InVivo Therapeutics Reports 2018 First Quarter Financial Results

May 07, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a business and clinical update and reported financial results for the quarter ended March 31, 2018.

Richard Toselli, M.D., President and Chief Executive Officer of InVivo, commented, “InVivo gained significant momentum in the first quarter of 2018, and we look forward to building on our positive momentum throughout the rest of the year. We remain focused on the development of our Neuro-Spinal Scaffold™ and continue to take steps to reduce our expenses and maximize shareholder value. Key spend reductions have involved the elimination of certain headcount and the assignment of the company’s lease, which is expected to result in lease-related savings of approximately $3M through 2019. In addition to the lease assignment, InVivo is undertaking other key cost-control initiatives, resulting in a projected average cash burn of approximately $1M per month over the last three quarters of 2018. Going forward, we continue to explore financing options and are looking forward to our upcoming shareholder meeting.”

InVivo’s clinical team has begun preparation for the second INSPIRE trial, INSPIRE 2.0. The Company has identified potential trial sites and a CRO and manufactured clinical product to initiate the trial. Once financing is secured, the INSPIRE 2.0 trial will begin enrolling subjects. The company is seeking to secure enough financing to complete the enrollment of the trial, which is estimated to be 18 months. The company’s financing strategy is dependent upon shareholder approval at the 2018 Annual Meeting of Shareholders of an increase in the number of authorized shares and an increase in the number of shares the company is authorized to sell to Lincoln Park Capital.

The Company also announced the appointment of Jeff Modestino as principal financial officer and principal accounting officer, effective May 11, 2018, and the resignation of Christopher McNulty as Chief Financial Officer. Mr. Modestino previously served as Chief Financial Officer of Clearline MD and brings to the company over two decades of significant healthcare and finance experience, including experiences spanning medical devices. Dr. Toselli stated, “Jeff brings valuable experience and has developed a strong understanding of the company, having served as a consultant for InVivo prior to his joining full-time. I would also like to thank Chris for his contributions to InVivo over the past four years, and wish him the best in his future endeavors.”

Recent Corporate Developments

  • Announced the appointment of Richard Toselli, M.D., as President and Chief Executive Officer of InVivo. Dr. Toselli, a Board-certified neurosurgeon, has led an accomplished career in surgical medical affairs, with senior leadership experience at Sanofi, DePuy, and Johnson & Johnson.
  • Entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC, a Chicago-based institutional investor, under which the Company has the right to sell up to $15 million in shares of common stock to Lincoln Park over a twenty-four-month period, subject to certain limitations and conditions set forth in the purchase agreement and registration rights agreement.
  • Received supplemental Investigational Device Exemption (IDE) approval from the FDA for a second pivotal clinical study of the Neuro-Spinal Scaffold™ in patients with acute spinal cord injury (SCI). The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the company’s single-arm INSPIRE study.
  • Presented CONTEMPO data at the 2018 Spine Summit medical meeting. The CONTEMPO data were designed to provide comprehensive natural history benchmarks for Neuro-Spinal Scaffold™ clinical study results. The CONTEMPO study included neurological recovery data from 170 patients across three registries of SCI patients with similar baseline characteristics to those in the INSPIRE study and validated the company’s previously established OPC with AIS conversion rates at approximately six months post-injury of 16.7% – 23.4% across the three registries.

Financial Results

For the three-month period ended March 31, 2018, the Company reported a net loss of approximately $4.8 million, or $3.34 per diluted share, compared to a net loss of $6.4 million, or $4.98 per diluted share, for the three-month period ended March 31, 2017. The results for the three-month period ended March 31, 2018 were favorably impacted by decreases in operating expenses of $1,986,000 in research and development offset by an increase of $149,000 in general and administrative. The decrease in operating expense can be attributed to the restructuring efforts that the company undertook in the third quarter of 2017 and subsequent cost cutting initiatives designed to reduce the company’s monthly cash burn rate. The increase in general and administrative costs is primarily attributable to severance related expenses in the first quarter of 2018, as the company further reduced its administrative headcount.

The Company ended the quarter with $11.6 million of cash and cash equivalents.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” and similar expressions, and include statements regarding potential financing, the commencement of enrollment in the INSPIRE 2.0 trial and the expected length of the trial, the impact of cost-control measures and the ability of the Company to continue clinical investigation of the Company’s Neuro-Spinal Scaffold. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to: successfully identify financing alternatives and raise the capital necessary to undertake the second pivotal trial, to successfully decrease costs and spend and to successfully open additional clinical sites for enrollment and to enroll additional patients if such trial is initiated; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2017 and its other filings with the SEC, including the company’s quarterly reports on Form 10-Q and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share data)

As of

March 31, 
2018

December 31,
2017

ASSETS:
Current assets:
Cash and cash equivalents 11,614 12,910
Restricted cash 378 361
Prepaid expenses and other current assets 1,151 535
Total current assets 13,143 13,806
Property, equipment and leasehold improvements, net 72 157
Other assets 76 82
Total assets 13,291 14,045
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable 1,228 988
Loan payable, current portion 459 452
Derivative warrant liability 2 4
Deferred rent, current portion 30 30
Accrued expenses 2,386 1,638
Total current liabilities 4,105 3,112
Loan payable, net of current portion 283 400
Deferred rent, net of current portion 522 367
Other liabilities 58 56
Total liabilities 4,968 3,935
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 4,000,000 shares; issued and

outstanding 1,562,284 shares at March 31, 2018; issued and outstanding 1,370,992

shares at December 31, 2017

1

1

Additional paid-in capital 197,013 194,016
Accumulated deficit (188,691) (183,907)
Total stockholders’ equity 8,323 10,110
Total liabilities and stockholders’ equity 13,291 14,045

(Reflects 1-for-25 reverse stock split effective April 16, 2018)

InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

(In thousands, except share and per share data)

Three Months Ended March 31,
2018 2017
Operating expenses:
Research and development 1,398 3,384
General and administrative 3,434 3,285
Total operating expenses 4,832 6,669
Operating loss (4,832) (6,669)
Other income (expense):
Interest income / (expense) 18 37
Other income / (expense) 42
Derivatives gain (loss) (12) 241
Other income (expense), net 48 278
Net loss (4,784) (6,391)
Net loss per share, basic and diluted (3.34) (4.98)
Weighted average number of
common shares outstanding, basic and diluted 1,432,963 1,283,206
Other comprehensive loss:
Net loss (4,784) (6,391)
Other comprehensive loss:
Unrealized loss on marketable securities (2)
Comprehensive loss (4,784) (6,393)

(Reflects 1-for-25 reverse stock split effective April 16, 2018)

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Vivex Biomedical, Inc. Announces Peer-Reviewed Study of VIA Graft

ATLANTAMay 4, 2018 /PRNewswire/ — Vivex Biomedical, Inc. (Vivex) is pleased to announce the publication of a peer-reviewed study examining the use of its cellular bone matrix product, VIA Graft, for spinal fusion surgery. The peer-reviewed study was published in the January edition of the International Journal for Spine Surgery, and demonstrates exceptional clinical results.

The study represents a retrospective review of a single practice, single surgeon evaluation of VIA Graft. The study evaluated 75 consecutive patients for fusion by CT and radiographic evaluation at 12 months with a minimally invasive surgical approach. In total, 96% of the 75 patients with a total of 85 levels achieved fusion at 12 months – 96% of patients, 96.5% of levels treated.

“These clinical results with VIA Graft demonstrate Vivex’s commitment to developing a disruptive product that will revolutionize the standard of care in orthopaedic surgery,” states Tracy Anderson, President & CEO of Vivex.

The VIA product line was first launched in August of 2014 and has grown significantly with adoption across several orthopaedic surgical specialties. VIA Graft retains a biocompatible, mesenchymal stem cell-rich population that includes marrow-isolated adult multi-lineage inducible cells. The product also utilizes a proprietary non-DMSO cryoprotectant, affording optimal cell protection and streamlined preparation in the OR.

About Vivex Biomedical, Inc.

Vivex is a regenerative biologics company, dedicated to creating new standards in patient care. Vivex strives to create treatment options and solutions that will improve clinical, surgical, and therapeutic patient care through innovation. Under the guidance of experienced and successful business professionals, Vivex tasks the brightest minds from the medical and material science industries to explore new and different ways to help others. Vivex focuses on core products and new technologies to meet the ever-growing biologic needs of surgeons and patients while continuing our 45-year history of serving and honoring both tissue donors and recipients.  As a part of this mission, Vivex works with services that are committed to providing care and compassion to donor families while inspiring communities to share life through their donation. Partnering with families in the prospect of regenerative options, Vivex assures appropriate options are available to support regeneration and translation of their gifts. Vivex and its affiliates have distributed more than two million tissue allografts to 18 countries worldwide to better serve the needs of patients.

For more information, please visit http://vivex.com/.

SOURCE Vivex Biomedical, Inc.

Related Links

http://www.vivex.com

Zimmer Biomet Wins Appeal Over $9 Million Durom Hip Damage Award

Walter Eisner • Fri, May 4th, 2018

A California appellate court has reversed a $9 million damage award against Zimmer Biomet Holdings, Inc. over the Durom Cup hip implant and granted the company a new trial to determine new, if any, damages. The court did not grant the company a new trial over liability, however.

Plaintiff Lawyer’s Loose Lips

The April 27, 2018 appellate decision, reported by Law360, cited comments by the plaintiff’s lawyer “about Zimmer’s value, passing reference to a recall of a different product and an indication that the Durom Cup isn’t sold anymore.” The appellate court also noted statements about the patient’s medical expenses.

According to court documents, after the suit was filed in 2010 against then Zimmer, Inc., a jury found the company negligently designed the Durom Cup, harming Gary Kline, the plaintiff, and failed to warn him about potential risks. The jury awarded Kline $153,317 in past medical expenses, even though the parties had already agreed that Kline’s medical expenses were about $73,000. The jury also awarded Kline $2.4 million for past noneconomic loss and $6.6 million for future noneconomic loss, according to court documents.

The trial court subsequently reduced the award of economic damages to roughly $73,000 but granted Zimmer Biomet a new trial for excessive noneconomic damages as well as the loose statements made by Kline’s attorney.

Kline appealed the ruling for a new trial.

The appeals court upheld the order for a new trial on damages because the trial court adequately considered evidence about Kline’s past and future pain when concluding the $9 million awarded was too high, according to the court filing reported by Law360.

 

READ THE REST HERE

 

Bone Therapeutics Business Update for First Quarter 2018

Gosselies, Belgium, 4 May 2018, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update for the first quarter ended 31 March 2018.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “During the first quarter, we have seen continued progress of our ALLOB® programme with the completion of recruitment into our Phase IIA lumbar spine fusion study. With the appointment of Jean Stéphenne as new Chairman and Claudia D’Augusta as senior Non-Executive Director, we have also significantly expanded the expertise in cell therapy, capital markets and corporate development in our leadership team. Supported by a successful convertible bond placement, we are excited to be advancing our products through the clinic closer to patients while preparing our products for commercial use and look forward to further value catalysts as we move through the year.

Business highlights

  • In February 2018, the Company announced the completion of patient recruitment into the Phase IIA lumbar spinal fusion study. This twelve-month, open-label clinical study aims to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to promote fusion of the lumbar vertebrae.
  • Promising interim results for the first 15 patients, reported in September 2017, showed radiological evidence of successful fusion in addition to substantial clinical improvement in function and a strong reduction in back and leg pain.
  • Efficacy and safety data for the full set of 32 patients are expected in mid-2019, following a follow-up period of 12 months.

Corporate highlights

  • In February 2018, Jean Stéphenne was appointed Chairman of the Board of Directors. Jean Stéphenne, a highly-experienced life sciences executive, has served in senior leadership roles at numerous biotechnology and pharmaceutical companies, including as Chairman of TiGenix and Chief Executive of GSK Biologicals (now GSK Vaccines).
  • Post period, Claudia D’Augusta, Chief Financial Officer of TiGenix, joined the board as a Non-Executive Director, adding more than 20 years’ experience in corporate finance, capital markets and M&A in the biotechnology space.

Financial highlights

  • In March, Bone Therapeutics secured a total amount of € 19.45 million in committed capital via a private placement of convertible bonds. Some of the investors decided to immediately exercise warrants resulting in immediate gross proceeds of € 6.58 million with 565,773 new shares to be created, increasing the total outstanding shares from 6,849,654 to 7,415,427 ordinary shares.
  • As a result, the Company ended the first quarter of 2018 with a cash balance of € 10.42 million.
  • The remaining warrants will be exercised over a maximum period of 19 months ending in October 2019, providing an additional proceed of € 12.87 million.

Outlook

  • Bone Therapeutics plans to report final results from the ALLOB® Phase I/IIA delayed-union study in mid-2018.
  • A value inflection point is anticipated in the second half of 2018, as the Company expects to present the conclusions of the interim analysis after a one-year follow-up period of the first 44 patients in the Phase III study of PREOB® in osteonecrosis of the hip.
  • Additionally, the Company has started preparing for a multicentre, controlled Phase IIB study in delayed-union fractures with ALLOB®.
  • Cash burn for the full year of 2018 is expected to be in the range of € 15-16 million. Based on its current priorities, the Company expects to have sufficient cash to carry out its objectives until end Q3 2019.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

SpineGuard Reinforces the Utility of Its Dynamic Surgical Guidance (DSG®) Technology Platform by Receiving a Second US Patent for “Bone Fusion Monitoring” Application

May 03, 2018

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, announced today it has been granted a second patent by the US Patent Office for the application of its Dynamic Surgical Guidance technology for a new application: bone quality measurement, in this particular patent with a focus on monitoring the consolidation of the bony fusion bed.

Stéphane Bette, CEO and co-founder of SpineGuard, said: “The success of skeletal fixation procedures is based on obtaining a solid bony fusion providing long-term stability of the repair, thanks to the implants that are inserted internally to hold the bone structures in place while they fuse. We believe that the DSG® technology can allow real-time in-situ monitoring of the progress of the bony fusion. This exciting new patent granted in the USA is one more illustration that our core technology is a platform that has multiple applications; our company is constantly innovating and working at providing valuable digital information about the health status of patients.”

The potential applications of in-situ monitoring of the bony fusion are multiple in the post-operative phase: from the adaptation of the physical therapy, the adjustment of the stiffness of braces, to the connection with the implants themselves to make them smart and adapting to the bone healing status.” concluded Maurice Bourlion, Co-inventor of the DSG® technology and Director of SpineGuard.

More information on the DSG® technology, its new applications and surgeons’ testimonials here.

Next financial press release: 2018 Half-year revenue: July 11, 2018

About SpineGuard®

Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG® (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG® enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG® platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette, +33 (0)1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

SeaSpine Reports First Quarter 2018 Financial Results

CARLSBAD, Calif., May 03, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the quarter ended March 31, 2018.

Summary First Quarter 2018 Financial Results and Recent Accomplishments

  • Revenue of $33.2 million, an increase of 4.0% year-over-year
  • U.S. revenue of $29.5 million, an increase of 3.2% year-over-year
    • U.S. Orthobiologics revenue of $15.8 million, a 4.9% increase year-over-year
    • U.S. Spinal Implants revenue of $13.7 million, a 1.4% increase year-over-year
  • International revenue of $3.6 million, an increase of 10.8% year-over-year
  • Transitioned OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh to full commercial launch

“We are pleased with our first quarter results, which reflect solid revenue growth in both our Orthobiologics and Spinal Implants portfolios, as well as operational efficiencies,” said Keith Valentine, President and Chief Executive Officer. “As we continue to upgrade our distribution footprint, we are well positioned to leverage our recently launched products and development pipeline across both franchises to deliver clinical value to surgeons, hospitals, and patients.”

First Quarter 2018 Financial Results
Total revenue for the first quarter of 2018 was $33.2 million, a 4.0% increase compared to the same period of the prior year. Total U.S. revenue was $29.5 million, a 3.2% increase compared to the same period of the prior year.

Orthobiologics revenue totaled $18.0 million, a 5.2% increase compared to the first quarter of 2017, and was led by growth in our DBM franchise. Spinal Implants revenue totaled $15.2 million, a 2.6% increase compared to the first quarter of 2017, and was driven by growth in the Shoreline and Mariner systems.

Gross margin for the first quarter of 2018 was 63.3%, compared to 58.7% for the same period in 2017. The increase was primarily driven by lower raw material and manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility.

Operating expenses for the first quarter of 2018 totaled $28.0 million, compared to $27.8 million for the same period of the prior year. The $0.2 million increase in operating expenses was driven by higher selling and marketing expenses, partially offset by lower R&D and general and administrative expenses.

Net loss for the first quarter of 2018 was $7.1 million, compared to a net loss of $9.1 million for the same period of the prior year.

Cash and cash equivalents at March 31, 2018 totaled $12.5 million and the Company had no outstanding borrowings against its $30 million credit facility.  The Company realized $8.5 million in net proceeds in the first quarter of 2018 through the sale of its common stock under its “at the market” equity offering program.

2018 Financial Outlook
SeaSpine reiterates expectations for full-year 2018 revenue to be in the range of $135 to $139 million, reflecting growth of 2.5% to 5.5% over full-year 2017 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 8167947.  To listen to the webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

The call will be archived until Thursday May 17, 2018. The audio archive can be accessed by calling (855) 859-2056 in the U.S. or (404) 537-3406 from outside the U.S. The passcode for the audio replay is 8167947.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Company’s expectations to leverage recently launched products and development pipeline to deliver clinical value; and the Company’s expectations for full-year 2018 revenue.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5405
ir@seaspine.com

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)

Three Months Ended March 31,
2018 2017
Total revenue, net $ 33,175 $ 31,894
Cost of goods sold 12,179 13,172
Gross profit 20,996 18,722
Operating expenses:
Selling, general and administrative 24,467 23,970
Research and development 2,789 3,050
Intangible amortization 792 792
Total operating expenses 28,048 27,812
Operating loss (7,052 ) (9,090 )
Other income (expense), net 20 (13 )
Loss before income taxes (7,032 ) (9,103 )
Provision for income taxes 73
Net loss $ (7,105 ) $ (9,103 )
Net loss per share, basic and diluted $ (0.50 ) $ (0.79 )
Weighted average shares used to compute basic and diluted net loss per share 14,085 11,586

SEASPINE HOLDINGS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)

March 31,
2018
December 31,
2017
(unaudited)
Cash and cash equivalents $           12,470 $ 10,788
Trade accounts receivable, net of allowances of $492 and $466 20,639 21,872
Inventories 43,285 41,721
Short-term debt
Total current liabilities 21,445 23,157
Long-term borrowings under credit facility
Total stockholders’ equity 107,625 105,653

Paradigm Spine Announces NASS Coverage Policy Recommendation For coflex® Interlaminar Stabilization®

NEW YORKMay 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression. This is particularly significant for coflex because it provides the evidence private health insurance companies require to allow access for patients to benefit from this important, proven technology. The coflex device is the exclusive lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe lumbar spinal stenosis.

NASS is the preeminent U.S. spine society in which health insurance companies and health care providers look to for guidance when determining appropriate coverage decisions for state-of-the-art technologies, such as coflex. NASS’ multi-disciplinary team of spine specialists systematically review available scientific literature. Searches include meta-analyses, clinical guidelines, and the highest level of clinical data with randomized controlled trials, of which there are two such trials for coflex.

The recently issued NASS coverage policy recommends the use of coflex for the treatment of patients with lumbar spinal stenosis. The recommendations only apply to devices that are used in conjunction with a direct decompressive procedure, which currently and in the foreseeable future is only coflex, and states, “More recently ISP devices have been used in conjunction with direct decompression via laminotomy. Some devices, such as coflex, according to its FDA labeling and available published data, are specifically approved for use in this manner.”

“It’s gratifying to see the NASS Coverage Committee issue a coverage recommendation for coflex,” said Dr. Richard D. Guyer of the Texas Back Institute and past-President of NASS. “I’ve been a member of NASS for over 20 years and trust in their process and recommendations for new technologies. I know the process is thorough and evidence-based which gives me confidence in offering the latest and proven technologies to my patients. In particular with coflex, I think we as surgeons have the opportunity and responsibility to utilize the abundant clinical evidence and our experience to provide a superior alternative to decompression alone or spinal fusion for our patients with lumbar spinal stenosis.”

“The NASS coverage policy recommendation for coflex is a major milestone for validating our technology and allows us to reach more private payors in the U.S. market,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “Over the past decade, Paradigm Spine has worked diligently to build the pieces of the puzzle in establishing coflex as the new standard of care for the treatment of moderate to severe lumbar spinal stenosis. Those pieces have been 1)  the FDA IDE clinical trial which demonstrated positive, long-term Level I evidence of coflex compared to fusion, 2) establishment of CPT and site-of-service facility coding pathways 3) the recent publication of the landmark Level 1 ESCADA clinical trial which demonstrated superiority of coflex compared to decompression alone, and now 4) the stamp of approval from NASS with their coverage recommendation in support of coflex. As a company, we believe these achievements provide the evidence private payors require to create access to this important technology for patients suffering from lumbar spinal stenosis.”

About Lumbar Spinal Stenosis (LSS)

Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent opioid pain control, epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About NASS

The North American Spine Society (NASS) is comprised of more than 8,000 members from several disciplines, including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research and physical therapy. Its mission is to foster the highest quality, evidence-based and ethical spine care.

About Paradigm Spine, LLC:

Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

RTI Surgical Announces First Quarter 2018 Results

May 03, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq:RTIX), a global surgical implant company, reported operating results for the first quarter of 2018.

“2018 is off to a positive start with the acquisition of Zyga at the very beginning of the year and a solid financial performance this quarter,” said Camille Farhat, chief executive officer. “The continued strength of our OEM and International franchises demonstrates the importance of our overall portfolio toward the achievement of our long-term strategic goals. With our senior team in place for the first full quarter, our strategic transformation is accelerating and we continue to deliver on our commitments.”

Farhat added, “Thanks to the hard work of numerous people across the Company, we successfully completed the acquisition of Zyga Technology and are well ahead of plan on the integration. The Zyga team hit the ground running, are a strong cultural fit with RTI and have maintained their focus and positive procedural momentum. In addition to differentiated product technology supported by strong clinical evidence, we gained a tremendous team with many individuals taking broader leadership roles at RTI.”

First Quarter 2018

RTI’s worldwide revenues for the first quarter of 2018 were $69.9 million, comparable with the prior year first quarter. First quarter revenues were driven by growth in the OEM and International lines of business, which were partially offset by declines in Sports and Spine and a $3.2 million reduction from the sale of substantially all the assets of the cardiothoracic closure business completed in August 2017. Gross profit for the first quarter of 2018 was $33.7 million, or 48.2% of revenues, compared to $35.8 million, or 51.2% of revenues, in the first quarter of 2017. Gross profit for the first quarter of 2018 was impacted by an inventory charge of $1.0 million from the write-off of inventory related to our international restructuring and $0.2 million due to the purchase accounting step-up of Zyga inventory.

During the first quarter of 2018, RTI incurred non-recurring pre-tax charges to support the ongoing strategic transformation of the business. The company incurred $0.9 million in severance and restructuring charges primarily in support of initiatives to reduce the complexity of its international organizational structure; $0.1 million related to asset impairment and abandonments of certain long-term assets as part of efforts to reduce complexity and improve operational excellence; and $0.8 million in expenses related to the January 2018 acquisition of Zyga Technology to support the acceleration of growth. During the first quarter of 2017, the company incurred $4.4 million of non-recurring pre-tax charges.

Net loss applicable to common shares was $1.9 million, or $0.03 per fully diluted common share in the first quarter of 2018, compared to a net loss applicable to common shares of $2.8 million, or $0.05 per fully diluted common share in the first quarter of 2017. As outlined in the reconciliation tables that follow, excluding the impact of the various non-recurring charges, adjusted net income applicable to common shares was $0.5 million, or $0.01 per fully diluted common share in the first quarter of 2018.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), for the first quarter of 2018 was $7.8 million, or 11% of revenues compared with $6.5 million, or 9% of revenues for the first quarter of 2017. The increase in Adjusted EBITDA is primarily driven by the reduction in operating expenses associated with efforts to reduce complexity and increase operational excellence implemented during 2017.

Fiscal 2018 Outlook

Based on our recent financial results and current business outlook, the Company is reiterating financial guidance for 2018, originally issued on January 5, 2018:

  • The Company expects full year revenues in the range of $280 million and $290 million.
  • The Company expects full year Adjusted EBITDA to be in the range of $32 million to $38 million.

Farhat explained, “As we continue to reduce the complexity of our operations, we remain committed to evaluating our portfolio and exploring partnership opportunities with organizations that are well positioned to be better stewards of selected assets. Our efforts to drive operational excellence focus on implementing lean manufacturing across facilities, as we continue to strengthen the organization and invest in the company. With our senior team in place and now operating efficiently, I am shifting more of my energy towards accelerating growth, by starting to rebuild the R&D pipeline and actively seeking attractive M&A opportunities at logical valuations.”

The Company noted the following assumptions are included in its guidance:

  • Relatively stable market conditions and regulatory environment;
  • Positive revenue contribution from the acquisition of Zyga Technology – announced January 4, 2018;
  • Ongoing positive impact of efforts to reduce complexity and implement operational excellence; and
  • Continued marketing of map3® cellular allogeneic bone graft and minimal negative revenue impact related to recent FDA warning letter.

Conference Call

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

 

About RTI Surgical, Inc.

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

Forward-Looking Statements

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

 

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
Three months ended
March 31,
2018 2017
Revenues $ 69,890 $ 69,939
Costs of processing and distribution 36,208 34,160
Gross profit 33,682 35,779
Expenses:
Marketing, general and administrative 28,389 29,671
Research and development 3,421 3,688
Severance and restructuring costs 884 4,403
Asset impairment and abandonments 129
Acquisition and integration expenses 800
Total operating expenses 33,623 37,762
Operating income (loss) 59 (1,983 )
Total other expense – net (775 ) (799 )
Loss before income tax (provision) benefit (716 ) (2,782 )
Income tax (provision) benefit (249 ) 910
Net loss (965 ) (1,872 )
Convertible preferred dividend (966 ) (910 )
Net loss applicable to common shares $ (1,931 ) $ (2,782 )
Net loss per common share – basic $ (0.03 ) $ (0.05 )
Net loss per common share – diluted $ (0.03 ) $ (0.05 )
Weighted average shares outstanding – basic 63,150,009 58,495,796
Weighted average shares outstanding – diluted 63,150,009 58,495,796

 

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EIT Cellular Titanium® Scaffold Provides Better Primary Stability, Less Subsidence and Similar Fusion Results to PEEK in Combination with Autograft

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that the results of the EFFECT trial have been presented at the SSA 2018 meeting in Adelaide.

The EFFECT Trial is a prospective controlled trial, evaluating the clinical and quantitative radiological results of 50 patients, who received a single level stand-alone EIT Cervical Implant with no addition of biologics and no use of a plate or screw-fixation. The 3, 6 month and 1-year results have been compared to historical data of a cohort of patients with single level stand-alone PEEK cages with autograft (acknowledged as the ‘golden standard’) that evaluated the exact same outcome parameters.

All clinical parameters (NDI, VAS neck, VAS arm, and EQ5D) improved significantly at 3 months follow up, with a slight improvement further over time. The results did not differ from the clinical outcome in the PEEK-autograft cohort.

That the EIT cervical implant warrants an excellent primary stability without additional fixation could be observed from the significant decline of the mean Range of Motion (RoM) from 8,7° pre-operatively to 2,5° after 3 months in the EIT group, whereas this remained 3,4° in the PEEK-autograft group. The decline of the RoM measured with validated software on functional X-rays over time was chosen as an objective criteria for the quality and speed of fusion. In calculating the fusion rate (less than 2° angular motion), the EIT group outperformed the PEEK-autograft group at every time frame.

“This study has objectified our experience with the international version of the EIT Cervical Implant, that has no graft hole window. Without the need for adding biomaterials or supplemental fixation we get favorable clinical and fusion results, which is also very interesting from a cost perspective”, said Jasper Wolfs, M.D., Neurosurgeon at the Medical Center Haaglanden, The Hague, Netherlands.

Although the EIT implant is made of titanium, the 3D-printed scaffold with 80% porosity, warrants a more ‘elastic’ biomechanical behavior. This was also reflected in the subsidence rate, which was lower for the EIT Cervical Implant compared to the PEEK cage.

“Frustration at the clinical shortcomings of existing cage designs and materials on the
market provided the impetus for the creation of EIT Cellular Titanium®”, says Nancy Lamerigts, M.D., Ph.D., VP research and marketing of EIT: “Previous market solutions had issues in either one or more of the areas of fusion, biocompatibility, subsidence, migration and imaging distortion. The results of the EFFECT trial objectify that we are able to tackle all areas for the better and significantly add value to the patients, surgeons and payers”.

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of EIT Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.

EIT Cellular Titanium® scaffold provides better primary stability, less subsidence and similar fusion results to PEEK in combination with autograft

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that the results of the EFFECT trial have been presented at the SSA 2018 meeting in Adelaide.

The EFFECT Trial is a prospective controlled trial, evaluating the clinical and quantitative radiological results of 50 patients, who received a single level stand-alone EIT Cervical Implant with no addition of biologics and no use of a plate or screw-fixation. The 3, 6 month and 1-year results have been compared to historical data of a cohort of patients with single level stand-alone PEEK cages with autograft (acknowledged as the ‘golden standard’) that evaluated the exact same outcome parameters.

All clinical parameters (NDI, VAS neck, vas arm, EQ5D) improved significantly at 3 months follow up, with a slight improvement further over time. The results did not differ from the clinical outcome in the PEEK-autograft cohort.

That the EIT cervical implant warrants an excellent primary stability without additional fixation could be observed from the significant decline of the mean Range of Motion (RoM) from 8,7° pre-operatively to 2,5° after 3 months in the EIT group, whereas this remained 3,4° in the PEEK-autograft group. The decline of the RoM measured with validated software on functional X-rays over time was chosen as an objective criteria for the quality and speed of fusion. In calculating the fusion rate (< 2° angular motion), the EIT group outperformed the PEEK-autograft group at every time frame.

“This study has objectified our experience with the international version of the EIT Cervical Implant, that has no graft hole window. Without the need for adding biomaterials or supplemental fixation we get favorable clinical and fusion results, which is also very interesting from a cost perspective”, said Jasper Wolfs, M.D., Neurosurgeon at the Medical Center Haaglanden, The Hague, Netherlands.

Although the EIT implant is made of titanium, the 3D-printed scaffold with 80% porosity, warrants a more ‘elastic’ biomechanical behavior. This was also reflected in the subsidence rate, which was lower for the EIT Cervical Implant compared to the PEEK cage.

“Frustration at the clinical shortcomings of existing cage designs and materials on the

market provided the impetus for the creation of EIT Cellular Titanium®”, says Nancy Lamerigts, M.D., Ph.D., VP research and marketing of EIT: “Previous market solutions had issues in either one or more of the areas of fusion, biocompatibility, subsidence, migration and imaging distortion. The results of the EFFECT trial objectify that we are able to tackle all areas for the better and significantly add value to the patients, surgeons and payers”.

__________________________________________

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of EIT Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.