Bioventus Names Greg Anglum Senior V.P and CFO, Tony D’Adamio Senior V.P and General Counsel

Posted On August 8, 2017 By OrthoSpineNews In Biologics /

August 07, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus^®, a leader in orthobiologic solutions, today announced two changes to its executive leadership team. Greg Anglum has been promoted to Senior Vice President and Chief Financial Officer. Anglum, who joined Bioventus in 2016 as its Chief Accounting Officer, brings more than 20 years of experience driving financial and growth strategies for both private and public companies in various industries. He will also be responsible for the business intelligence and IT teams at Bioventus.

In addition, Bioventus is pleased to announce Anthony (Tony) D’Adamio has joined the company as its Senior Vice President and General Counsel. D’Adamio has nearly 30 years of senior legal executive experience with diagnostic, health care data and clinical service companies. He will be responsible for all general and corporate legal matters as well as the ethics and compliance functions at Bioventus. Both Anglum and D’Adamio will also join the company’s executive leadership team and report to its CEO, Tony Bihl.

“Greg has done an exceptional job serving as Interim CFO for the past three months, seamlessly integrating into our executive team in this important role. He has provided the financial reporting, guidance, analysis, and leadership that gives us great confidence in his ability to perform and grow moving forward,” said Bihl. “One of Tony’s strengths is his ability to provide exceptional legal advice while always seeking to achieve the best overall business solution. His global experience in complex regulated healthcare industries, along with his engaging and collaborative approach make him a great addition to our leadership team.”

Prior to joining Bioventus, Anglum held CFO positions at Overture, a Raleigh-based technology company and StrikeIron, a Software-as-a-Service (SaaS) company. He also spent several years in public accounting roles with Arthur Andersen and Grant Thornton. Anglum earned a Bachelor of Arts degree in economics from Vanderbilt University and an MBA from the Owen Graduate School of Management at Vanderbilt.

D’Adamio most recently served as General Counsel & Secretary of Siemens Medical Solutions and earlier was Deputy General Counsel & Secretary of Siemens Healthcare Diagnostics. He also spent five years as Senior Counsel within the Diagnostics Division of Bayer Healthcare, prior to the acquisition of this business by Siemens. D’Adamio began his legal career at the law firm of Bond, Schoeneck & King before taking corporate legal positions with companies including Group Health Incorporated, Quest Diagnostics and Covance. He received his Juris Doctor cum laude from Howard University School of Law and a Bachelor of Arts from the State University of New York at Binghamton.

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. The company 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 uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

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 and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

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

Anika Announces Publication of Data Demonstrating the Efficacy and Safety of HYALOFAST® in Combination with Stem Cells for the Treatment of Cartilage Lesions on the Knee

Posted On August 7, 2017 By OrthoSpineNews In Biologics, Top Stories /

August 07, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the publication of data demonstrating that HYALOFAST^®, a biodegradable HA-based scaffold, used in combination with autologous adult mesenchymal stem cells (MSCs), regardless of a patients’ age, is a viable and effective option for the treatment of cartilage lesions of the knee joint. The data, published in the Knee Surgery Sports Traumatology Arthroscopy – Volume 25 – Number 8 edition of August 2017, demonstrated that treatment outcomes were equally effective among patients under the age of 45 as they were with patients over the age of 45, who are difficult to treat with traditional approaches such as microfracture.

“Cartilage lesions are reported in almost 2 out of 3 patients aged 40 to 50 years who are undergoing knee arthroscopy, and current interventions for cartilage repair have limited utility, in part due to the age-related decrease in regenerative potential of articular chondrocytes observed in vitro,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “This study shows that we may be able to fill a significant treatment gap in the management of cartilage defects among older patients, and offer a more convenient and cost-effective alternative or adjunct to traditional, invasive approaches such as microfracture with HYALOFAST.”

The study evaluated 40 patients with full thickness cartilage lesions of the knee joint, 20 of whom were over the age of 45 and the remaining, who were under the age of 45. All patients were implanted with HYALOFAST soaked in bone marrow aspirate concentrate (BMAC) containing MSCs, and were prospectively evaluated for 4 years. Functional outcomes were assessed using a variety of validated scales¹ preoperatively, at 2-years and at the final follow-up at 4 years. At final follow-up, all functional outcomes’ scores significantly improved (P < 0.001) in both groups of patients, and researchers concluded that the outcomes were not impacted by age or concomitant surgical procedures, but by the size and quantity of lesions.

“We’re encouraged by the results of this long-term study that shows the potential clinical utility of combining stem cells with the HYALOFAST biodegradable hyaluronic acid-based scaffold to treat cartilage defects in a simple one-step procedure,” said Alberto Gobbi, President of the OASI Bioresearch Foundation Gobbi NPO, visiting professor at the UC San Diego, the next President of the International Cartilage Repair Society (ICRS), and the study’s lead author. “One of the key learnings from our four-year follow-up was that cartilage lesion size and quantity might be a better indicator for surgery than advanced age, which we concluded did not impact outcomes associated with the use of stem cells and HYALOFAST.”

HYALOFAST is a non-woven biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used in more than 11,000 patients to date. HYALOFAST is pending regulatory submission in the United States and its ‘FastTRACK’ Phase III trial is currently enrolling patients across the U.S. and Europe.

The full manuscript is available here: https://link.springer.com/article/10.1007/s00167-016-3984-6

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC^®, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

¹ Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC), Knee Injury & Osteoarthritis Outcome Score (KOOS), and Tegner.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418, sonal@purecommunicationsinc.com

Knee surgery: Have we been doing it wrong?

Posted On August 7, 2017 By OrthoSpineNews In Extremities, Sports Medicine /

August 7, 2017, MDLinx/University at Buffalo Health and Medicine News

Cleaning up loose cartilage is not always beneficial, according to a new University at Buffalo study that could impact athletes and seniors, reduce health care costs.
A team of University at Buffalo medical doctors has published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

When treating meniscal tears surgeons also have clipped and smoothed any dislodged cartilage they found in the belief it was helping patients. But the new study finds that practice does not benefit the patient. Patients who did not have dislodged cartilage removed, recovered faster, with less pain, and ended up a year later with identical results.

“Those with less surgery got better faster in comparison with the people we did more surgery on,” said Leslie J. Bisson, MD, professor and chair in the Department of Orthopaedics at the Jacobs School of Medicine and Biomedical Sciences at UB and lead author of the study.

The finding was so surprising that an editor at The Journal of Bone & Joint Surgery, which published the study, also published a commentary that said, “The conclusion that unstable cartilage lesions do not need debridement could have a dramatic impact on practice management, save health–care dollars, and improve early patient outcomes.”

The American Academy of Orthopaedic Surgeons also distributed the study on its weekly collection of papers of note.

READ THE REST HERE

SeaSpine Reports Second Quarter 2017 Financial Results

Posted On August 7, 2017 By OrthoSpineNews In Financial /

CARLSBAD, Calif., Aug. 03, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the second quarter ended June 30, 2017.

Second Quarter 2017 Financial Highlights and Recent Accomplishments

Revenue of $34.2 million, an increase of 3.0% year-over-year
U.S. revenue of $30.4 million, an increase of 1.1% year-over-year
— U.S. orthobiologics revenue of $16.0 million
— U.S. spinal instrumentation revenue of $14.4 million
International revenue of $3.8 million, an increase of 20.5% year-over-year
Full commercial launch of the Mariner® Posterior Fixation System, a modular pedicle screw system that provides surgeons with multiple intra-operative options to facilitate posterior lumbar fixation
Limited commercial launch of the Skipjack™ Expandable Interbody System, an expandable interbody system that provides in-situ expansion in either height or lordosis for an improved anatomical fit

“We are pleased with our second quarter results, which reflect our ongoing commitment to develop innovative and cost effective solutions to treat spinal disorders and expand our distributor footprint,” said Keith Valentine, President and Chief Executive Officer. “We remain focused on our mission to drive improved procedural solutions that combine efficient spinal instrumentation systems with industry leading orthobiologics to deliver clinical value to surgeons, hospitals, and patients.”

Second Quarter 2017 Financial Results
Revenue for the second quarter of 2017 totaled $34.2 million, a 3.0% increase compared to the same period of the prior year. Total revenue in the U.S. was $30.4 million, a 1.1% increase compared to the same period of the prior year due primarily to the improved performance of orthobiologics distributors during the current year period.

Orthobiologics revenue totaled $17.6 million, a 4.8% increase compared to the second quarter of 2016. The growth in orthobiologics revenue was driven by an increase in U.S. sales. Spinal instrumentation revenue totaled $16.6 million, a 1.1% increase compared to the second quarter of 2016 that was driven by stocking orders from a recently added distributor in Latin America.

Gross margin for the second quarter of 2017 was 59.1%, compared to 58.0% for the same period in 2016. The increase in gross margin was mainly driven by lower manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility. This was partially offset by a $0.2 million increase in non-cash amortization of technology intangible assets acquired in September 2016 from N.L.T. Spine Ltd and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue in the second quarter of 2017 compared to the same period of the prior year.

Operating expenses for the second quarter of 2017 totaled $28.4 million, compared to $31.5 million for the same period of the prior year. The $3.1 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the second quarter of 2017 was $8.0 million, compared to a net loss of $12.0 million for the second quarter of 2016.

Cash and cash equivalents at June 30, 2017 were $12.3 million and the Company had $4.0 million of outstanding borrowings against its $30.0 million credit facility. The Company realized $4.6 million in net proceeds in the second quarter of 2017 through the sale of approximately 477,000 shares of its common stock under its “at the market” equity offering program.

2017 Financial Outlook
SeaSpine expects full-year 2017 revenue to be in the range of $130.0 million to $133.0 million, reflecting growth of 1% to 3% over full-year 2016 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 49156714. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal instrumentation solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal instrumentation portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: revenue expectations for full-year 2017. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the Company’s ability to attract and retain new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; unexpected expense, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

SEASPINE HOLDINGS CORPORATION UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data)
	Three Months Ended June 30,						Six Months Ended June 30,
	2017			2016			2017			2016
Total revenue, net	$	34,196		$	33,201		$	66,090		$	64,600
Cost of goods sold	13,994			13,930			27,166			28,213
Gross profit	20,202			19,271			38,924			36,387
Operating expenses:
Selling, general and administrative	24,249			26,989			48,219			52,363
Research and development	3,344			3,181			6,394			5,934
Intangible amortization	792			1,281			1,584			2,562
Total operating expenses	28,385			31,451			56,197			60,859
Operating loss	(8,183		)	(12,180		)	(17,273		)	(24,472		)
Other income (expense), net	185			(232		)	172			26
Loss before income taxes	(7,998		)	(12,412		)	(17,101		)	(24,446		)
Provision (benefit) for income taxes	45			(429		)	45			(456		)
Net loss	$	(8,043	)	$	(11,983	)	$	(17,146	)	$	(23,990	)
Net loss per share, basic and diluted	$	(0.68	)	$	(1.07	)	$	(1.46	)	$	(2.15	)
Weighted average shares used to compute basic and diluted net loss per share	11,888			11,179			11,705			11,173

SEASPINE HOLDINGS CORPORATION UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA (In thousands)

	June 30, 2017		December 31, 2016

Cash and cash equivalents	$	12,287	$	14,566
Trade accounts receivable, net of allowances of $522 and $483	21,689		20,982
Inventories	42,515		45,299
Short-term debt	—		445
Total current liabilities	25,617		24,418
Long-term borrowings under credit facility	3,994		3,835
Total stockholders’ equity	105,466		110,977

Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

OrthoPediatrics Corp. Launches New Pediatric Specific Clavicle Plates

Posted On August 7, 2017 By OrthoSpineNews In Recon, Top Stories /

WARSAW, INDIANA (PRWEB) AUGUST 04, 2017

OrthoPediatrics Corp. is pleased to announce the launch of the PediFrag™ Pediatric Specific Clavicle Plate. This innovative new plate is specifically designed for treating mid-shaft clavicle fractures in young patients. The OP Clavicle Plates are unique due to their pre-contoured shape. This curvature was derived from studying 36 pediatric clavicle skeletons from OrthoPediatrics’ exclusive access to the Hamann-Todd skeletal collection in Cleveland, Ohio.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, is excited to bring another device to the Pediatric Orthopedic market – saying, “We are successfully implementing our strategy of surrounding pediatric surgeons with all the surgical systems they need. The breadth and depth of our Trauma and Deformity Correction portfolio is unmatched and we are continuing to develop new products.”

President and Chief Executive Officer, Mark Throdahl echoed this excitement, adding “The launch of our clavicle plates is one more example of our continued growth. OrthoPediatrics is committed to improving the lives of children with orthopedic conditions through the development of new products and supporting clinical education for pediatric orthopedic surgeons.”

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 20 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics also has the only global sales organization focused exclusively on pediatric orthopedics and distributes its products to 32 countries outside the United States.

Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-point

Posted On August 7, 2017 By OrthoSpineNews In Neuro, Regulatory /

August 03, 2017

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8^®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that over half the required number of implants in the ReActiv8-B Clinical Trial have been performed.

The trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/show/NCT02577354.

69 subjects have been implanted with ReActiv8 in the trial. The trial design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re-estimation is planned when half the implanted subjects have data from the 120-day visit. The enrolment rate has been accelerating as the number of active sites has increased during 2017.

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.Mainstay has begun commercialization in Europe, focusing initially on Germany, where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. More recently, commercialization has begun in Ireland, Mainstay’s home market.

Peter Crosby, CEO of Mainstay, commented: “The ReActiv8-B Clinical Trial is advancing well, and, based on our experience to date, we anticipate completing enrolment around the end of this year, with results available in 2018. The ReActiv8-B trial is a key step towards commercialization in the US, our most significant target market, and we are pleased with the progress.

“Our initial commercialization of ReActiv8 in Europe is well underway. Our strategy is to work with key reference centers in Germany, and then build on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.”

ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit. Total number of subjects implanted will also include some enrolled and implanted as part of the surgical roll-in phase, in addition to subjects in the pivotal cohort. The Trial is designed with an “interim look” for sample size re-estimation when primary outcome data are available from half the subjects in the pivotal cohort, and if necessary the number of subjects in the pivotal cohort may be increased to achieve the targeted statistical significance. The interim analysis will be performed by a third-party independent statistician under the direction of the Data Monitoring Committee (DMC), and the interim results, other than a DMC recommendation regarding the findings, will remain blinded to the Company, study subjects, investigators and Clinical Trial sites.

The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide what is referred to as Level 1A Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8^®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
or
FTI Consulting (for Ireland)
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Louis-Victor Delouvrier
Tel: +: +33 1 44 71 98 53
Email: lvdelouvrier@newcap.fr
or
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
or
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com
or
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialisation of ReActiv8^®, the progress and success of the ReActiv8-B Clinical Trial,general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Short Name: Mainstay Medical

Category Code: STR

Sequence Number: 600858

Time of Receipt (offset from UTC): 20170802T174402+0100

Contacts

Mainstay Medical

SpineSource_Launches_Expandable_Lumbar_Interbody_Cage_In_U_S____OrthoSpineNews-300x251.jpg

SpineSource Awarded Department of Defense Distribution and Pricing Agreement

Posted On August 7, 2017 By OrthoSpineNews In Spine /

August 02, 2017

CHESTERFIELD, Mo.–(EON: Enhanced Online News)–SpineSource, Inc. today announced it has been awarded a national contract from the U.S. Department of Defense for its L-Varlock^® Expandable Lumbar Cage. Under the contract, SpineSource will supply L-Varlock^® through a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency which offers U.S. military medical treatment facilities access to a full spectrum of medical products for active U.S. military personnel and veterans.

“The L-Varlock^® continues to impress,” said Tom Mitchell, Founder/CEO of SpineSource. “The fundamental nature of spinal bone healing, sagittal balance and disc height restoration are all found within this implant.”

The L-Varlock^® is the only lordotic expandable device in the United States that can be expanded from any range of zero to 24.5° of angle, and from zero to 7.1 mm of expansion within the disc space. Made of titanium alloy, it provides a preferred material for bony osteointegration and a wide open framework for bony in-growth.

READ THE REST HERE

SurGenTec’s GRAFTGUN Receives Core Patent for Post Filling Cages Using Their Graft Delivery Technology

Posted On August 4, 2017 By OrthoSpineNews In Biologics /

August 03, 2017

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec® has been issued device and method patent No. 9,668,881 from the United States Patent and Trademark Office for its graft loading technology to post-fill implant cages. The Graftgun® is a universal graft delivery system that allows surgeons to use the bone graft of their choice. The device permits minimally invasive delivery of bone graft material into bone voids, disc spaces, cages, and implants. Once the implant has been positioned and the inserter is removed, the device can be connected to post-fill a variety of implants. The Graftgun kit will include a universal loading device which enables surgeons to load allograft, autograft, or synthetic biologics into the gun’s delivery tube and dispense it to an orthopedic site.

“We now have intellectual property that protects our ability to post-fill cages in situ,” said Travis Greenhalgh, CEO of SurGenTec. “One of the challenges when using expandable or monolithic cages is the ability to post-fill them once inserted into the disc space. The traditional way to post-fill a cage is to use a funnel or an elongated syringe. Most types of bone graft require significant force to extrude the material into the aperture of a cage. Our ratcheting technology provides users the force needed to extrude an array of bone graft materials, while maintaining superior control of the amount of graft that enters the cage and disc space. A concern with expandable cages is the ability to pack the implant with enough bone graft to provide maximum endplate contact. If there is a void between the bone graft and endplate there may be a higher risk of non-unions. The Graftgun ratcheting technology can help ensure the void is filled.”

SurGenTec has the capacity to customize the Graftgun so that it can be paired with nearly any cage on the market without requiring changes to their instruments. This will allow implant manufacturers seamless access to the Graftgun’s innovative technology, and the ability to offer an advantageous graft delivery solution to their end users. With the expandable cage market growing, this should be a viable option to optimize graft volume within a variety of implants.

SurGenTec looks forward to becoming the leader in bone graft delivery technologies, and has allocated a considerable amount of resources to ensure that they are on the forefront of this sector of orthopedic and spine surgery.

SurGenTec is a privately owned medical device company based out of Boca Raton, FL. They are focused on developing minimally invasive surgical technologies to help surgeons provide optimal care for their patients. SurGenTec anticipates the Graftgun to be released this summer.

Contacts

SurGenTec
Andrew Shoup, 561-990-7882

Orthofix to Present at Canaccord Genuity Annual Growth Conference

Posted On August 4, 2017 By OrthoSpineNews In Extremities, Spine /

August 04, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Canaccord Genuity 37^th Annual Growth Conference in Boston, MA on Thursday, August 10, 2017 at 1:30 p.m. ET.

A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

About Orthofix:

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Investor Contact:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Contact:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

SANUWAVE Health Announces Extension of HealthTronics Promissory Notes

Posted On August 4, 2017 By OrthoSpineNews In Financial /

SUWANEE, GA–(Marketwired – Aug 3, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) today announced it has entered into a third amendment to certain provisions of the two promissory notes dated August 1, 2005 between the Company and HealthTronics, Inc. with an aggregate outstanding principal balance of $5,372,743.

The third amendment provides for the extension of the due date of the promissory notes to December 31, 2018. In connection with the second amendment, the Company issued to HealthTronics, Inc. an additional 2,000,000 Class K warrants to purchase shares of common stock, subject to anti-dilution protection. The exercise price of these additional Class K warrants issued is $0.11. The warrants vested upon issuance and expire after ten years.

“We are pleased we were able to successfully further extend the terms of our promissory notes with HealthTronics, from whom we acquired SANUWAVE’s extensive patent and technology platform in 2005. As a result, we now have financial flexibility to pursue several of our strategic initiatives and growth strategies slated for the second half of 2017 and beyond,” commented Kevin A. Richardson II, SANUWAVE’s Chairman of the board of directors. “We have a positive and strong relationship with HealthTronics and appreciate their continued support as we pursue our FDA approval,” concluded Mr. Richardson.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com
investorrelations@sanuwave.com

SANUWAVE Health, Inc.
Kevin Richardson II
CEO & Chairman of the Board
617-306-1350
kevin.richardson@sanuwave.com

Author: OrthoSpineNews

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CONTACT INFORMATION