Month: November 2018

Aurora Spine Announces Exclusive Patent License Agreement for MIS SI Joint Product

CARLSBAD, Calif., Nov. 16, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today that it has acquired an exclusive license to US patent #9,451,986 titled “Percutaneous sacroiliac joint implant and method for surgically inserting and securing the implant into the sacroiliac joint” in an agreement with SILIF Corporation of Buffalo, New York (“SILIF”), the inventor of a posterior SI Fusion technology.

The license will enable Aurora Spine to develop a new Posterior Sacroiliac Joint Fixation System. The implant, named EASiFX™, will feature multiple retaining and bone locking mechanisms. The EASiFX procedure will offer less tissue disruption, decreased operating room time and radiation exposure. The procedure also offers minimal distraction of the SI joint through a safe, posterior method.

The license is another example of Aurora Spine’s vision and leadership in the provision of fusion solutions for a diverse range of spine surgery procedures. EASiFX is expected to add to the Company’s expanding product portfolio of unique implant products and add to the growth of Aurora Spine.

“Aurora Spine is changing spine surgery. The SILIF patent technology, which has been enthusiastically received by surgeons, has the potential to become the standard of care for spine patients with SI Joint pathologies,” said Trent Northcutt, President and CEO of Aurora Spine.  “The license provides access to a procedure that has been growing in excess of 20% in recent years, leverages the core competencies and vision of our minimally invasive spine portfolio of game-changing innovative products and provides new growth opportunities in the U.S.  We believe this opportunity is perfectly aligned with our spine-focused expansion strategy to pursue niche differentiated products, customer retention and support portfolio pull-through along the way.”

“The EASiFX implant is a differentiated product designed to drive fusion and is supported by an expanding market segment. We remain committed to growing our spine portfolio and infusing our expertise to help our hospital, surgeon and distribution partners,” said Northcutt.

“The EASiFX implant prototypes were successfully used in a cadaver lab setting earlier this year along with only a few surgical tools required to complete a successful implant placement,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine. “The implants performed remarkably well in our test and we are looking forward to presenting all the benefits the invention offers to patients and physicians.”

According to iData Research, the U.S. minimally invasive spinal implants market is expected to increase to over $2 billion by 2023. The fastest growing implant segment is the MIS sacroiliac joint fusion market. Clinical evidence demonstrates that sacroiliac joint fusion (“SIJF”) is an effective procedure. The popularity of SIJF has grown rapidly over the past five years.  The SIJF market is currently 5 percent of the overall spine market and it’s projected to reach 20 percent by 2021.  By 2024, the SIJF market in the US is expected to exceed $200 million, driven primarily by an increase in procedure volumes and adoption by new surgeons.

As consideration for the license, the Company will issue 1,000,000 common shares of the Company to SILIF at a price of CDN$0.30 per share, with all such shares being subject to a 5 year tiered lock-up agreement, with 20% of the shares released from the lock-up on each anniversary of the closing date of the transaction. In addition, the Company will issue SILIF warrants to purchase up to 1,750,000 common shares of the Company, exercisable at CDN$0.35 for a period of 5 years following the date of grant.  The warrants will vest in 20% increments on each anniversary of the closing date of the transaction.

All securities issued by Aurora Spine in connection with the transaction will be subject to a statutory four-month hold period. The transaction is subject to certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the TSX Venture Exchange.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies.  Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed transaction and Aurora Spine’s ability to complete the transaction. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

For more information, please contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

Spineway sets up the governing structure for its US subsidiary

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), is reorganizing and setting up the governing structure for its US subsidiary with the arrival of a new CEO.

Pursuant to the strategic plan, Stéphane Le Roux, CEO of Spineway SA, launched the reorganization of the US subsidiary in order to revitalize sales in said country. The first steps are the arrival of Jon Luedke as CEO of Spineway Inc. and Philippe Laurito moving to the position of CTO. He will perform his duties within the subsidiary until the end of the year so as to ensure a smooth transition for the new CEO and provide technical follow-up on current business.

Jon Luedke, 54 years old, has over 20 years’ experience in the spine sector. He has held positions as General Manager and Sales Manager with major groups (Zimmer Spine and Centinel Spine) and with innovative SMEs (Wenzel Spine and Prosidyan). During the course of his professional career, he was able to draw on his business-development skills to carry out projects from repositioning companies to reviving business activities, making it possible to improve the sales and profitability of the companies under his stewardship.

His thorough understanding of the spinal-column business and his knowledge of the various players on the US market will be an asset to the Group’s new strategy, make it possible to market competitive products via the various distribution networks in the US.

The new momentum generated as a result of this appointment should allow the Group to create a new growth model for Spineway Inc.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Meeting for the presentation of the strategic plan on 13 December 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW      

Contacts:

Shareholder-services line
Available Tuesday through Thursday 
(10 a.m.-12 p.m.)
+33 (0)811 045 555
  Investor relations
Solène Kennis
spineway@aelium.fr

Attachment

NuVasive Launches First-Of-Its-Kind Brigade® Lateral Implant And Instrumentation Optimized For Lateral Anterior Lumbar Interbody Fusion Spine Surgery

SAN DIEGONov. 15, 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. commercial launch of Brigade® Lateral, the industry’s first interbody implant and instrumentation optimized for lateral anterior lumbar interbody fusion (ALIF) spine surgery.

NuVasive’s Lateral ALIF™ is a proprietary spine procedure enabling access to L5-S1 from a lateral position, while retaining the characteristics of a traditional ALIF. Brigade Lateral features improved instrumentation, a new insertion method and an expanded lordotic implant offering, all optimized for improved workflow and outcomes through the Lateral ALIF procedure. The technology’s threaded in-line inserter is angled off the midline and positioned on the lateral edge of the implant to better access the L5-S1 spine levels, which have typically been very difficult to treat effectively. The instrumentation is designed to offer surgeons a low-profile and reproducible insertion method, enhancing the overall surgical workflow in the operating room (OR). With a variety of lordotic implant options, Brigade Lateral allows surgeons to customize lordosis based on a patient’s need which is important to preserving and restoring spinal alignment.

“The NuVasive Lateral ALIF procedure, coupled with the Brigade Lateral implant and instrumentation specifically designed for this approach, is a game changer for me and my patients,” said Dr. Michael Cluck, orthopedic surgeon at Bay Area Spine Care in San Jose, California. “When used with minimally invasive surgical techniques, Lateral ALIF allows surgeons to complete a standard ALIF and posterior fixation from one position for both single-level and, more importantly, multi-level lumbar spinal fusions.”

Lateral ALIF is integrated into NuVasive’s lateral single-position surgery platform which is intended to increase OR efficiency by reducing the need for patient repositioning which may result in a patient being under anesthesia for a decreased amount of time.

“NuVasive pioneered the lateral approach in spine surgery, and continues to lead the industry with disruptive procedural solutions that maximize the efficiency of these less invasive techniques while retaining the inherent benefits to surgeons, patients and hospitals,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “Brigade Lateral is no exception, and extends our comprehensive procedural offering to a wider range of indications from the lateral approach.”

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

OSN Interview with David Derminio – Executive Vice President Commercialization at Myoscience

Dave, would you please give us a brief overview of your Orthopedic career and how you got started in the business?

Immediately following my graduation from the Business School at Arizona State University I went to work for American Hospital Supply Corporation. As I progressed through my career with AHSC, they provided excellent training in Sales, plus Sales and General Management This foundation prepared me for my subsequent career in Orthopedics,

My Orthopedic career began in 1982. I have enjoyed the privilege of being a part of four startup/early-stage companies, a global contract manufacturer for Orthopedics and Spine, and some of the major joint companies. My responsibilities have ranged from Sales and Product Management, Senior Sales & Marketing roles, and General Management. They include running the US business for a European based multinational orthopedic company, President of a Digital Imaging company focused on Orthopedic practices, and Global Sales and Customer Satisfaction Leadership for the contract manufacturing division of a Swedish conglomerate who supplied implants and instrumentation to major Orthopedic and Spine companies. Early in my orthopedic career I realized my passion was for technology-based orthopedic, early-stage companies.

My first technology based startup was Intermedics Orthopedics where we introduced a new titanium mesh ingrowth surface to orthopedics. The next endeavor was Orthologic, a bone growth stimulation company which possessed a unique and very effective waveform for the healing of delayed and non-union fractures. As Vice President of Sales & Marketing we grew the company from $0 to $30 million in three years and subsequently acquired Sutter Biomedical. I also served as the Vice President of Sales & Marketing at DonJoy. From there I was recruited by Aesculap Orthopedics to run their U.S. business. Aesculap pioneered Computerized Surgical Navigation and introduced it to America. They also introduced the first Advanced Surface Technology coated knee for patients who are allergic to Cobalt, Chrome, and Nickel. Prior to coming to Myoscience, I spent five years as the West Area Vice President for Biomet Orthopedics with responsibility over Joint Reconstruction, Trauma, Sports Medicine and Biologics. I currently serve as the Executive Vice President, Commercialization for Myoscience.

There is no question the technology Myoscience has introduced is the most exciting I have experienced in my 36 year orthopedic career.

Can you share some of the back story on Myoscience as well as a general overview of where things stand today?

Myoscience, founded in 2005, is a private-equity funded medical technology company based in the Silicon Valley. Its proprietary technology, the iovera° system, was developed as a nontoxic alternative to Botox and initially marketed in Europe.

In 2013, the iovera system was cleared by the FDA for treating peripheral nerves with cryoanalgesia to block pain. The iovera° therapy blocks pain by cryoneurolysis, which is a localized disruption of the signal-carrying members of a nerve. This is referred to as cryoanalgesia – pain relief by applying extreme cold. Physicians explain this treatment to their patients as “freezing of nerves”.

Robust, level 1 clinical studies have found the iovera therapy to be effective as:

A non-opioid nerve block, the effects of which are immediate and long-lasting for treating chronic and perioperative pain.

Since 2016, Myoscience has focused its commercialization efforts on treating chronic knee pain due to osteoarthritis and acute knee pain after total knee arthroplasty. These well-defined market segments help Myoscience establish its iovera technology as a pain management modality of choice, especially to address the opioid crisis the country in currently facing.

Can you explain a high level overview of how the technology works?

The iovera system uses centuries-old, well-established principles of cryoanalgesia. The advantage of using nitrous oxide as the cryogen is it limits the temperature range (-20C to -88C) of cold applied to the target nerve(s). This ensures that the lysis of the nerve is within the 2nd degree of nerve disruption per Sunderland’s classification, which renders this to be reversible.

The therapy is delivered through a compact, cordless and hand-held device. Pressurized liquid nitrous oxide is delivered into closed-end needles, where it is allowed to expand to gas. The phase change produces -88C at the tips of the needles. Moisture from the surrounding tissue freezes to form a small tic-tac sized ice ball at the distal end of these needles. This is sufficient to cause the desired selective lysis of the targeted nerve.

The nitrous oxide gas is vented out through the hand-held device. Therefore, no drug or chemical is delivered into the body.

There is one important distinction – cryoneurolysis by the iovera system should not be confused with cryoablation. Cryoablation is a complete and permanent damage and removal of tissue, most commonly associated with Heat Radio Frequency treatments. The effect of cryoneurolysis, on the other hand, is transient and reversible.

What is the “Why” behind the iovera system?

The opioid crisis in our country is not expected to end any time soon. More than 15% of patients continue to depend on opioids six months after TKA surgery and 40% of patients who use opioids before TKA continue to depend on these drugs several months after surgery.

Physicians and surgeons are trying to use several modalities to limit the dependence on opioids. The iovera therapy has been identified as one of those modalities.

The significant advantage of the iovera therapy over all other modalities is it is drug-free, very localized and non-systemic. It takes a physician or a PA or NP less than 30 minutes to administer it. The provider receives positive confirmation of the treatment because the iovera therapy is administered while the patient is awake.

Where would we expect to see the iovera device being used in the market place?

The safety and efficacy of the iovera technology has been well-established via robust, randomized clinical studies, especially for treating knee pain. Myoscience is currently completing another study on the knee at the Campbell Clinic in Memphis, Tennessee. The results from this study are not only encouraging, but further confirm what has already been observed. The early results were presented at a symposium during the recent AAHKS Meeting. The study results have been selected for a podium presentation by William Mihalko, MD, the Principal Investigator, at the March 2019 American Academy of Orthopedic Surgeons Meeting.

We are currently enrolling patients in a study to establish the iovera therapy’s efficacy in treating patients who undergo ACL repair/reconstruction surgery. Additionally, we plan to expand the application of the iovera therapy to treat shoulder pain and the all-too-prevalent low back pain.

Any closing thoughts or remarks as we wrap up the interview?

The iovera therapy is intended for preventing opioid addiction. The federal government and several state governments are focused on fighting the crisis after the patient is addicted to opioids. Our objective is to prevent the addiction; not fight it after the fact.

Surgeons are beginning to refuse TKA for patients if they don’t receive the iovera therapy. This is a profound statement, especially from the thought leaders in the orthopedic industry. Several surgeons have referred to technology as a “game changer.”

I appreciate the contributions of Jessica Preciado, PhD, our Director of Clinical Research & Principal Scientist and Kris Kumar, our Director, Marketing and Product Management to this article.

Myoscience’s journey has just begun. We foresee the iovera therapy as the pain management modality of choice for treating the pain and symptoms of several diseases in the coming years.

Dave, we really appreciate your time today. Congratulations on all of the success thus far and we look forward to seeing what’s in store for you and the entire team at Myoscience.

Simplify Medical Completes Enrollment in U.S. IDE Pivotal Trial of Simplify® Disc for Two-Level Cervical Disc Replacement

SUNNYVALE, Calif., Nov. 14, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd., maker of the Simplify® cervical artificial disc, today announced that it has completed the enrollment and treatment of all patients in its U.S. Investigational Device Exemption (IDE) pivotal trial evaluating the Simplify® Disc for two-level cervical disc replacement. The Simplify Disc is designed for biomechanical motion, anatomical height-matching, and MRI compatibility with a goal of simplifying the treatment of degenerative disc disease.

The prospective, multi-center clinical trial enrolled a total of 200 patients at 18 clinical sites across the United States. The primary endpoint of the study is the clinical success rate of Simplify Disc in two contiguous levels from C3 to C7 compared with two-level anterior cervical discectomy and fusion (ACDF). The Company announced the completion of enrollment for its one-level IDE trial in February 2018.

David Hovda, CEO of Simplify Medical, said, “Our two-level trial has generated an exceptional level of interest, which has allowed us to complete study enrollment more quickly than anticipated. We thank all of our dedicated surgeon investigators who have participated in the trial and look forward to working with them to complete the study.”

Domagoj Coric, MD, Chief of Neurosurgery at Carolinas Medical Center and national co-primary investigator for the study as well as co-primary investigator of the one-level study, stated, “Given its compelling feature set and the early positive feedback, I believe the Simplify Disc represents the future of cervical disc arthroplasty. I look forward to providing my patients with this technology as it becomes commercially available and am eager to share clinical data when available.”

Richard Guyer, MD, chairman of the Texas Back Research Institute Foundation and national co-primary investigator for the study as well as co-primary investigator of the one-level study, commented, “The Simplify Disc has the potential to offer an attractive alternative for two-level disease by simplifying procedure complexity compared to other marketed devices, providing motion, and better matching patient anatomy with lower disc heights that avoid excessive wear. We look forward to sharing outcomes at upcoming spine meetings.”

The Simplify Disc is being evaluated in separate IDE trials in the U.S. for one- and two-levels. The Simplify Disc is CE Marked in Europe and commercially available in select European markets. Internationally, early market feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.

About Simplify® Disc
Simplify® Disc is a motion-preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and to better match patients’ anatomies. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

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

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

Xtant Medical Announces Third Quarter 2018 Financial Results

BELGRADE, MT, Nov. 14, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development of regenerative medicine products and medical devices, today reported financial and operating results for the third quarter ended September 30, 2018.

Third Quarter 2018 Financial Highlights and Recent Announcements:

  • Revenue for the third quarter of 2018 was $17.3 million, compared to $19.8 million for the third quarter of 2017
  • Gross profit for the third quarter of 2018 was 66.7%, compared to 57.5% for the same period in the prior year
  • Net loss incurred in the third quarter 2018 was $3.2 million compared to a loss of $8.5 million for the same period in the prior year
  • Non-GAAP Adjusted EBITDA was $1.5 million, compared to $1.4 million for the same period of the prior year
  • As previously announced, the Company appointed Michael Mainelli as Interim Chief Executive Officer and Kathie Lenzen as Senior Vice President, Finance & Administration and Chief Financial Officer

Xtant Interim CEO Michael Mainelli said “After my first few weeks on the job, it’s clear to me that Xtant is a company with great products, strong business partners, and talented employees.  We are pleased that we are starting to see the benefits of the recent facility consolidation efforts and cost reduction initiatives.   At the same time, our sales results are below our potential.  We are working on plans that are expected to improve sales through a combination of new products, marketing programs, and more effective channel management.”

Third Quarter 2018 Financial Results

Revenue for the third quarter of 2018 was $17.3 million, compared to $19.8 million in the same period last year.  This decrease occurred primarily due to company-initiated discontinued distributor arrangements and channel management challenges.

Gross profit for the third quarter of 2018 was 66.7%, up from 57.5% for the same period in 2017. This improvement is largely due to expenses for inventory reserves and impairment of surgical instrument asset values in the third quarter of 2017 that did not recur in 2018, and favorable impacts from cost reduction initiatives.

Operating expenses for the third quarter of 2018 were $13.0 million, a decrease of $3.1 million compared to $16.1 million in the quarter ended September 30, 2017. The reduction is primarily due to lower commission expense as a result of lower revenue due to discontinued distributor arrangements and channel management challenges. In addition, the Company continued to execute its cost reduction initiatives to consolidate facilities used for biologics and fixation systems operations.

Net loss from operations for the third quarter of 2018 was $3.2 million, or $0.24 per share, compared to a net loss of $8.5 million, or $5.62 per share, for the same period in the prior year, primarily the result of the reduced operating expenses and lower interest expense, and in the case of the net share decrease, increased shares outstanding during the current year period.

Non-GAAP Adjusted EBITDA for the third quarter of 2018 was $1.5 million compared to $1.4 million for the same period during 2017. Non-GAAP Adjusted EBITDA for the nine-month period ended September 30, 2018 was $3.4 million, compared to a loss of $0.8 million in the same period in the prior year.  The Company defines Adjusted EBITDA as net income/loss from operations before depreciation, amortization and interest expense, and as further adjusted to add back in or exclude, as applicable, non-cash compensation, change in warrant derivative liability, separation related expenses, litigation reserve, facility consolidation costs and restructuring expenses.  A calculation and reconciliation of non-GAAP Adjusted EBITDA to net loss can be found in the attached financial tables.

Amendments to Credit Facility and Issuance of Warrants

On September 17, 2018, the Company announced the execution of 24th and 25th amendments to its Amended and Restated Credit Agreement, which, among other provisions, reduced interest payable under the credit facility.  In connection with the 25th amendment, the Company issued warrants for the purchase of 1.2 million shares of Xtant common stock with an exercise price of $0.01 per share and an expiration date of August 1, 2028, to OrbiMed Royalty Opportunities II, LP and ROS Acquisition Offshore LP, which collectively own approximately 70% of Xtant’s outstanding common stock and are the sole holders of the Company’s outstanding long-term debt under the credit facility.

Conference Call

The Company will host a webcast and conference call to discuss the third quarter 2018 financial results on Wednesday, November 14, 2018 at 4:30 PM ET.  To access the webcast, Click Here.  To access the conference call, dial 877-407-6184 within the U.S. or 201-389-0877 outside the U.S.  A replay of the call will be available at www.xtantmedical.com, under “Investor Info.”

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures.  Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.

™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Non-GAAP Financial Measures  

To supplement the Company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures in this release, including Adjusted EBITDA. Reconciliations of the non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. The Company’s management believes that the presentation of these measures provides useful information to investors.  These measures may assist investors in evaluating the Company’s operations, period over period. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources.  Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

Important Cautions Regarding Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ “continue,” “future,” ‘‘will,’’ “potential,” similar expressions or the negative thereof, and the use of future dates. Forward-looking statements in this release include the Company’s plans to improve sales through a combination of new products, marketing programs, and more effective channel management.  The Company cautions that its forward-looking 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 Company’s future operating results and financial performance; its ability to increase revenue,  remain competitive and innovate and develop new products; the effect of management changes and ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products, ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which the Company may be subject; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 8, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. 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 the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.

XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except number of shares and par value)

As of As of
September 30, 
2018
December 31, 
2017
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents $ 5,064 $ 2,856
Trade accounts receivable, net of allowance for doubtful accounts of $2,108 and $1,923, respectively 9,869 12,714
Current inventories, net 22,187 22,229
Prepaid and other current assets 738 1,706
Total current assets 37,858 39,505
Non-current inventories, net 194
Property and equipment, net 8,069 9,913
Goodwill 41,535 41,535
Intangible assets, net 11,248 13,826
Other assets 560 732
Total Assets $ 99,270 $ 105,705
LIABILITIES & STOCKHOLDERS’ EQUITY (DEFICIT)
Current Liabilities:
Accounts payable $ 5,918 $ 9,316
Accounts payable – related party 160
Accrued liabilities 3,976 15,845
Warrant derivative liability 48 131
Current portion of capital lease obligations 478 366
Total current liabilities 10,420 25,818
Long-term Liabilities:
Capital lease obligations, less current portion 251 624
Long-term convertible debt, less issuance costs 70,853
Long-term debt, less issuance costs 75,944 67,109
Total Liabilities 86,615 164,404
Commitments and Contingencies (note 10)
Stockholders’ Equity (Deficit):
Preferred stock, $0.000001 par value; 10,000,000 shares authorized; no shares issued and outstanding
Common stock, $0.000001 par value; 50,000,000 shares authorized; 13,171,347 shares issued and outstanding as of September 30, 2018 and 1,514,899 shares issued and outstanding as of December 31,2017
Additional paid-in capital 171,008 86,247
Accumulated deficit (158,353 ) (144,946 )
Total Stockholders’ Equity (Deficit) 12,655 (58,699 )
Total Liabilities & Stockholders’ Equity (Deficit) $ 99,270 $ 105,705

XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except number of shares and per share amounts)

Three Months Ended 
September 30,
Nine Months Ended 
September 30,
2018 2017 2018 2017
Revenue
Orthopedic product sales $ 17,139 $ 19,618 $ 53,622 $ 62,986
Other revenue 127 171 319 294
Total Revenue 17,266 19,789 53,941 63,280
Cost of sales 5,743 8,416 17,711 23,472
Gross Profit 11,523 11,373 36,230 39,808
Operating Expenses
General and administrative 2,505 3,330 8,931 11,985
Sales and marketing 7,847 8,904 24,742 31,038
Research and development 347 504 1,179 1,843
Depreciation and amortization 1,029 1,354 3,074 4,105
Restructuring expenses 614 1,194 2,582 2,814
Separation related expenses 436 792 490 1,396
Non-cash compensation expense 180 (20 ) 585 217
Total Operating Expenses 12,958 16,058 41,583 53,398
Loss from Operations (1,435 ) (4,685 ) (5,353 ) (13,590 )
Other (Expense) Income
Interest expense (1,790 ) (3,809 ) (8,156 ) (10,538 )
Change in warrant derivative liability 42 (20 ) 83 136
Other (expense) income 30 18
Total Other (Expense) Income (1,718 ) (3,829 ) (8,055 ) (10,402 )
Net Loss from Operations $ (3,153 ) $ (8,514 ) $ (13,408 ) $ (23,992 )
Net loss per share:
Basic $ (0.24 ) $ (5.62 ) $ (1.19 ) $ (15.94 )
Dilutive $ (0.24 ) $ (5.62 ) $ (1.19 ) $ (15.94 )
Shares used in the computation:
Basic 13,158,326 1,514,126 11,262,642 1,505,493
Dilutive 13,158,326 1,514,126 11,262,642 1,505,493


XTANT MEDICAL HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)

Nine Months Ended 
September 30,
2018 2017
Operating activities:
Net loss $ (13,408 ) $ (23,992 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 4,943 7,433
Non-cash interest 7,853 9,966
(Gain) loss on disposal of fixed assets (15 ) 1,909
Non-cash compensation expense/stock option expense 585 593
Provision for losses on accounts receivable and inventory 298 1,711
Change in derivative warrant liability (83 ) (136 )
Changes in operating assets and liabilities:
Accounts receivable 2,842 4,135
Inventories (508 ) 1,718
Prepaid and other assets 1,138 (211 )
Accounts payable (3,557 ) (3,418 )
Accrued liabilities (867 ) (897 )
Net cash used in operating activities (779 ) (1,189 )
Investing activities:
Purchases of property and equipment and intangible assets (308 ) (1,456 )
Proceeds from sale of fixed assets 251
Net cash used in investing activities (57 ) (1,456 )
Financing activities:
Proceeds from long-term debt 12,787
Payments on capital leases (260 ) (203 )
Payments on revolving line credit (10,448 )
Expenses associated with private placement and convertible debt conversion (3,507 )
Proceeds from equity private placement 6,810
Proceeds from issuance of stock 1
Net cash provided by financing activities 3,044 2,136
Net change in cash and cash equivalents 2,208 (509 )
Cash and cash equivalents at beginning of period 2,856 2,578
Cash and cash equivalents at end of period $ 5,064 $ 2,069

XTANT MEDICAL HOLDINGS, INC.
CALCULATION OF NON-GAAP CONSOLIDATED EBITDA AND ADJUSTED EBITDA
AND RECONCILIATION TO NET LOSS FOR THE PERIODS ENDED
SEPTEMBER 30, 2018 AND 2017
(Unaudited, in thousands)

Three Months Ended September 30, Nine Months Ended September 30,
2018 2017 2018 2017
Net loss $ (3,153 ) $ (8,514 ) $ (13,408 ) $ (23,992 )
Other expense (30 ) (18 )
Depreciation and amortization 1,655 2,797 4,943 7,037
Interest expense 1,790 3,810 8,156 10,538
Non-GAAP EBITDA gain (loss) 262 (1,907 ) (327 ) (6,417 )
Non-GAAP EBITDA/Total revenue 1.5 % -9.6 % -0.6 % -10.1 %
NON-GAAP ADJUSTED EBITDA CALCULATION
Non-cash compensation 180 (20 ) 585 217
Change in warrant derivative liability (42 ) 20 (83 ) (136 )
Separation related expenses 436 792 490 1,396
Litigation reserve 1,342 1,342
Facility consolidation costs 9 195
Restructuring expenses 614 1,194 2,582 2,814
Non-GAAP Adjusted EBITDA gain (loss) $ 1,459 $ 1,421 $ 3,442 $ (784 )
Non-GAAP Adjusted EBITDA/Total revenue 8.5 % 7.2 % 6.4 % -1.2 %

Contact
Kathie Lenzen, Senior Vice President, Finance & Administration and Chief Financial Officer
406.388.0480
Email: klenzen@xtantmedical.com

Nanovis Expands the Range of Footprints for its Signature FortiCore Posterior Lumbar Interbody Fusion System

Nanovis, a leader in nanomedicine for the spine, today announced adding 22mm and 25mm lengths to its FortiCore® rotatable Posterior Lumbar Interbody Fusion (PLIF) devices.

With over 5,000 FortiCore interbodies now implanted, Nanovis plans to further accelerate its technology driven growth with the expansion of their FortiCore PLIF product line with the addition of 22 mm and 25 mm lengths that can be rotated in situ for optimal placement.

“Many of our customers asked for these new sizes so they could treat their lumbar patients after using FortiCore in the cervical spine. Our surgeon customers have converted from titanium, PEEK, plasma sprayed PEEK, and allograft for the benefit of a deeply porous interconnected titanium scaffold to secure the implant and the benefit of a PEEK core to visualize bridging bone. They’ve been very pleased with their patient’s results and are asking for more lumbar FortiCore options because of the difficulties in assessing and achieving the best outcomes with other interbody technologies.” said Matt Hedrick, CEO, Nanovis. FortiCore® interbody fusion devices are comprised of a deeply porous titanium scaffold designed to assist in securing the implant in the intervertebral space. The scaffold is intermolded with PEEK Optima® by InVibio to allow bridging bone visualization. This unique combination of technologies is designed to increase positive outcomes in spinal fusion procedures with the imaging capabilities preferred by surgeons. “These FortiCore sizes complete our lumbar TLIF and PLIF offering. Nanovis is growing quickly with the best technology portfolio for our distributors to build their revenue and their surgeon relationships. The science driven innovation and potential to help patients has helped achieve favorable hospital access as a technology product. Distributors interested in the best possible fixation technology should reach out to me at jeff.shepherd@nanovistechnology.com,” said Jeff Shepherd, VP of Sales, Nanovis. Nanovis’ technology driven growth strategy is based on its FortiCore, nanotube, and NanoPEEK fixation technology platform and it’s bactericidal nanotube and infection prevention and treatment technology platform. The FortiCore scaffold, sold in other orthopedic markets as the OsteoSync™ scaffold by the inventors of the technology, Sites Medical, shows positive results and attractive sales growth. Combined, these technologies provide exceptional fixation capability that supports years of spine and orthopedic implant upgrades, patient benefits, and technology driven sales growth. For more information about Nanovis, FortiCore or other proprietary Nanovis science-enhanced technologies, please visit us http://www.nanovisinc.com.

About Nanovis:

Nanovis’ mission is to develop science-enhanced, life-improving technologies. The Company’s patented and
proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Focused on aggressive, sustainable growth across multiple markets, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore® line of interbody fusion devices; an advanced nanotube surface; and a nanotube surface technology with anti-colonization and anti-microbial capabilities in pre-clinical studies.

Camber Spine Announces First Surgeries With ENZA®-A Titanium ALIF

Spokane Doctor Advancing Performance of Total Knee Replacements

SPOKANE, Wash.Nov. 13, 2018 /PRNewswire/ — Dr. David F. Scott, a leading orthopedic surgeon and researcher, is exploring new, innovative knee implant designs and surgical techniques made for custom fit total knee replacements.

The basis for this improved knee replacement performance is an anatomical approach, whereby an implant is placed in the native joint line of a patient’s knee using specific anatomic landmarks around the knee to guide the orientation of the prosthetic components in an attempt to restore the joint to its pre-arthritic position and function. This differs from the more widely used, traditional method where total knee replacements are performed with a mechanical alignment that places implants in an average position for all patients, regardless of their individual anatomy.

Dr. Scott already employs this anatomical approach in his surgical technique, a variation on a technique known as Kinematic Alignment (KA), a surgical method made popular by Dr. Stephen Howell in 2005, and has seen the benefits it provides to his patients, including improved knee function and overall patient satisfaction.

Now, Dr. Scott is building on and advancing the work done by himself, Dr. Howell, and others by helping perfect implants specifically designed for this technique — something that has the potential to shape the future of total joint replacement procedures.

While only a small fraction of surgeons use an anatomical approach for knee replacements, the technique is gaining more interest due to exposure in scientific publications and at joint replacement meetings, symposia, and educational events, of which Dr. Scott actively participates.

Dr. Scott and Dr. Howell have worked to vocalize and teach the merits of this approach through a series of learning centers, where didactic lectures are followed by cadaver surgeries. Additionally, Dr. Scott is designing instruments to aid and perform the surgical technique, as well as advising manufacturers of orthopaedic devices on the design of research protocols to compare KA to the the traditional mechanical alignment technique with the hope of providing more concrete evidence of its merits.

“Anecdotally, the single most important finding of the research surrounding the anatomical approach is that it’s possible to improve significantly the clinical outcomes after total knee arthroplasty (TKA),” says Dr. Scott. “My research shows that an anatomic approach can work very well — that a more anatomic knee implant design, coupled with an anatomic approach to the surgical procedure itself, produces the best results ever seen with TKA.”

Although more longer-term studies are needed to prove further these already stellar results, Dr. Scott feels confident that this approach is the future of knee replacement.

“This custom alignment process is where the future of knee replacements is going. Average alignments are the old school method which I believe will be phased out completely over time,” says Dr. Scott. “The research is already out there with more being done to prove the effectiveness of custom alignments every day, and we’re really happy to be leading this work.”

Dr. Scott has published and presented research extensively in the orthopaedic field, and, specifically, on the benefits of the anatomical approach to knee replacement and implant design. He recently published a paper in the May 2018 issue of the “Journal of Arthroplasty” titled “Prospective Randomized Comparison of Posterior-Stabilized Versus Condylar-Stabilized Total Knee Arthroplasty: Final Report of a Five-Year Study”; in an ongoing study titled “Medial-Pivot, Cruciate- Substituting, Post-Market Multicenter Outcomes Study,” a multi-center study comparing the results of knees implanted with the KA approach versus the results from other surgeons using the mechanical alignment approach; and in a podium presentation titled “Patient Satisfaction and Clinical Outcomes Are Better With a Medial-Stabilized Implant vs. a Posterior-Stabilized Implant” presented to the International Society for Technology in Arthroplasty in London, Englandin October of 2018.

For more of Dr. Scott’s research, visit the research section on the OSC website (https://orthospecialtyclinic.com/our-research).

About Dr. David F. Scott
Dr. Scott completed his orthopaedic residency in New York City at the Hospital for Joint Diseases. He received fellowship training in adult reconstruction at the University of Utah, where he was an adjunct assistant professor at the School of Medicine for over 5 years. He is currently a clinical instructor at the UW School of Medicine, and specializes in arthritis surgery with an emphasis on joint replacement. David F. Scott, MD is an active member of the American Association of Hip and Knee Surgeons. His practice, Orthopaedic Specialty Clinic, is based in Spokane, Washington. For more information about OSC, visit the website (https://orthospecialtyclinic.com).

Media Contact:
Geneva Randall 
204564@email4pr.com 
509-690-6085

SOURCE Dr. David F. Scott

Related Links

https://orthospecialtyclinic.com/our-research

Bio2 Technologies, Inc. Receives FDA IDE Approval to Begin Clinical Study of Resorbable Cervical Interbody Device for Spinal Fusion

WOBURN, Mass.Nov. 13, 2018 /PRNewswire/ — Bio2 Technologies, Inc., a privately held orthopedics company, announced today that it received U.S. Food and Drug Administration (“FDA”) approval to begin enrollment in an IDE clinical study to evaluate Vitrium as a cervical interbody fusion device.  Vitrium will be evaluated as a structural device that facilitates bone remodeling via a gradual conversion from Vitrium to the patient’s own bone.

A proprietary process is used to produce Vitrium’s structure and porosity, enabling exceptional bone conductivity.  Composed entirely of bioactive glass, Vitrium represents an innovative approach on a well-studied osteostimulative mechanism of action with a long track record of safe clinical use.

The randomized, controlled, non-inferiority pivotal study will capture safety and effectiveness data with a twelve-month end point. Vitrium is currently in commercial use under 510(k) clearances as a bone graft substitute.  “Our positive ovine study results presented at last year’s North American Spine Society, showing Vitrium’s safe resorption/bone formation profile, stimulation of new bone formation, and strength to share/bear physiologic loads – all ideal characteristics of an interbody fusion device, gave us the confidence and enthusiasm to proceed with the IDE study,” noted Janet Krevolin, Ph.D. and Bio2’s Chief Operating Officer.

“Spine implant manufacturers are incorporating incremental improvements to PEEK and Titanium interbody devices in an attempt to achieve better bony integration.  Vitrium offers the ideal clinical paradigm, achieving fusion exclusively with the patient’s own newly regenerated bone, with no foreign material remaining in the fusion mass.  This natural, self-healing process resonates with spine surgeons, and I believe it will for their patients as well,” stated Paul Nichols, President and CEO of Bio2 Technologies.

About Bio2 Technologies, Inc.:  Bio2 Technologies is a privately held medical device company headquartered in Woburn, Massachusetts.  Our team is engaged in the development of advanced bioactive orthobiomaterials utilizing a proprietary process capable of producing resorbable, three-dimensional structures with controlled, interconnected porosity. For further information please visit www.bio2tech.com.

SOURCE Bio2 Technologies, Inc.

Related Links

http://www.bio2tech.com