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

Posted On October 4, 2017 By OrthoSpineNews In Biologics, Top Stories /

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 13^th 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.

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

Posted On October 3, 2017 By OrthoSpineNews In Spine, Top Stories /

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

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

Posted On October 3, 2017 By OrthoSpineNews In Spine, Top Stories /

October 03, 2017-Photo: Business Wire

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

MiMedx Completes Divestiture Of Its Stability Biologics Subsidiary

Posted On October 3, 2017 By OrthoSpineNews In Biologics, Financial, Top Stories /

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.

NN, Inc. Announces The Acquisition Of DRT Medical

Posted On October 3, 2017 By OrthoSpineNews In Financial /

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.

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

Posted On October 3, 2017 By OrthoSpineNews In Biologics, Regulatory /

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 22^nd, 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

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.

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

Posted On October 3, 2017 By OrthoSpineNews In Spine, Top Stories /

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.

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

Posted On October 3, 2017 By OrthoSpineNews In Biologics, Top Stories /

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

OrthoPediatrics Corp. Announces Launch of Initial Public Offering

Posted On October 3, 2017 By OrthoSpineNews In Financial /

WARSAW, Ind., Oct. 02, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”), an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market, announced today the launch of the initial public offering of 4,000,000 shares of its common stock. OrthoPediatrics will grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock. The proposed offering price is expected to be between $12.00 and $14.00 per share of common stock. OrthoPediatrics has applied to list its common stock on the NASDAQ Global Market under the ticker symbol “KIDS.”

OrthoPediatrics intends to use the net proceeds that it receives from the proposed offering to pay accumulated and unpaid dividends on its Series B preferred stock, to invest in implants and instrument sets for consignment to its customers, to fund research and development activities, to expand its sales and marketing programs, and for working capital and general corporate purposes.

Piper Jaffray and Stifel are acting as joint book-running managers, William Blair is acting as lead manager and BTIG is acting as co-manager, of the proposed offering.

The proposed offering will be made only by means of a prospectus. Copies of the prospectus related to the proposed offering may be obtained from: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicole Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at prospectus@pjc.com; or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, via telephone at (415) 364-2720 or via email at syndprospectus@stifel.com.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. All statements other than statements of historical facts included in this press release, including statements concerning OrthoPediatrics’ plans, objectives, goals, beliefs, business strategies, future events, business conditions, results of operations, financial position, business outlook and business trends, are forward-looking statements. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “budget,” “goals,” “potential,” “continue,” “design,” “objective,” “would” and other similar expressions. The forward-looking statements are not historical facts and are based upon OrthoPediatrics’ current expectations, beliefs, estimates, projections and assumptions, many of which, by their nature, are inherently uncertain and beyond OrthoPediatrics’ control. OrthoPediatrics’ expectations, beliefs, estimates and projections are expressed in good faith, and OrthoPediatrics believes there is a reasonable basis for them. However, there can be no assurance that such expectations, beliefs, estimates and projections will result or be achieved, and actual results may vary materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ registration statement on Form S-1. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

About OrthoPediatrics Corp.

Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 21 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products to 35 countries outside the United States.

Investor Contacts:
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

Taking MIS TLIF to the Next Level

Posted On October 2, 2017 By OrthoSpineNews In Spine, Top Stories /

Tracey Romero/9-29-2017

Photo: PROLIFT® and Dr. Zeshan Hyder/Courtesy of Life Spine

In an arena of rapid technological advancement, it takes an innovation powerhouse to design products that have the ability to disrupt the spine industry. Life Spine, a manufacturer of spinal implants that launched 27 products in 2016, has revolutionized the TLIF taking it from a 90+ minute minimally invasive procedure to a micro-invasive procedure that has been completed in as little as 25 minutes.

Surgeons like Zeshan Hyder, D.O. of the Bone and Joint Specialists of Northwest Indiana are executing up to six of these procedures in one day. The potential benefits of a drastic reduction in procedural time are directly realized by surgeons and their patients. The system is designed to offer the benefits of: less time in the hospital and OR, reduced incision size, a safer surgery and a more reproducible procedure that caters to an ambulatory surgery center (ASC) setting.

The main benefit of the micro-invasive TLIF is less time in the operating room which typically correlates to a faster recovery.

Traditional TLIF procedures can take up to six hours. Six hours of muscle retraction, anesthesia, blood loss and fatigue to the hospital staff. Additionally, the longer the operating time, the fewer the patients a surgeon can operate on and the higher the cost of surgery.

READ THE REST HERE

Author: OrthoSpineNews

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Taking MIS TLIF to the Next Level

Tracey Romero/9-29-2017