International Life Sciences Appoints Aaron C. Smith as New Chief Executive Officer of Artelon®

Posted On May 9, 2017 By OrthoSpineNews In Biologics, Top Stories /

May 08, 2017

ATLANTA–(BUSINESS WIRE)–International Life Sciences, LLC, announces the appointment of Aaron C. Smith as Chief Executive Officer of Artelon®, the leader in synthetic biomaterial technology for orthopedic soft tissue reinforcement.

Mr. Smith is a 23-year orthopedic industry veteran and biomedical engineer who joins the company after 6 years with Amniox Medical, a subsidiary of TissueTech. As Co-Founder and General Manager of Amniox Medical, Smith and his team launched the first amniotic membrane and umbilical cord tissue product into the orthopedic reconstruction and wound care space, establishing the company as a leader in the $600 million regenerative tissue market. During his previous tenure as Senior Director, Extremity Management Group with Wright Medical Technology Inc., Mr. Smith oversaw the transformation of the company’s legacy extremities portfolio from a niche product line into a market leader in the burgeoning Foot and Ankle Surgery market. Smith also served in leadership roles with Spinal Concepts (acquired by Abbott Laboratories in 2003), Xomed Surgical Products (acquired by Medtronic in 1999), and Acromed (acquired by DePuy Orthopedics in 1997).

“We are extremely pleased to welcome Aaron Smith to Artelon,” said Mark Cohen, Chairman of the Board, International Life Sciences. “His established track record of bringing innovative technologies to bear in emerging musculoskeletal markets is an excellent and timely fit for our organization. Under Aaron’s leadership, we look forward to fulfilling the promise of our Artelon technology.”

Artelon’s biomaterials were developed specifically for medical applications and have demonstrated long-term clinical benefit to patients. The materials are made from a unique polymer textile that provides mechanical strength and tissue scaffolding, while degrading in a highly predictable fashion. They are sterile and biologically inert and avoid the unpredictability and safety concerns associated with reinforcement grafts manufactured from donated human tissue. Artelon’s products are available in the United States and select international markets through its network of independent sales agents.

“Artelon has a suite of proprietary biomaterials that has been in development for over 30 years and has been used by some of the most prominent orthopedists in the world to benefit more than 30,000 patients,” said Mr. Smith. “There is an impressive trove of scientific evidence and intellectual property supporting this unique technology. In our markets of interest, Artelon is well differentiated and highly complementary to other emerging regenerative technologies. We have an excellent opportunity to leverage our core competencies to solve major unmet clinical needs and ultimately improve patient care, recovery and surgical outcomes.”

About International Life Sciences, LLC

US-based medical device company International Life Sciences is committed to solving unmet clinical needs in the orthopedic and podiatric surgical communities with novel biomaterials solutions.

About Artelon

Artelon is a proprietary biomaterial technology designed specifically for soft tissue reinforcement and deformity correction during reconstructive surgery. It is the only synthetic biomaterial on the market with high mechanical strength, proven biocompatibility, and predictable resorption throughout the entire tissue healing process. Artelon products have been in development for more than 30 years and have successfully treated over 30,000 patients worldwide.

Artelon® is a registered trademark of International Life Sciences, LLC.

Contacts

Pascale Communications
Jessica Griffith, 610-618-0013
jessica@pascalecommunications.com

Stryker Orthopaedics 2016 Settlement Program reaches milestone

Posted On May 9, 2017 By OrthoSpineNews In Financial, Regulatory, Top Stories /

Kalamazoo, Michigan – May 8, 2017- Stryker Corporation (NYSE:SYK) announced that Howmedica Osteonics Corp. (referred to as “Stryker Orthopaedics”), a subsidiary of Stryker Corporation, has informed the courts in the New Jersey Multicounty and Federal Multidistrict litigations that 95% of additional registered eligible patients have enrolled in the Settlement Program under the Master Settlement Agreement announced in December 2016. As a result, Stryker Orthopaedics will move forward with the 2016 Settlement Program that provides for compensation to additional eligible U.S. patients who had surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem, known as a revision surgery, prior to December 19, 2016.

Shortly, the Claims Processor will begin notifying claimants and their attorneys regarding compensation payments. The exact timing and amount of payments will depend on factors and circumstances specific to each claim. It is expected that a majority of the payments under the Settlement Agreement will be made by the end of 2017.

The 2016 Settlement Program follows an initial 2014 Settlement Program that covered patients who had a revision surgery prior to November 3, 2014. In that initial program, over 95% of eligible patients also enrolled. The high participation rates in both the 2014 and 2016 Settlement Programs are a testament to the fair and efficient processes afforded to patients through both of these Programs.

For more information about the Settlement Program, please visit: www.strykermodularhipsettlement.com.

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Contacts

For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:
Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

Investor Contacts

Katherine A. Owen
Vice President, Strategy & Investor Relations
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
269-385-2600

Charles DeCoster IV, MSA
Manager, Investor Relations & Strategy
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002
P: 269-385-2600
C: 269-532-2118
Charles.DeCoster@Stryker.com

Spinal Stenosis Implant Market Set to Witness an Uptick During 2017–2025: Persistence Market Research

Posted On May 8, 2017 By OrthoSpineNews In Spine /

New York, NY — (SBWIRE) — 05/08/2017 — Spinal stenosis is a condition which usually occurs in the elderly patients. Stenosis mean abnormal narrowing of a body channel. This mean spinal stenosis is narrowing of the spinal canal. The narrowing of spinal canal occurs due to degeneration of intervertebral disk and facet joint. This condition mainly affects people above 50 years but can also affect younger people who are born with abnormal spinal canal. If the narrowing is minimal symptoms will not occur but too much narrowing can lead to compression of nerves and can be problematic. Spinal stenosis symptoms include lower back pain, numbness in legs and balance problem. It can occur anywhere along the spine.

Increasing prevalence of spinal stenosis is one of the major factor driving the growth of spinal stenosis implant market. Other factors contributing to the growth of the market are increasing older population and rise in the obesity cases which can lead to spinal injury or stenosis. Increasing demand and adoption of the minimally invasive surgeries and better relief over the medication are also factors driving growth in this market.

Spinal stenosis implant market is expected to show significant growth over the forecast period. Increasing case of arthritis and ageing of the population is expected to be the factor facilitating the growth of spinal stenosis implant market. Spacing is devices are expected to be highest revenue generating and fastest growing product segment due to increasing demand for minimally invasive treatments as this procedure has lesser risks involved and also it allows easy movement in comparison to fusion or fixation devices which involves long surgical process and higher blood loss. Along with this spacing devices provide faster and lasting symptoms relief and has lesser hospital stay. Titanium spinal stenosis implants are expected to be fastest growing, and highest selling as titanium is strong and light in weight when compared to the stainless steel implants and it has better elasticity which allows easy movement. Ambulatory surgical units are expected to have the highest number of such surgeries as these units are being used for performing the minimally invasive surgeries and patients don’t need to stay overnight.

READ THE REST HERE

New long-term data on the effect of lumbar total disc replacement on adjacent level degeneration reinforces outcomes from previous studies

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

CENTER VALLEY, Pa., May 8, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that Dr. Richard Guyer of the Center for Disc Replacement at Texas Back Institute presented the adjacent segment disease (ASD) outcomes of the activL^® Artificial Disc Investigational Device Exemption (IDE) trial at the International Society for the Advancement of Spine Surgery Annual Meeting (April 12-14, 2017, Boca Raton, FL). The data reiterates the role of lumbar total disc replacement in delaying the progression of ASD, a common downstream complication associated with lumbar fusion. ASD furthers the societal burden imposed by degenerative disc disease, a condition responsible for 62 million physician visits per year and the number two reason – second only to the common cold – for lost work time. The trial found that at five years, the activL Artificial Disc had a protective effect on the progression of DDD at adjacent levels in 91.2% of patients.

According to Dr. Guyer, former president of the North American Spine Society (NASS), “These outcomes complement the large body of evidence already available reporting on the long-term adjacent outcomes following lumbar disc replacement. Previously, lumbar fusion had been reported to be responsible for a rate of ASD as high as 28.6% in patients with five-year follow-up.”

In 2008, Harrop et al. published a systematic review of lumbar disc replacement data and reported that in patients with three to 22 years of follow-up, total disc replacement resulted in a 9% adjacent segment degeneration rate, whereas lumbar fusion resulted in a 34% rate. Later, in 2012, Zigler et al. worked with Medical Metrics Incorporated (MMI) to conduct a post-hoc analysis on ProDisc-L IDE subjects and found a three-fold reduction in ASD rates between lumbar TDR and fusion at five years. MMI employed the same methods used in Zigler et al., 2012 to analyze the ASD outcomes from the activL Artificial Disc IDE trial.

Until recently, patient access to lumbar arthroplasty, or total disc replacement, for patients suffering from symptomatic degenerative disc disease has been a challenge due to the lack of coverage on many insurance policies. However, outcomes such as those presented by Dr. Guyer have caused payers to reconsider their policies.

In May, national insurer Humana, which is responsible for insuring more than six million American lives, overturned their coverage determination for lumbar total disc replacement. This policy change, along with others, resulted in now nearly one in two privately-insured Americans having access to lumbar disc replacement. Additional long-term evidence will likely cause more payers to reconsider their stance in the coming months.

A group of surgeon investigators from the activL Artificial Disc IDE trial are currently compiling the full outcomes of this ASD analysis and are expected to seek publication of the full data set later this year.

SOURCE Aesculap Implant Systems, LLC

Medtronic executive presses Congress to changes in FDA plant inspections

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

By Jim Spencer Star Tribune – May 2, 2017

WASHINGTON – A high-ranking Medtronic official appeared on Capitol Hill on Tuesday to ask Congress to make changes in the way government regulators inspect device manufacturing facilities for flaws.

Pat Shrader, Medtronic’s vice president for global affairs, told a House subcommittee that inspections come with too little warning and are too “erratic” for companies to supply information, clarification and follow-up that might keep them from being sanctioned.

“Device facilities in the U.S. are often given very short advance notice of an inspection,” Shrader told the House Energy and Commerce Health Subcommittee. “This short notice, plus the often erratic schedules of investigators, leads to challenges in assembling the appropriate team members to provide the required documents and materials requested by the FDA.”

Shrader spoke not just for Minnesota-run Medtronic, but on behalf of the Advanced Medical Technology Association, the device industry’s main trade group, which includes other major Minnesota employers, such as 3M, St. Jude Medical (through its new owner, Abbott Laboratories) and Boston Scientific.

READ THE REST HERE

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

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

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 Implant^TM.

“It gives me great pride to announce that the iFuse Procedure^TM 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 pain^1-4, 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 Implant^TMwas 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.

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.

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.

²Olivares-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.

³Olivares-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

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 CRYOTEK^TMprocess, 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

Month: May 2017

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