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Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Lesser Tarsometatarsal (TMT) Joint Arthrodesis System

Warsaw, Indiana, January 6, 2020 — Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., today announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming InCore® TMT System.

“Preparing the lesser tarsometatarsal joint for fusion and placing fixation poses difficulties due to the challenging bony anatomy and soft tissue. The InCore TMT is an exciting addition to the successful InCore Lapidus system, addressing the need to provide the necessary distraction for visualization and joint preparation, in addition to controlled compression at the fusion site. This new system applies all the advantages of InCore Lapidus including the solid intraosseous fixation construct aimed to minimize hardware prominence. We look forward to seeing this become another important solution to this common but challenging procedure,” said Greg Denham, Director of Product Development, Early Intervention for Nextremity Solutions.

Building on the success of the three-part construct design of the InCore Lapidus System for first TMT fusion, the InCore TMT System focuses on second and third TMT fusion, more commonly known as a Lisfranc joint fusion. Lisfranc fusions are intended to help provide stability to the midfoot and restore the anatomical arch of the patient’s foot.

Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions said, “The team has done an excellent job of expanding our InCore technology platform and building on the clinical success of InCore Lapidus.  We’re excited about introducing InCore TMT to the market, as well as future variations in the pipeline.  The InCore TMT product launch will be one of many to come in 2020.  We remain focused on continuing to work with our surgeon and industry partners to bring exciting, Revenue Ready® solutions to the market.”

The Nextremity Solutions InCore TMT System is indicated as a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/3rd Tarsometatarsal Fusion).

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the extremity musculoskeletal space, offering innovative solutions and Revenue Ready products for various extremity musculoskeletal applications and for the benefit of its industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

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Nextremity Solutions, Inc. Announces Success of Initial Cases Using the InCore® Lapidus Single-Use Sterile Kit

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., recently completed the first several cases using its single-use sterile version of the already successful InCore Lapidus System.

The InCore Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform Arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion). The system allows for tri-planar correction through the use of a Targeting Guide that is intended to aid and stabilize angular/rotational correction in all three planes (transverse, sagittal and frontal plane).

Michael S. Lee, DPM of Clive, Iowa stated, “The single-use kit ensures the instruments are always clean and ready for my cases and every drill bit is new and sharp.  These single-use kits are a significant advancement for the InCore Lapidus System that will grow in appreciation by health systems that are looking to improve operational efficiencies.  I look forward to having these in the OR every week.”

A single-use sterile version of the reusable system was developed as a disposable option for health systems that desire to eliminate the need to sterilize a reusable set and have the ability to use brand new instrumentation with every procedure.

“The single-use kit is a very efficient system for the ASC where I practice and certainly saves our staff time by not having to prepare and then clean typical reusable instruments,” commented John G. Anderson, MD of Grand Rapids, Michigan.

Nicholas Dodson, DPM of Valdosta, Georgia said, “The new InCore single-use instrument kit and targeting guide performed exactly like the reusable instruments that I have been using. The transition to the single-use kit was seamless and the quality of the instruments and targeting guide was indistinguishable from the reusable set.”

The single-use sterile version of the InCore Lapidus System is currently in a limited commercial launch.

To learn more about this and other extremity musculoskeletal products developed by Nextremity Solutions, visit www.nextremity.com.

Nextremity Solutions, Inc. Announces Commercial Launch of Stratum™ MPJ Plating System

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., has recently made commercially available the Stratum MPJ Plating System as an extension to its already successful Stratum Foot Plating System.

The Stratum MPJ Plating System provides surgeons with twelve total plates with both 0-degree and 7-degree options. These plates address issues in the first metatarsophalangeal joint, which is the joint between the first metatarsal and proximal phalanx of the foot. MPJ fusion surgery is intended to help relieve pain in the front of the foot for the patient in need of surgery.

Ryan Schlotterback, Chief Technology Officer of Nextremity Solutions said, “The team has done an excellent job of developing our Stratum plating technology.  We are pleased with the recent clinical success with the Stratum MPJ system and the continued adoption by our surgeon customers.  Surgeons appreciate the combination of features that allow for efficient trialing and placement of the plate with the ability to dial in desired compression prior to final fixation.  The Stratum MPJ Plating System further builds on the Stratum family of plates and we are excited about the additional applications in the pipeline.”

The Stratum MPJ Plating System launch was preceded by the launches of the Stratum Foot Plating System, Stratum Lapidus Plating System, and InCore® Lapidus System. All of these systems address various deformities or traumatic injuries of the foot. Additionally, Nextremity Solutions notes that its success in product development is owed to its i3® Strategic Solutions micro-commercialization strategy.

“Over the last two and a half years we have remained passionately focused on our i3 Strategic Solutions strategy. This strategy is driven by our collaboration with surgeon designers and surgeon evaluators that are committed to the development and pre-market evaluation of innovative surgical solutions. The most recent integration of these technologies continues to validate our unique strategic commercialization model,” said Rod Mayer, President & Chief Executive Officer for Nextremity Solutions.

The Nextremity Solutions Stratum Foot Plating System, which includes the Lapidus and MPJ plating systems, is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. An application for a CE mark is pending.

The Nextremity Solutions InCore Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).

To learn more about these products, visit www.nextremity.com.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready® products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Stratum™ Foot Plating System

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., today announced it has recently received 510(k) clearance by the Food & Drug Administration to market its upcoming Stratum Foot Plating System.

Ryan Schlotterback, Chief Technology Officer of Nextremity Solutions said, “This is an important milestone for our company and the largest system we’ve brought to market to date.  The team has spent a tremendous amount of effort with our surgeons to develop a comprehensive foot plating system that includes several innovative components; all working together to make foot plating simpler and more reproducible.  The system includes implants with specific features that, along with a bicortical compression system, eliminate the decade’s old compression slots.  We believe these features, along with a host of others, create efficiency and stability not seen before in foot plating.  The team has achieved all of this with an efficient and fully disposable instrument set.  The Stratum Foot Plating system will be an important platform as we continue to develop our product portfolio.”

“We are very excited about initial responses we are receiving from surgeons.  Specifically, surgeons are intrigued by the unique tines that give the surgeon the ability to manipulate small bones and free up hands during the case.  They also see tremendous value in the innovative external compression ramp that helps generate bicortical, linear compression. The unique features of the comprehensive Stratum Foot Plating System truly make it the next generation in plating,” said Mike Coon, Chief Commercial Integration Officer for Nextremity Solutions.

The Nextremity Solutions Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. An application for a CE mark is pending.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready® products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

Nextremity Touts Success With New Strategy

By Kylie Veleta, Business of Health Reporter & Special Projects Editor for Inside INdiana Business

Warsaw-based Nextremity Solutions, Inc. says 2018 was a critical year of validation. The orthopedic company changed its business model in 2016—moving away from its roots as a traditional startup and becoming a strategic commercialization organization. Nextremity leaders say the shift was a success; the company recently ranked 331st on Deloitte’s Technology Fast 500 with a 246 percent revenue growth rate.

While taking leaps forward, Nextremity executives say the company’s strategy still centers on its visionaries: orthopedic surgeons. Dr. Lon Weiner and Dr. Stuart Katchis—both in New York City—co-founded the startup in 2007 by identifying unmet needs in the operating room. Nextremity Chief Technology Officer Ryan Schlotterback says the team took the surgeons’ East Coast ideas and brought them to the fertile soil of the Orthopedic Capital of the World in 2013.

“There’s huge value [being in Warsaw],” says Schlotterback. “Since 2016, our strategy is to develop products and deliver those to the large strategic OEMs. And here in Warsaw, there are some of the biggest; it works really well to be local and close to them.”

READ FULL STORY…

Nextremity Solutions, Inc. Ranked 331st Fastest Growing Company in North America on Deloitte’s 2018 Technology Fast 500™

Attributes 246.6% Percent Revenue Growth to a high achieving team collaborating with surgeons to develop and commercialize innovative products for the benefit of patients worldwide.

 Warsaw, Indiana, November 16, 2018 — Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., today announced it ranked 331st on Deloitte’s Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America. Nextremity Solutions, Inc. grew 246.6% percent during this period.

Dan Stichter, Chief Financial Officer for Nextremity Solutions, credits an innovative team, critical surgeon relationships, and strong manufacturing and distribution partnerships with the company’s 246.6% revenue growth. Stichter said, “Since Nextremity’s founding in 2007, the company has collaborated with surgeons to develop innovative solutions to unmet clinical needs. We are excited to see these solutions being rapidly adopted in the marketplace.  Nextremity looks forward to rewarding its investors with a growing legacy of innovation for many years to come.”

“We are honored to receive this ranking as part of Deloitte’s Technology Fast 500. Every member of our team has worked with excellence to ensure that the technology we develop gets into the hands of the surgeons we serve. Through strategic partnerships we have developed over the years, we are better able to do more of what we do best; more profitably every day,” commented Rod Mayer, President & CEO for Nextremity Solutions.

“Congratulations to the Deloitte 2018 Technology Fast 500 winners on this impressive achievement,” said Sandra Shirai, vice chairman, Deloitte LLP, and U.S. technology, media and telecommunications leader. “These companies are innovators who have converted their disruptive ideas into products, services and experiences that can captivate new customers and drive remarkable growth.”

Mohana Dissanayake, partner, Deloitte & Touche LLP, and Industry Leader for technology, media and telecommunications, within Deloitte’s audit and assurance practice. “This year’s ranking demonstrates what is likely a national phenomenon, where many companies from all parts of America are transforming the way we do business by combining breakthrough research and development, entrepreneurship and rapid growth.”

Overall, 2018 Technology Fast 500™ companies achieved revenue growth ranging from 143 percent to 77,260 percent from 2014 to 2017, with median growth of 412 percent.

 

About Deloitte’s 2018 Technology Fast 500™

Deloitte’s Technology Fast 500 provides a ranking of the fastest growing technology, media, telecommunications, life sciences and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2014 to 2017.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least $50,000 USD, and current-year operating revenues of at least $5 million USD. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready® products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

About Deloitte

Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about their global network of member firms.

Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Lapidus Procedure System

Warsaw, Indiana, May 4, 2018 — Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., today announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming InCoreTM Lapidus System.

“We’re excited about the 510(k) clearance of our InCore Lapidus System.  The team has worked hard to deliver a precision-guided, stable, intra-osseous solution for fusion of the first tarsometatarsal joint.  Our InCore Lapidus System aides the surgeon in correction and stabilization of the multi-planar deformity while providing distraction and visibility to allow for the surgeons preferred joint preparation.  The team was also focused on repeatable, procedural efficiency and controlled compression of the final construct.  We look forward to educating surgeons on this new technology,” said Ryan Schlotterback, Chief Commercial Officer of Nextremity Solutions.

Rod K. Mayer, President of Nextremity Solutions said, “I am very thankful for the collective efforts of our surgeon and product development team members that accomplished this milestone. We are confident that this innovative solution will become a leading technology that advances patient care.”

The Nextremity Solutions InCore Lapidus System is indicated as a three-part construct intended for internal fixation for First Metatarsocuneiform Arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion). An application for a CE mark is pending.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready® products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

 

For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

Nextremity Solutions, Inc. Announces Full U.S. Commercial Launch of the Arcus™ Staple System

Warsaw, Indiana, October 25, 2017 — Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., today announced the full release of the Arcus™ Staple System through its strategic alliance with Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare.

In October 2016, Zimmer Biomet announced an exclusive agreement with Nextremity Solutions to globally distribute the company’s foot and ankle deformity correction products. The initial three products to be distributed through this alliance included the Nextra® Hammertoe Correction System, Re+Line® Bunion Correction System, and the MSP™ Metatarsal Shortening System. Nextremity Solutions’ Arcus Staple System is the latest product to be added to Zimmer Biomet’s foot and ankle portfolio as part of this agreement.

During clinical trials, more than 200 Arcus staples were implanted during surgeries performed in facilities around the U.S.  During this micro-commercialization phase, Nextremity Solutions’ i3TM Strategic Solutions process was used to assess valuable surgeon feedback that led to improvements of the implant and instrumentation design.  The Arcus staple’s innovative arc design has been shown to provide greater and more sustained compression compared to competitive staples.1

  1. A Mechanical Evaluation of the Interfragmentary Compressive Forces of the Arcus Staple System, Lisa A. Ferra, Ph.D., Orthokinetic Technologies and Orthokinetic Testing Technologies, Southport, NC

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready™ products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

Nextremity Solutions, Inc. Announces Limited Release of the Axi+Line™ Proximal Bunion Correction System

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World” Warsaw, IN, is announcing the limited release of its newest product, the Axi+Line™ Proximal Bunion Correction System for the treatment of hallux valgus deformity, also known as a bunion. This announcement comes shortly after Nextremity Solutions announced the limited release of another new product, the PiroVue™ Gastrocnemius Recession System for the treatment of equinus deformities in patients.

According to a 2015 study in Foot & Ankle International® entitled, “A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal Rotation of the First Metatarsal in CT Scans”, patients with hallux valgus deformities (bunions) had a “more pronated first metatarsal than the control group”. The study showed that 87.3% of the patients sampled with hallux valgus deformity also had abnormal frontal plane rotation of the first ray.

Nextremity Solutions currently offers the Re+Line® Bunion Correction System, which specifically focuses on the treatment of hallux valgus deformities of lesser angles. However, the Axi+Line Proximal Bunion Correction System addresses treatment of deformities of larger angles and addresses correction in the frontal plane.

“The Axi+Line Proximal Bunion Correction System is a reproducible, guided, and fully disposable system for addressing hallux valgus deformities via a proximal metatarsal approach.  This system takes advantage of the modified Mau osteotomy and addresses the concerns of rotational correction in the frontal plane while simultaneously reducing the hallux valgus angle.  It provides surgeons with a great option between a distal approach and a Lapidus approach.  We’re excited about the introduction of Axi+Line as well as our soon-to-launch Lapidus system,” commented Ryan D. Schlotterback, Chief Commercial Officer for Nextremity Solutions, Inc.

The patent-pending Axi+Line Proximal Bunion Correction System will utilize a limited launch with key surgeons prior to a full commercial launch in 2018.

For more information or to schedule a demonstration of the Axi+Line Proximal Bunion Correction System, please visit https://nextremity.com/axiline.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready™ products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit www.nextremitysolutions.com or call Dave Temple, Executive Director, i3 Direct at 574-635-3022.

 

Nextremity Solutions, Inc. Achieves Record Setting Results for First Half of 2017

Nextremity Solutions, Inc., a Strategic Commercialization Organization (SCO) in the musculoskeletal space, located in Warsaw, IN, “The Orthopedic Capital of the World”, announced that it has achieved record setting revenue for the first half of 2017.

Nextremity Solutions believes that the successes the Company is seeing are directly tied to its surgeon-driven i3TM Strategic Solutions product development strategy, as well as its distribution agreement with a worldwide strategic partner. In October of 2016, Nextremity Solutions announced it had finalized an exclusive global distribution agreement for its first four commercialized products, which address unmet clinical needs in forefoot elective surgery.

“Our i3 Strategic Solutions product development pipeline in the foot and ankle space remains strong and the company will begin to expand into other markets in 2018. Nextremity Solutions’ team remains very excited as we continue to take the next steps to expand our product development portfolio and continue to pursue our mission of becoming recognized as the premier musculoskeletal Strategic Commercialization Organization (SCO). We have an amazing group of talented professionals who are passionate about creating innovative technology and solutions that advance the standard of care for surgeons and patients worldwide,” stated Ryan Schlotterback, Chief Commercial Officer for Nextremity Solutions.

“The Company continues to be EBITDA positive as it heads into its second half of 2017 and is on track to achieve annual revenue forecasts. Our recent financial performance is the result of our team’s hard work and dedication. Because of our mutually beneficial relationship with our strategic alliance partner, our team can focus strongly on our i3 Strategic Solutions strategy and continue to produce Revenue ReadyTM products and solutions that are beneficial to surgeons and patients worldwide,” commented Rod K. Mayer, President and CEO of Nextremity Solutions.

Nextremity Solutions, recently announced the limited release of its newest product, the PiroVueTM Gastrocnemius Recession System for the treatment of equinus deformities in patients and plans to announce the limited release of yet another new product in Q4 2017.

To learn more about i3 Strategic Solutions, visit www.i3strategicsolutions.com.

If you’re a surgeon inventor or have a product idea that you think would be a good fit for Nextremity Solutions, Inc., they can be contacted at 732-383-7901.