Implanet Announces Its Half-Yearly Report on the Liquidity Contract With ODDO Corporate Finance

Posted On July 10, 2017 By OrthoSpineNews In Financial /  

July 07, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Pursuant to the liquidity contract entrusted to ODDO Corporate Finance by IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), on 30 June 2017 the following assets appeared on the liquidity account:

  • Number of shares: 134,950
  • Cash balance of the liquidity account: €46,060.29

As a reminder, at the time of the last half-yearly report on 31 December 2016, the following resources were booked to the liquidity account:

  • Number of shares: 136,500
  • Cash balance of the liquidity account: €40,003.79

As a reminder, at the time of the settlement of the contract, the following resources were booked to the liquidity account:

  • Number of shares: 0
  • Cash balance of the liquidity account: €400,000.00

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

Read More
AAEAAQAAAAAAAAoPAAAAJGRjMDc0ZGQzLTZlZmMtNDNlMS1hNjdiLWU4YjExOTI3NWY4Yw.png

Providence Medical Technology Announces Publication of Two New Studies Supporting Tissue-Sparing Posterior Cervical Fusion

Posted On July 10, 2017 By OrthoSpineNews In Spine /  

WALNUT CREEK, Calif., July 10, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology, announced the publication of multiple independent studies demonstrating the results of its tissue-sparing posterior cervical fusion technology.

In the first study published by Lenzi J, et al. in World Neurosurgery (2017), the authors report results from the first ever prospective, randomized, controlled trial comparing operative results using the DTRAX® Expandable Cage system versus conservative care for patients diagnosed with single-level cervical radiculopathy. The study presents data on 40 patients from each group. The paper reports significant improvements in VAS neck and arm pain relative to the control group at all time points out to one year. The paper also reports marked improvements from baseline in NDI and SF-36. This publication was completed independent of any conflict of interest from the authors and not sponsored in any way by the company. The table below summarizes the VAS results.

Pre

1 Month

6 Months

12 Months

Surgery

VAS neck

5.725

1.925

0.75

0.33

VAS arm

8.65

0.575

0.35

0.25

Conservative Care

VAS neck

5.475

3.8

1.5

1.05

VAS arm

8.775

5.35

3.615

1.77

A complete copy of this study can be found at http://dx.doi.org/10.1016/j.wneu.2016.12.125

In the second publication by William Smith, et al. in Operative Neurosurgery (2017), the authors report the results of bilateral posterior cervical fusion cages for the treatment of anterior cervical pseudarthrosis again through the use of the company’s flagship tissue-sparing DTRAX Spinal System and CAVUX® Cervical Cages. This study was not sponsored by Providence in any way; however, some of the investigators and authors of this publication maintain ownership and compensation relationships with Providence. This paper reports results of 25 patients at a mean follow-up of 18 months. The table below summarizes improvements in VAS neck, VAS arm, and NDI scores. This study also reports that fusion was confirmed radiographically in all 25 patients.

Pre-Op

Follow-up

VAS neck

7.9

3.8

VAS arm

7.24

3.12

NDI

65.1

29.1

A complete copy of this study can be found at http://doi.org/10.1093/ons/opx103

“We were delighted to receive notification of these recent publications adding to the growing body of clinical evidence supporting our innovative tissue-sparing posterior cervical fusion technology,” said Jeff Smith, CEO of Providence. “We are grateful for the work of these authors and particularly thankful to the patients who volunteered to participate in a randomized controlled trial to study the impact of our novel surgical approach. These independent studies represent two of the more common applications of our cervical fusion technology, and it is encouraging that new clinical evidence continues to support these use cases. We are committed to clinical research and look forward to additional publications moving forward.”

The DTRAX Expandable Cage System used in the first study is CE marked and indicated for posterior cervical treatment at C3-C7 (inclusive) spinal levels for the following: patient with single level radiculopathy due to degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets. The DTRAX Expandable Cage System used in the first study is not cleared or approved by the FDA and is not available for order or sale in the United States.

The CAVUX Cervical Cage system used in the second study is CE marked and FDA cleared and indicated for use in skeletally mature patients, with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least size weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billionworldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

For other clinical publications regarding this technology visit www.providencemt.com/clinical

SOURCE Providence Medical Technology, Inc.

Related Links

http://www.providencemt.com

Read More

Titan Medical Partners With Florida Hospital Nicholson Center for SPORT Feasibility and Validation Studies

Posted On July 10, 2017 By OrthoSpineNews In Robotics /  

TORONTO, ON–(Marketwired – July 10, 2017) – Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD) (OTCQB: TITXF), a medical device company focused on the design, development and commercialization of a robotic surgical system for application in minimally invasive surgery (MIS), announces a collaboration with Florida Hospital Nicholson Center for feasibility and validation studies to support Titan’s regulatory application for its SPORT Surgical System. These studies are expected to commence in the fourth quarter of 2017 and continue into 2018.

David McNally, President and CEO of Titan Medical, said, “We are delighted to enter into this agreement with Florida Hospital Nicholson Center for continued feasibility and validation studies for the SPORT system. The Florida Hospital Nicholson Center is a world-class, state-of-the-art training and research facility with demonstrated leadership in robotic surgery innovation and training. With an accessible Orlando location, it has one of the country’s largest and most experienced medical learning and simulation incubation centers dedicated to advancing next-generation clinical knowledge. Through this strategic alliance, Titan will also benefit from access to many leading multispecialty key opinion leaders and their surgical expertise in fine-tuning the SPORT system during this critical development phase.”

“Florida Hospital Nicholson Center is one of three sites contemplated for our validation and feasibility studies. We look forward to engaging the other two sites during the current quarter, with completion of these studies in 2018,” added Mr. McNally.

J. Scott Magnuson, MD, Chief Medical Officer of Florida Hospital Nicholson Center, said, “We are excited about helping Titan Medical benefit from the clinical expertise our institution offers in further refining their SPORT surgical system for regulatory submission. Our brand-new, 54,000-square-foot facility is a model for open collaborations to advance practices and standards across the entire spectrum of minimally invasive, laparoscopic, robotic, telemedicine and medical simulation. It is a place where innovators come together to build upon the brilliant work of industry pioneers to achieve breakthroughs that will revolutionize the way we perform surgery. We believe that Titan’s single port surgical solution holds promise for continuing the surgical revolution.”

About Florida Hospital Nicholson Center

For more than a decade, the Florida Hospital Nicholson Center has trained more than 50,000 physicians from around the globe on leading-edge clinical and surgical techniques. Utilizing state-of-the-art surgical suites and labs, plus advanced medical simulation robotics and learning centers, medical professionals can acquire and advance their skills in a highly collaborative surgical learning environment.

About Titan Medical Inc.

Titan Medical Inc. is a Canadian public company focused on research and development through to the planned commercialization of computer-assisted robotic surgical technologies for application in minimally invasive surgery (“MIS”). The Company is currently developing the SPORT Surgical System, a single-port robotic surgical system. The SPORT Surgical System is comprised of a surgeon-controlled patient cart that includes a 3D high definition vision system and multi-articulating instruments for performing MIS procedures, and a surgeon workstation that provides the surgeon with an advanced ergonomic interface to the patient cart and a 3D endoscopic view inside the patient’s body during MIS procedures. With the SPORT Surgical System, the Company aims to pursue a broad set of surgical indications, including general abdominal, gynecologic and urologic procedures.

For more information, please 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, including statements with respect to the use of the net proceeds of the Offering and the anticipated listing of the Common Shares on the TSX, 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

Read More
Amendia-Tradeshows_600x400.jpg

Amendia Announces Corporate Name Change to Spinal Elements to Reflect Commitment to Spinal Surgical Market

Posted On July 10, 2017 By OrthoSpineNews In Spine, Top Stories /  

July 07, 2017

MARIETTA, Ga.–(BUSINESS WIRE)–Amendia, Inc.—a leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures—announced today that it is rebranding itself as Spinal Elements. The change reflects the company’s dedication to developing novel medical device technologies, biologics, and instrumentation to create positive surgical outcomes.

“Adopting the name Spinal Elements reflects our commitment to delivering innovative, best-in-class products and providing surgeon customers with the solutions they need to treat to their spinal patients,” said Chris Fair, CEO of Spinal Elements. “During the acquisition of Spinal Elements, Inc., one of the key attributes we identified was the deep brand awareness the company had developed over the past decade. This announcement highlights that awareness and signals to our customers that we will continue to be a leading innovator in the spine industry.”

Spinal Elements will continue to market its legacy Amendia-branded products, which have provided patients and healthcare providers with industry-leading spinal surgical solutions for nearly a decade, and will also maintain all of the leading-edge products acquired during its recent acquisition of Spinal Elements, Inc.

“We know surgeons want access to the most advanced spinal surgical technology to manage their patients’ outcomes,” said Jason Blain, President of Spinal Elements. “To that end, we will continue to provide them with the innovative tools they need to best navigate their patients’ care programs.”

The rebranding will be implemented across the company’s products and services over the course of 2017.

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, California and Marietta, Georgia. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, our mission is to develop novel medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.amendia.com or www.spinalelements.com.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760.450.7749
laurajohnsonpr@yahoo.com

Read More
Scoliosis-Lumbar-spine.jpg

Spine Biomechanics Laboratory Quantitates Functional Outcomes After Spine Surgery

Posted On July 10, 2017 By OrthoSpineNews In Spine /  

Written by 

Research emerging from the Spine Biomechanics Laboratory at Texas Back Institute (TBI) may better elucidate the biomechanical and neuromuscular risk factors associated with spinal conditions and help define the most appropriate and effective treatment options.

Using human motion capture, dynamic electromyography sensors, and force plates technology, the lab is designed to quantify patients’ functioning before and after spinal surgery in terms of gait, balance, posture, muscle coordination, stair climbing, and sit-to-stand motion analyses. The data also is used to define muscle activation parameters: onset (when the muscle is activating), magnitude (how much the muscles are working), and volume (energy expenditure). Together, this information is used to quantify short-term (3-months) and long-term (1-year) functional improvement postsurgery in patients who participate in research studies at TBI.

Lab Provides Quantitative Outcomes Data
The lab “offers objective, quantitative, and reliable data for spine surgeons and physical therapists to use when assessing the functional outcomes of surgery,” explained Ram Haddas, PhD, MSc, MEng, Director of Research at the TBI Research Foundation in Plano, TX.

The lab was created to overcome the potential limitations of traditional measures of spine surgery outcomes, namely imaging findings and patient questionnaires (eg, Oswestry Disability Index, SF-36). Imaging findings are reliable but conducted in static positions and findings can change with movement, Dr. Haddas noted. In addition, patient questionnaires are subjective with studies showing that patients do not always understand the survey questions or how to estimate pain level, Dr. Haddas said.

“We now have robust irrefutable data manifesting patients’ ability to walk and stand better” after treatment, said Ralph Rashbaum, MD, Orthopedic Spine Surgeon at TBI. “This is something that, from a standpoint of ongoing research, becomes a necessity in musculoskeletal medicine.”

 

READ THE REST HERE

Read More
1857.jpg

Corin USA expands headquarters in Hillsborough County, creating 100 new jobs

Posted On July 7, 2017 By OrthoSpineNews In Recon, Top Stories /  

7/6/2017

TAMPA, Fla. – Corin, a global manufacturer of orthopedic devices and high-tech solutions to improve surgical procedures, today announced that it will expand its US headquarters in Tampa. The company will up to 100 new high-wage jobs in marketing, operations, sales and other administrative roles and invest $500,000 in its new offices by 2022.

“We are fortunate to have such strong growth, which has enabled rapid expansion of our staff and facilities,” said Paul Berman, president of Corin USA. “Tampa has been and will continue to be a corridor of technological and healthcare innovation, which creates a strong base for talent and collaborative partnerships with other adjacent industries.”

Corin USA is a wholly-owned division of the 34-year-old British medical device company Corin Group LLC, located in Cirencester, UK.  Corin USA was established 14 years ago in Tampa and is home to the company’s business activities in the US. Sales, marketing, clinical, regulatory, finance, and operations and logistics groups supporting the sales and marketing of Corin’s medical devices and technologies throughout the US are located at its regional office in Tampa.

Corin USA, which employs 30 individuals locally and over 100 across the US, moved this month from offices on West Cypress Street to 7,000 square feet of new space at 12750 Citrus Park Lane, Suite 120, Tampa, FL 33625.

As a leader in orthopedic innovation, Corin has pioneered a number of landmark developments since its inception in 1985. The company has improved the quality of life of hundreds of thousands of patients across the world through the introduction of its groundbreaking products.

In March 2017, Corin introduced its revolutionary Optimized Positioning System (OPS™) System at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego. The technology may lead to one of the most significant changes to the way hip replacements are performed in more than 30 years.

The first-ever functional, patient-specific hip replacement procedures using OPS were performed in the US in November 2016, shortly after FDA clearance. More than 3,000 procedures have been done already in Europe and Australia, where the system was previously approved for use.

“No two patients are the same, so Corin is offering a patient-specific solution that gives the surgeon the information and tools necessary to enable an optimal hip replacement procedure based on each individual patient’s unique anatomy,” said Berman. “Feedback from surgeons who have used OPS has been excellent and interest in the system from the orthopedic community is very high.”

The Tampa Hillsborough Economic Development Corporation assisted Corin USA with its real estate property search as well as connections to workforce training programs and expedited permitting services.

“Hillsborough County’s life sciences sector is booming,” said Dr. Ken Atwater, chairman of the Tampa Hillsborough Economic Development Corporation and president of Hillsborough Community College. “The success that companies like Corin are enjoying is elevating our global reputation as an attractive location for others in this industry. Tampa offers Corin a highly skilled talent pool, close proximity to an exceptional international airport, and a business climate that supports their growth. We are proud to partner with Corin as they expand and thank them for bringing more great jobs to our community.”

Individuals interested in available jobs may refer to the company’s career website, here.

About Corin Group

Corin is a European orthopedic manufacturer based in the United Kingdom that markets its products throughout the world. Corin is committed to improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements; delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization; and empowering and rewarding our global talented teams to deliver excellence to our customers.

For further information about Corin, please visit www.coringroup.com.

About the Tampa Hillsborough Economic Development Corporation

The Tampa Hillsborough Economic Development Corporation is the lead designated economic development agency for Hillsborough County and the cities of Tampa, Plant City, and Temple Terrace. Established in 2009 as a partnership between the public sector and private corporate investors, the EDC works to develop and sustain a thriving local economy through the attraction, retention and expansion of high wage jobs and capital investment within targeted industry sectors.

Read More
Seaspine_010-L.jpg

SeaSpine Announces Full Commercial Launch of Mariner Posterior Fixation System

Posted On July 7, 2017 By OrthoSpineNews In Spine, Top Stories /  

CARLSBAD, Calif., July 07, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of  Mariner® Posterior Fixation System.

The Mariner Posterior Fixation System is a pedicle based system featuring modular screw technology and accompanying instrumentation.  Designed to reduce the number of trays needed for surgery, Mariner is intended to efficiently provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation.  Mariner offers versatility and adaptability by providing surgeons with a variety of instrument and implant solutions for degenerative and complex spine pathologies, including choices in rod diameter, rod material, construct configuration, and deformity correction techniques. Key market differentiators include in-situ modularity, motion limiting heads, and rod versatility with both 5.5mm and 6.0mm offerings.

“In today’s hospital environment, the key is to have as many options as you can for your patient without overburdening your staff,” stated Douglas Orndorff, MD.  “Mariner is versatile, yet simple to use. Ultimately, it helps me make intraoperative decisions seamlessly.”

Dr. Warren Yu, Director of Spine Surgery at George Washington Hospital commented, “Mariner’s state-of-the-art instrumentation and modular screw design provide me with the broad selection of implant configurations that I need to address the challenging patient anatomy I see in my adult spine practice – from basic degenerative to complex deformity cases.”

“The Mariner Poster Fixation System brings innovative features to the market and utilizes a modular design that increases surgeon flexibility while reducing the number of trays that need to be brought into the operating room,” stated Keith Valentine, Chief Executive Officer of SeaSpine. “The Mariner launch is an important enhancement to SeaSpine’s spinal hardware product offerings in the $1.8 billion posterior lumbar fixation market.”

About SeaSpine

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design benefits of the Mariner Posterior Fixation System, including its potential to reduce the number of trays needed for surgery and provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation; and ability of the Mariner Posterior Fixation System to complete in the $1.8 billion posterior lumbar fixation market.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Mariner Posterior Fixation System has undergone only limited clinical validation and may not address adequately surgeon requirements; surgeons’ willingness to use the Mariner Posterior Fixation System; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

Primary Logo

SeaSpine Holdings Corporation

 

 

Read More
download-1.jpeg

Robot wars: knee surgery marks new battleground for companies

Posted On July 7, 2017 By OrthoSpineNews In Robotics /  

July 6, 2017 – By Paul Sandle and Ben Hirschler | Reuters 

(Reuters) – The world’s top medical technology companies are turning to robots to help with complex knee surgery, promising quicker procedures and better results in operations that often leave patients dissatisfied.

Demand for artificial replacement joints is growing fast, as baby boomers’ knees and hips wear out, but for the past 15 years rival firms have failed to deliver a technological advance to gain them significant market share.

Now U.S.-based Stryker and Britain’s Smith & Nephew believe that is about to change, as robots give them an edge.

Robots should mean less trauma to patients and faster recovery, although they still need to prove themselves in definitive clinical studies, which will not report results for a couple of years.

Fares Haddad, a consultant surgeon at University College London Hospitals, is one of the first in Britain to use the new robots and has been impressed. However, he agrees healthcare providers need decisive data to prove they are worth an investment that can be as much as $1 million for each robot.

“The main reason for using a robotic system is to improve precision and to be able to hit very accurately a target that varies from patient to patient,” he said. “It is particularly useful in knees because they are more problematic (than hips) and there are a chunk of patients that aren’t as satisfied as we would like with their knee replacement.”

Satisfaction rates are only around 65 percent for knee operations, against 95 percent for hips, according to industry surveys.

The rival types of robots vary in cost and sophistication, assisting surgeons with precision image guidance for bone cutting and the insertion of artificial joints.

 

READ THE REST HERE

 

 

Read More
mectalif-ant-immagine-16-USA.jpg

Medacta Spine Delivers Strong Growth in Q1 2017 and Introduces Key New Products

Posted On July 7, 2017 By OrthoSpineNews In Spine, Top Stories /  

July 06, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta International, the privately held family-owned global leader in the design of innovative joint replacement and spine surgery products, today announced that the company’s USA Spine Division delivered strong growth in the first quarter of 2017 and introduced key new products that will continue to expand Medacta’s offerings in the spine field.

Coming off the appointment of a new medical director and important product launches, the Medacta USA Spine Division nearly doubled its sales revenue from the comparable quarter last year. The division released three new products in 2016, including the MySpine Low Profile Guide, receiving numerous accolades for their clinical success and high praise from the surgeons who use them.

Francesco Siccardi, Executive Vice President of Medacta International, commented: “Medacta always strives to produce exceptional products that are built around surgeon feedback and provide the best possible patient experience. The success of this team is a proof point for the Medacta way: a maintained focus on surgeon education and smart design.”

Medacta’s latest innovation, the MectaLIF Anterior Hybrid Interbody Fusion Device, was cleared by the U.S. Food and Drug Administration (FDA) in February 2017 and will be an addition to the MectaLIF Cage product suite. The MectaLIF System aims to provide enhanced in situ stability, restoration of the native disc space height and lordosis, and long-term maintenance of the spinal balance. With the addition of the new hybrid configuration, the MectaLIF product line will now offer four different configurations (hybrid, anterior flush, anterior long, and anterior L5-S1), three footprints, two materials (PEEK or Titanium-coated PEEK (TiPEEK)), and hyperlordotic 20-degree cage options, allowing surgeons to target any patient-specific abnormalities they may encounter.

“The addition of the hybrid makes MectaLIF even more versatile,” said Dr. S. Raymond Golish, Medical Director of Medacta’s Spine Division. “We offer surgeons a wide variety of implants tailored to surgeon technique and patient anatomy to optimize outcomes.”

The addition of the MectaLIF hybrid configuration will enable personalized care for patients where additional stability is required and low profile construct is necessary to deal with difficult, tilted anatomies, by offering a flush caudal and long cranial profile in conjunction with low angle, diverging screws. In addition to the new configuration, the FDA cleared the hyper lordotic option and a 40x30mm footprint to further supplement the MectaLIF product suite and offer a wider array of options to patients.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

Read More

K2M Receives FDA Clearance & CE Mark for NILE® Proximal Fixation Spinal System

Posted On July 6, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

LEESBURG, Va., July 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark for its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation. NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for NILE Proximal Fixation also includes the use of anchors, which are not cleared for use in the United States.

“I have used many band technologies for proximal construct augmentation from different companies and NILE Proximal is a huge leap forward in simplifying the design to achieve this goal,” said Greg Mundis, MD, a surgeon specializing in pediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, California. “K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion.”

I am excited about this addition to the NILE product family,” said John Ferguson, MD, an orthopedic spine surgeon in Auckland, New Zealand. “The implants are straightforward and easy to use. I think this product will be a very useful addition to many of my complex procedures.”

NILE Proximal Fixation has a versatile application in complex procedures, from scoliosis to adult degenerative. The NILE bands are manufactured from polyethylene terephthalate and can be used to provide additional fixation in a MESA® , MESA 2, EVEREST®, or DENALI® Spinal System construct through sublaminar passage or attachment to an anchor (OUS only). The band can then be integrated into the construct using the NILE transverse or medial offset connectors.

“Similar to our recent announcements around MOJAVE™ PL 3D Expandable, SAHARA® AL Expandable, and CAPRI™ Small 3D Static, we are incredibly proud to announce yet another innovative technology in NILE Proximal Fixation,” stated K2M President and CEO Eric Major. “This regulatory milestone—coupled with the recent launch of our Balance ACS™ platform— further emphasizes our focus on achieving three-dimensional spinal balance, and ultimately Total Body Balance, for patients.”

Balance ACS (BACS™) provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the NILE Proximal Fixation Spinal System and K2M, visit www.K2M.com. For more information about Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving threedimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forwardlooking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com

Investor Contact:

Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com

Read More