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Current Issues in Spine

February 2-4, 2017

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November 29, 2016 OrthoSpineNews

November 29, 2016

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced that Mr. Yuval Yanai, a medical device industry veteran, has been elected to the Company’s Board of Directors, effective immediately.

Mr. Yanai is a senior executive, who brings over 30 years of experience to Mazor. Currently Mr. Yanai serves as a Director in two publicly-traded companies listed on NASDAQ Global Market, Macrocure Ltd. and Check-Cap Ltd. Mr. Yanai also serves as a Director in two publicly traded companies listed on the Tel Aviv Stock Exchange, Medical Compression Systems (D.B.N) Ltd. and Clal Biotechnology Industries Ltd. In addition, Mr. Yanai serves as a Director of Haddasah Medical Center, Standard & Poors Maalot, Compulab Ltd. and Efranat Ltd. Mr. Yanai also acts as the Chairman of Endobetix Ltd. and the Israeli Fund for UNICEF. From 2005 through 2014, Mr. Yanai held the positions of Senior Vice President and Chief Financial Officer of Given Imaging Ltd., a developer and manufacturer of diagnostic products for the visualization and detection of disorders of the gastrointestinal tract. Given Imaging Ltd. was sold to Covidien Ltd. for $1 billion in 2014. Mr. Yanai holds a B.Sc. degree in Accounting and Economics from Tel-Aviv University.

“I am pleased to welcome Yuval to Mazor’s Board of Directors. His experience with industry and publicly-traded companies enhances our Board of Directors as we seek to further leverage two key recent accomplishments – the strategic agreements signed in May with Medtronic and the successful October launch of the Mazor X system,” commented Jonathan Adereth, Chairman of Mazor’s Board of Directors.

“Mazor’s performance and commitment to innovation have contributed to its position as the market leader in guidance systems for spine surgeries. I am looking forward to working with the Board and being part of Mazor’s continued success,” commented Mr. Yanai.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in a precise manner. For more information, please visit http://www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. For example, we use forward-looking statements when we discuss our plan to further leverage our two key accomplishments – the Medtronic agreement and the overwhelmingly positive response to the Mazor X launch, and when we discuss our mission to continue to transform and redefine the standard of care for spine surgeries. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

U.S. Contacts:
EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com


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November 29, 2016 OrthoSpineNews

November 28, 2016

HD Surgical, a custom surgical instrument & implant manufacturer for the Orthopaedic industry, has recently acquired certain assets of PAK Manufacturing, Inc. This new acquisition positions HD Surgical as one of the largest manufacturers of both forged and machined instrumentation in the USA.

HD Surgical offers custom‐manufactured instruments, full service instrument repairs and refurbishing to OEM standards, as well as implant manufacturing capabilities. HD Surgical, a division of Harwood Design, was founded in 1990 and is an ISO 13485 Certified and FDA Registered company.

The transaction supports HD Surgical’s strategy to continue as a North American instrumentation supplier offering design engineering and regulatory guidance submission strategies. Plans are underway to expand the company’s overall capacity, with a new building slated to begin construction in 2017.

 

For further information, please contact:

Richard J. Stephens, Vice President Sales & Marketing

Office: 215‐826‐8250 / Fax: 215‐826‐8253

Custom Instruments & Implants

HD Surgical (A Division of Harwood Design Inc.)

1507 Clyde Waite Drive, Bristol PA 19007

www.hdsurgical.com

 

 


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November 29, 2016 OrthoSpineNews

Magal, Israel, November 27, 2016 – MinInvasive Ltd., developer of the OmniCuff™ device for the treatment of rotator cuff repair, announced today the completion of a financing transaction and a strategic partnership with MicroPort Scientific Corporation (HKSE:0853). MicroPort is leading a financing round in MinInvasive and will be granted an exclusive right to distribute OmniCuff™ in the China market.

The field of shoulder rotator cuff repair is a fast growing market segment within the sports medicine market, with over one million procedures performed worldwide annually and an annual growth rate of 7%. The OmniCuff™ System enables arthroscopic rotator cuff repair, which obviates the need for suture anchors, provides the clinical advantages of minimally invasive transosseous repair and reduces overall procedure costs.

MinInvasive’s CEO, Ronen Raz, stated, “The partnership with MicroPort, a leading medical device company and a strategic global player, is a significant milestone for the company and we look forward to expanding our activity into the Chinese market with MicroPort.”

MinInvasive Ltd.

MinInvasive, founded in 2011 in the ATI incubator, is a privately held medical device company, with key investors Anatomy Medical Technology Fund, Access Medical Ventures and several private investors from Israel and the U.S. The company has developed the OmniCuff™ System – a disposable device enabling arthroscopic, transosseous rotator cuff repair that obviates the need for suture anchors. The company recently completed a successful post-market multi-center clinical study in leading medical centers in the U.S., with excellent clinical results and high patient and surgeon satisfaction. The company plans to initiate commercialization of the OmniCuff™ System with a partner in the U.S. in 2017.

MicroPort Scientific Corporation

MicroPort Scientific Corporation (the “MicroPort Group”) is a leading medical device company with business focusing on innovating, manufacturing and marketing high- ERM/1006776v1 quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, the MicroPort Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiology, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management and others. The MicroPort Group is dedicated to becoming a patient oriented global enterprise improving and reshaping patient lives through the application of innovative science and technology.

 

Contact: Ronen Raz, CEO MinInvasive Ltd. 137 Hashachaf, Magal, Israel info@mininvasive.com +972-4-6287455

 


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November 29, 2016 OrthoSpineNews

Joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally invasive spinal surgery, again exhibited at Chinese OrthopedicAssociation (COA), which took place Nov. 17th to 20th, 2016 at China National Convention Center in Beijing, China. During the exhibition, the new NASS – joimax® MISS Training Centre was inaugurated.

The 18th Chinese Orthopedic Association Annual Meeting and the 11th International Congress of Chinese Orthopedic Association (COA) this year has again taken place in Beijing and was visited by more than 35,000 surgeons who gathered for the latest research results and up-to-date information on technology and clinical progression in orthopedics including spine surgery. joimax® had a major presence with a large booth showing its endoscopic minimally invasive product range. Furthermore on the two major meeting days, 30 lectures from well-known experts were given at its booth.

During the COA, the new NASS-joimax® MISS Training Centre in China was inaugurated on Friday Nov. 18th, 2016. The ceremony took place at the joimax® booth together with leaders from the Peking University Third Hospital and members of the NASS Board of Directors. The Chinese market is a very important one for joimax® because Chinese surgeons are highly interested in adopting and deepening their knowledge in endoscopic minimally invasive techniques. joimax® is playing a major role in advanced training and is a driving power in the field of continuing education.

“With the launch of TESSYS® ISeeUTM, which has been newly designed especially for the Chinese market, joimax®offers an even more simplified access under facilitated orientation,” says Wolfgang Ries, CEO and founder of joimax®. “The existing TESSYS® trays can furthermore be upgraded with the TESSYS® ISeeUTM supplements,” he continues.

Moreover, joimax® also presented its latest product, the newly launched Intracs® Interaoperative Navigation Tracking & Control System for the first time in China.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS®(cervical) for decompression procedures, MultiZYTE® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF® and Percusys® for endoscopic minimally-invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications. With the newly launched Intracs® system, navigation is now faster, safer and more accurate than ever before using an electromagnetic (EM) field.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax®technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

View source version on businesswire.com: http://www.businesswire.com/news/home/20161128005589/en/

MULTIMEDIA AVAILABLE:http://www.businesswire.com/news/home/20161128005589/en/


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November 29, 2016 OrthoSpineNews

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November 29, 2016 OrthoSpineNews

2016-11-28 – (GLOBE NEWSWIRE) —

Episurf will achieve its 150th implant during the week of 28th November 2016. This milestone of Episealer knee implant surgeries demonstrates the increasing rate of adoption within the orthpaedic community for the Episurf Medical’s patient specific approach for the treatment of focal cartilage lesions.

“The Episealer concept is gaining traction and less than 6 months after case number 100, we are now reaching 150.  The orthopaedic surgical implant market is decidedly conservative and incrementally, Episurf is moving into the area of evidence-based medicine. The results to date are very encouraging and builds further optimism as they show rapid recovery along with a significant improvement in the quality of life for our patients”, said Dr Leif Ryd, Senior Medical Advisor to Episurf Medical.

“We are pleased to have reached this point so quickly after our 100th surgery”, said Rosemary Cunningham Thomas, CEO of Episurf Medical. “Surgeons are deciding for themselves in increasing numbers that the Episealer procedure provides significant improvements for their patients. The personalised approach, which starts with our Epioscopy® process to fully visualise and assess a patient’s cartilage damage, enables Episurf to tailor every implant to a patient’s specific anatomy and pathology. Our results are being borne out through solid clinical outcomes and a growing forward order book.’’

 

For more information, please contact:

Rosemary Cunningham Thomas, CEO, Episurf Medical

Tel: +46 (0) 70-7655892

Tel: +44 (0) 7803-753603

Email: rosemary@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.

 


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November 29, 2016 OrthoSpineNews

BELGRADE, Mont., Nov. 23, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Xsert Lumbar Expandable Interbody System.

The Xsert System is an all titanium expandable interbody device that expands in-situ. It is available in various sizes and lordotic angulations to fit the most complex anatomical needs of patients. These spacers are designed to simplify surgeon insertion technique[s] while offering implant height adjustability. Osteointegration will be encouraged through nanotextured endplate surfaces as well as central and lateral implant graft windows. The system is intended for use at one or two contiguous levels (L2-S1 inclusive).

Xsert is also cleared to be packed with autograft or allograft bone graft. Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Xsert due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.

“We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy,” stated Dr. David Kirschman, developer of Xsert and current member of the Xtant Medical Board of Directors. “With the clearance of allograft use with Xsert, Xtant Medical further expands combined device and biologic solutions for surgeons and their patients.”

Xtant Medical estimates the U.S market for lumbar interbody devices at $1.3M and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Xsert will be available in an initial product release in mid 2017.

About Xtant Medical Holdings

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical 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 Medical 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: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our 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.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. 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. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

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November 28, 2016 OrthoSpineNews

November 28, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today the official opening of the first EOS site in South Korea, the third largest market in Asia, at the Konyang University Hospital. The University Hospital serves an adult and pediatric population of 7 million outpatients and 25 million inpatients on average per year.

The University Hospital has a strong orthopedics department for surgical and non-surgical treatment of the spine and joints. Patients of the specialized spine clinic will benefit from the low dose, full body images and weight-bearing, 3D analysis that EOS provides for deformative and degenerative spine conditions. In addition, the joint replacement clinic will use the EOS images and 3D torsion and alignment measurements to improve the planning of arthroplasty surgeries and control post-operative outcomes.

Prof Kim Sang Beom, Chief of the Spine Centre and Orthopedics Department and Board Member of the Korea Spine Surgeon Association, commented, “EOS is a real innovative technology with low dose biplanar 2D/3D radiography that’s approved by NECA. We are happy to be able to extend our services and care to our patients with this technology, including beginning to screen children and students utilizing the applicable Micro Dose option. The Konyang University Hospital uses the most advanced technology for better patient outcome. EOS will be the gold standard for musculoskeletal treatment in the near future.”

Marie Meynadier, CEO of EOS imaging, commented, “The Konyang University Hospital will be a strong reference center for the EOS platform in South Korea. Together with the Innovative Technology status obtained from the NECA Center for New Health Technology earlier this year, this will fuel adoption in the important South Korean market. We look forward to serving more Korean hospitals, healthcare professionals and patients with our low dose 2D/3D technology.”

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

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

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

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot
CFO
Ph: +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Valentine Brouchot
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com


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November 28, 2016 OrthoSpineNews

November 28, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, announced today that the Company’s patient-specific UNiD™ Rod technology has now been used in more than 1,000 procedures.

Adoption of the UNiD™ technology continues to grow and gain momentum with over 110 orthopedic and neurosurgeons using UNiD™ Rods in the United States and Europe and represents a major milestone in establishing MEDICREA as an industry innovator in the global complex spine market. Surgeons discuss what UNiD™ means to their practice in this video. A special animation commemorating the 1,000-surgery milestone is also available here.

Dr. Evalina Burger, of University Colorado Hospital, stated, “We now realize how important it is to provide a specific alignment of the spine that is unique to each patient. If we do not achieve the optimal alignment during surgery, then we are too-often revising that patient later. UNiD™ is using precision technology and analysis to solve this clinical issue for patients as well as providing an invaluable support service and feedback loop for surgeons.” Dr. Burger has performed more than 40 procedures utilizing UNiD™ Rods since the patient-specific technology was FDA-cleared in November 2014 and published her early results in Orthopedics.

Denys Sournac, President and CEO, added, “It is MEDICREA’s unique vision to bring personalized planning and analytical services to complex spine, forming a virtuous cycle of clinical improvement. We believe UNiD™ technology has the potential to significantly improve patient treatment and limit the costly burden placed on healthcare providers by reducing the occurrence of revision surgery.”

The 1,000-procedure milestone is achieved on the heels of the Company’s UNiD™ LIFETIME WARRANTY launch, announced on October 25, 2016 with the UNiD™ Premier Service, making MEDICREA the only player in Spine to provide a guarantee against one of the leading causes of revision surgery in complex spinal indications: structural compromise to the rod.

MEDICREA’s UNiD™ Thoracolumbar and Cervical Rods provide a complementary solution to the Company’s comprehensive solution package for complex spine, including PASS LP® and PASS OCT® fixation systems. The systems are marketed by MEDICREA within a global marketspace representing an annual value estimated to near $6 billion for the thoracolumbar and cervical fixation segments.

MEDICREA anticipates the announcement of FDA 510k clearance in the coming weeks for the Company’s next extension to its complex spine portfolio: a range of top-loading, self-locking tulip screws, the most prevalent screw type in the complex spine market.

About MEDICREA (www.medicrea.com)

MEDICREA specializes in bringing pre-operative digital planning and pre and post-operative analytical services to the world of complex spine. Through the lens of predictive medicine, MEDICREA leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, MEDICREA is an SME with 150 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and deep learning technologies supported by an expansive collection of clinical and scientific data, MEDICREA is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: medicrea.com.

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

MEDICREA is listed on ALTERNEXT Paris ISIN: FR 0004178572 – Ticker: ALMED

Contacts

MEDICREA
Denys Sournac
Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice Kilfiger
Chief Financial Officer
fkilfiger@medicrea.com
+33 (0)4 72 01 87 87
or
Media
Russell Ward for MEDICREA
russell@theconfluencegroup.com
+1 310 424 8356


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November 28, 2016 OrthoSpineNews

FARMINGDALE, N.Y., Nov. 28, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON) (“Misonix” or the “Company”), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, announced that The Nasdaq Stock Market LLC (“Nasdaq”) has accepted the Company’s plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) which would permit the continued listing of Misonix common stock on the Nasdaq Global Market.

As previously disclosed, on September 15, 2016, the Company received a deficiency letter from Nasdaq indicating that the Company, as a result of not filing its Annual Report on Form 10-K (“10-K”) on September 13, 2016, was not in compliance with Listing Rule 5250(c)(1) of the Nasdaq Listing Rules (the “Listing Rules”) for continued listing.  In addition, on November 10, 2016, the Company received a second deficiency letter from Nasdaq indicating that the Company, as a result of not filing its Quarterly Report on Form 10-Q (the “10-Q”) by November 9, 2016, together with its prior and ongoing failure to timely file its 10-K, was not in compliance with Listing Rule 5250(c)(1) for continued listing. In the letters, Nasdaq requested that Misonix submit a plan to regain compliance with the Listing Rules by November 14, 2016.

On November 14, 2016, Misonix submitted to Nasdaq a plan to regain compliance with the Listing Rules. After reviewing Misonix’s plan to regain compliance, Nasdaq granted an exception to enable the Company to regain compliance with the Listing Rules. Under the terms of the exception, Misonix must file its 10-K and 10-Q on or before March 13, 2017. In the event that Misonix does not satisfy the terms set forth in the extension, Nasdaq will provide written notification that Misonix’s common stock will be delisted. At that time, Misonix may appeal Nasdaq’s determination for a panel review.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications.  Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the completion of the investigation related to identified deficiencies in internal control over financial reporting, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact          Investor Contact
Misonix Contact: Joe Diaz
Joseph Dwyer Lytham Partners
631-694-9555 602-889-9700
invest@misonix.com info@misonix.com

Logo – http://photos.prnewswire.com/prnh/20160201/328020LOGO

 

SOURCE Misonix, Inc.

Related Links

http://www.misonix.com