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Kuros Biosciences Advances its Fibrin-PTH (KUR-113) Spinal Fusion Product Candidate Program

Posted On October 18, 2018 By OrthoSpineNews In Biologics /  

SCHLIEREN (ZURICH), Switzerland, Oct. 18, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences AG (SIX: KURN) announced today that the Company has reached a key milestone in its Fibrin-PTH (KUR-113) spinal fusion product candidate development program with the submission of a 510(k) regulatory package for its enabling lumbar intervertebral body fusion device to the U.S. Food and Drug Administration (FDA).

Kuros Biosciences will include this news in its program update to the North American Association of Spinal Surgeons (NASS) orthobiologics course ‘2018 Biologic Interventions for Spinal Pathologies: Stem Cells, Growth Factors & Novel Therapeutics’ being held in Chicago on Friday October 19.

“The submission of this US FDA 510(k) regulatory package keeps our KUR-113 spinal fusion product candidate development on track. Completion of the lumbar intervertebral body fusion device development is an important corporate milestone as the device will be used in the upcoming clinical trials in combination with Kuros’ spinal fusion product candidate KUR-113,” said Joost de Bruijn, CEO of Kuros.  “Coupled with the invitation to present an update at such a highly focused spine meeting of acknowledged experts in orthobiologics science marks the successful progress of our Company.”

About KUR-113
KUR-113 consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog). KUR-113 is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. KUR-113 will be combined with the interbody spacer device in the upcoming clinical trial for interbody spinal fusion.

About the NASS ‘2018 Biologic Interventions for Spinal Pathologies’ Meeting
The field of spinal biologics is rapidly evolving as patients, researchers, and clinicians are recognizing its potential to treat challenging painful conditions. While the roles of both nonoperative and surgical treatment are relatively well-defined in the spine care treatment landscape, the indications, risks, and concerns regarding biologics for a variety of spinal conditions have not been agreed upon. Because of the differences in regulatory pathways for many of these products, the availability of data is variable making administrative decision-making difficult. This meeting will bring together exciting minds from academia and industry to discuss pertinent technologies and relevant issues in biologics use for spinal conditions.

For further information, please contact:
Kuros Biosciences AG Media & Investors
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors
Tel +41 44 733 47 47 +41 79 598 7149

About Kuros Biosciences AG 
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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Simplify Medical Appoints IP Attorney Veteran to VP, General Counsel

Posted On October 18, 2018 By OrthoSpineNews In Spine /  

SUNNYVALE, Calif., Oct. 18, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced that it has appointed Cindy Lynch to Vice President, General Counsel. Ms. Lynch has nearly 15 years of experience providing strategic legal and intellectual property advice to medical device startups.

Ms. Lynch’s appointment comes at a time when Simplify is expanding commercial efforts in Europe and nearing completion of its two-level U.S. IDE clinical trial for the implantation of its cervical artificial disc. The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018.

David Hovda, Chief Executive Officer of Simplify Medical, commented, “Cindy has led our intellectual property program for years, and we are very excited she has joined our team as General Counsel.  While continuing to lead our IP program, which we believe is the largest and most impactful portfolio in cervical spine motion preservation, she will lead our overall legal strategy and continue to ensure our technology remains fully protected.”

Ms. Lynch specializes in intellectual property law and business venture advising. Prior to consulting for companies including Simplify Medical as in-house Counsel, she worked as the VP of Intellectual Property at Elixir Medical Corporation, Moximed, Inc., SpinalMotion, Inc., Conor Medsystems, Inc., and as a partner at Burns, Doane, Swecker & Mathis, LLP. Lynch will complete her M.B.A. from San Francisco State University in 2018 and earned her J.D. from George Mason University School of Law in 1995.

“I am thrilled to be part of the Simplify Medical team,” Cindy Lynch, J.D., said. “This is an exciting time to be working with Simplify as we near completion of the two-level Simplify Disc IDE trial enrollment and work toward the highly-anticipated commercial launch of the Simplify Disc, which will provide patients an innovative option for cervical disc replacement. As we continue to expand our commercial efforts, the protection of Simplify’s legal and IP interests is critical, and I look forward to working closely with the management team in these efforts.”

About Simplify Disc
Simplify® Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

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TransEnterix CEO, Todd Pope Named One of TIME Magazine’s 50 Most Influential People in Health Care 2018

Posted On October 18, 2018 By OrthoSpineNews In Robotics, Top Stories /  

October 18, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, congratulates its President and Chief Executive Officer, Todd M. Pope, for being named to TIME Magazine’s 50 Most Influential People in Health Care for 2018. In this inaugural list, Pope is highlighted for his role as one of those leaders whose work right now is transforming health care.

“Being named one of TIME Magazine’s 50 Most Influential People in Health Care for 2018 is a tremendous honor,” said Todd M. Pope, TransEnterix president and CEO. “It’s humbling to be recognized alongside other talented, boundary-pushing individuals across the spectrum of health care. This recognition reflects the efforts of our global team at TransEnterix who work every day to deliver innovative solutions that help surgeons achieve better outcomes for their patients.”

As Chief Executive Officer, Mr. Pope sets the company’s strategic vision and oversees its continuing growth. Mr. Pope has spent more than 25 years working in key leadership positions within the medical-device industry. Prior to joining TransEnterix, Mr. Pope served as worldwide president of Cordis, a multi-billion-dollar division within Johnson & Johnson’s medical-device sector. He previously held a number of senior leadership positions within Johnson & Johnson and Boston Scientific.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance Surgical System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the delivery of TransEnterix’s innovative solutions help surgeons achieve better outcomes for their patients. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investor Contact:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Contact:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

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Amplitude Surgical – 2017-18 Annual Results: Sales of over €100 Million, up +8% Like-for-Like, and Solid EBITDA Growth of +17%

Posted On October 18, 2018 By OrthoSpineNews In Financial /  

October 17, 2018

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

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces its 2017-18 annual results.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Our strong growth, with annual sales exceeding €100 million, and the improvement in our profitability demonstrate the relevance and quality of execution of Amplitude Surgical’s strategy. The strengthening of our structures, following substantial industrial and commercial investments, supports our ambition of doubling our sales in 5 years thanks to, in particular, our ongoing development on the American market and the enrichment of our portfolio of innovative products”.

Over the 2017-18 financial year to June 30, 2018, Amplitude Surgical continued to implement its strategy targeting high-potential countries, particularly the United States, and recorded further significant growth in activity. Sales exceeded €100 million, up +7.5% in actual terms and +8.2% like-for-like (constant currency and scope). Despite the negative currency effect and the increase in the workforce, the Group’s EBITDA grew by +17% to €18.1 million, giving a +140 bp improvement in the margin to 18%.

Key events:

  • During the past year, Amplitude Surgical:
    • in France, continued the strengthening of its sales force and intensified its market coverage with the integration of several independent sales agents, in eastern France and the Paris area;
    • strengthened its industrial integration with the acquisition of the remaining 50% stake in the Sofab Orthopédie group, which specializes in high-precision manufacturing for implants;
    • completed work on a state-of-the-art ISO 5 clean room, on its Valence site, that has been operational since June 2018.
  • Since the end of the financial year, the Group:
    • in early September, recorded the first arthroplasty performed with an ANATOMIC® knee prosthesis in the United States, the world’s largest market, at a hospital in Champaign, Illinois. Since then, the growth of the US market has started with new client surgeons and new distributors choosing Amplitude Surgical;
    • further strengthened its presence on the French market with the creation of its Amplitude Sud subsidiary;
    • and strengthened its organization with the appointment of Mrs. Muriel Benedetto Marmilloud to the newly-created position of Chief Operations Officer (COO). Reporting directly to the Chairman and CEO, she will be responsible for steering the R&D, Supply chain and Quality assurance & Regulatory affairs departments, in order to ensure total control over the entire logistics value chain and to continue the structuring of operations in order to accompany Amplitude Surgical international development while complying with future regulatory changes.

Financial summary (actual currency):
€ thousands – IFRS 2017-18

2016-17

 Δ
Sales 100,336 93,356 +7.5%
Gross margin 75,743 70,519 +7.4%
as a % of sales 75.5% 75.6% –
Sales & Marketing costs 39,933 38,626 +3.4%
General & Administrative costs 10,958 9,321 +17.6
Research & Development costs 6,784 7,072 -4.1%
EBITDA 18,068 15,500 +16.6%
as a % of sales 18.0% 16.6%
Core operating profit 2,264 17
Net non-core operating expenses -2,503 -1,063
Operating profit/loss -239 -1,046
Financial profit/loss -8,129 -8,510
Attributable net profit/loss -9,446 -12,052
Net financial debt 93,697 80,043
Net cash position 29,338 41,610

EBITDA of €18.1 million and +140 bp improvement in the margin to 18%, despite the negative currency effect

During the 2017-18 financial year, Amplitude Surgical continued to record solid growth in activity with sales totaling €100.3 million, up +7.5% in actual terms and +8.2% like-for-like (constant currency and scope).

This performance was the result of a sustained commercial momentum both on the French market, +9.4% to €63.6 million, where the Group is continuing to significantly outperform the market, and at international subsidiary level, +12.5% at constant currency to €26.6 million. Sales of Novastep products – innovative solutions for lower-limb (foot and ankle) surgery – have really begun to take off, and totaled €6.6 million over the year with growth of +50% overseas, notably on the American market.

The gross margin was 75.5%, a similar level to that recorded in 2016-17, with the benefits of the industrial integration, following the acquisition of Sofab, offseted by the negative currency effect, notably vis-à-vis the Brazilian real and the Australian and US dollars.

During the year, the Group continued its investments, notably human investments, to conquer and develop its target markets. Thus, at June 30, 2018, Amplitude Surgical had a workforce of 428 staff, compared with 368 at end-June 2017; a third of this increase is related to staff at companies acquired by the Group over the period. Personnel costs thus increased by +14% to €26.6 million. Simultaneously, for R&D, Amplitude Surgical stabilized the budget at €6.8 million and teams at 64 staff.

Given the stabilization of overheads, Group EBITDA was up +16.6% at €18.1 million, giving a +140 bp increase in the EBITDA margin to 18%. The weakening of the main currencies affected EBITDA to the tune of €0.4 million. Restated for the costs associated with the launch of the Japanese and US subsidiaries, EBITDA would be €19.9 million, a +21.3% improvement, i.e. 19.8% of sales.

The annual Core Operating Profit was €2.2 million, compared with a figure close to zero in 2016-17, despite non-recurring elements. There was a slight Operating Loss of €0.2 million, versus a loss of €1.0 million in 2016-17, following the writing down of a further €2.6 million provision of to cover the entire risk associated with its dispute with URSSAF (social security contribution collection authority) regarding tax on medical devices.

There was a financial loss of €8.1 million. Beyond a €6.5 million cost of debt, this figure also reflects net currency impacts of €2.8 million, due to the strengthening of the euro versus the US and Australian dollars and Brazilian real, and financial income of €1.2 million associated with the completion of the Sofab group’s acquisition at a lower price than anticipated.

The tax burden was essentially the result of tax on overseas subsidiaries.

The attributable net loss was €9.4 million, versus a loss of €12.1 million in 2016-17.

Operating cash flow surplus of €4.9 million – Net cash position of €29.3 million at end-June 2018

Net cash flow generated by operating activity doubled over the year, to €4.9 million, thanks to a good EBITDA level and fine control over working capital requirements, almost stable despite the growth in activity. Half of the €4.5 million increase in instrument and implant inventories was attributable to the launch of the American subsidiary’s commercial activity.

Investments totaled €13.8 million, down on the previous year’s figure of €32.3 million, notably attributable to the acquisition of agents in France for €5.4 million and the completion of the clean room on the Valence site for €2.0 million. Furthermore, the Group paid out €2.4 million to settle two disputes, entirely provisioned.

Thus, at the end of June 2018, the Group had a solid financial structure with Cash and Cash Equivalents of €29.6 million. The Group’s Net Financial Debt was €93.7 million, giving gearing (Net Financial Debt over Shareholders’ Equity) of 0.99, versus 0.77 at end-June 2017.

Next financial press release: Q1 2018-19 sales, on Thursday November 22, 2018, after market.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2018, Amplitude Surgical had a workforce of 428 employees and recorded sales of over 100 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
finances@amplitude-surgical.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

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SI-BONE Announces Pricing of Initial Public Offering

Posted On October 17, 2018 By OrthoSpineNews In Financial /  

SANTA CLARA, Calif., Oct. 16, 2018 /PRNewswire/ — SI-BONE, Inc. (Nasdaq: SIBN) (“SI-BONE”), a medical device company that pioneered the minimally invasive surgical treatment of the sacroiliac joint with the iFuse Implant System®, today announced the pricing of its initial public offering of 7,200,000 shares of common stock at a price to the public of $15.00 per share. In addition, SI-BONE has granted the underwriters a 30-day option to purchase up to an additional 1,080,000 shares of common stock, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Market under the ticker symbol “SIBN” on October 17, 2018.

Morgan Stanley and BofA Merrill Lynch are acting as joint book-running managers. Canaccord Genuity LLC and JMP Securities LLC are acting as co-managers.

The offering is being made only by means of a prospectus.  When available, a copy of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC  28255-0001, Attn: Prospectus Department, or email at dg.prospectus_requests@baml.com.

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

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Two new studies demonstrate INTERTAN™ Intertrochanteric Antegrade Nail improves patient outcomes and lowers healthcare costs when treating hip fractures

Posted On October 17, 2018 By OrthoSpineNews In Recon /  

LONDON, Oct. 17, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN,NYSE: SNN), the global medical technology business, today announced at the Orthopaedic Trauma Association Annual Meeting in Orlando, FL USA two new studies showing positive clinical results and cost savings through using its INTERTAN Intertrochanteric Antegrade Nail.

Patients recovering from a hip fracture often deal with various complications, including decline in mobility and daily living activities, and reduced ability to walk following fracture union. More than 6% will require reoperation due to complications and approximately 1 in 4 patients over the age of 65 die within 12 months of fracture.1,2,3

In a meta-analysis published in Rheumatology and Orthopedic Medicine, the INTERTAN implant, which uses the Smith & Nephew proprietary “Integrated Compression Screw”, was compared to other intertrochanteric nails using a customary “single screw”. The results showed that INTERTAN significantly reduced the risk of implant related failures by 81% (p<0.00001) and revision surgery by 65% (p<0.0001) when compared to single screw nails.4

According to a further study, published in Journal of Orthopaedic Surgery and Research, the improved clinical outcomes from the meta-analysis also led to a cost savings of $2700 USD per patient when using the INTERTAN nail compared to single screw nails.5

“Hip fractures and their sequelae in elderly patients can be debilitating, and potentially life threatening, and contribute a significant portion to overall health care expenditure. These new studies demonstrate that the Integrated Compression Screw used in the INTERTAN nail not only improved the clinical outcomes for these patients studied, but also reduced the cost to the overall health economic system by reducing the revision rates, compared to those that have been demonstrated in prior studies,” commented J. Tracy Watson MD, Orthopaedic Traumatologist,  Phoenix, Arizona and co-author for both papers.

“Smith & Nephew is dedicated to developing products that will improve patient lives. The INTERTAN nail is a prime example of the type of game-changing technology we at Smith & Nephew strive to create. These two publications show how true innovation can both make clinical improvement and provide economic benefits,” said Andy Weymann MD, Chief Medical Officer, Smith & Nephew.

For more information on the INTERTAN nail, please visit us at the Orthopaedic Trauma Association Annual Meeting, Booth #805 or online at hipfx.com.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN,NYSE: SNN).

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

Forward-looking Statements

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

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

References:

1. American Academy of Orthopaedic Surgeons. Hip fractures in seniors: a call for health system reform. Position Statement 1144. Rosemont, IL: 1999.

2. Mundi S et al. Similar mortality rates in hip fracture patients over the past 31 years: A systematic review of RCTs. Acta Orthopaedica 2014; 85(1): 54-59.

3. Bentler SE, Liu L, Obrizan M, Cook EA, Wright KB, Geweke JF, et al. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am. J Epidemiol. 2009 Nov 15;170(10):1290-9. doi: 10.1093/aje/kwp266.

4. Nherera LM, Trueman P, Horner A, Johnstone AJ, Watson JT. A meta-analysis of integrated compression screw compared to single screw nails using a single lag screw or single helical blade screw for intertrochanteric hip fractures. Rheumatol Orthop Med 2018; 3(4): 1-10. doi: 10.15761/ROM.1000156

5. Nherera LM, Trueman P, Horner A, Johnston AJ, Watson JT, Fatoye FA. Comparing the costs and outcomes of an integrated twin compression screw (ITCS) nail with standard of care using a single lag screw or a single helical blade cephalomedullary nail in patients with intertrochanteric hip fractures. Journal of Orthopedic Surgery and Research (2018) 13:217. doi: 10.1186/s12018-018-0923-x

SOURCE Smith & Nephew

(PRNewsfoto/Smith & Nephew)

Related Links

http://www.smith-nephew.com

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Pedicle Screw System Market – Global Forecast to 2023: Rising Geriatric Population, Technological Advancements & Growing Preference for Minimally Invasive Surgeries

Posted On October 17, 2018 By OrthoSpineNews In Financial /  

DUBLIN, Oct. 17, 2018 /PRNewswire/ —

The “Pedicle Screw System Market by Product Type (Monoaxial & Polyaxial Pedicle Screw), Surgery (Open, Minimal Invasive), Indication (Spinal Deformities, Spinal Trauma), Application (Thoracolumbar, Cervical Fusion) – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.

The global pedicle screw systems market is expected to reach USD 724.23 million by 2023 from USD 538.64 million in 2018, at a CAGR of 6.1%.

The major factors driving the growth of this market are the increasing incidence of spinal cord injuries, the growing preference for minimally invasive surgeries, and a rising geriatric population.

By product type, the pedicle screw systems market is segmented into monoaxial, polyaxial, and other pedicle screw systems. In 2018, the polyaxial pedicle screw systems segment is estimated to command the largest share of the pedicle screw systems market. The large share of this segment can be attributed to the increasing incidences and prevalence of spinal cord injuries.

On the basis of surgery type, the pedicle screw systems market has been segmented into open surgery and minimally invasive surgery. The open surgery segment is expected to account for the largest share of the pedicle screw systems market in 2018. The large share of this segment can be attributed to the rising geriatric population and increasing incidence of spinal deformities.

Based on indication, the pedicle screw systems market has been segmented into spinal degeneration, spinal trauma, spine deformities, and other indications. In 2018, the spinal degeneration segment is projected to account for the largest share of the pedicle screw systems market. The increasing incidence of degenerative spinal disorders is the major driving factor for this market.

By application, the market is categorized into thoracolumbar fusion and cervical fusion. In 2018, thoracolumbar fusion is expected to command the largest share of this market. The increasing incidences of lumbar degenerative disc diseases and the launch of new products are key factors driving the growth of the thoracolumbar fusion segment.

The market is dominated by North America, followed by Europe. North America will continue to dominate the market during the forecast period. The rising geriatric population and increasing incidence of spinal disorders in this region are the major factors supporting the growth of the pedicle screw systems market in North America.

Stringent regulatory frameworks and time-consuming product approval processes may hinder the growth of the pedicle screw systems market to a certain extent.

The major players in the pedicle screw systems market include Globus Medical (US), DePuy Synthes (US), Zimmer Biomet (US), B. Braun (US), Stryker (US), and Medtronic (Ireland).

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Pedicle Screw Systems Market Overview
4.2 Asia Pacific: Pedicle Screw Systems Market, By Product Type (2018)
4.3 Pedicle Screw Systems Market, By Region (2018)
4.4 Geographical Snapshot of the Pedicle Screw Systems Market

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Increasing Incidence of Spinal Injuries
5.2.1.2 Rising Geriatric Population
5.2.1.3 Technological Advancements
5.2.1.4 Growing Preference for Minimally Invasive Surgeries
5.2.2 Opportunities
5.2.2.1 Emerging Economies Present Significant Growth Opportunities
5.2.3 Challenges
5.2.3.1 Stringent Regulatory Framework and Time-Consuming Approval Process
5.2.3.2 Product Failures and Recalls

6 Pedicle Screw Systems Market, By Product Type
6.1 Introduction
6.2 Polyaxial Pedicle Screw Systems
6.3 Monoaxial Pedicle Screw Systems
6.4 Other Pedicle Screw Systems

7 Pedicle Screw Systems Market, By Surgery Type
7.1 Introduction
7.2 Open Surgery
7.3 Minimally Invasive Surgery

8 Pedicle Screw Systems Market, By Indication
8.1 Introduction
8.2 Spinal Degeneration
8.3 Spinal Trauma
8.4 Spinal Deformities
8.5 Other Indications

9 Pedicle Screw Systems Market, By Application
9.1 Introduction
9.1.1 Thoracolumbar Fusion
9.1.2 Cervical Fusion

10 Pedicle Screw System Market, By Region
10.1 Introduction
10.2 North America
10.2.1 US
10.2.2 Canada
10.3 Europe
10.4 Asia Pacific
10.4.1 China
10.4.2 India
10.4.3 Japan
10.4.4 Rest of Asia Pacific
10.5 Rest of the World

11 Competitive Landscape
11.1 Overview
11.2 Market Ranking Analysis, 2017
11.3 Competitive Scenario
11.3.1 Product Launches and Approvals
11.3.2 Acquisitions
11.3.3 Expansions

12 Company Profiles

  • Alphatec Spine, Inc. (A Subsidiary of Alphatec Holdings, Inc.)
  • B. Braun Melsungen AG
  • Depuy Synthes (A Subsidiary of Johnson & Johnson)
  • Globus Medical, Inc.
  • KM Group Holdings, Inc.
  • Medtronic PLC
  • Orthofix International N.V.
  • RTI Surgical, Inc.
  • Stryker Corporation
  • Zimmer Biomet Holdings, Inc.

For more information about this report visit https://www.researchandmarkets.com/research/krbcqv/pedicle_screw?w=5

Did you know that we also offer Custom Research? Visit our Custom Research page to learn more and schedule a meeting with our Custom Research Manager.

Media Contact:

Research and Markets 
Laura Wood, Senior Manager 
press@researchandmarkets.com 

For E.S.T Office Hours Call +1-917-300-0470 
For U.S./CAN Toll Free Call +1-800-526-8630 
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Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

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Bone Therapeutics announces single intra-articular injection of viscosupplement JTA-004 delivered higher pain reduction than the reference in first study in knee osteoarthritis

Posted On October 17, 2018 By OrthoSpineNews In Biologics /  

Gosselies, Belgium, 17 October 2018, 6 pm CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces results of the first efficacy study of the Company’s enhanced viscosupplement, JTA-004, in patients with moderate symptomatic knee osteoarthritis, supporting future clinical development of the product.

JTA-004 is a patented, non-cellular viscosupplement product for the treatment of knee osteoarthritis (KOA), which Bone Therapeutics has been developing in parallel with its core cell therapy pipeline and addressing its mission of bringing innovative solutions to orthopaedic conditions.

The Company believes the favourable safety and efficacy profile of JTA-004 observed in this first efficacy study supports the move to registration studies and will begin dialogue with the regulatory authorities to determine next steps.

About the trial

The trial was a prospective, multicentre, randomised, double-blind, controlled study including three JTA-004 strengths and one reference product, hylan G-F 20, the global market leader in viscosupplements(1). The main objective of the study was to demonstrate the superiority of a single intra-articular JTA-004 injection to the reference product.

164 patients were randomly assigned to the reference group or one of the three JTA-004 groups. The primary endpoint of the study was the mean change in WOMAC® VA 3.1 pain subscale score (ranging between 0 and 100 mm) between baseline and 6 months after treatment.

Trial results

The single intra-articular injection of JTA-004 was generally well tolerated. At six months, patients in the three JTA-004 groups showed an improvement in pain vs. baseline ranging from 23.6 mm to 25.9 mm, while patients in the reference group only showed a 14.3 mm improvement. Due to high variability in primary endpoint at six months, statistically significant differences between the individual JTA-004 groups and the reference group were not achieved.

Analysis of the results revealed that the three JTA-004 strengths had a similar efficacy. Therefore, a post hoc exploratory analysis was subsequently performed between the reference group and all pooled JTA-004 treated patients. The exploratory analysis showed a 26.1 mm improvement for the pooled JTA-004 group vs. 15.6 mm(2) for the reference group at month 6, demonstrating a statistically significant superiority of the pooled JTA-004 group compared to the leading viscosupplement on the market.

Professor Jean-Francois Kaux, Head of the department of Physical and Rehabilitation Medicine at University Hospital CHU, Liège, Belgium, commented: “Globally, millions of patients are suffering from knee osteoarthritis which is a leading cause of chronic pain and disability. The management of this condition represents a continuing challenge for clinicians and patients, who are seeking stronger and longer-lasting pain relief alternatives for this painful disease. The strong safety and efficacy profile demonstrated by JTA-004 in this clinical study, in comparison with the most scientifically validated reference product, suggests potential for it to become one of the preferred treatments for patients suffering from knee osteoarthritis. I look forward to the future development of this unique product.”

Osteoarthritis is a progressive disease of the joints and is the most prevalent joint disorder globally. It is characterized by joint pain, tenderness, limitation of movement and stiffness. Knee osteoarthritis, the most common form, affects approximately 250 million people worldwide(3). The prevalence of KOA is expected to increase at a rate of 8% per year in the coming years due to increasingly aging and obese population. The worldwide sales of viscosupplements, one of the commonly used treatments for KOA, had an estimated value of $2.1B in 2016(1).

Viscosupplements are injectable solutions containing hyaluronic acid (HA), a main component of knee joint’s synovial fluid and aim to provide added lubrication and protection to the cartilage of the arthritic joint. JTA-004, which consists of hyaluronic acid, an analgesic and anti-inflammatory agent and an enriched protein solution, showed distinct advantages in preclinical studies over other viscosupplements due to its anti-inflammatory and lubrication properties.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, added: “We’re delighted with the data from this first trial of JTA-004 in patients with moderate symptomatic knee osteoarthritis, which shows the potential of this enhanced viscosupplement. Based on the favourable efficacy and safety profile observed in this trial, JTA-004 can offer advantages over currently available viscosupplements on the market and we plan to continue the development of this promising product. JTA-004 is a promising addition to our existing pipeline of bone cell therapy clinical programmes, and highly complementary to our broader goal of bringing to market innovative, best-in-class solutions to orthopaedic conditions and bone diseases.”

Continued clinical and manufacturing progress

The positive JTA-004 data complement recent positive clinical and manufacturing developments at Bone Therapeutics which support the continued progress of its pipeline and the increased focus on preparing for commercialisation. Notable recent progress includes:

·In September, Bone Therapeutics announced a positive final readout in the Phase I/IIA delayed-union study of allogeneic bone cell therapy product, ALLOB, adding to a growing body of clinical efficacy and safety data.

·Also in September, the Company presented preclinical in vitro and in vivo results at the 26th Annual Meeting of the European Orthopaedic Research Society (EORS) in which the scientific community acknowledged the potent bone-forming properties of its allogeneic platform.

·Bone Therapeutics also recently announced an optimized production process for ALLOB which allows the Company to achieve a consistent, easy to scale up and economical (around 100,000 doses per donor) manufacturing process and to offer an easy to use, cryopreserved product, all critical parameters required for future commercialisation. The Company plans to implement this optimized process for all future clinical development programmes. Bone Therapeutics received positive feedback on the quality control programme and non-clinical strategy for ALLOB from a Regulatory Agency for the optimization of the manufacturing process.

·The Company’s focus over the next few years is on progressing the clinical development of ALLOB in delayed union fractures and lumbar spinal fusion, subsequently leading to Phase III clinical trials in EU and USA.

·In addition, Bone Therapeutics expects to present the conclusions of the interim analysis after a one-year follow-up of the Phase III study of PREOB, its autologous cell therapy product, in osteonecrosis of the hip in Q4 2018.

(1) Viscosupplementation: Global Analysis and Market Forecasts, April 2017, Global Data
(2) The difference in the mean improvement of the reference group at Month 6 between the two analyses was a consequence of the statistical adjustments for both sample size and sample variation.
(3) Vos et al., A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163-96

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. In addition, the Company also has an autologous bone cell therapy product, PREOB, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip, and JTA-004, a viscosupplement in development for the treatment of knee osteoarthritis.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About WOMAC® Index

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium Median Enquiries
Comfi
Laure-Eve Monfort and Sabine Leclercq
Tel: +32 (0)2 290 90 93, +32 (0)2 290 90 91
monfort@comfi.be, sabine.leclercq@comfi.be

International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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SPINEWAY : Marketing of new Mont-Blanc Evo product line authorized in the United States

Posted On October 17, 2018 By OrthoSpineNews In Spine /  

Ecully, October 17 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), completed all the regulatory steps and can market its Mont-Blanc Evo product line (presented at the Eurospine conference) in the United States.

This development of the flagship Mont-Blanc line that is already distributed on territory provides surgeons with an implant that can be screwed twice as fast, and with more efficient insertion tools. There will be a standard version (non-sterile) and a “ready-to-use” sterile version, a differenciating feature which is to become popular with US surgeons.

Spineway has already begun production of these new implants and instruments, and should be able to record its first US sales during the first quarter of 2019. In addition, the EC label should be granted in 2019 for distribution throughout Europe and the rest of the world.

Spineway has thus taken its first step toward reconquering the US market and will be accelerating the reorganization of its US subsidiary as per its strategic plan.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication: Half-year results for 2018 – 24 October 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW      

Contacts :

Spineway

Investor relations
David Siegrist – CFO
finance.dsg@spineway.com		   Aelium

Financial communication
Jérôme Gacoin / Solène Kennis
skennis@aelium.fr

Attachment

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OrthAlign, Inc. Announces First KneeAlign® Cases Using the All New Rotation and Soft Tissue Balancing System

Posted On October 17, 2018 By OrthoSpineNews In Recon /  

Aliso Viejo, CA, Oct. 17, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced the first cases of the KneeAlign® CFS™ system. The CFS system is an accessory that can be used during KneeAlign-assisted total knee arthroplasty (TKA) surgeries, that provides for rotation and soft tissue balancing. The cases were completed by David Mayman, M.D. at Hospital for Special Surgery in New York, NY.

OrthAlign technology provides real-time, actionable data for precise alignment and positioning of implant components. With surgical applications for Total Knee (KneeAlign®), Partial Knee (UniAlign™) and Total Hip arthroplasties (HipAlign®), OrthAlign deploys a platform of solutions directly into the surgeons’ hands via a hand-held device not much bigger than a cellphone. Now, with these new capabilities, the KneeAlign application applies the same levels of accuracy and simplicity to guiding rotation of the femoral component as well as balancing soft tissue in both the extension and flexion gaps during TKA.

“With the addition of rotation and soft tissue balancing, KneeAlign provides me with all of the information I need to achieve an aligned and balanced knee,” said David Mayman, M.D. “This now puts the capabilities of KneeAlign equal to any robotics or navigation system on the market, while at the same time being much faster, simpler, and easier to use.”

“KneeAlign has already powered more than 75,000 cases around the world, providing surgeons with the type of information that delivers confidence to their results on a daily basis,” said Eric Timko, OrthAlign’s CEO and Chairman. “After a diligent research and development process, we’re now bringing that same confidence to rotation and balance during a total knee procedure, which positions KneeAlign among the most complete navigation and robotics solutions available as we power the next 100,000 cases in the coming years.”

OrthAlign will be showcasing its full portfolio of products at this year’s AAHKS meeting in Dallas, TX, November 2-4, 2018 at booth #715.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (asimone@orthalign.com).

“ORTHALIGN®, KNEEALIGN®, HIPALIGN® and UNIALIGN™ are [registered] trademarks of OrthAlign, Inc.”

Adam Simone
OrthAlign
asimone@orthalign.com
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