Princeton, NJ and Or Akiva, Israel, September 26 — Regentis Biomaterials, a developer of hydrogels for tissue regeneration, announced it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate a pivotal Phase III clinical study of GelrinC, a novel treatment for focal cartilage defects in the knee. This clinical study will be used to support a Premarket Approval Application (PMA) which will allow Regentis to market GelrinC in the U.S.

The cartilage repair market is the largest unmet need in orthopedic sports medicine today, and represents an estimated market opportunity of more than US $1 billion. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Cartilage has limited ability to repair itself, which means that surgical intervention is often required. Focal defects typically occur as a result of trauma and are extremely painful to the patient. Microfracture, the standard of care procedure, provides only short-term relief to patients and often requires additional surgical intervention.

“Gaining IDE approval is a significant step forward for Regentis and brings us that much closer to helping US patients recover from damaged articular knee cartilage,” said Regentis President and CEO Alastair Clemow. “GelrinC has been shown to effectively regenerate high quality cartilage, a key challenge in treating these kinds of knee injuries. GelrinC has already demonstrated excellent clinical outcomes in our European study, and we look forward to substantiating these results in the U.S.”

The GelrinC procedure is easy and quick for surgeons to perform and can be carried out using a minimally invasive approach.  It is administered as a liquid allowing it to fill any size and shape of defect, making it suitable for all lesion types. After a  short exposure to ultra-violet light, GelrinC is converted into a solid implant completely filling in the lesion.  The implant naturally degrades within 6-12 months and is gradually replaced with functional and durable cartilage.

“GelrinC is a potential game changer in the cartilage repair space, and can be an attractive and viable option for patients,” said Dr. Brian J. Cole, Associate Chairman and Professor within the Department of Orthopedics at Rush University Medical Center in Chicago.  “GelrinC has promising clinical outcomes to date and the pre-clinical work is very supportive.”

This FDA trial will evaluate the safety and efficacy of GelrinC compared to the raw level data of a historical microfracture control arm. The study design overcomes the limitation of randomized control studies in this field, which is expected to result in faster patient enrollment and significantly reducing the time for product approval.

About Regentis Biomaterials

With offices in Or Akiva, Israel and Princeton, NJ, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company’s core technology is a biodegradable hydrogel called Gelrin™. It is based on polyethylene glycol diacrylate and denatured fibrinogen originally developed at the Technion – Israel Institute of Technology by Dr. Dror Seliktar. The Gelrin hydrogel platform combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance for a range of clinical applications. For more information, please visit www.regentis.co.il.
For media inquiries, please contact:

Josh Turner

Media Relations

Phone: 917-231-0550

josh@jtpublicrelations.com

Alastair Clemow, PhD

President & CEO

1-508-930-8865

LEESBURG, Va., Sept. 21, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced at the Scoliosis Research Society (SRS) 51^st Annual Meeting & Course in Prague, Czech Republic that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for screw and connector components toward a growing spine application for its MESA^® Spinal System. This clearance enables these screw and connector components to be used as a part of a growing rod construct designed to accommodate growth in patients under 10 years of age.

“We are excited to receive FDA clearance for a growing spine application, which will provide surgeons with a new treatment option for correcting spinal deformity among a specific subset of the pediatric spinal deformity population,” said Eric Major, K2M’s President and CEO.

K2M’s growing spine application features closed-head screws and previously-cleared axial connectors, providing a surgical solution for patients less than 10 years of age to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.

With this growing spine application, surgeons can utilize components from a traditional fusion construct for a growth-enabling construction, allowing implants to be surgically lengthened on a periodic basis as the patient grows. This growing spine application also offers a growth guidance option, combining standard instrumentation and placement of unlocked closed-head screws at non-fusion levels, to allow for rod passage as the patient grows.

K2M’s growth guidance implants may be used with any cleared K2M rod construct ranging in diameter from 4.5 mm to 6.35 mm. K2M’s growth rod conversion implants may be used with 4.5 mm and 5.5 mm rod constructs.

Major added, “This regulatory milestone, coupled with our recent data announcement of findings surrounding our motion-preserving scoliosis technology, reinforce our ongoing commitment to achieving the highest level of excellence in developing innovative technologies that provide enduring treatments for young patients suffering from complex spinal deformities, such as early-onset scoliosis and adolescent idiopathic scoliosis.”

In July, K2M announced findings from a multi-year study surrounding the Company’s recently-acquired motion-preserving scoliosis technology* from K-Spine. The study found that the innovative apical fusion technique achieved corrected deformity profiles in AIS patients and maintained mobility of non-fused segments with a lower implant density, sparing 52 percent of the spanned area from fusion.

For more information on K2M’s comprehensive product portfolio, visit www.K2M.com.

*This device is not available for sale within the United States.

About K2M

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

Find K2M on Facebook: https://www.facebook.com/K2MInc
Follow K2M on Twitter: http://twitter.com/K2MInc
Watch K2M on YouTube: http://www.youtube.com/user/K2MInc

Forward-Looking Statements
This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies and techniques; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; the greater resources available to some of our competitors; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarters facility; our ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation including by the FDA; in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and FDA clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; our reliance on the performance of third parties who assist us in clinical trials and pre-clinical development; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; volatility in our common stock; our current plans not to pay dividends; potential dilution due to our issuance of common stock under our incentive plans, for acquisitions or otherwise; the amount of common stock held by our pre-IPO owners; the impact of anti-takeover provisions in our organizational documents and under Delaware law; our status as an emerging growth company, our ability to use our net operating loss carryforwards; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com  

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

September 19, 2016

September 19, 2016

ALACHUA, Fla. (DATE) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced it has recently received regulatory clearance from the Australian Therapeutic Goods Administration (TGA) for nanOss^® Bioactive bone void filler in Australia. The company also announced it has received CE Mark from BSI for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe.

NanOss Bioactive bone void filler is an advanced bone graft substitute composed of nano-structured hydroxyapatite granules and an open structured engineered collagen carrier. It is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. NanOss Bioactive is among few synthetic-based grafts* with peer-reviewed evidence of posterolateral fusion. NanOss Bioactive bone void filler will be distributed for RTI Surgical in Australia by LifeHealthcare Group Limited (ASX: LHC), one of Australia’s leading independent medical device distributors.

NanOss Bioactive Loaded bone void filler is a closed system with a pre-filled mixing syringe for consistency, sterility, compression and easy delivery of NanOss Bioactive bone void filler. NanOss Bioactive 3D bone void filler is an advanced bone graft composed of nano-structured hydroxyapatite granules suspended in a porous gelatin-based foam matrix. NanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler will be distributed by RTI Surgical and its independent distributors in Europe.

“We are pleased to have received regulatory clearance to launch nanOss Bioactive bone void filler in Australia, as well regulatory approval for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe,” said Carrie Hartill, executive vice president and chief scientific officer. “These clearances expand our broad portfolio of surgical implants offered across the globe and give surgeons worldwide more options to help their patients improve their quality of life.”

*A product that is manufactured from synthetic material but may also include carrier materials derived from non-human materials.

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 is headquartered in Alachua, Fla., and 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 Statement

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 atwww.rtix.com or the SEC’s website at www.sec.gov.

MARIETTA, Ga., Sept. 15, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that the Company urged the Food and Drug Administration (“FDA”) to reconsider its Draft Guidances on Minimal Manipulation and Homologous Use of Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) during hearings conducted on September 12 and 13, 2016.

Parker H. Petit, Chairman and CEO of MiMedx, said, “I am encouraged that the FDA agreed to hear input from industry, academia, healthcare practitioners and patients. As expected, the almost universal sentiment from industry and the scientific community was that the Draft Guidances should be amended significantly or withdrawn in their entirety. Many presenters also noted that some provisions of the Draft Guidances are outside the scope of FDA’s authority to regulate HCT/Ps.”

Summary of the Majority of Industry, Clinical and Scientific Sentiments Expressed During the Hearing:

• Draft Guidances introduced new concepts or proposed changes to the current regulatory scheme, which is inappropriate for guidance. Therefore, Draft Guidances cannot be lawfully adopted in their current form.
• Many of the principles in the Draft Guidances are scientifically unsound. Specifically, most presenters objected to the characterization of tissue as either structural or nonstructural, noting that many tissues have multiple functions, both structural and nonstructural.
• Multiple objections to the concept that each tissue type has a single “main function.” 
• Draft Guidances should be amended significantly or withdrawn in their entirety;
• If FDA wants to change the way tissue products are regulated, it must do so through a formal notice and comment rulemaking process.
• For tissues that don’t currently qualify for regulation under Section 361, many presenters advocated for a new, abbreviated regulatory pathway that would take into account the unparalleled safety record of tissue products and the needs of patients for new and improved products.
• Many physicians and patients testified as to the safety and efficacy of HCT/Ps.

An overwhelming majority of the parties who testified at the hearing, including the American Association of Tissue Banks (“AATB”), called for notice and comment rulemaking or stated that the Draft Guidances constitute major changes to the current regulatory scheme. A small minority of presenters called for greater restrictions on the use of HCT/Ps. This minority was roughly a dozen individuals, at least eight of whom were Organogenesis’ current or former associates, including its Senior Vice President of Regulatory & Government Affairs, its former President and CEO, one of its Tissue Bank Directors, its former Clinical Program Manager, three members of its speakers bureau, and a consultant that was formerly its Director of Technology Implementation.

Petit commented, “Organogenesis continues to attempt to discredit human tissue allografts, and in particular, amniotic membrane allografts.  The basis for their position is that almost 20 years ago their Apligraf® product went through the Premarket Approval (“PMA”) regulatory pathway whereas human tissue allografts are subject to a different regulatory pathway, namely Section 361 of the Public Health Service Act, which they deem to be inferior.  This argument is baseless, and it reflects negatively on the FDA’s regulatory history and expertise.  Also, this concept has been previously rejected by the Centers for Medicare and Medicaid (“CMS”), the Department of Veterans Affairs (“VA”), and many thousands of physicians.”

Draft Guidances Cannot Lawfully be Adopted in Their Current Form

MiMedx does not believe the FDA lawfully can adopt the Draft Guidances on minimal manipulation and homologous use in their current form because the FDA cannot reverse its well-established practice and effectively amend existing substantive regulations via informal guidance.

Petit stated, “Simply put, the issuance of these Draft Guidances in their existing form requires notice-and-comment rule making with Congressional oversight and possible Office of Management and Budget (“OMB”) review. Similarly, the majority who testified at the hearings alleged that the Draft Guidances introduce new concepts that are contrary to the existing regulations and/or FDA’s prior positions.”

During the Monday, September 12, 2016 session, Frank Wilton, President & CEO of the AATB, called upon the FDA to formally withdraw the Draft Minimal Manipulation Guidance document.  Further, he asserted that if the FDA wished to proceed with their new “main function concept,” then the FDA must do so via the formal rulemaking process.  Mr. Wilton also pointed out numerous ways in which the provisions in the Draft Guidance on Homologous Use deviated from positions taken previously by the FDA.

Many of the Principles that Underlie the Guidance Documents are Scientifically Unsound

Bill Taylor, President and COO of MiMedx, commented, “We also believe that many of the principles that underlie the Draft Guidances are scientifically unsound. For example, the Draft Guidance on Minimal Manipulation postulates that HCT/Ps must be intended for the HCT/P’s ‘main function’ in order to qualify for regulation under Section 361 of the Public Health Service Act (“PHSA”).  This new concept is not based on science.  It ignores the fact that many HCT/Ps have more than one important function, and can have both structural and non-structural functionality in the donor.   An overwhelming number of the parties who commented on the Draft Guidance on Minimal Manipulation during the initial comment period, as well as the parties that testified throughout the course of the hearings, criticized this aspect of the Draft Guidance.”

“Specifically with respect to amniotic membrane, both the Draft Guidance on Manipulation and the Draft Guidance on Homologous Use characterize amniotic membrane as a purely structural tissue with limited, purely structural functions, which is not correct,” added Petit.

During the Tuesday, September 13, 2016 session, Dr. Rebecca Baergen, a leading expert in placental pathology, author of Manual of Bernirschke and Kaufmann’s Pathology of the Human Placenta (2005, 2011) and co-author of Pathology of the Human Placenta (2006, 2012), which generally is recognized as the most comprehensive and authoritative text in the field, testified to the myriad functions of amniotic membrane in the donor, both structural and nonstructural, none of which is more important than another.

Petit stated, “Another instance of the Draft Guidances not comporting with science is one of the examples included in the Draft Guidance on Minimal Manipulation that characterizes amniotic membrane powder as being more than minimally manipulated because it ‘alters the tissue’s physical integrity, tensile strength, and elasticity that allow it to serve as a membranous barrier.’ This example is problematic for a number of reasons, including that it gives no consideration whatsoever to the labeled indication of the product.  Suppose, for example, the product was labeled for homologous uses as an anti-scarring and anti-inflammatory agent, and it was not intended to serve as a membrane barrier.  These are explicit non-structural functions the FDA has already acknowledged.”

“But more significantly, the FDA does not present any scientific evidence to support its contention that micronization of amniotic membrane reduces its tensile strength and elasticity,” noted Taylor. “In fact, two years ago, MiMedx presented the FDA with three sets of test results from independent laboratories demonstrating that micronizing its allograft products does not reduce their tensile strength and modulus of elasticity. The FDA has never refuted or even acknowledged receipt of those test results.”

During the Monday, September 12, 2016 session, Lisa A. Ferrara, Ph.D., President and CEO of OrthoKinetic Testing Technologies, LLC, which is one of the independent laboratories that performed these tests, explained that tensile strength and elasticity are material properties of amniotic membrane and, as such, do not vary with the size of the sample.  Dr. Ferrara also presented the results of her lab’s testing of MiMedx’s micronized product, as well as the results of the testing by the other two independent laboratories, all of which confirmed that processing amniotic membrane into smaller pieces does not alter its tensile strength and elasticity.

“In summary, we believe this and other scientific evidence presented at the hearing is irrefutable and should preclude adoption of these Draft Guidance documents in their current form,” said Petit.

Guidance Documents are Non-Binding

The Company reported that even if the Draft Guidances were finalized in their current form, they are non-binding on the FDA or industry.  Page one of each of the Draft Guidance documents provides as follows:  “This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

In his remarks at the FDA workshop held on Thursday, September 8, 2016, Stephen Bauer, PhD, Chief of the Cellular and Tissue Therapy Branch (CTTB), U.S. Food and Drug Administration, likewise characterized guidance as “non-binding advice.”

Taylor noted, “MiMedx continues to believe that its marketing of its products as Section 361 HCT/Ps is consistent with the applicable statutes and regulations.”

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone.  “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ and AmnioFill™ brands; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix,  EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft;  EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and  CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.

We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to the Company’s position that different regulatory pathways are neither inferior nor superior to each other, that the issuance of the Draft Guidance documents in their existing form would constitute a substantive rulemaking that could only be properly completed through notice-and-comment rulemaking, that many of the principles underlying the draft guidance documents are scientifically unsound, and that the scientific evidence presented at the hearing is irrefutable and should preclude adoption of the draft guidance documents in their current form. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that regulators such as the FDA may determine that certain regulatory pathways are superior or grant certain privileges over other pathways used to bring products to market, that it could be determined that the draft guidances in their existing form do not constitute a substantive rulemaking or that the draft guidance documents are finalized even though they do constitute a substantive rulemaking and/or are scientifically unsound, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year endedDecember 31, 2015 and its most recent 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

September 15, 2016 04:15 ET | Source: Episurf Medical AB

The patent covers a surgical drilling guide with a functionality for depth adjustments. This guide constitutes a component of Episurf’s toolkit for implantation of patient specific joint implants.

“To look forward and secure intellectual property protection in new markets is an important field for an expanding company”, comments Rosemary Cunningham Thomas, CEO of Episurf Medical.

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, at 10.15 CET on 15 September 2016.

ATLANTA, GA (PRWEB) SEPTEMBER 15, 2016

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

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

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

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

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

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

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

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

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

ABOUT DR. CRAIG HUMPHREYS AND KENAI SPINE

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

ABOUT CURE INTERNATIONAL

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

Caption & Copyright:

Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved.

PEEK-OPTIMA® is a registered trademark of Invibio, Ltd. All rights reserved.