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MiMedx Postpones Release of its Fourth Quarter and Fiscal Year 2017 Financial Results

Posted On February 20, 2018 By OrthoSpineNews In Financial /  

MARIETTA, Ga., Feb. 20, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it will postpone the release of its financial results, as well as the filing of its Form 10-K, for the year ended December 31, 2017.

The Audit Committee of MiMedx’s Board of Directors has engaged independent legal and accounting advisors to conduct an internal investigation into current and prior-period matters relating to allegations regarding certain sales and distribution practices at the Company. Company executives are also reviewing, among other items, the accounting treatment of certain distributor contracts.

The Audit Committee is working closely with its advisors to complete this investigation in as timely a manner as possible. The Company will not be in a position to release its financial results until the Audit Committee’s internal investigation is completed.

The Company believes, based on information available to date, that the outcome of such investigation should not have a material impact on revenue guidance for 2018. The Company’s unaudited cash and cash equivalents as of December 31, 2017 were approximately $33 million, after giving effect to the use of approximately $24 million for share repurchases in the fourth quarter of 2017 as part of the Company’s Share Repurchase Program. The Company had no debt outstanding as of December 31, 2017. The Company also does not expect this delay to affect its operational performance and clinical research activities.

“Our Board of Directors and executives believe it is in the best interests of our Company and shareholders for our Audit Committee to address these allegations in an internal investigation with the support of independent legal and accounting advisors. We look forward to releasing our 2017 financial results as soon as this process is complete,” said Parker H. “Pete” Petit, Chairman and CEO. “MiMedx has been experiencing rapid growth over the last few years as our product portfolio continues to meet significant, unmet needs in the marketplace. We are literally saving lives by saving limbs, and we expect to continue to deliver operational and clinical success in the months and years to come.”

About MiMedx

MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements that may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.  Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

 

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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Bone Therapeutics SA completes patient recruitment for Phase IIA Spinal Fusion study with ALLOB®

Posted On February 19, 2018 By OrthoSpineNews In Biologics /  

Gosselies, Belgium, 19 February 2018, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it has completed the recruitment of its Phase IIA lumbar spinal fusion study with its allogeneic bone-cell therapy product, ALLOB®. Given this timing, efficacy and safety data for the full set of 32 patients are expected mid-2019, following a follow-up period of 12 months.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are pleased to announce recruitment of the last patient into our Phase IIA spinal fusion study with ALLOB®, on schedule. Our promising interim results showed bone formation in ALLOB®-treated patients, who also reported significant improvement in pain and day to day functional abilities. We look forward to reporting the full data set in mid-2019 as further positive results would continue to confirm the potential of our allogeneic cell therapy product to provide patients and physicians with improved treatment outcomes.“

The Phase IIA trial in lumbar spinal fusion is designed to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to achieve fusion of the lumbar vertebrae. Endpoints of the study include radiological assessments: the evaluation of fusion and intervertebral mobility; and clinical assessments: the improvement in functional disability and reduction in pain; and safety assessments. Positive interim safety and efficacy results were reported in September 2017.

About Spinal Fusion

Due to ageing populations and sedentary lifestyles, an increasing amount of people are suffering from degenerative spine disorders. Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, – placed into the intervertebral space – for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Over 500,000 lumbar spinal fusions are performed each year in Europe and the US and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-union and failure to relieve pain are still frequent and up to 35% of spinal fusion patients are not completely satisfied with their surgery.

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.

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

Our 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. 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, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.

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.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and 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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Nexxt Spine Marks 250th Implantation of the NEXXT MATRIXX® System Interbody

Posted On February 19, 2018 By OrthoSpineNews In Spine, Top Stories /  

February 19, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced the milestone of the 250th implantation of the NEXXT MATRIXX® System.

Launched in 2017 the NEXXT MATRIXX® System is a collection of 3D printed porous titanium interbodies that leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

“It is exciting to review the images surgeons are submitting showing the level of bone formation 12 weeks post-operative,” stated Nexxt Spine President, Andy Elsbury. Mr. Elsbury continued, “Multiple surgeons are taking so much pride in the results they are achieving.”

One of the first implantations of the NEXXT MATRIXX System® was conducted by Dr. George Picetti, Orthopedic Surgeon with Sutter Medical Group in Sacramento, California. “I am particularly pleased with the bone formation and cage integration I have seen in my twelve-week follow-up appointments with the NEXXT MATRIXX® Interbody System,” remarked Dr. Picetti.

Mr. Elsbury also stated, “Another pleasantly surprising trend since launch is how quickly surgeons progressed from initial cervical usage to the lumbar interbodies. Surgeons have moved to the NEXXT MATRIXX® System being their standard of care now that they have seen the post-operative results.”

Dr. Michael McNamara, Orthopedic Surgeon with the Bone and Joint Institute of Tennessee, was also one of the first surgeons to implant the device. “The surgeries have gone extremely well. The instrumentation is intuitive and allows me to accurately place the implants,” said Dr. McNamara.

The first products to feature the NEXXT MATRIXX® technology are available for both cervical and lumbar indications in an assortment of height, length, width and lordotic angulation combinations to accommodate the unique anatomic and clinical circumstances of each patient. The NEXXT MATRIXX® System will launch additional product lines in 2018.

About Nexxt Spine

Nexxt Spine, LLC is a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions. The company is dedicated to increasing efficiency and patient outcomes through the development of new and innovative products. Nexxt Spine manufactures on the most technologically advanced platforms in order to treat painful and debilitating spinal injuries. Nexxt Spine is located in Noblesville, Indiana where all spinal implants and 95% of surgical instruments are manufactured in a state of the art facility.

Contacts

Nexxt Spine
Sarah Koch
Info@NexxtSpine.com

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Shoulder Arthroplasty Market Global Growth Forecast at 6.12% CAGR to 2022

Posted On February 16, 2018 By OrthoSpineNews In Recon /  

PUNE, India, February 16, 2018 /PRNewswire/ —

ReportsnReports.com adds Global Shoulder Arthroplasty Market 2018-2022 report that says one driver in the market is growing prevalence of arthritis coupled with increasing geriatric population. The geriatric population is prone to degenerative bone diseases like arthritis and osteoporosis. The increasing prevalence of arthritic conditions such as rheumatoid arthritis and the high occurrences of bone fractures among the geriatric population drive the growth of this market. Geriatric population is increasing across the world.

Get complete report on Shoulder Arthroplasty Market spread across 127 pages, analyzing 5 major companies and providing 82 data exhibits now available at http://www.reportsnreports.com/reports/1346596-global-shoulder-arthroplasty-market-2018-2022.html .

The analysts forecast global shoulder arthroplasty market to grow at a CAGR of 6.12% during the period 2018-2022. One trend in the market is growing utilization of robotics in surgeries. Robotics is being increasingly utilized to improve surgical outcomes for patients. The use of robotics in surgeries reduce hospital stays and lowers the rate of complications. It also helps surgeons perform surgical procedures with more precision, accuracy, flexibility, and control when compared with conventional techniques.

Main companies in the global shoulder arthroplasty market: DePuy Synthes, Integra LifeSciences, Smith & Nephew, Wright Medical Group, and Zimmer Biomet. The shoulder joint is a highly mobile joint. It comprises four joints, namely the sternoclavicular joint, scapulothoracic joint, acromioclavicular joint, and glenohumeral joint. Shoulder arthroplasty is a surgical procedure for partial or total replacement of the glenohumeral joint by a prosthetic implant. The surgery is conducted to relieve arthritic shoulder pain and fix severe joint damage due to injury.

Order a copy of Global Shoulder Arthroplasty Market 2018-2022 report at http://www.reportsnreports.com/purchase.aspx?name=1346596 .

Further, the report states that one challenge in the market is high cost of technological development. The high cost of technological development can affect the growth of the global shoulder arthroplasty market. Due to technological advances, the cost of shoulder arthroplasty and associated devices is increasing. This report covers the present scenario and the growth prospects of the global shoulder arthroplasty market for 2018-2022. To calculate the market size, the report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.

Another related report is Global Inferior Vena Cava (IVC) Filters Market 2018-2022, the analysts forecast global inferior vena cava (IVC) filters market to grow at a CAGR of 11.24% during the period 2018-2022. Key players in the global inferior vena cava (IVC) filters market: Argon Medical Devices, B. Braun Melsungen, Boston Scientific, C. R. Bard, and Cook Medical.

According to the inferior vena cava (IVC) filters market report, one driver in the market is increasing incidence of venous thromboembolism (VTE). The incidence of VTE and its related risk factors is increasing globally. VTE is a combination of a PE and DVT. DVT is a medical condition that occurs when a blood clot forms in a deep vein. PE is a medical condition in which a clump of material, usually a blood clot, gets wedged into an artery of the lung. There are more than nine million cases of VTE every year globally. Browse complete Inferior Vena Cava (IVC) Filters Market report at http://www.reportsnreports.com/reports/1346580-global-inferior-vena-cava-ivc-filters-market-2018-2022.html .

Explore other new reports on Medical Devices Market at http://www.reportsnreports.com/market-research/medical-devices/ .

About Us:

ReportsnReports.com is an online market research reports library of 500,000+ in-depth studies of over 5000 micro markets. Not limited to any one industry, ReportsnReports.com offers research studies on agriculture, energy and power, chemicals, environment, medical devices, healthcare, food and beverages, water, advanced materials and much more.

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SOURCE ReportsnReports

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Medicrea Reports Directors’ Dealings Disclosure

Posted On February 16, 2018 By OrthoSpineNews In Spine /  

February 16, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA Group (Euronext Growth: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD ASI™ technology, announces transactions on securities of the Company by its Chairman and Chief Executive Officer.

In accordance with Article 19 of Regulation (EU) No 596/2014 of April 16th, 2014, the Company has declared to the AMF the acquisition of 60,000 shares on February 13th, 2018 by its Chairman and Chief Executive Officer, Denys Sournac.

About Medicrea (www.Medicrea.com)

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 40 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

For further information, please visit: www.medicrea.com

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

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Xtant Medical Announces Compliance with NYSE American

Posted On February 15, 2018 By OrthoSpineNews In Financial /  

BELGRADE, Mont., Feb. 15, 2018 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today reported a positive stockholders’ equity of approximately $47.4M as of February 15, 2018, on an unaudited, pro forma basis, which reflects Xtant’s: (i) conversion of certain 6.00% convertible senior unsecured notes due 2021 (the “Notes”), in the aggregate principal amount of $1.627 million, into a total of 2,275,745 shares of the Company’s common stock, par value $0.000001 per share (“Common Stock”), on January 17, 2018, (ii) exchange of all other outstanding Notes, in the aggregate principal amount of $70.238 million, into a total of 10,401,309 shares of Common Stock on February 14, 2018 (which occurred after the Company’s 1:12 reverse stock split), (iii) private placement of 945,819 shares of Common Stock on February 14, 2018 (which occurred after the Company’s 1:12 reverse stock split), and (iv) results of operations.

Subsequently, Xtant received correspondence from the NYSE American LLC (“NYSE”) dated February 15, 2018 confirming that Xtant has resolved the previously cited stockholders’ equity deficiency and has regained full compliance with the Exchange’s continued listing standards.  The Company will continue to trade on the NYSE American exchange under the symbol “XTNT”.

About Xtant™ Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the consequences of consummating the restructuring; the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE American; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Contact:
CG CAPITAL
877.889.1972
investorrelations@cg.capital
cg.capital

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RTI Surgical® Schedules Fourth Quarter and Full Year 2017 Earnings Call for March 1, 2018

Posted On February 15, 2018 By OrthoSpineNews In Financial /  

February 15, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results from the fourth quarter and full year of 2017 on Thursday, March 1, 2018 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss fourth quarter and full year 2017 results at 9:00 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical, Inc.
MEDIA CONTACT:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
INVESTOR CONTACT:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

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ORTHALIGN ANNOUNCES CLINICAL MILESTONE HAVING PERFORMED 75,000 JOINT ARTHROPLASTY CASES

Posted On February 15, 2018 By OrthoSpineNews In Recon /  

Aliso Viejo, CA, Feb. 15, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a leading provider of orthopedic surgical navigation solutions, is proud to announce a clinical milestone with 75,000 navigation-assisted joint replacement surgeries. OrthAlign’s hand-held sensor-based technologies support a wide array of indications including total knee replacement, partial knee replacement and total hip replacement. The company’s flagship application, KneeAlign® for total knee replacement, provides both tibial and femoral intra-operative navigation in a simple, palm-sized, single-use device.

The KneeAlign application is compatible with all standard implant systems. The UniAlign™ application launched in early 2017 leveraging the clinical success of KneeAlign, and allowing for seamless transitions between partial and total knee replacement interventions. In 2017, the Company also introduced HipAlign® for total hip replacement into limited market evaluation. The HipAlign application provides cup navigation and measures changes in leg length and will be fully commercially available in 2018.

“We are thrilled to pass this significant milestone, building and servicing technologies that have assisted surgeons worldwide in completing more than seventy-five thousand successful arthroplasty surgeries,” said Eric Timko, Chairman and CEO of OrthAlign. “In ORs around the world, OrthAlign has become a trusted and reliable tool that our customers depend on to achieve their desired results.”

“What is remarkable about OrthAlign’s technology is that every post-operative result is consistent, every x-ray looks the same,” noted David Mayman, Co-Director of Computer Assisted Surgery at Hospital for Special Surgery. “I’m impressed by the rate of innovation happening at the company right now. The clinical advantage, along with the economics of the single-use disposable model, makes OrthAlign well poised for continued growth.”

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).

Attachments:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/3bcf00e9-7096-400c-8f72-674ca85a457d

Adam Simone
OrthAlign
asimone@orthalign.com
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TranS1® Announces Three New Patents

Posted On February 15, 2018 By OrthoSpineNews In Spine, Top Stories /  

Denver, Feb. 13, 2018 (GLOBE NEWSWIRE) — TranS1®, a spinal device company focused on breakthrough solutions that minimize tissue trauma, today announced it has added three new patents to its portfolio. The patents relate to two new developments associated with presacral interbody fusion, including two new expandable cages designed to create lordosis at L5-S1, along with a new technique to perform sacroiliac (SI) fusion.

“TranS1’s patent portfolio remains one of the strongest in the industry,” said Jeffrey Schell, chief executive officer of TranS1, who is also a patent attorney. “Our strategy remains to advance the most innovative technologies to lessen tissue trauma during spine surgery and to vigorously guard those technological innovations through domestic and international patent protection.”

TranS1 offers a full complement of minimally invasive surgery (MIS) solutions for spinal pathologies, including the award-winning Pylon™ posterolateral decortication and bone graft placement system, the KeyLIF™ MIS Oblique Lateral Interbody Fusion system and the AxiaLIF® presacral interbody fusion system.The AxiaLIF procedure allows for minimally invasive spinal fusion at L5-S1 for patients with certain spinal pathologies. Presacral interbody fusion at L5-S1 was awarded a Category 1 CPT® Code (22586) in 2013 by the American Medical Association’s CPT Editorial Committee.  According to the CPT Editorial Panel, procedures recognized as Category 1 are widely performed throughout the United States, consistent with accepted medical practice and supported by relevant published research demonstrating the clinical efficacy of the procedure.

In addition to its full suite of MIS procedures and devices, TranS1 has also created and continues to develop a patent portfolio focused on spinal health technologies. The company remains committed to becoming the most innovative in the industry by developing new technologies, applying lessons learned from its development of related approaches, and by attracting the most experienced engineers and surgeons to its team. In all, TranS1 has more than 100 issued patents and has filed more than 50 new patent applications in the last three years.

About TranS1
Headquartered in Denver, TranS1 develops medical breakthroughs to solve spinal pathologies that minimize trauma to the tissues surrounding the spine. The company’s flagship product, AxiaLIF+, is a minimally invasive option for surgeons to accomplish spinal fusion at the L5-S1 joint. The company was named Denver’s Most Innovative Workplace by the 80/95 Awards, presented by the Denver Post. In 2017, the company won the “New Spine Technology” award from Orthopedics This Week for its Pylon™ MIS Posterolateral Decortication and Bone Graft Placement System. For more information, visit www.TranS1.com.

# # #

Doyle Albee
dalbee@mapr.agency
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Episurf Medical in the final stages of development of an ankle implant

Posted On February 15, 2018 By OrthoSpineNews In Extremities /  

FEB 14, 2018

With three Episealer® knee implant products currently approved and on the market in Europe, Episurf Medical (NASDAQ: EPIS B) has initiated the development of a new line of personalised Episealer® implant products intended for osteochondral lesions of the talus bone in the ankle joint. Such lesions are a common and growing problem, along with few alternative treatment methods. Episurf Medical is now responding to a significant demand voiced by its network of surgeon partners. The ambition is to perform the first surgeries during Q2 2018.

The new ankle implant and associated surgical instruments are based on the same technology platform as the company’s Episealer® knee devices, with a patient-specific design based on medical imaging and 3D modelling.

Episurf Medical has previously delivered one custom-made implant solution for a patient in Germany with an ankle joint lesion. The ankle implant was custom-made to the surgeon’s specifications in a difficult case where a custom-made patient-specific implant was the only available solution. The surgeon saw no other reasonable treatment alternative, as there is no such implant on the market today. The surgery was performed in 2016. The surgery was successful and the patient reported excellent results at the 12 months’ clinical follow-up visit.

“An osteochondral ankle defect is a lesion of the talar cartilage and subchondral bone, which commonly causes deep and intractable ankle pain. These lesions are generally caused by a single or multiple traumatic events, often sport injuries. We are convinced that Episurf’s knee technology should adapt well to the ankle, and the 12-months’ data from Germany is very encouraging. The technical synergies, along with the lack of adequate techniques for treatment of this kind of ankle lesions, as well as careful market analysis, led us to the decision to pursue this new initiative. We look forward to providing the same kind of benefits to patients with ankle injuries as we today do to those with lesions in the knee,” comments Prof. Leif Ryd, Senior Medical Advisor to Episurf Medical.

“Adding additional products to our platform is an important part of our long-term strategy and the ankle implant brings a significant long-term revenue potential to Episurf Medical,” comments Pål Ryfors, CEO of Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.55 CET on 14 February 2018.

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Episurf Medical , EpiSurf
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