WishBone Medical News

FDA Annual Report Emphasizes Critical Need for Pediatric Orthopedic Implants

A recently released FDA annual report validates the existence of an overwhelming need for anatomically appropriate implants for children…… a need too large to be met by the traditional, re-useable case and tray business model in a market with restricted access by non-clinical gatekeepers and “vendor approval committees” at nearly each and every facility across the US.

As history will later confirm, this overwhelming need for anatomically appropriate orthopedic implants for children can only be addressed through the unparalleled, strategic distribution channels recently established AND the sterile, single-use, disposable pediatric procedural kit platform we are pioneering at WishBone Medical!

Read full report here: FDA Annual Report | Premarket Approval of Pediatric Uses of Devices

WISHBONE MEDICAL ADDS RESORBABLE IMPLANTS TO PRODUCT OFFERINGS

in Press Releases, WishBone News

FOR IMMEDIATE RELEASE

Contact:

Kaitlyn Hughes
574-306-4006
KHughes@wishbonemedical.com
wishbone-medical-migration.mysites.io

WISHBONE MEDICAL ADDS RESORBABLE IMPLANTS TO PRODUCT OFFERINGS

WishBone Medical Gains Distribution Rights to OsteoCrete^®

WARSAW, Ind. AUGUST 15, 2019 — WishBone Medical announces a private label distribution agreement with Bone Solutions, Inc. (BSI) for worldwide rights within pediatric orthopedics to license and sell OsteoCrete^® — the first FDA (510K) approved magnesium-based bone void filler in the orthopedic marketspace, designed to assist with bone repair and regeneration. Expanding beyond the original application, OsteoCrete^®developers are now harnessing the product’s unique properties to create bioresorbable implants to ultimately replace many current metal technologies simultaneously improving patient outcomes.

Affording BSI the North American Bone Graft Technology Leadership of the Year Award in 2009, OsteoCrete^® is an injectable, moldable solution to attach ligaments and tendons to bone, and bone-to-bone, with a robust composition that is three times stronger than cancellous bone.¹

“This product is the holy grail for pediatric orthopedics as the resorbable properties eliminate the need for secondary operations,” says WishBone Founder and CEO, Nick Deeter. “Kids already harbor a lot of anxieties around the idea of surgery alone. If we can save patients and their families the expense and worries of follow-up procedures, that alone is a big win.”

“For so many years, the orthopedics industry demonstrated a clear demand for osteogenic implants which mimic properties of the human bone. Prior to OsteoCrete^®, calcium-based solutions contributed to bone healing, but with little mechanical support,” explains BSI President and CEO, Drew Diaz. “Not only is OsteoCrete^® 100% resorbable – it offers excellent bone remodeling during the window of healing with uncompromised strength.”

BSI surpassed 600 cases implanting OsteoCrete^®this year with a 100% success rate. Moving forward, the company is focused on further development of bioresorbable implants and will continue exploring innovative applications for this unprecedented orthobiologics technology.

“While patients of all ages and stature benefit from OsteoCrete^®advancements, the greatest improvement will be felt by children whose bodies are continually growing and changing,” adds Kevin Blue, WishBone’s Chief Revenue Officer. “Our team could not be more excited to offer such a clearly advantageous solution to better equip the surgeons caring for them.”

1. Bone Solutions’ Report 755635-01 Rev A, “Static Axial Compression Testing of the OsteoCrete System.”

About WishBone Medical

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. Through recent acquisitions, WishBone Medical now offers 42 pediatric orthopedic product systems with operations in Warsaw, IN, Istanbul, Turkey, and Singapore. For further information, visit wishbone-medical-migration.mysites.io or call Kaitlyn Hughes, Director of Marketing & Communications, at 574-306-4006.

About Bone Solutions Incorporated

Bone Solutions Inc. (‘BSI’) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler. For more information, visit BoneSolutions.net or contact Drew Diaz, BSI President/CEO, by phone 817-809-8850 or email diaz@bonesolutions.net.

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Happy International Youth Day! Highlights from Grace Engineering Camp 2019

in WishBone News

Happy International Youth Day! In celebrating this year’s theme of Transforming Education, we’re featuring a few of the many moments of inspired learning at last month’s Grace Engineering Camp — a one-of-a-kind program designed to spark students’ interest in STEM and engineering-related fields as they learn the fundamentals of mechanical engineering, computer-assisted design (CAD), 3D printing, and more. As part of the program’s debut curriculum, students were guided through the design, creation and testing of their own CO2 race dragsters.

WishBone Medical was thrilled to be a sponsor of the program’s first year, and our very own, Mary Wentorf, spent a couple of days as a speaker, herself: “In my session, I taught the students about the design process; leading them through a Fortnite vehicle design challenge to test out their new skills . . . The students learned not only about the formal design process, but also gained experience in teamwork, brainstorming, concept generation, presentation skills, design evaluation, and constructive feedback.”

“On my second day, I was able to share with them all the fun things I’ve been able to do with my engineering degree over the past 20 years and led them in brainstorming/concept generation activities for their CO₂race cars. The students were very inquisitive and were especially interested in how we at WishBone create product solutions for kids like them. All of that raw energy and talent, being able to see the spark of interest in young people’s eyes as they explored what will definitely be future successful careers made for an awesome week! I’m so thankful to work at a place that values giving back to the community, and made it possible for me to invest my time hopefully inspiring future engineers!”

– Mary Wentorf
WishBone Medical
Director of Quality Assurance
& Regulatory Affairs

Learn more about Grace Engineering Camp at www.grace.edu/graceengineeringcamp

RESPONSE ORTHO CELEBRATES 15 YEARS OF SUCCESS, IS ONLY GETTING STARTED

in Press Releases

Pioneer of Web-based Pre-Op Planning Software and ExFix Technologies Makes Big Plans for Future

WARSAW, Ind. JUNE 10, 2019 — Founded in 2004, Response Ortho (RO) is celebrating 15 years of business – with 2019 proving to be the most exciting since joining the WishBone Medical Family of Companies. Based in Istanbul, Turkey, RO designs, develops and manufactures patented solutions for advanced fracture fixation and bone deformity correction. To date, the company has delivered 35 CE marked systems to Europe, the Middle East and Africa (EMEA), with sales projections bolstered since being acquired by WishBone Medical, Inc.

On the forefront of orthopedic technology, Response Ortho boasts a diverse portfolio of leading-edge solutions, from external fixators, to plates, rods, screws, pins and pre-operative/post-operative software.

“I started Response Ortho with the dream of creating innovative, thoughtfully designed orthopedic products to help surgeons deliver optimal results for their patients. From the beginning, we invested in state-of-the-art resources to design, test, validate and manufacture in-house to maintain the highest standards of quality.”

– Sehmuz Isin,
Founder and CEO, Response Ortho
President, WishBone Medical International

Response Ortho is an innovator in Radiographic Navigation Software for Hexapod Fixators – a groundbreaking improvement from manual measurement. This pioneered technology is integrated into their CE marked Smart Correction^® Circular Hexapod External Fixator System, which received the highly-respected TÜBİTAK-TTGV-TÜSİAD Technology Grand Prize Award* in 2012. With great demand, Smart Correction^® sales quickly made a positive impact on the domestic economy and became the first Turkish-made product of the orthopedic industry to gain global recognition.

Additionally, the RO team was an early developer of web-based pre-operative planning software and today, offers Click2Correct^® – a free, secure, highly-intuitive planning and templating software utilizing Dynamic Vectoral Drawing Technology. Accessible from any desktop or mobile device, Click2Correct^® improves efficiency and can receive multiple data formats.

Since its first launch, Response Ortho has focused sales efforts in EMEA markets – an effective approach for both the company and Turkish economy. Moving forward, RO is working with WishBone Medical to expand market reach into the United States.

Response Ortho’s 15 years of innovation serves as a springboard for the WishBone R&D team – RO systems will be further refined and offered in sterile packed, single-use disposable kits around the world.

*National competition organized by TÜBİTAK (National Science and Technology Research Organization) – TTGV (National Technology Development Society) – TÜSİAD (Turkish Businessman Club)

About Response Ortho
Response Ortho is dedicated to increasing procedural efficiency and cost-effective patient outcomes for the treatment of complex orthopedic conditions through the development of innovative, patented solutions for advanced fracture fixation and bone deformity correction, utilizing the most technologically advanced manufacturing platforms and impeccable quality standards. Response Ortho has more than 36,000 sq. feet of state-of-the-art manufacturing in Istanbul, Turkey, and will be adding sterile packaging clean room capabilities by year-end.

Response Ortho is at the forefront of orthopedic technology, redefining the standard of care by targeting the next frontier in orthopedic surgery – Pre-operative and post-operative surgical planning software designed to help surgeons increase the predictability of fracture fixation and anatomical alignment in orthopedic procedures.

Response Ortho’s award-winning Smart Correction® Hexapod Fixator and Click2Correct^® pre-operative/post-operative planning software are proprietary, procedurally-integrated, digital platforms designed to streamline procedural efficiency and impact positive clinical outcomes across the surgical workflow by allowing the surgeon to confidently and reproducibly calculate, correct, and confirm optimal anatomical alignment.

Response Ortho was founded in 2004 and became a WishBone Medical Company in 2019.

About WishBone Medical

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. Through recent acquisitions, WishBone Medical now offers 42 pediatric orthopedic product systems with operations in Warsaw, IN, Istanbul, Turkey, and Singapore.

For further information, visit wishbone-medical-migration.mysites.io or call Kaitlyn Hughes, Director of Marketing & Communications, at 574-306-4006.

POSNA MEETING 2019 | MAY 15-18

in WishBone News

May 15-18, WishBone Medical will be at the POSNA Annual Meeting in Charlotte, NC. Attending? We’d love to see you! Stop by Booth 20 and see why WishBone Medical truly is the Future of Pediatric Orthopedics!

Click here for event information

Event Location:
Charlotte Convention Center
501 South College St
Charlotte, NC 28202

WISHBONE MEDICAL ACQUIRES INDIANA BASED SPINAL SYSTEMS COMPANY

in Press Releases, WishBone News

Acquisition propels development of WishBone spine solutions for children.

WARSAW, Ind. MAY 8, 2019 — WishBone Medical is pleased to announce the recent purchase of CSpine, Inc., an Indiana based company that designs, develops and manufactures spine and orthopedic implants and instruments. As WishBone’s third strategic, vertically-integrated acquisition announcement made in the past six months, CSpine provides the capabilities to enter a key market segment within pediatric orthopedics to address the unmet needs of children with spinal deformities.

While this opportune partnership is recent, WishBone and CSpine executives share academic ties dating back to 1995. With over 100 years of combined expertise in medical device engineering, development and manufacturing, CSpine boasts a cutting edge manufacturing platform with irreproachable quality standards. A history dense in clinical testing and data will prove invaluable as WishBone Medical enters the global spine arena. This year alone, over 29,000 adolescents with scoliosis will be surgically treated in the United States (WJO 2015).

“CSpine extends the concept of Design for Manufacturability to an advanced product development model by leveraging concurrent engineering principles to produce the highest quality products, at the lowest cost, in approximately 1/3 of the time compared to leading orthopedic device companies.”

– Dr. Robert Wertz, VP of Market Development, WishBone Medical

As WishBone Medical continues to grow with remarkable speed through its acquisition strategy, CSpine is the perfect addition to the WishBone lineup. CSpine provides the full continuum of services from concept to commercialization for orthopedic and spinal device companies, including FDA regulatory submission, mechanical testing referral/oversight, and various engineering and design functions such as functional relationship analysis (FRA). Vertical integration also renders a streamlined production process – CSpine will make implants onsite to be combined and sterile packed with disposable instruments at Red Star Contract Manufacturing, which is ISO certified. Moving forward, CSpine will operate under the new name of Red Star Medical Solutions, as part of the Red Star family. All Red Star facilities will continue to provide contract manufacturing for the medical device industry

The ultimate objective is to produce highly-innovative surgical solutions for pediatric spinal deformities, to be packaged in sterile, single-use disposable kits – unlike any other spine system existing to date. The WishBone scoliosis kits, based on years of clinical history from CSpine, will prove to be an essential solution on mission trips made worldwide by The WishBone Orthopaedic Foundation:

“Our foundation supporting surgeons could literally throw these kits into their backpacks and take it with them on missions to remote areas all over the globe. We’ll be able to aid children with severe spine issues who wouldn’t be able to afford treatment otherwise.”

– Rob Seewald
Corporate Chaplain, WishBone Medical
Location Selection & Active Chair, WBOF

Representatives from the WishBone Medical, Red Star and CSpine offices stand excited
for opportunities to come, after closing the deal Wednesday afternoon.

About

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. Through recent acquisitions, WishBone Medical now offers 42 pediatric orthopedic product systems with operations in Warsaw, IN, Istanbul, Turkey, and Singapore.

For further information, visit wishbone-medical-migration.mysites.io or call Kaitlyn Hughes, Director of Marketing & Communications, at 574-306-4006.

WishBone at AAOS 2019

in WishBone News

The WishBone team is at the annual AAOS meeting in Las Vegas March 12-16.

Attending? Stop by booth 4809 and learn about some exciting projects in the works!

Meeting Location:

Venetian / Sands Expo
201 Sands Avenue
Las Vegas, Nevada 89169

WishBone Medical Breaks Ground with Foot & Ankle Solutions for Children

in Press Releases

New technology optimized by sterile, single-use packaging.

WARSAW, Ind. MARCH 6, 2019 — WishBone Medical expands the pediatric orthopedic market with leading edge foot and ankle solutions in sterile, single-use packaging. Adding to the industry’s largest product portfolio dedicated to kids, the company will reveal an array of new products with the global launch of their foot and ankle platform at the American Academy of Orthopaedic Surgeons (AAOS) – booth 4809 – in Las Vegas on March 13^th. WishBone zeros in on pediatric foot and ankle solutions with the objective to treat juvenile conditions severely neglected until later in adulthood. These systems are designed around the unique anatomy of growing children with benefits unmatched by rivaled systems currently in the market.

WishBone Medical is pushing for industry participants to recognize the invaluable features integral to each original system, which directly benefit surgical teams, ambulatory surgery centers, hospitals, and most importantly – the patient. This comprehensive platform translates to a one-stop shop for pediatric foot and ankle surgical needs, including the AlloMate Bone Pin System; Foot and Ankle K-Wire Kits and a full plating system to fix juvenile bunions, flatfoot, fractures, etc.

“Kids suffer from the same foot and ankle issues more often associated with adults, but they rarely receive proper treatment, as the condition is typically less severe in earlier years. Ailments like bunions and flatfoot inevitably worsen with time and grow too painful to put off later in life. However, if patients proactively seek treatment in earlier stages, corrective surgery is less invasive, and suffering may be avoided altogether.”

– Daniel Schulman, DPM, Arizona Institute of Footcare Physicians

Utilizing a WishBone Medical system means pediatric patients benefit from a device designed around their rapidly changing bodies. Unlike its adult counterpart, each product is designed to avoid growth plates and growth interruption. Moreover, sterile-packed, disposable implants and instruments are always brand new, reduce risk of infection, and are ready to go every time – veritably enabling optimal, efficient surgical performance and reproducible outcomes. Better yet, this model opens the door for kids’ procedures to be done in any surgical setting, including ambulatory surgery centers.

About

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 wishbone-medical-migration.mysites.io or call Mary Wetzel, Chief Operating Officer, at 574-306-4006.

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