10 orthopedic device company CEOs: Who is paid the most?

Written by  Laura Dyrda – Becker’s Spine Review, 09 May 2017

Orthopedic and spine device company leader compensation varies across the board based on the company’s size and market share. While some have a larger base salary, others have higher bonus and stock option value.

Here is the compensation for 10 orthopedic and spine device company leaders based on data from Salary.com. The information is reported according to the proxy statements filed for the 2015 fiscal year.

1. Alex Gorsky. Chairman and CEO of Johnson & Johnson: $21.2 million

2. Omar Ishrak. Chairman and CEO of Medtronic PLC: $15 million

3. Kevin Lobo, Chairman, President and CEO of Stryker: $12.8 million

 

 

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Stryker and AlloSource announce collaboration to distribute biologics for use in sports medicine procedures

DENVER, May 18, 2017 /PRNewswire-USNewswire/ — Today at the 2017 Annual Arthroscopy Association of North America (AANA) Meeting (booth #109), Stryker’s Sports Medicine business and AlloSource® formally announced their collaboration to provide high quality, innovative biologics for use in sports medicine procedures. This collaboration is driven by the companies’ combined commitment to better serve their customers, help patients in need and fully honor the gift of tissue donation.

“We believe biologics will play a critical role in advancing the field of Sports Medicine, so we are very excited about the opportunity to collaborate with AlloSource given their history of quality and innovation,” said Matt Moreau, Vice President & General Manager of Stryker’s Sports Medicine business. “The collaboration between Stryker and AlloSource will enable us to combine our unique areas of expertise to develop new ways to improve patient outcomes.”

Through the collaboration, Stryker’s Sports Medicine nationwide sales force will distribute AlloSource biologics for use in a variety of sports medicine procedures.

“Deepening our relationship with Stryker through this sports medicine collaboration will help us further advance patient healing and honor our tissue donors by getting biologics in the hands of more surgeons,” said Kerr Holbrook, AlloSource Chief Commercial Officer. “We look forward to working and growing together.”

For more information, please visit Stryker’s website or AlloSource’s website.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media contacts
Jon Zimmer, Stryker, jon.zimmer@stryker.com
Megan Duggan, AlloSource, mduggan@allosource.org

 

SOURCE AlloSource

Related Links

http://www.allosource.org

VEXIM in Facts, Five Years after the Stock Market Listing on the Alternext Market

May 17, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its fifth-year anniversary on the Alternext market.

“After five years of quotation on the Alternext market, VEXIM has made tremendous progress on all fronts. VEXIM has successfully implemented its direct go to market strategy in Europe reaching 10% market share in 2016 and reached profitability on the second half of 2016. VEXIM also attracted and recruited more than 30 talented and experienced employees supporting the growth of VEXIM’s business and serving our customers every day. We also generated value for our shareholders by tripling our market capitalization in 5 years. With the US market, EU market, international expansion and our product portfolio extension projects, VEXIM has a great potential of growth for the next coming years. We would like to thank all VEXIM’s shareholders from the first days and the ones who have joined recently for their trust and support“, said Vincent Gardès, CEO of VEXIM.

EUROPE, A GREAT SUCCESS IN 5 YEARS

In 2012, we launched our Go-to-market strategy in Europe that was to address 90% of the market through a direct sales force organization. After 5 years, VEXIM results are impressive with a compounded average growth rate of our sales of 74% since 2011. We now have reached a 10% market share position1 as of end of 2016 and a leading market position in France2, VEXIM’s domestic market. We aim to continue to gain market share in the coming years in Europe by focusing mainly in Germany and all other countries.

EXPANDING OUR PRODUCT PORTFOLIO

The SpineJack® remains VEXIM’s main product representing close to 90% of our sales but in the past 5 years we also launched new products to extend our portfolio. The Interface™ launched in 2014, a cement with 50% of Hydroxyapatite to be used in younger patients. The Masterflow™ launched in 2015, is a sophisticated solution providing a controlled high viscosity cement injection, at a safe distance3from the radiation field for multi-level procedures. And more recently the Masterflow™ PLUS launched in March 2017 in Germany that allows a Controlled Cement Augmentation Procedure first through vertebral body height elevation, and second by stabilizing the fracture using Cohesion® Bone Cement injection. We have also other projects in the pipeline to extend our portfolio into high energy vertebral fractures and tumor. This promising portfolio will strenghthen our Spine trauma positioning and expertize.

BUILDING CLINICAL EVIDENCE

We have successfully conducted 7 international clinical studies and 4 biomechanical studies to support the efficacy and safety of our SpineJack® product. These studies have led to 14 publications in renowned medical journals4. VEXIM is continuously looking and investing to build more clinical evidence. VEXIM’s US FDA 510K clinical study, the clinical and health economic study comparing the SpineJack® vs conservative treatments and the future clinical study in Germany where the SpineJack® will be more evidence based towards a wider range of indications to follow, are demonstrating VEXIM’s commitment to build clinical evidence and demonstrate benefits of its technology.

HIGH PERFORMING ORGANIZATION

VEXIM’s culture of execution, passion and customer focus are key strengths that supported the development of the company on the past 5 years. Vexim more than doubled its number of employees in 5 years reaching 66 employees across all entities with diverse and experienced talents across the company. VEXIM will continue to recruit talents across the globe to sustain its objectives and projects.

STRATEGIC INTERNATIONAL EXPANSION

There has been a growing interest in the SpineJack® across the world. The SpineJack® is today available in more than 15 countries across the world from Central & Latin America to Eastern Europe, Middle East, South Africa and South East Asia. We will continue to expand our footprint by opening new markets such as Brazil, Australia, South Korea, China.

OPERATIONAL AND FINANCIAL EXCELLENCE

VEXIM successfully achieved to turn profitable on a full semester in the second half of 2016 and generated positive cash flows. VEXIM also increased its Gross Margin on sales from 59% to 72% in average by optimizing its production costs and inventory processes. VEXIM aims at reaching profitability on a full year basis in 2017 and future cash flows should allow VEXIM to self-finance, in line with its ambitions.

Click here to consult VEXIM’s 2016 results presentation

Financial reporting schedule:
2nd quarter sales: July 11th, 20175

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital6, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®7, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 Internal Vexim source.
2 Internal Vexim source.
3 Mehlman, Charles T., DiPasquale, Thomas G. Journal of Orthopaedic Trauma: August 1997 – Volume 11 – Issue 6 – pp 392-398 Radiation Exposure to the Orthopaedic Surgical Team During Fluoroscopy: “How Far Away Is Far Enough?”
4 http://en.vexim.com/professionals/scientific-and-clinical-communication/
5 Indicative date, subject to changes.
6 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
7 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery

May 17, 2017

LA JOLLA, Calif.–(BUSINESS WIRE)–XpandOrtho, Inc., a designer of soft tissue balancing instruments, received FDA clearance on April 25th of 2017 for their electronic soft tissue balancing instrument for total knee replacement surgery.

The US Food and Drug Administration (FDA) awarded XpandOrtho 510(k) clearance for its sterile-packaged wireless disposable device that utilizes multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint during a full range of motion. The device uses a novel constant pressure bellows system which wirelessly communicates with a display to provide dynamic multiaxial balance and selection of optimal thickness of the tibial component. The device can be conveniently used by all surgeons regardless of whether they choose to make the femoral cut first or the tibial cut first. Soft tissues can be released with the device in place enabling real time visual feedback to the surgeon. The “universal” design is compatible with almost all total knee implant systems from major manufacturers. This low-cost disposable device can also preserve an electronic record of the entire 3D balance of the knee at the end of the surgical procedure.

XpandOrtho has initiated a clinical study at Scripps Clinic, La Jolla, CA and will be conducting a limited release of their product to selected surgeons in the US. “We are excited to give large and small volume surgeons the ability to reproducibly and accurately balance the ligaments of the knee over a full range of motion during total knee replacement,” said Clifford Colwell, M.D., President and Chairman of the Board, XpandOrtho, Inc.

About XpandOrtho, Inc.

XpandOrtho, Inc. is developing and commercializing orthopedic devices that provide real time visual feedback to surgeons during their surgical procedure. XpandOrtho is a privately held medical device and technology company that is committed to improving the standard of care in total knee replacement surgeries by providing measurable and consistent results to all surgeons and patients. Our future development plans will leverage this technology to provide solutions for a broader range of orthopedic procedures.

Contacts

XpandOrtho, Inc.
Dr. Cliff Colwell, 858-663-7092
colwell@scripps.edu

Titan Medical Completes Initial Formative Human Factors Studies for SPORT Robotic Surgical System

TORONTO, ON–(Marketwired – May 17, 2017) – Titan Medical Inc. (TSX: TMD) (OTCQB: TITXF), a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (MIS), announces completion of initial formative human factors studies for its SPORT single port robotic surgical system. Formative human factors studies involve the evaluation of prototypes by expert users that focus on simulated task exercises that are critical to product safety.

David McNally, President and CEO of Titan Medical, said, “The completion of initial formative human factors studies is a key development milestone, and we are pleased to have achieved it on schedule. We are grateful to the independent surgeons and nurses who participated in these studies. Initial formative human factors studies are a foundational step in the development of a safe and effective complex medical device, such as a robotic system. In addition to evaluating the ergonomics of the workstation and patient cart during simulated procedures, clinicians provided insights regarding the setup and maneuverability of the central unit, the positioning of the insertable camera and the loading of instruments. The results of the studies provide valuable perspectives on user interaction and user experience for the development of the SPORT system. This end-user feedback will be integrated with information gained from the ongoing testing and evaluation of certain subsystems, so that appropriate design enhancements can be prioritized and implemented.”

Mr. McNally continued, “Based on our progress and the commitment of our employees and subcontractors, we remain on track to deliver the next of our stated milestones during the second quarter of the year. While our product development team focuses on system design improvements, other members of management are actively engaged in evaluating prospective strategic facilities for preclinical studies in the U.S. and Europe.”

About Titan Medical Inc.

Titan Medical Inc. is focused on the design and development through to the planned commercialization of a robotic surgical system for application in MIS. Titan’s SPORT Surgical System, currently under development, includes a surgeon-controlled robotic platform that features multi-articulating instruments for performing MIS procedures through a single port. The surgical system also includes a workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view inside a patient’s body. The SPORT system is designed to enable surgeons to perform a broad set of general abdominal, gynecologic, urologic and colorectal procedures. For more information, visit the Company’s website at www.titanmedicalinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Information Form dated March 31, 2017 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

 

CONTACT INFORMATION

Knee osteoarthritis: Steroid injections offer no benefit, study suggests

Written by  , Published 5-16-2017

Patients with symptomatic knee osteoarthritis do not benefit from steroid injections, concludes a new study published in JAMA.

Study co-author Timothy E. McAlindon, of Tufts Medical Center in Boston, MA, and colleagues found that steroid injections administered every 3 months were no better than a placebo for alleviating knee pain in patients with knee osteoarthritis (OA).

In fact, the researchers found that steroid injections actually led to a greater loss in the volume of bone cartilage over 2 years.

Based on their findings, McAlindon and colleagues recommend against the use of steroid injections for the treatment of knee OA.

OA, also referred to as degenerative joint disease, is the most common form of arthritis, affecting more than 30 million adults in the United States.

OA is caused by the breakdown of cartilage, the tissue that covers and protects the ends of bones, and it most commonly affects the joints of the knees, hips, hands, and spine. The “wear and tear” of cartilage can lead to pain, inflammation, and movement problems.

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Study results demonstrate 74% reduction in surgical site infections with use of PICO™ Single use Negative Pressure Wound Therapy system

16 May 2017

Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, proudly supports results of an independent, randomised clinical trial1 concluding that, in the patients studied, the use of the PICO Single Use Negative Pressure Wound Therapy (NPWT) system significantly reduced the rate of surgical site infections (SSI) by 74%, compared to standard care in patients undergoing major abdominal incisions.

The randomized, controlled, open-label trial of 50 patients investigated the role of PICO Single Use NPWT used prophylactically in patients undergoing major abdominal surgery. Thirty days after operations, the incidence rates of SSI significantly reduced by 74% (8.3% in treatment group vs. 32% in control group). Patients’ length of stay also reduced by approximately eight days (6.1 vs. 14.7 days). The treatment group included the use of the PICO Single Use NPWT system.

Patients at risk of poor healing may benefit from the PICO Single Use NPWT System, as it can help to improve the speed, strength, and quality of incisional wound closure, and may minimise the failures of healing that may lead to infection and/or dehiscence2. The PICO system is suitable for use in both a hospital and community setting and approved for a number of indications, including surgically closed incision sites.

“This study underscores the importance of PICO Single Use NPWT in treating patients who have undergone a laparotomy (open abdominal surgery),” said Colin Peirce, Consultant General and Colorectal Surgeon, University Hospital Limerick, Ireland. “As surgeons, we are always looking for effective and cost efficient ways to treat patients, and this study demonstrates that PICO Single Use NPWT can significantly reduce both the incidence of surgical site infection and the length of stay, resulting in a potential reduction in healthcare costs,” concludes Colin Pierce.

Up to 60% of all SSIs are preventable but they continue to be a large burden on the healthcare system3. With approximately 500,000 SSIs per year in the US and 8,000 connected annual deaths, the cost of SSIs are in excess of $7 billion and over £758 million per year  in the UK3.

“This study is the latest addition of research that reinforces the importance of PICO Single Use NPWT and the significant impact it has on reducing SSIs, healthcare costs and ultimately improving the patient’s quality of life,” said Andy Weymann, Chief Medical Officer in Smith & Nephew. “It follows the recent release of global guidelines from the World Health Organisation (WHO) recommending the use of NPWT prophylactically,” added Andy Weymann.

The PICO Single Use NPWT system is being investigated in a number of clinical trials worldwide. For more information about the clinical trials, please visit: www.clinicaltrials.gov.

Enquiries

Media

Karley Ura
Madano
+44 (0) 20 3595 2415

Jaclyn Confalone
Madano
+44 (0) 20 3595 2441

Dave Snyder
Smith & Nephew
+1 (978) 749-1440

About Negative Pressure Wound Therapy (NPWT)

Negative Pressure Wound Therapy (NPWT) has been in use for more than 20 years for the management of a wide range of different wound types in adults, including traumatic hard-to-heal and chronic wounds, and wounds covered with flaps and/or skin grafts. It has also been used for the management of complex wounds. More recently, NPWT systems have been used to manage closed surgical incisions in patients at high risk of surgical site complications.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic ReconstructionAdvanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.comfollow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce surgical site complications, please visit www.closertozero.com.

Reference:

  1. O’Leary, D.P. et al, Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations. A randomized, controlled, open-label trial: The PICO Trial. Annals of Surgery, published online 06 December 2016.
  2. S. Karlakki, M. Brem, S. Giannini, V. Khanduja, J. Stannard, R. Martin. Negative pressure wound therapy for management of the surgical incision in orthopaedic surgery. Bone Joint Res 2013;2:276–84.
  3. World Union of Wound Healing Societies (WUWHS) Consensus Document. Closed surgical incision management: understanding the role of NPWT. Wounds International, 2016

Forward looking statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™ Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office

Xtant Medical Enters into Licensing Agreement for Sites Medical’s OsteoSync Ti Technology

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

SANUWAVE Health Reports First Quarter Financial Results and Provides a Business Update

SUWANEE, GA–(Marketwired – May 16, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV), today reported financial results for the three months ended March 31, 2017 and provided a business update. The Company will host a conference call at 9AM Eastern Time on Tuesday, May 16, 2017.

Highlights of the first quarter and recent weeks:

  • The Company hired André Mouton to head the Company’s international sales and relations. André’s focus is on adding additional countries and regions to our portfolio and centralize the management of SANUWAVE’s existing distributor and customer base.
  • SANUWAVE launched a blog entitled “SHOCK THIS” to bring together in one setting various information about the Company, the products and the science behind the technology in a useful and entertaining way. Two blogs have been published to date, with a third coming shortly. Please visit our website at www.sanuwave.com to view the blogs.
  • SANUWAVE has appointed LOK North America to act as Territory Sales Manager for sourcing and screening of potential distributors for the Company’s products in Canada. LOK North America will give SANUWAVE an extended reach and establish rigorous evaluation methods of the regional distribution options in Canada to ensure the development of a strong distribution network.
  • SANUWAVE exhibited, in conjunction with Ortho-Medico, a member of B&Co, at EWMA in Amsterdam, The Netherlands on May 3 -5, 2017.

“The first quarter came in as we had expected and announced on our most recent conference call. The weakness was due to economic concerns in South Korea. The good news is since the recent election in South Korea and a successful Korea Diabetic Conference, held in BEXCO from May 11th to 13th orders have returned and the outlook in South Korea for 2017 remains very robust. We also remain on track to add 3 new countries in the second quarter and 7-10 during the full year, as we had indicated on our year end conference call. Lastly, we have submitted our response to the FDA’s questions and are hopeful of a positive response by year end,” stated Kevin Richardson, CEO and Chairman.

First Quarter Financial Results

Revenues for the three months ended March 31, 2017 were $149,569, compared to $269,324 for the same period in 2016, a decrease of $119,755, or 44%. Revenues resulted primarily from sales in Europe, Asia and Asia/Pacific of our orthoPACE device and related applicators. The decrease in revenues for 2017 was due to lower sales of new orthoPACE devices and applicators, lower applicator refurbishments and lower wound kit sales in Europe and Asia/Pacific in 2017.

Research and development expenses for the three months ended March 31, 2017 were $260,338, compared to $309,955 for the same period in 2016, a decrease of $49,617, or 16%. Research and development expenses decreased in 2017 due to lower payments to consultants related to the de novo petition submission to the FDA in July 2016.

General and administrative expenses for the three months ended March 31, 2017 were $448,606, as compared to $499,132 for the same period in 2016, a decrease of $50,526, or 10%. The decrease in general and administrative expenses is primarily due to reduced salary and related costs due to reduction in headcount in June 2016, lower rent expense due to move to new facility and lower travel expenses.

Net loss for the three months ended March 31, 2017 was $493,532, or ($0.00) per basic and diluted share, compared to a net loss of $1,724,576, or ($0.02) per basic and diluted share, for the same period in 2016, a decrease in the net loss of $1,231,044, or 71%. The decrease in the net loss for 2017 was primarily due to a gain on warrant valuations and lower operating expenses as noted above.

Conference Call
The Company will also host a conference call on Tuesday, May 16, 2017, beginning at 9AM Eastern Time to discuss the first quarter financial results, provide a business update and answer questions. Shareholders and other interested parties can participate in the conference call by dialing 866-682-6100 (U.S.) or 862-255-5401 (international) or via webcast at http://www.investorcalendar.com/IC/CEPage.asp?ID=175965.

A replay of the conference call will be available beginning two hours after its completion through May 30, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 10400.

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 CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. 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.

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
March 31, December 31,
2017 2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 97,538 $ 133,571
Accounts receivable, net of allowance for doubtful accounts 451,369 460,799
Inventory 202,879 231,953
Prepaid expenses 115,377 87,823
TOTAL CURRENT ASSETS 867,163 914,146
PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation 70,818 76,938
OTHER ASSETS 13,841 13,786
TOTAL ASSETS $ 951,822 $ 1,004,870
LIABILITIES
CURRENT LIABILITIES
Accounts payable $ 1,033,341 $ 712,964
Accrued expenses 546,829 375,088
Accrued employee compensation 64,860 64,860
Interest payable, related parties 246,264 109,426
Short term loan, net 100,000 47,440
Warrant liability 861,525 1,242,120
Notes payable, related parties, net 5,367,912 5,364,572
TOTAL LIABILITIES 8,220,731 7,916,470
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ DEFICIT
PREFERRED STOCK, SERIES A CONVERTIBLE, par value $0.001,
6,175 authorized; 6,175 shares issued and 0 shares outstanding
in 2017 and 2016
PREFERRED STOCK, SERIES B CONVERTIBLE, par value $0.001,
293 authorized; 293 shares issued and 0 shares outstanding
in 2017 and 2016, respectively
PREFERRED STOCK – UNDESIGNATED, par value $0.001, 4,993,532
shares authorized; no shares issued and outstanding
COMMON STOCK, par value $0.001, 350,000,000 shares authorized;
138,815,329 and 137,219,968 issued and outstanding in 2017 and
2016, respectively 138,815 137,220
ADDITIONAL PAID-IN CAPITAL 92,569,540 92,436,697
ACCUMULATED DEFICIT (99,926,980 ) (99,433,448 )
ACCUMULATED OTHER COMPREHENSIVE LOSS (50,284 ) (52,069 )
TOTAL STOCKHOLDERS’ DEFICIT (7,268,909 ) (6,911,600 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $ 951,822 $ 1,004,870
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three Months Ended Three Months Ended
March 31, March 31,
2017 2016
REVENUES $ 149,569 $ 269,324
COST OF REVENUES (exclusive of depreciation and amortization shown below) 55,144 73,181
OPERATING EXPENSES
Research and development 260,338 309,955
General and administrative 448,606 499,132
Depreciation 6,120 836
Amortization 76,689
Gain of sale of assets, property and equipment (1,000 )
TOTAL OPERATING EXPENSES 715,064 885,612
OPERATING LOSS (620,639 ) (689,469 )
OTHER INCOME (EXPENSE)
Gain (loss) on warrant valuation adjustment and conversion 323,223 (797,697 )
Interest expense, net (192,738 ) (234,430 )
Loss on foreign currency exchange (3,378 ) (2,980 )
TOTAL OTHER INCOME (EXPENSE), NET 127,107 (1,035,107 )
NET LOSS (493,532 ) (1,724,576 )
OTHER COMPREHENSIVE LOSS
Foreign currency translation adjustments 1,785 2,972
TOTAL COMPREHENSIVE LOSS $ (491,747 ) $ (1,721,604 )
LOSS PER SHARE:
Net loss – basic and diluted $ 0.00 $ (0.02 )
Weighted average shares outstanding – basic and diluted 138,042,070 75,220,485
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Three Months Ended Three Months Ended
March 31, March 31,
2017 2016
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (493,532 ) $ (1,724,576 )
Adjustments to reconcile net loss to net cash used by operating activities to net cash used by operating activities
Depreciation 6,120 836
Change in allowance for doubtful accounts 5,152 1,052
Amortization 76,689
Stock-based compensation – employees, directors and advisors 4,500
(Gain) loss on warrant valuation adjustment (323,223 ) 873,118
Amortization of debt discount 55,900 5,694
Amortization of debt issuance costs 74,549
Gain on sale of asset, property and equipment (1,000 )
Changes in assets – (increase)/decrease
Accounts receivable – trade 4,278 27,370
Inventory 29,074 26,413
Prepaid expenses (27,554 ) (23,530 )
Other (55 ) (94 )
Changes in liabilities – increase/(decrease)
Accounts payable 320,377 (153,022 )
Accrued expenses 171,741 (107,371 )
Accrued employee compensation 44,613
Interest payable, related parties 136,838 (56,835 )
Promissory notes, accrued interest (79,948 )
NET CASH USED BY OPERATING ACTIVITIES (114,884 ) (1,011,542 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from sale of property and equipment 1,000
NET CASH PROVIDED BY INVESTING ACTIVITIES 1,000
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from warrant exercise 77,066
Proceeds from 2016 Public Offering, net 1,352,775
Proceeds from convertible promissory notes, net 106,000
NET CASH PROVIDED BY FINANCING ACTIVITIES 77,066 1,458,775
EFFECT OF EXCHANGE RATES ON CASH 1,785 2,972
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (36,033 ) 451,205
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 133,571 152,930
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 97,538 $ 604,135
SUPPLEMENTAL INFORMATION
Cash paid for interest, related parties $ $ 209,549

CONTACT INFORMATION

Invibio and Double Medical Driving Implantable Devices Using PEEK-OPTIMA Into China

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.