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July 17, 2018 OrthoSpineNews

LEESBURG, Va., July 17, 2018 (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 that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and a CE Mark for its CAYMAN® United Plate System following completion of its first surgical cases. CAYMAN United is designed for rigid fixation to K2M’s CASCADIA Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology, the first and only 3D-printed cage with modular fixation capabilities. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

“The CAYMAN United Plate System, which firmly fixates to K2M’s CASCADIA Lateral 3D implants, is a notable advancement,” said Robert Lee, FRCS (Tr&Orth), a spine surgeon at Royal National Orthopaedic Hospital NHS Trust in Stanmore, UK. “Its streamlined technique and versatile insertion options provide an elegant solution for my minimally invasive lateral cases, while also utilizing a 3D-printed device to encourage bony integration throughout the implant.”

The CAYMAN United Plate System’s single level, 1- and 2- hole plate configurations precisely match all CASCADIA Lateral 3D height and lordosis options, allowing surgeons to customize the construct using a lateral approach. Single-level plate sizes minimize retraction required for placement and an assembly alignment feature keys into the CASCADIA implants to resist rotation. Versatile insertion options allow for plate assembly with a central assembly screw prior to implantation, or in-situ after the cage has been placed.

“We are excited to receive FDA clearance and a CE Mark for our CAYMAN United Plate System, designed to enhance our CASCADIA Lateral 3D Interbody System and making it the first and only 3D-printed cage available on the market with modular fixation capabilities,” said K2M Chairman, President, and CEO, Eric Major. “As a leading innovator of 3D-printed spinal solutions, we remain committed to developing advanced technologies that when complemented by our comprehensive Balance ACS platform, help surgeons facilitate 3D spinal balance in their patients.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CASCADIA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity.

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

For more information on the CASCADIA Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology and the CAYMAN United Plate System, visit www.K2M.com. For more information on 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 three-dimensional 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 FacebookTwitterInstagramLinkedIn 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 and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; 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 maintain adequate working relationships with healthcare professionals; 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 to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; 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 remediate the material weaknesses in our IT general controls; 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 associated with the exit of the United Kingdom from the European Union; 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 a fiscal 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; 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; potential volatility in our stock price; our lack of current plans to pay cash dividends; 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 forward-looking 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


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July 17, 2018 OrthoSpineNews

July 17, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer of orthopedic medical imaging 2D / 3D, today announced that it entered into a binding agreement with Fosun Pharmaceutical AG, an indirect subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, stock code: 600196.SH, 02196.HK), related to an equity investment to be made by Fosun Pharmaceutical AG through an issuance of EOS imaging news shares.

At the closing of the investment, the Company will issue 3,446,649 new shares to be subscribed by Fosun Pharmaceutical AG at a nominal value of €0.01, for a price per share of €4.37, issue premium included, which amounts to a total amount of c. €15.1m. The price per share negotiated between the parties represents a discount of 6.8% on the closing price on July 16th, 2018, and a discount of 9.2% on the volume weighted average share price of the Company’s shares on the regulated market of Euronext Paris over the last 20 trading days prior to the signature of the subscription agreement. Fosun Pharma, through Fosun Pharmaceutical AG, will hold approximately 13.2% of the sum of the Company’s existing Shares and the shares subscribed by Fosun Pharma post transaction (on a non diluted basis and taking into account shareholding and voting rights of the Company at the date of this press release) and will be the largest shareholder of the Company.

Marie Meynadier, CEO of EOS imaging says: “We are very happy to welcome Fosun Pharma, a strategic investor in healthcare with acumen in capital equipment, joining EOS imaging. After the strong investment made by the Company in the US in 2017 and early 2018, this important step reinforces our presence in the Asia-Pacific region and, together with our historical European base, completes our global strategy of strengthened presence in the Company’s three major markets. We look forward to continuing to develop EOS imaging and making available the EOS® technology to a growing number of patients worldwide, amongst which the Chinese population. Companies within Fosun are key players in the high growth global market and will undoubtfully contribute to this development.

Chen Qiyu, co-president of Fosun International and chairman of Fosun Pharma says: “We are very pleased to have EOS imaging to join Fosun family and to bring its intelligent imaging solutions to the Group. EOS imaging is a global medical device company that develops and markets advanced imaging and image-based solutions for musculoskeletal pathologies and orthopedic surgical care. EOS imaging’s mission is ‘connect imaging to care’ which fully complements Fosun’s mission of creating happier life for families worldwide. With the joining of EOS imaging, it will further enhance and complement Fosun Pharma’s existing resources in medical diagnosis.

The completion of the investment is subject to the approvals from Chinese government authorities and to the visa of the AMF (Autorité des Marchés Financiers, the French market authority) on a prospectus consisting of the Document de Référence filed with the AMF on April 27th, 2018 under number D.18-0439, and a Note d’Opération which will include a summary of the prospectus. The regulated information related to the Company and the Company’s press releases can be found on the Company website. The Company also publishes today a press release for the first half 2018 Sales.

The investment will be implemented on the basis of the delegation granted by the shareholders extraordinary general meeting dated May 18th, 2018, to the Board of Directors of the Company pursuant to the 20th resolution of such shareholders meeting. On an illustrative basis, a shareholder holding 1% of EOS imaging’s capital before the investment will then hold a stake of 0.87% (on a non diluted basis and taking into account shareholding and voting rights of the Company at the date of this press release).

Following the resignation of Ms Paula Ness Spears from her Board position, Mr Antoine Vidal representing Fosun Pharmaceutical AG will be appointed at the closing of the investment as Board member by co-optation of the Board of Directors of the Company. His co-optation will be ratified at the next Shareholders’ meeting. The Company will do all its best efforts to propose to the shareholders meeting the appointment, before the end of 2018, of an independent director in order to comply with the recommendations of the Middlenext governance code.

In addition, the Company undertakes to offer the possibility to Fosun Pharmaceutical AG to participate in any future dilutive issuance of equity carried out with cancellation of the preferential subscription right and authorized by the General Meeting of Shareholders, during a period of five years after closing and for so long as Fosun Pharmaceutical AG holds, directly or indirectly, at least 25% of the shares subscribed at the closing of the investment. No specific clause for bearance or retention of the shares subscribed is provided for in the context of this transaction. There is no related agreement to this transaction between the parties concurrently with the signing of the investment agreement.

The issuance of the new shares to Fosun Pharmaceutical AG and their admission to trading on Euronext Paris are expected to occur after the approval by the relevant Chinese government authorities and the visa from the AMF on the prospectus. The new shares will then be admitted to trading on the Euronext regulated market in Paris under ISIN FR0011191766 – EOSI. EOS imaging’s share capital will consist of

26,130,407 shares following the settlement-delivery.

Agile Capital Markets acted as a financial advisor to the Company.

Next financial release: Announcement of 2018 Half-Year results on September 13th, 2018

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

ABOUT FOSUN PHARMA

Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare group in China. Adhering to the mission of improving human health, Fosun Pharma’s business covers all key sectors of healthcare industry chain, including pharmaceutical manufacturing and R&D, healthcare services, medical devices and medical diagnosis, as well as pharmaceutical distribution and retail. Fosun Pharma always regards innovation as the driving force for its business growth. The company continuously optimizes its pharmaceutical R&D system that integrates biosimilars and innovative drugs and has established international R&D teams in China, the United States, India, etc., forming a globally interactive R&D system. Fosun Pharma maintains a national recognized enterprise technology center and establishes innovative chemical drugs platform, biologics platform, high-value generic drugs platform and cellular immunotherapy platform. At present, Fosun Pharma maintains the leading position with its core products in various therapeutic areas, including oncology, cardiovascular system, central nervous system, blood system, metabolism and alimentary system and anti-infection. All products occupy the leading position in each market segment.

Looking forward, Fosun Pharma will adhere to the brand philosophy of “Innovation for Good Health”. Focusing on the unmet needs in the medical field, it will adhere to the development model of “organic growth, external expansion and integrated development” under the guidance of “4IN” strategy (Innovation, Internationalization, Integration, Intelligentization), striving to become a first-tier enterprise in the global mainstream pharmaceutical and healthcare market.

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman
The Ruth Group
Ph: 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com


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July 17, 2018 OrthoSpineNews

July 16, 2018 – Author,

Dive Brief:

  • Executive and clinician respondents to a new NEJM Catalyst survey said knowing out-of-pocket costs is important to patients and more than 60% said physicians are responsible for educating patients about these costs. However, nearly half don’t think physicians should be held accountable for those costs.
  • Slightly more than three-fourths of respondents said their organizations consider the cost to the practice and system when making clinical decisions. A slightly lower number (72%) said they consider patient out-of-pocket costs, while 68% said they think about the total cost of care.
  • Respondents said the stakeholders that have the biggest impact on healthcare costs are pharmaceutical/biotech companies (87%), health plans (81%) and hospitals/health systems/physician organizations (75%). Only 28% pointed the finger at individual clinicians and even fewer blamed employers (26%) and patients (23%).

Dive Insight:

These results show that thought leaders believe physicians should play a role, but shouldn’t be penalized for the actual cost of care. Plus, other healthcare stakeholders are encouraged to improve processes and tools to better educate patients on costs.

The findings come as more payers are pushing providers into value-based contracting. The different payment method incentivizes and penalizes physicians and health systems to keep costs under control and provide a minimum level of care quality. The concept behind value-based payment does include holding doctors accountable for costs to an extent.

 

READ THE REST HERE

 


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July 17, 2018 OrthoSpineNews

JUL 16, 2018 – Jeff Lagasse, Associate Editor

There’s a lot of work involved in making the transition from fee-for-service payment models to performance-based arrangements. Changes are needed to outdated delivery models, there needs to be more responsibility for care coordination, and providers are tasked with finding ways to gain a competitive advantage in the market.

Jeff Smith, senior vice president and head of U.S. markets at Lumeris, said addressing these issues positions health systems to solve the dilemma created by the industry’s long-standing structural separation of care delivery — its costs, reimbursement, and quality — by integrating actionable intelligence, information, workflows incentives and tools.

This, he said, creates a new paradigm of behaviors that drives better clinical outcomes, lowers cost and creates superior engagement and satisfaction among providers and consumers.

It’s an issue that Lumeris and Cerner are attempting to tackle with a new partnership that has created Maestro Advantage, which combines the technology of both companies and allows providers to streamline redundant services — a nagging problem in the volume-to-value shift.

These redundant services include “lengthy claims processing and reimbursement cycles, and obstacles to sharing data and records,” Smith said. “Healthcare must continue to shift its focus from a system focused on sick care to well care — a system that promotes health and wellness. The transition to value-based care is a long journey.”

The shift to value creates other challenges as well. Increasingly, providers are determining physician pay through a number of different means. The options include straight salary, compensation based on personal productivity (as has been the case in a fee-for-service world), bonus structures and tying pay to an organization’s overall financial performance.

 

READ THE REST HERE

 


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July 16, 2018 OrthoSpineNews

Acron Medical, LLC (http://www.Acron-Medical.com), part of the spineMED Group, is a spine technology organization, dedicated to developing and commercializing globally innovative spinal implants. The company is proud to announce that it has received 510(k) clearance from the FDA for its signature new technology, the ACRON TLIF Interbody system.

“The ACRON Interbody is an exciting innovation for safe & stable thoracolumbar interbody fusion,” says Christian Schawrda, Acron Medical’s Co-Founder and CEO. “The engineering behind the development of the cage makes it the gold standard for surgeons looking for solid anchorage and optimal load distribution between the implant to protect osteoporotic patients from bone subsidence. The cage is designed to be strategically placed along the outer rim of the endplates, or ring apophysis, with superior load-bearing capacity. That approach, maximizes the strength of the fusion construct, increases fusion rates and minimizes the risk of subsidence.”

The ACRON is made of PEEK-OPTIMA, a material with a proven clinical history and a modulus of elasticity similar to bone. It also comes with a graft chamber and side windows to facilitate the formation of a robust fusion column.

The system includes a full range of implant sizes and heights that are carefully designed to accommodate different types of vertebral anatomy, and to allow surgeons to address each patient’s sagittal plane requirements.

Andreas Bernegger, Acron Medical’s Co-Founder says, “The ACRON comes to the United States after 3 years of clinical validation in Austria, Germany and Switzerland. The launch of the technology in the United States is major milestone for our group. We are currently looking for distributors and strategic partners around the country.”

Acron Medical’s management team will be attending NASS in September in Los Angeles (Sep 26-29) and is looking forward to many fruitful discussions with potential partners. For more information on Acron Medical, please visit http://www.Acron-Medical.com.

About Acron Medical, LLC. 
Acron Medical is the US subsidiary of the spineMED group, based in Austria. Acron Medical founded in 2017, has leveraged its Austrian DNA, 35 years of clinical experience and the core competencies of the spineMED Group to develop a range of clinical relevant spinal technologies. The ACRON TLIF, as well as all the technologies in the spineMED R&D pipeline, are designed to harmoniously combined the latest scientific advances with intuitive designs and instrumentation. Additional information is available online at http://www.Acron-Medical.com.


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July 16, 2018 OrthoSpineNews

July 16, 2018

ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc., (Company) a medical device company focused on the treatment of osteoarthritis of the extremities, announced today the presentation of five-year follow up results from its pivotal MOTION Study, a prospective, randomized multi-center study which evaluated the safety and effectiveness of its Cartiva Synthetic Cartilage Implant (SCI) for the treatment of arthritis at the base of the big toe, the most common site of arthritis in the foot. The objective of the MOTION study, which involved 197 patients treated at 12 centers, was to establish non-inferiority of Cartiva SCI compared to fusion, the historical standard of care.

Judith Baumhauer, M.D., M.P.H., Professor and Associate Chair of Academic Affairs, University of Rochester Medical Center and Principal Investigator of the MOTION Study, presented the data July 14 at the annual meeting of the American Orthopaedic Foot and Ankle Society (AOFAS) in Boston, MA.

In the original MOTION Study, 135 patients received the Cartiva implant. Of these, long-term outcomes were available for 106 patients with a mean follow-up of 5.8 ± 0.7 (range: 4.4 to 8.0) years. These outcomes demonstrate that Cartiva SCI provides:

  • Durable pain relief, with patients achieving a 97% median reduction in pain.
  • Sustainable functional improvement, with patients demonstrating a 176% median improvement in sporting activities.
  • Motion preservation, with patients experiencing a 25% improvement in range of motion from baseline.
  • A high rate of satisfaction with the treatment, with 93% of patients saying they would have the procedure again.

“Cartiva SCI has now been proven to be a viable alternative to fusion for patients wanting to maintain range of motion,” said Mark Glazebrook, MD, FRCSC, MSc, PhD, Professor of Orthopaedics Surgery at Queen Elizabeth Sciences Centre in Nova Scotia, Canada and a lead enroller in the MOTION Study. “With almost six years of follow up from a rigorously conducted clinical trial, the data supports Cartiva being a game-changer in the treatment of this condition.”

Cartiva SCI gained Food and Drug Administration (FDA) premarket approval for use in arthritis at the base of the big toe in July 2016. As a condition to the approval, FDA required additional data to evaluate the long-term safety and effectiveness of Cartiva SCI, including the durability and survivorship of the implant. The primary endpoint (implant survivorship) and secondary endpoints (clinical and radiographic success for the Cartiva subjects through five years) were met and the data has been submitted to FDA.

“We were very excited to share the long-term results with the attendees of the AOFAS Annual Meeting,” said Tim Patrick, President and CEO of Cartiva. The excellent follow-up out to as long as eight years is a testament to our clinical investigators and their research staff. We believe these data support Cartiva as the standard of care for a motion-preserving alternative to fusion.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. is a medical device company focused on the treatment of osteoarthritis of the extremities. Cartiva’s synthetic cartilage is the only FDA-approved biomedical implant that mimics natural cartilage. The company’s venture investors include New Enterprise Associates and Windham Venture Partners. Additional information is available on the company’s website at www.cartiva.net.

Contacts

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer


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July 16, 2018 OrthoSpineNews

MORTON GROVE, ILJuly 16, 2018 /PRNewswire/ – Orthopedic surgeon, Ritesh Shah, MD, was honored with the IJS Innovation Trailblazer Award of Excellence acknowledging early adoption of intellijoint HIP® into his practice at Illinois Bone & Joint Institute and in an Ambulatory Surgery Center (ASC) setting at Illinois Sports Medicine & Orthopedic Surgery Center (ISMOSC) in Morton Grove.

intellijoint HIP is a highly accurate 3D mini-optical navigation system used to assist in proper size selection and positioning of artificial implants during a hip replacement. Dr. Shah is the first orthopedic surgeon in Illinois to offer this new technology in an outpatient or ASC setting.

“Many of my patients come to me in pain looking to regain their former mobility, but are worried about the short- and long-term risks associated with total hip replacements,” explained Dr. Shah. “By utilizing the quantitative measurements that intellijoint HIP provides intraoperatively, I am able to ensure the implants have been positioned accurately resulting in a significant decrease of associated risks. Patients are back to their active lifestyles in just days, confident in their surgical outcomes.”

A total hip replacement is typically an effective surgery that can reduce hip pain and restore mobility. The risks of this procedure can include leg length discrepancy, dislocation, joint instability, reduced muscle strength, reduced hip range of motion, and long-term pain. intellijoint HIP addresses these risks by providing accurate, intraoperative measurements for cup position, leg length, and offset to assist the surgeon in placing implants in a location that best matches the patient’s native anatomy.

“Intellijoint Surgical is proud to present the Innovation Trailblazer Award to Dr. Shah today,” said Armen Bakirtzian, CEO, Intellijoint Surgical. “We want to acknowledge not only his adoption of intellijoint HIP, but his overall commitment to better surgical outcomes through exploring new advances in the field — both in technique and in technology.”

About Dr. Ritesh Shah:

Dr. Shah is a nationally recognized, board-certified, fellowship-trained orthopedic surgeon who specializes in hip and knee replacements in the outpatient setting. His mission is to return patients to their active lifestyle as quickly and as safely as possible. He travels and teaches colleagues worldwide about new advances in same day hip and knee replacement, hip arthroscopy, joint revision surgery, and the Rapid Recovery Reality approach to orthopedic care.

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure accurate positioning of orthopedic implants during Total Hip Arthroplasty. Intellijoint is committed to improving patients’ lives by providing every surgeon with effective, easy-to-use technology.

SOURCE Intellijoint Surgical Inc.

Related Links

https://www.intellijointsurgical.com/


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July 16, 2018 OrthoSpineNews

July 13, 2018

SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo Biologics, Inc., a fully integrated regenerative medicine company, announced today it has entered into a co-marketing agreement with SurGenTec, a privately-owned medical device company based in Boca Raton, FL. The Company will supply ViBone, its proprietary bone repair product, to SurGenTec for marketing and distribution with its patented GraftGun universal graft delivery system.

“As we continue to grow our portfolio of proprietary orthopedic surgery products, innovative partnerships like this allow us to expand the reach of our product marketing and distribution in a very rapid and efficient way,” said Darryl Roberts, Ph.D., Executive Vice President and General Manager, Musculoskeletal Products. “The GraftGun system is an optimal device to deliver ViBone, enabling a next generation viable bone graft to be easily delivered and used in challenging surgeries.”

This co-marketing agreement calls for Aziyo to provide its viable bone matrix product, ViBone, to SurGenTec for use with the GraftGun System. ViBone pre-filled cartridges will be marketed through the SurGenTec distribution network.

Travis Greenhalgh, Founder and CEO of SurGenTec added, “Our Company is focused on creating intuitive solutions to improve the quality of life for patients. ViBone complements our GraftGun system by providing surgeons and patients with a bone matrix product that is as close as possible to the gold standard of autograft. This unique combination offering of ViBone and GraftGun pre-filled cartridges will significantly reduce time in the operating room.”

ViBone was launched in 2017 as a better option for bone repair procedures. The advanced science and proprietary product processing was designed for handling and clinical performance closer to that of autograft. Similarly, SurGenTec’s patented GraftGun system was also launched in 2017 with a focus on improving delivery of intraoperative bone graft materials. Both products have been used in numerous orthopedic procedures and continue to see strong market adoption.

About ViBone

ViBone is a next generation viable bone matrix that was designed to perform and handle more like high quality autograft. The proprietary manufacturing process was designed to optimally protect the tissue environment with less disruption. ViBone is based on science that brings bone grafting closer to meeting the surgeon and patient’s needs and provides a better option for bone repair. To learn more about ViBone, visit www.Aziyo.com/ViBone/.

About GraftGun

GraftGun is part of SurGenTec’s Graft Delivery System (GDS). It is designed to allow for universal, quick and accurate bone graft delivery to a surgical site without the problems of a traditional funnel. Its patented, controlled release method is designed to safely dispense bone graft with enough pressure to easily fill any bone void during bone graft surgery. The GraftGun GDS includes SurGenTec’s loading device technology, which provides surgeons the freedom to choose the bone graft that best suits their needs. To learn more about the GraftGun system, visit www.SurGenTec.com/GraftGun.php.

About Aziyo Biologics, Inc.

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For more information, visit www.Aziyo.com.

About SurGenTec, Inc.

SurGenTec is a privately-owned medical device company based out of Boca Raton, FL that strives to bring the next level of technology to the spine and orthopedic industry. SurGenTec develops and manufactures innovative products with patient and surgeon safety at the heart of everything they do. For more information, visit www.SurGenTec.com.

Contacts

Aziyo Biologics, Inc.
Erica Elchin, 510-730-7896
PR@aziyo.com

(Graphic: Business Wire)


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July 16, 2018 OrthoSpineNews

SAN DIEGOJuly 16, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the launch of Reline MAS Midline (RMM), the next evolution of the Reline system that provides procedural versatility in a compact midline construct.

RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce adjacent segment transition syndrome. The system, when combined with NuVasive access and interbody technologies, is designed to provide a minimally invasive approach to bilateral decompression under complete visualization, interbody fusion and stabilization with pedicle screws. Delivering screw modularity, RMM allows for greater procedural flexibility while enhancing visibility and access. Furthermore, RMM tulip pull-off strength is comparable to preassembled pedicle screws. Enhanced fixation is achieved with NuVasive’s cortical cancellous traction thread form. The system’s 5.0mm cobalt chrome construct is low in profile and boasts fatigue strength comparable to 5.5mm titanium.

“RMM posterior fixation represents the most advanced midline cortical pedicle screw system on the market,” said minimally invasive spine surgeon Dr. Nitin Khanna, Clinical Faculty of Orthopedic Surgery at the Indiana University School of Medicine and partner at Orthopedic Specialists of Northwest Indiana. “The introduction of modular, low-profile tulip heads was designed to address concerns with adjacent segment facet joint impingement. This system furthers NuVasive’s midline portfolio as best-in-class.”

The NuVasive RMM solution utilizes adaptable, streamlined instruments to support both cortical and standard trajectory techniques. The midline approach is further simplified with the integration of access, interbody and fixation, while modular screw assembly is confirmed with visual and tactile feedback.

“Innovation is in our DNA and we are constantly looking for ways to take our existing solutions to the next level,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “RMM, a low-profile midline solution that stands out with its versatility, strength and reliability, exemplifies our commitment to innovation and provides relevant solutions to meet the diverse and evolving needs of our surgeons worldwide.”

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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July 16, 2018 OrthoSpineNews

July 16, 2018

LONDON–(BUSINESS WIRE)–Digital Surgery, a health tech company shaping the future of surgery through the convergence of surgical expertise and technology, today announced it has developed and successfully demonstrated the world’s first real-time, dynamic artificial intelligence (AI) system designed for the operating room (OR). The company is building the data to power the future of surgery through its world-class and proprietary surgical procedure road maps, which aim to aid the surgical team in the OR, reducing risk and making surgery safer. Digital Surgery is the first patented AI platform bringing this scale of knowledge to the surgical community.

“This is a huge milestone for the future of surgery because it lays the foundation for how AI and computer vision will support surgical teams to deliver safer surgeries. It also enables the next generation of robotic surgery, giving these future systems the capability to function more intelligently and safely,” said Dr. Jean Nehme MD, co-founder and CEO of Digital Surgery. “We have already developed AI algorithms for multiple procedures across bariatrics and other surgical specialties like orthopedics, and our library will continue to grow. With AI, we have the unique ability to scale global surgical best practices.”

More than 5 billion people do not have access to safe surgical care, with surgical knowledge being one of the critical factors that hasn’t been able to scale globally. Addressing this problem will require emerging technologies, including AI, particularly given other technological alternatives, like robotics and telemedicine platforms, require expensive equipment or resources that limit their scalability.

Digital Surgery’s AI platform can provide road maps and act as a navigational system for every OR and surgery center, addressing the countless variables that surgical teams face — from staff turnover, language, culture, tools, resources, to the training and skill level of the surgical team. The AI recognizes what is happening during surgery through a camera view, and cross-checks and correlates the anatomy and actions against the largest library of surgical road maps. The OR team can then see in real time the platform analyzing and predicting next steps.

Quotes from leading surgeons

  • “What Digital Surgery has done with this technology feels like a comparison with the advent of laparoscopy, which was a truly disruptive and groundbreaking revolution and paradigm shift in surgery. This resulted in a huge change in approach from maximally invasive to minimally invasive surgery. In the next five years, I expect there to be a transformation from non-AI to AI supported surgery as common practice, benefiting training, patient safety, data collection and outcomes analysis. This is something my OR teams, clinical teams and I would look forward to and will truly impact patient care.” — Dr. Sanjay Purkayastha, Consultant Laparoscopic, Bariatric & Robotic Surgeon, Imperial College Healthcare NHS Trust and Clinical Senior Lecturer at Imperial College London
  • “The impact of a technology leap like this is astounding. Digital Surgery is creating the technologies that will drive the ‘integrated ORs’ and robotic systems of the future.” — Dr. Daniel Buchbinder, Mount Sinai School of Medicine

The team at Digital Surgery is best known for its leading mobile surgical training app, Touch Surgery, which is embedded in more than 160 residency programs and used by more than 2 million surgeons, healthcare professionals and others globally. Touch Surgery has more than 200 surgical simulations across 14 specialties, and it has been validated by 15 peer-reviewed publications for its approach to virtual surgical training.

About Digital Surgery

Digital Surgery, founded by surgeons for surgeons and healthcare professionals, believes safe surgical care should be accessible for all. Co-founders Dr. Jean Nehme and Dr. Andre Chow set out to shape the future of surgery by building a digital ecosystem that sits at the intersection of surgical expertise and technology. Digital Surgery is comprised of two products, Touch Surgery, the award-winning interactive training platform downloaded more than 2 million times, and GoSurgery, an operating room efficiency platform launching later this year. The company is based in London with teams around the world. For more information, please visit: http://www.digitalsurgery.com.

Contacts

For Digital Surgery
Elizabeth Soares
415-583-4433
elizabeth@brewpr.com

(Photo: Business Wire)