31 Mar

Also Made in Mexico: Lifesaving Medical Devices

By SARAH VARNEY, March 31, 2017

TIJUANA, Mexico — The North American Free Trade Agreement has transformed this sprawling border town from gritty party spot to something entirely different: a world capital of medical devices.

Trucks choke boulevards lined with factories, many bearing the names of American-run companies: Medtronic, Hill-Rom, DJO Global and Greatbatch Medical. Inside, Mexican workers churn out millions of medical devices each day, from intravenous bags to artificial respirators, for the global market.

Nearly everyone in America who has a pacemaker — in fact, people all over the world — walks around with parts from here.

When President Trump threatens to redo trade deals and slap steep taxes on imports in an effort to add more manufacturing jobs, he focuses largely on car companies and air-conditioner makers. But the medical devices business makes a particularly revelatory case study of the difficulties of untangling global trade.

America imports about 30 percent of its medical devices and supplies. The trouble is, these jobs are among the most difficult to relocate to the United States. To ensure the safety of products that often end up inside the human body, medical devices are strictly regulated and require lengthy approvals from the Food and Drug Administration and other inspectors.

If the companies do keep major operations outside the country, new taxes on imports would most likely increase the cost of their products — a change that could jolt not only the devices industry in coming years, but also health care nationwide.

Here in Tijuana the factories are bound to stay put for years, at least. During that time, health executives say, a border tax could fracture the industry’s sophisticated global supply chain and force American hospitals to pay more for vital necessities — or worse.

“The real danger is the supplies won’t be available at all,” said Dr. John Jay Shannon, chief executive of the Cook County Health and Hospitals System in Chicago.

American hospitals rely on heaps of bandages and surgical gloves from China, suturing needles and artificial joints from Ireland, and defibrillators and catheters from Mexico. In all, the annual imports of medical devices more than tripled from 2001 to 2016, when it reached $43.9 billion, according to BMI Research, a unit of the Fitch Group.

Mexico is the leading supplier, ahead of Ireland, Germany and China. And few places illustrate this changing landscape, or help explain the complexity of the industry, as well as Tijuana, 20 miles south of San Diego.

The city houses the highest concentration of Mexico’s medical device firms, 70 percent of which are American-owned, according to the local development group. Companies including Medtronic, CareFusion, DJO Global and Hill-Rom-Welch Allyn — some that have their headquarters just up the road in San Diego — have invested heavily in Tijuana, constructing long, low-slung factories tucked into the hilly terrain. Giant banners hanging from manufacturing plants plead for workers to join them.

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31 Mar

Here’s Why the Best Is Yet to Come for Intuitive Surgical, Inc.

Keith Speights (TMFFishBiz), March 31, 2017 For several years, it looked like Intuitive Surgical (NASDAQ:ISRG) might be past its prime. The robotic surgical system maker's stock experienced a malaise throughout much of the period between 2012 and late 2015. Now, however, Intuitive Surgical is on a roll. Its share price is up close to 20% so far in 2017. Could the best be yet to come for Intuitive? I think so.

Trends in its favor

Most people think about the aging of the baby boomer generation as a key demographic trend. And it is. However, millennials (individuals born between 1981 and 1997) have surpassed baby boomers as the largest generation in the U.S. The aging of both groups should benefit Intuitive Surgical. Hysterectomy ranks as the top surgical procedure performed using Intuitive's da Vinci robotic surgical system. More than 40% of da Vinci procedures performed in the U.S. last year were hysterectomies. The average age of American women who have hysterectomies is 42. Many in the millennial generation will reach this age in only a few years. Intuitive Surgical's second most performed surgical procedure is radical prostatectomy for patients diagnosed with prostate cancer. The average age of American men who are diagnosed with prostate cancer is 66. Some baby boomers have already reached the prime age for developing prostate cancer, but most aren't quite that old yet. It's not just demographic trends that are working in Intuitive Surgical's favor. The company generated 71% of total revenue in 2016 from recurring sales of instruments, accessories, and services. This percentage has steadily increased in recent years. Intuitive's huge recurring revenue provides it stability and flexibility that many other companies don't enjoy.   READ THE REST HERE

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31 Mar

Total Joint Center at The Miriam Hospital awarded second Joint Commission Gold Seal of Approval

PUBLIC RELEASE: 

PROVIDENCE, R.I. - The Total Joint Center at The Miriam Hospital has earned The Joint Commission's Gold Seal of Approval® for Advanced Certification for Total Hip and Total Knee Replacement. The certification recognizes the Total Joint Center's quality, consistency and safety of services and patient care set by The Joint Commission. The Total Joint Center is the only such program in the state and among only three in New England to earn the advanced designation. "This advanced Joint Commission certification is recognition of The Miriam Hospital's team approach to ensuring patients have the best possible outcome. This is achieved by providing safe, state-of-the-art care, starting prior to surgery and through the rehabilitative process," said John A. Froehlich, M.D., program director of the Total Joint Center. Earlier this month, The Miriam Hospital underwent a rigorous onsite review by the Joint Commission to become one of only 32 advanced total hip and knee centers in the country. Joint Commission experts evaluated compliance with advanced disease-specific care standards and total hip and total knee replacement requirements, including orthopedic consultation, and pre-operative, intraoperative and post-surgical orthopedic surgeon follow-up care.
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31 Mar

SANUWAVE Health to Hold 2016 Financial Results and Business Update Call on Tuesday, April 4, 2017

SUWANEE, GA--(Marketwired - Mar 31, 2017) - SANUWAVE Health, Inc. (OTCQB: SNWV) announced today that the Company will release financial results for the year ended December 31, 2016, on April 4, 2017. The Company will also host a conference call on Tuesday, April 4, 2017, beginning at 10AM Eastern Time to discuss the 2016 financial results, provide a business update and answer questions. Shareholders and other interested parties can participate in the conference call by dialing 866-682-6100 (U.S.) or 862-255-5401 (international) or via webcast at http://www.investorcalendar.com/IC/CEPage.asp?ID=175797. A replay of the conference call will be available beginning two hours after its completion through April 18, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 10303. About SANUWAVE Health, Inc. SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA's de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for non-medical uses, including energy, water, food and industrial markets. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company's product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company's ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement. For additional information about the Company, visit www.sanuwave.com.

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30 Mar

AMNIOX Study Confirms Benefits of CLARIX FLO for Plantar Fasciitis

ATLANTA--(BUSINESS WIRE)--

AMNIOX Medical, Inc., a TissueTech, Inc. company, announced today the results of a study demonstrating the application of its unique cryopreserved human umbilical cord tissue for the treatment of patients with plantar fasciitis. The findings were recently presented at the American College of Foot and Ankle Surgeons in Las Vegas.

In this study, forty-three patients received injections of CLARIX FLO human amniotic membrane and umbilical cord matrix, and were followed for 18 weeks. The authors concluded that injections of CLARIX FLO significantly decreased pain from baseline and improved overall functional recovery. Increasing dose resulted in better therapy outcomes.

The study, Particulate Umbilical Cord/Amniotic Membrane for the Treatment of Plantar Fasciitis, was authored by Dr. Ryan Scott of The CORE Institute in Phoenix, and Dr. David Garras of Midwest Orthopaedic Consultants and an Assistant Professor at University of Illinois at Chicago. Plantar fasciitis is the most common cause of debilitating heal pain. It affects up to 1 million patients annually in the United States and as many as 30 percent of those patients fail conservative therapy. The condition is characterized by an accumulation of small tears in the plantar fascia, causing the structure to weaken and become irritated, often to the point of interfering in daily activities. Previously available therapies have demonstrated inconsistent outcomes or have negative side effects.

“These study results continue to demonstrate the compelling therapeutic benefits of a human tissue matrix composed of both umbilical cord and amniotic membrane,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Furthermore, Amniox Medical is the only provider of an injectable form of umbilical cord, allowing for the non-invasive delivery of the biological components of umbilical cord, which have proven regenerative properties.”

In utero, wound healing occurs rapidly and with minimal scar. This restorative ability is innate to placental tissues, including umbilical cord and amniotic membrane. Heavy chain hyaluronic acid/pentraxin-3 is the key protein complex present in these tissues to orchestrate the 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™ process, a cryopreservation technology, to preserve the biological and structural integrity of the native tissue and published studies have demonstrated that the CryoTek process more effectively preserves the structural and biological integrity of the tissue.

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 250,000 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170330005905/en/

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30 Mar

CollPlant Provides Commercial and Operational Update

NESS ZIONA, Israel, March 30, 2017 /PRNewswire

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, "rhCollagen"), today provided a commercial and operational update in its annual reports.
Most recently, in November 2016, the Company announced the signing of an exclusive distribution agreement with Arthrex GMBH to distribute Vergenix™STR, CollPlant's CE Mark-approved treatment for tendinopathy, in Europe, and has supplied Arthrex with first orders. Arthrex, an affiliate of Arthrex Inc., based in Naples, FL, is a leading orthopedics company and is widely considered to be the world leader in sports medicine. Additionally, since mid-2016, CollPlant signed a number of marketing agreements for Vergenix™FG, its wound care product, covering Italy, Switzerland and Turkey. Commercial treatments have been completed over several months in Switzerland and Italy, and physicians' feedback regarding patient results have been very positive. CollPlant has also reported extensively for the first time on the development of its collagen-based biological ink, bioInk, for use in 3D printing of organs and tissues. Specifically, the Company is developing rhCollagen-based bioInk formulations for indications including skin, orthopedics, ophthalmology, heart and lung. The Company's goal for the coming year includes working with a strategic international partner to further develop a specific indication of this product. CollPlant's Highlights for 2016 and the start of 2017
  • Vergenix™FG - a wound filler based on the Company's rhCollagen technology, for treatment of acute and chronic wounds: The product received CE Mark approval and distribution agreements have been signed in Italy, Switzerland and Turkey, including first orders, a portion of which were supplied in 2016. The initial target market for Vergenix™FG is estimated at $500 million annually. The Company has received positive feedback from physicians who have treated patients with the product in Europe.
  • Vergenix™STR - a gel based on the Company's rhCollagen technology, indicated for the treatment of tendinopathy: The product was granted CE Mark approval following successful clinical trials, and an exclusive distribution agreement was signed with Arthrex covering Europe, India and Africa. To date, CollPlant has reported on two orders supplied to Arthrex, and the product is currently in the initial stages of penetrating the European market. First treatments have commenced in Europe. The target market for Vergenix™STR is estimated at about three million procedures per annum worldwide, with a value of $2 billion.
  • BioInk for 3D printing of organs and tissues - the Company is developing a biological ink (bioInk) based on its rhCollagen technology, intended for use with 3D printers, to print tissues and organs. In parallel, the Company is assessing potential joint ventures with international companies to further develop various applications such as skin, bones, ophthalmology, heart and lungs. The Company's objective for this year is the development of a specific indication in order to achieve the creation of multilayer tissue combined with stem cells and other cells.  The segment of 3D printing addresses the entire global medical market.
About CollPlant CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company's cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant's rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company's broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant's business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products. For more information about CollPlant, visit http://www.collplant.com Contact at CollPlant: Eran Rotem Chief Financial Officer Tel: +972-73-2325600/612 Email: Eran@collplant.com Contact at Rx Communications Group, LLC Paula Schwartz (for US Investors) Senior Vice President Tel: +1-917-322-2216 Email: pschwartz@rxir.com SOURCE CollPlan

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30 Mar

Restructuring at Stryker will mean ‘limited reductions of workforce’

By Al Jones | March 29, 2017 PORTAGE, MI -- Stryker Instruments division is undergoing an organizational restructuring that will mean a loss of jobs for an undisclosed number of people at the medical technologies company. "After a thoughtful evaluation, we have determined that organizational changes are needed to help drive efficiencies across our business, including limited reductions in our workforce," the company stated in a press release issued in response to inquiries Wednesday. It went on to say, "These changes will allow us to invest in important areas to build new capabilities that will help us keep growing in Kalamazoo and continue meeting the needs of our customers." Stryker Instruments designs, manufactures and markets specialty surgical equipment, operating room products, orthopedic saws, drills and accessories. It also make advanced systems for such things as pain management and waste management. "The Kalamazoo community has played an important role in our company's history," the company stated. "Our founder started the business here and today we have multiple manufacturing and corporate offices in the area. We are committed to strengthening that relationship through our upcoming expansion in Portage." Portage Mayor Peter Strazdas said he has not been told how many people will be affected by the restructuring and he hopes the company is working to find them other opportunities. But he said he understands that large corporations have ups and downs and hopes internal changes will help make Stryker a stronger company in the long run.   READ THE REST HERE

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30 Mar

Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System

QUEBEC CITY, March 29, 2017 /PRNewswire/ -- Bodycad announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodycad Unicompartmental Knee System, enabling the commercial launch of this truly personalized orthopaedic restoration. Bodycad is the first Canadian company to receive FDA clearance for a joint reconstruction implant system. Bodycad's revolutionary Unicompartmental Knee System is designed to optimize personalized restoration of the patient's unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient's anatomy. The restoration is delivered as a "procedure in a box" that completely revolutionizes the way orthopaedic implant and instrument applications are delivered and utilized in the operating room environment.

"The personalized restoration is created only after proper acquisition of data from the patient on an individualized level," says Etienne Belzile, MD, orthopaedic surgeon and assistant professor at Laval University. "The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall."

Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient's knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction while improving economic quality metrics. "Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopaedic implant and instrument design," says Jean Robichaud, founder and CEO of Bodycad. "I am delighted to have FDA clearance to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care." About Bodycad Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com. Contact Andy McLeod 2035 rue du Haut-Bord Quebec, Quebec, Canada G1N 4R7 (418) 527.1388 info@bodycad.com  

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29 Mar

OrthAlign, Inc. Announces Milestone Achievement 60,000th Joint Arthroplasty Case

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced another milestone achievement in its 60,000th completed joint arthroplasty case. This milestone reflects the continuing and rapid adoption of OrthAlign's handheld precision alignment and positioning technology by surgeons throughout the world.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign's accuracy, simplicity of use, and benefits of use for the patient.

David W. Anderson, MD of the University of Kansas Medical Center in Kansas City, KS used KneeAlign to mark the 60,000th OrthAlign case milestone. "What I like about OrthAlign technology is that it is quick and easy to use and it doesn't require all of the extra hassle and cost that comes with using robotics or other competing technologies," said Dr. Anderson. "Furthermore, I've also noticed that my patients don't have as much swelling when OrthAlign technology is used, as I don't have to enter the femoral canal. I believe this is a good system for me, my OR staff, and most importantly, for my patients."

“The global adoption rate of our products highlights the power of OrthAlign technology,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “We are only scratching the surface with 60,000 cases and are confident that our efforts in expanding customer reach and portfolio expansion will further drive penetration of our technology. Congratulations to Dr. Anderson and the hundreds of other surgeons around the world who have adopted OrthAlign technology into their practices for better outcomes.”

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.”

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29 Mar

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ -- Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and Mr. Scott have over 40 years of relevant industry experience. Mr. Lynch joins the company with over 22 years of medical device and 15 years of spine industry marketing experience having previously served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine.

Mr. Scott joins Providence following over 16 years at ArthroCare as Vice President of OUS Sports Medicine, Vice President of Asia Pacific Commercial Operations, and US Vice President ENT Sales at Smith & Nephew.

Providence also announced recent 510(k) clearances from the FDA for the standalone use of the CAVUX™ Cervical Cage-L System as well as approval for its ALLY™ Facet Screws.  These new clearances are complimentary to the company's flagship DTRAX® Spinal System and are all provided terminally sterile for single-use to ensure efficiency and consistency. "Scott Lynch and Michael Scott are important additions to our Executive Management team at Providence.  Their veteran leadership and successful experience with high growth businesses make them an ideal fit for Providence at this exciting stage of our business," said Jeff Smith, CEO of Providence Medical Technology.  "With these new 510(k) clearances, we are pleased to offer our surgeon customers stand-alone anterior stabilization and posterior non-segmental stabilization for their cervical fusions." The CAVUX™ Cervical Cage-L System is manufactured from medical grade titanium and available in a variety of sizes.  The implant offers proprietary grit-blasted and acid-etched surfaces, a large space for allogenic and autogenous bone graft and includes self-drilling and self-tapping screws for additional, standalone fixation. The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.  The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved. Providence Medical Technology's family of products for cervical spinal fusion includes instruments, intervertebral cages, orthopedic bone screws, and allograft bone.  All products are provided sterile for single use only. About Providence Medical Technology, Inc. Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company's focus is on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and CAVUX™ and ALLY™ implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients. For more information, visit www.providencemt.com   SOURCE Providence Medical Technology, Inc.

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