Amend Surgical Announces 510(K) Clearance for NanoFUSE® BA

March 02, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced today that they have received 510(K) clearance to market NanoFUSE® BA as a bone graft extender for spine and orthopedic applications.

NanoFUSE BA is a novel composite containing 45S5 Bioactive Glass and a patent protected carrier that provides optimal surgical handling performance and graft stability. Bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation). It creates a highly favorable environment for bone fusion as it remodels into the recipient’s skeletal system and is an important tool for the orthopedic surgeon. With this most recent clearance Amend Surgical now has two U.S. Food and Drug Administration (FDA) cleared product lines.

“NanoFUSE BA offers our surgeons and their patients a synthetic alternative to NanoFUSE Bioactive Matrix,” stated Robby Lane, president and chief executive officer of Amend Surgical. “We are continuing to expand our market presence with the only demineralized bone bioactive glass combination product on the market and are excited about the opportunities offered by the launch of NanoFUSE BA. This product provides surgeons the superior handling characteristics they expect with the long and successful clinical history of bioactive glass.”

About Amend Surgical

Amend Surgical is a specialty medical device company focused on enhancing the bone healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, clinically evaluated, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.


Amend Surgical, Inc.
Robby Lane, 386-518-5546
President and CEO

SPINEWAY: New distribution contract in the USA Appointment of Philippe Laurito as head of the US subsidiary

 Ecully, 1 March 2017

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine,) announces the signature of a contract with a new US distributor for the sale of its implants and instruments.

The distributor is based in the Midwest and has a client portfolio that includes several hospitals and surgical centers. Spineway USA Inc. received a 1st order for a hospital in the region and should receive a 2nd order in April. These orders are for items from the Mont Blanc and the Twin Peaks lines, which are the Spineway Group’s mid-range offerings.

This new distribution contract is in addition to the two already signed, one with a California distributor (September 2016) and the other with a Texas distributor (January 2017), thus allowing Spineway to create a network that is slowly expanding throughout the United States.

Philippe Laurito becomes President of Spineway USA Inc.

In order to steer and roll out Spineway’s offer in the US, Philippe Laurito, Managing Director of Spineway, will become President of the Group’s US subsidiary as from 1 March 2017.

His expertise and in-depth knowledge of the American continent will allow him to guide and expedite the sale of Spineway products on the largest market in the world for spinal surgery. Philippe Laurito remains Deputy Managing Directory and member of the Spineway Group’s Executive Committee.

Thanks to these three distribution contracts and the in-situ steering of its US subsidiary, Spineway should increase its presence on the territory and see its sales grow quickly to represent at a short term almost 40% of the total sales of the group.

Find out all about Spineway at

Next communication:
2016 Annual Results – 25 April 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW     


Investor Relations
David Siegrist – Finance Director
Tel: +33 (0)4 72 77 01 52
Financial Communication
Jérôme Gacoin / Solène Kennis
Tel: +33 (0)1 75 77 54 68

Mazor Robotics to Exhibit New Mazor X™ Surgical Assurance Platform at AANS/CNS Spine Summit Meeting

ORLANDO, FL–(Marketwired – March 01, 2017) – Mazor Robotics (TASE: MZOR) (NASDAQ: MZOR), a pioneer and leader in the field of surgical guidance systems, will demo the new Mazor X system at Spine Summit 2017, the Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves in Las Vegas, March 8-11.

Visit booth #1110 during exhibit hours or attend the following special presentations to learn more about Mazor X:

Lunch Seminar: Introducing Mazor X™: Mazor Robotics’ Next-Gen System
Moderator: Dr. Michael Steinmetz
Location: Valencia Ballroom
Date: Wednesday, March 8
Time: 12:30 – 1:30 pm

“What’s New” Session: Clinical Experience of Mazor Robotics Guidance Systems and O-Arm® Imaging in Degenerative and Deformity Cases
Faculty: Dr. Jeffrey L. Gum
Location: Demo Theater
Date: Friday, March 10
Time: 9:47 – 9:57 am

The Mazor X system consists of sophisticated 3D planning tools and an intra-op guidance system with a precision Surgical Arm indicated for implant and instrument positioning in spine surgery — the core of the Surgical Assurance Platform.

“Mazor’s core technology has been used in over 23,000 procedures. This unparalleled clinical and operating room experience has provided us with deep insight into what the surgeons want next for themselves and their patients,” said Mazor Robotics CEO Ori Hadomi. “So, we pushed the envelope, moving from a precise mechanical system, to a complete expandable platform that incorporates integrated analytics and state-of-the art guidance.”

“You plan your surgery and there is no heartache anymore,” said Orthopedic Surgeon Kornelis Poelstra, MD, PhD. “You know exactly where the screws are going to go.” Click here to watch full testimonial

Following Spine Summit, Mazor Robotics will also be exhibiting Mazor X at AAOS Annual Meeting in San Diego, March 14-18 (booth #2339).

About Mazor

Mazor Robotics (TASE: MZOR) (NASDAQ: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit

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DJO Global Announces Appointment of Bryan McMillan as President, Regeneration

March 1, 2017


DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, today announced the appointment of Bryan McMillan as President Regeneration, effective March 1, 2017.

As President of DJO’s Regeneration business, Mr. McMillan will be responsible for both commercial growth strategies and corporate payor development and reimbursement initiatives. Mr. McMillan will report directly to DJO President and Chief Executive Officer, Brady Shirley.

“We are very excited to announce the appointment of Bryan McMillan as President of our Regeneration Business, Reimbursement, and Payor Development to provide effective, affordable solutions, giving patients and providers the attention they deserve to enhance the continuum of care,” said Brady Shirley, DJO President and Chief Executive Officer. “Throughout his career, Bryan has proven to be an agile leader with an extensive understanding of our specific segment and healthcare economics. We are confident that his ability to thrive in a variety of business environments to reach collective goals will serve DJO Global well in its commitment of being a world class organization.”

Mr. McMillan most recently served as the President of CoorsTek Medical, a position he was appointed to in March of 2014 after completing the successful integration of IMDS (Innovative Medical Device Systems) to the Coors family enterprise. In his role, Mr. McMillan was responsible for all functional areas and strategy for a division of the largest engineered ceramics company worldwide.

From 2010 to 2012, Mr. McMillan served in several key leadership positions at Orthofix International, N.V., culminating in his final role there as President for the Global Spine Business Unit. Prior to Orthofix, Mr. McMillan had a successful nine-year tenure at Stryker Corporation, where he held significant roles of increased responsibility, ultimately being promoted to the position of Vice President, Stryker Finance. In this capacity, Mr. McMillan built, developed and led a cross-divisional entity for Stryker to offer internal financing and strategic sales programs. During the “Great economic recession” and with capital equipment sales down, he led the division to record sales with nearly 30% growth in 2009. A large part of his unprecedented achievements can be attributed to Mr. McMillan’s demonstrated leadership skills, unique business acumen, and ability to transform multi-discipline business strategies into tangible outcomes.

Prior to entering the medical device industry, Mr. McMillan spent nearly ten years in investment management and banking with prestigious firms such as Rauscher Pierce, Everen Securities and CIBC Oppenheimer. Mr. McMillan received a Bachelor’s degree in Political Science and Business with honors from Arizona State University, and successfully completed the Harvard Executive Leadership program and Strategic Marketing Curriculum at the University of Texas, Austin.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, REGEN™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit

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Synergy Biomedical Receives CE Mark for BIOSPHERE PUTTY

February 28, 2017

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced today that it has received CE Mark clearance in the European Union for its next generation bone graft, BIOSPHERE PUTTY.

Originally launched in the U.S. in 2013, BIOSPHERE PUTTY is a synthetic bone graft product that utilizes a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range.

“Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”

Under its cleared European indication, BIOSPHERE PUTTY is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with autograft or allograft.

“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles,” said Erik Westerlund MD, FACS, Director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in the U.S. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with BIOSPHERE PUTTY over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.”

BIOSPHERE PUTTY is the first of several bone graft products being developed by Synergy Biomedical that utilize patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BIOSPHERE PUTTY provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques.

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial based products to the orthopaedic and spinal markets. The Company’s BioSphere Technology represents a unique approach to advancing bone graft technology, and improving bone healing and patient outcomes.


Synergy Biomedical, LLC
Mark Borden, Ph.D.

Global Hip and Knee Orthopedic Surgical Robots Industry Research Report 2016 to 2022


The 2016 study has 145 pages, 64 tables and figures. Worldwide Hip and Knee Orthopedic surgical robot markets are poised to achieve significant growth. The accuracy provided by the robot is not reproducible by the human surgeon, so ultimately all surgeons will want to perform the orthopedic implants using this technology.

Robot assisted medial knee arthroplasty: orthopedic surgical robots are poised to take knee and hip surgery quality far beyond what has previously been available. The quality of knee arthroplasty is improved with robotic capability. All the advantages of surgical robots carry into the Stryker Mako orthopedic reconstruction surgical products.. When the knee and hip surgical robots are used, patients have less bleeding, reduction of post-operative pain, fewer re-admissions to hospital and faster recovery. Robots support high-precision surgery. A clinic in Switzerland, La Source, has reported a reduction in the average days of hospitalization from 10 to 6.

Knee and hip surgical robots provide consistent reproducible precision. This capability is so significant for implant surgery that the robots are positioned to become the defacto standard of care for knee and hip surgery within five years. Any one getting a knee or hip replaced will demand attention to quality of life, to maintenance of lifestyle provided by a robot when they have a joint replacement.

As next generation systems, hip and knee robotic units provide a way to improve traditional orthopedic hip and knee replacement surgery. Total hip replacement surgery has evolved dramatically as advances in technology have brought improved surgical techniques. Surgical robots are a significany [art of that advance.

Once, the penetration achieves this 35% level, all orthopedic surgeons will demand that hospitals offer robotic orthopedic surgical capability because the outcomes are more predictable and better. If the hospital does not offer the robot, the surgeon will move to a more modern facility.

Knee and Hip Surgical Robots have been impacted by the reduction in insurance payments. Payment reductions have forced hospitals to start acting as businesses. The cost of delivering care has become as much a factor as providing quality care when making decisions about patient improvement in condition. Cost-cutting has been made in the supply chain. Suppliers were examined closely for quality and cost.



High-Quality Low-Cost Patient Care: Why the ASC Model May Well Represent the Future of Healthcare Providers in the US?

The major challenge dominating the healthcare industry has always been to lower the cost of patient care while not sacrificing quality. As technology continues to advance in surgery, more procedures can be done outside a traditional hospital setting (such as in surgery centers and physician offices). Ambulatory Surgery Centers (ASCs) have stood as the “high-quality low-cost patient care” model despite many regulatory changes in the healthcare scene.

With ASCs, Medicare and its beneficiaries share in more than $2.6 billion in savings annually because Medicare pays significantly less for procedures performed in ASCs compared to hospital outpatient departments (HOPDs). This trend encompasses more than just Medicare; ASCs are highly sought after by payers who are looking for lower facility fees. Commercial insurance providers and their beneficiaries save $38 billion each year with ASCs.

In its 2017 ASC Payment System rates and policies, CMS projects a 1.9 percent increase. On the other hand, as part of the Bipartisan Budget Act of 2015 (Budget Deal), Congress mandated that, beginning in 2017, all off-campus physician practices and ASCs acquired by a hospital, following enactment of the law in November 2015, would no longer be reimbursed using the HOPD payment rates. CMS calls them “off-campus provider-based departments (PBDs).” Off-campus PBDs will be paid under MPFS (Medicare Physician Fee Schedule) in most cases instead of the higher-paying OPPS.

On the patient’s side, co-pays are significantly lower when care is received in an ASC. For instance, a (Medicare beneficiary) patient could be paying $496 for co-insurance in a cataract extraction procedure if performed in the HOPD; whereas in an ASC setting, the patient could pay as little as a $195 co-pay.

Here’s an infographic of how ASCs have evolved over the years and helped bring healthcare costs down while increasing patient satisfaction.

Hospitals who want to avoid the cost of running non-acute outpatient departments are also beginning to establish ASCs of their own or entering into joint partnerships. Hence the rise of ASCs in recent years. In 2014 alone, there were more than 5000 ASCs performing 23 million surgeries a year.



Tissue Regenix Introduces Revolutionary dCELL® Platform Technology to the United States

SAN ANTONIO–(BUSINESS WIRE)–Tissue Regenix, the U.K.-based leader in regenerative medicine, has established its decellularization (dCELL®) Technology in wound care in the United States with plans to expand into other medical sectors. The company has opened up new possibilities in regenerative medicine in the U.K., applying its dCELL® Technology to several therapeutic applications. The company launched U.S. operations through their chronic and acute wound care product, DermaPure®, and will progress into other applications, including orthopedics in early 2018.

The patented dCELL® Technology is a multi-tissue regenerative medical platform which can be used in a wide range of medical applications to allow the body to regenerate critical tissue through utilizing decellularized animal and human biological materials. DNA and other cellular material are removed from the tissue, leaving the acellular scaffold intact. dCELL® Technology provides support for cell migration during the healing process all while preserving necessary tissue strength. It avoids rejection by the patient’s body and integrates into the host tissue without the use of harsh chemicals or treatments.

“We have seen first-hand how life changing these products have been in Europe, and we are thrilled to bring our dCELL® Technology to the United States to help a new population of patients heal faster and more effectively,” said Antony Odell, CEO of Tissue Regenix. “These solutions are bringing hope to people who have conditions that may otherwise be beyond repair.”

DermaPure®, the decellularized human dermis product from Tissue Regenix, is currently available in the U.S. for patients with hard-to-heal acute and chronic wounds. DermaPure is produced from donated human tissue and it is 99% DNA free. This minimal DNA content closely mimics the structure and function of the native tissue it is replacing. It signals a bio-normal response by not eliminating but reducing inflammation, and stimulates the body to progress through the phases of natural wound healing. Wounds can be healed with as little as one use, potentially providing patients with faster healing and delivering a quicker recovery.

Tissue Regenix is currently undertaking clinical trials in the EU and will look to introduce dCELL® Technology to orthopedic applications in the U.S. in 2018, initially addressing ACL repair. They will be attending the American Academy of Orthopedic Surgeons (AAOS) annual meeting in March to share more information on this progress with a team of orthopedic and sports medicine experts. Members of Tissue Regenix’s clinical advisory board will attend AAOS, including:

“The application of dCELL® Technology in orthopedics will give surgeons and clinicians an innovative new way to provide care to patients requiring anterior cruciate ligament (ACL) reconstruction, meniscus replacement and other injuries,” said Drew Distin, VP of Orthopedics at Tissue Regenix.

Tissue Regenix will be exhibiting at booth #5750 at the American Academy of Orthopedic Surgeons meeting in San Diego, CA March 14-17.

Tissue Regenix was founded in the U.K. in 2006 to develop and commercialize decellularization research from the University of Leeds and listed on the London Stock Exchange in 2010. With U.S. headquarters in San Antonio, TX, the company continues to develop its roster of products using this technology.

For more information about Tissue Regenix, please visit

About Tissue Regenix
Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularization (‘dCELL®‘) Technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.


Tissue Regenix
Jeff Stoecker, 617-624-3424

Andrew Cottingham, MD First Pain Management Doctor to Perform the Vertiflex Superion Procedure for the Treatment of Lumbar Spinal Stenosis in North Texas

Pain management doctor, Andrew Cottingham, MD of OPTIMAL Pain & Regenerative Medicine is the first physician in North Texas to implant the new Vertiflex Superion Indirect Decompression System®. The Vertiflex Superion is a minimally invasive, safe, out-patient procedure that gives patients an alternative to spine surgery for the treatment of lumbar spinal stenosis.

Back and leg pain affects millions of Americans every year. Lumbar spinal stenosis is caused by aging and “wear” on the discs between the vertebrae. The degeneration of the discs causes the spinal canal to narrow, which leads to additional pressure on the nerves in the lower back. This pressure leads to lower back pain and radiating leg, buttock and/or groin pain. Symptoms typically intensify during standing and walking and decrease when sitting and bending forward.

Conservative treatment of lumbar spinal stenosis typically involves rest, physical therapy, medication management and epidural steroid injections. When non-surgical treatment does not alleviate symptoms, surgical treatment historically involves direct compression surgery. The Vertiflex Superion device is an FDA approved minimally invasive treatment option for patients suffering from lower back pain and radiating leg pain caused by lumbar spinal stenosis.

The procedure uses a Superion implant, which is a small titanium device that is inserted through a small incision in the lower back. The implant is then placed in the spinal structure to keep the spine positioned such that the nerves in the spinal canal are not compressed. The device has been implanted in more than 2,000 patients worldwide. The clinical trial results showed a decrease in pain. Four years post-procedure, almost 90% of the clinical trial patients expressed continuing satisfactory results.

“The Vertiflex Superion is an elegant, minimally invasive procedure that can change so many people’s lives who are suffering from lower back pain and radiating leg pain caused by lumbar spinal stenosis,” said Dr. Andrew Cottingham.

To learn if you are a candidate, please call us at 817-468-4343 or visit our website: The Vertiflex Superion Procedure.

About OPTIMAL Pain & Regenerative Medicine

The pain management doctors at OPTIMAL, Drs. Cottingham, Berlin and Phillips, are dedicated to staying on the forefront of pain management and regenerative medicine procedures. Each physician is double-board certified in anesthesiology and pain medicine. Through their collective expertise, the OPTIMAL team delivers comprehensive, current and compassionate medical care to patients in Dallas, Fort Worth and Arlington, Texas.

MedPlast Announces Agreement To Acquire Vention Medical Device Manufacturing Business

TEMPE, Ariz., Feb. 20, 2017 /PRNewswire/ — MedPlast, Inc., a global services provider to the medical device industry, announced today that it has signed a definitive agreement to acquire Vention Medical’s Device Manufacturing Services business.   The acquisition broadens MedPlast’s portfolio of capabilities and bolsters its position as a leading services provider to the world’s largest original equipment manufacturers.

MedPlast’s acquisition will further expand the company’s capabilities in assembly and packaging, enabling it to offer customers a comprehensive suite of services producing a wide range of medical products.  It also will extend MedPlast’s global footprint to 22 manufacturing facilities located in key markets throughout North and Central America, Asia and Europe.  Once complete, the acquisition will more than double MedPlast’s size.  The company will employ more than 3,500 engineers, technicians and assembly workers specializing in producing surgical, orthopedic, diagnostic and other medical devices.

“This acquisition will significantly strengthen MedPlast’s leadership position in the medical device manufacturing industry,” said MedPlast Chief Executive Officer Harold Faig.  “We will provide our customers a broad spectrum of integrated manufacturing capabilities and services from strategic locations around the world.  This is something our customers have been asking for, and we are committed to continuing to expand our capabilities in areas that will bring value to our customers.”

Bill Flaherty, president of Vention Medical’s Device Manufacturing Services business, added, “We are excited to come together with MedPlast.  We serve many of the same customers who will benefit from our combined offering and shared commitment to providing the highest quality standards and facilities in the industry.”

MedPlast’s acquisition comes two months after the company partnered with two investment firms to expand its offering.  JLL Partners, a middle-market private equity firm, and Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, invested in MedPlast in December 2016.

“This is the first of what we expect will be more strategic acquisitions to build MedPlast into a market leader. Water Street and JLL are working closely with management to identify and pursue opportunities that will achieve MedPlast’s goal of offering customers a comprehensive, integrated portfolio of end-to-end product solutions,” said Kevin Swan, partner, Water Street.

The transaction is expected to close in the second quarter of 2017.  Financial terms of the agreement are not being disclosed.

About MedPlast
MedPlast is a global services provider to the medical device industry.  The company offers a range of engineering and manufacturing capabilities that support the world’s leading original equipment manufacturers with producing diagnostic, orthopedic, surgical and other medical products.  Headquartered in Tempe, Ariz., the company operates 11 ISO-certified facilities around the world.  For more information about MedPlast, visit

About Vention Medical
Vention Medical is a global integrated solutions provider with more than 30 years of experience in design, engineering and manufacturing of complex medical devices and components.  Vention Medical specializes in molded components, and finished device assembly and packaging for the interventional and minimally invasive surgical markets.
Visit Vention at


SOURCE MedPlast, Inc.

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