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Oska® Wellness Wins Another MedTech Breakthrough Award

Posted On June 6, 2018 By OrthoSpineNews In Extremities, Top Stories /  

CARLSBAD, Calif., June 6, 2018 /PRNewswire/ — Oska Wellness, a technology company committed to developing consumer health and wellness products, announced that its Oska Pulse has been selected for the “Best New Technology Solution – Pain Management” award from MedTech Breakthrough, an independent organization that recognizes the top companies, technologies, and products in the global health and medical technology market.  This is the second straight MedTech Breakthrough win for Oska Pulse, which was also selected in 2017 for “Best IoT Healthcare Wearable Device.”

“All of us at Oska are excited to receive this second award from MedTech, who have recognized Oska’s mission to provide non-invasive, drug-free pain management solutions,” said Greg Houlgate, Founder, Chief Business Development and Product Officer for Oska Wellness. “This is an important industry recognition for our young company and our flagship device, Oska Pulse.”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,000 nominations from more than 10 countries.

“We are thrilled to recognize Oska Wellness and congratulate them on back-to-back industry recognition for their innovative health tech product, the Oska Pulse,” said James Johnson, managing director, MedTech Breakthrough. “The level of innovation displayed by nominees in the MedTech Breakthrough Awards program is incredibly high and Oska Wellness was able to stand out once again to take home the trophy, a significant achievement for the Company. Congratulations to the entire Oska Wellness team and we look forward to seeing continued innovation and success from them in the future.”

Oska Pulse is a safe, easy-to-use, portable and wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.  Oska Pulse is available for purchase at FSAstore.com, HSAstore.com, Amazon.com, and www.oskawellness.com or ask your doctor.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oskawellness.com.

About MedTech Breakthrough
The MedTech Breakthrough Awards program is devoted to honoring excellence in medical and health related technology companies, products and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough MedTech companies and products in categories including Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Genomics, Medical Data, Healthcare Cybersecurity and more. For more information visit www.MedTechBreakthrough.com

CONTACT:
Robin Carr, Oska, Inc.
415-971-3991
196704@email4pr.com

SOURCE Oska Wellness

Related Links

http://www.oskawellness.com

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IMPLANET Announces Opening of a United Kingdom Sales Branch

Posted On June 6, 2018 By OrthoSpineNews In Spine, Top Stories /  

June 05, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the opening of a branch in the United Kingdom, accelerating expansion and direct growth in the growing adult degenerative market.

The Implanet UK branch will capitalise on the success of the approach adopted in France and the United States, where local teams have built up a mixed network of direct sales representatives and exclusive sales agents. Implanet is replicating this proven sales model, with focus on the main European markets. The Implanet UK branch is led by an experienced team, which will penetrate the market for adult degenerative spine disease, with first surgeries planned for June 2018. The partnership with Lindare Medical, the current distributor specialising in paediatric surgery, is continuing to progress.

Ludovic Lastennet, Chief Executive Officer of Implanet, comments: “Following the announcement of JAZZ Evo® last month, the opening of this branch in the United Kingdom confirms the roll-out of our strategy in the lucrative market of adult degenerative spine disease. This marks a major step forward in our commercial development in Europe, in particular the replication of the proven direct sales model used in France and the United States. This model facilitates direct customer contact and allows us to be more responsive to the clinical needs of surgeons and patients. The team is already operational, with in-depth knowledge of our JAZZ® technology. We are confident in the roll-out of JAZZ® in the British market for adult degenerative spine disease, estimated at over $100 million1. This structural move fits in with our 2018-2019 strategic plan, which aims to promote the Implanet range directly in key European markets and prepare for the integration of the products offered by our partner L&K Biomed.”

Next press release: first-half 2018 sales on Wednesday 11 July 2018

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 Mordor Intelligence 2017 study

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

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Vertiflex Announces Appointments to Board of Directors, Ray Baker, MD, and Richard Mott

Posted On June 6, 2018 By OrthoSpineNews In Spine /  

June 05, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex, Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, today announced two new members of its Board of Directors, adding strong clinical and industry expertise to the company’s leadership team.

Ray Baker, MD, brings extensive clinical experience to Vertiflex. He is currently chief medical officer at Relievant Medsystems, Inc. Dr. Baker has advised the Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) on matters related to pain management. Dr. Baker previously chaired the multi-society pain workgroup for CMS and is past president of both the North American Spine Society and the Spine Intervention Society. His previous leadership experience includes vice president and executive medical director of EvergreenHealth Medical Group where he served on the Board of the Evergreen Surgical Center, chaired the EvergreenHealth Medical Group Leadership Council and was medical director of the Spine and Musculoskeletal Programs.

Richard Mott brings a tremendous wealth of experience in management and consulting of various private and public companies. He is currently a principal in Walkabout Consulting, LLC, a management consulting and private equity firm. Previously, he served as president, chief executive officer and director of Kyphon Inc., a NASDAQ-listed global medical device company, through its acquisition by Medtronic. Mr. Mott has held other executive positions, including chief operating officer at Wilson Greatbatch Technologies, Inc., a NYSE-listed medical technology company, and executive operating roles within Bristol-Myers Squibb.

“We are excited to welcome the proven expertise and leadership of Dr. Baker and Mr. Mott to our Board. They both have excelled in their respective fields, and I am confident they will help shape and strengthen the strategic direction of Vertiflex,” said Earl Fender, president and CEO of Vertiflex. “This is an exciting time for the company as the Superion® Indirect Decompression System is enjoying a steep growth trajectory. We see enormous potential for this therapy to help patients, with debilitating spinal stenosis, return to a full and functioning life.”

Vertiflex recently reached important milestones, including the completion in March of a $45 million financing to support the significant and accelerating commercial growth of the PMA-approved Superion® Indirect Decompression System. To date, Superion has been used in more than 2,500 commercial cases, after one of the most extensive, rigorous FDA clinical trials on spinal stenosis. The company is also conducting an extensive registry to track commercial safety and efficacy of Superion, which continues to show outcomes equivalent to, or better than, the clinical results that were part of the filing for FDA approval.

About Vertiflex, Inc.

Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, Calif., Vertiflex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery. Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflexspine.com.

Contacts

Vertiflex, Inc.
Kathryn Larson, Sr. Director, Strategic Marketing
+1 442.325.5941
klarson@vertiflexspine.com

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Aesculap Implant Systems Announces U.S. Military’s TRICARE Now Covers Lumbar Total Disc Replacement

Posted On June 6, 2018 By OrthoSpineNews In Spine /  

CENTER VALLEY, Pa., June 4, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that TRICARE now covers the company’s activL® Artificial Disc for active duty and retired military members and their families in need of Lumbar Total Disc Replacement (CPT® procedure code 22857). Aesculap is a privately-held spine and orthopaedic implant company and a U.S. market leader in Lumbar Total Disc Replacement (TDR) with the activL Artificial Disc, a high-value alternative to spinal fusion for chronic low back pain.

In late 2017, Aesculap Implant Systems leadership met with the United States Defense Health Agency and provided critical decision makers from the agency with updated long-term evidence supporting the broader adoption of Lumbar Total Disc Replacement for single-level Degenerative Disc Disease. Evidence presented to the Agency included level 1a meta-analytic data demonstrating the superiority of Lumbar TDR to fusion in this patient population and five-year adjacent segment disease data from the activL Artificial Disc Investigational Device Exemption (IDE) study.

On May 8, 2018 the Agency published a policy stating that they found Lumbar TDR to be proven and medically necessary following their due diligence.

“I greatly respect the Agency’s willingness to listen to and truly hear the evidence available for Lumbar TDR and the activL Artificial Disc,” said Kim Norton, who heads the Reimbursement and Payer Relations strategy at Aesculap. “It is refreshing to experience their collaboration and appreciation for this procedure, which has been proven to provide better outcomes than fusion in a select patient population,” continued Norton.

Along with TRICARE, numerous commercial insurance plans have recently adopted positive coverage policies for Lumbar TDR over the last year. “Over 30 million more Americans now have access to this procedure due to the overwhelming evidence and our efforts,” said Norton.

“I have been able to offer my active duty military patients motion-preserving surgeries as an alternative to spinal fusion to treat degenerative disc disease of the lumbar spine,” said orthopaedic surgeon Anton Jorgensen, who treats military service members. “I am pleased that the same motion-preserving treatments will now be available for our retired military patients and dependents. The long-term value of motion preservation is supported by prospective studies and should be an option for select patients,” concluded Dr. Jorgensen.

“I am pleased to learn that I can now offer this life changing procedure to a segment of the population most qualified for it,” said orthopaedic surgeon William Reed, MD. Reed, who operates out of Blue Valley Hospital in Kansas City, KS, frequently sees patients with TRICARE. “In general, this population wants to get better and my experience so far has been that lumbar disc replacement with next generation technologies like the activL Artificial Disc makes a great deal of sense for them.”

The TRICARE policy is retroactive to November 2017.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

SOURCE Aesculap Implant Systems, LLC

Related Links

http://aesculapimplantsystems.com

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Diamond Orthopedic Announces 510(k) Clearance for Sterile Faceted Screw Technology

Posted On June 5, 2018 By OrthoSpineNews In Regulatory /  

CHARLOTTE, N.C. (PRWEB) JUNE 05, 2018

Diamond Orthopedic announced today that it has received FDA 510k clearance for sterile packaged faceted bone screws in headless compression, cortex, and cannulated screws and pins and guidewires.

“With this new FDA clearance, we have achieved an important milestone in our value proposition to the orthopedic industry. We are now in a position to provide sterile products to healthcare providers to help them compete in an environment where supply chain management and cost containment are a continual challenge,” says Diamond Orthopedic CEO Roy Bivens. “Further, we believe that our offer is an attractive option where bundled payments are in play.”

The approval is a major step toward Diamond’s strategic goal to penetrate ambulatory surgery center markets, and the orthopedic group networks within them. Sterile products enable providers to reduce sterilization requirements that can be cumbersome and costly to manage.

Diamond’s patented faceted screw design allows surgeons to insert screws into bone with less torque, thereby reducing the potential for microfractures. The faceted design also exhibits better purchase at the bone-screw interface and reduced compressive stress as compared to traditional, helical screws.

Diamond Orthopedic will be attending this year’s 7th Annual Extremity Summit from June 8-10, 2018 in White Sulphur Springs, WV.

About Diamond Orthopedic
Diamond Orthopedic, LLC, headquartered in Charlotte, NC, is a medical device company that offers a revolutionary fixation technology to achieve better patient outcomes at a lower total cost. Diamond Orthopedic is the exclusive provider of faceted threadform technology for orthopedic applications worldwide. With proven superiority over traditional helical threadforms, Diamond Orthopedic is the new fixation standard in orthopedics.

Media Contact: 
Guillaume Viallaneix
MedTech Momentum
Phone: 407-960-2994
Email: guillaume(at)medtechmomentum(dot)com

Diamond Orthopedic Contact: 
1600 Camden Road
Charlotte, NC, 28203
Phone: 704-585-8270
Email: info(at)diamondortho(dot)com

Safe Harbor Statements 
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risk factors contain certain forward-looking statements that involve risks and uncertainties. These statements relate to the Company’s future plans, objectives, expectations and intentions. The Company’s actual results could differ materially from those discussed in these statements. It is difficult to accurately predict the impact of each of these risks on the Company due to the dependence on many factors outside the Company’s control. These risks and uncertainties include, but are not limited to, factors affecting our financial results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. It is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. 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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EOS imaging Announces US FDA Clearance For hipEOS 3.0 Software

Posted On June 5, 2018 By OrthoSpineNews In Regulatory /  

June 05, 2018

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its hipEOS 3.0 surgical planning software.

hipEOS 3.0 is the latest generation of the surgical planning software for total hip arthroplasty (THA) and is part of the EOSapps suite of online 3D surgical planning solutions (spineEOS, hipEOS, kneeEOS). The EOSapps, based on unbiased, weight-bearing EOS images and an accurate 2D/3D patient-specific data set, automatically select and best-position implants in 3D, enabling surgeons to identify patient risks and develop customized plans based on each patient’s unique 3D anatomy. Specifically, hipEOS 3.0 simulates the patient’s hip range of motion based on EOS functional standing and seated exams allowing physicians to visualize and anticipate impingement and dislocation risks based on the position of the implant components.

“The EOS platform combines efficient full body, low dose biplanar imaging with online 3D EOSapps that allow physicians to simulate, plan and control post-operative results,” said Marie Meynadier, Chief Executive Officer of EOS imaging. “In addition to providing improved tools for selecting and positioning implants, our EOSapps make it easier for surgeons to engage with and educate patients by showing their treatment plan in a user-friendly 3D environment. With this new clearance, we are thrilled to offer a solution that can help surgeons identify patients at risk, use 3D data to plan a customized treatment to mitigate these risks, and ultimately improve outcomes.”

When the hipEOS solution is utilized, the software offers an initial plan for the size and position of the implant components based on the patient’s 3D data and anatomical model. The plan can be further adjusted by the physician with immediate feedback on how changes affect relevant clinical parameters. With the patient-specific data from full body, weight-bearing 2D/3D EOS images, hipEOS can be used to anticipate and better plan for the outcome of the surgical strategy, including leg length discrepancies, femoral offset and torsion, as well as hip mobility.

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopaedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman
The Ruth Group
Ph: 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com

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CoreLink Acquires Expanding Orthopedics, Inc.

Posted On June 5, 2018 By OrthoSpineNews In Spine, Top Stories /  

June 05, 2018

LITTLE ROCK, Ark.–(BUSINESS WIRE)–CoreLink, LLC (“CoreLink”), a portfolio company of The Stephens Group, LLC, has acquired the assets of Expanding Orthopedics, Inc. Terms of the transaction were not disclosed.

Expanding Orthopedics, founded in 2001, develops and commercializes innovative expandable devices for minimally invasive spine surgery. Along with the FDA-cleared expanding and articulating FLXfit™ and FLXfit 15™ titanium interbody systems, CoreLink has also acquired a broad array of additional patents and in-development products addressing the rapidly growing expandable interbody and spinal fusion market. CoreLink will provide enhanced support for existing users of both the FLXfit and FLXfit 15 systems, while utilizing its unique vertical integration to quickly incorporate system upgrades for a full commercial re-launch in Q3 2018.

“The acquisition of Expanding Orthopedics allows us to better serve our customers’ needs by adding important product lines and intellectual property in the fastest growing categories within the spine market. We look forward to supporting Expanding Orthopedics’ existing customer base with CoreLink’s broader product offering and leading sales, training, distribution and manufacturing infrastructure, and we’re particularly excited to introduce these new product lines to CoreLink’s customers,” said Jay Bartling, founder and CEO of CoreLink.

Clay Hunter, Managing Director at The Stephens Group, added, “We are very pleased to support CoreLink in this first complementary acquisition which adds a high-growth product line to CoreLink’s already broad portfolio. Jay and his team are great partners, and we look forward to continuing to support their efforts to build the leading vertically integrated manufacturer and distributor of highly engineered spinal implants and instrumentation.”

ABOUT CORELINK, LLC
Headquartered in St. Louis, Missouri, CoreLink is a leading provider of medical devices, primarily highly engineered spinal implants and instrumentation. The company employs both traditional precision manufacturing and additive manufacturing techniques to produce and sell a broad and growing line of pedicle screw systems, interbody spacers, plates, biologics and surgical instruments through a network of distributors and independent sales representatives as well as its internal salesforce to hospitals, surgery centers and other healthcare providers.

ABOUT THE STEPHENS GROUP, LLC
The Stephens Group is a private, family-owned firm investing its capital in companies with exceptional management teams and high returns on invested capital in growing industries. The Stephens Group has a long history of successfully investing in both minority and control positions across multiple industries. The Stephens Group, through its affiliates, has or has had significant investments in industrial products and services, healthcare, specialty distribution, telecom, media and technology, communications, financial services, consumer and specialty retail, energy services and gas exploration and production and other industries.

Contacts

The Stephens Group, LLC
Ronald M. Clark, 501-377-2356
General Counsel
rclark@stephensgroup.com

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Astura Medical Receives FDA 510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems

Posted On June 5, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

CARLSBAD, CA – June 4, 2018 – Astura Medical, a high growth, innovative spine technology company, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ALTA ACDF Interbody Spacers and HALF DOME Lumbar Interbody Spacers in PEEK-OPTIMAä HA Enhanced from Invibio Biomaterial Solutions.

Combining the clinically proven strength and versatility of PEEK-OPTIMA with Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, PEEK-OPTIMA HA Enhanced provides an innovative biomaterial for interbody fusion devices. HA is fully integrated, not coated, into the PEEK-OPTIMA matrix, ensuring it is present on all surfaces and throughout the implant.

“As surgeons continue to explore different surface technology options, we are excited about the addition of HA PEEK to our suite of interbody solutions,” said Thomas Purcell, Vice President of Astura Medical. “It once again reinforces Astura’s commitment to providing our surgeon partners with differentiated technology to enhance their ability to provide the best in patient care.”

ALTA and HALF DOME HA PEEK are now commercially available in multiple footprint, height, and lordotic options for ACDF, PLIF, and TLIF procedures. In addition to the launch of their HA PEEK lineup, Astura will be introducing its MIS Percutaneous Screw System and Expandable Posterior Lumbar Interbody Cages later this year.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:

Steve Haayen

Astura Medical

858.472.8825

steve@asturamedical.com

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SANUWAVE Hires Shri Parikh as President for Global Healthcare Division

Posted On June 4, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, June 04, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is excited to announce that Shri Parikh has joined SANUWAVE Health effective May 31, 2018 as President of our Healthcare division. Shri most recently joins us from Molnlycke Health Care where he held the title of Vice President, Sales and Marketing. Prior to Molnlycke, Shri was the Director of National Accounts at Stryker, a leading medical technology company with products and services in Orthopaedics, Medical and Surgical Equipment, and Neurotechnology and Spine.

Shri began his career in sales at Bristol-Myers Squibb and held various roles with increasing sales, marketing and corporate accounts responsibility at Guidant and St. Jude Medical before joining Stryker.

“We are thrilled that Shri chose to join the SANUWAVE family. His leadership, ethics and commercialization expertise will further spearhead the design of a carefully thought out go-to market strategy among other growth management initiatives as we continue to develop partnerships around the globe,” said Chief Executive Officer, Kevin Richardson who further stated, “We enthusiastically look forward to returning more value to our shareholders under Shri’s direction.”

President, Shri Parikh also commented, stating, “I am honored to join the SANUWAVE team and excited about our future.  SANUWAVE’s unparalleled innovative technology and clinical evidence has far reaching implications benefiting patients suffering from diabetic foot ulcers and beyond.  I look forward to working with the talented team at SANUWAVE to deliver sustainable capabilities and scale to support our global growth and commercialization plans, while taking all the necessary steps to enhance value for all shareholders.”

Shri was born and raised in Charlotte, NC. He holds a Bachelor of Arts degree in Medical Ethics and Economics from Davison College, a Master of Business Administration from Jacksonville University and an Advanced Management Program degree from the University of Chicago.

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 System 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 US FDA cleared for the treatment of Diabetic Foot Ulcers.  The dermaPACE® System is also CE Marked throughout Europe and has license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. 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® System, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®, Evotron® and orthoPACE® Systems 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: 

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com
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OrthoPediatrics Corp. Announces First Surgery Performed with Pediatric Nailing Platform | FEMUR

Posted On June 4, 2018 By OrthoSpineNews In Extremities /  

WARSAW, Ind., June 04, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the first surgery utilizing OrthoPediatrics’ newly launched rigid intramedullary nailing system, the Pediatric Nailing Platform|FEMUR (“PNP | FEMUR”), was performed on May 23, 2018 by Dr. Eric Gordon in St. Louis. Dr. Gordon, the original designer of OrthoPediatrics’ PediNail, served as a designing surgeon for the PNP|FEMUR system along with an internationally represented surgeon design team. The innovative system features two distinct child and adolescent implant offerings optimized for pediatric-specific anatomy and accompanied by an entire suite of new/enhanced high precision instrumentation. Capable of addressing trauma and deformity corrections alike, the first surgery performed with the new system represents the culmination of 18 months of development as the Company enters the next step in the evolution of its Intramedullary Nailing franchise.

The surgery performed was bilateral rotational osteotomies for excessive femoral anteversion, a procedure intended to correct a femur rotated too far forward, in a 13 year-old female. Each femur saw a 40-degree rotational correction achieved utilizing a 9mm Intramedullary Child Nail. After the case, Dr. Gordon stated, “The system’s innovative and pediatric-specific design allowed us to achieve superior results as the components fit smoothly together with ease. This is a substantial improvement in the ease of insertion and the anatomic fit, leading to an improved anatomic correction.  I am excited to offer my patients a better outcome and experience with this fantastic new system.”

Joe Hauser, Vice President of Trauma & Deformity Correction at OrthoPediatrics, commented, “We are incredibly pleased with the outcome of the first surgery and grateful for the opportunity to help this young patient. I’m especially thankful for the designing surgeons and engineers involved with this project and for their efforts in developing a system that treats a wider range of children and pathologies. This platform represents the next evolution of innovation from OrthoPediatrics, and I look forward to many more success stories.”

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an 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 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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