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Histogenics Agreement With Japan Pharmaceuticals and Medical Devices Agency and Regulatory Pathway for NeoCart®

Posted On May 8, 2017 By OrthoSpineNews In Biologics, Regulatory /  

WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) regarding the Marketing and Manufacturing Authorization pathway for Histogenics’ NeoCart (autologous cell therapy designed to treat cartilage defects in the knee) in the Japanese market.  Histogenics is currently nearing the completion of enrollment in a 245 patient Phase 3 clinical trial of NeoCart that is being conducted under a Special Protocol Assessment (the SPA) with the U.S. Food and Drug Administration (the FDA).

“We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in Japan, and appreciate the thoughtful, rapid and collaborative approach provided by Japan regulators,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “These successful consultations and meetings are evidence of our execution of a broadening global regulatory strategy launched only seven months ago where we initiated efforts to leverage the robust U.S. clinical, preclinical and cGMP data for NeoCart into international markets.  We believe the clarity on this efficient regulatory pathway for full Marketing Authorization will be important to our efforts to seek a development and commercialization partner for NeoCart in Japan and other markets in Asia.”

Various aspects of the Japanese regenerative medicine laws were updated in 2014 to potentially expedite the clinical development and commercialization pathways for innovative, qualified regenerative cell-based medicines that have demonstrated safety and probable efficacy.  Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in May 2016, Histogenics initiated preparatory pre-consultations (Jizen-Mendan) with the PMDA for the three discreet modules of the regulatory process: Clinical Trial, Non-clinical Safety and Quality/Manufacturing.

During the first quarter of 2017, Histogenics held a series of consultations with the PMDA, including face-to-face (Taimen-Jogen) meetings.  In these consultations, the PMDA agreed that Histogenics’ ongoing Phase 3 clinical trial with its one-year primary endpoint could be appropriate and provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan. Furthermore, the PMDA agreed that a 30-patient, one-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan.  This Japanese study will utilize the same protocol as the ongoing Phase 3 clinical trial of NeoCart.  Histogenics also confirmed that NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in Japan, and that Histogenics’ current good manufacturing process (cGMP) in the U.S. could be utilized to manufacture and supply the confirmatory clinical study. These consultations with the PMDA were attended by representatives of Histogenics, including co-founder Dr. Shuichi Mizuno, regulatory and regenerative medicine experts, and two esteemed orthopedic surgeons from Japan, Dr. Akihiro Tsuchiya and Dr. Takumi Nakagawa, both of whom have trained on NeoCart procedures with U.S. surgeons.

In addition to the confirmatory clinical trial, Histogenics agreed with the PMDA to conduct additional minor, non-clinical safety studies, including a short-term (three-month) general toxicity study and in vitro tumorigenicity studies to reflect current standards and to augment the significant amount of pre-clinical data previously generated by Histogenics.  These additional study protocols will be reviewed with the PMDA and will be conducted prior to the Marketing and Manufacturing Authorization.  With regards to Histogenics’ Quality/Manufacturing applications, the PMDA and Histogenics agreed to several updates for certain procedures and testing methodology, all of which are planned as part of Histogenics’ continuous improvement activities for the biologics license application (BLA) submission planned with the FDA. Histogenics believes that the PMDA’s conclusions are based on the strength of the NeoCart clinical and non-clinical data package and the long 15+ year cGMP manufacturing history of NeoCart.

“We are thankful for the leadership and partnership with the PMDA,” commented Dr. Shuichi Mizuno, Ph.D., Co-founder of Histogenics, and Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital, and Harvard Medical School.  “We have been working collaboratively for nearly 20 years to provide substantial supportive basic science and non-clinical data as well as novel cell culture technology to guide the development of this important innovative therapy for cartilage defects.”

In conjunction with the launch of its commercial partnering efforts, Histogenics commissioned through Locust Walk’s Japan team a quantitative market research study with approximately 80 orthopedic surgeons including a mix of hospital physicians and general practitioners in Japan regarding the market opportunity for NeoCart for knee cartilage defects in the Japanese market.  The findings paralleled what is observed from surgeons and patients in the United States – a market with a high unmet need characterized by long recoveries and variable clinical outcomes from current therapies, leaving many patients choosing to avoid having unsatisfactory treatments.  These data may reflect the opportunity for innovative regenerative medicine products such as NeoCart to grow the market substantially by providing satisfactory outcomes and better quality of life, while avoiding progression to osteoarthritis (OA) and unnecessary surgeries.

The findings from the Japan survey include:

  • Cartilage defects account for approximately 40% of total knee trauma cases causing pain and loss of function in the knee (with or without other injuries).
  • Approximately 60% of patients with knee cartilage defects are either not treated at all, or treated only with conservative therapies (such as debridement) to temporarily treat pain.
  • Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA, and 15-20% of their patients currently suffering from knee OA have such OA likely due to cartilage defects.
  • More than 85% of orthopedic surgeons are not satisfied with the currently available treatment options for pain and loss of function due to knee cartilage defects.
  • Approximately 80% of the surgeons consider early improvement in pain and function to be important and over half of the surgeons feel they would prescribe NeoCart based on the data already published.

“As is the case in the United States, we believe Japanese surgeons and patients are seeking new regenerative medicine options to repair cartilage defects that may offer both a more rapid recovery in terms of pain and function, as well as a more durable response over time with fewer repeat surgeries, which improves overall quality of life,” commented Dr. Tsuchiya, Vice President, Funabashi Orthopaedic Hospital, Chiba, Japan, and Chairman, Tokyo Women’s Medical College, Tokyo, Japan, and Dr. Nakagawa, Professor of Department of Orthopaedic Surgery, School of Medicine, Teikyo University, Tokyo, Japan.  “We have followed the development of NeoCart for many years and have trained with surgeons in the U.S., and along with our medical colleagues, look forward to potentially introducing this novel non-NSAID and non-opioid cell-based therapy product to our patients in Japan that currently do not have good options to treat the pain and loss of function due to knee cartilage defects.”

Histogenics estimates the Japanese market represents a significant opportunity, with an estimated 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee and limited options to treat the defect or related pain.  If left untreated, cartilage defects may result in OA and ultimately, total knee replacements as patients age, with a substantial economic impact on patients and insurance companies.  Market forecasts predict that the number of OA patients in Japan aged 40 and older amounts to more than 25 million and is expected to accelerate with the aging population. Once a development and commercial partner is identified, Histogenics intends to file with such partner the Clinical Trial Notification (CTN) to the PMDA to begin the proposed clinical trial.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace.  Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year.  NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates in the U.S. and Japan, and the labeling for any approved products; Histogenics’ ability to find a development and commercialization partner for NeoCart in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics may incur in connection with its exclusive channel collaboration agreement with Intrexon Corporation and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016, which is on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, to be filed with the SEC in the second quarter of 2017.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Investor Relations
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com

Source: Histogenics Corporation

Read more: http://www.nasdaq.com/press-release/histogenics-announces-agreement-with-the-japan-pharmaceuticals-and-medical-devices-agency-regardin-20170508-00226#ixzz4gVichFvl

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HCA Announces Agreement to Acquire Three Houston Hospitals from Tenet

Posted On May 8, 2017 By OrthoSpineNews In Financial, Regulatory, Top Stories /  

May 01, 2017

NASHVILLE, Tenn.–(BUSINESS WIRE)–HCA (NYSE: HCA), which operates 171 hospitals, 119 freestanding surgery centers, and numerous other outpatient centers in 20 states and the United Kingdom, today announced an agreement to purchase three hospitals in Houston from Tenet Healthcare.

The agreement includes 423-bed Houston Northwest Medical Center, 181-bed Cypress Fairbanks Medical Center Hospital and 444-bed Park Plaza Hospital.

“The addition of these hospitals will help us expand our network to serve patients in a growing part of the Greater Houston market,” said Sam Hazen, president and chief operating officer of HCA. “We are excited about the prospect of them joining us, and we believe there’s an opportunity to add to the services they currently offer and create a more comprehensive provider network for our patients in Houston.”

HCA’s healthcare network in Houston currently includes 10 hospitals, eight surgery centers, two freestanding ERs and 10 imaging centers.

The transaction, which is subject to regulatory approval, is expected to close in the third quarter.

About HCA

Nashville-based HCA is one of the nation’s leading providers of healthcare services, operating 171 locally managed hospitals and 119 freestanding surgery centers in 20 states and the United Kingdom. With its founding in 1968, HCA created a new model for hospital care in the United States, using combined resources to strengthen hospitals, deliver patient-focused care and improve the practice of medicine. HCA has conducted a number of clinical studies, including one that demonstrated that full-term delivery is healthier than early elective delivery of babies and another that identified a clinical protocol that can reduce bloodstream infections in ICU patients by 44 percent. HCA is a learning healthcare system that uses its more than 27 million annual patient encounters to advance science, improve patient care and save lives.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, which involve risks and uncertainties. Forward-looking statements include statements that do not relate solely to historical or current facts. Forward-looking statements can be identified by the use of words like “may,” “believe,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “initiative” or “continue.” These forward-looking statements are based on our current plans and expectations and are subject to a number of known and unknown uncertainties and risks, many of which are beyond our control, which could significantly affect current plans and expectations and our future financial position and results of operations. These factors include, but are not limited to, the ability to consummate and realize the benefits of the proposed acquisition as well as the risk factors described in our annual report on Form 10-K for the year ended December 31, 2016 and our other filings with the Securities and Exchange Commission. Many of the factors that will determine our future results are beyond our ability to control or predict. In light of the significant uncertainties inherent in the forward-looking statements contained herein, readers should not place undue reliance on forward-looking statements, which reflect management’s views only as of the date hereof. We undertake no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

All references to “Company” and “HCA” as used throughout this document refer to HCA Holdings, Inc. and its affiliates.

Contacts

HCA
Investor Contact:
Mark Kimbrough, 615-344-2688
or
Media Contact:
Ed Fishbough, 615-344-2810

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SI-BONE, Inc. Announces U.S. Military’s TRICARE Now Covers MIS SI Joint Fusion

Posted On May 8, 2017 By OrthoSpineNews In Spine /  

SAN JOSE, Calif., May 8, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that TRICARE has established a written coverage policy for minimally invasive SI joint fusion surgery.  TRICARE is a regionally managed health care program for active duty and retired members of the uniformed services, their families, and their survivors.  The policy provides coverage for the 9.4 million members of the United States military’s health care system, including access to 55 military hospitals and 373 military clinics, and states that “minimally invasive surgery (CPT® procedure code 27279) for the treatment of sacroiliac joint pain is proven.”  The positive coverage policy is retroactive to August 23, 2016 and was established based on the high quality prospective clinical evidence published on the iFuse ImplantTM.

“It gives me great pride to announce that the iFuse ProcedureTM is considered a proven treatment by the United States Defense Health Agency and can now be appropriately offered to active and retired military personnel and their family members,” said Michael Mydra, SI-BONE’s Vice President, Health Outcomes & Reimbursement.  “SI-BONE is pleased to be able to help all the brave men and women in our armed forces for their service to our country.”

“Earlier this year, we met with Colonel Stephen C. Phillips, DO, MPH and his staff at the Defense Health Agency in Washington, D.C. and reviewed the extensive published clinical evidence for the iFuse Implant.  Following that meeting, the TRICARE policy team determined that coverage for MIS sacroiliac joint fusion was appropriate and warranted,” said Tony Recupero, Chief Commercial Officer at SI-BONE.  “We are now fully engaged with physicians at military facilities across the country to assist them in providing iFuse to appropriately diagnosed military personnel.”

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse ImplantTMwas designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer reviewed publications including two level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

CPT copyright 2017 America Medical Association.  All rights reserved.  CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9876.050817

1.

Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.

2.

Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.

3.

Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.

4.

Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.

5.

DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

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Titan Spine Appoints Spine Industry Expert Ed Graubart as Vice President of Professional Development

Posted On May 8, 2017 By OrthoSpineNews In Spine /  

May 08, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced Ed Graubart has joined the leadership team as Vice President of Professional Development. Mr. Graubart will be responsible for enhancing and building the Company’s infrastructure for training and professional development at Titan Spine as demand accelerates for its nanoLOCK® surface technology, the only nano-cleared interbody device on the market shown to elicit a nano-cellular level response for bone growth.1

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Ed is a highly accomplished veteran of the orthopedic medical device industry, with more than 27 years of sales team infrastructure and personnel building experience at leading spine companies including NuVasive, DePuy Spine, and EBI. We are excited to have such a highly regarded leader join our Titan Spine team and we look forward to Ed’s contributions to enhance and build the infrastructure for training and professional development during a time of tremendous growth and momentum at Titan Spine as demand accelerates for both our original Endoskeleton® surface technology implants and the recently introduced interbody systems with our unique and proprietary nanoLOCK® technology.”

Mr. Graubart added, “Titan Spine’s nanoLOCK® technology is aggressively paving the way for devices to create an osteogenic response in the spine interbody device industry. The Company has recently shifted into a critical period marked by scaling up to manage its substantial growth over the last few years, achieving record sales for the first quarter of 2017, increasing the number of nanoLOCK® surgeon adopters across the U.S., and significantly increasing sales volume of nanoLOCK® since launch in the fourth quarter of last year. I am immensely excited to join the Titan team and look forward to supporting this drive and energy through all aspects of the organization, including tailoring training programs and aligning structure to support our growth and success.”

Mr. Graubart joins Titan Spine from Ceterix Orthopaedics, a developer of novel surgical tools that improve a surgeon’s ability to perform meniscal repairs, where he served as Vice President of Sales. Prior to Ceterix, Mr. Graubart spent 10 years in leadership and executive sales and sales training positions at NuVasive, supporting the company’s growth from $38 million in 1995 to over $800 million in 2015. Before this, Mr. Graubart was Director of Spine Arthroplasty at DePuy Spine, Inc. where he was part of an elite team hired to train and support the introduction of the first lumbar artificial disc approved in the United States. Mr. Graubart started his career in orthopedic and spine medical device sales in 1992 with EBI Medical Systems (A Biomet Company), where he spent 14 years in various sales and leadership roles during his tenure. Mr. Graubart received his B.S. in Business Administration and Marketing at the University of Dayton.

Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary nanoLOCK® surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

1 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

2 Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

3 Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company:
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media:
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

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New Clinical Evidence Continues to Support the Effectiveness and Value of AMNIOX Medical Products

Posted On May 8, 2017 By OrthoSpineNews In Biologics /  

May 08, 2017

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, announced today that nine clinical posters demonstrating the effectiveness of NEOX® Wound Allograft – Amniox’s proprietary cryopreserved Umbilical Cord and Amniotic Membrane (UC/AM) product for chronic wound management – were presented at the Symposium on Advanced Wound Care (SAWC) and Wound Healing Society Meeting. The meeting was held at the San Diego Convention Center in San Diego, California, from April 5-9.

Following peer review, all nine posters were accepted for presentation at the symposium. These posters present therapeutic and surgical applications of NEOX Wound Allograft in a range of severe wound types that are resistant to the current standard of care. These wounds include wounds resulting from radiation therapy; wounds due to Charcot arthropathy; severe burns; trauma wounds; chronic non-healing ulcers; skin grafts and wounds post-treatment for Basal Cell Carcinoma. With all of these complex, hard-to-heal cases, patients achieved closure of their wounds subsequent to applications of NEOX, including a number of situations where these patients had failed other advanced therapies.

“The posters presented at SAWC highlight NEOX’s clinical effectiveness and value in a variety of wounds that are difficult to treat with typical wound care modalities,” said Thomas J. Dugan, Chief Executive Officer of Amniox Medical. “Across all of this clinical experience, patients treated with NEOX experienced closure of hard-to-heal wounds. The strength of this clinical evidence continue to drive demand for unique regenerative properties of umbilical cord tissue.”

Studies presented at SAWC included the following posters:

  • Cryopreserved Umbilical Cord* (cUC) Treatment of Radiation Wound Post Melanoma Removal Involving Soft Tissue and Bone, David F. Fernandez, MD
  • Injectable Lyophilized Human Umbilical Cord and Amniotic Membrane (UC/AM) as an Interventional Treatment in Early Charcot Foot Presentation, Wayne J. Caputo, DPM
  • Use of Cryopreserved Umbilical Cord as Adjunctive Therapy for Multiple Burn Wounds of the Lower Extremity, Kimberly Jackman, MD, and Leslie Harris, APRN
  • Cryopreserved Umbilical Cord * (cUC) Use for Acute Orthopedic Trauma Wounds, Kaitlyn Griffin, BS and Christopher Stewart, MD
  • Combination of Cryopreserved Umbilical Cord (cUC)* with Negative Pressure Therapy for the Treatment of Chronic Non-Healing Ulcers, Allen Raphael, DPM
  • The Use of Cryopreserved Umbilical Cord/Amniotic Membrane (cUC) to Generate Granulation Tissue over Scalp Post Basal Cell Carcinoma (BCC) Removal in Order to Prep for a Split-thickness Skin Graft, Charles L. Dupin, MD, Meghan Bias, MD, Amanda Gregoire, NP and Renata Falgout, RN
  • The Use of Cryopreserved Human Amniotic Membrane and Umbilical Cord (AM/UC) Allografts to Expedite Healing in Patients with Chronic Non-healing Wounds, Justin Goldsmith, DPM, Aamir Mahmood, DPM, Patrick Sanchez, DPM, Anna Tien, DPM, Sarah Park, DPM, Jake Ruff, DPM, Andrea Seat, DPM, Michael Czurylo, DPM, Laith Shaman, DPM and Matthew Garoufalis, DPM, FASPS, FACFAOM, CWS
  • The Use of Cryopreserved Human Umbilical Cord in the treatment of an Irradiated Tissue Wound Post Treatment for Basal Cell Carcinoma, Amesh Patel, MD, and Carolyn Hewett, RN, CWOCN
  • Surgical Implantation Technique for Treating Chronic Ulcers with Cryopreserved Umbilical Cord*, Allen Raphael, DPM

Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. In utero, wound healing occurs rapidly and with minimal scar. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process.

Amniox Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. Amniox utilizes its proprietary CRYOTEKTM process, a cryopreservation technology that preserves the biological and structural integrity of these tissues more effectively than other available technologies. Since inception, more than 300,000 human transplants of its products have been performed and more than 300 peer-reviewed studies supporting its technology platform have been published.

About Amniox Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; Bio-Tissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) have supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

Contacts

for AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883
cgale@greentarget.com

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Scopis Introduces the First Mixed-Reality Surgical Holographic Navigation Platform Integrating Microsoft HoloLens

Posted On May 5, 2017 By OrthoSpineNews In Spine /  

May 05, 2017

CAMBRIDGE, Mass. & BERLIN–(BUSINESS WIRE)–Scopis, a company specializing in surgical navigation and medical augmented and mixed reality technologies, announced today the launch of its newest development, the Holographic Navigation Platform for use in surgery. Scopis developed this platform to offer greater precision and speed to surgeons, and better outcomes to patients undergoing open and minimally-invasive spinal procedures. The added innovation of incorporating Microsoft HoloLens into the Scopis Navigation Platform lets surgeons plan the positioning and alignment of pedicle screws during multiple vertebrae fixation surgeries, for example.

To use the Scopis Holographic Navigation Platform during such an operation, the surgeon wears Microsoft HoloLens glasses, which communicate wirelessly with the Scopis system. The planned positioning of the pedicle screws is projected onto the surgeon’s field of view and overlaid exactly onto the patient, creating the mixed reality experience. This allows the surgeon to find the screws’ planned positions faster and to align surgical instruments interactively with the holographic visualization.

“Scopis’ holographic solution has the potential to make spine surgery more effective, safe, and precise,” said Professor Christian Woiciechowsky, Chief of the Spinal Surgery Clinic at Vivantes Humboldt Hospital in Berlin. “Integrating mixed-reality tools into surgery is a huge technological advancement toward enhancing a surgeon’s vision and may provide greater benefits to patients.”

Scopis’ technology improves the accuracy of mixed reality overlay using additional 3-D position tracking. The Scopis holographic platform revolutionizes surgical workflows by enabling surgeons to use gestures to place virtual monitors into their visual field near the patient, so their eyes remain on the operative field. A video demonstrating the platform’s technological advantages is featured on Scopis’ YouTube channel: https://www.youtube.com/user/ScopisMedical/

Scopis’ technology could also benefit patients and medical professionals by reducing the radiation exposure from fluoroscopy devices that are currently used to determine the optimal position for screw placement during surgery, as well as improve surgical outcomes through more precise alignment and shorter surgery times.

“Scopis’ Holographic Navigation Platform is a universal solution that offers specific advantages for spinal surgeries and can also be applied in the many other areas where the highest levels of precision and speed are critical. In neurosurgery, for example, brain tumors could be located faster and with higher accuracy,” said Bartosz Kosmecki, CEO and Founder of Scopis. “The development of this holographic platform further highlights Scopis’ leading role in medical mixed and augmented reality.”

About Scopis

Scopis is a leader in medical augmented reality (AR), mixed reality, and hybrid navigation, creating innovative solutions for the healthcare market, including technology for surgical education, and planning and navigation systems for otorhinolaryngology (ENT), craniomaxillofacial (CMF), neuro- and spine surgery, and bronchoscopy. In over 50 countries worldwide, surgeons have performed more than 10,000 surgeries with the aid of Scopis’ products and have benefitted from the highly-advanced image guidance and visualization capabilities of Scopis’ technology.

Scopis is known as one of the top vendors and innovators for surgical navigation systems and has business operations in Germany and the United States. www.scopis.com

For Visual and Multimedia Representations of Scopis’ Products:

http://holographic.scopis.com

http://www.scopis.com

https://www.youtube.com/user/ScopisMedical/

Regional availability. Not all Scopis products are available for sale in the United States.

Contacts

Scopis:
Bartosz Kosmecki
CEO & Founder
(+1) (512) 578-9127
pr@scopis.com
or
Media Contact:
MacDougall Biomedical Communications
Joanne Tudorica or Gretchen Schweitzer
+49 89 2424 3494 or +49 176 210 37191
jtudorica@macbiocom.com
For Commercial and Surgical Inquiries:
Scopis Inc.
inquiries@scopis.com

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Ready, steady, go: Tightened EU medical device regulations are here

Posted On May 5, 2017 By OrthoSpineNews In Regulatory /  

by , Medical Plastics News – May 5, 2017

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR).

The next step is a transition period of three years for medical devices and five years for in-vitro devices (IVD)s meaning that the new rules will fully apply at the end of May 2020 for medical devices and at the end of May 2022 for IVDs.

“The medical technology industry welcomes the fact that the transition and implementation period has finally come” said Serge Bernasconi, CEO of MedTech Europe. “Now we open a new chapter – the industry is ready to collaborate with all actors to ensure a timely and smooth transition to the new regulations.”, he added.

Going forward, implementation of the regulations is a top priority for the industry and MedTech Europe. With the publication of the regulations, a new and intensive phase of work begins for regulators and stakeholders. Many pieces of secondary legislation and guidelines will need to be developed in order to be able to implement the regulations on time.

It is important that notified bodies are designated early in the transition period and have the capacity to manage the assessment of over 500,000 medical technologies to the updated requirements within the set timeframe.

 

READ THE REST HERE

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Orthofix International Reports First Quarter 2017 Financial Results

Posted On May 5, 2017 By OrthoSpineNews In Financial /  

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the first quarter ended March 31, 2017. Net sales were $102.7 million, loss per share from continuing operations was ($0.13) and adjusted earnings per share from continuing operations was $0.27.

“We are very pleased with the top-line results for the first quarter 2017 and the momentum we achieved in each of our businesses,” said Brad Mason, President and Chief Executive Officer. “The solid execution of our commercial strategies is delivering results as demonstrated by another strong quarter in our BioStim business and an earlier than expected return to growth in both Biologics and Spine Fixation. Although each strategic business unit has its own commercial strategy, our overriding corporate focus is on expanding distribution in underserved markets, improving engagement of our legacy distributors and providing our salesforce with a robust stream of new products. Our bottom-line results reflect the investments we are making in these key strategies, which are proving effective in driving our top line growth.”

Financial Results Overview

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change

Constant
Currency
Change
BioStim $ 44,539 $ 41,044 8.5 % 8.5 %
Biologics 14,987 14,094 6.3 % 6.3 %
Extremity Fixation 23,945 24,709 (3.1 %) (1.0 %)
Spine Fixation 19,267 18,832 2.3 % 2.3 %
Net sales $ 102,738 $ 98,679 4.1 % 4.6 %

Gross profit increased $3.6 million to $80.2 million. Gross margin increased slightly to 78.0% compared to 77.6% in the prior year period, which was in line with our expectations. Net margin (gross profit less sales and marketing expenses) was $31.6 million compared to $31.7 million in the prior year period. The decrease in net margin was primarily due to higher sales and marketing expenses, driven by a higher mix of sales from new distributors in our Biologics and Spine Fixation SBUs, who typically receive higher commission rates in their first year.

Net loss from continuing operations was ($2.3) million, or ($0.13) per share, compared to net income of $4.6 million, or $0.24 per share in the prior year period. The net loss for the quarter was impacted by strategic investments in the quarter of $7.1 million, including a pre-tax impairment of $5.6 million on our eNeura investment. Adjusted net income from continuing operations was $4.9 million, or $0.27 per share, compared to adjusted net income of $5.2 million, or $0.28 per share in the prior year period.

EBITDA was $6.6 million, compared to $13.8 million in the prior year period. Adjusted EBITDA was $15.7 million or 15.3% of net sales for the first quarter, compared to $15.5 million or 15.7% of net sales in the prior year period.

Liquidity

As of March 31, 2017, cash and cash equivalents were $41.7 million compared to $39.6 million as of December 31, 2016. As of March 31, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations decreased $1.2 million to $3.5 million, while free cash flow increased $1.3 million to ($0.4) million.

2017 Outlook

For the year ending December 31, 2017, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 407.0 $ 411.0 $ 411.0

1

 $ 415.0

1
Net income from continuing operations $ 24.4 $ 29.3 $ 20.6

2

 $ 23.7

2
Adjusted EBITDA $ 76.0 $ 79.0 $ 76.0

3

 $ 79.0

3
EPS from continuing operations $ 1.33 $ 1.59 $ 1.12

4

 $ 1.29

4
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.48

5

 $ 1.58

5
1 Represents a year-over-year increase of 0.3% to 1.3% on a reported basis
2 Represents a year-over-year increase of 489.1% to 577.7%
3 Represents a year-over-year decrease of 0.4% to 4.2%
4 Represents a year-over-year increase of 489.5% to 578.9%
5 Represents a year-over-year increase of 1.4% to 8.2%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the first quarter of 2017. Interested parties may access the conference call by dialing (888) 364-3109 in the U.S. and (719) 457-2631 outside the U.S., and referencing the conference ID 9028875. A replay of the call will be available for two weeks by dialing (888) 203-1112 in the U.S. and (719) 457-0820 outside the U.S., and entering the conference ID 9028875. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict. Therefore, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2016, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX INTERNATIONAL N.V.
Consolidated Statements of Operations
Three Months Ended
March 31,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016
Net sales $ 102,738 $ 98,679
Cost of sales 22,581 22,137
Gross profit 80,157 76,542
Sales and marketing 48,532 44,822
General and administrative 18,282 17,005
Research and development 7,424 7,640
Operating income 5,919 7,075
Interest income (expense), net 45 (38 )
Other income (expense), net (4,348 ) 1,833
Income before income taxes 1,616 8,870
Income tax expense (3,924 ) (4,294 )
Net income (loss) from continuing operations (2,308 ) 4,576
Discontinued operations
Loss from discontinued operations (527 ) (990 )
Income tax benefit 181 254
Net loss from discontinued operations (346 ) (736 )
Net income (loss) $ (2,654 ) $ 3,840
Net income (loss) per common share—basic
Net income (loss) from continuing operations $ (0.13 ) $ 0.25
Net loss from discontinued operations (0.02 ) (0.04 )
Net income (loss) per common share—basic $ (0.15 ) $ 0.21
Net income (loss) per common share—diluted
Net income (loss) from continuing operations $ (0.13 ) $ 0.24
Net loss from discontinued operations (0.02 ) (0.04 )
Net income (loss) per common share—diluted $ (0.15 ) $ 0.20
Weighted average number of common shares:
Basic 17,979,675 18,477,881
Diluted 17,979,675 18,758,751
ORTHOFIX INTERNATIONAL N.V.
Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) March 31,

2017

 December 31,

2016
(unaudited)
Assets
Current assets
Cash and cash equivalents $ 41,652 $ 39,572
Restricted cash — 14,369
Accounts receivable, net of allowances of $8,394 and $8,396, respectively 59,443 57,848
Inventories 66,271 63,346
Prepaid expenses and other current assets 19,478 19,238
Total current assets 186,844 194,373
Property, plant and equipment, net 47,962 48,916
Patents and other intangible assets, net 8,530 7,461
Goodwill 53,565 53,565
Deferred income taxes 41,431 47,325
Other long-term assets 16,413 20,463
Total assets $ 354,745 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 16,555 $ 14,353
Other current liabilities 46,316 69,088
Total current liabilities 62,871 83,441
Other long-term liabilities 24,740 25,185
Total liabilities 87,611 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,042,834 and

17,828,155 issued and outstanding as of March 31, 2017 and December 31,

2016, respectively

 1,804 1,783
Additional paid-in capital 208,686 204,095
Retained earnings 61,525 64,179
Accumulated other comprehensive loss (4,881 ) (6,580 )
Total shareholders’ equity 267,134 263,477
Total liabilities and shareholders’ equity $ 354,745 $ 372,103

ORTHOFIX INTERNATIONAL N.V.
Non-GAAP Financial Measures

The following tables present reconciliations of net income (loss) from continuing operations, earnings per share from continuing operations, gross profit, and net cash from operating activities, in each case calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to, as applicable, non-GAAP financial measures, referred to as “EBITDA,” “Adjusted EBITDA,” “Adjusted net income from continuing operations,” “Adjusted earnings per share from continuing operations,” “Net margin” and “Free cash flow” that exclude items specified in the tables. A more detailed explanation of the items excluded from these non-GAAP financial measures, as well as why management believes the non-GAAP financial measures are useful to them, is included following the reconciliations.

EBITDA and Adjusted EBITDA
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net income (loss) from continuing operations $ (2,308 ) $ 4,576
Interest expense (income), net (45 ) 38
Income tax expense 3,924 4,294
Depreciation and amortization 5,075 4,873
EBITDA $ 6,646 $ 13,781
Share-based compensation 2,816 2,099
Foreign exchange impact (1,013 ) (1,815 )
Strategic investments 7,100 198
SEC / FCPA matters and related costs 141 245
Infrastructure investments — 962
Legal judgments/settlements 227 —
International restructuring (239 ) —
Adjusted EBITDA $ 15,678 $ 15,470
As a % of net sales 15.3 % 15.7 %

Adjusted Net Income from Continuing Operations
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net income (loss) from continuing operations $ (2,308 ) $ 4,576
Foreign exchange impact (1,013 ) (1,815 )
Strategic investments 7,100 198
SEC / FCPA matters and related costs 141 245
Infrastructure investments — 962
Legal judgments/settlements 227 —
International restructuring (239 ) —
Long-term income tax rate adjustment 948 1,079
Adjusted net income from continuing operations $ 4,856 $ 5,245

Adjusted Earnings per Share from Continuing Operations
Three Months Ended

March 31,
(Unaudited, per diluted share) 2017 2016
EPS from continuing operations $ (0.13 ) $ 0.24
Foreign exchange impact (0.06 ) (0.10 )
Strategic investments 0.39 0.01
SEC / FCPA matters and related costs 0.01 0.01
Infrastructure investments — 0.05
Legal judgments/settlements 0.01 —
International restructuring (0.01 ) —
Long-term income tax rate adjustment 0.06 0.07
Adjusted EPS from continuing operations $ 0.27 $ 0.28
Weighted average number of diluted common shares 18,235,660 18,758,751

Net Margin
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Gross profit $ 80,157 $ 76,542
Sales and marketing (48,532 ) (44,822 )
Net margin $ 31,625 $ 31,720
BioStim $ 17,133 $ 16,408
Biologics 6,171 6,104
Extremity Fixation 6,412 7,175
Spine Fixation 2,007 2,335
Corporate (98 ) (302 )
Net margin $ 31,625 $ 31,720

Free Cash Flow
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 3,470 $ 4,646
Capital expenditures (3,905 ) (6,399 )
Free cash flow $ (435 ) $ (1,753 )

2017 Outlook
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 24.4 $ 29.3 $ 20.6 $ 23.7
Interest expense, net 0.1 0.2 0.1 0.2
Income tax expense 16.2 15.7 13.6 14.3
Depreciation and amortization 20.0 20.0 20.0 20.0
EBITDA $ 60.7 $ 65.2 $ 54.3 $ 58.2
Share-based compensation 11.8 11.8 11.8 11.8
Foreign exchange impact — — (1.0 ) (1.0 )
Strategic investments 1.2 0.7 8.6 8.1
SEC / FCPA matters and related costs 1.3 0.8 1.3 1.0
International restructuring 1.0 0.5 0.8 0.7
Legal judgments/settlements — — 0.2 0.2
Adjusted EBITDA $ 76.0 $ 79.0 $ 76.0 $ 79.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 1.33 $ 1.59 $ 1.12 $ 1.29
Foreign exchange impact — — (0.05 ) (0.05 )
Strategic investments 0.06 0.04 0.46 0.44
SEC / FCPA matters and related costs 0.07 0.04 0.07 0.05
International restructuring 0.05 0.03 0.04 0.04
Legal judgments/settlements — — 0.01 0.01
Long-term income tax rate adjustment (0.03 ) (0.12 ) (0.17 ) (0.20 )
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.48 $ 1.58
Weighted average number of diluted common shares 18,400,000 18,400,000 18,400,000 18,400,000

Constant Currency

Constant currency is a non-GAAP measure, which is calculated by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

EBITDA

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income (expense), net; income tax expense; and depreciation and amortization to net income (loss) from continuing operations. EBITDA provides management with additional insight to its results of operations.

Adjusted EBITDA, Adjusted Net Income from Continuing Operations and Adjusted Earnings per Share from Continuing Operations

These non-GAAP financial measures provide management with additional insight to its results of operations and are calculated using the following adjustments:

  • Share-based compensation – costs related to our share-based compensation plans, which include stock options, restricted stock awards, performance-based restricted stock awards, market-based restricted stock awards and our stock purchase plan
  • Foreign exchange impact – gains and losses related to foreign currency transactions; guidance presented does not include the impact of any future foreign exchange fluctuations
  • Strategic investments – costs related to our strategic investments, including our investment in eNeura, Inc.
  • SEC / FCPA matters and related costs – legal and other professional fees associated with the SEC Investigation, Securities Class Action Complaint and Brazil subsidiary compliance review
  • Infrastructure investments – costs associated with our multi-year process and systems improvement effort, “Bluecore,” which was completed in 2016
  • Legal judgments/settlements – adverse or favorable legal judgments or negotiated legal settlements
  • International restructuring – costs related to a planned restructuring, primarily consisting of severance charges and the write-down of certain assets
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 38%, which is based on current tax law and current expected income; actual tax expense will ultimately be based on GAAP performance and may differ from the 38% effective tax rate due to a variety of factors, including the jurisdictions in which profits are determined to be earned and taxed, the resolutions of issues arising from tax audits with various tax authorities, and the ability to realize deferred tax assets

Net Margin

Net margin is a non-GAAP financial measure, which is calculated by subtracting sales and marketing from gross profit. Net margin is the primary metric used by our Chief Operating Decision Maker in managing our business.

Free Cash Flow

Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

The non-GAAP measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as equity compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation.

Usefulness of Non-GAAP Financial Measures to Investors

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
markquick@orthofix.com

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SeaSpine Reports First Quarter 2017 Financial Results

Posted On May 5, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., May 04, 2017 (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 first quarter ended March 31, 2017.

First Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $31.9 million, an increase of 1.6% year-over-year
  • U.S. revenue of $28.6 million, an increase of 0.2% year-over-year
    • U.S. orthobiologics revenue of $15.1 million
    • U.S. spinal hardware revenue of $13.5 million
  • International revenue of $3.3 million, an increase of 15.0% year-over-year
  • Initial launch of the reusable Rapid Graft Delivery System, which is designed to provide surgeons a cost-effective and controlled method to predictably deliver a broad range of orthobiologic grafts efficiently to the disc space
  • Initial launch of the Daytona Small Stature Pediatric Deformity System, a minimal profile version of our existing Daytona system that provides both a clinical and cosmetic benefit for pediatric patients

“Our first quarter performance reflects early traction with our strengthening distributor base and our expanding and updated product portfolio,” said Keith Valentine, President and Chief Executive Officer. “We are continuing to invest in key objectives aimed at top line performance while simultaneously reducing our net cash spend to extend our liquidity horizon.”

First Quarter 2017 Financial Results
Revenue for the first quarter of 2017 totaled $31.9 million, a 1.6% increase compared to the same period of the prior year. Total revenue in the U.S. was $28.6 million, a 0.2% increase compared to same period of the prior year.

Orthobiologics revenue totaled $17.1 million, a 2.8% increase compared to the first quarter of 2016. The increase in orthobiologics revenue was driven by an increase in both U.S. and international sales, primarily due to the addition of new distributors in both markets. Spinal hardware revenue totaled $14.8 million, a 0.2% increase compared to the first quarter of 2016. The increase in spinal hardware revenue was driven by the recent addition of a new distributor in Latin America.

Gross margin for the first quarter of 2017 was 58.7%, compared to 54.5% for the same period in 2016.  The increase in gross margin was primarily driven by a $1.7 million provision for excess orthobiologics raw material inventory recorded in the first quarter of 2016. This was somewhat offset by a $0.2 million increase in the first quarter of 2017 in non-cash amortization of technology intangible assets from the NLT acquisition and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue compared to the same period of the prior year.

Operating expenses for the first quarter of 2017 totaled $27.8 million, compared to $29.4 million for the same period of the prior year.  The $1.6 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the first quarter of 2017 was $9.1 million, compared to a net loss of $12.0 million for the first quarter of 2016.

Cash and cash equivalents at March 31, 2017 were $12.7 million and the Company had $3.9 million of outstanding borrowings against its $30 million credit facility.

2017 Financial Outlook
Consistent with prior guidance, SeaSpine expects full-year 2017 revenue to be in the range of $129 to $133 million, reflecting growth of 0% to 3% over full-year 2016 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: 2407268. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

About SeaSpine
SeaSpine 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 hardware 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 hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive, complex, deformity and degenerative procedures. We believe expertise in both orthobiologic sciences and spinal hardware product development helps SeaSpine to offer its surgeon customers a complete 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: revenue expectations for full-year 2017; and the Company’s ability to drive top-line performance and revenue growth while simultaneously reducing net cash spend.  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 our existing products and to adopt our newly launched products; 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; disruption to our existing distribution network as new distributors are added and the inability of new distributors to generate growth, or even offset lost business; the risk that our products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing, including in ongoing and future studies, the outcomes of which inherently are uncertain; the lack of clinical validation of products in “alpha release” and the fact they may require substantial additional development activities, which could introduce unexpected expense and delay; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; third-party payors’ willingness to continue to provide, for our existing products, and to initiate, for our newly launched products, appropriate coverage, coding and reimbursement and uncertainty resulting from healthcare reform, both in the U.S. and abroad; unexpected expense, including as a result of developing and launching new and next generation products and product line extensions; our ability to sustain current operations and to continue to invest in product development, sales and marketing initiatives at levels sufficient to drive future revenue growth in light of cost-reduction initiatives first implemented in 2016 and that continue to impact current operations; our ability to obtain funding on a timely basis on acceptable terms, or at all, to execute our business strategy; general economic and business conditions in the markets in which we do business, both in the U.S. and abroad; and other risks and uncertainties more fully described in our 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.

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended March 31,
2017 2016
Total revenue, net $ 31,894 $ 31,399
Cost of goods sold 13,172 14,283
Gross profit 18,722 17,116
Operating expenses:
Selling, general and administrative 23,970 25,374
Research and development 3,050 2,753
Intangible amortization 792 1,281
Total operating expenses 27,812 29,408
Operating loss (9,090 ) (12,292 )
Other income (expense), net (13 ) 258
Loss before income taxes (9,103 ) (12,034 )
Benefit for income taxes — (27 )
Net loss $ (9,103 ) $ (12,007 )
Net loss per share, basic and diluted $ (0.79 ) $ (1.08 )
Weighted average shares used to compute basic and diluted net loss per share 11,586 11,167
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
March 31, 2017 December 31, 2016
Cash and cash equivalents $ 12,726 $ 14,566
Trade accounts receivable, net of allowances of $480 and $483 19,388 20,982
Inventories 42,993 45,299
Total current liabilities 22,064 24,418
Short-term debt 67 445
Long-term borrowings under credit facility 3,914 3,835
Total stockholders’ equity 106,654 110,977 
Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com
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MiMedx EpiFix® Receives Coverage From Kaiser Permanente

Posted On May 5, 2017 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., May 4, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Company’s EpiFix® product has received coverage from insurer Kaiser Permanente, effective April 1, 2017.

Founded in 1945 and headquartered in Oakland, California, Kaiser Permanente is one of the nation’s largest not-for-profit health plans. With this coverage decision, the Kaiser 7.4 million commercial members now have coverage for EpiFix. Kaiser’s medical policy, “Wound Care Treatments,” now includes EpiFix for up to eight applications in 12 weeks when there is evidence of wound healing. Kaiser considers EpiFix medically necessary for treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). EpiFix is the first and only placental-based product covered by Kaiser for the treatment of DFUs and VLUs.

Parker H. “Pete” Petit, Chairman and CEO said, “We are pleased to have received coverage from Kaiser and to add them to our list of insurers providing access to our dehydrated Human Amnion/Chorion Membrane (dHACM) allografts for their covered members. Kaiser joins the broad list of insurers providing coverage, which list already includes major national health plans such as Aetna, Cigna, Anthem and virtually all of the other Blue Cross/Blue Shield health plans, plus a vast number of regional insurers. With the addition of Kaiser, over 317 million commercial covered lives and Medicare/Medicaid beneficiaries now have reimbursement access to EpiFix.”

Bill Taylor, President and COO, commented, “Our evidence-based publications demonstrating the clinical efficacy and cost effectiveness of our allografts have been instrumental in gaining coverage for our allografts from both the commercial payers such as Kaiser, as well as the federal and state payers. Our Compendium, now totaling 46 peer-reviewed published studies including completed Randomized Control Trials (RCTs), scientific studies and significant case studies, is unmatched in our industry, and it is the catalyst for our success in gaining awards of coverage. We are very gratified that so many commercial health plan members and federal and state beneficiaries have access to the positive clinical outcomes that our allografts produce.”

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the Company’s belief that evidence-based publications demonstrating the clinical efficacy and cost effectiveness of its allografts have been instrumental in gaining coverage for the allografts from both commercial payers and federal and state payers. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that future evidence-based publications may not be as impactful in gaining reimbursement coverage, reimbursement is always subject to change and may therefore impact cost effectiveness of care, access to coverage may not translate into broader use of the Company’s products, individual results from using the Company’s products may vary, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016 and its most recent 10-Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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