Paragon 28 announces launch of unprecedented small bone fixation system for foot & ankle-Baby Gorilla Mini Plating System

ENGLEWOOD, Colo., Jan. 30, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

Today, Paragon 28 continues to honor a tradition of comprehensive and innovative solutions with the launch and release of the Baby Gorilla® Mini Plating System.

The Baby Gorilla® Mini Plating System leverages the modularity, optionality and specificity admired in the classic Gorilla® Plating system and offers a comprehensive set of implants for procedures that may require narrower plates and smaller screws matching the size and anatomy of small bones within the foot and ankle.

The system provides 65 unique Baby Gorilla® plating options from 13 plating families.  All plates are designed to accept both 2.0 mm and 2.5 mm locking and non-locking variable angle plate screws.

The system offers the most extensive array of universal utility, fracture, and procedure specific plates which require minimal manipulation to achieve satisfactory results.

Plate options found within the Baby Gorilla® Plating System include:

The Baby Gorilla® Mini Plating System also includes a robust assortment of specially designed instrumentation including curettes, reduction clamps, osteotomes, plate bending tools and compression and distraction devices engineered specifically for use in the foot and ankle for small bone fractures and reconstruction procedures.

Paragon 28 is grateful for the significant contributions Dr. Patrick Yoon, MD Hennepin County Medical Center Minneapolis, MN and Dr. Thomas Harris, MD UCLA-Harbor Medical Center, Torrance, CA made as surgeon designers of this system.

About Paragon 28, Inc.

Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. From the onset, Paragon 28 has made it our goal to re-invent the space of foot and ankle surgery. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

Product Page:
http://www.paragon28.com/by-system/baby-gorilla/

 

SOURCE Paragon 28, Inc.

Intralink-Spine’s Réjuve Treatment Nears Completion Of Safety Study And Begins Multi-Site Pivotal Study

January 31, 2017 – LEXINGTON, Ky.–(BUSINESS WIRE)–

With extremely positive clinical results at the six-month juncture from its early safety and feasibility study in Malaysia, Intralink-Spine, Inc. (ILS) confirms that the Réjuve™ System is now poised to begin its multi-site pivotal study beginning with sites in Southeast Asia.

“After a six-month period, patients have had excellent results from the Réjuve treatment,” says Lyle Hawkins, CEO of Intralink-Spine, Inc. “Think of it, these patients with chronic low back pain are now enjoying a better quality of life from just one treatment of Réjuve. They’re enjoying activities like hiking, rock climbing, and golf. And, these patients were enjoying their improved quality of life within days after the treatment; so, the positive effects of Réjuve are as expected, both rapid and long-lasting,” says Hawkins. (Message from CEO)

“Two of the four patients with six-month data have no pain or disability. A third patient has only mild pain (67% reduction) and zero disability at 6 months. All five of the patients at three-months and 75% at six-months have excellent results (both VAS and ODI decreased more than 50% from baseline). I’d say that is an exceptional start to our clinical studies of this injectable device,” says Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky. “We’ve demonstrated the safety of this device, and based on my 30-plus years of experience in this field, the prospects for this revolutionary microinvasive treatment are unique compared to all other existing and emerging surgical and minimally invasive treatments for degenerative disc disease and chronic low back pain.”

“These patients are doing remarkably well following a relatively simple image-guided procedure. Even the one patient with moderate pain claims to be better than prior to the procedure,” states orthopedic surgeon, Dr. Harwant Singh from the Pantai Medical Centre, Kuala Lumpur, Malaysia. ”I’m excited to continue my participation in the multi-site study.”

“About 80 percent of the adults in the U.S. experience significant back pain at some point in their life and most back pain sufferers find no relief. In fact, low back pain (LBP) is a challenging condition to treat, which is why we’re excited about our data thus far and another reason we’re eager to begin our multi-site study,” states Hawkins.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170131005896/en/

Behind bars for fraud: Neurosurgeon Dr. Aria Sabit receives nearly 20-year prison sentence — 8 key insights

Written by  Megan Wood, Beckers Spine – 10 January 2017

Neurosurgeon Aria Sabit, MD, received a 235-month prison sentence today for fraud, as reported by Medscape.

Here are eight things you need to know:

Criminal history

1. Dr. Sabit possesses a significant criminal history, dating back to 2010. While practicing at Ventura, Calif.-based Community Memorial Hospital, Dr. Sabit “invested $5,000 in a physician-owned distributorship of screws, plates, rods and other pieces of spinal instrumentation,” according to Medscape. He earned profits from the POD, called Apex Medical Technologies, and urged his hospital to use the equipment. Dr. Sabit performed numerous “unnecessary surgeries,” receiving illegal kickbacks. Court documents revealed the Apex Medical Technologies illegal kickbacks totaled $440,000.

2. As a result of these unnecessary surgeries, about 30 of Dr. Sabit’s patients sued him for malpractice. Community Memorial Hospital cut ties with Dr. Sabit in December 2010 to protect patients.

3. With a California career in the rearview, Dr. Sabit took his practice to Detroit. His fraudulent ways were far from over, however. He convinced patients to receive spinal fusions with metal instrumentation, but “subsequent diagnostic imaging revealed that he never installed the hardware, just bone dowels, and never achieved fusion,” according to Medscape.

 

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Vizient, Inc. Shares Results of Post-Election Health Care Survey

January 30, 2017

IRVING, Texas–(BUSINESS WIRE)–According to Vizient’s post-election survey of member hospital C-suite and hospital pharmacy executives, more than 90 percent are in favor of keeping the protections afforded to patients with preexisting conditions currently included in the Affordable Care Act (ACA). A top concern for the future is lower reimbursements, followed by fewer insured/covered patients.

Vizient, Inc., the nation’s largest member-driven health care performance improvement company, conducted the survey to understand how its member hospitals are reacting to proposed changes by the new Administration to the ACA. The survey also asked executives about their top concerns for the future and their priorities for 2017.

“In reviewing the survey results, central themes come through: uncertainty and concerns about financial viability. There are many open questions about the future of the ACA, and what a repeal and replacement strategy could look like,” said Byron Jobe, president and chief administrative officer for Vizient. “As Congress wrestles with these decisions, it’s important to ensure reimbursement levels are enough to allow hospitals to continue their mission of caring for patients in their communities. Equally important, hospitals must quickly gain a clear understanding of where health policy is heading so they can begin to prepare.”

Top findings from the survey include:

  • An overwhelming majority of hospital C-Suite leaders (89.5%) and hospital pharmacy executives (96.2%) want to keep the ACA’s protections of patients with pre-existing conditions in place
  • The majority of hospital C-Suite leaders want to see value-based reimbursement continued in the event that changes are made to the ACA
  • The top concern for the future of the executives surveyed was lower reimbursement, followed by fewer insured/covered patients
  • Looking ahead, the leaders surveyed cited reimbursement from Medicare/Medicaid, followed by health policy, as having an influence over hospital merger and acquisition activity
  • In light of recent price spikes and drug shortages, 55% of hospital executives surveyed said they would like the Trump administration to work with the FDA to fast-track competitive drugs to market
  • Across all executives surveyed, their top 3 priorities for 2017 were (1) reducing clinical variation across care delivery, (2) migrating toward value-based models and (3) the integration of existing technology systems

“We believe there is broad consensus among hospital leaders that the traditional fee-for-service payment model alone is not sustainable. There have been significant investments made in the migration toward value-based care, and hospitals require a coherent direction in order for these programs to deliver on their promise,” said Jobe. “During this time of uncertainty, executives should focus on factors they can control. Addressing operational efficiency, reducing clinical variation and driving down costs will help executives ensure that their organizations can sustainably weather a changing and potentially leaner operating environment.”

Survey Methodology

The survey was conducted online, with the results based on responses from 222 health care C-suite leaders (CEO, COO, CFO, CMO, CNO, CIO) and hospital pharmacy executives between Dec. 1—14, 2016.

About Vizient, Inc.

Vizient, Inc., the largest member-driven health care performance improvement company in the country, provides innovative data-driven solutions, expertise and collaborative opportunities that lead to improved patient outcomes and lower costs. Vizient’s diverse membership and customer base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents almost $100 billion in annual purchasing volume. The Vizient brand identity represents the integration of VHA Inc., University HealthSystem Consortium and Novation, which combined in 2015, as well as the recently acquired MedAssets’ Spend and Clinical Resource Management (SCM) segment, which includes Sg2. In 2016, Vizient received a World’s Most Ethical Company designation from the Ethisphere Institute. Vizient’s headquarters are in Irving, Texas, with locations in Chicago and other cities across the United States. Please visit www.vizientinc.com as well as our newsroom, blog, Twitter,LinkedIn and YouTube pages for more information about the company.

Contacts

Vizient, Inc.
Angie Boliver, 972-830-7961
angie.boliver@vizientinc.com

Bioventus Shares 2017 Science Summit Schedule, Enhancements to Bioventus Academy

January 30, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced the dates of its 2017 Advances in Bone Healing Science Summits. Taking place on April 28 at the Grand Hyatt Denver in Denver, CO, on April 28 at the Novotel Schiphol Airport in Amsterdam, and on May 19 at the Westin Fort Lauderdale in Ft. Lauderdale, FL, these programs are geared toward geared towards practitioners who regularly treat fractures and patients with knee osteoarthritis (OA). Each one-day course is developed to allow participants a better understanding of treatment methods and the underlying biologic science through didactic presentations and in-depth case study discussions.

In 2017, Bioventus is also underwriting medical education programs at the American College of Foot and Ankle Surgeons 75th Anniversary Scientific Conference taking place February 27- March 2 in Las Vegas and the Physician Assistants in Orthopaedic Surgery 18th Annual Conference occurring August 21-25 in Baltimore.

In addition, Bioventus has launched several new web-based training courses on www.BioventusAcademy.com. Bioventus Academy is the company’s online medical education platform that provides clinicians with access to in-depth clinical and scientific information on bone healing, bone grafts and OA. The courses are titled: Bone Graft Substitutes, Bone Marrow Aspirate, EXOGEN® & Bone Healing, and DUROLANE® and Early OA Treatment Options.

“Bioventus is committed to becoming the global leader in orthobiologics but leadership is not only measured in sales or global footprint,” said Tony Bihl, CEO, Bioventus. “Furthering medical education for clinicians through both face-to-face and virtual channels underscores the commitment we have to partner with the healthcare community to help people resume and enjoy active lives.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal

Bioventus, the Bioventus logo, DUROLANE and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

 

Trump signs executive order to slash regulations

By Ayesha Rascoe – Reuters, January 30, 2017

WASHINGTON (Reuters) – President Donald Trump signed an order on Monday that will seek to dramatically pare back federal regulations by requiring agencies to cut two existing regulations for every new rule introduced.

“This will be the biggest such act that our country has ever seen. There will be regulation, there will be control, but it will be normalized control,” Trump said as he signed the order in the Oval Office, surrounded by a group of small business owners.

Trump’s latest executive action will prepare a process for the White House to set an annual cap on the cost of new regulations, a senior official told reporters ahead of the signing.

For the rest of fiscal 2017, the cap will require that the cost of any additional regulations be completely offset by undoing existing rules, the official said on customary condition of anonymity.

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$7.82 Billion Foot and Ankle Devices (Prostheses, Bracing and Support Devices and Orthopedic Implants and Devices) Market 2016 – Forecast to 2025

Dublin, Jan. 26, 2017 (GLOBE NEWSWIRE) — Research and Markets has announced the addition of the “Foot and Ankle Devices Market Analysis & Trends – Product (Prostheses, Bracing and Support Devices and Orthopedic Implants and Devices ), Cause of Injury (Neurological Disorders, Trauma and Diabetes) – Forecast to 2025” report to their offering.

The Global Foot and Ankle Devices Market is poised to grow at a CAGR of around 7.9% over the next decade to reach approximately $7.82 billion by 2025.

Some of the prominent trends that the market is witnessing include increasing numerous sports injuries, growing geriatric population worldwide and increasing new product launches.

Based on product the market is categorized into prostheses, bracing and support devices and orthopedic implants and devices. Prostheses segment is further segmented into Microprocessor-Controlled (MPC) prostheses, Solid Ankle Cushion Heel (SACH) foot, multiaxial prostheses, single-axial prostheses, dynamic response/energy-storing prostheses. Bracing and support devices are further segregated into hinged braces and soft bracing. Orthopedic implants and devices segment is further classified into soft-tissue orthopedic devices, joint implants and fixation devices.

Depending on the cause of injury the market is segmented by neurological disorders, trauma, diabetes and other causes.

This industry report analyzes the global markets for Foot and Ankle Devices across all the given segments on global as well as regional levels presented in the research scope. The study provides historical market data for 2013, 2014 revenue estimations are presented for 2015 and forecasts from 2016 till 2025.

The study focuses on market trends, leading players, supply chain trends, technological innovations, key developments, and future strategies. With comprehensive market assessment across the major geographies such as North America, Europe, Asia Pacific, Middle East, Latin America and Rest of the world the report is a valuable asset for the existing players, new entrants and the future investors.

Key Topics Covered:

1 Market Outline

2 Executive Summary

3 Market Overview
3.1 Current Trends
3.1.1 Increasing Numerous Sports Injuries
3.1.2 Growing Geriatric Population Worldwide
3.1.3 Increasing New Product Launches
3.1.4 Growth Opportunities/Investment Opportunities
3.2 Drivers
3.3 Constraints
3.4 Industry Attractiveness

4 Foot and Ankle Devices Market, By Product
4.1 Prostheses
4.1.1.1 Microprocessor-Controlled (MPC) Prostheses
4.1.1.2 Solid Ankle Cushion Heel (SACH) Foot
4.1.1.3 Multiaxial Prostheses
4.1.1.4 Single-Axial Prostheses
4.1.1.5 Dynamic Response/Energy-Storing Prostheses
4.2 Bracing and Support Devices
4.2.1.1 Hinged Braces
4.2.1.2 Soft Bracing
4.3 Orthopedic Implants and Devices
4.3.1.1 Soft-Tissue Orthopedic Devices
4.3.1.1.1.1 Musculoskeletal Reinforcement Devices
4.3.1.1.1.2 Artificial Tendons & Ligaments
4.3.1.2 Joint Implants
4.3.1.2.1.1 Phalangeal Implants
4.3.1.2.1.2 Ankle Implants (Ankle Replacement Devices)
4.3.1.2.1.3 Subtalar Joint Implants/Subtalar Joint Reconstruction Devices
4.3.1.3 Fixation Devices
4.3.1.3.1.1 Internal Fixation Devices
4.3.1.3.1.1.1.1 Fusion Nails
4.3.1.3.1.1.1.2 Screws
4.3.1.3.1.1.1.3 Plates
4.3.1.3.1.1.1.4 Wires & Pins
4.3.1.3.1.2 External Fixation Devices
4.3.1.3.1.2.1.1 Ring Ankle Fixators
4.3.1.3.1.2.1.2 Unilateral Fixators
4.3.1.3.1.2.1.3 Hybrid Fixators

5 Foot and Ankle Devices Market, By Cause of Injury
5.1 Neurological Disorders
5.2 Trauma
5.3 Diabetes
5.4 Other Causes

6 Foot and Ankle Devices Market, By Geography

7 Leading Companies
7.1 Acumed, LLC
7.2 Arthrex, Inc.
7.3 Extremity Medical, LLC
7.4 Integra Lifesciences Holdings Corporation
7.5 Ossur
7.6 Smith & Nephew PLC.
7.7 Stryker Corporation
7.8 Tornier N.V.
7.9 Wright Medical Technology, Inc.
7.10 Zimmer Biomet Holdings, Inc.
7.11 De Puy Synthes
7.12 Biomet, Inc.
7.13 BioPro, Inc.
7.14 Orthofix Holdings Inc.
7.15 Mondeal Medical Systems GmbH

For more information about this report visit http://www.researchandmarkets.com/research/kphvcg/foot_and_ankle

Vexim: Amendment of the financial agenda for 2017

Toulouse (France), January 30th, 2017 (8:30AM CET)VEXIM (FR0011072602 – ALVXM / PEA-PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, will announce its 2016 Full-Year Results on Wednesday, 22 March, 2017 – before the market opening.

The other dates announced on the original schedule remain unchanged:

 

Announcement Date*
2016 Full-Year Sales Tuesday January 17th, 2017
2016 Full-Year Results Wednesday March 22nd, 2017
1st quarter 2017 Sales Wednesday April 19th, 2017
Annual General Meeting Wednesday May 24th, 2017
2017 Half-Year Sales Tuesday July 11th, 2017
2017 Half-Year Results Thursday September 14th, 2017
3rd quarter 2017 Sales Thursday October 12th, 2017
  Financial year ended December 31

* Subject to modification. Press releases are distributed either before the financial markets opening, or after the closure

 

Financial reporting schedule:

2016 Full-Year Results: March 22nd, 20171]

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital[2] and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors.

VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® [3], a revolutionary implant for treating Vertebral Fractures

The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

MasterflowTM 2, a high-performance orthopedic cement delivery system

The MasterflowTM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the MasterflowTM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The MasterflowTM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

 

CONTACTS
VEXIM

Vincent Gardès, CEO

José Da Gloria, Chief Financial Officer

investisseur@vexim.com

Tél. : +33 5 61 48 48 38

 

PRESS

ALIZE RP

Caroline Carmagnol / Wendy Rigal

vexim@alizerp.com

Tél. : +33 1 44 54 36 66

Tél. : +33 6 48 82 18 94

   

 

Name : VEXIM

ISIN code : FR0011072602

Ticker : ALVXM

 
       

 

SpinalCyte, LLC Enrolls First Patient in Landmark Phase I Human Clinical Trial

January 26, 2017

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on the regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today the enrollment of its first patient in a study for the development of CybroCell, the first dermal fibroblast cell product for treatment of degenerative disc disease.

“This unprecedented study marks the first time a human patient will receive dermal fibroblasts for treatment of degenerative disc disease,” said SpinalCyte Chief Executive Officer Pete O’Heeron. “Our preclinical trials resulted in significant regrowth of the spinal disc nucleus, increases in disc height, and gene expression such as proteoglycan. This could be the beginning of a new wave of cell-based treatments for degenerative disc disease, in lieu of surgery.”

The clinical trial will enroll 18 patients between the ages of 18 and 85. Each patient will be administered CybroCell alone, in combination with platelet-rich plasma (PRP), or saline only. The measurable outcomes of the study will take 12 months. SpinalCyte aims to show that using its allogenic “prepackaged” cell therapy product will lead to a reduction in pain, improved function, and regeneration of damaged discs.

“We are excited about the potential of this new technology to treat degenerative disc disease,” said Carlos Manuel Ruiz Macias, M.D., Principal Investigator of the SpinalCyte clinical trials. “We believe that regenerative cell therapy is the future of medicine, and the life-changing opportunities that lie ahead could have enormous impact on the millions around the world who deal with back pain and problems due to injury, age, or other factors.”

To learn more about SpinalCyte, LLC, please visit www.spinalcyte.com.

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 12 U.S. and international issued patents, and has filed for an additional 40 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

Investor Contact:
SpinalCyte, LLC
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com
or
Media Contact:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

Alphabet’s life science spinoff raises $800M from Singapore investor

Luke Stangel, Contributing writer – Jan 26, 2017

Verily Life Sciences, one of the startups spun out of Alphabet, disclosed on Thursday it has closed an $800 million investment from Singapore-based Temasek, an investment company that recently landed in the Bay Area with plans to expand its holdings in North America.

Verily, previously known as Google Life Sciences, says it’ll get the majority of the money in the coming days, with the remainder coming later this year. Temasek will take a minority stake in the company and get a seat on Verily’s board.

The investment marks Alphabet’s latest attempt to reduce the financial risk inherent in its more experimental business units like Verily. In the past, a spinoff like Verily might have instead asked its corporate parent for the investment.

Around this time last year, Verily partnered with Johnson & Johnson to create a new robotic surgery startup called Verb. A few months later, it announced a $715 million joint venture with Glaxosmithkline to create a new bioelectronics medicine company called Galvani Bioelectronics. In September, Verily announced it was creating a $500 million joint venture with Sanofi called Onduo.

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