Minimally invasive lumbar decompression may be performed safely without prior experience

23rd November 2016

Junyoung Ahn (Department of Orthopedic Surgery, Rush University Medical Center, Chicago, USA) and others report in The Spine Journal that continued surgical experience in the context of minimally invasive lumbar decompression, with or without discectomy, is associated with reduced operative times and reduced hospital stay, but not improved clinical outcomes. They conclude that a minimally invasive lumbar decompression could, therefore, be performed safely without prior experience.

According to the authors, minimally invasive spinal surgery procedures “carry an inherently difficult” learning curve “based on anecdotal evidence”. Noting that few studies have investigated the learning curve associated with minimally invasive laminectomy or laminotomy, with or without discectomy, they sought to “describe the surgical curve” of this technique using a prospectively maintained surgical registry “with the largest surgical series by a single surgeon to date”.,,

In a primary analysis, the initial 50 consecutive patients of 228 who underwent a level one or two minimally invasive lumbar decompression (with or without discectomy) by a single surgeon were compared with the remaining 178. “Perioperative parameters (preoperative visual analogue scale scores, procedural, estimated blood loss, and length of hospital stay) were assessed between cohorts. Postoperative visual analogue scale (VAS) scores and complications were also compared between cohorts,” Ahn et al report.

Both procedural time (52.2±2.2 minutes versus 39.4±19.8 minutes; p<0.001) and length of hospital stay (22.1±25.4 hours versus 15.2±15 hours; p<0.01) were significantly reduced in the second cohort.

Furthermore, the authors comment: “Pearson correlation coefficient demonstrated that the case number is related to decreased surgical time (r=0.23; p<0.001) and decreased length of hospitalisation (r=0.12; p=0.08).” They add that their findings are consistent with those of a study that suggested the learning curve for minimally invasive lumbar discectomy was between 25 and 100 cases, commenting that—in the present study—the “procedural time plateaued following 50 cases, signifying the learning curve of the minimally invasive lumbar decompression”.

However, estimated blood loss, VAS scores, body mass index, complication rates, and recurrent herniation rates (index and adjacent levels) were similar between cohorts. “The rates of reoperation at the index level did not differ between the first and second cohorts (12% versus 8.4%, respectively).

No differences were demonstrated in the rates, indications, and the type of second surgery between cohorts. In addition, no differences were demonstrated in the reoperation rates before and after 12 months following the index procedure,” Ahn et al comment. According to the authors, the recurrent herniation rates, for both cohorts, were “within range” of those reported in previous studies.

Furthermore, in a secondary analysis, Ahn et al compared the first cohort with 50 patients who had undergone open lumbar decompression (by the same surgeon). They found that open surgery was associated with greater procedural time, higher estimated blood loss and longer length of hospital stay, but had similar reoperation rates and 30-day readmission rates to the minimally invasive surgery patients.

Concluding their findings, the authors comment that they “do believe that the refinement of the technique occurs with time as evidenced by the lower reoperation rate (not statistically significant) in the second cohort” but add—given the comparable outcomes and safety between cohorts—that minimally invasive lumbar decompression may initially be performed “without prior experience”. “We believe this finding may be helpful and comforting for those surgeons contemplating the incorporation of minimally invasive surgical decompression techniques into their practice,” Ahn et al add.

Co-author Kern Singh (Chicago, USA) told Spinal News International, “There are many factors that may possibly affect the learning curve for different surgeons. One potential factor includes the amount of prior experience a surgeon has in performing both open and minimally invasive procedures. While it is logical to assume that a more experienced surgeon will have a reduced learning curve for new procedures, further study is necessary to confirm that notion. Multi-surgeon studies are required to better elucidate the effect of surgeon training and years in practice on the learning curve for minimally invasive procedures.”

Writing in an accompanying commentary, Choll W Kim (San Diego, USA) notes that the learning curve “remains a significant factor” affecting the adoption of minimally invasive spinal surgery technologies. He adds that an important aspect of the learning curve “that is often neglected” is the specific training to the surgeon in the operating room before the first case, noting “little attention has been given to the training and preparations of the surgical team for a specific new procedure”. According to Kim, the “skin-to-skin” programme—an intensive two-day course on minimally invasive surgery—focuses on performing procedures multiple times and initial results indicate that it is associated with an improved learning curve and could lead to greater adoption of minimally invasive techniques.

“It is reasonable to assume that the learning curve is not static; it can be affected in multiple ways: training, preparation, changes in equipment, technique modifications, and even identification of disease states and patient factors that make certain surgical procedures more or less difficult. To do this, measurement parameters of the learning curve must be established,” he states.

First Choice Healthcare Solutions Issues Formal Financial Guidance for 2017 Full Year Revenues and Adjusted EBITDA Margin

MELBOURNE, FL–(Marketwired – Nov 22, 2016) – First Choice Healthcare Solutions, Inc.(OTCQB: FCHS) (“FCHS,” “First Choice” or the “Company”), one of the nation’s only non-physician-owned, publicly traded healthcare services companies focused on the delivery of total musculoskeletal solutions with an emphasis on Orthopaedics, including spine care and treatment, today issued formal financial guidance of $40-$45 million for 2017 full year revenues and 15%-20% for 2017 full year adjusted EBITDA margin.

Company President and CEO Chris Romandetti, noted, “As discussed on our recent third quarter results conference call, we are very confident in First Choice’s ability to perpetuate our success with executing key organic and strategic initiatives designed to fuel our revenue and earnings growth through 2017. More specifically, organic growth will stem from the following:

  • the addition of new surgeons and physician assistants who have signed to join our clinical teams between now and the first quarter of next year;
  • increasing the number of Orthopaedic and Spine surgical procedures we perform each year due to the aforementioned expansion of our medical team — in 2016, we saw this number grow from an annualized run-rate of approximately 2400+ in Q116 to 3100+ in Q316, and expect to increase it to 5,000 in 2017;
  • expansion of our Physical and Occupational Therapy division throughout the greater Space Coast, Florida service region; and
  • materially increasing utilization of our ambulatory surgery center facilities and services.

“First Choice’s strategic growth will be propelled by possible acquisition of other healthcare service businesses that will either enhance or expand our current ancillary service lines and through the launch of our Orthopaedic bundled payment pilot programs early in the new year,” Romandetti added. “Given our confidence in successfully executing these, among other initiatives, we have no reservations about issuing formal revenue guidance of $40-$45 million for next year and adjusted EBITDA guidance of 15-20%. However, as we move through the new year, we will reevaluate our guidance quarterly and revise or reiterate our expectations, as appropriate.”

For those unable to participate on First Choice’s live third quarter results conference call, an audio replay of the event is available on the Company’s website investor relations page, found at

About First Choice Healthcare Solutions, Inc.
Headquartered in Melbourne, Florida, First Choice Healthcare Solutions (FCHS) is implementing a defined growth strategy aimed at expanding its network of non-physician-owned medical centers of excellence, which concentrate on treating patients in the following specialties: Orthopaedics, Spine Surgery, Neurology, Interventional Pain Management and related diagnostic and ancillary services in key expansion markets throughout the Southeastern U.S. Serving Florida’s Space Coast, the Company’s flagship integrated platform currently administers over 100,000 patient visits each year and is comprised of First Choice Medical Group, The B.A.C.K. Center and Crane Creek Surgery Center. For more information, please visit,, and

Safe Harbor Statement
Certain information set forth in this news announcement may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of First Choice Healthcare Solutions, Inc. Such forward-looking statements are based on current expectations, estimates and projections about the Company’s industry, management beliefs and certain assumptions made by its management. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Information concerning factors that could cause the Company’s actual results to differ materially from those contained in these forward-looking statements can be found in the Company’s periodic reports on Form 10-K and Form 10-Q, and in its Current Reports on Form 8-K, filed with the Securities and Exchange Commission. Unless required by law, the Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise to reflect future events or circumstances or reflect the occurrence of unanticipated events.


Konica Minolta Partners with Mindray to Further Expand MSK Ultrasound Portfolio

WAYNE, NJ –(Marketwired – November 21, 2016) – Konica Minolta Healthcare announced today it has entered into a partnership with Mindray, a leading developer, manufacturer and marketer of medical devices worldwide, to bring exclusive musculoskeletal (MSK) portable ultrasound solutions to the market. Konica Minolta solidifies its leadership position in MSK imaging by continuing to establish partnerships and develop solutions that enable specialists to deliver the best care possible to their patients.

“The unique relationship with Mindray further underscores Konica Minolta’s commitment to being a market leader in MSK ultrasound,” said Brian Noyes, Sr. Vice President and General Manager, Ultrasound Division. “Mindray’s dedication to improving patient care complements Konica Minolta’s cutting-edge technologies and award-winning customer satisfaction.”

Konica Minolta is committed to providing physicians with solutions that assist with more accurate assessment and treatments of musculoskeletal ailments. “It’s important to place excellent technology in the hands of MSK experts who can support orthopedists, sports medicine physicians, rheumatologists, podiatrists and beyond,” said Glen McLaughlin, Chief Product Officer of Mindray Ultrasound. “Konica Minolta has extensive experience in this field and is a longstanding provider of MSK solutions to this group of specialists.”

The partnership with Mindray addresses the need for cutting-edge ultrasound technology in out-of-hospital settings like MSK, and demonstrates Konica Minolta’s commitment to develop strategic relationships, Noyes explained.

“By working together, industry experts bring value to musculoskeletal providers by giving them the best tools at the point of care,” he added.

About Konica Minolta Healthcare Americas, Inc.
Konica Minolta Healthcare Americas, Inc. is a world-class provider and market leader in medical diagnostic imaging and healthcare information technology. With over 75 years of endless innovation, Konica Minolta is globally recognized as a leader providing cutting-edge technologies and comprehensive support aimed at providing real solutions to meet customer’s needs. Konica Minolta Healthcare Americas, Inc., headquartered in Wayne, NJ, is a unit of Konica Minolta, Inc. (TSE: 4902). For more information on Konica Minolta Healthcare Americas, Inc., please visit

Headquarters JP TOWER, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo, Japan
Founded December 1936
FY 2015 Revenue $8.6 Billion
Number of employees Approx. 41,600 (2015)
Business Lines The Konica Minolta Group operates in sectors ranging from business technologies, where our products are typified by MFPs (multi-functional peripherals), and Industrial Business (former Optics Business), where our products include pickup lenses for optical disks, and TAC film, a key material used in LCD panels, to healthcare, where we make digital X-ray diagnostic imaging systems.


SPINEWAY : Increase in capital of €1.4 million and entry of TINAVI Medical Technologies into Spineway”s capital

By GlobeNewswire,  November 21, 2016

SPINEWAY, a company specialising in implants and surgical instruments for the treatment of vertebral (spinal) problems, is proud to announce that the Chinese company TINAVI Medical Technologies has joined its capital, following a €1.4 million increase in capital.

Following approval by the General Meeting on 4 November, Spineway increased its reserve capital through the issue of shares with attached warrants (Actions à Bons de Souscription d’Actions or ABSA in French) excluding preferential right of subscription, for a total of €1.4 million (including issue premium).

This increase in capital, made on November 18 through the issue of 355,260 new shares with attached warrants, was paid for entirely by TINAVI Medical Technologies, which now holds 9.09% of the capital and 5.04% of Spineway’s voting rights.

Stéphane Le Roux, Chief Executive Officer of Spineway, says: “We are delighted to welcome TINAVI Medical Technologies into our capital. In keeping with our Skyway 2018 plan, this partnership will open great potential for our development in China, which is a key nation in our Group’s history. On top of that, the synergies between our areas of expertise and know-how will help our respective companies grow and develop more rapidly in the spinal surgery market, which is continually striving to innovate.”

Find out all about Spineway at


Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.

Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.

Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) -Talent INPI award (2015).


Investor Relations

David Siegrist, Finance Director

Tel: +33 (0)4 72 77 01 52

Financial Communication

Jérôme Gacoin / Solène Kennis

Tel: +33 (0)1 75 77 54 68

Capital increase and Tinavi entry

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: SPINEWAY via Globenewswire


This article appears in: News Headlines

Referenced Stocks: ALSPW

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Zimmer Biomet Named Indo UK Institutes of Health Medicities Program’s Preferred Orthopaedic Partner to Improve Delivery of Care in India

WARSAW, Ind., Nov. 22, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the Company has been chosen as an Indo UK Institutes of Health (IUIH) preferred orthopaedic partner to improve the delivery of and access to quality, affordable musculoskeletal healthcare for approximately 400 million people in India over the next 20 years through IUIH’s 11 centers of excellence (“Medicities”) to be created in major states across the country.  IUIH Medicities will offer patients throughout India and abroad access to world-class services and clinical expertise in a modern, technology-led hospital.  In addition, each Medicity will establish a medical college, nursing college, post-graduate training center, global standard research and development center and medical manufacturing facilities.  The partnership was announced by the IUIH Medicities Program at the India-UK Technology Summit inaugurated by the Prime Minister of India, Narendra Modi, and the Prime Minister of the UK, Theresa May.  The UK Secretary of State for International Trade, Dr. Liam Fox, chaired the roundtable that announced the partnership.

“At its one-year anniversary, the IUIH Medicities Program is delighted to announce Zimmer Biomet as a preferred orthopaedic partner for the next two decades,” said Ajay Rajan Gupta, M.D., Group Chief Executive Officer of IUIH.  “IUIH shares Zimmer Biomet’s commitment to improve the quality of life for patients around the world.  This partnership demonstrates a significant step toward achieving our vision to transform the delivery of quality healthcare and medical education services across India.”

The newly created partnership between IUIH and Zimmer Biomet delivers value throughout the orthopaedic care continuum.  Total Zimmer Biomet commitments to the program include an equity investment in UK Global Healthcare Limited (UKGH), the parent organization for IUIH; the supply and distribution of quality large joint implants, trauma products and small fixation devices for replacement surgery; the implementation of the Rapid Recovery and Theatre Care Rapide programs to optimize patient-focused processes and protocols in the hospitals and operating rooms across the 11 Medicities; and the establishment of the Zimmer Biomet Institute of India, a state-of-the-art medical training and education facility.  In addition to the opportunity to improve patient outcomes, the efficiencies created through the long-term partnership are expected to significantly contribute to the delivery of affordable care in India by reducing the total cost of orthopaedic care by approximately 25 percent.

“Zimmer Biomet is proud to be chosen as a preferred orthopaedic partner for the IUIH Medicities program,” said David Dvorak, President and CEO of Zimmer Biomet.  “This long-term commitment demonstrates an unprecedented level of partnership between a forward-looking healthcare provider and a leading musculoskeletal healthcare company, putting transformational patient care and exponential value creation within reach.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit or follow Zimmer Biomet on Twitter at

About Indo UK Institutes of Health

On November 12, 2015, the Indian and British Prime Ministers signed a historic Health Collaboration Agreement for the establishment of the Indo UK Institutes of Health (IUIH). The IUIH is a Private Public Partnership (Indo UKpartnership) that is linked to the Indian Government’s Smart Cities programme and aims to build 11 IUIH “Medicities” along with 89 Indo UK Clinics (IUCs).

The IUIH facilities’ global operations and research expertise will be supported by collaboration with the UK National Health Service (NHS) and partnerships with leading international healthcare industry companies and international partners in research, education, manufacturing and healthcare delivery.

The vision is to develop fully integrated healthcare that is Affordable, Available and Accountable.

Please visit for more information or contact

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

Logo –

To view the original version on PR Newswire, visit:

SOURCE Zimmer Biomet Holdings, Inc.

News Provided by Acquire Media

A New System to Detect Spinal Deformity

By Hokkaido University | November 21, 2016

Image analyses of idiopathic scoliosis sufferers using a three-dimensional, back-surface-symmetry-recognition system Top: images of a case in which a patient is to be treated with a brace. The thoracic vertebra curves by 34 degrees. Bottom: images of a case in which a patient requires surgery. The thoracic vertebra curves by 60 degrees. (a): a three-dimensional image of the back’s surface (b): based on image (a), the system evaluates the degree to which a patient’s back deviates from the ideal symmetry for a human back within a few seconds. The larger the deviation, the deeper the color. (c): comparison to X-ray photos. Deviations in the image correspond with curvatures. (Credit: Hokkaido University/Noa Co., Ltd.)

Hokkaido University researchers have developed a symmetry-recognition system for the surface of the human back that can three-dimensionally detect the early stages of idiopathic scoliosis, a type of spinal deformity, without the help of a specialist doctor.

Individuals with idiopathic scoliosis, many of whom are pubescent girls, suffer from serious curvature of the spine. The disease has a characteristically high affliction rate, affecting one in 50 people.

Early detection of the progressive ailment is regarded as essential for treatment, as it is effective to wear a special brace when the spine is curved by 30 degrees or more. In recent years, genetic study of the disease has progressed, boosting the development of treatments.




Artoss Announces FDA Clearance to Market of NanoBone® SBX Putty

November 8, 2016

Artoss, Inc. is pleased to announce that, on October 26, 2016, Artoss GmbH received notice from the U.S. Food & Drug Administration that NanoBone® SBX Putty has been cleared to market as 510(k) K161351.

Walter Gerike, Managing Director of Artoss GmbH said, “Nanotechnology is the key technology for the 21st century and Artoss is harnessing this potential for orthopaedic surgery. In NanoBone SBX Putty, we have a product that combines Applied NanoBiology™ for bone repair with perfect handling for the surgeon.” NanoBone synthetic bone graft products have been used in Europe for ten years in approaching 400,000 clinical cases across all indications.

James J. Cassidy, Ph.D., Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, stated, “NanoBone technology has been in great demand by U.S. surgeons since we launched NanoBone Granules in 2015. NanoBone SBX Putty offers the same clinical performance in an easier to use presentation. We look forward to introducing this product in a variety of sizes to the U.S. market in the coming weeks.”



Artoss, Inc.

15900 155th St. NE

Foley, MN 56329




Global Surgical Navigation Systems Market to Witness Growth Through 2020, Owing to Popularity of Minimally Invasive Surgeries: Reports Technavio

November 22, 2016

LONDON–(BUSINESS WIRE)–Technavio analysts forecast the global surgical navigation systems market to grow at a CAGR of more than 7% during the forecast period, according to their latest report.

The research study covers the present scenario and growth prospects of the global surgical navigation systems market for 2016-2020. The report segments the market by application into neurosurgical, spine, orthopedic, and ENT surgical navigation systems.

According to Barath Palada, a lead analyst at Technavio for medical devicesresearch, “The launch of portable surgical navigation systems is a new trend in the market which can help solve the issue of space constraints in the already crowded hybrid operating rooms and can also be moved to low-tier hospitals on a fee-per-use basis for critical surgeries.”

Request a sample report:

Technavio’s sample reports are free of charge and contain multiple sections of the report including the market size and forecast, drivers, challenges, trends, and more.

Technavio healthcare and life sciences analysts highlight the following three factors that are contributing to the growth of the global surgical navigation systems market:

  • Growing popularity of minimally invasive surgeries
  • Expansion of outpatient settings
  • Innovative marketing strategies

Growing popularity of minimally invasive surgeries

The growing incidence of complications for open surgeries and slow post-operative healing of the incision area has led to a rise in adoption of minimally invasive techniques for surgery. Surgical navigation systems with advanced intraoperative imaging system and wide high-resolution monitors enable surgeons to perform even critical surgeries with minimal incision of skin.

Growing demand for minimally invasive surgeries coupled with the awareness related to its benefits has led a large section of surgeons to opt for computer-assisted surgery using surgical navigation systems.

Expansion of outpatient settings

Many surgeons have started practicing surgeries using surgical navigation systems in an outpatient setting, especially for spinal, ENT, and orthopedic disorders. This trend is expected to continue, and very soon many complicated open surgeries will undergo a rapid transition into minimally invasive surgeries performed with surgical navigation systems. “The procedures performed by surgical navigation systems reduce the risk of hospital-acquired infections and hospital stay, cause minimal blood loss, scarring, and less pain, thus leading to a quick recovery and better clinical outcome,” says Barath.

Thus, there is an opportunity for surgeons to invest in setting up ambulatory surgery centers (ASCs) to perform various spinal, ENT, and orthopedic surgeries in an outpatient setting. Low-priced ENT-specific navigation platforms represent a cost-effective option for surgeons performing outpatient procedures.

Innovative marketing strategies

Surgical navigation system vendors are implementing innovative marketing strategies such as offering cumulative training/medical education classes to surgeons and other healthcare professionals, to increase awareness and adoption of these systems and thereby leading to an increase in the sales of products. For instance, Medtronic offers educational programs for orthopedic, spinal, and ENT procedures.

OrthAlign recently launched OrthAlign Academy, an online portal dedicated to educating surgeons and hospital staff on the use of its KneeAlign technology for total knee arthroplasty surgery. KneeAlign offers tibial and femoral navigation in a simple, palm-sized, single-use device and is compatible with all implant systems. Other strategies include offering fee-per-use of equipment, customer portals, and operating room assistance facilities to end-users.

The US, Western Europe, and Japan are the primary markets for these vendors, whereas emerging markets such as India, Brazil, China, and Mexico serve as opportunities for increased penetration and revenue generation during the forecast period.

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Do you need a report on a market in a specific geographical cluster or country but can’t find what you’re looking for? Don’t worry, Technavio also takes client requests. Please contact with your requirements and our analysts will be happy to create a customized report just for you.

About Technavio

Technavio is a leading global technology research and advisory company. The company develops over 2000 pieces of research every year, covering more than 500 technologies across 80 countries. Technavio has about 300 analysts globally who specialize in customized consulting and business research assignments across the latest leading edge technologies.

Technavio analysts employ primary as well as secondary research techniques to ascertain the size and vendor landscape in a range of markets. Analysts obtain information using a combination of bottom-up and top-down approaches, besides using in-house market modeling tools and proprietary databases. They corroborate this data with the data obtained from various market participants and stakeholders across the value chain, including vendors, service providers, distributors, re-sellers, and end-users.

If you are interested in more information, please contact our media team at


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Jesse Maida
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Amedica Slides on Mixed FDA Updates

 November 22, 2016

Amedica Corp. (NASDAQ: AMDA) is watching its shares drop on Tuesday despite receiving mixed news from the U.S. Food and Drug Administration, along with a new appointment to its management team. Although the FDA did give some good news, the bad far outweighed the good.

First the company announced that Dana Lyons has been appointed to Vice President of Sales and Marketing, in an effort to increase the adoption of silicon nitride implants in the spinal fusion market. Previously, Lyons has worked in leadership positions with Stryker Orthopaedics, Zimmer Spine, and Zimmer Biomet Spine.

As for the good news, the FDA also notified Amedica that the new pedicle screw system, Taurus, has been cleared for commercialization. The company is on target for surgical implantation and a full market launch of the Taurus system by the end of the year.

B. Sonny Bal, MD, MBA, JD, PhD; the CEO and President of Amedica Corporation commented:

Amedica is building a top-tier sales team with skilled veterans from the spine industry, such as Mr. Lyons. Going forward, our focus is on driving sales, surgeon engagement, and data collection to validate the unparalleled volume of basic material science data that we have already published. Surgeon intrigue about our material, and a market need for clinical advantages that only our material can deliver, combine to make spine an attractive growth opportunity. As part of the new sales team, I will focus on driving clinical trials, surgeon relations, and publishing clinical data to impact our revenue growth.




Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, November 21st, 2016

Move over cell phone…there is another portable device that may want to share that space—the world’s first pocket-sized diagnostic device for osteoporosis. Bone Index Ltd., a company based in Finland, has been granted a U.S. patent for its unique product, known as Bindex.

Bone Index’s CEO, Dr. Ossi Riekkinen said in the November 11, 2016 news release, “Bindex is unique technology. Now we have a total of 19 patents globally including the U.S., China, Japan and large European countries. The United States is a very significant market and we are actively seeking a partner who has the capabilities to take advantage of this unique opportunity. The overall aim is to prevent osteoporotic fractures and improve the quality of life of families in the U.S.”

Dr. Riekkinen told OTW, “Bindex is the first reliable, fast and easy to use point-of-care instrument for osteoporosis diagnostics. We have received 510(k) clearance from FDA for the Bindex to help in osteoporosis diagnosis.”

“Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA [dual-energy X-ray absorptiometry]. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.”