Rotation Medical Announces Key Events at Arthroscopy Association of North America Annual Meeting

May 09, 2017

PLYMOUTH, Minn.–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced key events for the upcoming Arthroscopy Association of North America Annual Meeting May 18-20 in Denver. These events include first-ever presentation of results of the REBUILD study of the company’s Bioinductive Implant for rotator cuff repair, as well as multiple podium presentations.

Rotation Medical’s REBUILD (Rotation MEdical BioindUctive ImpLant Database) is a prospective, non-randomized, real-world registry study designed to collect patient-reported outcomes, including shoulder function, pain and quality of life, after receiving the Bioinductive Implant. Dr. Louis McIntyre of Northwell Health Physician Partners Orthopaedic Institute at Sleepy Hollow (New York) will share results of the first 200 patients enrolled in the study, as well as provide case examples and an overview of published clinical data on Thursday, May 18, 11:40 a.m. to 12:30 p.m.

Attendees will also have the opportunity to learn more about the Rotation Medical Bioinductive Implant at the following events:

  • Clinical Case Panel #1: Rotator Cuff. Dr. Jeffrey Abrams of Princeton Orthopaedic Associates (New Jersey) will highlight his use of the Bioinductive Implant. Thursday, May 18, 10:20-10:50 a.m.
  • Symposium 1: The Failed Cuff, What Now? Dr. Michael O’Brien of Tulane Institute of Sports Medicine (Louisiana) will discuss patch options and results. Thursday, May 18, 10:50-11:30 a.m.
  • The Holy Grail: Can We Successfully Treat the Overhead Athlete? Expert Advice and Experience. Dr. Michael T. Freehill of Michigan Medicine Orthopaedic Sports Medicine will highlight his use of the Bioinductive Implant. Thursday, May 18, 4:45-6:15 p.m.
  • State of the Art Grafts and Patches in Rotator Cuff Surgery: Augmentation, Interpositions, Superior Capsular Reconstruction and Bioinductive Implant. Dr. Richard Ryu of the Ryu Hurvitz Orthopedic Clinic (California) and Dr. Matthew T. Provencher of The Steadman Clinic and Steadman Philippon Research Institute (Colorado) will present the biology and mechanics of rotator cuff patches and grafts, including the surgical technique for the Bioinductive Implant. Friday, May 19, 7:45-9:15 a.m.
  • Feature Lecture #8: Patch Options and Results. Dr. Ryu will also provide an overview of the Bioinductive Implant for full thickness and partial tears. Friday, May 19, 3:15-3:30 p.m.

“Given the high failure rate and difficult recovery required for traditional approaches to rotator cuff repair, we believe the results of our REBUILD real-world study will speak to the potential of our Bioinductive Implant to transform the treatment of rotator cuff disease,” said Martha Shadan, president and CEO of Rotation Medical. “Attendees at this year’s AANA Annual Meeting will also have many opportunities to hear from their peers how our Bioinductive Implant can improve outcomes for people with rotator cuff tears.”

About Rotator Cuff Tears

Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.

About the Rotation Medical BioInductive Implant

Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address both the biomechanics and biology required to heal a rotator cuff tendon tear by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly. For important safety information, visit http://rotationmedical.com/our-solution/risks/.

About Rotation Medical

Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit http://www.rotationmedical.com/.

Contacts

Merryman Communications
Joni Ramirez
323-532-0746
joni@merrymancommunications.com

OrthAlign, Inc. Announces Appointment of Andy Turner as Country Director of Australia and New Zealand

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the appointment of Andy Turner as Country Director of Australia and New Zealand to support continued growth and investment of OrthAlign technologies in that region of the world. He will be based in Sydney.

Andy has over twenty years experience in the orthopaedic industry, in both the sales and marketing functions. His career began in Europe with DePuy, followed by a move to Biomet, where he was responsible for launching the Vanguard knee system across Europe. Andy moved to Australia in 2008 and has held senior management and executive positions for Smith & Nephew and ZimmerBiomet, where he was responsible for marketing, sales, and product management of the orthopedic portfolios. During his career, he has successfully managed some of the largest global orthopedic brands, namely, Legion, CPCS, Polar, NexGen, Oxford, and CPT, respectively. Andy’s strong commercial acumen and sales drive has resulted in meeting corporate objectives and financial targets at every stage of his career. He holds an Honors Degree in Management with a Major in Physiology from Hallam University, Sheffield, UK.

“The addition of Andy as a local leader for OrthAlign in Australia and New Zealand is just one of many major investments that we are making in those very important markets. KneeAlign® has already established itself as one of the leading orthopaedic technologies in ANZ, but OrthAlign technology is just scratching the surface,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “Andy’s local presence will greatly enhance our continued efforts in customer expansion, growth in our portfolio of products, and focus in providing world class customer service to our surgeons, hospitals, and surgery centers. With 65,000 knee and 45,000 hip arthroplasties completed in Australia and New Zealand in 2016, we are excited about the growth opportunities that are before us.”

About OrthAlign, Inc.

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

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

CartiHeal Raises $18.3 Million

KFAR SABA, Israel, May 8, 2017 /PRNewswire/ —

Funds will support IDE clinical study for company’s Agili-C™ implant

CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the culmination of an $18.3M financing round. The funds will finance the company’s recently-approved IDE clinical trial toward a PMA application.

The two-year pivotal study will involve US and OUS centers, with the aim of demonstrating the Agili-C™ implant’s superiority over the surgical standard of care.

The investment was led by aMoon, together with CartiHeal’s existing investors: Johnson & Johnson Innovation (JJDC Inc.), Peregrine Ventures and Elron, who has been consistently supporting and investing in CartiHeal over the years.

“CartiHeal delivers hope to those who suffer daily from degenerative and non-degenerative joint conditions, regenerating both bone and cartilage with its Agili-C single-step implantation procedure,” says Dr. Yair Schindel, Managing Partner at aMoon. “We are excited to take part in this promising endeavor, already showing remarkable results, and join the highly capable management team and strong investors, in bringing this technology to a growing population of patients globally.”

“This latest investment round is yet another testament to our investors’ confidence in our technology,” says Nir Altschuler, CartiHeal’s founder and CEO. “We believe the implant can greatly benefit patients suffering from a variety of cartilage lesions, who wish to return to a painless and active lifestyle, and who currently don’t have good alternatives.”

About Agili-C™

CartiHeal’s cell-free, off-the-shelf implant for use in cartilage and osteochondral defects was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 250 patients with cartilage lesions in the knee, ankle, and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, as per its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

Results of these prior investigations demonstrated the potential for cartilage regeneration and the remodeling of underlying subchondral bone, along with pain and symptom relief.

About CartiHeal

CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

The company’s flagship product, Agili-C™, is CE marked and has been recently approved by the FDA for an Investigational Device Exemption (IDE) clinical trial toward a PMA application.

(Logo: http://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg )

For more information, please contact:
Caty Pearl
Catyp@pearlcom.co.il
+972-9-8810400

SOURCE CartiHeal (2009) Ltd.

CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities

WARRINGTON, Pa., May 8, 2017 /PRNewswire/ — CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position.

The InReach is an ultra-compact CT scanner that provides high-contrast 3D datasets of bony anatomy, which could potentially replace radiographs as a first line of diagnosis.

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

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

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

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

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

By Star Tribune – May 2, 2017

– 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

HCA Announces Agreement to Acquire Three Houston Hospitals from Tenet

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

VTI has Partnered with Medikon to Distribute Its InterFuse® Products in Turkey

VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has partnered with the Turkish Medical Distribution company Medikon to distribute its InterFuse® product line in Turkey. Medikon will serve as an extension to VTI to meet the growing demand of high quality spinal fusion products in Turkey.

“We are excited to start working with Medikon, the company has been serving the Turkish spine surgeon community since 1995 with highly differentiated products and I’m convinced they will do an excellent job selling the InterFuse® product line,” says VTI’s Vice President of International Sales Ben Wasscher.

Sinan Kazmaci Managing Director of Medikon stated, “At Medikon we are excited to be working with the InterFuse® modular cage. When we presented the product to our most important surgeons, there was a great deal of enthusiasm and excitement for the product. Surgeons thought that the modular approach to achieve a large footprint through a small access channel was a great idea and many of them are keen to start with InterFuse®, especially for their more challenging patients.”

ABOUT MEDIKON
Medikon Ltd. Was founded in 1995, and is active in the field of spinal surgery, neurosurgery and orthopedic surgery products. Medikon is the foremost distributor of unique spinal products manufactured by some of the world’s leading companies. The company employs close to 100 people operates with 7 branches and 15 dealers all over Turkey including Ankara and İstanbul. Learn more about Medikon here: http://www.medikon.net/

ABOUT VTI’S INTERFUSE® SPINAL FUSION SYSTEM
VTI’s InterFuse® System is an intra-operative assembly technology, which allows surgeons to implant a large footprint device through a minimally invasive approach. The shape of each device is biomechanically optimized to match the contours of the endplate and the unique anatomical shape and size of each patient’s disc space. Learn more about VTI’s InterFuse product here: http://www.vti-spine.com/product/interfuse/

ABOUT VTI – VERTEBRAL TECHNOLOGIES, INC.
VTI – Vertebral Technologies, Inc. is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells its InterFuse® modular interbody fusion devices worldwide. Learn more about VTI here: http://www.vti-spine.com/

For more information, visit: http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or + 1.877.912.5401.