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Stimwave Receives CE Mark Approval for World’s First Fully Percutaneous Stimulator Anchoring System

Posted On May 31, 2017 By OrthoSpineNews In Neuro, Regulatory /  

May 26, 2017

BREDA, Netherlands–(BUSINESS WIRE)–Freedom Neuro BV, a medical device distributor for Stimwave Technologies Incorporated, today announced CE Mark approval for the world’s first Percutaneous Injectable Anchor System. The injectable anchor is utilized in conjunction with the company’s wireless neurostimulator devices to provide true innovation in fixating Stimwave’s Wireless Pain Relief®technology through a minimally-invasive outpatient procedure for those who suffer from chronic pain.

“A wireless system that enables clinicians to actually have the full programming capabilities of IPGs, all in a device that can be injected, represents a paradigm shift in the field of options to provide the best in customization for patients to manage their pain profiles,” said Bart Billet, MD, from AZ Delta hospital group in Roeselare, Belgium.

Once the stimulator is injected, the SandShark is slid down over the device, progressing the un-deployed anchor into ligaments and strong connective tissues. Once the radiopaque anchor is in the desired location, the clinician pulls back on the handle, simultaneously deploying the wings of the anchor and pushing them laterally into the tissue. This injection process secures the anchor to the stimulator and secures the stimulator to the surrounding tissue to prevent migration throughout the life of the micro-implant. The injectable anchor stays in line with the body’s nerves, allowing for a freedom of movement generally not available in other neuromodulation devices.

“The SandShark Percutaneous Injectable Anchor System is a breakthrough for spinal cord stimulators, peripheral nerve stimulators, and all neurostimulation devices,” said Laura Tyler Perryman, founder and CEO of Stimwave. “It allows clinicians to inject a stimulator and its anchor through the same needle puncture port, opening the door for more clinicians to more easily provide patients with our highly efficient stimulators.”

Aiming to provide a non-opioid alternative in the treatment of chronic pain, Stimwave has pioneered the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave’s devices use Wireless Pain Relief®technology, are 95 percent smaller than any other neuromodulation device on the market and are the only system to have full body 3T MRI Conditionality. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the most versatile system available in the industry. The CE Marked Freedom-8A SCS System can provide European patients with up to 64 electrode contacts and offer traditional programming options, as well as other programming options, including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS System with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options. The devices deliver small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief.

For more information, visit www.stimwave.com.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

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Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs

Posted On May 30, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

Recalled Product:

  • Product Description: The SpF® PLUS-Mini (60μA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators
  • Serial Numbers:
    • SpF-XL IIB: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667
    • SpF-PLUS: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171
  • Distribution Dates: March 28, 2017 to April 6, 2017
  • Manufacturing Dates: October 11, 2016 to January 18, 2017
  • Devices Recalled in the U.S.: 33

Device Use

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine (backbone) together. The device is implanted into the patient’s back and provides constant electrical stimulation to the surgical site.

Reason for Recall

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company’s routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.

The use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death.

 

READ THE REST HERE

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Bone Therapeutics strengthens Board with the appointments of Steve Swinson and Damian Marron as Non-Executive Directors

Posted On May 30, 2017 By OrthoSpineNews In Biologics, Top Stories /  

Gosselies, Belgium, 29 May 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces the appointment of Steve Swinson and Damian Marron to its Board of Directors as Non-Executive Directors.

The appointments of Steve Swinson and Damian Marron, effective 26 May 2017, complement an already strong Board of Bone Therapeutics bringing in specific public company, orthopaedic and cell therapy understanding and expertise and will provide ongoing support to the leadership team. Steve Swinson and Damian Marron will replace Jacques Reymann and Jean-Jacques Verdickt.

Steve Swinson has served in a number of senior roles in orthopaedic medical technology and electronics companies, including general management, senior strategy, sales, marketing and commercial operation positions at Medtronic International, a global leader in medical technology. At Medtronic, he led the Spine and Biologics division for Canada and Western Europe, and was Vice President and General Manager for the international spine divison with substantial revenue responsibility. In a 30 year international business career covering Asia, US, Europe and Africa, he has also held senior positions at the diagnostic and medical departments of the blue chip engineering multinationals, General Electric and Hewlett Packard. Steve has a PhD in electrical engineering from the University of Manchester and a MBA from the University of Chicago.

Damian Marron is an experienced life sciences executive with a successful track record of value creation through public and venture capital financing, portfolio planning and turnaround, M&A, licensing agreements and research and marketing collaborations. He has particular competencies in cell therapy, immuno-oncology and orphan diseases. Damian served most recently as Chief Executive Officer of Agalimmune and has also served as Chief Executive Officer of TxCell, a France-based specialist in personalised T-cell immunotherapies, where he led the Company’s IPO on Euronext Paris. As Chief Executive Officer of Trophos, France, he helped raise EUR 34 million in financing and positioned the company for a subsequent acquisition by Roche for EUR 700 million. Damian also served as Executive Vice President, Corporate Development, for NiCox, where he supported the CEO in financing rounds raising over EUR 175 million.

Michel Helbig de Balzac, Chairman of Bone Therapeutics, commented: “We are delighted to welcome Steve and Damian to the Board of Bone Therapeutics. Their collective track record in leadership and value creation in the healthcare sector and their industry knowledge and expertise in orthopaedic medical technology and cell therapy respectively will be a major asset to the Company. They will be a valuable sounding board to the leadership team as it focuses on advancing our innovative allogeneic cell therapy platform towards commercialization. We would like to thank Jacques Reymann and Jean-Jacques Verdickt for their many years of dedication to Bone Therapeutics and wish them the best in their well-deserved retirement.”

Commenting on his appointment, Steve Swinson said: “Bone Therapeutics leads the field in regenerative approaches to orthopaedics and bone diseases, and its allogeneic cell therapy platform has the potential to transform medicine in these areas. I’m delighted to have the opportunity to use my deep experience in orthopaedic medical technology to help support this Company as it advances its technology towards commercialization.”

Damian Marron added: “I am very excited to be joining Bone Therapeutics. I look forward to bringing my experience in strategic development and my expertise in cell therapy to support the Company as it approaches key value inflection points with its innovative allogeneic cell therapy platform.”

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

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Paragon 28® launches PRECISION™ Jones Fracture Screw System

Posted On May 30, 2017 By OrthoSpineNews In Extremities /  

ENGLEWOOD, Colo., May 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.

The PRECISION™ Jones Fracture Screw System is the latest addition to Paragon 28®’s robust foot and ankle specific portfolio.  The system is comprised of 120 unique screw options spread across four screw families (4.0 mm, 4.5 mm, 5.5 mm, and 6.2 mm).  Solid and cannulated options of each screw length (34-60 mm; 65 mm) are available to address varying anatomies and fracture patterns. The screws are constructed from titanium alloy that is type II anodized for improved fatigue strength. All screws have a short thread and blunt tip to minimize disruption to the cortical bone and to ensure the intended trajectory through the intramedullary canal of the 5thmetatarsal is maintained during insertion. Additionally, the screws have a low profile head to minimize prominence and avoid impingement of the cuboid.

The PRECISION™ Jones Fracture Screw System also includes instrumentation designed to facilitate placement of a K-wire high and inside the proximal portion of the 5th metatarsal.  The patent pending PRECISION™ Jones Curved K-wire Guide has a tip which matches the base curvature of the 5th metatarsal and radius of curvature which aims the handle of the guide away from the lateral malleolus and cuboid.  This guide’s primary function is to aid in positioning a nitinol K-wire into the center of the intramedullary canal simplifying placement which may reduce intraoperative fluoroscopy time. Constructed from nitinol, the K-wire will flex and follow the curvature of the intramedullary canal while limiting the chance of broaching the surrounding cortex.

In addition to the Curved K-wire Guide, the system includes implant specific taps, countersinks, and standard and long drills to aid in implanting the screw through either a traditional or cannulated technique.

Product Page:
http://www.paragon28.com/products/jones-fracture-screw-system/

Contact: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

SOURCE Paragon 28

Related Links

http://www.paragon28.com

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VEXIM: ANVISA Approves SpineJack® Implants in Brazil

Posted On May 30, 2017 By OrthoSpineNews In Regulatory, Spine /  

May 29, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces it has received the regulatory approval from ANVISA1, Brazil’s National Health Surveillance Agency, in order to commercialize the SpineJack® in Brazil.

The approval from ANVISA is a key achievement opening a new opportunity for VEXIM in this important international market with untapped potential. This clearance will provide us with new growth opportunities in this key Latin American market. VEXIM estimates that Brazil alone today represents a €15 million market in the vertebral compression fractures field.

“This approval will enable us to have substantial growth in our international business. The Company is expecting to initiate export to Brazil in the coming months, after the conclusion of the product’s evaluation process and of distribution partnerships”, said Vincent Gardès, CEO of VEXIM.

Financial reporting schedule:
2nd quarter sales: July 11th, 20172

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 Capital3, and from OSEO 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 NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®4, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed 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, which is intended to enable 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 compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 Agência Nacional de Vigilância Sanitária.
2 Indicative date, subject to changes.
3 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
4 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

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Zimmer Biomet Announces Quarterly Dividend for Second Quarter of 2017

Posted On May 30, 2017 By OrthoSpineNews In Financial /  

WARSAW, Ind., May 30, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the second quarter of 2017.

The cash dividend of $0.24 per share will be paid on or about July 28, 2017 to stockholders of record as of the close of business on June 23, 2017.  Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

 

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

www.zimmerbiomet.com

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DJO Global Announces Appointment of Jeffery McCaulley as Global President, DJO Surgical

Posted On May 30, 2017 By OrthoSpineNews In Extremities, Top Stories /  

May 30, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, announced the appointment of Jeffery McCaulley as Global President, DJO Surgical, effective immediately. Mr. McCaulley will succeed Brady Shirley, who was appointed DJO’s President and Chief Executive Officer in November, 2016 after successfully doubling revenue and profitability of DJO Surgical since he joined DJO in 2014.

Mr. McCaulley is an experienced senior executive with more than 25 years in the healthcare industry, most recently serving as President and CEO of Smiths Medical, a $1.2B division of Smiths Group, plc. Before joining Smiths Medical, Mr. McCaulley served as President of the Global Reconstructive Division at Zimmer, where he oversaw five global business units and numerous functions. He held previous roles as President and CEO of the Health Division of Wolters Kluwer and Vice President and General Manager of the Global Diabetes Business Unit at Medtronic. Mr. McCaulley began his career at GE Healthcare, where he held progressively more senior roles during his 13 years there, last serving as President and CEO of GE Clinical Services.

Mr. McCaulley received a Bachelor of Science in Aerospace Engineering from the University of Cincinnati and an Executive MBA from the Owen Graduate School of Management at Vanderbilt University.

“Our Surgical business’ best in market performance has and will continue to be the key transformation catalyst in our company. I am excited to combine Jeff’s talent and experience in the space with our exceptional leadership team. Throughout his career, Jeff has a proven track record of accelerating innovation, improving employee and customer engagement, and delivering results. I look forward to this great next chapter for DJO Surgical!” said Mr. Shirley.

“I am very excited to be joining Brady and the team at DJO,” said Mr. McCaulley. “The growth in recent years has been spectacular and I am convinced that we are positioned to continue to make significant market share gains across our portfolio and have the right internal and external teams to improve key areas of patient care and experience.”

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, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for continued market performance, sales growth and growth in market share for DJO’s Surgical Segment. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results and market growth to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results and market growth for our Surgical Segment to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the continued growth of the surgical implant markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
ir@djoglobal.com

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Neuromonitoring Company Founded by Former NFL Quarterback Set to Go Public

Posted On May 30, 2017 By OrthoSpineNews In Financial, Neuro, Spine /  
Source: The Life Sciences Report – May 29, 2017

Assure Neuromonitoring, a wholly owned subsidiary of Assure Holdings Inc. (IOM:TSX.V), provides intraoperative neuromonitoring (IONM) services. The standard of care in the United States is to provide IONM services to monitor the nervous systems of patients undergoing invasive surgeries such as spine, ear, nose and throat, and others, to monitor the activity and warn the surgeon if he/she is getting close to a nerve, thereby preventing nerve damage.

Most IONM services are staffed by onsite technologists and offsite neurologists who are provided by third-party services, which does not provide consistency or accountability. According to the company, the Assure platform “employs its own staff of highly trained technologists and uses its own state of the art monitoring equipment, handles 100% of intraoperative neuromonitoring scheduling and setup, and bills for all technical services provided.” Assure’s technologists and neurologists are dedicated to specific surgeons and work as a team, thereby developing rapport and trust.

The company notes that “Assure has developed a comprehensive platform that engages all stakeholders including the surgeon, the technologist, the neurologist, and the patient.”

The company began operations in Colorado in 2015 and has primarily serviced spine surgeries. The company plans to expand into additional states and into additional types of surgeries.

 

READ THE REST HERE

 

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Here’s what Trump’s head of the FDA wants to do about high drug prices

Posted On May 30, 2017 By OrthoSpineNews In Regulatory /  

 – May 26, 2017

Food and Drug Administration commissioner Dr. Scott Gottlieb has a plan to tackle high drug prices.

“Simply put, too many patients are priced out of the medicines they need,” Gottlieb said Thursday at the FDA’s budget hearing.

The FDA is responsible for regulating food and drugs. It’s also responsible for regulating medical devices, blood donations, veterinary products, cosmetics, and tobacco. The FDA doesn’t directly play a role in setting drug prices.

Even so, Gottlieb said there are a few main ways he thinks the agency can help.

  • By stopping the industry from gaming regulations to get more time without competition beyond what Congress intended.
  • Making it more straightforward for complex generic drugs to get to market. Complex drugs are devices like the EpiPen or inhalers that competitors have a hard time getting approved. It’s something Gottlieb has been advocating for for years.
  • Getting through of the backlog of generic drug applications.

 

READ THE REST HERE

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Amedica Announces Delayed Filing of Quarterly Report on Form 10-Q and Receipt of Nasdaq Letter

Posted On May 26, 2017 By OrthoSpineNews In Financial /  

SALT LAKE CITY, UT–(Marketwired – May 26, 2017) – Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has delayed the filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 (“Form 10-Q”).

On May 16, 2017, Amedica filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the “SEC”) regarding its delayed Form 10-Q. Prior to filing the Form 10-Q the Company requires additional time to fully consider whether there is any potential impairment in relation to certain of its long-lived assets in connection with the completion of the audit of its 2016 financial results and the filing of its 2016 Annual Report on Form 10-K. Management and the Audit Committee of the Company’s Board of Directors are continuing to work diligently to complete its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and file it with the SEC as soon as possible. Upon filing of the annual report the Company expects to promptly file the Form 10-Q.

Because the filing of the Company’s Form 10-Q has been delayed beyond the 5-day extension period of Form 12b-25, on May 23, 2017, Amedica received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market (“NASDAQ”) indicating that the Company is not in compliance with Listing Rule 5250(c)(1) because the Company has failed to file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017.

Under the NASDAQ Listing Rules, because the Company is also delinquent on filing its Annual Report on Form 10-K for the period ended December 31, 2016, the Company has until June 19, 2017 to submit a plan to NASDAQ as to how it plans to regain compliance with NASDAQ’s continued listing requirements. If the Company is still unable to file its Form 10-K and Form 10-Q by that time, then the Company intends to submit a compliance plan on or prior to that date. If NASDAQ accepts the Company’s plan, NASDAQ can grant an exception of up to 180 calendar days from the filing’s due date, or until September 27, 2017, to regain compliance. The Company may regain compliance at any time during this 180-day period upon filing with the SEC its Form 10-K and Form 10-Q, as well as all subsequent required periodic financial reports that are due within that period. If NASDAQ does not accept the Company’s plan, Amedica will have the opportunity to appeal that decision to a NASDAQ Hearings Panel.

The NASDAQ notification letter has no immediate effect on the listing of Amedica’s common stock on the NASDAQ Capital Market.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world’s largest ceramic manufacturer. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, there can be no assurance that we will be able to maintain our listing on any NASDAQ market. Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

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