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February 2-4, 2017
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Financial

Misonix Names Leading Medical Device Executive Gwen Watanabe to Board of Directors

July 19, 2018 OrthoSpineNews

FARMINGDALE, N.Y., July 19, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (NASDAQ:MSON) (“Misonix” or the “Company”), a provider of minimally-invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced the appointment of Gwen Watanabe to its Board of Directors. Ms. Watanabe replaces John Gildea, the founding principal of Gildea Management Co., who has retired from his position on the Board of Directors.

“Gwen is a highly respected executive in the medical device sector who brings outstanding entrepreneurial skills to the Misonix Board as well as a proven, long-term track record of success in mergers and acquisitions at Teleflex,” stated Stavros Vizirgianakis, President and Chief Executive Officer of Misonix. “The ongoing execution of our cohesive strategy to grow Misonix’s leading ultrasonic surgical product platform is providing the Company with a solid foundation to continue expanding market share domestically as well as abroad. As we pursue the next phase of inorganic and organic growth for Misonix, we are confident Gwen’s presence on the Board of Directors will be tremendously valuable in helping the Company achieve our goals for sustainable revenue growth and profitability, as well as the enhancement of long-term shareholder value.”

Ms. Watanabe commented, “I am very excited at the opportunity to join the Misonix Board of Directors and be part of a fast-growing company that is leveraging its unique proprietary ultrasonic technology to bring to market medical devices that deliver demonstrated clinical benefits and improve patient outcomes. I look forward to sharing the experience and business relationships built over my career working with medical device start-ups and large public organizations to offer sound business counsel to Misonix as the Company continues to pursue its strategic growth initiatives and expand its leadership position in the ultrasound medical device industry.”

Stavros Vizirgianakis added, “I want to thank John Gildea for his many contributions and service to the Board and the Company over the last fourteen years. His leadership and financial expertise were instrumental in guiding Misonix through a period of significant change and positioning the Company for continued growth in the future.”

Gwen Watanabe has over 24 years of financial and executive management experience in the medical device industry. Ms. Watanabe presently serves as the vice president of global corporate development, strategy, and strategic partnerships for Teleflex Incorporated, a global provider of medical technology products, where she also serves as a member of the executive leadership team, reporting to Teleflex’s CEO. In her role at Teleflex, she is responsible for worldwide corporate strategy and mergers and acquisitions.

Prior to Teleflex, Ms. Watanabe served as president and chief executive officer of medical device start-up Hotspur Technology, Inc., where she led the company from initial idea and design concept in 2009 through commercial release before negotiating the successful sale of the business to Teleflex in 2012. From 2004 to 2009, Ms. Watanabe served as chief business officer and chief financial officer of Nellix Endovascular, Inc., a medical device start-up that she co-founded, where she successfully raised venture capital financing and led a broad range of strategic initiatives that resulted in the acquisition of the company by Endologix. Earlier in her career, she served as a business development manager at Bacchus Vascular, Inc. (acquired by Covidien) and a project engineer at Aneurx, Inc. (acquired by Medtronic). In addition, Ms. Watanabe was a general partner at Saratoga Ventures V, L.P. and Saratoga Ventures VI, L.P., which were all medical device venture funds.

Ms. Watanabe earned a Bachelor of Science degree in Mechanical Engineering from the Massachusetts Institute of Technology. She obtained her Master of Science in Mechanical Engineering, Design Division from Stanford University and a Master in Business Administration from Harvard University. She formerly served on the Board of Directors for Hotspur Technologies, Catharos Medical, NovaSom (formerly Sleep Solutions), Axis Surgical, Tibion, American Red Cross of Hawaii and the Gift Foundation of Hawaii.

About Misonix, Inc.

Misonix, Inc. (NASDAQ:MSON) designs, develops, manufactures and markets ultrasonic medical devices for the precise removal of hard and soft tissue, including bone removal, wound debridement and ultrasonic aspiration. Misonix is focused on leveraging its proprietary ultrasonic technology to become the standard of care in operating rooms and clinics around the world. Misonix’s proprietary ultrasonic medical devices are used in a growing number of medical procedures, including spine surgery, neurosurgery, orthopedic surgery, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. At Misonix, Better Matters to us. That is why throughout the Company’s history, Misonix has maintained its commitment to medical technology innovation and the development of ultrasonic surgical products that radically improve patient outcomes. Additional information is available on the Company’s web site at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Contact: 
Joe Dwyer
Chief Financial Officer
Misonix, Inc.
631-694-9555		 Joseph Jaffoni, Norberto Aja, Jennifer Neuman
JCIR
212-835-8500 or mson@jcir.com
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Regulatory

MiMedx Appoints Mark Graves Chief Compliance Officer To Strengthen Corporate Compliance Practices

July 19, 2018 OrthoSpineNews

MARIETTA, Ga., July 18, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it has appointed Mark P. Graves to the position of Chief Compliance Officer.  Mr. Graves will be responsible for providing direction and oversight of MiMedx’s compliance program, including the Company’s regulatory and legal compliance matters related to the Company’s risk management, sales operations and financial reporting. Mr. Graves will report to Ed Borkowski, the Company’s Executive Vice President and Interim Chief Financial Officer on a day-to-day basis. He will also report directly to the newly formed Ethics and Compliance Committee of the Board of Directors.

“We are implementing plans to improve our corporate compliance practices in order to ensure our Company adheres to policies with the highest integrity, ethics and legal standards,” said David Coles, interim Chief Executive Officer, MiMedx. “Mark has a strong background in driving compliance strategy, risk awareness, training, and crafting effective policy. He will help MiMedx apply and execute on best-in-class compliance standards that reflect our commitment to enhancing value for all stakeholders. We are pleased to welcome him to our organization.”

Graves brings more than 20 years of pharmaceutical and biotech industry experience to MiMedx, ranging from compliance and sales management to government affairs. He most recently was the U.S. leader for the global Patient Experience & Value function in the neurology division of UCB, Inc., a biopharmaceutical company. From 2011 to 2015, he was UCB’s Deputy Compliance Officer involved in all aspects of compliance, including the implementation and management of the company’s corporate integrity agreement. Prior to that, Graves was Senior Director in the Office of Ethics and Compliance for the Pharmaceutical Products Division of Abbott Laboratories, as well as Deputy Ethics & Compliance Officer for Takeda Pharmaceuticals North America, Inc. and TAP Pharmaceutical Products, Inc. Prior to his pharmaceutical and biotech career, he practiced labor and employment law.

Graves holds a B.A. in Criminology and Law, and a J.D. from the University of Florida as well as an MBA from the University of Chicago Booth School of Business.

The Audit Committee and the Company are developing and implementing corrective measures to improve MiMedx’s accounting and internal control practices. As part of this initiative, and as noted in the Company’s June 7, 2018 press release, the MiMedx Board of Directors established an Ethics and Compliance Committee, which includes independent directors Luis A. Aguilar and Neil S. Yeston M.D. The Company also is conducting a formal search to fill the newly established positions of Chief Accounting Officer and Internal Auditor.

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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SpineTop Stories

Nuvasive Launches MAGEC X For Early Onset Scoliosis Treatment

July 19, 2018 OrthoSpineNews

SAN DIEGO, July 19, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the U.S. launch of MAGEC X, a new procedural solution within the MAGEC product family that addresses Early Onset Scoliosis (EOS).

MAGEC X features updates across all rod diameters in the portfolio, including 5.0mm diameter rods for patients, delivering a 68 percent performance increase over the previous generation in titanium rod fatigue testing. When paired with the NuVasive Reline® Small Stature system, the first pediatric deformity fixation solution to integrate both 4.5mm and 5.0mm rods in a low-profile tulip, MAGEC X provides increased construct strength without sacrificing the optimal profile for EOS patients.

“NuVasive’s MAGEC X 5.0mm solution is unique because it allows you to upsize your rod with low-profile screws, giving you the flexibility at the time of surgery to use a larger rod without having to change your screws – that’s really key,” said Dr. Peter Sturm, Alvin H. Crawford Chair of Spine Surgery, Cincinnati Children’s Hospital Medical Center. “Further, the upgrade of the internal components in MAGEC X rods gives me even more confidence in the performance of a system that has radically changed how we treat this challenging patient population.”

The development of MAGEC X is also distinguished by a number of internal rod mechanism advancements, most notably a reinforced locking pin and a robust actuator seal designed to further contain and reduce the release of titanium wear debris. Additionally, it includes an anti-jam feature to simplify intraoperative and postoperative rod lengthening. Key aesthetic improvements, such as laser-marked sagittal bending lines, help to enhance surgeon workflow efficiency and ease of use.

“More than 100,000 children are diagnosed with scoliosis each year in the United States; the launch of MAGEC X exemplifies our continued dedication to the advancement of EOS treatment and support of the pediatric surgeon community,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “MAGEC X represents the culmination of over a decade of clinical experience and innovation, resulting in a stronger and smarter MAGEC implant design.”

This full commercial launch of MAGEC X follows the Company’s preview announcement, which occurred at the POSNA Annual Meeting in May in Austin, Texas.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Financial

RTI Surgical® Schedules Second Quarter 2018 Earnings Call for August 2, 2018

July 19, 2018 OrthoSpineNews

July 19, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results from the second quarter of 2018 on Thursday, August 2, 2018, prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss second quarter 2018 results at 9:00 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical, Inc.

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

Forward-Looking Statements

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

Contacts

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

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RegulatorySpine

FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion

July 18, 2018 OrthoSpineNews

July 17, 2018

NASHUA, N.H.–(BUSINESS WIRE)–Vallum Corporation, a medical device company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus® nanotextured1 surface created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology.

PEEKplus® is the first and only FDA-cleared nanotextured surface on a PEEK interbody device.

Vallum’s PEEKplus® nanotextured surface is unique in the spinal device market. Nano-scale concavities of 20-50 nanometers are created by the impact of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus®. Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.2,3

PEEKplus is not a coating, it is not porous, and no chemicals are infused into the PEEK.

“Technological advances to improve the performance of implantable medical devices are taking many forms,” said Prof. Elazer R. Edelman, MD, PhD, who provided the earliest advice and encouragement to Vallum’s management team. “I believe one of the most important of those technological advances is surface modification at the nano-scale, and Vallum’s FDA clearance is a significant step down that very promising path.”

While this FDA clearance is specific to Vallum, its nanotexturing technology can be inexpensively applied to any fully manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties. Exact same PEEK interbody device – only now, truly differentiated in the spine market with a PEEKplus® nanotexture.

“Our PEEKplus® is a breakthrough innovation in spinal fusion surgery and the result of a collaborative effort among surgeons, researchers, ion beam scientists, and biomedical engineers,” said Stephen M. Blinn, President and CEO of Vallum. “A substantial investment in time and capital has been made in developing our proprietary ANAB processing technology as well as the nano-processing techniques and protocols used to produce PEEKplus®.”

Eric J. Woodard, M.D., Chairman of Vallum’s Medical Advisory Board, commented, “Receiving the first FDA clearance for a PEEK interbody fusion device incorporating nanotechnology is a tremendous milestone for Vallum. It is an important demonstration of Vallum’s leadership in developing advanced nano-processing technology for the spine and potentially for other orthopedic applications. It has been shown that nano-scale surface topographies generate osteogenic responses that drive bone growth required for a solid fusion. The ability to produce a nanotextured topography into the surface of a PEEK interbody device has the potential to set a new standard in the performance of spinal fusion interbody implants.”

About Vallum Corporation
Vallum is a medical device company headquartered in Nashua, New Hampshire. It has developed advanced technology and processing protocols for nano-scale surface engineering of implantable medical devices. The company is currently focused on nano-scale surface modification of PEEK interbody fusion devices to improve their performance in spinal fusion.

The company’s management believes its advanced technology and processing protocols can ultimately be developed to improve other implantable orthopedic devices for treating disorders throughout the body. Accelerated Neutral Atom Beam (ANAB) technology and its medical applications for nano-scale surface modification, including PEEKplus®, are covered by multiple issued patents and trade secrets.

Vallum’s mission is to develop, produce and deliver innovative and disruptive nano-scale surface technologies to affordably improve implantable medical devices and thereby improve patient outcomes and quality of life. More information can be found at www.vallumcorp.com.

Upcoming Corporate Events
Vallum management will be presenting at the Medical Alley Innovation Summit being held in Minneapolis on October 2-3, 2018 at the Minneapolis Marriott City Center.

1 ISO/TS 80004-1:2015(en): Nanoscale-length range approximately from 1 nm to 100 nm
2 Ganesan Balasundaram and Thomas J. Webster. A perspective on nanophase materials for orthopedic implant applications. Journal of Materials Chemistry, Issue 38, 2006
3 Gabriel Colon. Brian C. Ward, Thomas J. Webster. Increased osteoblast and decreased Staphylococcus epidermidis functions on nanophase ZnO and TiO2. Published online 2 June 2006 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.a.30789

Contacts

Vallum Corporation
Stephen M. Blinn, 1-603-493-4457
President and CEO
sblinn@vallumcorp.com

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Spine

ChoiceSpine™ Expands Its US Western Region Sales Team

July 18, 2018 OrthoSpineNews

KNOXVILLE, TENN. (PRWEB) JULY 18, 2018

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced the hiring of a Western Regional Sales Director and Clinical Sales Manager expanding its sales team and emphasizing its commitment to growth.

The two new additions to the sales team are:

  • Rajeev Shrikhande as Western Regional Sales Director; and
  • Aaron Logan as Clinical Sales Manager

“ChoiceSpine is committed to growth in all aspects of our business,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “The addition of Rajeev and Aaron ensures our sales success in the Western region, a key contributor to our corporate revenue growth and product expansion.”

Rajeev was recently hired into his leadership position with over 8 years of successful spine sales experience. “Raj’s sales acumen, work ethic and industry knowledge fits well with our corporate strategy and the ChoiceSpine culture,” exclaimed Rick.

“Aaron is extremely knowledgeable in spinal anatomy, procedures and products. His knowledge, enthusiasm and passion are a welcome addition to our clinical sales team,” said Marty.

ChoiceSpine is appropriately positioned to quickly expand its Western region and grow its sales revenue in 2018 and beyond. The new additions to the team emphasize the company’s long-term strategic focus and expectations of industry-leading profitable growth.

About ChoiceSpine 
ChoiceSpine is a privately held spinal implant company located in Knoxville, TN. Founded in 2006, ChoiceSpine offers an extensive array of innovative, surgeon focused systems designed with the best clinical outcomes in mind.

In addition, ChoiceSpine offers a full regenerative and osteobiologics portfolio including synthetics, DBM’s, structural allograft, and amnion allografts. With cutting edge technologies like our Veo™ VLIF lateral fusion system, 3D printed additive manufacturing in TigerShark™, and the incorporation of our impregnated Hydroxyapatite (HA) PEEK® interbodies, ChoiceSpine is committed to always staying ahead of market trends and to provide surgeons with dynamic solutions for their patients.

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Biologics

AlloSource Awards Dr. Kevin Shea The Annual Dr. Steven Gitelis Inspiration Award

July 18, 2018 OrthoSpineNews

CENTENNIAL, Colo., July 17, 2018 /PRNewswire-USNewswire/ — AlloSource, one of the largest nonprofit cellular and tissue networks in the country, offering life-saving and life-enhancing solutions in orthopedic, spine, burn and wound procedures to help restore patient health and mobility, today announced that it will award Dr. Kevin Shea with its second annual Dr. Steven Gitelis Inspiration Award. The award honors a doctor or clinician that inspires AlloSource through his or her work in treating patients with allografts.

Dr. Shea recently joined the Stanford University School of Medicine as a professor of orthopedic surgery and also serves as director of the Stanford Children’s Health Sports Medicine Program. He specializes in the treatment of knee ligament and cartilage injuries, osteochondritis dissecans (OCD), fractures, and pediatric trauma and is one of the founders of The ROCK Group, an organization dedicated to researching OCD and improving its treatment methods.

“I am honored to receive this award,” said Dr. Shea.  “I look forward to continued advancements in the field of orthopedics.”

Dr. Shea has been crucial in coordinating efforts between The ROCK Group and AlloSource in research on OCD and other pediatric orthopedic conditions.  Dr. Shea works tirelessly to find unique uses for donated allograft material for pediatric orthopedic applications. In 2018, Dr. Shea was a recipient of the American Academy of Orthopedic Surgeons (AAOS) Senior Achievement Award in recognition of his volunteer work for the AAOS and orthopedic community.

“Dr. Shea truly embodies the spirit of honoring the gift of tissue donation to help heal his patients,” said Thomas Cycyota, AlloSource president and CEO. “His commitment to research and improving treatment methods using donated tissue is an inspiration to all of us at AlloSource. We admire his dedication to the profession of orthopedic surgery and to his patients.”

The award honors a physician who understands and embraces the use of donated human tissue in surgical applications. The award is named after Dr. Steven Gitelis, a highly regarded orthopedic surgeon and one of the founders of AlloSource.

About AlloSource 

AlloSource is dedicated to advancing the science and use of transplantable allogeneic cells and tissue through pioneering research in regenerative therapies. The organization offers life-saving and life-enhancing solutions in orthopedic, spine, burn and wound procedures to help restore patient health and mobility. As a world leader in cell-based products, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource’s products bridge the proven science of allografts with the advanced technology of cells. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org.

Media Contact 

Megan Duggan

AlloSource

720. 382. 2766

mduggan@allosource.org

                                                                                      

SOURCE AlloSource

Related Links

http://www.allosource.org

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SpineTop Stories

Zavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage)

July 18, 2018 OrthoSpineNews

FLOWOOD, Miss., July 17, 2018 /PRNewswire/ — Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today that it has received 510(k) clearance from the FDA to market Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage).

For More Information on Zavation’s Complete Product Portfolio, Visit: http://zavation.com/.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy.  The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients.  The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The Normandy VBR System is indicated for use in the cervical spine (C2-C7) and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Jeffrey Johnson (Zavation CEO) stated, “Our research and development team has hit a home run with this new expandable corpectomy device.  Not only is it one of the first expandable corpectomy devices cleared for cervical use; but the ease of insertion, ease of expansion, and large graft area sets a new industry standard!”

Zavation will showcase the Normandy VBR Corpectomy Cage System at the North American Spine Society (NASS) in Los Angeles, CA September 26-29, 2018.

About Zavation Medical Products, LLC– Based in Flowood, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, and minimally invasive surgery.

SOURCE Zavation

Related Links

http://zavation.com

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Financial

EOS imaging Announces First Half 2018 Sales of €17.5 Million Supported by Strong Growth in Asia-Pacific and North America

July 18, 2018 OrthoSpineNews

July 17, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of orthopedic medical imaging, 2D/3D, today announced its non-audited consolidated sales revenue for the six months ended June 30, 2018.

  • +11% sales growth over first half 2017 excluding forex impact1, driven by 36% growth in Asia-Pacific and 33% in North America (excluding forex impact), compensating partially postponed sales in EMEA
  • Notable increase of +4% in average selling price (ASP) despite significant forex impact, boosted by +22% rise in ASP in dollar over North America

Marie Meynadier, Chief Executive Officer of EOS imaging, commented: “We experienced strong commercial dynamics in all regions, which are not fully represented by our second quarter 2018 sales revenues due to postponing to the second half of the year a number of equipment sales in EMEA, and to a lesser extent in North America. APAC delivered very strong growth. The positive market environment for EOS® technology is also reflected in the steady growth of the average selling price, an important area of focus for the Company. Despite a significant forex impact over the semester, ASP has improved in all regions, particularly in North America. The market demand for EOS® solutions continue to grow rapidly. We look forward to a very strong second half year and are confident regarding EOS imaging’s performance for the full year 2018.”

  • Sales for First Half 2018
Revenues / non-audited / € millions
As of June 30th		 H1 2018 H1 2017 % change % change
excl. forex
impact
Sales of Equipments 13.61 13.15 4% 8%
Sales of maintenance contracts 3.46 2.83 22% 28%
Sales of consumables and services 0.48 0.49 -3% -3%
Total revenues 17.54 16.46 7% 11%

In the first half of 2018, EOS imaging generated revenue of €17.5 million, up +7% compared to the first half of 2017, including forex impact, i.e. €18.3 million, up +11% compared to H1 2017 excluding forex impact.

The Group sold 34 EOS® systems during the first half of the year, in line with H1 2017, with average selling price showing a +4% increase including forex impact (+8% excluded). Revenues from equipment sales was €13.6 million, up +4% compared to 2017 (+8% excluded forex impact).

Recurring revenues grew +19% to €3.9 million, including €3.5 million in maintenance revenue and €0.5 million in consumables and services revenues. The +22% rise in maintenance revenue reflects the continued increase in the installed base of EOS® systems under contract.

  • First Half 2018 Sales by geography
Revenues / non-audited / € millions
As of June 30th		 H1 2018 H1 2017 % change
(excl. forex
impact)
EMEA 6.28 7.39 -16%
North America 6.83 5.74 19% (33%)
Asia-Pacific 4.44 3.34 36%
Total revenues 17.54 16.46 7% (11%)

First half 2018 revenue growth has been driven by strong sales in Asia-Pacific and North America but was partially offset by postponed sales in Europe-Middle-East-Africa (EMEA).

Revenue decreased -16% in EMEA as a result of delays in the three largest European markets of the Company (France, United Kingdom and Germany), where several sales decisions were postponed to the second half of the year.

In North America, revenues grew by 19% (33% excluding forex impact). In April, EOS imaging launched its dedicated private practice program, EOSone, which is expected to achieve its full impact over the coming months.

Revenues grew by 36% in Asia-Pacific, reflecting rapid adoption of the EOS® system in the region, particularly in Korea and Australia. No sales were recorded in China in the second half of 2018.

  • Sales for Second Quarter 2018
Revenues / non-audited / € millions 2018 2017
Q1 Q2 Q1 Q2
Equipment sales 7.56 6.05 5.47 7.67
Var. Q2 2017 / excl. forex impact -21%/-14%
As a % of total revenues 79% 76% 77% 82%
Sales of maintenance contracts 1.72 1.74 1.40 1.43
Var. Q2 2017 / excl. forex impact +21%/+32%
As a % of total revenues 18% 22% 19% 15%
Sales of consumables and services 0.26 0.21 0.26 0.23
Var. Q2 2017 / excl. forex impact -7%/-6%
As a % of total revenues 3% 3% 4% 3%
Total revenues 9.54 8.00 7.13 9.34
Var. Q2 2017 / excl. forex impact -14%/-6%

In the second quarter of 2018, EOS imaging achieved revenues of €8.0 million, compared to €9.3 million in second quarter of 2017 (-6% at constant forex), mainly due to sales postponements in EMEA.

The Company sold 15 EOS® systems over the quarter at an average selling price of €404 thousand, up +5% from the second quarter of 2017. Excluding forex impact, the average selling price for the North America region in the second quarter was up 33% from that of the same period last year.

  • Update on Cash Position

In the first half of the year, EOS imaging has refinanced its debt with IPF and successfully raised €29.5 million in convertible notes to fully reimburse that debt and suppress all associated pledges.

This has allowed the Company to enter into a first agreement to factor part of its receivables, that will be broadened in the second half year. As of June 30th, 2018, EOS imaging had €8.9 million in cash covering its financing needs for the next 12 months.

  • Signature of a binding agreement with Fosun Pharmaceuticals AG related to an equity investment

EOS imaging also announces today the signature of a binding agreement with Fosun Pharmaceutical AG, an indirect subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., related to an equity investment to be made by Fosun Pharmaceutical AG through an issuance of EOS imaging news shares. For more information, please refer to the dedicated press release published today on EOS imaging’s website: www.eos-imaging.com.

Next financial release: Announcement of 2018 Half-Year results on September 13th, 2018

ABOUT EOS IMAGING

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

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

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

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

1 Forex impact: impact of the variation of the euro / foreign currencies exchange rate, mostly due to variation in euro / US dollar exchange rate. Variations excluded forex impact are calculated based on the average of exchange rates over H1 2017.

Contacts

EOS imaging
Marie Meynadier, Ph: +33 (0)1 55 25 60 60
CEO
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman, Ph: 646-536-7006
The Ruth Group
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
Ph: 646-536-7008 / 7024
The Ruth Group
EOS-imagingIR@theruthgroup.com

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SpineTop Stories

K2M Enhances CASCADIA™ Lateral 3D Interbody System Featuring Lamellar 3D Titanium Technology™ Following Clearances for CAYMAN® United Plate System

July 17, 2018 OrthoSpineNews

LEESBURG, Va., July 17, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and a CE Mark for its CAYMAN® United Plate System following completion of its first surgical cases. CAYMAN United is designed for rigid fixation to K2M’s CASCADIA™ Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology™, the first and only 3D-printed cage with modular fixation capabilities. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

“The CAYMAN United Plate System, which firmly fixates to K2M’s CASCADIA Lateral 3D implants, is a notable advancement,” said Robert Lee, FRCS (Tr&Orth), a spine surgeon at Royal National Orthopaedic Hospital NHS Trust in Stanmore, UK. “Its streamlined technique and versatile insertion options provide an elegant solution for my minimally invasive lateral cases, while also utilizing a 3D-printed device to encourage bony integration throughout the implant.”

The CAYMAN United Plate System’s single level, 1- and 2- hole plate configurations precisely match all CASCADIA Lateral 3D height and lordosis options, allowing surgeons to customize the construct using a lateral approach. Single-level plate sizes minimize retraction required for placement and an assembly alignment feature keys into the CASCADIA implants to resist rotation. Versatile insertion options allow for plate assembly with a central assembly screw prior to implantation, or in-situ after the cage has been placed.

“We are excited to receive FDA clearance and a CE Mark for our CAYMAN United Plate System, designed to enhance our CASCADIA Lateral 3D Interbody System and making it the first and only 3D-printed cage available on the market with modular fixation capabilities,” said K2M Chairman, President, and CEO, Eric Major. “As a leading innovator of 3D-printed spinal solutions, we remain committed to developing advanced technologies that when complemented by our comprehensive Balance ACS platform, help surgeons facilitate 3D spinal balance in their patients.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CASCADIA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity.

Balance ACS® (or BACS®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information on the CASCADIA Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology and the CAYMAN United Plate System, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

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.  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 in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; 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 to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; 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. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

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

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