, head of European High Growth Opportunities Manco SA, commented as follows: “This partnership between Spineway and Alpha Blue Ocean is part of our global project to invest in players in the field of healthcare. This investment program, which aims to strengthen activity in the short term as well as start developing long-term projects right away, will allow the company to reinforce its role as a leader in severe spinal-column disorders. We are firmly convinced that their international development strategy will be successful, and that this financing will enable them to acquire the market shares necessary for them to establish a lasting presence.”
Characteristics of the Tranche Warrants, OCEANE and Warrants
The main characteristics of the Tranche Warrants, OCEANE and Warrants are as follows:
Main characteristics of the Tranche Warrants
The Tranche Warrants require their bearer, at the Company’s request ([1]) (a “Request“) pursuant to the Initial Commitment and the Additional Commitment or pursuant to the Investor’s call option(1) (the “Investor Option“) exclusively under the Additional Commitment, to subscribe OCEANE with attached Warrants, i.e., one OCEANE per Tranche Warrant exercised, at a price set at 95% of the par value of an OCEANE. The Company can therefore request the exercise of the Tranche Warrants in order to allow the issuance of OCEANE in several tranches. Each exercise date of a Tranche Warrant is a “Tranche Warrant Exercise Date.”
A Request for the issuance of a Tranche pursuant to the exercise of one hundred (100) Tranche Warrants shall be deemed submitted by Spineway to the Investor on the following dates:
9 July 2018 (exercise of 100 Tranche Warrants issued pursuant to the Initial Commitment);
15 September 2018 (exercise of 100 Tranche Warrants issued pursuant to the Initial Commitment);
30 October 2018 (exercise of 100 Tranche Warrants issued pursuant to the Additional Commitment, as the case may be);
1 January 2019 (exercise of 100 Tranche Warrants issued pursuant to the Additional Commitment, as the case may be).
As from the third Tranche under the Additional Commitment and for the following Tranches, a Request for the issuance of a Tranche pursuant to the exercise of the Tranche Warrants shall be deemed submitted by Spineway to the Investor upon expiration of each period of 40 trading days following the exercise of a Tranche Warrant (the “Rest Period“).
The Tranche Warrants are freely transferable to any other fund or company controlling or controlled by European High Growth Opportunities Securitization Fund but cannot be transferred to a third party without the Company’s prior approval. They shall not be the subject of a request for admission to trading on Euronext Growth and therefore shall not be listed.
Main characteristics of the OCEANE
The OCEANE shall be issued in several Tranches. The nominal amount of the two Tranches of the Initial Commitment shall be equal to €1M each. The nominal amount of the first two Tranches of the Additional Commitment shall be equal to €1M each, then the aggregate nominal amount of each of the following Tranches shall be equal to €0.5M.
The OCEANE have a par value of €10,000 each and are subscribed at 95% of par.
The OCEANE have a maturity of 12 years from their date of issuance. In case of an event of default([2]) or if new shares are not delivered in accordance with the Issuance Agreement, the OCEANE that have not been converted shall be redeemed by the Company at par. Upon maturity, the OCEANE shall automatically be converted into shares. The OCEANE do not bear interest.
At its discretion, the Investor may convert all or any of the OCEANE into new and/or existing shares (a “Conversion“). Upon a Conversion, the Investor shall determine the number of OCEANE to be converted and the corresponding aggregate par value so converted (the “Conversion Amount“). The number of shares to be issued to the Investor upon each Conversion shall be equal to the Conversion Amount divided by 95% of the Market Price (as defined below) on the Conversion date.
Upon a Conversion, the Company shall have the right at its sole discretion to remit to the Investor the corresponding new and/or existing shares (as described above).
The market price (the “Market Price“) shall be the lowest daily volume-weighted average price of the Company’s share over the fifteen (15) consecutive trading days immediately preceding the applicable date (the “Pricing Period“). By way of exception, in the case of a Conversion, or upon exercise of Tranche Warrants or Investor Option during the Additional Commitment, the Pricing Period shall mean the last fifteen (15) trading days immediately preceding the applicable date during which the Investor did not sell any shares of the Company on the market.
The OCEANE are freely transferable to any other fund or company controlling or controlled by European High Growth Opportunities Securitization Fund but cannot be transferred to a third party without the Company’s prior approval. They shall not be the subject of a request for admission to trading on Euronext Growth and therefore shall not be listed.
Main characteristics of the Warrants
Each OCEANE shall be issued with a number of Warrants equal to 50% of the par value of an OCEANE divided by the strike price of the Warrants in question (the “Strike Price“). The Warrants shall immediately be detached from the OCEANE and each Warrant shall give its bearer the right to subscribe for one (1) new share in the Company, subject to possible adjustments.
The Strike Price of the Warrants attached to the OCEANE shall be equal to 115% of the average daily volume-weighted price of the Spineway share over the fifteen (15) trading days preceding the Request in question (or on the Tranche Warrant Exercise Date in the event that the Investor Option is exercised during the Additional Commitment), it being specified that, for the first Tranche, the Warrant Strike Price shall be equal to 115% of the lower of (i) the Market Price immediately preceding the signature of the commitment letter (i.e., 1.3641 euros) and (ii) the Market Price immediately preceding the Request to be submitted for the first Tranche.
The Warrants shall be exercisable in new shares for a period of five years from their respective issuance dates.
The Warrants are freely transferable to any other fund or company controlling or controlled by European High Growth Opportunities Securitization Fund but cannot be transferred to a third party without the Company’s prior approval. They shall not be the subject of a request for admission to trading on Euronext Growth and therefore shall not be listed.
For reference, based on the share’s closing price on 6 July 2018 (i.e., €1.45), the theoretical value of a Warrant would be between €0.34 and €0.69 depending on the volatility applied (i.e., between 30% and 60%). The theoretical value of a Warrant is obtained using the Black & Scholes formula based on the following hypotheses:
maturity: 5 years;
risk-free interest rate: 0%;
dividend payout rate: 0%.
New shares resulting from the Conversion of OCEANE or the exercise of Warrants
The new shares issued upon conversion of the OCEANE and/or exercise of the Warrants shall be admitted to trading on Euronext Growth as from their issuance, will carry immediate and current dividend rights and will be fully assimilated to and fungible with the existing shares.
The Company shall update a summary table on its website showing the Tranche Warrants, OCEANE, Warrants and number of shares outstanding.
Theoretical impact of the issuance of the OCEANE with attached Warrants (based on the Company share’s closing price on 6 July 2018, i.e., €1.45)
For reference, assuming the Company decides to remit only new shares upon Conversion of the OCEANE, the impact of the issuance of the OCEANE with attached Warrants would be as follows:
Impact of the issuance on the consolidated net assets per share (based on the shareholders’ equity as at 31 December 2017, i.e., €3.0M, and the number of shares making up the Company’s share capital as at 6 July 2018, i.e., 4,467,371 shares):
Consolidated net assets per share (in €)
Non-diluted basis
Diluted basis(1)
1stTranche
Total
1stTranche
Total
Before issuance of the new shares resulting herefrom
€0.67
€1.12
After issuance of a maximum of 1,080,333 shares (1st Tranche) or of 8,025,340 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares
€0.71
€1.00
€1.08
€1.15
After issuance of a maximum of 1,399,065 shares (1st Tranche) or of 11,212,661 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares and the exercise of the Warrants
€0.76
€1.12
€1.10
€1.23
(1) assuming the exercise of all the dilutive instruments existing to date that could result in the creation of an indicative maximum of 2,230,088 new shares.
Impact of the issuance on the investment of a shareholder currently holding 1% of the Company’s share capital (based on the number of shares making up the Company’s share capital as at 6 July 2018, i.e., 4,467,371 shares):
Shareholder’s investment (as a %)
Non-diluted basis
Diluted basis(1)
1stTranche
Total
1stTranche
Total
Before issuance of the new shares resulting from this capital increase
1.00%
1.00%
After issuance of a maximum of 1,080,333 shares (1st Tranche) or of 8,025,340 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares
0.81%
0.36%
0.57%
0.30%
After issuance of a maximum of 1,399,065 shares (1st Tranche) or of 11,212,661 new ordinary shares (total Tranches) resulting from the reimbursement of the OCEANE in shares and the exercise of the Warrants
0.76%
0.28%
0.55%
0.25%
(1) assuming the exercise of all the dilutive instruments existing to date that could result in the creation of an indicative maximum of 2,230,088 new shares.
The Company specifies that, in the event that the OCEANE are converted, it has the right to remit existing shares instead of new shares in order to limit dilution for its shareholders.
Next communication: Revenue for the first half of 2018 – 11 July 2018 after market closes
SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.
Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column. Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports. Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW
Investor relations David Siegrist – Finance Director Phone: +33 (0)4 72 77 01 52 finance.dsg@spineway.com
([1]) The following conditions must be met on the day the Warrants are exercised:
The issuer must comply with the obligations set forth in the Issuance Agreement;
No event or change causing the representations put forth by the issuer in the Issuance Agreement to become false or incorrect;
No binding commitment has been undertaken by the issuer with respect to a change in control;
No competent authority (in particular the AMF) has taken position against the issuance of the OCEANE or the Warrants, or their conversion or exercise;
No event constituting a case of default as per the Issuance Agreement is occurring and not been resolved during the applicable grace or appeal period;
The commitment period of 32 months as from 30 October 2018 has not expired;
The Spineway shares (i) are listed on the Euronext Growth Paris market and (ii) their listing has not been suspended on the date in question, whether by the AMF or Euronext, on the Euronext Growth Paris market (iii) have not been threatened, as from the date in question, whether (a) in writing by the AMF or Euronext or (b) by failure to meet the minimum requirements to remain listed on the Euronext Growth Paris market;
The issuer must have at least a number of authorized, available and approved shares for the Investor upon conversion of all the OCEANE outstanding, equal to the par value of the OCEANE to be issued upon expiration of the Rest Period in question (plus the par value of any other OCEANE outstanding, as the case may be) divided by the average daily volume-weighted price on the end date of each Rest Period;
The closing price of the Spineway share on the Euronext Growth Paris market must have exceeded 200% of the par value of the Spineway share over a period of over 60 trading days prior to the submission of the Request or prior to the date on which the Request is deemed to have been submitted (or, if this is not the case, an extraordinary general shareholders meeting shall have been held during such period in order to decrease the share capital by dividing the par value of the Spineway share in half or at least lowering it as much as possible).
([2]) Events of default include, in particular:
– continued failure to perform the obligations set forth in the Issuance Agreement for a period of 30 days as from the first of the following dates: (i) the date on which the Company becomes aware of the failure and (ii) the date on which the Investor notifies the Company of said failure;
– the Company’s failure to deliver the shares owed to the Investor within the three trading days following the date the OCEANE are converted or the Warrants are exercised.
BELGRADE, MT, July 10, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the appointment of Kevin Brandt to the new executive position of Chief Commercial Officer effective July 9, 2018.
“We are excited to have such a talented and experienced executive officer join our team,” said Carl O’Connell, chief executive officer of Xtant. “Kevin’s past accomplishments in the medical device industry show that he is an accomplished business strategist with a unique ability to provide the leadership in sales and marketing to build our Company’s revenues and profitability. I expect his contributions will be transformative for Xtant.”
Brandt brings to Xtant more than 28 years of experience in the medical device industry. As the former executive vice president and chief commercial officer of RTI Surgical, Inc.’s domestic direct business, Brandt led all domestic direct lines of business and R&D for a global surgical implant company marketing biologic, medical and synthetic implants. Prior to joining RTI Surgical in 2012, Brandt spent 18 years at Stryker Corporation from 1994-2012 in various senior commercial leadership positions. Most notably, while at Stryker he served as President of Osteokinetics from 2002-2012 as one of their largest distributors and prior to that he was Senior Director of US Spine sales from 2000-2001 responsible for creating and leading Stryker’s US Spine sales organization.
“I’m thrilled to be joining the Xtant team to lead the development and execution of their commercial strategy”, indicated Kevin Brandt. “Xtant’s legacy portfolio of biologics and fixation products provide a great foundation to build upon in the field of regenerative medicine and medical devices”.
About Xtant Medical
Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.
Important Cautions Regarding Forward-looking Statements
This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘continue,’’ ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘strategy,’’ ‘‘will,’’ “can” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. The Company cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to increase revenue; the ability to achieve expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.
Contact:
Xtant Medical Holdings, Inc.
Molly Mason
mmason@xtantmedical.com
