Xtant Medical Announces Compliance with NYSE American

BELGRADE, Mont., Feb. 15, 2018 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today reported a positive stockholders’ equity of approximately $47.4M as of February 15, 2018, on an unaudited, pro forma basis, which reflects Xtant’s: (i) conversion of certain 6.00% convertible senior unsecured notes due 2021 (the “Notes”), in the aggregate principal amount of $1.627 million, into a total of 2,275,745 shares of the Company’s common stock, par value $0.000001 per share (“Common Stock”), on January 17, 2018, (ii) exchange of all other outstanding Notes, in the aggregate principal amount of $70.238 million, into a total of 10,401,309 shares of Common Stock on February 14, 2018 (which occurred after the Company’s 1:12 reverse stock split), (iii) private placement of 945,819 shares of Common Stock on February 14, 2018 (which occurred after the Company’s 1:12 reverse stock split), and (iv) results of operations.

Subsequently, Xtant received correspondence from the NYSE American LLC (“NYSE”) dated February 15, 2018 confirming that Xtant has resolved the previously cited stockholders’ equity deficiency and has regained full compliance with the Exchange’s continued listing standards.  The Company will continue to trade on the NYSE American exchange under the symbol “XTNT”.

About Xtant™ Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant 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 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 consequences of consummating the restructuring; 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 American; 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.” 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.

Contact:
CG CAPITAL
877.889.1972
investorrelations@cg.capital
cg.capital

RTI Surgical® Schedules Fourth Quarter and Full Year 2017 Earnings Call for March 1, 2018

February 15, 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 fourth quarter and full year of 2017 on Thursday, March 1, 2018 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss fourth quarter and full year 2017 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, trauma and cardiothoracic 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

ORTHALIGN ANNOUNCES CLINICAL MILESTONE HAVING PERFORMED 75,000 JOINT ARTHROPLASTY CASES

Aliso Viejo, CA, Feb. 15, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a leading provider of orthopedic surgical navigation solutions, is proud to announce a clinical milestone with 75,000 navigation-assisted joint replacement surgeries. OrthAlign’s hand-held sensor-based technologies support a wide array of indications including total knee replacement, partial knee replacement and total hip replacement. The company’s flagship application, KneeAlign® for total knee replacement, provides both tibial and femoral intra-operative navigation in a simple, palm-sized, single-use device.

The KneeAlign application is compatible with all standard implant systems. The UniAlign™ application launched in early 2017 leveraging the clinical success of KneeAlign, and allowing for seamless transitions between partial and total knee replacement interventions. In 2017, the Company also introduced HipAlign® for total hip replacement into limited market evaluation. The HipAlign application provides cup navigation and measures changes in leg length and will be fully commercially available in 2018.

“We are thrilled to pass this significant milestone, building and servicing technologies that have assisted surgeons worldwide in completing more than seventy-five thousand successful arthroplasty surgeries,” said Eric Timko, Chairman and CEO of OrthAlign. “In ORs around the world, OrthAlign has become a trusted and reliable tool that our customers depend on to achieve their desired results.”

“What is remarkable about OrthAlign’s technology is that every post-operative result is consistent, every x-ray looks the same,” noted David Mayman, Co-Director of Computer Assisted Surgery at Hospital for Special Surgery. “I’m impressed by the rate of innovation happening at the company right now. The clinical advantage, along with the economics of the single-use disposable model, makes OrthAlign well poised for continued growth.”

ORTHALIGN, INC.

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

Attachments:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/3bcf00e9-7096-400c-8f72-674ca85a457d

Adam Simone
OrthAlign
asimone@orthalign.com

TranS1® Announces Three New Patents

Denver, Feb. 13, 2018 (GLOBE NEWSWIRE) — TranS1®, a spinal device company focused on breakthrough solutions that minimize tissue trauma, today announced it has added three new patents to its portfolio. The patents relate to two new developments associated with presacral interbody fusion, including two new expandable cages designed to create lordosis at L5-S1, along with a new technique to perform sacroiliac (SI) fusion.

“TranS1’s patent portfolio remains one of the strongest in the industry,” said Jeffrey Schell, chief executive officer of TranS1, who is also a patent attorney. “Our strategy remains to advance the most innovative technologies to lessen tissue trauma during spine surgery and to vigorously guard those technological innovations through domestic and international patent protection.”

TranS1 offers a full complement of minimally invasive surgery (MIS) solutions for spinal pathologies, including the award-winning Pylon™ posterolateral decortication and bone graft placement system, the KeyLIF™ MIS Oblique Lateral Interbody Fusion system and the AxiaLIF® presacral interbody fusion system.The AxiaLIF procedure allows for minimally invasive spinal fusion at L5-S1 for patients with certain spinal pathologies. Presacral interbody fusion at L5-S1 was awarded a Category 1 CPT® Code (22586) in 2013 by the American Medical Association’s CPT Editorial Committee.  According to the CPT Editorial Panel, procedures recognized as Category 1 are widely performed throughout the United States, consistent with accepted medical practice and supported by relevant published research demonstrating the clinical efficacy of the procedure.

In addition to its full suite of MIS procedures and devices, TranS1 has also created and continues to develop a patent portfolio focused on spinal health technologies. The company remains committed to becoming the most innovative in the industry by developing new technologies, applying lessons learned from its development of related approaches, and by attracting the most experienced engineers and surgeons to its team. In all, TranS1 has more than 100 issued patents and has filed more than 50 new patent applications in the last three years.

About TranS1
Headquartered in Denver, TranS1 develops medical breakthroughs to solve spinal pathologies that minimize trauma to the tissues surrounding the spine. The company’s flagship product, AxiaLIF+, is a minimally invasive option for surgeons to accomplish spinal fusion at the L5-S1 joint. The company was named Denver’s Most Innovative Workplace by the 80/95 Awards, presented by the Denver Post. In 2017, the company won the “New Spine Technology” award from Orthopedics This Week for its Pylon™ MIS Posterolateral Decortication and Bone Graft Placement System. For more information, visit www.TranS1.com.

# # #

Doyle Albee
dalbee@mapr.agency

Episurf Medical in the final stages of development of an ankle implant

FEB 14, 2018

With three Episealer® knee implant products currently approved and on the market in Europe, Episurf Medical (NASDAQ: EPIS B) has initiated the development of a new line of personalised Episealer® implant products intended for osteochondral lesions of the talus bone in the ankle joint. Such lesions are a common and growing problem, along with few alternative treatment methods. Episurf Medical is now responding to a significant demand voiced by its network of surgeon partners. The ambition is to perform the first surgeries during Q2 2018.

The new ankle implant and associated surgical instruments are based on the same technology platform as the company’s Episealer® knee devices, with a patient-specific design based on medical imaging and 3D modelling.

Episurf Medical has previously delivered one custom-made implant solution for a patient in Germany with an ankle joint lesion. The ankle implant was custom-made to the surgeon’s specifications in a difficult case where a custom-made patient-specific implant was the only available solution. The surgeon saw no other reasonable treatment alternative, as there is no such implant on the market today. The surgery was performed in 2016. The surgery was successful and the patient reported excellent results at the 12 months’ clinical follow-up visit.

“An osteochondral ankle defect is a lesion of the talar cartilage and subchondral bone, which commonly causes deep and intractable ankle pain. These lesions are generally caused by a single or multiple traumatic events, often sport injuries. We are convinced that Episurf’s knee technology should adapt well to the ankle, and the 12-months’ data from Germany is very encouraging. The technical synergies, along with the lack of adequate techniques for treatment of this kind of ankle lesions, as well as careful market analysis, led us to the decision to pursue this new initiative. We look forward to providing the same kind of benefits to patients with ankle injuries as we today do to those with lesions in the knee,” comments Prof. Leif Ryd, Senior Medical Advisor to Episurf Medical.

“Adding additional products to our platform is an important part of our long-term strategy and the ankle implant brings a significant long-term revenue potential to Episurf Medical,” comments Pål Ryfors, CEO of Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.55 CET on 14 February 2018.

Tags:

Stryker Crosses The 95% Thresholds in VEXIM and Announces Its Intention to File a Proposed Public Buy-out Offer Followed by a Squeeze-out for the Outstanding Shares of VEXIM

February 14, 2018 – BALMA, France–(BUSINESS WIRE)–Regulatory News:

Stryker Corporation (NYSE:SYK) announced that it has crossed the 95% thresholds in VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM) and intends to file a proposed public buy-out offer followed by a squeeze-out for the outstanding shares of VEXIM, in accordance with French tender offer laws and regulations.

After the acquisition of 92.19% of the share capital and 91.56% of the voting rights of VEXIM following a simplified public tender offer opened from November 16, 2017 to December 6, 2017, Stryker acquired 300,016 additional shares on the market (at a maximum price of EUR 20, i.e., the price paid in the simplified public tender offer) and crossed upwards the 95% thresholds in share capital and voting rights of VEXIM. Stryker now holds indirectly, through its French subsidiary Stryker France MM Holdings SAS, 8,716,415 shares and voting rights of VEXIM, representing 95.48% of the share capital and at least 95.14% of the voting rights.

As a result, Stryker intends to file, within the coming weeks, a proposed public buy-out offer for all the outstanding shares it does not own for a price per share of EUR 20, which will be followed automatically by a squeeze-out of all the remaining non-tendered shares. The public buy-out offer followed by a squeeze-out will be subject to the clearance decision of the French stock market authority (the “AMF”).

In accordance with Article 261-1, I and II of the general regulation of the AMF, the board of directors of VEXIM will appoint an independent expert to issue a report regarding the fairness of the financial conditions of the proposed public buy-out offer followed by a squeeze-out.

The squeeze-out is expected to occur during Q2 2018.

The suspension of trading of VEXIM shares will be maintained until the filing of the proposed offer.

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column, and the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 61 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on Euronext Growth Paris since May 2012. Following the simplified tender offer carried out in December 2017, the global leader in medical technology, Stryker, held 92,19% of VEXIM’s capital at the end of year 2017. For further information, please visit www.vexim.com

SpineJack®1, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

About STRYKER
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès
CEO
José Da Gloria
Chief Financial Officer
Tél. : +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

Phase 1/2 Clinical Trial Results Positive for SpinalCyte’s CybroCell™ Dermal Fibroblasts

February 13, 2018

HOUSTON–(BUSINESS WIRE)–Degenerative disc disease has long been considered an inevitable part of aging, but new breakthrough research from SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), suggests a new cell-based therapy could provide a cure for millions of sufferers. SpinalCyte has completed the first double blind, placebo-controlled human trial using HDF injections to treat sufferers of degenerative disc disease.

Almost 70 percent of patients who were treated with the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease, called CybroCell, reported significant therapeutic improvement. Prior research has shown that intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn generate the jelly-like material (disc nucleus) that provides cushioning for the spine1.

“CybroCell, in my opinion is the future of cell therapy,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “The current data suggests that CybroCell has the ability to significantly reduce pain, improve patient quality of life and be more effective than conventional stem cells. It has the added benefit of being more economical to produce and easier to acquire. Compared to all of the stem cells that I have worked with in my career, fibroblasts used in CybroCell are much superior.”

The landmark Phase 1/2 trial included 16 patients with chronic lower back pain caused by degenerative disc disease. The patients were randomly assigned to one of three groups. The first group received a placebo in the form of saline only; the second group received a single intradiscal injection of 10 million cells of CybroCell and the third group received a single intradiscal injection of 10 million cells of CybroCell in combination with platelet-rich plasma (PRP).

Using the Oswestry Disability Index (ODI), a widely used questionnaire measuring the intensity and disabling effect of lower back pain on daily activities, researchers determined that the ODI of four of the six patients (67 percent) treated with CybroCell decreased by more than 15 points, which is considered a significant therapeutic improvement. One of the four patients (25 percent) treated with CybroCell in combination with platelet-rich plasma (PRP) reported an ODI decrease of more than 15 points while one of six patients (17 percent) in the placebo group reported an ODI decrease of more than 15 points.

“The U.S. opioid crisis is a national emergency, so we consider the development of CybroCell, which may reduce or eliminate the need for opioids among patients suffering from chronic back pain as a result of degenerative disc disease, to be an urgent public health priority,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “Chronic lower back pain effects nearly 33 million Americans and over 7 million are related to degenerative disc disease 2. This creates a national crisis for their quality of life. Our human trials exceeded our most optimistic projections and we believe it will ultimately lead to a cure for degenerative disc disease. On behalf of everyone at SpinalCyte, I would like to thank the patients and physicians who participated in our Phase 1/Phase 2 trial and let them know we are committed to advancing this novel approach so all patients can benefit.”

SpinalCyte’s Phase 1/2 trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

Photo available for download: https://www.dpkpr.com/files/701/

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in biologics.

1Chee et al. Cell Therapy with Human Dermal Fibroblasts Enhances Intervertebral Disk Repair and Decreases Inflammation in the Rabbit Model. Global Spine J. 2016 Dec;6(8):771-779. https://0201.nccdn.net/1_2/000/000/18d/7d6/Global-Spine-Journal.pdf

2https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/pme.12809

 

(Photo: Dr. Torsten Wittmann/Science Photo Library/Getty Images)

 

Contacts

SpinalCyte, LLC
Investor Contact:
281.461.6211
info@spinalcyte.com
or
Media Contact:
Daniel Keeney, APR, 832.467.2904
dan@dpkpr.com

Mazor Robotics Reports Record Fourth Quarter & Full Year 2017 Financial Results

CAESAREA, IsraelFeb. 14, 2018 /PRNewswire/ — Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of robotic guidance systems, reported record fourth quarter and full year revenues of $19.1 million and $64.9 million, respectively. As previously announced, the Company received purchase orders for 27 systems in the 2017 fourth quarter, including 24 Mazor X systems. For the 2017 full year, the Company received 73 system orders, of which 64 were for the Mazor X system and nine were for the Renaissance system.

“Our effective execution during 2017 continued to strengthen our global leadership position in spine robotics and led to record systems sales and recurring revenue,” commented Ori Hadomi, Chief Executive Officer. “2018 will be a year of transition during which we will emphasize synergy with Medtronic as well as procedure growth. Mazor is well positioned to benefit from the accelerating adoption of robotics for spine surgeries.”

FOURTH QUARTER 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended December 31, 2017 increased 36% to $19.1 million compared to $14.0 million in the year-ago fourth quarter. U.S. revenue increased 38% to $17.4 million compared to $12.6 million in the year-ago fourth quarter, as the Company recognized revenue from 21 Mazor X systems, compared to 13 Mazor X and two Renaissance systems in the fourth quarter of 2016. International revenue was $1.7 million compared to $1.4 million in the year-ago fourth quarter. Recurring revenue from kit sales, services and other increased 107% to $9.3 million in the fourth quarter of 2017 compared to $4.5 million in the year-ago fourth quarter, which is primarily attributed to the higher system installed base. The Company ended the quarter with a backlog of 16 systems (14 Mazor X and two Renaissance systems).

The Company’s gross margin for the three months ended December 31, 2017 was 59.3% compared to 70.5% in the year-ago fourth quarter. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X system compared to the Renaissance system and the pricing terms with Medtronic. Total operating expenses were $11.4 millioncompared to $14.2 million in the year-ago fourth quarter, mainly due to lower operating expenses, following the transition to the global distribution phase of the Medtronic partnership. Operating loss was $0.1 million compared to an operating loss of $4.3 million in the year-ago fourth quarter. Net income for the fourth quarter of 2017 was $0.4 million, or $0.01 per share, compared to a net loss of $4.3 million, or $0.09 per share, for the year-ago fourth quarter.

Cash generated by operating activities was $3.8 million compared to cash used in operating activities of $1.9 million in last year’s fourth quarter. The change is primarily a result of strong collections in the fourth quarter of 2017. As of December 31, 2017, cash, cash equivalents and investments totaled $108.3 million.

FOURTH QUARTER 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

The tables below include reconciliations of the Company’s GAAP results to non-GAAP results. The reconciliations relate to non-cash expenses in the amount of $1.5 million with respect to share-based payments and amortization of intangible assets recorded in the fourth quarter of 2017. On a non-GAAP basis, the net income in the fourth quarter of 2017 was $1.9 million, or $0.03 per share, compared to net loss of $3.1 million, or $0.07 per share, for the year-ago fourth quarter.

FULL YEAR ENDED DECEMBER 31, 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

For the full year ended December 31, 2017, revenue increased 78% and totaled $64.9 million compared to $36.4 millionfor the full year ended December 31, 2016, due to higher system sales and an increase in recurring revenue. Recurring revenue totaled $27.8 million, an increase of 65% compared to $16.8 million in the full year ended December 31, 2016. The growth in recurring revenue is attributed to the increase in the installed base and high utilization of the Company’s robotic guidance systems. Gross margin for the full year ended December 31, 2017 was 63.5% compared with 71.6% for the full year ended December 31, 2016. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X system compared to the Renaissance system and to the pricing terms with Medtronic. Operating expenses for the full year ended December 31, 2017 were $55.1 million, compared to $45.1 million for the full year ended December 31, 2016. The Company’s sales and marketing expenses are now expected to decrease, as Medtronic assumed commercial responsibility for the Mazor X, effective September 18, 2017. Net loss for the full year ended December 31, 2017 was $12.4 million, or $0.25 per share, compared to a net loss of $18.7 million, or $0.42 per share for the full year ended December 31, 2016.

FULL YEAR ENDED DECEMBER 31, 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

On a non-GAAP basis, the net loss for the full year ended December 31, 2017 was $5.7 million, or $0.12 per share, compared to a net loss of $16.1 million, or $0.36 per share for the full year ended December 31, 2016.

ADJUSTMENTS TO REPORTED THIRD QUARTER 2017 FINANCIAL RESULTS

As previously disclosed on January 8, 2018, the Company’s revenue for the third quarter ended September 30, 2017 was adjusted from $17.2 million to $18.6 million. The corresponding cost of goods sold was also adjusted from $5.3 million to $5.9 million. The increase is due to system deliveries to Medtronic which were incorrectly recorded as delivered after the third quarter ended September 30, 2017.

Following an additional analysis of the 2017 third quarter results, the Company is further adjusting its cost of goods sold by $1.1 million to $7.0 million due to the inaccurate recording of purchase of goods.

As a result of these adjustments, the gross margins for the three and nine months ended September 30, 2017 were adjusted from 69.2% and 68.0% to 62.3% and 65.3%, respectively. The net loss for the same periods was increased by $0.3 million to $3.9 million and $12.9 million, respectively.

The amended financial results for three and nine months ended September 30, 2017 are available through the Company’s website at

https://www.mazorrobotics.com/index.php/investors-relations/financial-reports.

CONFERENCE CALL INFORMATION

The company will host a conference call to discuss these results on Wednesday, February 14, 2018, at 8:30 AM EST (3:30 PM IST).  Investors within the United States interested in participating are invited to call 800-289-0438. Participants in Israel can use the toll-free dial-in number 1809 212 883. All other international participants can use the dial-in number +1 323-794-2423.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-888-203-1112 and reference the Replay Access Code: 5797376. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.comand select ‘Investor Relations.’

Use of Non-GAAP Measures

In addition to disclosing financial results calculated in accordance with generally accepted accounting principles in conformity with International Financial Reporting Standards (GAAP), this press release contains Non-GAAP financial measures for gross profit, operating expenses, operating profit (loss), net income (loss) and basic and diluted earnings per share that exclude the effects of capitalization of development costs, non-cash expense of amortization of intangible assets and share-based payments. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s net income and earnings per share and to compare them to historical net income and earnings per share.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding that 2018 will be a year of transition for Mazor, Mazor benefitting from the accelerating adoption of robotics for spine surgery, the expected decrease in sales and marketing expenses, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

 

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Simplify Medical Completes Enrollment in IDE Trial Studying Simplify Disc in One Level of Spine for Cervical Disc Replacement

February 14, 2018

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced completion of enrollment in its U.S. IDE trial studying the Simplify Disc used for one-level cervical implantation of the device between C3 to C7 compared with a historical control group. The trial enrolled 166 patients at 16 U.S. sites.

“We want to thank the surgeon investigators, their staffs and the patients participating in the Simplify trial for their time and tremendous support,” said David Hovda, chief executive officer of Simplify Medical. “Recognizing that most of the devices used in disc replacement today require patients to be exposed to substantial ionizing radiation from CT scans post-operatively, it’s important for patients and physicians to have an alternative that minimizes that risk.”

The trial’s national co-primary investigator Domagoj Coric, MD, with Carolina Neurosurgery and Spine Associates, said, “The Simplify Disc is straightforward to implant, with materials designed to optimize biocompatibility and lower disc heights to better match cervical anatomy. We are pleased with the positive early clinical outcomes and look forward to seeing the longer-term study results, anticipating that they will validate the promise seen to date.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “The Simplify Disc is made of materials designed to optimize MRI imaging of the disc space and adjacent spinal canal without artifact. This can minimize or eliminate the use of post-operative CT scans and their risk of radiation to patients, and we look forward to having this capability as an option for treating our patients with cervical disc disease.”

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT scans post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. 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. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

The Simplify Disc used in two levels of the spine is being studied in a second IDE trial in the U.S., which is approximately 40 percent enrolled and enrollment is expected to be completed by the end of 2018. The prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. For information about eligibility or enrollment in the two-level clinical trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly 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: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant

February 14, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that enrollment is now complete in the Company’s SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

Spineology’s deployable graft containment mesh implant is a uniquely porous device that deploys within the disc space as it is filled, permitting the contained bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

Spineology’s OptiMesh® deployable graft containment implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data to support a regulatory submission for expanded indications, allowing the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Dr. Stéphane Lavoie of DeLand, Florida enrolled the first SCOUT subject. As one of the top enrolling sites, Dr. Lavoie also enrolled the final study subject. “The Spineology interbody fusion system allows me to efficiently prepare the disc space for fusion through a very small access, reducing surgical time and trauma to the surrounding tissues. It has been exciting to participate in the clinical trial for this unique fusion system and I have been pleased with my patient outcomes.”

“The unique deployable mesh allows me to create a confirming bone graft pack to support new bone growth,” added Dr. Martin Krag, Professor of Orthopaedics at the University of Vermont Larner College of Medicine. “Importantly, patient satisfaction is very good. At our institution we have observed rapid and substantial improvements in pain and function scores for study subjects post-surgery.”

Early results in the SCOUT trial have been encouraging. Dr. John Chi will be formally presenting interim SCOUT results at the upcoming meeting of the International Society for the Advancement of Spine Surgery (ISASS) to be held this April in Toronto, Canada. Dr. Chi is an Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital, the top enrolling site in the SCOUT IDE trial.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients will be followed for 24 months minimum and the company is gathering data on hospital parameters, pain and function, patient satisfaction, safety and radiographic fusion. The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Subsequent to appropriate follow-up, the clinical outcomes data collected will allow Spineology to submit a De Novo application to the FDA to seek marketing clearance for interbody mesh fusion indications in the U.S.

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

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com