Spineology Receives a Notice of Allowance for a New US Patent on its Duo™ Lumbar Interbody Fusion Implant

March 05, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application No. 15/476,911, “Mesh Spacer Hybrid.” The allowed claims include three independent device claims covering Spineology’s Duo implant, a novel proprietary intervertebral implant that includes PEEK intervertebral spacer elements and an expandable mesh graft containment element. Spineology expects the patent to be issued within the next several weeks.

“We always strive to attain protection for strategic intellectual property,” said John Booth, Chief Executive Officer of Spineology. “This Notice of Allowance is an important extension to our IP Portfolio.”

The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. This design dramatically reduces the access required to implant a device compared to traditional lateral systems. By significantly minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

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.


Spineology Inc.
John Booth, 651-256-8511
Dave Folkens, 651-286-6713

Conformis iTotal CR Knee Replacement System Awarded “3A” Rating from the Orthopaedic Data Evaluation Panel in the United Kingdom

BILLERICA, Mass., March 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) (http://www.odep.org.uk/ODEPExplained.aspx)awarded the Conformis iTotal CR knee replacement system a “3A” rating.  The 3A rating is based on strong evidence of implant performance over three years, including low revision rates as indicated in the United Kingdom’s National Joint Registry.

ODEP is an independent panel of leading orthopedic surgeons and experts in the UK that evaluates data related to use of hip and knee implant technologies and provides a rating to indicate performance in key areas including survivorship. ODEP provides the National Health Service (NHS) with an approved list of products that meet the revision rate standard set by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. The 3A rating (as explained in more detail at http://www.odep.org.uk/ODEPExplained.aspx#2) is based on three-year performance data. ODEP ratings provide a simple, independently verified assessment as to the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants that they use comply with these national guidelines.  Only products that demonstrate compliance with NICE guidance are awarded a rating.

“The positive ODEP 3A rating reaffirms my experience treating patients with the Conformis iTotal CR knee replacement system, which I believe offers my patients a more natural feeling knee with improved performance and mobility,” said Mr. Ian McDermott FRCS, Senior Consultant Knee Surgeon at London Sports Orthopaedics, based at the London Bridge Hospital in London, UK. “The clinical evidence and three-year survivorship data together are consistent with the improvement I am seeing with my patients’ outcomes after knee replacement surgery using Conformis knee prostheses.”

“ODEP ratings provide a reliable, simple and independent assessment of the performance of an implant” said, Mr. Fahad G. Attar, MBChB, FRCS, Consultant Trauma & Orthopaedic Surgeon at BMI Alexandra and Whiston Hospital, St. Helens & Knowsley Teaching Hospitals, United Kingdom. “I expect that this 3A rating will now provide additional reassurance and peace of mind to my patients and reinforce the performance reputation of Conformis iTotal CR knee replacement implants that contribute to the improved clinical outcomes I am seeing in my practice.”

“The ODEP awarded the Conformis iTotal CR system a 3A rating based in part on positive implant survivorship and performance data from the UK National Joint Registry at three years’ post-surgery,” said Mark Augusti, Chief Executive Officer and President of Conformis.  “This rating provides another independent verification that our design philosophy, predicated on patient conforming implants, results in performance where it counts the most, in patients.  “We hope that this 3A rating also provides an opportunity for Conformis to expand our product offering to more patients receiving their healthcare in NHS facilities.”

More information on the ODEP can be found on their website at http://www.odep.org.uk/ODEPExplained.aspx

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy.  Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital.  Conformis owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Conformis, including statements about the ability to offer implants to patients in the United Kingdom, that potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Conformis views as of the date hereof. Conformis anticipates that subsequent events and developments may cause Conformis’s views to change. However, while Conformis may elect to update these forward-looking statements at some point in the future, Conformis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Conformis’ views as of any date subsequent to the date hereof.

Kelly Wakelee
Berry and Company Public Relations

Oksana Bradley
Investor Relations

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/acfb1db3-b005-40af-8b6e-dffa8c838cfe


RTI Surgical Announces Fourth Quarter and Full Year 2017 Results

March 01, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq:RTIX), a global surgical implant company, reported operating results for the fourth quarter and full year of 2017.

“We are pleased to have delivered on our 2017 commitments through four consecutive quarters and produced organic growth in every core product category,” said Camille Farhat, chief executive officer. “As I approach my first anniversary at the Company, I believe we have made significant progress. We have assembled a world class management team and began implementation of our strategic transformation. We successfully divested the cardiothoracic closure business to initiate the reduction in complexity and implemented programs to drive operational excellence and margin enhancement, while reorienting the organization around key customer segments. We are making the necessary investments to accelerate the growth of our spine franchise, most notably, the acquisition of Zyga Technology announced at the start of 2018.”

Farhat added, “While our initial progress is gratifying, we are still in the midst of our transformation with considerable work ahead of us. Moving forward, we are focused on executing our strategic initiatives to create a dynamic company focused on its core capabilities with consistent, predictable earnings and cash flow and growing spine focused operations.”

Fourth Quarter 2017

RTI’s worldwide revenues for the fourth quarter of 2017 were $70.8 million, a slight decline from the prior year quarter revenues of $71.3 million. Fourth quarter revenues were driven by stable performance in most product lines with growth in OEM, which were offset by a $2.8 million reduction from the sale of substantially all the assets of the cardiothoracic closure business completed in August 2017. Gross profit for the fourth quarter of 2017 was $36.3 million, or 51.2% of revenues, compared to $28.1 million, or 39.4% of revenues in the fourth quarter of 2016.

During the fourth quarter of 2017, RTI incurred substantial non-recurring pre-tax charges to support the ongoing strategic transformation of the business and to optimize the tax benefit of the related actions. The company incurred $1.6 million in severance and restructuring charges primarily in support of initiatives to reduce the complexity of its organizational structure; $2.8 million in executive transition costs primarily for non-cash executive inducement awards and stock-based compensation expenses; $3.7 million related to asset impairment and abandonments of certain long-term assets as part of efforts to reduce complexity and improve operational excellence; and $0.6 million in expenses related to the January 2018 acquisition of Zyga Technologies to support the acceleration of growth. During the fourth quarter of 2016, the company incurred $6.2 million of non-recurring pre-tax charges primarily driven by $5.4 million asset impairment and abandonment charges in our German facility.

Net loss applicable to common shares was $8.6 million loss, or $0.14 per fully diluted common share in the fourth quarter of 2017, compared to a net loss applicable to common shares of $11.8 million, or $0.20 per fully diluted common share in the fourth quarter of 2016. As outlined in the reconciliation tables that follow, excluding the impact of the various non-recurring charges and the impact of the Tax Cuts and Jobs Act in the fourth quarter of 2017, adjusted net income applicable to common shares was $1.6 million, or $0.03 per fully diluted common share in the fourth quarter of 2017.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)1, for the fourth quarter of 2017 was $9.4 million, or 13% of revenues compared with $6.1 million, or 9% of revenues for the fourth quarter of 2016. The increase in Adjusted EBITDA is primarily driven by the reduction in operating expenses through the efforts to reduce complexity and increase operational excellence implemented during 2017.

Full Year 2017

Worldwide revenues were $279.6 million for the full year 2017, an increase of 2.5 percent compared to revenues of $272.9 for the full year 2016. Growth across all product categories were offset by a $3.0 million reduction from the sale of substantially all of the assets of the cardiothoracic closure business in August 2017 and a reduction in other revenues. Gross profit for the full year 2017 was $142.5 million, or 51.0% of revenues compared to $132.3 million, or 48.5% of revenues in 2016.

During the year, the company recorded non-recurring pre-tax charges including: $12.2 of severance and restructuring charges; $2.8 million of executive transition expenses, $3.7 million of asset impairment and abandonment expenses; and $0.6 million in expenses related to the January 2018 acquisition of Zyga Technologies. During 2016 the Company incurred $26.6 million of pre-tax non-recurring charges.

During the third quarter of 2017, RTI completed the sale of substantially all the assets related to its cardiothoracic closure business for total consideration of $54 million, plus an additional $6 million in contingent cash consideration. In conjunction with the sale of the cardiothoracic closure business, the company recognized a gain of $34.1 million, or $18.2 million after tax.

Net income applicable to common shares was $2.5 million, or $0.04 per fully diluted common share for the full year 2017, compared to net loss applicable to common shares of $17.9 million, or $0.31 per fully diluted common share for the full year 2016. As outlined in the reconciliation tables that follow, excluding the after-tax impact of the non-recurring charges and the impact of the cardiothoracic closure sale gain, adjusted net income applicable to common shares was $3.1 million, or $0.05 per fully diluted common share in 2017.

Adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA) for the full year 2017 was $32.3 million, or 12% of revenues compared with $29.8 million, or 11% of revenues in 2016.

Fiscal 2018 Outlook

Based on its 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 EBITDA to be in the range of $32 million to $38 million.

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 4th, 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.

Farhat noted, “We believe 2018 will be a year of focused execution, which will include finalizing the remaining portfolio decisions to further reduce the complexity of our structure. We are also deploying lean manufacturing across additional manufacturing sites to continue the drive for operational excellence, while strengthening our R&D discipline and beginning to rebuild our innovation pipeline. In addition, we will opportunistically explore acquisition possibilities to further accelerate our growth trajectory.”

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, 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.

Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
Three months ended Twelve months ended
December 31, December 31,
2017 2016 2017 2016
Revenues $ 70,816 $ 71,347 $ 279,563 $ 272,865
Costs of processing and distribution 34,548 43,246 137,042 140,516
Gross profit 36,268 28,101 142,521 132,349
Marketing, general and administrative 28,258 31,447 115,103 116,125
Research and development 3,146 4,056 13,375 16,090
Severance and restructuring costs 1,550 12,173 2,146
Strategic review costs 500 1,150
Executive transition costs 2,781 297 2,781 4,404
Contested proxy expenses 2,680
Asset impairment and abandonments 3,739 5,435 3,739 5,435
Acquisition expenses 630 630
Gain on cardiothoracic closure business divestiture (34,090 )
Total operating expenses 40,104 41,735 113,711 148,030
Operating (loss) income (3,836 ) (13,634 ) 28,810 (15,681 )
Total other expense – net (615 ) (667 ) (3,085 ) (1,779 )
(Loss) Income before income tax (provision) benefit (4,451 ) (14,301 ) 25,725 (17,460 )
Income tax (provision) benefit (3,202 ) 3,399 (19,453 ) 3,061
Net (loss) income (7,653 ) (10,902 ) 6,272 (14,399 )
Convertible preferred dividend (951 ) (897 ) (3,723 ) (3,508 )
Net (loss) income applicable to common shares $ (8,604 ) $ (11,799 ) $ 2,549 $ (17,907 )
Net (loss) income per common share – basic $ (0.14 ) $ (0.20 ) $ 0.04 $ (0.31 )
Net (loss) income per common share – diluted $ (0.14 ) $ (0.20 ) $ 0.04 $ (0.31 )
Weighted average shares outstanding – basic 61,601,040 58,426,241 59,684,289 58,236,745
Weighted average shares outstanding – diluted 62,495,577 58,426,241 60,599,952 58,236,745




Centrexion Therapeutics to Present CNTX-4975 Clinical Data at the American Academy of Orthopaedic Surgeons 2018 Annual Meeting

March 01, 2018

BOSTON, Mass.–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced it will present Phase 2b data of CNTX-4975 for the treatment of moderate to severe osteoarthritis knee pain at 4:00 p.m. CST on Tuesday, March 6 at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting taking place from March 6-10, 2018 at the Ernest N. Morial Convention Center in New Orleans, LA.

More information can be found at www.aaos.org. Details of the oral presentation are listed below.

Title: Intra-articular CNTX-4975 for Osteoarthritis Knee Pain: Analyses From a 24-Week Randomized Phase 2b Study
Paper Number: 868
Session Title: Adult Reconstruction Knee IX (868-882)
Presentation Time: Tuesday, March 6 at 4:00 p.m. CST
Location: Theater A, Ernest N. Morial Convention Center

About Osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, affecting approximately 14 million people in the United States.1 OA occurs when the protective cartilage on the ends of the bones wears down over time, and the bone around the joints harden and form edges. These changes cause pain, swelling and problems moving the joint. OA also causes an inflammatory process to occur in the affected joint, further damaging the cartilage. Although OA can damage the majority of joints in the body, it most commonly affects joints in the knees, hips, hands and spine. OA can cause pain severe enough that patients experience difficulty walking, climbing stairs or even rising from a chair. Despite currently available therapies, many patients opt for total joint replacement to manage the painful condition.

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI™ technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultra-pure, synthetic form of trans-capsaicin. CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe joint pain without affecting touch sensibility or position sense. CNTX-4975 works by targeting the capsaicin receptor (TRPV1) to selectively and rapidly inactivate the local pain fibers transmitting signals to the brain. With a short half-life, CNTX-4975 is cleared from the body within 24 hours. This approach is designed to provide pain relief that can last for months until the ends of the local pain fibers regenerate, while maintaining normal sensation, such as touch, pressure and position, and without the risks of toxicities of NSAIDs and injected corticosteroids, or the side effects, including abuse and addiction, associated with opioid treatments. In January 2018, CNTX-4975 was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of pain associated with knee osteoarthritis.

About Centrexion Therapeutics

Centrexion Therapeutics Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest, exclusively pain-focused pipelines of non-opioid, non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion people living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. For more information about Centrexion Therapeutics, visit http://www.centrexion.com.

1. Deshpande, B., et al. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care & Research. Published online November 3, 2016


W2O pure
Media Contact
Julie Normart, +1 415-946-1087
Investor Contact
Courtney Dugan, +1 212-257-6723

Biomatlante Continues To Invest In Innovative Solutions For Active Healing Through Orthobiologics

After the success of the European program REBORNE (FP7) focused on safety and efficacy of the Biomatlante matrix combined with autologous bone marrow expanded mesenchymal stem cells (MSC), MBCP+™*, made from our well-known MBCP Technology, was confirmed as the adapted matrix for tissue engineering and chosen for 2 new European research programs (H2020): MAXIBONE and ORTHOUNION.

The current challenge is to compare the clinical performances of this Advanced Therapy Medicinal Product (MBCP+™/MSC) with autograft, considered as the gold-standard for bone reconstruction: MAXIBONE (150 patients) for bone augmentation in maxillofacial surgery before dental implant placement and ORTHOUNION (about 100 patients) focused on non-union after long bone fractures.

BIOMATLANTE will showcase its technology at the American Academy of Orthopaedic Surgeons (AAOS) Congress, held 6-10 March 2018 in New Orleans, USA.

About BIOMATLANTE, experts in bone regeneration 
Based near Nantes, France, Biomatlante specializes in synthetic biomaterials for bone regeneration and is a world leader in bone graft technologies, selling its products in over 50 countries. Biomatlante’s products are routinely used in orthopedics and trauma surgery, in spine and dental surgery. BIOMATLANTE strives to integrate a strategy of strong innovation and product development required to meet and exceed the needs of today’s market. Our R&D collaborates closely with universities and research centers across the world, bringing together competences in innovation, technological transfers of new biomaterials, surgical technologies and providing the intellectual protection required to foster long-term projects.

About MBCP™ Technology*, worldwide reference in synthetic bone graft 
The unique manufacturing process developed by BIOMATLANTE confers its core MBCP biphasic HA/ ß-TCP technology unique properties for hard tissue regeneration. Its micro-macroporous structure mimics that of human bone and provides an ideal osteogenic matrix for bone regeneration in general and tissue engineering in particular.

About REBORNE, Regenerating Bone Defects using New biomedical Engineering approaches 
The objective of REBORNE is to develop new biomaterials that stimulate bone tissue formation with a view to correcting bone regeneration defects in orthopedic and maxillofacial surgery. Biomaterials, combined with the use of stem cells, are interesting alternatives to biological grafts.

About MAXIBONE, Personalized maxillofacial bone regeneration 
This European project aims at performing a multicenter clinical trial on 150 patients for bone augmentation in maxillofacial surgery prior to dental implants with autologous bone marrow expanded mesenchymal stem cells and biomaterials versus autologous bone grafting. Personalized 3D printed calcium phosphate biomaterials are also developed and in the R&D workpackage, a new optimized smart scaffold for cells and drugs combination will also be tested and developed.

The “ORTHOpaedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs” (ORTHOUNION) is a 5 years project funded with 6M EUR by the EU H2020 programme, in the topic SCI-PM-11-2016-17: Clinical research on regenerative medicine.

For further information about BIOMATLANTE and its technologies, please visit http://www.biomatlante.com

  • 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