Meditech Spine Receives FDA Clearance for the CURE Anterior Cervical Plate System

Posted On September 15, 2016 By OrthoSpineNews In Regulatory /

ATLANTA, GA (PRWEB) SEPTEMBER 15, 2016

Meditech Spine has received the US Federal Drug Administration (FDA) 510(k) clearance to market the next generation of cervical plates to complement its Talos®-C (HA) line of interbody devices. Named in honor of CURE International, the CURE Anterior Cervical Plate (ACP) allows surgeons to utilize a next generation cervical plate along with its novel cervical interbody fusion device, cleared in 2015, and made from Invibio Biomaterial Solutions, PEEK-OPTIMA® HA Enhanced. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.

When a cervical disc wears out and loses height it can compress on nerves, causing neck pain, arm pain, and numbness or tingling in the arms and hands. These are common symptoms of Degenerative Disc Disease (DDD). A cervical decompression and fusion may help relieve the symptoms of DDD in the neck. It is estimated that over 300,000 cervical fusions are performed each year in the United States. The CURE ACP is the newest product offered by Meditech Spine to treat patients who need an anterior cervical fusion.

The CURE ACP is a titanium plate that incorporates a unique, patent pending, one-step locking mechanism to prevent screws anchored on the spine from loosening and backing out. It is also designed with a large graft window and streamlined instruments to make it easier on hospital and surgery centers to process the system.

The CURE ACP System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with DDD (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and failed previous fusions.

Dr. Craig Humphreys, a board-certified spine surgeon, co-developer of the CURE ACP System, and founder of Kenai Spine, a center of excellence for spine care in Alaska, performed the first procedure with the CURE ACP in Soldotna, Alaska.

Meditech’s philosophy of giving back led to a partnership with CURE International, the namesake of the CURE ACP, an organization that serves children with physical disabilities in underserved areas of the world. Dr. Humphreys also has a relationship with CURE International, as he and the Kenai Spine medical team have visited the CURE hospital in Kijabe, Kenya, multiple times to provide direct surgical care, surgical training, and essential supplies.

“We are humbled to be part of the healing that will take place in the lives of so many because of the CURE ACP System. This innovative product, along with the generous hearts of those who utilize it, will not only help patients here in the United States, it will also help heal many children in underserved countries around the world,” said Rick Klein, CURE Internationals’s Senior Vice President of Development and Sustainability.

“One of our goals from the inception of our company was to partner with leaders across all spectrums. This includes surgeons, suppliers, manufacturers, and organizations like CURE International,” Eric Flickinger, Co-founder of Meditech Spine, noted.

Meditech Spine, LLC, is a growing spinal implant company that currently partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives the design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best technologies available. Meditech’s belief in the spinal marketplace is to value and honor their partners and all who are touched by their interactions in the development and distribution process, so that each experience leaves a positive impact and impression upon those they serve. For more information, visit http://www.meditechspine.com.

ABOUT DR. CRAIG HUMPHREYS AND KENAI SPINE

At age 48, Dr. Craig Humphreys, a fellowship-trained orthopedic surgeon, left a busy spine practice in Tennessee to return home to where he grew up — Alaska. He and his family are back in Kenai and he is eager to use his skills in spine care to help the Kenai community. Dr. Humphreys’ goal is to provide the most advanced spine care for Alaska residents, particularly those in the Kenai region of the Central Peninsula. Traditionally, those people living with back pain or neck pain in places like Soldotna, Kenai, Anchor Point and Homer, often faced a three-hour drive to Anchorage. Our goal is to provide a more convenient option with the expertise of a fellowship-trained, board-certified orthopedic spine surgeon who has done more than 5,000 successful spine surgeries over his career. For more information, visit http://www.kenaispine.com.

ABOUT CURE INTERNATIONAL

CURE International is a Christian health care network that operates charitable hospitals and programs in 29 countries worldwide where patients experience the life-changing message of God’s love for them, receiving surgical treatment regardless of gender, religion, or ethnicity. Since 1998, CURE has had over 2.9 million outpatient visits, provided over 218,000 life-changing surgeries, and trained over 8,100 medical professionals. For more information, visit http://www.cure.org.

Caption & Copyright:

Tissue Regenix Group plc: DermaPure® – Two Peer Reviewed Clinical Papers Published

Posted On September 15, 2016 By OrthoSpineNews In Biologics /

September 15, 2016

LEEDS, England–(BUSINESS WIRE)–

Tissue Regenix Group (TRX.L) (“Tissue Regenix” or “The Group”) will publish for the first time retrospective analysis on wound care product DermaPure^® providing real world evidence of its use in clinical practice.

Retrospective Observational Analysis of the Use of an Architecturally Unique Dermal Regeneration Template (DermaPure^®) for the Treatment of Hard-to-Heal Wounds by Kimmel, Howard, Gittleman, Haley, is now available online and will feature in the ‘International Wound Journal’, the first time a US physician has published a DermaPure^® study in a peer reviewed journal.

The data which has been collated from 37 patients across 29 treatment centres, mainly focusses on the use of DermaPure^® in the treatment of chronic wounds such as Diabetic Foot Ulcers (DFU) 37.8% and Venous Leg Ulcers (VLU’s) 18.9%, with the remaining patients being treated for either traumatic or surgical wounds.

At the time of application, the average wound size was 12.88cm²and had been present for 56 weeks. The end point of the study was considered to be once complete closure was established, something which was achieved with one application of DermaPure in an average time of 10.58 weeks.

The retrospective data analysed proved to be consistent with what has been observed in published studies previously undertaken by NHSBT in the UK and showed complete healing for:

DFU’s – 52% at 4 weeks

73% at 8 weeks

85% at 12 weeks

Average time to heal 8.21 weeks

VLU’s – 49% at 4 weeks

70% at 8 weeks

81% at 12 weeks

Average time to heal 11.29 weeks

When compared with two other retrospective trials of acellular dermis used to treat DFUs DermaPure^® was proven to heal more effectively with fewer applications.

Alongside this, a study undertaken at the University of Manchester looking into gene expression and the effect that this has on healing chronic wounds has been published in ‘Wound Repair and Regeneration’.

The findings of this research, led by Dr. Ardeshir Bayat, is of particular importance as optimal wound healing is dependent upon appropriate gene expression. The outcome of this study has confirmed that by applying DermaPure^® to a chronic wound, such as a DFU, post debridement, the wound is converted to an acute wound, allowing the body to progress naturally through the wound healing cycle. Chronic wounds that did not receive this treatment had different gene expression and remained unable to advance appropriately through the healing process. Thus, proving a treatment such as DermaPure^® to have a significant advantage when treating patients suffering with chronic wounds, such as DFU’s, where the amputation rate can be as high as 15%.

Greg Bila, President, Tissue Regenix Wound Care Inc. said: “The publication of this clinical data is key in highlighting the problems physicians face when treating chronic wounds, and how regenerative treatments such as DermaPure^®address, and potentially revolutionize, the outlook for these patients. Many times products illustrate outcomes in the study environment that are seldom seen in the real world clinical environment. However, we now have two substantive pieces of research that illustrate the effectiveness of Tissue Regenix dCELL^® Technology in the treatment of chronic and acute wounds, and demonstrates the potential effectiveness of this technology in other areas of healthcare.”

A full copy of the peer reviewed paper is available here

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL^®‘) technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, as part of its commercialisation strategy for its dCELL^® technology platform.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160915005782/en/

ottobock_healthcare_heinrich_popow_runs_paralympics_2.jpg

Here’s How to Convince the Brain That Prosthetic Legs Are Real

Posted On September 15, 2016 By OrthoSpineNews In Extremities /

By Oliver Alan Kannape – September 12, 2016

The carbon fiber legs or “blades” used by lower limb amputee runners have arguably become one of the most iconic symbols of the Paralympic Games. Although different lower-limb sports prostheses are used for running, jumping, and other activities, they share a single common aim: they are designed to help paralympians run faster and jump higher or further than other competitors. Form follows function.

For those who have prostheses for more everyday uses, however, their replacement limbs need to be able to adapt to different scenarios and perform a variety of functions, not just excel in one discipline — just like an actual leg. So how can we make prostheses feel more like the real thing rather than a specialist tool?

Whereas modern running blades have a distinctive hook shape, one of the most promising engineering approaches for everyday prostheses is to closely model the biological design of a leg, ankle and foot. This approach is referred to as “biomimicry.”

A “passive” ankle-foot prosthesis generally uses elastic like a spring to replicate the behavior of the Achilles tendon, storing elastic energy and releasing it before ankle push-off. “Active” prostheses additionally use an actuator or motor to make up for the power previously provided by the calf muscle at every step. Such prostheses have been shown to help users walk more like a non-amputee and improve symmetry between the biological and the artificial limb. At the moment, this mainly applies to walking overground at steady speeds rather than activities such as climbing stairs.

Simple design, advanced technology

Other ways to make a prosthesis more like a biological leg and improve the user’s comfort are more simple. They also illustrate how important it is to involve the amputee in the design process. One user of the most advanced bionic ankle currently available told me its greatest feature was not that it provided a powered push-off or that it allowed them to walk more like a non-amputee. Instead, it was that the foot dropped flat on the ground when sitting with an outstretched leg, rather than sticking up awkwardly at a 90-degree angle (as is the case for the majority of prosthetic feet).

READ THE REST HERE

Zimmer Biomet Adds 3D Range-of-Motion Simulation Capability with Strategic Acquisition of Clinical Graphics

Posted On September 15, 2016 By OrthoSpineNews In Financial /

WARSAW, Ind., Sept. 15, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, recently announced the strategic acquisition of Clinical Graphics, B.V., a novel imaging company specializing in 3D range-of-motion simulation technology to inform treatment decisions for common hip conditions requiring early intervention. Zimmer Biomet plans to integrate the new imaging platform to enhance its hip preservation portfolio.

“3D imaging represents the next generation of treating joint pain, and we’re excited to team up with Clinical Graphics and integrate our technologies to further enhance the clinical utility of our market leading hip portfolio,” said Dan Williamson, Group President, Joint Reconstruction for Zimmer Biomet.

Clinical Graphics is a recognized pioneer in the field of 3D interactive range-of-motion simulation reports for common hip conditions such as femoroacetabular impingement and dysplasia, and physicians rely on its technology to characterize the physiology of a patient’s pain and direct treatment approaches.

“Zimmer Biomet is a well-respected leader in musculoskeletal healthcare, and an ideal parent company to usher our breakthrough technologies into mainstream clinical practice as the standard of care for managing joint disease,” said Peter Krekel, Managing Director of Clinical Graphics. “We’re thrilled to join the Zimmer Biomet family and look forward to working together to improve the care of patients living with joint pain.”

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; spine, bone healing, 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 www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

About Clinical Graphics
Clinical Graphics began in 2010 as a spin-off from Delft University of Technology and is headquartered in The Netherlands at technology incubator Yes! Delft. The company enables physicians to see beyond the usual by converting medical scans into 3D motion simulations of patients’ anatomy. Clinical Graphics’ analysis reports provide an interactive 360◦ dynamic view of the joint, supporting both physicians and patients to make well-informed treatment decisions. For more information, visitwww.clinicalgraphics.com.

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

Medovex Corporation Enters Into International Distribution Agreement With M. Fast Technologies LTD

Posted On September 14, 2016 By OrthoSpineNews In Financial /

ATLANTA, GA–(Marketwired – Sep 14, 2016) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or “Company”), a developer of medical technology products, today announced that the Company has entered into an international distribution agreement with M.Fast Technologies LTD, a supplier of innovative Spine surgery products. The agreement covers the distribution of its DenerveX™ System throughout Israel.

Dennis Moon, Medovex Executive Vice President, stated, “M.Fast Technologies LTD serves as a perfect call point fit for our mission to provide a successful distribution, sales and marketing foundation for our entry of the DenerveX System in the Middle East.”

“With M.Fast Technologies LTD as a specialized distributor offering complex and innovative spine products throughout Israel, we are closing a gap while showing a professional presence in a major market,” added Manfred Sablowski, Senior Vice President Sales & Marketing. “Today’s news importantly enables Medovex to expand the use of the DenerveX System into the Middle East, where M.Fast Technologies is a well established successful distributor. We expect the agreement will help in our efforts to increase worldwide adoption of the DenerveX System.”

Sablowski continued, “Our goal remains to continuously improve our international market presence by expanding our network of strong distributors with knowledgeable sales and support personnel, and in close proximity to our customers.”

Medovex already has distribution agreements for the DenerveX System in Germany, Spain, UK, Denmark, Norway, Sweden, Finland in Europe and Asia Pacific, as well as in select other countries around the world.

The Company’s patented DenerveX System, currently in final development and not yet commercially available, is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX device kit containing a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX System is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

About M.Fast Technologies LTD

M.Fast Technologies is a supplier of well known and innovative Spine surgery products that takes pride in finding and supplying its customers with the very best and innovative products of the world.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward- looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

Progenerative Medical Obtains Exclusive Rights to Tissue Regeneration Technology

Posted On September 14, 2016 By OrthoSpineNews In Financial /

SAN ANTONIO, Sept. 14, 2016 /PRNewswire

Progenerative Medical, Inc. (PGM), a clinical-ready medical device company announced today they have entered into a technology licensing agreement with Kinetic Concepts (KCI). The license grants PGM exclusive, world-wide rights to KCI’s extensive intellectual property and preclinical product development portfolio enabling effective delivery of negative pressure therapy for orthopedic and spine indications.

“This agreement provides the foundation for our team, rich in talent and experience, to translate the very promising results seen in extensive preclinical studies into products with the potential to significantly improve clinical outcomes and patient satisfaction in orthopedic and spinal surgeries,” said James Poser, PhD, CEO and Cofounder of Progenerative Medical, Inc.

Dr. Poser continues, “As a group the cofounders have a twenty-year collaborative history in development and commercialization of clinically proven products. We each made significant contributions to KCI’s R&D efforts that led to these new spine and orthopedic indications for negative pressure therapy. PGM is now uniquely positioned to continue development and innovation in this field, and to proceed with outcomes-based clinical studies and regulatory filings.”

PGM is based in San Antonio, TX, a community instrumental in the development, worldwide adoption and commercial success of negative pressure technologies. The license enables a first-in-its-class negative pressure technology specifically targeting the skeletal system (bone, cartilage and joints) and, therefore, affords the opportunity to expand the applications of clinically proven negative pressure therapy and to transform industry-wide clinical practice.

For more information, contact:

James Poser, PhD
CEO
Progenerative Medical, Inc
P.O. Box 5366
San Antonio, TX 78201
e: jposer@progenerativemedical.com
c: +1 844 977 6436

This content was issued through the press release distribution service at Newswire.com. For more info visit:http://www.newswire.com.

SOURCE Progenerative Medical, Inc.

Collagen Meniscus Implant

Posted On September 14, 2016 By OrthoSpineNews In Sports Medicine /

Am J Orthop. 2016 September –

Author(s): Wayne K. GersoffMDAdvanced Orthopedics & Sports MedicineDenverCO

Collagen Meniscus Implant

The number of patients undergoing arthroscopic partial meniscectomy has continued to increase. However, this is potentially not a benign procedure, as there are increased contact pressures on the articular cartilage even with the removal of only a segment of the meniscus.

The Collagen Meniscus Implant (CMI, Ivy Sports Medicine) is a resorbable and biocompatible Type I collagen matrix that was developed to restore the segmental loss of meniscal tissue in the knee. It consists of a porous cross-linked matrix scaffold that allows for the ingrowth of the body’s own cells. The CMI is the only meniscal implant composed of purely biological materials and is available in an off-the-shelf supply.

The CMI is available in the United States for use in the restoration of segmental loss of the medial meniscus. The CMI can be utilized in either an acute or chronic situation. In the acute case, it would be indicated when the medial meniscus is irreparable, and that segment must be removed. In the chronic case, the patient would have had a previous partial meniscectomy and/or failed meniscus repair and had developed either pain or signs of early articular cartilage wear in the compartment. The procedure can be done arthroscopically and as an outpatient. The CMI can be kept on the shelf to be available as needed; it has a 2-year shelf life. There are specialized instruments for measuring the length of implant needed and for delivery of the implant.

READ THE REST HERE

Author’s Disclosure Statement: Dr. Gersoff reports that he is a consultant for Ivy Sports Medicine and Vericell.

Ivy Sports Medicine(http://www.ivysportsmed.com/en)

Health IT experts discuss: Which MACRA pathway is best for providers in 2017? And what could they be doing to get ready for Jan.1, 2017?

Posted On September 14, 2016 By OrthoSpineNews In Financial /

September 13, 2016 – by Rajiv Leventhal

When the Centers for Medicare & Medicaid Services (CMS) announced on Sept. 8 that it will allow eligible Medicare physicians to pick their pace of participation for the first performance period of Medicare Access and CHIP Reauthorization Act (MACRA) that begins Jan. 1, 2017, the initial industry reaction seemed to be a collective sigh of long-awaited relief.

After all, ever since the MACRA proposed rule, which is set to overhaul physician payment as the healthcare industry shifts to paying doctors for value rather than volume, was released in April, many doctors were wondering how they would be able to learn all of the regulations and be able to comply with just a few months’ time to prepare. And, smaller physician practices were even more concerned; a Black Book survey from June revealed that two-thirds of high Medicare-volume small practices said they foresee the end of their independence due to the physician payment changes that will take place under MACRA.

But then came the program flexibility news last week, delivered via a blog post on CMS’ website by the agency’s Acting Administrator, Andy Slavitt. Slavitt, while previously leaving the door open for a delay to the outcomes-based program, implied in his blog that the Jan. 1 reporting period start date (which would affect payment adjustments for eligible doctors in 2019) would stay intact, but that other flexibilities would be granted. Although no final rule on MACRA has been published to date, with most healthcare policy experts targeting sometime this fall as when it will come, Slavitt said participating providers will have four pathways to choose from for the first year of MACRA in 2017. These pathways range from sending in only some data to MACRA’s Quality Payment Program, which includes two paths—the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs); to sending in more data but for a reduced period of time; to “going all in” as is. The idea, CMS said, is to allow doctors to choose their pace for easing into a brand new physician payment program full of complexities, while at the same time avoiding negative payment adjustments in 2019.

In an in-depth analysis of the CMS announcement from last week, Healthcare Informatics Editor-in-Chief Mark Hagland cited multiple healthcare association groups, who at the very least, were appreciative of the government’s efforts to ease the burden on Medicare doctors. But what are providers on the ground saying? John David Goodson, M.D., staff internist at Massachusetts General Hospital (MGH) and associate professor at Harvard Medical School, for one, says that CMS’ message was a strategic move to get doctors to be involved in reporting their data starting next year. Goodson notes how the Physician Quality Reporting System, or PQRS, has been around for a long time, “but many doctors decided to take the financial hit rather than comply with it.” He says that the reporting required in MACRA’s Quality Payment Program will require good, solid data which CMS will never get unless they get doctors to buy into the reporting mechanisms. As such, the pathways laid out by the federal agency are attempts to at the least, get the community of providers engaged at a minor level, Goodson says.

READ THE REST HERE

SpineGuard Reports Six-Month 2016 Financial Results

Posted On September 14, 2016 By OrthoSpineNews In Financial /

September 14, 2016

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today financial results for the half year ending June 30, 2016, as approved by the Board of Directors on September 13, 2016.

Pierre Jérôme, CEO of SpineGuard, said: “We are very pleased with these results for the first half of 2016. The combination of sustained strong growth in sales with good operating cost control allowed us to invest further in the deployment of our Dynamic Surgical Guidance platform. At the same time, we improved our operating results. In a market constantly seeking innovation and better clinical outcomes, SpineGuard continues to demonstrate the great medico-economic value of its DSG™ technology, unique in its ability to enable surgeons to make spine surgeries safer.”



€ thousands – IFRS	H1 2016	H1 2015
Revenue	3,633	2,970
Gross margin	3,105	2,557
Gross margin (% of revenue)	85,5%	86,1%
Sales, distribution, marketing	-3,477	-3,098
Administrative costs	-1,076	-1,146
Research & Development	-764	-646
Operating profit / (loss)	-2 ,212	-2,332
Pre-tax profit / (loss)	-2,472	-2,180
Net profit / (loss)	-2,472	-2,180
NB : unaudited

Sales growth and reduced operating loss

For H1 2016, the Company reported revenue of €3,633k, up 22% (cc) compared with H1 2015.

Revenue in the United States increased 26% (26% cc) to €2,866k in the first half of 2016, compared with €2,274k in the first half of 2015. In the rest of the world, revenue increased 10% during the first half of 2016 to €767k compared with €696k in the first half of 2015.

4,351 PediGuard units were sold in the first half of 2016 compared with 3,716 in the first half of 2015, including 2,441 in the United States, representing 56% of total units sold.

Gross margin of 85.5% at June 30, 2016, compared with the prior year of 86.1% and remains solid. The change mainly reflects the lower ASP with the US stocking distributors but this is offset by the absence of sales commissions. Excluding stock distributors, ASP remained flat in the US while ASP was down 4% OUS due to a different country mix compared to the same period of 2015.

Operating expenses were €5,318k compared with €4,890k for H1 2015, an increase of €428k compared with June 30, 2015. This increase is due to the agents’ commissions proportioned to sales, to the hires made in sales R&D, to the gathering of the scientific advisory board in the first half of 2016 and to the accrual of variable compensation in line with the performance of the company.

Working capital requirements were €728k compared with € -65k at December 31, 2015. This continues to illustrate the relatively low operating cash needs of the Company and the efficient management of its financial resources. It should also be noted that the Company; i) sourced several raw materials and finished products in order to cover manufacturing requirements for the entire product line, and ii) is impacted by longer payment terms agreed upon for the Saudi tender that are secured by letters of credit, of which €105k was paid on July 25, as anticipated.

At June 30, 2016, cash and cash equivalents were €3,257k compared with €3,229k at December 31, 2015, and is explained as follows:

The operating cash flow of €(2,732)k compared with the same period last year of €(1,943)k.
The payment of interests to IPF Partners of €145k and to Bpifrance of €22k.
The on-going repayment of the BPI Innovation loan, of €63k.
The second draw of the IPF Partners bonds for a gross amount of €1,500k.
The Innovation loan received from Bpifrance for a gross amount of €1,500k.

The Company also has access to the following financing:
a) Tranche C of the loan with IPF Partners for an amount of 1,500 K€ by December 31, 2016 with the condition of attaining a 12-month rolling revenue threshold;
b) An equity line (Paceo) in place since 2014 for a maximum number of 265,000 shares.

The Company’s workforce count is 28 at H1 2016, compared with 26 at the end of December 2015.

Recent events and outlook:

The half-year revenue for 2016 is encouraging and follows the excellent performance of 2015. PediGuard^® Threaded, which was launched in May at the international SpineWeek congress and cleared by the US FDA mid-June, has started to contribute to revenue growth, confirming the excellent feedback received by the surgeons who performed the first cases.

The commercial launch of the PediGuard^® Threaded in the USA will occur at the NASS (North American Spine Society) annual conference at the end of October in Boston. Prior to NASS, the DSG™ screw will be presented in a symposium at the European congress for spine surgery (Eurospine), and its US-FDA clearance is progressing well with the company planning to file the 510k in the third quarter of 2016.

Next financial press release: 2016 third quarter revenue, October 12, 2016.

SpineGuard will participate at the Large & Midcap Event 2016 on October 5 and 6 in Paris.

SpineGuard will participate at Actionaria on November 18 and 19 in Paris.

About SpineGuard^®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard^®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 47,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris.

For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Orthopaedic Surgeons to Use HipGrid Drone at the ICJR 2016 5th Annual Direct Anterior Approach Hip Course

Posted On September 14, 2016 By OrthoSpineNews In Recon /

SALT LAKE CITY, Sept. 14, 2016 /PRNewswire/ — This September 22-24, the International Congress for Joint Reconstruction (ICJR) will hold its 5^th Annual Direct Anterior Hip Course for orthopaedic surgeons in Houston, TX. OrthoGrid Systems, Inc.’s (Salt Lake City, UT) will be in attendance at the meeting for the fourth year in a row.

OrthoGrid’s presence at the meeting has grown over the past four years. Richard Boddington, OrthoGrid CEO says, “We thank ICJR for the opportunity to showcase the efficacy of our HipGrid technology for direct anterior total hip arthroplasty. We’re thrilled to offer orthopaedic surgeons a simple, elegant solution to ease the learning curve of an already challenging procedure.”

OrthoGrid’s mix of innovative culture, emphasis on research and development, and technological advances provides a high level of ease, efficiency, and accuracy to orthopaedic surgical procedures such as total hip replacement (THR). “We look forward to meeting the surgeons attending this year’s ICJR Direct Anterior Hip Course and making their learning experience even more valuable with HipGrid,” says Mr. Boddington.

Direct anterior total hip arthroplasty (THA) has been gaining in popularity amongst surgeons and patients, as it is less invasive than standard, posterior approach total hip arthroplasty. With HipGrid, surgeons can quickly and effectively assess anatomic alignment and implant positioning in real time in the operating room using fluoroscopy and make necessary adjustments to optimize the surgical outcomes.

HipGrid’s effectiveness has been demonstrated in peer-reviewed and ongoing direct anterior THA clinical studies, which show improved acetabular cup angle, leg length, and hip offset outcomes and decreased mean surgical time with HipGrid compared to without.

“We have a unique product that marries seamlessly with the other tools required to successfully implement a direct anterior approach program, and we look forward to making it available to as many surgeons as possible who are interested in improving and standardizing their fluoroscopic technique without breaking the bank,” says Edouard Saget, OrthoGrid president.

To learn more about OrthoGrid and HipGrid Drone technology, visit OrthoGrid.com.

About OrthoGrid Systems, Inc.

OrthoGrid Systems, Inc. is a privately owned medical device company based in Salt Lake City, Utah. Its focus is inventing more accurate and cost-effective ways to assist in proper positioning of implants and restoration of leg length when performing total hip replacement (THR). OrthoGrid supplies a growing portfolio of patented and patent-pending technologies related to intraoperative alignment using radiopaque grid patterns for orthopedic total joint arthroplasty and trauma. Please visit company website for more information: www.OrthoGrid.com.

OrthoGrid® Systems, Inc.
Media Contact: Tonya Trest, VP of Sales and Marketing
Email
Phone: 801-703-5866
Source: OrthoGrid Systems, Inc.

SOURCE OrthoGrid Systems, Inc.

Related Links

http://www.orthogrid.com

Our Blog

Simple design, advanced technology

CONTACT INFORMATION

Contacts