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Life Spine Announces Full Commercial Launch of PROLIFT® Lordotic Expandable Interbody Solution

May 16, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders today announced the full commercial launch of PROLIFT Lordotic expandable interbody solution with OSSEO-LOC™ technology.

PROLIFT Lordotic allows for in-situ disc height restoration, for minimally invasive PLIF, TLIF and oblique approaches. PROLIFT Lordotic, which incorporates the proprietary surface technology OSSEO-LOC, provides the surgeon the ability to restore normal spinal pelvic parameters with the multiple lordotic options, while continuing to build upon the patented expandable technologies at Life Spine.

OSSEO-LOC, Life Spine’s proprietary surface treatment, creates a geometric surface architecture which offers the clinical advantage of providing an osteoclastic environment, documented for the recruitment of bone building cells (osteoblasts) on titanium implants to assist with healing and solid fusions.

Mariusz Knap, Vice President of Marketing noted, “We are excited to offer PROLIFT Lordotic with the OSSEO-LOC subtractive process, as it deepens Life Spine’s commitment to providing surgeons access to our highly differentiated, minimally invasive spinal solutions. Addressing a variety of pathologies, Life Spine’s procedural based solutions increase the value of care by delivering both the ability to correct spinal alignment, an improved patient experiences. Life Spine continues to develop technologies that centers on achieving restoration of spinal alignment, which has been proven to be a significant driver to successful, long-term surgical outcomes. This will be a driving force as we continue to expand the Life Spine armamentarium of surgical solutions, and partner with surgeons to help them deliver superior surgical outcomes.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

EOS Announces NYU Langone’s 3rd System Installation

May 15, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced the EOS System is now available for patients at The Scoliosis Center, a division of Advocare The Orthopedic Center, which is the third site within the world-class NYU Langone Medical Center Healthcare System to offer the EOS System to patients. The first two units within the organization were dedicated to adult patients at the Center for Musculoskeletal Care and the Hospital for Joint Diseases.

The EOS solution including the low-dose, 2D/3D EOS imaging equipment, the 3D modeling workstation and the spineEOS software for 3D surgical planning will allow physicians to plan and manage treatment for scoliosis and other orthopedic conditions in 3D while avoiding high levels of radiation exposure. Advocare The Orthopedic Center provides pediatric and adolescent patients with the highest quality care for these pathologies.

Dr. Mark A. Rieger, MD, FAAOS, pediatric orthopedist, founding partner, and senior physician at Advocare The Orthopedic Center, commented, “The Scoliosis Center, established in 1994, is the first center within our network exclusively dedicated to the treatment of patients with scoliosis, which is a complex condition affecting the curvature of the spine. The addition of the EOS System is an important step as we create a world-class scoliosis center right here in New Jersey, thanks to our affiliation with NYU Healthcare System, offering high-end quality treatment management options leading to better outcomes for our patients.”

Researchers from NYU Langone Medical Center presented a study at the last American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting on the ‘Concepts in Radiation Exposure and Dosage’ that included a comparison of the radiation exposure with EOS imaging to traditional x-rays for pediatric patients. The study reported that a full 2D/3D EOS spine exam uses 60% less radiation than traditional x-rays. The importance of reducing radiation exposure from imaging exams was supported by new data on radiation-induced fatal cancer and genetic defects for female scoliosis patients associated with the significant number of imaging exams required to diagnose and follow the progression of their disease and treatment.

Marie Meynadier, CEO of EOS imaging, said, “The installation of a third EOS system within the NYU Langone network provides further validation of our technology and its potential to become a standard of care for orthopedic patients. The placement at The Scoliosis Center will facilitate access to the EOS technology to patients in the suburban communities served by NYU, a first class healthcare system adopting the latest technologies to provide optimal care to its patients.”

The Scoliosis Center, a division of Advocare The Orthopedic Center, is located at 218 Ridgedale Avenue in Cedar Knolls, New Jersey 07927. Interested patients and their families can call the office at (973)-538-7700.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Jamie Milas, +33-7-7695-2955
Vice President of Marketing
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
+33 (0)1-4471-9496
eosimaging@newcap.eu
or
Media Relations
Annie-Florence Loyer
+33 (0)1-4471-0012 / 6-8820-3559
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

DePuy Synthes Awarded U.S. Department of Defense Contract for Orthopaedic Products

RAYNHAM, Mass., May 15, 2017 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced it has been awarded a national contract from the U.S. Department of Defense for its orthopaedic products. Under the contract, DePuy Synthes will supply up to $260 million worth of orthopaedic products to the Defense Logistics Agency’s electronic catalog (ECAT) of medical products, which offers U.S. military medical treatment facilities worldwide access to a full spectrum of medical products for active U.S. military personnel and veterans.

“Our commitment to U.S. military servicemen, women and their families has spanned more than a century, and we are excited to continue that commitment by bringing our innovative orthopaedic products to U.S. military medical treatment facilities worldwide through the ECAT system,” said Juan-José Gonzalez, President, DePuy Synthes, U.S. “ECAT not only creates a more efficient online purchasing system, but it also enables us to deliver on our promise to provide products and capabilities that help to improve overall care and increase patient satisfaction.”

For more information, visit https://www.defense.gov/News/Contracts/Contract-View/Article/1165420/.

About DePuy Synthes
DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*Contracted through Johnson & Johnson Health Care Systems Inc. for DePuy Synthes Sales, Inc. spine orthopaedic products.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

The third-party trademarks used herein are the trademarks of their respective owners.
©DePuy Synthes 2017. All rights reserved.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

OrthAlign, Inc. Announces JMHLW Approval for use of Direct Anterior HipAlign®and UniAlign™ in Japan

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today that the Japanese Ministry of Health, Labour, and Welfare (JMHLW) has approved Direct Anterior HipAlign® for use in supine position Total Hip Arthroplasty (THA) surgeries and UniAlign™ for use in Unicompartmental Knee Arthroplasty (UKA) surgeries in Japan.

“I am very excited that OrthAlign technology will be available for use in Japan for supine position THAs and UKAs,” said Yukihide Minoda, MD, PhD of Osaka City University in Osaka, Japan. “I already use KneeAlign® for my TKAs and have found it to be a very important part of my surgeries. Clinically, it has been very valuable for my patients in Japan and I am very happy with the excellent outcomes. I expect the same with these new technologies.”

Recent statistics have shown that the direct anterior (supine position) approach is growing in popularity amongst Japanese surgeons as it arguably leads to quicker recovery, less pain, more normal function for Japanese patients after a hip replacement, and is more minimally invasive. HipAlign provides accurate cup placement positioning and does not require any pre-operative imaging, intraoperative fluoroscopy, or additional personnel in the operating room to control components outside of the sterile field.

Based on FDA cleared bench test data, HipAlign technology provides cup placement accuracy of ±3°, with at least 97% confidence. The system accounts for pelvic tilt when measuring the abduction and anteversion angles of the acetabular cup.

UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

Just as KneeAlign and Posterior Approach HipAlign have been distributed in Japan through OrthAlign’s partner ZimmerBiomet Japan, so too will Direct Anterior HipAlign and UniAlign.

“We are very pleased with the Japanese Ministry’s approval for use of Direct Anterior HipAlign and UniAlign in Japan,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “There were approximately 20,000 supine position THAs and 8,000 UKAs completed in Japan during 2016, and these are the fastest growing procedures in joint replacement in the country. Japan is extremely important for OrthAlign’s international growth strategy and we will continue providing new technologies that address the market’s needs, following the successes of KneeAlign and Posterior Approach HipAlign. We are thrilled to be expanding our partnership with ZimmerBiomet Japan and hope we can continue our contribution in raising the standard of care for Japanese joint replacement surgeries.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology

GAINESVILLE, Fla.–(BUSINESS WIRE)– May 15, 2017

Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS® Shoulder Application. Combining preoperative planning with computer-assisted surgery, the industry-leading technology allows for greater intraoperative visibility in both standard and challenging shoulder arthroplasty.

“The ExactechGPS Shoulder Application offers groundbreaking technology that is unique to the industry and should continue our selling momentum that delivered 21% growth in the first quarter,” said Darin Johnson, Vice President, Extremities Marketing. “Allowing surgeons to preoperatively plan the surgery and then execute it with a computer-assisted solution will help patients by ultimately improving outcomes. Importantly, it also reflects Exactech’s philosophy of keeping intraoperative decision making and control in the surgeon’s hands.”

An introduction to the new technology was the focal point at the recent 2017 Exactech Shoulder Masters Course, with live broadcasts of two surgeries performed by Pierre-Henri Flurin, MD, in Bordeaux, France.

“The live surgeries featuring the new ExactechGPS shoulder application for both anatomic and reverse total shoulder cases were incredible as it felt like we were in the operating room. It was exciting to witness the most advanced innovation in shoulder arthroplasty since reverse shoulders were first introduced,” said attendee Samuel Antuña, MD.

Setting a new standard in medical education, the Masters Course’s comprehensive scientific program featured 35 presentations by distinguished faculty who shared their experiences and philosophies with more than 150 surgeons from 17 countries around the world. Faculty member Joseph Zuckerman, MD, said, “This was one of the highest quality educational meetings I have participated in during my professional career. Between the scientific and technical presentations, debates, live surgeries and interactions between our surgeon peers, it was a truly unique and rewarding experience.”

The ExactechGPS Shoulder Application’s preoperative planning tool is designed to help surgeons understand their patient’s anatomy prior to surgery. Intraoperatively, ExactechGPS provides visibility into the glenoid vault in real time and allows for consistent, accurate glenoid placement.1 A recent study showed that more accurate glenoid placement minimizes complications and theoretically increases implant survivability.2 In addition, ExactechGPS provides a real-time view of retroversion and inclination, reaming and drilling depth, screw placement and the ability to adjust surgical plan intraoperatively, offering surgeons more flexibility.

The ExactechGPS Shoulder Application has been used successfully in the U.K., Spain, France and Australia. The initial launch in the U.S. is planned for this quarter. It is the latest addition to the Equinoxe® Shoulder System, which has been one of the fastest growing shoulder lines on the market since its introduction more than a decade ago. This year marks the 10th anniversary of the first implantation of the Equinoxe reverse shoulder; Equinoxe products will be implanted in the 100,000th patient before the end of this year.

  1. Data on file at Exactech*
  2. Walch G et al. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J. Shoulder and Elbow Surg. (2011) 20; 385-394.

* In vitro (bench) test results may not necessarily be indicative of clinical performance.

About ExactechGPS

ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the implant in the optimal position. Exactech first introduced ExactechGPS to surgeons in the United States for total knee arthroplasty, and has since broadened its reach by providing medical education and supporting surgeries in more than 11 countries. The technology has steadily gained market acceptance and worldwide reach.

About Exactech

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

Kyphoplasty for Vertebral Fractures Reduces Pain, Opioid Use

Nancy A. Melville – May 11, 2017

LOS ANGELES — Balloon kyphoplasty shows safety and efficacy in improving quality of life, pain, and functional outcomes, while reducing opioid use, among patients treated for vertebral compression fractures (VCFs), new research suggests.

“We found that all primary endpoints demonstrated statistical improvement and these were maintained or improved throughout a 12-month follow-up,” said first author, John W. Amburgy, MD, a resident with the Department of Neurosurgery at the University of Alabama, Birmingham, in presenting the findings here at the American Association of Neurological Surgeons (AANS) 2017 Annual Meeting.

“Secondary endpoints, including opioid usage, activity, angulation correction, and height  restoration, also showed statistical improvement,” he reported.

In balloon kyphoplasty, a minimally invasive treatment for VCFs caused by bones weakened from osteoporosis or cancer, the compressed bone is gently raised to its normal position and the cavity created is filled with orthopedic cement to stabilize the fracture.

The procedure differs from vertebroplasty only in the use of the balloon approach.

The prospective EVOLVE outcomes analysis, which Dr Amburgy noted is the largest prospective outcomes trial for kyphoplasty to date, involved 350 patients with painful, acute, or subacute VCF who were enrolled at 24 sites and underwent kyphoplasty.

The patients had a mean age of 78 years; 77% were female. All had one to three acute or subacute fractures less than 4 months old. Approximately half (54.9%) had bilateral kyphoplasty.

Most patients had VCF due to osteoporosis (343 of 350), and the remaining cases were due to cancer.

The patients’ average pain scores were greater than 7 on a scale of 1 to 10, and disability on the Oswestry Disability Index (ODI) was greater than 30 on a scale of 0 to 100.

Follow-up data collected at 1-, 3-, 6-, and 12-month time points showed significant improvements in various measures.

 

READ THE REST HERE

CURASAN Bone Graft Foam Debuts In LA Knee Fusion

By JSHAMP – 5-11-2017

A California surgeon has performed the first U.S. bone graft using a pliable foam produced by Research Triangle Park–based medical biomaterials company CURASAN Inc.

Divakar Krishnareddy, M.D., used CURASAN’s CERASORB Ortho Foam bone graft product in a knee fusion procedure, technically called knee arthrodesis, at Los Angeles Community Hospital.

It was the first surgery using CERASORB since the U.S. Food and Drug Administration approved it in December 2016.

“It’s exciting to see a product that has both excellent handling and strong clinical evidence become available in the U.S.A.,” said Krishnareddy. “CERASORB Ortho Foam’s handling is very easy to adapt to underlying anatomy, preventing large gaps while allowing graft placement where you need it.”

 

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Colorado Therapeutics Appoints Medtronic Executive John Lorbiecki as Chief Operating Officer in Advance of XI-S+™ Launch

BROOMFIELD, Colo., May 15, 2017 (GLOBE NEWSWIRE) — Colorado Therapeutics LLC, a commercial-stage medical device company with a proprietary technology platform for the production of innovative cross-linked tissue products, announced that John Lorbiecki has been appointed to the newly created position of chief operating officer effective March 21, 2017. Mr. Lorbiecki brings broad leadership experience from a career at Medtronic in finance, business development and commercial operations to Colorado Therapeutics.

“John’s experience in the areas of marketing, regulatory, reimbursement and financial accounting will be a significant benefit to Colorado Therapeutics as we prepare to launch our first FDA cleared commercial product, XI‑S+™,” stated Joseph B. Horn, Colorado Therapeutics’ president and CEO. “His experience with surgical biologics products is particularly applicable to our product line, which has shown utility in the repair of hernia and other soft tissue applications. We welcome John to our team and look forward to capitalizing on his experience with our impending product launch as well as our open Series A financing.”

“From my experience, I believe that the team at Colorado Therapeutics has developed a truly unique biologic tissue product. The characteristics of XI-S+™ will provide surgeons with a blend of strength, flexibility, and biocompatibility that is not currently available on the market in either synthetic or biologic products,” Mr. Lorbiecki added. “I’ve spent my career at a large, established medical device company. The opportunity to join a nimble, innovative organization at this stage of commercial growth was one I could not pass by.”

During his 25-year career at Medtronic, Mr. Lorbiecki held several positions of increasing responsibility, most recently as Senior Finance Director of Strategic Scientific Operations where he was responsible for developing long-term and annual operating goals, providing business support to clinical, regulatory, reimbursement, and other strategic scientific operations in the company.  Prior to that role, Mr. Lorbiecki held two divisional CFO roles, managed financial integration of multiple acquisitions, and provided analytical and strategic insight on high-value business development opportunities.  During his term, he dedicated six years to managing the development of pricing strategy and tactics for the Cardiac Surgery division, including national accounts.  He earned a MBA from the University of Chicago and a BA in economics from the University of St. Thomas in St. Paul, Minnesota.

About Colorado Therapeutics
Colorado Therapeutics is a commercial-stage company developing strong, durable and biocompatible tissue from xenogenic sources using a proprietary cross-linked tissue processing technology. Resulting tissue products demonstrate superior benefits compared to currently available biologic or synthetic products. XI-S+™, Colorado Therapeutics first commercial product, received U.S. FDA 510(k) clearance in 2016 for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Colorado Therapeutics’ products target the $2.25 billion U.S. soft tissue reinforcement and regeneration markets, and may have utility in a broad range of applications. Colorado Therapeutics’ corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

Eric Schauble, Vice President	
Colorado Therapeutics LLC
(303) 469-9459
eschauble@co-therapeutics.com

Aline Sherwood
Scienta Communications
Telephone: (312) 238-8957
asherwood@scientapr.com 

Primary Logo

 

© GlobeNewswire 2017

Xtant Medical Announces OrbiMed Financing and Engagement of Aurora Management Partners

BELGRADE, Mont., May 12, 2017 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced it has entered into an amendment to its senior credit facility with affiliates of OrbiMed Advisors (“OrbiMed”) for a financing of up to $15 million with the proceeds being used to pay off its outstanding balance of approximately $9 million under its accounts receivable credit facility with Silicon Valley Bank (“SVB”) with the remainder for general working capital purposes.  Additionally, OrbiMed has deferred the interest originally due under the senior credit facility January 2, 2017 and March 31, 2017 to June 30, 2017.

Xtant Medical also announced it has entered into an agreement on May 8, 2017 with Aurora Management Partners Inc. to engage David Baker and Wayne Tanner as restructuring officers to assist with day-to-day operations of the company and implementation of an operating business plan. The restructuring officers will report to the special restructuring committee of Xtant Medical’s Board of Directors.

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant 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 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 that are subject to significant risks and uncertainties. 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,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution 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 comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; 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; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. 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.

 

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

Arthroscopic Surgery Doesn’t Help With Arthritis Knee Pain

Carmen Heredia Rodriguez, Kaiser Health News – May 11, 2017

An international panel of surgeons and patients has challenged the effectiveness of one of the most common orthopedic procedures and recommended strongly against the use of arthroscopic surgery for patients with degenerative knee problems.

The guidelines, published Wednesday in the journal BMJ, reviewed 13 studies involving nearly 1,700 patients and found the surgery did not provide lasting pain relief or improve function for most of them. Those studies compared the surgery with a variety of options, including physical therapy, exercise and even placebo surgery.

Fewer than 15 percent of patients felt an improvement in pain and function three months after the procedure, and that those effects disappeared after one year, the review found. In addition, the surgery exposed patients to “rare but important harms,” such as infection.

Casey Quinlan, 64, who had the surgery in 2003 and was on the panel issuing the guidelines, said her orthopedist told her the procedure would not only help restore mobility in her knee after a nasty ski accident but also improve her arthritis.

Quinlan, of Richmond, Va., said the procedure did not deliver, since her arthritis remained unchanged. “It was not what I was told to expect,” she says.

In an arthroscopic knee surgery, physicians make several small incisions around the joint and insert a tiny camera that allows them to see inside the knee as well as insert small instruments to correct problems they identify. Often the surgery is performed to remove part of a damaged meniscus, a disc of cartilage that helps cushion the knee.

The panel said meniscal tears “are common, usually incidental findings, and unlikely to be the cause of knee pain, aching or stiffness.”

 

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