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Current Issues in Spine

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August 16, 2018 OrthoSpineNews

August 16, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market The FoundationTM 3D Anterior Lumbar (ALIF) Interbody device. This marks the launch of the latest addition to CoreLink’s Foundation 3D Interbody Cage family.

Jay Bartling, CEO, said, “The Foundation 3D ALIF demonstrates our increasing capabilities with 3D printing titanium alloy. We’re proud to have the largest ALIF cage footprint on the market, which will allow surgeons to maximize endplate contact area and hold up to 8cc’s of graft.”

Prior to the newly 510(k) cleared ALIF device, CoreLink released 3 other sterile-packaged Foundation 3D interbody cages: Cervical, Straight Lumbar, and Curved Lumbar.

“I have been very pleased since converting to Foundation 3D Cervical last year. I am excited about the Mimetic Metal technology and have had great clinical outcomes with very happy patients.” said Todd Stewart, MD.

Foundation 3D ALIF leverages CoreLink’s proprietary Mimetic Metal™ technology that mimics key characteristics of natural bone – 100% open-pore architecture and micro roughened porosity with significant hydro-wicking properties. The new ALIF design also features patent pending StrutSure™ technology which creates a combination of load-sharing support structure and interconnected lattice designed to provide optimal balance between strength, stiffness, and stability. This unique structure minimizes implant material density, providing good imaging characteristics. Foundation 3D devices have a low modulus that may reduce stress shielding and enable the benefits of Wolff’s Law.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where the portfolio of Foundation 3D Products will be featured.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

(Photo: Business Wire) Foundation 3D

www.corelinksurgical.com

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808


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August 16, 2018 OrthoSpineNews

Lund, Sweden, 18:00 CET, 16 August 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, announces that its antibiotic-eluting product CERAMENT G has been approved by Health Canada.

CERAMENT G is the first and only CE-marked gentamicin-eluting injectable ceramic bone graft substitute on the market.  CERAMENT G sales have been growing strongly based on the clinical benefits it delivers when used for indications where infection may be present or of concern.

BONESUPPORT is currently conducting the FORTIFY trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial  include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G   in the US, where the product is expected to be launched in 2021. 

Emil Billbäck, CEO of BONESUPPORT said: “We are looking forward to commercializing CERAMENT G in Canada following its approval by Health Canada. CERAMENT G will be the first injectable antibiotic eluting ceramic bone graft substitute to be launched on the Canadian market. We are currently in dialogue with potential distributors to assist us in bringing this novel product to orthopedic surgeons managing bone voids where infection is present or an important risk.”

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 16 August 2018.

 

Pip Batty

Account Manager

 

3 London Wall Buildings

London Wall

London EC2M 5SY

Tel: +44 (0)20 7282 1022

Mob: +44 (0)7808 642 922


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August 16, 2018 OrthoSpineNews

SAN DIEGOAug. 16, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the appointment of Dale Wolf as vice president, Manufacturing, who will oversee the Company’s West Carrollton, Ohio manufacturing facility.

Mr. Wolf will fill a newly created role emphasizing the importance of the company’s goal to become a world-class manufacturer. He will manage the 180,000 square foot manufacturing operations, and focus on optimizing output, advancing the insourcing strategy and streamlining processes, reporting directly to Steve Rozow, executive vice president, Global Process Transformation. With accelerated improvements over the second half of 2018, the manufacturing facility is expected to produce 70 percent of its spinal implant products by year-end. The NuVasive insourcing effort represents a tremendous opportunity to control costs and implant quality, along with overall positive margin expansion.

With nearly two decades at General Electric (GE), Mr. Wolf has extensive experience in medical device manufacturing operations. He has held various leadership roles managing GE Healthcare manufacturing facilities, streamlining new product introductions, implementing Lean Six Sigma processes, supporting high-performance work teams and operating with the philosophy of continuous improvement. Most recently, Mr. Wolf led GE Healthcare’s Florence, South Carolina plant producing magnetic resonance imaging (MRI) components for the past four years. There, he led a site of more than 400 employees, and directed all supply-chain operations supporting $1 billion in revenue and $60 million in inventory.

“Dale brings a dynamic pedigree of experience in medical device manufacturing to NuVasive that will be instrumental in scaling our insourcing output,” said Steve Rozow. “His knowledge and expertise of managing complex operations will be integral in driving growth for our business as our manufacturing efforts continue to expand. Dale is a proven leader who will be a great addition to the robust manufacturing talent we are cultivating at NuVasive.”

Mr. Wolf earned a bachelor of science in Mechanical Engineering from the University of Wisconsin-Madison, and holds a Six Sigma Green Belt certification.

About NuVasive 

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements 

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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August 15, 2018 OrthoSpineNews

NEW YORKAug. 14, 2018 /PRNewswire/ — HSS, the New York-based health system that includes Hospital for Special Surgery, is forming a strategic co-management partnership with Aspen Valley Hospital (AVH) and its OrthoAspen specialist group, to provide the world’s most advanced orthopedic care to Aspen community members and visitors. Following months of development, the relationship was endorsed by a vote on August 13 among the AVH Board of Directors.

Hospital for Special Surgery has been ranked the No. 1 orthopedic hospital in the nation for the past nine consecutive years by U.S. News & World Report ‘Best Hospitals’ (2018-19). AVH, Colorado’s only five-star rated critical access hospital by the Centers for Medicare and Medicaid Services, will adopt HSS best practices standards and leverage its orthopedic resources and capabilities. HSS will provide AVH with services including clinical knowledge transfer, medical staff development, professional education, research and academic programming, and practice quality enhancement.

“This partnership is a great example of our different approach to transforming healthcare,” said Louis A. Shapiro, president and CEO of HSS. “Innovative collaboration amongst two organizations committed to excellence in a focused specialty offers an alternative source of value to the trend of mass consolidation and commoditization in healthcare.”

“Embedding HSS’s knowledge, expertise, and best practices in AVH, enables world-class care to be more accessible and more individuals to live life to the fullest,” he added.

“We are thrilled to partner with Aspen Valley Hospital, an exceptional institution in its own right,” said HSS Surgeon-in-Chief and Medical Director Dr. Todd J. Albert. “Together we will provide an even higher standard of quality to a community with an especially strong appreciation for the value that will come from that.”

“This is a unique opportunity to advance the excellence of OrthoAspen and assure the most discerning consumers of world-class orthopedic care right here in Aspen,” said Dave Ressler, CEO, Aspen Valley Hospital. “This transformative partnership is very exciting for both AVH and HSS because it clearly demonstrates our shared commitment to delivering the best possible orthopedic outcomes.”

“It will also enable us to better control costs and deliver value to the Aspen community,” added Mr. Ressler.

Both nonprofit hospitals have long histories serving their respective communities – HSS was founded in 1863 and AVH has been serving Aspen for 127 years.

ABOUT ASPEN VALLEY HOSPITAL

Founded in 1891, Aspen Valley Hospital (AVH) is one of the most sophisticated rural hospitals in the U.S. With twenty-five beds, AVH is designated as a critical access hospital and level III trauma center, meeting the needs of the Aspen and Roaring Fork Valley communities, plus thousands of visitors from around the world every year. Combining the warmth and friendliness of a small town with the technical expertise of a major medical center, AVH has been recognized with numerous awards, including a Five-Star Rating from the Centers for Medicare and Medicaid; “Hospital of Choice” award (based on Hospital Consumer Assessment of Healthcare Providers and Systems results); and a “Top 20 Best Practice in Financial Stability” designation from the National Rural Health Association for critical access hospitals in the U.S., among others. AVH offers a full range of services with board-certified specialists in 25 fields of medicine, with expanded expertise in orthopedics and sports medicine. For over 125 years, Aspen Valley Hospital has been working to deliver extraordinary healthcare in an environment of excellence, compassion and trust. Learn more at aspenhospital.org or 970-925-1120.

ABOUT ORTHOASPEN

The OrthoAspen team of physicians is dedicated to improving and restoring the health of recreational and competitive athletes, adults, seniors and children. OrthoAspen has earned worldwide acclaim for its expertise in orthopedic care, providing the latest technologies and comprehensive services for its patients. Utilizing diagnostic imaging technology, minimally-invasive techniques, and the Mako surgical robot for total and partial joint replacements, OrthoAspen brings state-of-the-art orthopedic care to Aspen and surrounding communities. OrthoAspen’s research findings have been reported in major medical journals and at academic conferences throughout the world. Learn more at orthoaspen.org or 970-544-1289.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

Related Links

http://www.hss.edu


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August 15, 2018 OrthoSpineNews

The growing interest in PEEK-OPTIMA™ spinal implants in China received further impetus at the 11th Congress of the Chinese Association of Orthopaedic Surgeons (CAOS) held in partnership with the North American Spine Society (NASS). At this event, Fule Science & Technology Development, Beijing, and Invibio Biomaterial Solutions partnered to demonstrate the new Uplifter® Expandable Anterior Lumbar Interbody Fusion Device in a hands-on workshop in Shanghai.

The Uplifter is the first domestic expandable hybrid cage, whose constituent materials are Invibio’s PEEK-OPTIMA™ Natural polymer and titanium. Indications for use of the Uplifter comprise Degenerative Disc Disease (DDD) of L2-L5, nerve root-canal stenosis, and lumbar spondylolisthesis.

During the live demonstration on a cadaver using the Uplifter, Dr Patrick C. Hsieh, from the USC Spine Center in Los Angeles, demonstrated the Direct-Lateral Lumbar Interbody Fusion (DLIF) procedure and device specifics: “The benefits of using PEEK1 for spinal implants include radiolucency that assists in accurate fusion assessment as well as having a track record of excellent long-term clinical results and radiographic fusion rates. Invibio PEEK-OPTIMA polymer combined with the features of Fule’s expandable cage allows 3-5mm of expansion, supporting the restoration of disc height and lordosis with more optimal foraminal height.”

Further clinical features of this hybrid implant include according to Fule:

  • Minimized impaction contributing to preservation of endplate integrity
  • Controlled expansion and anatomical fit helping to maximize indirect decompression through disc height restoration
  • Continuous expansion that can maintain stability by optimizing the fit

Professor Renfu Quan, a faculty member at Hangzhou Xiaoshan TCM hospital responsible for on-site cadaver workshops, explained the standard surgical techniques for OLIF and demonstrated the procedures for the surgeons present in a lab setting. Using Fule’s retractors and instruments, he showed how to implant their expandable ”Poster“ cage.

This live demo was available to surgeons who attended the workshop in Shanghai and was also broadcast directly to the CAOS/NASS congress in Hangzhou. The demo has also been published through the CAOS online education platform, being available to more than 10,000 participants in the CAOS congress.

Radiolucent biomaterial allows better fusion assessment
“PEEK has been used for interbody fusion devices for many years. Both, the literature and my personal experience indicate that PEEK provides better clinical outcomes compared with titanium-only approaches in spinal fusion. There is a higher fusion rate and lower subsidence”, Dr. Xifeng Zhang, from Beijing 301 Hospital, emphasized in his ‘Review of Clinical Applications and results associated with Direct-Lateral Lumbar Interbody Fusion (DLIF). Indeed, the potential benefits of PEEK-OPTIMA Natural in conventional spinal cages may translate to expandable cages. They include radiolucency, with no artifacts present, allowing better fusion assessment by CT and MRI and a modulus of elasticity close to that of bone, reducing stress shielding, which may otherwise contribute to implant subsidence.“

Guoping Fan, Technology Director at Fule Science & Technology Development Company commented: “To drive advances in orthopedics we partner with a variety of experts ranging from material and technology experts to orthopedic surgeons treating patients. The in-depth technical cooperation with Invibio for example allowed the development and introduction of this first hybrid PEEK-titanium expandable cage in China for DLIF and OLIF procedures. Now we are working full speed to develop the spinal fusion devices with PEEK-OPTIMA HA Enhanced.”

In China, Invibio´s enhanced PEEK is a relatively new thermoplastic biomaterial offering all of the clinical advantages of the unfilled “PEEK-OPTIMA Natural” polymer. In addition, it has been shown to improve bone apposition compared to unfilled PEEK-OPTIMA Natural in a pre-clinical ovine model at 4 weeks and 12 weeks (2), and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at 6 and 12 weeks. (2) In PEEK-OPTIMA HA Enhanced, Hydroxyapatite (HA), a well-known osteoconductive material, is fully integrated into the polymer matrix, and not simply coated on the surface. Early clinical results for cervical and lumbar spinal fusion reveal potential patient benefits and specific improvements for the enhanced biomaterial including solid fusions as early as 6 months, beneficial clinical outcomes at early time points, improvements in overall pain and neurological function. (3)

With China’s accelerating interest in innovative materials such as PEEK-OPTIMA from Invibio for spinal implants, it is expected that more and more patients can potentially benefit from implants using the high performance polymer. Today, more than 140 devices in China have been approved by the CFDA [China Food and Drug Administration, aka SFDA (State Food Drug Administration) ], with over 10 years of accumulated clinical history in China. (4)

The 11th CAOS/NASS congress in May marks the second time Invibio has partnered with a medical-device manufacturer in China to support surgeon education. The company´s PEEK-OPTIMA implants now have over 15 years of clinical history and approximately nine million PEEK-OPTIMA devices have been implanted worldwide. (5)

References:
(1) PEEK” is the abbreviation for polyetheretherketone, a high-performance polymer from the PAEK (polyaryletherketone) family.
(2) Walsh WR, Pelletier MH, Bertollo N, Christou C, Tan C. Does PEEK/HA Enhance Bone Formation Compared With PEEK in a Sheep Cervical Fusion Model? Clin Orthop Relat Res. 2016 Nov; 474(11):2364-2372.
(3) Testimonials presented have been provided by practicing orthopaedic surgeons. Their view and experience are their own and do not necessarily reflect those of others. “Invibio” disclaims any liabilities or loss in connection with the information herein.
(4) Data on file at Invibio Biomaterial Solutions.
(5) Data on file at Invibio Biomaterial Solutions.
Further information is available on https://invibio.com

About Fule Science & Technology Development 
Established in 1994, Beijing Fule Science & Technology Development Co. Ltd is a manufacturer and trader specialized in the research, development and production of Orthopaedic products including spinal products, trauma products, multi-functional external fixator, knee meniscus suturing device, rehabilitation instrument and related instruments. The company’s products have been widely used by thousands of large and medium-sized hospitals and achieved a good report, winning a high reputation from many orthopedic experts. Further information is available on http://www.fulekeji.com/en/index.php

About Invibio Biomaterial Solutions 
Invibio, part of the Victrex plc group of companies, is a global leader in providing high-performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic and dental medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in approximately 9 million implanted devices worldwide. Find out more at https://invibio.com/


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August 14, 2018 OrthoSpineNews

CHICAGOAug. 14, 2018 /PRNewswire/ — U. S. News & World Report released its 2018-2019 Best Hospitals National Ranking and the Department of Orthopaedic Surgery at Rush University Medical Center (RUMC), consisting of Midwest Orthopaedics at Rush (MOR) physicians, moved from the fifth to the fourth best orthopedic program in the nation. The report also continues to honor RUMC/MOR as the highest ranked orthopedic program in Illinois.


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August 14, 2018 OrthoSpineNews

WARSAW, Ind., Aug. 14, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the expansion of its Warsaw, Indiana headquarters. The planned $1M expansion will double the Company’s existing warehouse while creating additional open-concept office space and dedicated training and education facilities.

The Company will host a ground-breaking ceremony on Thursday, August 16th, at 2:00pm ET.

The Indiana Economic Development Corporation (IEDC) is a great supporter of this initiative, adding “Indiana is known as one of the leading hubs for orthopedics, and we are excited to see this trend not only continue but strengthen with the commitment of companies like OrthoPediatrics,” said Elaine Bedel, IEDC President. “Our industry leaders are innovating new products and developing 21st century solutions for people in need across the world, while serving Hoosiers and their families here at home by providing good, skilled jobs. We are glad that OrthoPediatrics is choosing to expand here in Indiana, and we can’t wait to see what’s next for this growing team.”

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, commented, “For the last 10 years, OrthoPediatrics has grown revenue 20% or more every year, and we reported 28% revenue growth last quarter.  Since our IPO in October 2017, we have been aggressively investing in growth initiatives, including hiring additional associates, tripling the deployment of consigned implant/instrument sets, increasing our investment in R&D, and expanding our clinical education programs.  With all the exciting opportunities we are pursuing, we have simply outgrown our current building! The physical expansion of our headquarters reflects OrthoPediatrics’ growth and commitment to our surgeons and their patients so we can continue strengthening our leadership in pediatric orthopedics.”

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.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

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


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August 14, 2018 OrthoSpineNews

SUWANEE, Ga., Aug. 14, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) reported financial results for the three months ended June 30, 2018 with the SEC on Tuesday, August 14, 2018 and will provide a business update on a conference call today, August 14, 2018 at 10:00 a.m. Eastern Time.

Highlights of the second quarter and recent weeks:

  • Record revenue for the second quarter of 2018 was $453,210, up 308% from the second quarter of 2017.
  • The Company named Shri Parikh President of SANUWAVE’s Global Healthcare division.
  • The Company entered into an agreement with Johnfk Medical Inc. (“FKS”), pursuant to which the Company and FKS will enter into a joint venture for the manufacture, sale and distribution of the Company’s dermaPACE® and orthoPACE® devices covering 11 countries in Southeast Asia.  The initial payment per the agreement has been received, initial orders have been shipped in Q3 and this agreement is expected to drive significant growth in the near term.
  • The Company signed a binding term sheet for a joint venture with Tarbaca Lightning covering 3 countries in Central America.
  • The Company appointed Dr. Perry Mayer, Medical Director and principal at The Mayer Institute in Hamilton, Ontario, Canada, to its Clinical Advisory Board.
  • The Company appointed AMBIENSYS SRL as its distributor for dermaPACE in Romania.  The initial orders have been shipped and training successfully occurred in Q2.
  • Third quarter medical conference attendance activity for the Company is expected to be a record eight meetings.
  • Perfusion case study kicked off in July with Rutgers, UCLA, and Northwestern University.  We anticipate full results from this clinical work to be released in early 2019.

Since the FDA clearance, we have begun to develop and implement a platform for rolling out the dermaPACE System for treating DFU’s in the US.  We are taking a methodical approach to the roll out to ensure we ultimately achieve our goal – the delivery of a dermaPACE System to any location in the US that will be treating DFU’s. As we have stated on prior calls, we have five goals for 2018 which will deliver accelerating growth throughout the year and establish the platform for continued growth in 2019 and beyond as we penetrate the US and global wound care market.  The goals for 2018 remain:

  • Initial revenue in the U.S.
  • Expand senior management team in U.S. wound market
  • Enter 4 new international markets
  • Begin supportive clinical work
  • Expansion of Board of Directors and Science Advisory Board

We are well on track to achieve or exceed all the goals we established for 2018 and this translates to revenue increases throughout the year.  As we hire experienced senior managers in the areas of Reimbursement, Clinical, and Sales, we anticipate revenue expansion occurring in the US toward the end of 2018 building a strong foundation to deliver substantial domestic revenue in 2019.

Second Quarter Financial Results

Revenues for the three months June 30, 2018 were $453,210, compared to $111,045 for the same period in 2017, an increase of $342,165, or 308%.  Revenues resulted primarily from sales in the United States and Europe of our dermaPACE and orthoPACE devices and related applicators.  The increase in revenues for 2018 was due to the higher sale of devices and both new and refurbished applicators in the United States and Europe as compared to the same period in 2017.

Research and development expenses for the three months ended June 30, 2018 were $368,377, compared to $437,909 for the same period in 2017, a decrease of $69,572, or 16%.  The decrease in research and development expenses was due to lower stock-based compensation expense and to lower consultant costs related to the FDA submission and follow up which was partially offset by the hiring of a full-time software engineers and an accrual of bonus for 2018.

General and administrative expenses for the three months ended June 30, 2018 were $2,030,799, as compared to $951,908 for the same period in 2017, an increase of $1,078,891, or 113%.  The increase in general and administrative expenses was due to the hiring of a president and human resources director and the related stock-based compensation expense for stock options issued, higher travel costs, accrual of bonus, higher public company costs related to investor relations, higher costs related to leasing of product, and higher consultant fees related to the commercialization of the dermaPACE System.

Net loss for the three months ended June 30, 2018 was $2,888,259, or ($0.02) per basic and diluted share, compared to a net loss of $1,415,937, or ($0.01) per basic and diluted share, for the same period in 2017, an increase in the net loss of $1,472,322.  The increase in the net loss for 2018 was primarily due to higher general and administrative expenses as noted above as well as higher interest expense related to convertible promissory notes which was partially offset by gain on warrant valuation adjustment.

We anticipate that our operating losses will continue over the next few years as we incur expenses related to commercialization of our dermaPACE system for the treatment of diabetic foot ulcers in the United States. If we are able to successfully commercialize, market and distribute the dermaPACE system, we hope to partially or completely offset these losses in the future.

Six Months ended June 30, 2018 Financial Results

Revenues for the six months June 30, 2018 were $797,482, compared to $260,614 for the same period in 2017, an increase of $536,868, or 206%.  Revenues resulted primarily from sales in the United States and Europe of our dermaPACE and orthoPACE devices and related applicators.  The increase in revenues for 2018 was due to the higher sale of devices and both new and refurbished applicators in the United States and Europe as compared to the same period in 2017.

Research and development expenses for the six months ended June 30, 2018 were $717,781, compared to $698,247 for the same period in 2017, an increase of $19,534, or 3%.  The increase in research and development expenses was due to the hiring of two full-time software engineers, stock-based compensation expense for stock options issued, accrual of bonus, and consulting fees related to reimbursement strategy which was partially offset by lower consultant costs related to the FDA submission and follow up.

General and administrative expenses for the six months ended June 30, 2018 were $2,976,405, as compared to $1,400,514 for the same period in 2017, an increase of $1,575,891, or 113%.  The increase in general and administrative expenses was due to the hiring of a president and human resources director and the related stock-based compensation expense for stock options issued, higher travel costs, accrual of bonus, recruiting fees for open positions, higher legal and accounting fees related to SEC filings and higher consultant fees related to the commercialization of the dermaPACE System.

Net loss for the six months ended June 30, 2018 was $8,744,914, or ($0.06) per basic and diluted share, compared to a net loss of $1,909,469, or ($0.01) per basic and diluted share, for the same period in 2017, an increase in the net loss of $6,835,445.  The increase in the net loss for 2018 was primarily due to higher general and administrative expenses as noted above as well as higher interest expense related to convertible promissory notes and loss on warrant valuation adjustment.

Cash and cash equivalents decreased by $59,470 for the six months ended June 30, 2018 and decreased by $71,502 for the six months ended June 30, 2017.  For the six months ended June 30, 2018 and 2017, net cash used by operating activities was $1,598,202 and $572,492, respectively, primarily consisting of compensation costs, research and development activities and general corporate operations. The increase of $1,025,710 in the use of cash for operating activities for the six months ended June 30, 2018, as compared to the same period for 2017, was primarily due to the increased operating expenses and decreased payables in 2018.  Net cash used by investing activities for the six months ended June 30, 2018 consisted of purchase of property and equipment of $13,612.  Net cash provided by financing activities for the six months ended June 30, 2018 was $1,563,313, which consisted of $1,159,785 from the issuance of convertible promissory notes, $38,528 from the exercise of warrants, $136,000 net increase in line of credit, $85,000 from the issuance of short term notes payable and $144,000 from an advance from related party.  Net cash provided by financing activities for the six months ended June 30, 2017 was $514,757, which consisted of $421,690 from advances from related parties and $93,067 from exercise of warrants.

“During the second quarter we continued to meet our objectives for 2018 by signing 3 international deals, hiring Shri Parikh to lead the healthcare group, adding science advisor in Dr. Perry Mayer, and kicking off clinical work to support sales domestically,” stated Kevin A. Richardson II, Chairman of the Board of SANUWAVE.  “We expect continued growth over last year as we continue to market our products both domestically and abroad,” concluded Mr. Richardson.

Conference Call

The Company will host a conference call on Tuesday, August 14, 2018, beginning at 10AM Eastern Time to discuss the second quarter financial results, provide a business update and answer questions.

Shareholders and other interested parties can participate in the conference call by dialing 877-407-8033 (U.S.) or 201-689-8033 (international) or via webcast at http://www.investorcalendar.com/event/36506.

A replay of the conference call will be available beginning two hours after its completion through August 28, 2018, by dialing 877-481-4010 (U.S.) or 919-882-2331 and entering PIN 36506 and a replay of the webcast will be available at http://www.investorcalendar.com/event/36506 until November 14, 2018.

About SANUWAVE Health, Inc. 
SANUWAVE Health, Inc. (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®, received US FDA clearance in December 2017 for the treatment of Diabetic Foot Ulcers.  dermaPACE is the only Extracorporeal Shockwave Technology (ESWT) device cleared or approved in the US for the treatment of DFUs.  Internationally, 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, and South Korea.  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/PacificIn 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
CEO & Chairman
978-922-2447
investorrelations@sanuwave.com

(FINANCIAL TABLES FOLLOW)

 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES  
CONDENSED CONSOLIDATED BALANCE SHEETS  
  (UNAUDITED)  
       
 
June 30, December 31,  
2018 2017  
ASSETS      
CURRENT ASSETS      
Cash and cash equivalents $   670,714 $   730,184
Accounts receivable, net of allowance for doubtful accounts   144,330   152,520
Contract assets   40,000   –
Inventory, net of losses and obsolescence   216,316   231,532
Prepaid expenses   144,816   90,288
TOTAL CURRENT ASSETS   1,216,176   1,204,524
     
PROPERTY AND EQUIPMENT, net   59,787   60,369
OTHER ASSETS   17,789   13,917
TOTAL ASSETS $   1,293,752 $   1,278,810
     
LIABILITIES      
CURRENT LIABILITIES      
Accounts payable $   951,034 $   1,496,523
Accrued expenses   966,984   673,600
Accrued employee compensation   195,874   1,680
Contract liabilities   491,055   –
Advances from related and unrelated parties   144,000   310,000
Line of credit, related parties   517,279   370,179
Convertible promissory notes, net   2,648,548   455,606
Short term notes payable   85,041   –
Interest payable, related parties   842,653   685,907
Warrant liability   3,637,207   1,943,883
Notes payable, related parties, net   5,297,743   5,222,259
TOTAL CURRENT LIABILITIES   15,777,418   11,159,637
NON-CURRENT LIABILITIES
Contract liabilities   76,500   –
TOTAL NON-CURRENT LIABILITIES   76,500   –
TOTAL LIABILITIES   15,853,918   11,159,637
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ DEFICIT
PREFERRED STOCK, SERIES A CONVERTIBLE, par value $0.001,
6,175 authorized;  6,175 shares issued and 0 shares outstanding
in 2017 and 2016   –   –
PREFERRED STOCK, SERIES B CONVERTIBLE, par value $0.001,
293 authorized;  293 shares issued and 0 shares outstanding
in 2017 and 2016, respectively   –   –
PREFERRED STOCK – UNDESIGNATED, par value $0.001, 4,993,532
shares authorized; no shares issued and outstanding   –   –
COMMON STOCK, par value $0.001, 350,000,000 shares authorized;
151,852,757 and 139,300,122 issued and outstanding in 2018 and
2017, respectively   151,853   139,300
ADDITIONAL PAID-IN CAPITAL   99,059,031   94,995,040
ACCUMULATED DEFICIT   (113,716,298 )   (104,971,384 )
ACCUMULATED OTHER COMPREHENSIVE LOSS   (54,752 )   (43,783 )
TOTAL STOCKHOLDERS’ DEFICIT   (14,560,166 )   (9,880,827 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $   1,293,752 $   1,278,810
     

 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
 
  Three Months Ended Three Months Ended Six Months Ended Six Months Ended
   June 30,  June 30,  June 30,  June 30,
2018 2017 2018 2017
REVENUES $   453,210 $   111,045 $   797,482 $   260,614
COST OF REVENUES (exclusive of depreciation shown below)   166,643   24,695   332,109   79,839
OPERATING EXPENSES
Research and development   368,337   437,909   717,781   698,247
General and administrative   2,030,799   951,908   2,976,405   1,400,514
Depreciation   6,008   5,958   11,024   12,078
Loss on sale of property and equipment   3,170   –   3,170   –
TOTAL OPERATING EXPENSES   2,408,314   1,395,775   3,708,380   2,110,839
OPERATING LOSS   (2,121,747 )   (1,309,425 )   (3,243,007 )   (1,930,064 )
OTHER INCOME (EXPENSE)
Gain (loss) on warrant valuation adjustment   1,161,520   35,410   (1,812,162 )   358,633
Interest expense, net   (1,929,755 )   (143,281 )   (3,674,722 )   (336,019 )
Gain (loss) on foreign currency exchange   1,723   1,359   (15,023 )   (2,019 )
TOTAL OTHER INCOME (EXPENSE), NET   (766,512 )   (106,512 )   (5,501,907 )   20,595
NET LOSS   (2,888,259 )   (1,415,937 )   (8,744,914 )   (1,909,469 )
OTHER COMPREHENSIVE INCOME
Foreign currency translation adjustments   (11,904 )   (15,552 )   (10,969 )   (13,767 )
TOTAL COMPREHENSIVE LOSS $   (2,900,163 ) $   (1,431,489 ) $   (8,755,883 ) $   (1,923,236 )
LOSS PER SHARE:
Net loss – basic and diluted $   (0.02 ) $   (0.01 ) $   (0.06 ) $   (0.01 )
Weighted average shares outstanding – basic and diluted   148,582,386   138,992,669   144,168,215   138,517,370

 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)  
 
Six Months Ended Six Months Ended  
June 30, June 30,  
2018 2017  
               
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $   (8,744,914 ) $   (1,909,469 )
   Adjustments to reconcile loss from continuing operations
    to net cash used by operating activities
Depreciation   11,024   12,078
Change in allowance for doubtful accounts   (61,344 )   116,833
Stock-based compensation – employees, directors and advisors   836,796   482,295
Loss (gain) on warrant valuation adjustment   1,812,162   (358,633 )
Amortization of debt issuance costs   2,683,936   –
Amortization of debt discount   75,484   57,349
Stock issued for consulting services   106,500   –
Warrants issued for consulting services   737,457   –
Loss on sale of fixed assets   3,170   –
Changes in assets – (increase)/decrease
    Accounts receivable – trade   69,534   152,034
    Inventory   15,216   33,175
    Prepaid expenses   (54,528 )   (7,918 )
    Contract assets   (40,000 )   –
    Other   (3,872 )   (191 )
Changes in liabilities – increase/(decrease)
    Accounts payable   (425,489 )   475,495
    Accrued expenses   91,459   95,497
    Accrued employee compensation   194,194   294
    Contract liabilities   769,480   –
    Accrued interest   168,787   –
    Interest payable, related parties   156,746   278,669
  NET CASH USED BY OPERATING ACTIVITIES   (1,598,202 )   (572,492 )  
 
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment   (13,612 )   –
  NET CASH USED BY INVESTING ACTIVITIES   (13,612 )   –  
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from convertible promissory notes, net   1,159,785   –
Proceeds from line of credit, related party   280,500   –
Advances from related parties   156,000   421,690
Proceeds from note payable, product   96,708   –
Proceeds from short term note   85,000   –
Proceeds from warrant exercise   38,528   93,067
Payment on line of credit, related party   (144,500 )   –
Payments on note payable, product   (96,708 )   –
Payments on advances from related parties   (12,000 )   –
  NET CASH PROVIDED BY FINANCING ACTIVITIES   1,563,313   514,757  
EFFECT OF EXCHANGE RATES ON CASH   (10,969 )   (13,767 )  
  NET DECREASE IN CASH AND CASH EQUIVALENTS   (59,470 )   (71,502 )  
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD   730,184   133,571
  CASH AND CASH EQUIVALENTS, END OF PERIOD $   670,714 $   62,069  
SUPPLEMENTAL INFORMATION
Cash paid for interest, related parties $   151,227 $   –
Cash paid for note payable, product $   96,708 $   –
NONCASH INVESTING AND FINANCING ACTIVITIES
Stock issued for services $   106,500 $   –
Cashless exercise of warrants $   118,838 $   56,740
Advances from related and unrelated parties converted to Convertible promissory notes $   310,000 $   –
Accounts payable converted to Convertible promissory notes $   120,000 $   –
Beneficial conversion feature on 10% convertible promissory notes   709,827   –
Beneficial conversion feature on convertible promissory note   35,396   –
Beneficial conversion feature on convertible debt $   745,223 $   –
Warrants issued with 10% convertible promissory notes $   808,458 $   –
Warrants issued with convertible promissory note   36,104   –
Warrants issued for debt $   844,562 $   –
Conversion of 10% convertible promissory notes $   631,000 $   –

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August 14, 2018 OrthoSpineNews

FLOWOOD, Miss.Aug. 14, 2018 /PRNewswire/ — Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today the launch of a fenestrated Facet Screw system and a Sacroiliac (SI) Screw system.

For more information on Zavation’s complete product portfolio, visit http://zavation.com/.


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August 14, 2018 OrthoSpineNews

NEW YORKAug. 14, 2018 /PRNewswire/ — For the ninth consecutive year, Hospital for Special Surgery (HSS) has been ranked the No. 1 hospital in the nation for orthopedics by U.S.News & World Report “Best Hospitals 2018-2019” survey. HSS was also recognized as a leader in the field of rheumatology, maintaining the No. 3 ranking in the country. This is the 27th consecutive year HSS has been among the top rated hospitals.

“We are fully committed to our singular focus on musculoskeletal health which allows us to not only provide the highest quality of care and value but also to be a leader in the field through innovation,” said Louis A. Shapiro, president and CEO of HSS. “We are invested in helping people move better so they can live better.”

For the 2018-19 rankings, U.S. News evaluated more than 4,500 medical centers nationwide in 25 specialties, procedures and conditions. In the 16 specialty areas, 158 hospitals were ranked in at least one specialty.

“Whether it’s a routine or complex case, our patients benefit from highly specialized physicians with the shared goal of delivering an unmatched level of personalized care to each patient,” said Todd J. Albert, MD, surgeon-in-chief and medical director of HSS. “It is truly an honor to be a part of such a dedicated, patient-centric medical staff.”

In 2017, HSS cared for over 135,000 pediatric and adult patients surgically and non-surgically for conditions including joint pain, trauma and sports injuries, osteoarthritis, rheumatoid arthritis, back pain and spinal disorders, and conditions of the hand and upper extremity, and foot and ankle.

“Rheumatic and autoimmune diseases often present as diagnostic puzzles, and medical management can be challenging,” said Mary K. Crow, MD, physician-in-chief and chief of the Division of Rheumatology. “The chronic nature of these disorders requires sustained attention and a personal approach to care. I am regularly impressed at the level of specialized expertise that our outstanding rheumatologists provide for these complex patients and the coordinated teamwork and commitment of our HSS staff that optimizes patient outcomes and quality of life.”

HSS also provides care to elite, professional and collegiate athletes and organizations around the world, including USABasketball, Fédération Internationale de Football Association (FIFA), UFC, the Brooklyn Nets, New York Giants, New York Knicks, New York Mets and New York Red Bulls, among others.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery