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February 2-4, 2017
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ReconRegulatory

OrthAlign, Inc. Receives CE Mark Approval Expanding Global Product Portfolio to include Precision Technologies for DAA Total Hip and Unicompartmental Knee Arthroplasty

October 4, 2017 OrthoSpineNews

ALISO VIEJO, CA (PRWEB) OCTOBER 03, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company, received CE Mark Approval to market its advanced precision technologies for Direct Anterior Approach Total Hip (DAA HipAlign®) and Unicompartmental Knee Arthroplasty (UniAlign®) surgeries, in Europe and other countries.

“As OrthAlign has focused on expanding customer reach and its application pipeline in 2017, we are pleased that surgeons outside of the United States and Japan can now have access to our newest precision technologies DAA HipAlign and UniAlign,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We will continue providing orthopedic surgeons and healthcare facilities throughout the world our clinically beneficial portfolio of products, staying true to our core design principles of ease of use, precision, and cost effectiveness.”

Recent global statistics have shown that the direct anterior approach for total hip arthroplasty is growing, as it arguably leads to quicker recovery, less pain, and more normal function for patients after hip replacement. DAA HipAlign does not require any pre-operative imaging or intraoperative fluoroscopy, while providing more clinically relevant positioning for cup placement and leg length measurement. Early clinical data from the United States demonstrates that surgeons can expect to reduce fluoroscopy exposure time by about 45%. Early clinical data from Japan shows cup placement (for both inclination and anteversion) accuracy of ±10°, with at least 95.9% confidence.

Unicompartmental knee arthroplasty procedures are also growing in popularity, worldwide. UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

“As international expansion has been one of OrthAlign’s priorities, receiving CE Mark approvals for use of our technology in two rapidly growing segments is great news,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “Our international distributor network has been waiting for these approvals, as many of their local surgeons have been asking for the technology.”

DAA HipAlign and UniAlign will be included in OrthAlign Plus® handheld navigation devices, along with OrthAlign’s award-winning KneeAlign® technology. To date, OrthAlign technology has successfully been used in over 65,000 cases, in over 25 countries, with more than 15 published international clinical studies demonstrating its accuracy.

About OrthAlign, Inc.

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

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

 

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SpineTop Stories

Dr. Dan Kendall First in D.C./Northern VA to Use New, Minimally Invasive Technology for Treating VCF

October 4, 2017 OrthoSpineNews

WASHINGTON, Oct. 3, 2017 /PRNewswire/ — National Spine & Pain Centers (NSPC) (https://treatingpain.com/) is pleased to announce one of its physicians, Dr. Dan Kendall, recently treated a vertebral compression fracture (VCF) using the AVAflex Balloon System from Stryker. This technology is less invasive than traditional VCF treatments, with potential for less risk and patient trauma. National Spine & Pain Centers is committed to pioneering solutions to chronic pain, and this first application of the AVAflex Balloon System in the D.C. Metro area is only the latest example.

“In using Stryker’s AVAflex technology during a balloon kyphoplasty procedure,” says Dr. Kendall, “I was able to treat the patient using only one trocar while still achieving the results I look for with using two trocars. Using one trocar provides less patient trauma and further minimizes risk for infection.”

Balloon kyphoplasty is a minimally invasive treatment for vertebral compression fractures. In a standard balloon kyphoplasty, two trocars are inserted into the fractured vertebrae.  Balloon catheters are then inserted through the trocar needles and inflated to create a void.  The hardened bone cement creates an internal cast in the fractured vertebrae stabilizing the fracture and alleviating pain. Stryker’s AVAflex Balloon System represents a crucial step forward for balloon kyphoplasty, offering a less invasive approach.

Dr. Kendall performs balloon kyphoplasty’s in his office in McLean, Virginia.  With the advancement of technology in treating VCF’s, patients no longer have to go to the hospital and can receive the treatment without receiving general anesthesia.  Dr. Kendall now is able to treat his patients with painful compression fractures with a short 20-minute procedure and mild sedation. This allows the patient to be treated as out-patient enabling them to walk out of the office when released.

“I am always looking for the best and most effective way to treat my patients,” adds Dr. Kendall. “Typically, my patients with VCFs are elderly and in severe pain. Stryker’s AVAflex balloon technology allows me to perform a balloon kyphoplasty procedure efficiently while still delivering great results.”

In addition to treatments for VCFs, National Spine & Pain Centers also provides solutions for people experiencing arthritis, migraine headaches, spinal stenosis and diabetic neuropathy, among many other conditions. Innovative treatment modalities include discography, epidural nerve block, platelet rich plasma (PRP) therapy, stem cell therapy and spinal cord stimulation.

In view of the opioid crisis, Interventional Pain Management (IPM) groups such as National Spine & Pain Centers are playing a pivotal role in delivering outcome-driven treatment solutions that provide comprehensive, effective care for patients suffering from chronic pain.

Dr. Dan Kendall joined NSPC in 2004 after completing an interventional pain management fellowship at Johns Hopkins Hospital. He has published numerous articles and lectured nationally on interventional pain topics, and has earned not only the esteem of his peers but also the admiration of his patients.

About National Spine & Pain Centers

National Spine & Pain Centers (NSPC) is the nation’s leading network of pain management practices with over 65 pain physicians on staff at more than 60 locations in Connecticut, Maryland, New Jersey, New York, North Carolina, Virginia, Washington DC and West Virginia. Many NSPC physicians are among the most respected pain practitioners in the world.

Contact:

Manju Regmi
P: 301-881-7246 ext: 10163
11921 Rockville Pike #505
Rockville, MD 20852
http://www.treatingpain.com/
177514@email4pr.com

SOURCE National Spine & Pain Centers

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BiologicsTop Stories

Dr. Gloria Matthews Joins MiMedx As Its Senior Vice President Of Research And Development

October 4, 2017 OrthoSpineNews

MARIETTA, Ga., Oct. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that Dr. Gloria Matthews has joined the Company as its Senior Vice President, Research and Development.  Dr. Matthews will lead the Company’s overall research function as well as the development of new products.

Parker H. “Pete” Petit, Chairman and CEO, stated, “Dr. Matthews brings over 20 years of experience encompassing programs from discovery into Phase 3 clinical development for devices, orthobiologics, combination products, and new chemical entities for osteoarthritis, cartilage repair, and regenerative medicine.  She is an accomplished scientific leader with broad ranging expertise in orthopedic and rheumatologic diseases, among other therapeutic areas, and she has significant functional experience in cellular and gene therapy, biomaterials and growth factors.”

Bill Taylor, President and COO, commented, “The addition of Dr. Matthews to our staff is an important step in our continued expansion into biopharmaceuticals. We will continue to expand our clinical and scientific talent and resources to further drive our growth in this area. We are very excited to welcome Dr. Matthews to our organization.”

Immediately prior to joining MiMedx, Dr. Matthews served as Chief Medical Officer at Histogenics Corporation, where she oversaw all clinical and medical affairs activities with strategic oversight of various United States and global development programs across biologics, drugs and devices.

Prior to Histogenics, Dr. Matthews spent 12 years at Genzyme Corporation and Sanofi Genzyme.  During her tenure at Genzyme, Dr. Matthews held progressively more responsible leadership positions and was involved in clinical and preclinical development and/or post-market support of cell, gene, growth factor, small molecule and biomaterial based products in the orthopedic and rheumatologic space. Dr. Matthews last served with Sanofi Genzyme in the role of Senior Director and Global Head of Bone and Joint Disease Research and Development.

Dr. Matthews earned her DVM and Ph.D. from Cornell University.  Dr. Matthew’s Ph.D. concentration was in cell and molecular biology of osteoarthritis.

The Company also reaffirmed its previously communicated revenue expectations for the third quarter of 2017. “In our press releases of September 5 and September 13, 2017, we communicated that we expected to exceed the $80 millionupper end of our forecasted third quarter revenue range in spite of the disruption from Hurricane Harvey and Hurricane Irma. Our preliminary revenue estimates clearly show that our forecasting was correct. We are experiencing robust revenue growth, and we look forward to reporting our actual third quarter revenue on or about the 13th of October,” added Petit.

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 our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 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.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding revenue expectations for the 2017 third quarter; and expectations for sales performance, despite the effects of Hurricane Harvey and Hurricane Irma.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the Company’s revenue for the 2017 third quarter may not materialize as expected; and that the Company’s sales performance, may be more negatively impacted than anticipated due to  Hurricane Harvey and Hurricane Irma.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our 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 we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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SpineTop Stories

Medicrea Presents Patient-Specific UNiD™ Rod Clinical Results Showing Very Significant Reduction in Rod Breakage

October 3, 2017 OrthoSpineNews

October 02, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today the results of a new White Paper titled Patient-Specific Rods show a reduction in rod breakage incidence. The paper shows that, relative to manually bent rods, patient-specific rods generated using Medicrea’s UNiD ASI technology significantly reduce the incidence of postoperative rod breakage in adult complex spine surgical cases.

The study, authored by an international group of 9 complex spine surgeons from the U.S. and France, reviews a cohort of more than 450 Adult Spinal Deformity (ASD) patients with at least 1 year from the surgical implantation of patient-specific UNiD™ Rods, generated by Medicrea’s UNiD ASI™ systems-based technology for personalized spinal care. This cohort includes more than 120 patients who additionally had pedicle subtraction osteotomy (PSO) performed.

The White Paper demonstrates the rate of rod fracture is considerably less in ASD patients implanted with UNiD™ Rods, when compared to current literature, especially in those having undergone PSO. With a UNiD™ Rod, breakage was detected in 2.2% of all ASD patients and in 4.7% of cases with a PSO performed. These rates decrease further when you remove patient-specific rods that were adjusted during the operation. In the current literature involving non-personalized spinal implants, overall rod breakage incidence is reported as high as 14.9% of patients following ASD surgery [3-5]. When a PSO is performed, the rod fracture rate increases up to 22% and in these cases, 90% of failure is found to occur at, or adjacent to, the PSO level [3-4]. Furthermore, the time to failure is most often seen to occur within 10 months after surgery.

Rod Fracture Incidence

ASD Patients

ASD Patients
with PSO

ASD Patients
with no manual
rod bending

ASD Patients
with PSO and
no manual rod
bending
Standard Rod 14.9% 22.0% — —
Patient-Specific UNiD™ Rod 2.2% 4.7% 1.8% 3.1%
Fracture Reduction with UNiD™ Rod -85% -79% -88% -86%

Adult Spinal Deformity surgery is increasingly prevalent in an aging population and poses particular challenges with high complication rates that can lead to revision surgery in a reported 16.5% of cases [1] at a substantial cost to the healthcare system found to total around $80,000 per surgery [2]. Thus, avoiding revision surgery can provide a significant savings to the health care system.

Dr. Themistocles Protopsaltis, of NYU Langone Medical Center and co-author of the White Paper, stated, “This review demonstrates that utilizing digitally planned, patient specific UNiD™ Rods which avoids manual rod contouring has a major impact on rod fracture incidence in the treatment of Adult Spinal Deformity. This is important because rod breakage leads to revision surgery at significant cost to the patient, hospital and payer.” Dr. Protopsaltis continued, “Adopting an iterative, data-based approach that is shown to make spinal surgery more efficient can change a surgeon’s practice, making UNiD ASI™ a true advance in our standard of care.”

Denys Sournac, President and CEO of Medicrea, stated, “These results highlight how our proprietary UNiD system can improve both clinical and economic outcomes in spine surgery. We will continue to follow these cases and add to our growing database of more than 1,700 cases. The advanced data science built into our recently FDA-cleared UNiD HUB™ software allows Medicrea to perform advanced surgical simulations as we further harness the power of big data to plan the optimal surgical strategy and design implants adapted to the specific requirements of each patient and surgeon.”

White Paper Authors: A. Vaccaro, V. Fiere, S. Fuentes, T. Raabe, P. Passias, T. Protopsaltis, A. Faure, P. Tropiano, B. Blondel

To receive a pdf of Patient-Specific Rods show a reduction in rod breakage incidence please contact clinicalstudy@medicrea.com.

References

1 – Passias, P.G., et al., Predictors of Revision Surgical Procedure Excluding Wound Complications in Adult Spinal Deformity and Impact on Patient-Reported Outcomes and Satisfaction. J Bone Joint Surg Am, 2016;98:536-543.
2 – McCarthy IM, Hostin RA, Ames CP, et al. Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study. Spine J. 2014.
3- Smith, J.S., et al., Prospective multicenter assessment of risk factors for rod fracture following surgery for adult spinal deformity. J Neurosurg Spine, 2014;21:994-1003.
4 – Barton, C., et al., Risk factors for rod fracture after posterior correction of adult spinal deformity with osteotomy: a retrospective case-series. Scoliosis, 2015:10-30.
5 – Hamilton, D.K., et al., The Fate of Adult Spinal Deformity (ASD) Patients Incurring Rod Fracture After Thoracolumbar Fusion. World Neurosurgery, 2017. In press.

About Medicrea (www.Medicrea.com)

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.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 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.

For further information, please visit: Medicrea.com.

Connect with Medicrea:

FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

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

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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SpineTop Stories

Spineology® Initiates Full Market Release of Elite™ Expandable Interbody Fusion System

October 3, 2017 OrthoSpineNews

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in Anatomy-Conserving Surgery™, is pleased to announce the full market release of the Elite Expandable Interbody Fusion System. More than 300 cases have been completed using Elite, and system utilization continues to accelerate as the full market release of Elite is initiated.

“Following the successful completion of the Elite Expandable Interbody Fusion System limited release and the receipt earlier this year of the expanded FDA clearance, which included the addition of a narrower 10mm footprint and allograft bone labeling, we have now initiated the full market release of Elite,” said John Booth, CEO of Spineology. “The Elite’s robust design, broad size offering, and allograft bone labeling which allows the surgeon to pair Elite with Incite™ Cortical Fibers, have all been received extremely well by our customers. We are excited to continue to accelerate the growth of Elite in the expandable cage market.”

The Elite Expandable Interbody Fusion System implant is inserted into the lumbar disc space at a contracted minimum height and, once in position, is expanded to restore anatomic disc height, provide anterior column support, and potentially indirectly decompress. Elite offers the surgeon the ability to control device expansion and lock the device at any position in the expansion range. The Elite implant is constructed of titanium alloy and has a large graft window to enable bone through-growth, maximizing fusion potential.

Incite Cortical Fibers are a unique and versatile bone grafting solution. The fibers offer an osteoconductive and inductive matrix, excellent handling properties, in-situ expansion, and placement options via a variety of delivery methods.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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BiologicsFinancialTop Stories

MiMedx Completes Divestiture Of Its Stability Biologics Subsidiary

October 3, 2017 OrthoSpineNews

MARIETTA, Ga., Oct. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that it has completed the previously communicated divestiture of the Company’s subsidiary, Stability Biologics LLC (f/k/a Stability Inc.), back to the former stockholders of Stability Inc.

The transaction closed on September 30, 2017.  In the Company’s press release of August 18, 2017, MiMedx reported that the consideration included a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability Inc. of all claims and rights to any Earn-Out consideration. In that release, the Company also reported that it expects to book a one-time gain on this transaction. The amount of the gain will be disclosed in the Company’s third quarter of 2017 earnings release.

Parker H. “Pete” Petit, Chairman and CEO, said, “When we signed the definitive agreement for the divestiture, we communicated that if the transaction closed in the third quarter, we would maintain our full year revenue guidance, and even without the Stability Biologics revenue contribution in the fourth quarter, we were confident in our ability to meet our revenue guidance for the year. With the transaction’s closing completed within our projected timeline, we remain very confident in that guidance.”

Bill Taylor, President and COO, commented, “Our new ‘private label’ distribution agreement with Stability Biologics whereby we have retained the Stability Biologics key sales relationships for the spine and orthopedics areas of our surgical business, will also be an asset to the Company in our exclusive focus on our biopharma strategy. We are dedicating our efforts to continuing down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our human placental-based technology.”

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 our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 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.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s expectations relative to its revenue guidance for the year and its belief that its distribution agreement with Stability Biologics will be an asset to the Company.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the Company is not able to meet its revenue guidance without the revenue contribution of Stability Biologics or for some other reason, and that the distribution agreement with Stability Biologics does not produce the expected key sales relationships.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our 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 we assume no obligation to update any forward-looking statement.

 

SOURCE MiMedx Group, Inc.

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Financial

NN, Inc. Announces The Acquisition Of DRT Medical

October 3, 2017 OrthoSpineNews

JOHNSON CITY, Tenn., Oct. 2, 2017 /PRNewswire/ — NN, Inc., (NASDAQ: NNBR) a diversified industrial company, today announced it has completed the acquisition of DRT Medical, LLC, a supplier of precision manufactured medical instruments and orthopedic implants, from DRT Holdings, Inc. Financial terms of the transaction were not disclosed.

Richard Holder, President and CEO commented, “We are excited to welcome DRT Medical into the NN family as we continue to grow our life sciences portfolio through the addition of complementary and adjacent technologies. This acquisition aligns perfectly with our strategic plan and long-term objective to further diversify our portfolio and expand into markets that we believe have strong growth potential. DRT Medical’s focus on medical instruments and orthopedic implants is an ideal expansion of our capabilities as we continue to concentrate on doing more for our customers and work to meet their needs by providing them with end to end solutions.”

NN, Inc., a diversified industrial company combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis.  NN has 36 facilities in North America, Western Europe, Eastern Europe, South America and China.

Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These, and similar statements, are forward-looking statements concerning matters that involve risks, uncertainties and other factors which may cause the actual performance of NN, Inc. and its subsidiaries to differ materially from those expressed or implied by this discussion. All forward-looking information is provided by the Company pursuant to the safe harbor established under the Private Securities Litigation Reform Act of 1995 and should be evaluated in the context of these factors. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “assumptions”, “target”, “guidance”, “outlook”, “plans”, “projection”, “may”, “will”, “would”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “potential” or “continue” (or the negative or other derivatives of each of these terms) or similar terminology. Factors which could materially affect actual results include, but are not limited to: general economic conditions and economic conditions in the industrial sector, inventory levels, regulatory compliance costs and the Company’s ability to manage these costs, start-up costs for new operations, debt reduction, competitive influences, risks that current customers will commence or increase captive production, risks of capacity underutilization, quality issues, availability and price of raw materials, currency and other risks associated with international trade, the Company’s dependence on certain major customers, and the successful implementation of the global growth plan including development of new products. Similarly, statements made herein and elsewhere regarding pending and completed transactions are also forward-looking statements, including statements relating to the future performance and prospects of an acquired business, the expected benefits of an acquisition on the Company’s future business and operations and the ability of the Company to successfully integrate recently acquired businesses or the possibility that the Company will be unable to execute on the intended redeployment of proceeds from a divestiture, whether due to a lack of favorable investment opportunities or otherwise.

For additional information concerning such risk factors and cautionary statements, please see the section titled “Risk Factors” in the Company’s periodic reports filed with the Securities and Exchange Commission, including, but not limited to, the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Except as required by law, we undertake no obligation to update or revise any forward-looking statements we make in our press releases, whether as a result of new information, future events or otherwise.

SOURCE NN, Inc.

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BiologicsRegulatory

Court Sets the Trial Date for MiMedx Patent Infringement Lawsuit Against MTF, Medline and Liventa

October 3, 2017 OrthoSpineNews

MARIETTA, Ga., Oct. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the United States District Court for the Northern District of Georgia has set a trial date of January 22, 2018 for the Company’s patent infringement lawsuit against Musculoskeletal Transplant Foundation, Inc. (“MTF”), Medline Industries, Inc. (“Medline”) and Liventa Bioscience, Inc. (“Liventa”).

In the Company’s press release of September 18, 2017, MiMedx communicated that the efforts of MTF, Liventa and Medline to avoid a trial through summary judgment and other legal maneuvers had failed, and that the matter was finally at a stage where the court could set a trial date. In that press release, the Company committed that once the Court advised MiMedx of the specific trial date, the Company would issue a subsequent press release announcing the trial date.

Parker H. “Pete” Petit, Chairman and CEO, said, “We filed this lawsuit in April 2014, and are very pleased to finally have a hard date set for this trial. We are anxiously awaiting January  22nd, and look forward to presenting our patent infringement allegations against these defendants during the five day period the court has allocated for this trial. The numerous legal maneuvers to avoid trial that were employed by MTF, Liventa and Medline have failed, and we are highly confident in our case against these defendants.”

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 our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 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.

Important Cautionary Statement

This press release includes forward-looking statements, including statements regarding the Company’s confidence in its case and expectations for results of a trial.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our 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 we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

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SpineTop Stories

Zimmer Biomet Announces U.S. Launch of Avenue® T TLIF Cage with Integrated VerteBRIDGE® Plating

October 3, 2017 OrthoSpineNews

WARSAW, Ind., Oct. 2, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it is officially launching in the United States the Avenue® T TLIF Cage. Avenue T advances posterior lumbar cage technology by incorporating VerteBRIDGE® plating, which facilitates simplified cage insertion and zero-profile, intradiscal fixation through a direct, minimally invasive surgical (MIS) approach. Avenue T is the first and only posteriorly implanted cage with integrated, anti-migration fixation, solidifying Zimmer Biomet as the first company to offer a suite of lumbar cages with integrated fixation for every fusion approach. Avenue T joins a family of cages with VerteBRIDGE plating, including ROI-C® Cervical Cage, Avenue® L Lateral Lumbar Cage and ROI-A® ALIF Cage.

Dr. Craig Chebuhar, a board-certified orthopaedic spine surgeon in Atlanta, Georgia, who implanted one of the first Avenue T cages in the U.S., commented, “I regularly use Zimmer Biomet’s ROI-C Cervical Cage featuring VerteBRIDGE plating in my practice.  Transforaminal lumbar surgery is another attractive application for integrated plating.  For my TLIF patients, I appreciate the additional fixation VerteBRIDGE provides to the construct, all via a minimally invasive approach.”

The Avenue T Cage is a prime example of Zimmer Biomet’s commitment to the advancement of MIS surgery. The Avenue T Cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a simplified technique. The VerteBRIDGE plates are sterile packaged and pre-assembled on a PEEK cartridge. The cartridge simplifies the technique, enabling the cage and plates to be loaded simultaneously on the Inserter. Once the cage is implanted, the Impactor advances both plates at the same time, reducing implantation steps. The unique anterior column fixation provided by the plating may permit the surgeon to select from a greater array of options for supplemental fixation.

Indications: The Avenue T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

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BiologicsTop Stories

Vivorté announces the commercial availability of FORTERA™ and REGENTO™ bone grafting solutions for orthopedic surgery

October 3, 2017 OrthoSpineNews

LOUISVILLE, KY — (October 3, 2017) — Vivorté, Inc., a vertically-integrated, specialty orthopedic biomaterials company, today announced the commercial availability of a complete line of bone grafting product solutions. Joining Trabexus EB, the company’s flagship bone grafting solution, Fortera is a completely synthetic calcium phosphate cement, capable of controlled delivery through a 16-gauge cannula.  REGENTO is a resorbable, particulate b-TCP bone void filler with engineered macroporosity to promote protein deposition and cell attachment.

These newly introduced products join Trabexus EB, which first received 510(k) clearance in 2015.  TRABEXUS EB is a self-setting, gradually resorbable, calcium phosphate matrix enhanced with partially demineralized allograft particles.  The engineered bone component is formed into “hourglass” shapes (TRABS®) using a proprietary manufacturing process.

This novel shape provides multiple benefits, including increased “interconnectivity” of adjacent particles, creation of channels for accelerated remodeling and greater overall surface area.  Further, the TRABS are partially demineralized, exposing key osteoinductive proteins, which are known to influence and direct the formation of new bone.  Trabexus EB is resorbed and remodeled by the body as new bone formation occurs during the healing process.

“With the introduction of Fortera and Regento to our product portfolio, Vivorté now offers a complete line of synthetic biomaterials possessing a wide range of clinical performance attributes” said Ruth Voor, CEO of Vivorté, Inc. “Vivorté is a unique, emerging company, with multiple 510(k) cleared technologies, vertically-integrated manufacturing capability and an R&D pipeline of orthopedic biomaterials and traditional metallic implants. To date, our products have been well-received in the marketplace by orthopedic surgeons and hospitals, and we continue to expand our distribution network to reach institutions across the United States.”

According to BioMedGPS, the current market for bone graft substitute products exceeds $1.7B annually in the United States alone.  Bone grafting procedures are necessary to fill defects or cavities in bone as the result of injury, reconstructive surgical procedures such as a joint replacement, or surgical excision following the removal of tumors or cysts.

Clinical considerations vary across these procedures, requiring biomaterials with differing handling characteristics, biological activity and mechanical performance.  Vivorté continually seeks to understand the surgical environment in order to design and develop products that best complement each surgeon’s unique operative technique.

The Fortera and REGENTO products will be made available concurrent with the Orthopaedic Trauma Association (OTA) Annual Meeting, being held October 11-14, 2017 in Vancouver, B.C., Canada.  Representatives from Vivorté will be attending the OTA meeting to further address product requests and inquiries.

 

About Vivorté, Inc.

Vivorté, Inc., headquartered in Louisville, Kentucky, is a privately-held, ISO-certified orthopedic biomaterials manufacturer, focused on developing innovative and cost-effective, surgical products for the benefit of surgeons, hospitals and patients.  The company’s products include TRABEXUS® EB™ Osteoinductive Bone Matrix, Fortera™ Injectable Bone Graft and Regento™ Bone Void Filler.  To learn more, please visit our website at www.vivorte.com.

Contact: Therese Montano / Vivorté, Inc. / 502-714-7234 / tmontano@vivorte.com

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