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Kuros Ends Transformational Year With First MagnetOs Sales, Lead Clinical Program on Track, and Successful Capital Raise

Posted On December 17, 2018 By OrthoSpineNews In Biologics /  

SCHLIEREN (ZURICH), Switzerland, Dec. 17, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) has completed a transformational year, having realized first sales of its MagnetOs bone graft substitute in the U.S. and Europe and raised capital to support the roll-out of MagnetOs, and fund the Phase II clinical trial of fibrin-PTH (KUR-113) in spinal fusion.

Kuros raised gross proceeds of CHF 16.1 million from a capital increase on December 13, which will enable it to advance its pipeline, in particular the Phase II clinical study of its proprietary KUR-113 product in spinal fusion, and to progress commercialization of MagnetOs in the U.S. and selected geographies in Europe.

The Phase II study of KUR-113 is scheduled to start enrolling patients in Q2 2019 with an anticipated interim readout by the second half of 2020.

The Kuros team has also been strengthened with two new appointments. Michael Grau joined as Chief Financial Officer, bringing extensive experience in corporate financing and auditing in private and public companies and a strong operational background. Pascal Longlade, M.D., joined as Chief Medical Officer, bringing more than 20 years international experience in clinical research and development with leading pharmaceutical, biotech and medical device companies.

Joost de Bruijn, Ph.D., Chief Executive Officer of Kuros, said: “We have made excellent progress on our new course in 2018 and have a strong team in place to take the company forward. The recent capital raise adds to those solid foundations and allows us to build on that success. The first sales of MagnetOs are a realization of the hard work and dedication the Kuros team has put in and we are now focusing on the commercial roll-out, which is proceeding well. On top of that, we are pushing on with the exciting Fibrin-PTH program. Largely de-risked in successful trauma trials, it targets an important medical need in spinal fusion, which represents a significant commercial opportunity.”

For further information, please contact:

Kuros Biosciences AG Investors & Media
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors, LLC
Tel +41 44 733 47 47 +41 79 598 7149
michael.grau@kurosbio.com hherklots@lifesciadvisors.com

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

US indications statement
MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

EU indications statement
MagnetOs is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. MagnetOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. MagnetOs is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. MagnetOs should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, MagnetOs is to be used in conjunction with internal or external fixation devices.

About Kuros Biosciences AG
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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Conformis Announces Strategic Actions to Reach Profitability and Reduce Debt

Posted On December 14, 2018 By OrthoSpineNews In Financial /  

BILLERICA, Mass., Dec. 13, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants designed to fit each patient’s unique anatomy, today announced it is implementing steps to improve its overall business model, including the prioritization of certain product development opportunities, cost reduction initiatives with the optimization of sales, marketing and administrative expenses and a reduction of its workforce.  In connection with these cost-saving measures, Conformis also announced today the reduction of its debt facility from $30 million to $15 million.  Conformis is taking these strategic actions to strengthen its focus on specific areas of opportunity that it believes will enable it to achieve profitability in 2021.

“We are taking decisive actions to prioritize our highest-impact new product opportunities, our Conformis Hip System and our cementless Press Fit total knee, which we believe provide us an opportunity to build a stronger, more sustainable business. As a result of these actions, we believe we can achieve profitability in 2021,” said Mark Augusti, Chief Executive Officer, Conformis. “These actions included the difficult decision to part ways with many valued employees. On behalf of the entire Company, I thank these colleagues for their many contributions to the business.”

The immediate organization-wide actions include:

Expense Management

Conformis is now taking actions to leverage its improvements in gross margin, which began in the third quarter of 2017, by optimizing its overall operating expense structure. As a result, Conformis believes that the actions taken today will lead to a reduction in the use of cash by operating activities from approximately $10 million per quarter during 2018 to less than $4 million per quarter in 2019. These expense reductions are company-wide, impacting sales and marketing, research and development and general and administrative expenses.

New Product Development Opportunities

Conformis plans to continue to execute its new product development programs focusing on the Conformis Hip System, iTotal G3 and cementless Press Fit knee. In the second half of 2019, Conformis expects to achieve full commercial launch of its Conformis Hip System, as well as the limited commercial release of its iTotal G3 total knee. Conformis also remains on track to deliver the limited commercial release of its cementless knee offering in early 2020.

“We recently achieved our 100th total hip arthroplasty case at Conformis and remain very positive about the status and value proposition of our Conformis Hip System. One of our goals when identifying the cost reductions announced today was to insure that they do not affect our previously announced commitment and investment plans for full commercial launch of our Conformis Hip System in the second half of 2019,” said Mark Augusti. “Entering the $7 billion hip arthroplasty market remains a key growth opportunity and a priority for the Company.”

International Expansion

Recognizing demand for its custom orthopedic knee replacement implants outside the United States, Conformis has selectively identified opportunities to expand its distribution in certain international markets. The expansion into other international markets is intended to help offset the sales weakness the Company is experiencing in Germany.

Organizational Transformation

To create a more focused organization and better align internal resources with the Company’s strategic priorities, Conformis reduced its personnel base this week, resulting in a reduction of approximately 10% of its total workforce. As a result of this action, Conformis expects to incur employee severance charges and other exit costs of approximately $700,000 in the fourth quarter and generate annual personnel expense savings in excess of $4 million in 2019.

Debt Reduction and Restructuring

With the reduced need for capital and to create an improved capital structure, Conformis and Oxford Finance LLC have entered into an amendment to their current Loan and Security Agreement.  Under the amended agreement, the Company used cash on-hand to pay down $15 million of its $30 million debt facility, and thereby reduced the total debt outstanding to $15 million and the associated interest expense going forward. The amendment also adjusted certain financial covenants.

“We believe this new plan will help right-size the Company, significantly lowering our cash needs,” noted Paul Weiner, Chief Financial Officer. “When combined with the planned continuation of gross margin improvements, we believe we can achieve cash flow breakeven within the next three years.”

2019 Operating Expenses Commentary

The Company expects the following operating expenses for the full year 2019:

  • Sales and marketing expense of approximately $32 million. This represents a reduction of approximately $8 million over our estimated 2018 sales and marketing expense.
  • Research and development expense of approximately $16 million. This represents a reduction of approximately $1.5 million over our estimated 2018 research and development expense.
  • General and administrative expense of approximately $21 million. This represents a reduction of approximately $10 million over our estimated 2018 general and administrative expense.
  • Capital expenditure of approximately $3.5 million versus our estimated 2018 $4 million.
  • Cash used, excluding financing activities, of less than $16 million versus our estimated 2018 $38 million.

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. Conformis offers a broad line of customized knee and hip implants and customized pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.  Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover customized implants and customized patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, ability to achieve profitability, total revenue, product revenue, gross margin, operations, operating expenses, and financing plans, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including whether our cash resources will be sufficient to fund our continuing operations for the periods anticipated; risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations; risks related to our impact of our reduction in force; risks associated with our ability or inability to satisfy loan covenants; and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONTACT:
Investor Relations
ir@conformis.com
(781) 374-5598

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WishBone Medical, Inc. signs licensing agreement for the Guided Growth Plate

Posted On December 14, 2018 By OrthoSpineNews In Extremities /  

WARSAW, Ind., Dec. 14, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc. has been granted a global, non-exclusive license for the sale of a patented guided growth plating system in children with deformed limbs.  These 3 patents were created and designed for the gradual correction of pediatric deformities in both the upper and lower extremities.

WishBone Medical is designing and developing its own guided growth plate and instrumentation systems in sterile packed, single use, disposable kits.  This product will come in both the 2-hole and 4-hole plates systems in multiple sizes as well as options in stainless steel and titanium.  The anticipated launch will be in first quarter 2019, following FDA Clearance.

Nick Deeter, Chairman of the Board WishBone Medical, said, “We are excited to enter into this license agreement of patented technologies to develop, produce and sell our guided growth systems.  These systems will provide global access in sterile packed, single use disposable kits for children who are suffering with these pediatric deformities around the world.”  Mr. Deeter added, “With this sterile packed system, we can go into hospitals and surgery centers that have not had access to the traditional reusable systems.”

Dr. Robert von Seggern, Executive Vice President at WishBone Medical, commented, “As a dedicated pediatric orthopedic company, WishBone Medical needed this product to round out its large portfolio of orthopedic implants designed specifically for children with orthopedic issues.”

About WishBone Medical, Inc.

WishBone Medical is a global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing.  WishBone Medical currently has 42 pediatric orthopedic product systems with operations in Warsaw, IN, Istanbul, Turkey, and Singapore.

For further information, visit www.WishBoneMedical.com or call Mary Wetzel, Chief Operating Officer, at 574-306-4006.

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Global $10.66 Bn Sports Medicine Devices Market Analysis and Forecasts 2017-2018 & 2025

Posted On December 13, 2018 By OrthoSpineNews In Financial, Sports Medicine /  

Dublin, Dec. 13, 2018 (GLOBE NEWSWIRE) — The “Sports Medicine Devices Market to 2025 – Global Analysis and Forecasts By Product, Application, and Geography” report has been added to ResearchAndMarkets.com’s offering.

The global sports medicine devices market is expected to reach US$ 10,662.5 Mn in 2025 from US$ 5,822.6 Mn in 2017. The market is estimated to grow with a CAGR of 7.9% from 2018-2025.

The growth of the sports medicine devices market is primarily attributed to increasing incidence of sports injuries. Moreover, the presence of large number of sports medicine associations is expected to fuel the market growth. The introduction of advanced technology in the sports medicine market is expected to offer significant growth opportunity in the sports medicine devices market during the forecast period.

The innovations of the new technologies are expected to introduce new therapies and procedures that will help to reduce time and costs and provide optimized and personalized results to continue to shape the medical device industry. Also the intelligent orthopedics in combination with traditional techniques and high-end technology will enable to change the future of industry.

The associations for the sports medicine are increasing across the countries in the world. The associations are involved in spreading the awareness about the sport medicine which is helping sports players and athletes to recover from their injuries. Some of the global groups and associations for the sports medicine are International Council of Sports Science and Physical Education (ICSSPE), International Federation of Sports Medicine (FIMS) and World Federation of Athletic Training & Therapy (WFATT).

Global sports medicine devices market, based on product was segmented as, body reconstruction and repair, body support and accessories. In 2017, body reconstruction and repair segment held the largest share by the market, by product. This is mainly attributed to the benefits offered such as, reduction in pain and improved functioning. In addition, it also amplify the body’s natural healing abilities and enhances the growth of new cartilage, ligaments and tendons.

Global sports medicine devices market, based on application was segmented knee, shoulder, ankle/foot, elbow & wrist, and others. In 2017, knee segment held the largest share of market, by application. In addition, the segment is anticipated to witness a significant growth among other applications, during the forecast period.

Some of the major primary and secondary sources for sports medicine devices included in the report are World Health Organization (WHO), Organisation for Economic Co-operation (OECD), National Research Foundation (NRF), International Diabetes Federation (IDF), Canadian Institutes of Health Research (CIHR) and others.

Key Topics Covered:

1. Introduction 
1.1 Scope Of The Study
1.2 Research Report Guidance

2. Global Sports Medicine Devices Market – Key Takeaways 

3. Global Sports Medicine Devices- Market Landscape 
3.1 Overview
3.2 Market Segmentation
3.3 Pest Analysis

4. Global Sports Medicine Devices Market – Key Market Dynamics 
4.1 Key Market Drivers
4.1.1 Increase In The Number Of Sports Medicine Associations
4.1.2 Increasing Incidences Of Sports Injuries
4.1.3 Rising Demand For Minimally Invasive Methods
4.2 Key Market Opportunities
4.2.1 Penetration Into Emerging Economies
4.2.2 Introduction Of Advanced Technologies
4.3 Future Trends
4.3.1 Prevention Through Genomics
4.4 Impact Analysis

5. Sports Medicine Devices Market – Global Analysis 
5.1 Global Sports Medicine Devices Market Revenue Forecasts And Analysis
5.2 Global Sports Medicine Devices Market, By Geography – Forecasts And Analysis
5.3 Performance Of Key Players
5.3.1 Arthrex Inc.
5.3.2 Smith And Nephew
5.4 Expert Opinions

6. Global Sports Medicine Devices Market Analysis – By Product 
6.1 Overview
6.2 Global Sports Medicine Devices Market, By Product, 2017 & 2025 (%)
6.3 Body Reconstruction And Repair Market
6.3.1 Overview
6.3.2 Global Body Reconstruction And Repair Market Revenue And Forecasts To 2025 (US$ Mn)
6.3.3 Fracture And Ligament Repair Devices Market
6.3.4 Orthobiologics Market
6.3.5 Arthroscopy Devices Market
6.3.6 Prosthetic Market
6.4 Body Support Market
6.4.1 Overview
6.4.2 Global Body Support Market Revenue And Forecasts To 2025 (US$ Mn)
6.4.3 Braces Market
6.4.4 Topical Pain Relief Market
6.4.5 Compression Clothing Market
6.4.6 Thermal Therapy Devices Market
6.4.7 Others Market
6.5 Accessories Market

7. Global Sports Medicine Devices Market Analysis – By Application 
7.1 Overview
7.2 Global Sports Medicine Devices Market, By Application, 2017 & 2025 (%)
7.3 Elbow & Wrist Market
7.4 Shoulder Market
7.5 Knee Market
7.6 Ankle/Foot Market
7.7 Others Market

8. North America Sports Medicine Devices Market Revenue And Forecasts To 2025 

9. Europe Sports Medicine Devices Market Revenue And Forecasts To 2025 

10. Asia-Pacific Sports Medicine Devices Market Revenue And Forecasts To 2025 

11. Middle East & Africa Sports Medicine Devices Market Revenue And Forecasts To 2025

12. South And Central America Sports Medicine Devices Market Revenue And Forecasts To 2025 

13. Sports Medicine Devices Market – Industry Landscape 
13.1 Overview
13.2 Growth Strategies In The Sports Medicine Devices Market, 2015-2018
13.3 Organic Growth Strategies
13.3.1 Overview
13.3.2 Product Launches
13.3.3 Expansion
13.4 Inorganic Growth Strategies
13.4.1 Overview
13.4.2 Partnership
13.4.3 Acquisitions

14. Sports Medicine Devices Market, Key Company Profiles 

  • DJO Global
  • Zimmer Biomet
  • STRYKER
  • Smith & Nephew
  • DePuy Synthes
  • Wright Medical Group N.V.
  • Arthrex, Inc.
  • CONMED Corporation
  • Mueller Sports Medicine, Inc.
  • RTI Surgical, Inc.

For more information about this report visit https://www.researchandmarkets.com/research/7q4x59/global_10_66_bn?w=12

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

CONTACT: ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Sports Medicine and Physiotherapy
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OrthoPediatrics Corp. Announces Full-Scale U.S. Launch of Small Stature Scoliosis System

Posted On December 13, 2018 By OrthoSpineNews In Spine /  

WARSAW, Ind., Dec. 13, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the full-scale U.S. launch of its 26th surgical system, the RESPONSE 4.5/5.0mm System following U.S. Food and Drug Administration (FDA) 510(k) clearance in October. The Company’s newest system represents a significant product expansion for physicians to treat complex scoliosis in smaller stature patients at a younger age.

The RESPONSE 4.5/5.0mm System, designed in collaboration with pediatric orthopedic surgeons, builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System to expand the platform offering. The new small stature scoliosis system offers a hybrid implant technology allowing the option of either a 4.5mm rod in cobalt-chromium or 5.0mm rod in titanium or cobalt-chromium, multiple implant connector options, and innovative, new instrumentation.

Dr. Jonathan Phillips, Pediatric Orthopedic Surgeon & Associate Professor of Orthopedics at University of Central Florida, College of Medicine, served as a design surgeon for the small stature system and commented, “I am excited for the launch of the highly anticipated small stature RESPONSE system from the leader in children’s orthopedic technologies. Conceived to mesh seamlessly with the exceptionally successful RESPONSE system for larger statures, this instrumentation has been designed to serve a unique weight and size demographic in children’s orthopedics and extends the versatility of OrthoPediatrics’ spinal instrumentation options. I look forward to this radical improvement to care for a diverse cohort of the most underserved children.”

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts multiple rod diameters in either cobalt chrome or titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

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 26 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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Overland Park Surgical Suites First Outpatient Surgery Center In Region To Offer Robotics-Assisted Partial And Total Knee Replacement Surgery Using The NAVIO™ Surgical System

Posted On December 13, 2018 By OrthoSpineNews In Robotics, Top Stories /  

OVERLAND PARK, Kan., Dec 13, 2018 /PRNewswire/ — Overland Park Surgical Suites is a state of the art outpatient surgical center and is the first outpatient surgery center in the Midwest to offer patients a robotics-assisted alternative to traditional knee replacement surgery.

“We were eager to bring the NAVIO robotics-assisted surgery to the area,” said Scott Abraham, M.D., Orthopedic Surgeon and founder of Overland Park Surgical Suites, LLC. “This exacting technique is the preferred approach for most patients and we’ve seen dramatic surgical outcomes.”

The NAVIO Surgical System starts with an advanced computer system that gathers precise anatomic and alignment information about a damaged knee that a surgeon uses to create a specific surgical plan, according to Dr. Abraham.

“This extra layer of data collection is designed to ensure the knee procedure is performed as accurately as possible for the best long-term outcome,” he said.

Abraham has already performed more than 100 robotic-assisted partial and total knee replacements at Overland Park Surgical Suites and St. Joseph Medical Center, and draws patients to his practice from throughout Kansas, Missouri and Iowa. He said the NAVIO System is particularly well suited for active adults in their 40s and 50s who have developed knee problems, but have opted to put off surgery as a remedy.

“Knee replacement surgery has a controversial reputation,” Abraham added.

Unfortunately, this leads many patients to delay medical intervention because of concerns about invasive surgery, painful rehab and significant downtime. The NAVIO System helps offset these concerns with the improved accuracy and the potential for faster recovery, leading to the goal of improved surgical outcomes and increased patient satisfaction.

The first knee implant procedure was performed 50 years ago in 1968, according to the American Academy of Orthopaedic Surgeons. Now, more than 600,000 knee replacement surgeries are performed each year, making it one of the most in-demand surgical specialties in the country. Yet often, patients are dissatisfied with the outcome.

Not so for Beth Archer of Leawood, who in October was the first person in the state of Kansas to undergo a partial knee replacement using robotic surgical assistance at Overland Park Surgical Suites.

“I’d been living with knee pain for four years,” Archer said. “The quality of my life dramatically improved with my partial knee replacement done with the NAVIO Surgical System. I returned home immediately and was self-sufficient, had little pain and within a week I was walking without a cane or walker. I highly recommend this robotic surgery.”

Abraham added that the NAVIO benefits are many, yet robotic surgical-assist is still in its infancy.

“We’re proud that Overland Park Surgical Suites is the first outpatient surgery center in the region to offer this state of the art NAVIO knee replacement procedure,” Abraham said. “But we won’t be the last. In fact, we think this is the future of the surgical field. It puts the power of robotics in the skilled hand of the surgeon. And that means a better outcome for all our patients.”

For more information or to schedule a NAVIO consultation with Dr. Abraham, call APEX ORTHOPEDICS and Sports Medicine at 913-642-0200.

NOTE: Not all patients are candidates for surgery using the NAVIO Surgical System. Discuss your condition and implant options with your surgeon. Individual results of joint replacement vary. Implants may not produce the same feel or function as your original knee. There are potential risks with knee replacement surgery such as loosening, fracture, dislocation, wear and infection that may result in the need for additional surgery. NAVIO is not for everyone. Children, pregnant women, patients who have mental or neuromuscular disorders that do not allow control of the knee joint, and morbidly obese patients should not undergo a NAVIO procedure.

(www.OverlandParkSS.com) 
Overland Park Surgical Suites is a state-of-the-art, orthopedic outpatient surgical center in Overland Park, KS. It was established by clinical personnel to offer safe, high quality surgical care. It is one of the first surgery centers in the Kansas City area to perform outpatient total joint replacements and is licensed by the State of Kansas and accredited by The Joint Commission.

About Smith & Nephew: 
(www.RediscoverYourGo.com) 
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were more than $4.8 billion. Smith & Nephew is a member of the FTSE100.

TM is a Trademark of Smith & Nephew

Contact:      

Betsy Donnelly

Phone:         

913 208 5400

Email:           

Betsy@TrailheadMarketingTeam.com

SOURCE Overland Park Surgical Suites

Related Links

http://www.overlandparkss.com

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Zimmer Biomet Announces Quarterly Dividend for Fourth Quarter of 2018

Posted On December 13, 2018 By OrthoSpineNews In Financial /  

WARSAW, Ind., Dec. 12, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the fourth quarter of 2018.

The cash dividend of $0.24 per share is payable on January 31, 2019 to stockholders of record as of the close of business on December 28, 2018.

About the Company

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

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

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

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

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EDGe Surgical Secures $4 Million in Series A Financing

Posted On December 13, 2018 By OrthoSpineNews In Financial /  

December 12, 2018

CHICAGO–(BUSINESS WIRE)–EDGe Surgical, Inc., a privately held medical device company dedicated to innovative precision measurement solutions for orthopedic surgery, announced today that it has completed $4 million in financing. The Series A round includes $3 million raised plus a convertible note, bringing total funding secured by the company to $5.7 million, all from angel investors. Proceeds will be used for increased manufacturing, marketing and sales surrounding the company’s first device, the EDG® Ortho 65mm, as well as development and launch of a second device focused on the spinal surgery market.

The EDG Ortho 65mm is the first and only single-use electronic depth gauge. It is designed to more accurately measure length for orthopedic surgical screws, and also mitigate bioburden contamination, a leading cause of surgical site infections. EDGe Surgical’s device provides healthcare professionals, hospitals, and outpatient medical facilities with a digital alternative to analog depth gauges for greater accuracy at a decreased cost, all while mitigating infection risk.

“The positive reception we’ve received from surgeons to our pilot launch, which started earlier this year, illustrates that our device fills a major market need for a depth gauge that enables more accurate screw selection without the worry of bioburden contamination risk,” said Christopher Wilson, president and CEO of EDGe Surgical. “We appreciate the continued support of our sophisticated angel investors, who bring surgical and medical device C-suite expertise, to help us quickly move the needle. Closing our Series A round will allow us to expand availability of our EDG Ortho 65mm and develop additional new products to serve customers seeking cost-effective and highly advanced solutions.”

Until now, the most common approach for orthopedic surgical measurement has been using a traditional analog depth gauge with a sliding metal scale to determine drill depths and screw lengths. The EDG Ortho 65mm can overcome the drawbacks of these traditional depth gauges, invented almost a century ago, by eliminating many of the inefficiencies and financial costs, such as:

  • Up to 20 percent of measurements using the traditional analog depth gauge are inaccurate. Mismeasurement is a leading cause for wasted screws/implants, which is estimated at a $200 million a year cost to the healthcare system.
  • Traditional analog depth gauges are reusable by design and are difficult if not impossible to clean properly, and sterilization is not effective on insufficiently cleaned surgical instruments based on a recent study at a university hospital Level 1 trauma center.
  • Per case costs associated with using a traditional depth gauge are estimated to be greater than $400, with traditional device downsides including bone non-unions, implant-related complications, infection risk, and unnecessary radiation exposure.

The EDG Ortho 65mm can significantly reduce costs as a result of greater accuracy (i.e., less wasted screws), reduced infection risk, and greater measurement consistency. For example, the EDG Ortho 65mm reduced measurement error by up to 90 percent in recent cadaver and sawbones accuracy labs, and a study presented at the 2018 Annual Meeting of the American Society for Surgery of the Hand (ASSH) found a significant reduction in the rate of major measurement error in sawbones models compared to the traditional analog depth gauge.

For more information on EDGe Surgical and its products, visit www.edgesurgical.com and follow the company on Twitter, LinkedInand YouTube.

About EDGe Surgical, Inc.

EDGe Surgical is a privately held medical device company that is innovating state-of-the-art digital technology to set a new standard in orthopedic surgery instrumentation that is bringing better outcomes to patients and reducing healthcare system costs. Founded in 2015, EDGe is focused on developing and delivering products that deliver precision to healthcare professionals specializing in orthopedic trauma and spine surgery – a potential $1.1 billion U.S. market. Located in Chicago, Illinois, EDGe is a proud member of MATTER and an active company within the iBIO Institute PROPEL Center.

Contacts

MEDIA CONTACT:
Jim Hughes
Merryman Communications
jim@merrymancommunications.com
323-397-7077

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Reston Hospital Center is First in the Nation to Acquire a Second Mazor X System for Rapidly Expanding Spine Program

Posted On December 12, 2018 By OrthoSpineNews In Robotics, Spine /  

Reston, Virginia, Dec. 12, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has acquired a second Mazor X System for their rapidly growing spine program, making it the first in the nation to have two of these robotic systems at one hospital location.

The Reston Hospital Center (RHC) Spine Team is comprised of nationally-recognized spine surgeons who excel in implementing the latest in surgical advancements for spinal procedures. One of the first in the country to acquire and use Mazor Technology in 2012, RHC, in collaboration with its surgeons, has been a pioneer in using advanced technology and procedures in the operating room.  In 2016, the facility was the first in the Mid-Atlantic to acquire and perform a procedure using the latest Mazor X platform. More than 1,500 spine surgeries are performed annually at RHC, with over 600 of these procedures utilizing the advanced technology of the Mazor X system, offering patients an advanced, minimally invasive surgical option for the spine.

“Providing our surgeons with the technology and resources they need to keep our surgical program at the forefront of innovation means that our patients receive the most advanced care in the safest environment,” said John Deardorff, CEO of Reston Hospital Center and President of HCA’s Northern Virginia Market. “As a leader in spine surgery we are committed to delivering exceptional care and the best possible outcomes for our patients.”

Reston Hospital Center is one of only eight Visiting Clinician Programs (VCP) in the United States where surgeons from around the world come to train on the latest in Mazor technology.  The VCP gives surgeons the opportunity to learn about the latest in robotic-assisted spine surgery capabilities from the proctoring surgeon, Dr. Christopher Good of the Virginia Spine Institute. In addition to the surgical training, surgeons also learn how a comprehensive robotic surgical program runs from an operational and administrative perspective.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 197-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence.  Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourth‐largest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com. 

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com
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Ortho RTi’s Data selected for Podium Presentation at International Conference

Posted On December 12, 2018 By OrthoSpineNews In Recon /  

KIRKLAND, QC, Dec. 12, 2018 /PRNewswire/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTi” or the “Corporation”), an emerging Orthopaedic and Sports Medicine technology company, announced that its recently completed study has been chosen by a peer reviewed panel as worthy of a podium presentation at the 2019 ICORS (International Combined meeting of Orthopaedic Research Societies) congress in June. ICORS attracts Orthopaedic surgeons, sports medicine specialists, physicians and research scientists from around the globe and is focused on how new discoveries translate into improved clinical care. The podium presentation will  feature the study titled  “Freeze-dried chitosan solubilized in platelet-rich plasma in a sheep model of rotator cuff repair”.

“Our scientific evidence continues to excel and gather the attention of world experts. This will be our 16th peer-reviewed abstract, poster, manuscript and now podium presentation in the last two years. Further, this is another key publication resulting from work with experts at New York City’s renowned Hospital for Special Surgery,” said Ortho RTi’s Chief Scientific Officer, Dr. Michael Buschmann.

Business Update

Over the last weeks our business and exposure has continued to progress significantly.

  • Last Friday we submitted our formal Pre-Submission package to the FDA seeking guidance after our recent data showed statistically significant results in as little as 3 months. The package included data from all of our studies and highlighted that Ortho-R has shown structural improvements at 6 months and as a second clinical benefit has showed improved speed of healing as evidenced by our 3-month data.
  • Over the same time period our Intellectual Property assets continued to grow with progress on multiple patent files as well as another European patent issuing in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland & Liechtenstein and the United Kingdom.
  • As part of the evolving scientific validation of our technology, a recent manuscript was selected for publication in an upcoming issue of the Journal of Biomaterials which is expected to be published in the first months of 2019.
  • Finally, our technology transfer to production and scale-up has progressed through a critical milestone with our first finished product lots in the process of being completed.

“The combination of these initiatives have also allowed us to make strong progress with strategic partners and our goals of assessing and co-developing our product for other potential clinical uses” said Dr. Brent Norton, CEO of the company.”

About the ICORS

The International Combined Orthopaedic Research Societies (ICORS) serves as an alliance of societies to promote basic, translational, and clinical musculoskeletal research worldwide. The Combined Meeting was launched in 1992 by founding member societies; Orthopaedic Research Society, Canadian Orthopaedic Research Society, European Orthopaedic Research Society, and the Japanese Orthopaedic Association.  The meeting has convened every three years since 1992 and rotated to the different country organizations. For 2019 the ICORS annual meeting is being held in Montreal, Quebec, in conjunction with the Canadian Orthopaedic Research Society and the Canadian Orthopaedic Association annual meetings.

About Rotator Cuff Injury

The rotator cuff is the name given to the collection of four tendons that stabilize the shoulder joint. The tendons around the joint can suffer tears as a result of injury to the tendon or as a result of degeneration over time. Repetitive overhead activity is often associated with cuff tears. Symptoms include a dull, aching pain, and patients often suffer secondary symptoms including lack of sleep and weakness in the arms resulting from a lack of exercise. If conservative therapy is not successful, surgery will often be performed. The principal aim of surgical intervention is to reattach the torn tendon to the bone. The standard of care involves the use of suture anchors placed into the bone and the tendon then being held in place with sutures.

About Ortho Regenerative Technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Further information about Ortho RTi is available on the Company’s website at www.orthorti.com and on SEDAR at www.sedar.com.

Forward-Looking Statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

SOURCE Ortho Regenerative Technologies Inc.

Related Links

http://www.orthorti.com/

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