BELGRADE, Mont., May 16, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, today announced it has entered into a licensing agreement with Sites Medical LLC, for utilization of their proprietary OsteoSync™ Ti technology, a best-in-class porous titanium scaffold.

“We are very excited to work with Sites Medical,” said Carl O’Connell, CEO of Xtant Medical. “As market dynamics shift towards emerging titanium technologies, Sites Medical’s OsteoSync Ti technology places us firmly at the forefront of this trend.  This technology exhibits great synergy with our entire line of spinal implants further enhancing the value of this relationship as well as Xtant’s potential impact in its core market.”

“We are thrilled to be partnering with Xtant Medical, a company with a rich history of innovation in the spine field,” said Greg Stalcup, President/CEO of Sites Medical. “We look forward to working with the Xtant team to combine our respective technologies to deliver a new generation of high performance, high value products to the market.”

OsteoSync Ti technology is a highly porous titanium scaffold designed to meet the needs of today’s patients from both clinical and economic standpoints. Its high friction coefficient ensures high initial implant stability and its open pore geometry and micro-texturing facilitate superior bone ingrowth. Preclinical testing has demonstrated bone attachment strength nearly twice that of titanium plasma spray and approximately seven times that of PEEK material at the 5-week follow up period, a performance differential that can impact clinical outcomes, especially in spinal fusion patients. OsteoSync Ti technology has also been engineered to reduce the potential for abrasion debris generation during implant insertion, offering an additional measure of safety for the patient. The material is manufactured using highly innovative methods and offers substantial value in today’s cost-conscious healthcare environment.

Utilizing Q2 Metrics data, Xtant Medical estimates the total addressable US market for its technologies that can utilize OsteoSync Ti at $2.5B with a 5 year CAGR approaching 4.75%. Xtant Medical’s first devices to utilize the technology will be featured at this year’s NASS annual meeting to be held on October 25-28 in Orlando, FL.

About Xtant Medical Holdings

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.

About Sites Medical

Sites Medical has recognized the shift in healthcare reimbursement paradigms and is entirely focused on Value-Driven Innovation in orthopedics. With its suite of proprietary orthopedic implant technologies and manufacturing process improvements, Sites aims to deliver improved clinical outcomes and reduced cost to all stakeholders. SITES can further serve the needs of its OEM partners through its Concept-to-Launch capability, where we conduct all necessary R&D activity and use state-of-the-art manufacturing equipment and techniques to deliver the highest quality product. Additional information about the company can be found at www.sitesmedical.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.” 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.

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

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

THORNTON CLEVELEYS, UK – (May 16, 2017) – At the 10th Annual Congress of the Chinese Association of Orthopaedic Surgeons (CAOS), long-standing development partners Invibio Biomaterial Solutions, UK, and China’s Double Medical Technology Inc. collaborated on an interbody spine surgery workshop to help expand knowledge of the implantation of Double Medical’s Direct Lateral Interbody Fusion (DLIF) spinal cages made with PEEK-OPTIMA™. The biomaterial PEEK-OPTIMA polymer by Invibio was introduced to medical device manufacturers in China after the approval by the China Federal Drug Administration (CFDA) in 2004.

Hosted in conjunction with the North American Spine Society (NASS), the CAOS workshop “Principles and Techniques of Complex Spine Surgery Workshop” took place on May 12, 2017, at the Zhongshan School of Medicine, Sun Yat-sen University, in Guangzhou. The event was the fifth joint NASS-CAOS workshop and delivered a full day of hands-on cadaver labs with over one hundred surgeons attending and multiple one-hour product demonstrations streamed live to the audience, including the demonstration of Double Medical and medical-grade PEEK innovator Invibio.

Double Medical, a large medical equipment group whose broad product range includes orthopaedic implants, dental implants, general surgical products, neurosurgical products and electronic medical devices, and Invibio have been working together since 2009. At this jointly planned NASS-CAOS event, the two companies demonstrated a Direct Lateral Interbody Fusion (DLIF) spinal cage made with PEEK-OPTIMA and showed how the DLIF cage, which has already been used in lumbar surgeries, can provide a better overall therapeutic experience for patients.

“The design of this state-of-the-art DLIF cage incorporates advances in medical technology contributed by both our companies,” commented Michael Veldman, global strategic marketing manager at Invibio. During the NASS-CAOS workshop he delivered a short introduction on PEEK-OPTIMA, its potential clinical benefits and outlined how the adoption of the new PEEK-OPTIMA HA Enhanced is progressing, both globally and within China.

Veldman said, “It is important to note that advanced surgical technique now allows the placement of the DLIF Cage across the disc space, while avoiding the anterior vessels, and the posterior neural and bony elements. As well, the bullet-nose design allows for ease of insertion, while autogenous bone graft or bone graft substitute are accommodated, allowing fusion to occur through the cage. This is a remarkable design. It’s innovation in action.”

Double Medical is driving progress based on Invibio’s implantable biocompatible polymers into China and globally. Double Medical´s orthopaedic implants are a leading product in the domestic market in China, and the company has branches in more than 30 of China’s provinces and cities. Double Medical is also cooperating with more than 3,500 hospitals and nearly 1,000 business enterprises in China; its products have been exported to more than 40 countries and regions that include the US, EU, Russia, Southeast Asia, Middle East and South Africa.

“At Double Medical it is our professional goal, as a specialist in medical products, to be in the top three of the industry in China,” said Jack Zhu, Sales Director at Double Medical’s Spine Business Unit. The company is one of the key high-tech enterprises of China’s National Torch Plan.* “We will do this by implementing a strategy to diversify our products for the medical field, to become a comprehensive supplier of high-value, high-quality medical materials. The cooperation with Invibio, over a number of years, is central to that policy, where innovation is key. With Invibio, we have been able to launch medical products that utilize new technology and build an innovation-driven enterprise.”

Worldwide, the number of implanted medical devices that incorporate PEEK-OPTIMA polymer has increased to around nine million. Invibio is building on this pioneering success, working within China’s flourishing and advanced medical sector, where enhanced therapeutic technologies and techniques are being prioritised by official government policy. Developed by Invibio, a leading provider of biomaterial solutions, PEEK-OPTIMA polymer solutions are widely recognized for spinal interbody fusion and are frequently used in medical applications. The advanced material offers a variety of clinical advantages including a modulus close to that of human bone, reduced stress shielding and, in contrast to metals, artifact-free imaging that allows for clear fusion assessment.  For further information please visit https://invibio.com/spine

* The National Torch Plan was established in 1988, by China’s Ministry of Science and Technology, to encourage innovation and promote the development of China’s high-tech industry. Projects and enterprises listed in the plan have access to a series of support programs for projects in new technological fields, such as new material, biotechnology, electronic information, integrative mechanical-electrical technology, and advanced energy-saving technology.

About Double Medical Technology Inc.

Founded in 2004, Double Medical Technology Inc. is one of the key high-tech enterprises listed on the National Torch Plan and today a large medical equipment group. The broad product portfolio includes orthopaedic implants, dental implants, general surgery products, neurosurgery products, medical electronic devices. Double Medical´s orthopaedic implants are a leader in the domestic market in China. The company has branches in over 30 provinces and cities and is cooperating with more than 3,500 hospitals and nearly 1,000 business enterprises in China; its products have been exported to more than 40 countries and regions that include the US, EU, Russia, Southeast Asia, Middle East and South Africa. For more information, please visit www.double-medical.com/en.

Note:  If you would like more information about this story, or if you would like to speak with an Invibio spokesperson, please contact Kris Jommersbach at krisj@geminiinc.com.

Orlando, Florida- May 15, 2017 – Mazor Robotics. a pioneer and leader in the field of surgical guidance systems, congratulates Dr. Kornelis Poelstra, board-certified orthopedist and founder of the “The Spine Center of Excellence at Sacred Heart on the Emerald Coast”, for becoming the first surgeon to reach the milestone of 200 patient procedures using the newly launched Mazor X Surgical Assurance platform.

Dr. Poelstra, who is a pioneer of MIS pedicle systems, lateral interbody cages and reconstructive systems, has used the Mazor X to benefit patients in a wide variety of spinal procedures. Recently, he also performed the first ever Mazor X lateral procedure, which enables posterior instrumentation without requiring the patient to be repositioned from their side to a prone position during surgery, saving valuable operating room time.

According to Dr. Poelstra “The Mazor X has been utilized in over 90% of our minimally invasive procedures and has allowed for greater patient safety, shorter operating times and faster recovery for my patients. We believe that we are redefining the standard of spinal surgery in our facility.”

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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.

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Nancy A. Melville – May 10, 2017

LOS ANGELES — The preoperative use of opioid analgesics is associated with worse clinical postoperative outcomes at 12-month follow-up of lumbar fusion surgery for degenerative lumbar conditions, new research shows.

“The results suggest the use of opioid medication is a potentially modifiable factor that could be controlled to maximize clinical outcomes,” said first author, Alan T. Villavicencio, MD, from Boulder Neurosurgical Associates, Colorado.

He presented the findings here at the American Association of Neurological Surgeons (AANS) 2017 Annual Meeting.

While a high number of patients with low back pain can be expected to have been prescribed opioid medications for pain, research on the relationship between use of the medications before surgery and lumbar fusion surgery outcomes is lacking.

For the prospective study, Dr Villavicencio and colleagues enrolled 93 patients receiving one- to two-level transforaminal lumbar interbody fusion surgeries for degenerative low back conditions.

Of the patients, who had an average age of 59 years, 60 (64.5%) had preoperatively used prescribed opioids, with an average preoperative dose of 64.4 mg (range, 10 to 270 mg).

Demographic and surgical characteristics did not significantly differ between patients who did and didn’t have preoperative opioid use, with the exception of average symptom duration, which was longer in nonusers (113 months vs 56 months; P = .008).

In the opioid use group, preoperative disability was higher than in nonusers (average Oswestry Disability Index, 40.3 vs 33.7; P = .04) and measures of mental health were lower (Short Form-36 [SF-36] Mental Component Summary [MCS], 42.7 vs 49.2; P = .01).

However, other clinical scores of back and leg pain visual analogue scale and SF-36 Physical Component Summary (PCS) were not statistically different.

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By Sky McCarthy – May 5, 2017

An Australian man is suing American Airlines, alleging that he suffered serious injuries after being seated next to two passengers he claims were “grossly obese.”

Michael Anthony Taylor, of Wollongong, New South Wales, was flying from Sydney, Australia to Los Angeles in December 2015—a 14-hour journey.

Taylor was seated in the window seat of economy class and, according to court documents, two overweight passengers were seated in his row. According to the lawsuit, the body of the passenger next to Taylor “spilt over and encroached” upon his seat, forcing him to “contort his body into a series of positions including standing up, crouching, keeling and leaning forward,” reports news.com.au.

Though it’s been well over a year since the trip, Taylor, who suffered from a pre-existing spinal curvature, claims that he suffered even more severe back injuries and neck pain, arguing that the uncomfortable plane ride exacerbated his condition.

Taylor’s lawyer, Thomas Jansen of Shine Lawyers, said his client  asked the cabin crew if he could change seats but was reportedly denied re-accommodation requests multiple times.

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