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Providence Medical Technology Announces Regulatory Approval From Australian (TGA) For its DTRAX® Line

Posted On July 26, 2017 By OrthoSpineNews In Regulatory, Spine /

WALNUT CREEK, Calif., July 25, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology today announced regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DTRAX line of instruments and implants used in tissue-sparing posterior cervical fusion. The TGA approval covers GL-DTRAX Spinal System, GL-DTRAX Cervical Cage-T System, GL-DTRAX Cervical Cage-B, GL-DTRAX Expandable Cage, and GL-DTRAX Bone Screw. Providence plans to submit products to the Prostheses List in August 2017 for inclusion in early 2018.

“We are excited to deliver our innovative spinal technology to the Australian market and provide patients with less disruptive options for cervical spine surgery,” said Michael Scott, VP of International with Providence. “Australiarepresents an important, strategic market as it boasts a robust healthcare system, offers established reimbursement, and has a history of embracing innovative treatments for spine surgery.”

Providence’s DTRAX line of devices and instruments are designed to increase procedural efficiency, improve clinical outcomes, minimize complications, and reduce recovery times. Tissue-sparing posterior cervical fusion with intervertebral cages offers distinct advantages over traditional posterior fusion techniques. The products have seen continued, rapid adoption by spine surgeons, hospitals, and ambulatory surgery centers since their introduction and, to date, over 7,000 procedures have been performed worldwide.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billionworldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

SOURCE Providence Medical Technology, Inc.

LongueVue Capital, in Partnership with Management, Completes Investment in Zavation Medical Products, LLC

Posted On July 26, 2017 By OrthoSpineNews In Spine, Top Stories /

New Orleans, Louisiana – July 25, 2017 – LongueVue Capital (“LVC”) is pleased to announce it has partnered with management to acquire Zavation Medical Products (“Zavation” or the “Company”) and provide capital for growth. Zavation is a designer and manufacturer of high quality spinal implants, instruments, and biologics. Zavation expands LVC’s healthcare portfolio and is the second medical device business LVC has partnered within the past 18 months.

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, and minimally invasive surgery. Founded in 2010 with its first sale in 2012, Zavation has experienced exceptional growth and created a national network of 100+ distributors across approximately 35 states. The Company has commercialized over 10 product families since inception, with 10 additional novel products expected to launch over the next two years. Zavation operates a 24,000 square foot vertically integrated facility with approximately 50 employees.

“Zavation has demonstrated exceptional growth and is a perfect cornerstone to our expanding healthcare portfolio. This is our fourth healthcare platform investment and our third in the past 18 months,” said Ryan Nagim, Principal and deal lead at LVC. “Furthermore, we believe the Company is at an inflection point and has the opportunity to become a market leader in the spinal implant sector, as management has shown an incredible ability to execute. As such, we look forward to our partnership with Zavation’s management team and driving significant growth, both organically and through acquisitions of unique technologies.”

“Zavation fits well within LVC’s investment strategy,” added Rick Rees, Founder and Managing Partner of LVC. “We love partnering with entrepreneur owned businesses at inflection points that have proven management teams willing to invest meaningfully alongside LVC. The Company’s rapid growth is a testament to management’s ability to capitalize on compelling demographics and other industry tailwinds favoring smaller, more agile, and customer focused OEMs. Lastly, although we are geographically agnostic, it is always great to partner with entrepreneurs in our back yard, the Gulf South. As such, we are incredibly excited to partner with management and welcome Zavation into the LVC family.”

“The management team at Zavation chose LVC due to their entrepreneur-friendly investment approach to value creation and their knowledge and expertise in growing middle market companies at inflection points like ours. With a shared vision and culture, we are confident Zavation will remain focused on its core values of excellent customer service and quality products,” said Jeffrey Johnson, President and CEO of Zavation. “LVC’s financial and operational resources will allow us to introduce new products, meet and exceed distributor and surgeon expectations, expand our market presence, and take market share at an even faster and more deliberate speed. We are excited for our Company, our distributors, our surgeons, and our LVC partners.”

Robert W. Baird & Co.’s healthcare team, led by Robert Andrews and Manish Gupta, served as exclusive financial advisor to LVC on the transaction. Abacus Finance Group, LLC provided the senior debt financing to Zavation Medical Products in support of the transaction. LVC’s legal counsel was provided by McGuireWoods, LLP.

To learn more information about Zavation and its products, visit www.zavation.com

About LongueVue Capital:
LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented equity and debt investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions and growth. LVC currently has $425 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

For inquiries, please contact lvc@lvcpartners.com or call 504-293-3600.

Vertera Spine Announces FDA Clearance of COALESCE™ porous PEEK Lumbar Interbody Fusion Device

Posted On July 25, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, July 25, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCE™ Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. COALESCE features Vertera Spine’s novel proprietary porous PEEK biomaterial and is the second porous PEEK device to receive FDA clearance behind Vertera Spine’s COHERE® Cervical Interbody Fusion Device. Vertera Spine will be launching COALESCE for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations later this year.

COALESCE combines the osseointegration capabilities of porous metal implants with the favorable imaging and mechanical properties of traditional PEEK implants. Unlike metal-coated PEEK implants that can delaminate, COALESCE’s porous PEEK architecture is grown directly out of the implant’s solid PEEK base and has an interfacial strength stronger than the shear strength of vertebral trabecular bone. Furthermore unlike 3D-printed metal implants, porous PEEK behaves mechanically similar to bone under compression, essentially eliminating any stress shielding effects, and does not produce any imaging artifacts enabling accurate visual assessment of fusion.

Vertera Spine’s porous PEEK was first clinically introduced in May 2016 with the launch of the COHERE device for anterior cervical discectomy and fusion (ACDF) procedures. To date, over 2,000 implants have been successfully implanted with early successful clinical outcomes already reported in a peer-reviewed publication.¹

“Based on the initial success with the COHERE Cervical porous PEEK device, we saw the need to apply this innovative technology to other spine applications,” said Chris Lee, Vertera Spine CEO. “We are pleased to have received FDA clearance for COALESCE and look forward to further serving surgeons’ clinical demands for a durable fusion device that successfully osseointegrates and allows for integration to be assessed on imaging.”

“I initially became convinced of porous PEEK’s clinical benefits by the successful ACDF outcomes I obtained with the COHERE device,” said Gurvinder Deol, MD, an early COHERE adopter from WakeMed Health and Hospitals in Raleigh, NC. “However, I believe porous PEEK’s true value will be demonstrated with the COALESCE device in lumbar procedures where the biologic fusion environment can be more challenging, and the biomechanics more demanding on fusion devices.”

Prior studies have demonstrated the importance of adding porosity to implants to create a strong bone-to-implant interface and more stable union.² Supported by extensive research at Duke University and the Georgia Institute of Technology, COALESCE’s porous PEEK architecture, with 60% porosity and 300 mm average pore size, is specifically tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores. Dr. Ken Gall, Ph.D., Chair of Mechanical Engineering and Materials Science at Duke University, will be presenting new benchtop and clinical research on porous PEEK at the upcoming NASS Summer Spine Meeting this week in San Diego, Ca.

According to Dr. Gall, “Our latest results show that porous PEEK is able to effectively osseointegrate by forming a mechanical and biological interface with bone. Our next steps are to translate what we have learned in animal models to the clinical setting by assessing this bony ingrowth into porous PEEK on X-Ray and CT.”

About Vertera Spine:
Vertera Spine is a privately-held medical device company that develops, markets, and sells implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance, and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.comor call 678.705.9039.

COALESCE is a trademark of Vertera Spine. COHERE is a registered trademark of Vertera Spine.

¹Smith KE, Burkus JK, Gall K, et al. Getting PEEK to Stick to Bone: The Development of Porous PEEK for Interbody Fusion Devices. Techniques in Orthopaedics (accepted, in press).
²Svehla M, et al. Morphometric and mechanical evaluation of titanium implant integration: Comparison of five surface structures. J Biomed Mater Res, 2000.

Media Contact:
Jenn Pratt
Carabiner Communications
678.655.2273
jpratt@carabinercomms.com

Company Contact:
Lindsay Larson
Vertera Spine
571.758.3783
info@verteraspine.com

SOURCE Vertera Spine

Painful Choices: Why The GOP Health Plan Had To Fail

Posted On July 25, 2017 By OrthoSpineNews In Regulatory /

Published on July 24, 2017/Robert Pearl, M.D., Forbes Healthcare Contributor

Pain is a more powerful emotion than pleasure. Loss has a far greater impact on the human psyche than gain. For these reasons, the Republican plan to “repeal and replace” the Affordable Care Act (ACA) had to fail. And if our nation fails to reform the healthcare delivery system, as well, the impact will be even more painful.

Seven years ago, not long after the ACA became law, the GOP reassured supporters that repeal would happen—that for the good of the nation it had to happen. In drafting their replacement plan, legislators embraced healthcare spending reductions as a path to lower taxes. As a result, each of the healthcare bills introduced this term would cause tens of millions of Americans to lose their health coverage.

Congressional Republicans underestimated the pain this would cause. Now, they’re the ones feeling it. With healthcare reform efforts in limbo, President Trump resolved last week to “let ObamaCare fail,” later telling White House reporters, “I’m not going to own it. I can tell you, the Republicans are not going to own it.”

No one can say when or whether those on Capitol Hill will make another attempt at repealing or replacing the ACA. But one thing is for certain. Reform or no reform, pain is coming. And for politicians, pain always has an owner.

The Source Of Pain

Elected officials on both sides of the aisle recognize American healthcare today fails to deliver the quality and convenience patients deserve, especially given its $3 trillion annual price tag.

Healthcare today is dangerously expensive and inefficient, and will continue to be without radical change to the current system’s structure, financing and technology. For decades, these changes in care delivery have constituted the “third rail” of the debate, and few politicians have dared touch it. That’s because insurers, drug makers, national physician groups, hospitals and other institutional powers have openly, and effectively, lobbied against any legislation that would cause them financial harm.

This leaves the legislative process at an impasse. Unless care delivery is made more efficient, efforts to expand coverage, as Democrats desire, will demand higher taxes. And without delivery system reform, Republicans hoping to lower healthcare spending face the brutal reality that millions of people will lose coverage.

Photo: Mandel Ngan (AFP/Getty Images)

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Dr. Skidmore Reports Promising Results on a 30 Patients’ Series with EOI’s 3D Expandable FLXfit™ Cage

Posted On July 25, 2017 By OrthoSpineNews In Spine, Top Stories /

OR AKIVA, Israel, July 25, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that Dr. Grant Skidmore of Chesapeake Regional Medical Center has reported promising results with the FLXfit™ 3D Expandable TLIF Cage. Dr. Skidmore noted that “I take a lot of precautions in preserving the patient’s spinal anatomy and bony structure. My focus is on relieving the patient’s pain but also restoring his balance to assure a long term clinical outcome.” He said “With the FLXfit™, I finally have the ability to offer my patients the ultimate outcome thanks to the cage’s unique articulation and lordotic expansion feature.”

Dr. Grant Skidmore, Chesapeake Regional Medical Center, Norfolk, Virginia, explained “I am big believer of offering my patients immediate, robust and long term stability but was always puzzled how I could achieve this through a single and minimal posterior incision while preserving the spinal anatomy”. He concluded “our initial 30 patients’ series demonstrates the capability to place a large footprint cage at the front of the disc space, expand it lordotically in a controlled manner to achieve unique, anatomical fit, customized per patient.”

Ofer Bokobza, CEO of EOI, says that “we are excited to collaborate with such a skillful surgeon as Dr. Skidmore. His initial 30 patients’ series show very encouraging results and confirm the FLXfit™’s unique ability to restore lordosis and positively impact the patient’s sagittal balance.” Ofer emphasizes that “EOI recognizes the need for continuous clinical data collection through collaboration with leading surgeons. We believe that the FLXfit™ represents a new breed of expandable devices providing customized, anatomical fit solution that could lead to better patients’ outcome and new standard of care.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by seasoned management team, and is advised by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through MIS approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)3219683

SOURCE Expanding Orthopedics Inc.

Thomas Wickiewicz, MD, Inducted Into the AOSSM Hall of Fame

Posted On July 25, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

New York, NY—July 21, 2017

Thomas Wickiewicz, MD, sports medicine surgeon at Hospital for Special Surgery (HSS), was inducted today into The American Orthopaedic Society for Sports Medicine (AOSSM) Hall of Fame. This recognition is one of the highest honors given to an AOSSM member. Dr. Wickiewicz was presented with an award plaque during the AOSSM Annual Meeting in Toronto, Ontario.

“I am truly honored to be in the company of these extraordinary leaders in sports medicine,” said Dr. Wickiewicz. “I have focused my career on developing innovative minimally invasive surgical techniques designed to help patients get back to what they love doing most. For athletes of all levels, that is typically a return to sport.”

AOSSM Hall of Fame members are first nominated by their peers and then selected by the Hall of Fame committee. The Hall of Fame was established in 2001 to honor members of the orthopedic sports medicine community who have contributed significantly to the specialty. AOSSM is a world leader in sports medicine education, research, communication and fellowship, and includes national and international orthopaedic sports medicine leaders.

“Sports medicine is constantly evolving over the years as our research continues to advance the field,” said Dr. Wickiewicz. “Being a surgeon means being a student for the rest of your life. Education is critical to maintaining a robust medical practice over time.”

Dr. Wickiewicz joins fellow HSS sports medicine surgeon Russell F. Warren, MD, in the Hall.

READ THE REST HERE

Spinal Kinetics Surpasses 50,000 Implants of its M6© Artificial Disc Since Launch

Posted On July 25, 2017 By OrthoSpineNews In Spine, Top Stories /

July 25, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Spinal Kinetics, Inc., the designer and manufacturer of the innovative M6^© artificial disc, today announced total implantations of the company’s M6-C Cervical and M6-L Lumbar discs have now exceeded 50,000 throughout the international markets where the M6 is commercially available. Since the launch of the M6-C in 2006 and the M6-L in 2010, this “natural,” artificial disc design has consistently established itself as a technology of choice among spine surgeons for both cervical and lumbar disc replacement. With this strong surgeon preference, as well as patient demand for the next generation artificial disc technology, the M6 has become an industry leader in the rapidly growing artificial disc market. Additionally, the company is preparing its Pre-Market Approval (PMA) application to the FDA to obtain United States approval to treat single level cervical degenerative disc disease with the M6-C. The M6-C IDE study enrollment has been completed, and the PMA application is scheduled to be submitted to the FDA later this year.

The M6 artificial disc is designed to help patients suffering from degenerative disc disease of the spine; a common cause of chronic neck and back pain. The M6 technology provides an alternative to spinal fusion and is designed to restore natural and physiologic motion to the spine. Preserving motion with the M6 artificial disc provides an opportunity to restore biomechanical function at the treated level after native disc removal, as well as the possibility to reduce subsequent degeneration of adjacent segments. The M6 is the only physiologically designed artificial disc that mimics the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus in its design. Like a natural disc, this unique construct of the M6 allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements. Extensive biomechanical studies at world renowned institutions have continuously confirmed the M6’s ability to replicate natural physiologic motion.

“We are extremely proud as an organization to reach the 50,000 implant level and are appreciative of the spine surgeon community in adopting the M6 technology,” states Tom Afzal, President and CEO of Spinal Kinetics. “We believe this milestone continues to validate the market demand for more advanced artificial disc technologies that are designed to closely mimic a natural disc’s motion characteristics, ultimately benefiting patient outcomes. Disc replacement in the cervical and lumbar spine is not solely about how much motion an artificial disc provides, but more importantly, the quality of that motion and how that motion can affect other surrounding structures like facets and adjacent segments. The M6’s ability to replicate a natural disc’s quality of motion and biomechanics is what continues to differentiate it against all other artificial discs in the market.”

About Spinal Kinetics, Inc.

Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to the unique biomechanical properties that replicate the motion of a natural disc and the positive clinical outcomes for patients. The company is located in Sunnyvale, California.

For more information on Spinal Kinetics or the M6 Artificial Disc, please visit www.spinalkinetics.com. Spinal Kinetics, M6-C, M6-L are trademarks or registered trademarks of Spinal Kinetics, Inc.

CAUTION–Investigational device. Limited by Federal (or United States) law to investigational use.

Contacts

Spinal Kinetics, Inc.
Mike Gandy, 408-636-2557
mgandy@spinalkinetics.com

SpinalCyte acquires a new Japanese patent

Posted On July 24, 2017 By OrthoSpineNews In Regulatory /

July 21, 2017

Houston – ( BUSINESS WIRE ) – SpinalCyte, LLC, a tissue engineering technology company that is based in Texas and focuses on the regeneration of the disc nucleus pulposus using human skin fibroblasts , today announced that Japan Patent 6151006 ” Method and composition for cartilage repair using body bioreactor “announced the registration.

The technique described in this patent concerns the preparation of a cell / scaffolding composition of chondrocyte or chondrocyte-like cells. In this patent, we apply human skin fibroblasts (HDF) to the scaffold and subject the fibroblasts to mechanical stress, hypoxia, intermittent hydrostatic pressure. Furthermore, this technique also describes the use of bone formation growth factor.

SpinalCyte ‘s Chief Executive Officer Pete O’Heiron says: “This new Japanese patent shows that we have independently achieved international protection on our fibroblast technology, and our international understanding to regrow cartilage using fibroblasts It will develop a property portfolio. ”

Thanks to this addition, 23 registered patents (US and overseas) directly owned by the company and 46 patents under application are owned by SpinalCyte’s portfolio.

About SpinalCyte, LLC

SpinalCyte, LLC based in Houston, Texas, as a tissue engineering technology company, has developed an innovative solution for nucleus replacement using human dermal fibroblasts. SpinalCyte currently holds 23 registered patents in the United States and overseas, and has applied for further 46 patents. SpinalCyte, which receives all of its investment from angel investors, symbolizes the advancement of next-generation medicine for biopharmaceuticals and cell therapy.

The official version of this press release is the original language version. The translated language version is provided for the convenience of the reader and has no legal effect. When using the translated language version as a document, we ask you to compare against the original language version which is the only version with legal effect.

Contacts

Investors:
SpinalCyte, LLC
Pete O’Heiron, 281-461-6211
CEO
info@spinalcyte.com
or
Media:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

Anika Announces Regulatory Approval for MONOVISC® in India

Posted On July 24, 2017 By OrthoSpineNews In Regulatory /

July 24, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in India granted approval to MONOVISC^®, its single injection viscosupplement for the treatment of pain associated with osteoarthritis of all human synovial joints. MONOVISC is commercially available in the United States, Canada and Europe, and Anika plans to expand into India, Australia, New Zealand and additional international markets over the next six to nine months.

“Expanding our global commercial footprint is one of our key strategic pillars of growth, and the approval of MONOVISC in India is a proof point for our ability to execute against the benchmarks we define each year,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics. “There is a growing demand for non-invasive, long-acting treatments for osteoarthritis in emerging countries such as India where knee replacement surgery is often the last option or not an option at all, due to limited medical resources outside major cities and high costs of surgery and postsurgical care.With its ability to safely relieve pain for up to six months with fewer office visits, lower treatment costs and no downtime after treatment, MONOVISC is poised to be well-received by physicians and patients in India.”

The global expansion of MONOVISC is the primary international orthobiologics revenue driver for Anika, and India represents a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Modi-Mundipharma Pvt. Ltd. (“MMP”) to market MONOVISC in India. MMP is a leading multinational pharmaceutical company with a significant focus on pain management. Utilizing their large, dedicated sales force, MMP will be able to introduce MONOVISC to a broad range of physicians that treat a substantial number of patients suffering from the symptoms of osteoarthritis.

About MONOVISC

MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit Anika’s website at www.anikatherapeutics.com.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the second sentence of the first paragraph, second sentence of the second paragraph, and first sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s international expansion plans, the market for the Company’s products in emerging countries such as India, and the Company’s Monovisc Product as a revenue driver for the Company. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

Xtant Medical to Announce Second Quarter 2017 Results on August 9th, 2017

Posted On July 24, 2017 By OrthoSpineNews In Financial /

BELGRADE, Mont., July 24, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that it will release its financial results for the second quarter ended June 30, 2017, after the close of the financial markets on Wednesday, August 9, 2017.

An accompanying conference call will be conducted by Carl O’Connell, Chief Executive Officer and President, and John Gandolfo, Chief Financial Officer, to review the results. The call will be held at 10:00 AM ET, on Thursday, August 10, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Details
Conference Date: Thursday, August 10, 2017 10:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Xtant Medical Holdings, Inc. Second Quarter 2017 Results Call
Webcast Registration: Click Here
Following the live call, a replay will be available on the Company’s website, www.xtantmedical.com, under “Investor Info”.

About Xtant Medical
Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements
This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

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

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

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