News

News

Zimmer Biomet Expands Foot and Ankle Portfolio Through Exclusive Global Distribution Agreement with Nextremity Solutions, Inc.

(WARSAW, IN) October 20, 2016—Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced an exclusive agreement with Nextremity Solutions, Inc. to globally distribute the company’s foot and ankle deformity correction products. The financial terms of the transaction were not disclosed.

“We’re excited to expand the clinical capabilities of our foot and ankle portfolio with Nextremity Solutions’ deformity correction products,” said Brad Quick, General Manager of Zimmer Biomet Foot and Ankle. “The agreement helps advance our commitment to provide customers with the broadest range of cutting-edge technologies and strengthens our position in the foot and ankle market.”

Nextremity Solutions designs and manufactures the following procedure-ready, sterile implant systems for the correction of foot and ankle pathologies, which will be globally distributed by Zimmer Biomet:

  • Nextra® Hammertoe Correction System, the industry’s only adjustable two-piece hammertoe implant.
  • MSP™ Metatarsal Shortening System, an osteotomy guide and implant in one. The innovative design provides precision and stability for metatarsal shortening procedures.
  • Re+Line® Bunion Correction System, a unique, low profile tension-band compression plate designed for performing precise, repeatable bunion correction surgery.
  • ArcusTM Staple System, an arc-styled staple design that provides greater and more uniform compression than conventional staples1.

“The agreement with Zimmer Biomet allows us to expand the reach and influence of our forefoot portfolio by leveraging the commercial capabilities of a global musculoskeletal healthcare leader,” said Rod K. Mayer, President and Chief Executive Officer of Nextremity Solutions, Inc. “Our partnership with Zimmer Biomet enables us to focus on our current strategy of working with our surgeon partners to deliver innovative solutions that help advance the standard of care in the foot and ankle market with speed, efficiency and excellence.”

About Zimmer Biomet

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.

1. Comparison of Compressive Force for Bone Staples, Lisa A. Ferra, Ph.D., OrthoKinetic Technologies LLC and OrthoKinetic Testing Technologies, Southport, NC. Laboratory studies are not necessarily indicative of clinical results.

 

New Study in The Journal of Foot and Ankle Surgery Shows Significant Advantages of Nextremity Solutions, Inc. Hammertoe Device Over Kirschner Wires

Warsaw, Indiana, May 16, 2016 — An article now in press in The Journal of Foot and Ankle Surgery entitled, “Dual-Component Intramedullary Implant Versus Kirschner Wire for Proximal Interphalangeal Joint Fusion: A Randomized Controlled Clinical Trial,” shows significant advantages of using the Nextra® Hammertoe Correction System as opposed to using traditional Kirschner Wires (K-wires) for the treatment of hammertoe deformity.

The Nextra® device is a two-piece implant developed by Nextremity Solutions, Inc., a pure-play foot and ankle orthopedic company located in Warsaw, IN. This device differed from K-wires by achieving more than a 5x higher rate of bone fusion. Additionally, the Nextra® implant exhibited an 84% fusion rate, compared to just 16% with K-wires.

“Some of the issues with the utilization of K-wires in hammertoe surgery are a lack of fusion, lack of rotational stability, risk of infection with post-operative K-Wire exposure, and poor patient satisfaction. According to the study, patients with the Nextra implant not only had drastic improvements in fusion rates but also experienced greater pain relief, a decrease in disability and an increase in activity levels. Simply put, the Nextra patients had greater patient satisfaction outcomes. These clinically proven results help to redefine the standard of care for hammertoe patients,” said Mike Coon, Executive Director of Sales & Marketing for Nextremity Solutions, Inc.

Executive Director of Product Development for Nextremity Solutions, Ryan Schlotterback, commented, “This study is a great example of our commitment to proving the clinical efficacy and benefits of our products and technology. Nextremity Solutions will continue to work with our surgeon partners to develop innovative solutions with improved and proven clinical outcomes. We are steadfast in our belief that the foot and ankle market is primed for continued advancements that lead to better surgical outcomes and patient satisfaction.”

The surgeons involved in this randomized controlled clinical trial are Richard M. Jay, DPM, FACFAS, D. Scot Malay, DPM, MSCE, FACFAS, Adam S. Landsman, DPM, PhD, FACFAS, Nathan Jennato, DPM, James Huish, DPM, and Melissa Younger, DPM. The study is available to subscribers of the journal now at the following link and will be available soon in the printed journal: http://www.jfas.org/article/S1067-2516%2816%2900152-6/abstract.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies 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. Awarded “2016 Entrepreneurial Firm of the Year”

(Pictured L to R - Rod K. Mayer and Nick A. Deeter)

(Pictured L to R – Rod K. Mayer and Nick A. Deeter)

Warsaw, Indiana, February 2, 2016 — Nextremity Solutions, Inc., a pure-play foot and ankle implant company located in “The Orthopedic Capital of the World” Warsaw, IN, has been awarded, “2016 Entrepreneurial Firm of the Year” by the Kosciusko Chamber of Commerce. Both CEO and Chairman of the Board, Nick Deeter and President, Rod Mayer received the award.

Nextremity Solutions was initially founded in 2008 as a foot and ankle surgical implant company by two New York City orthopedic surgeons. In 2015 the decision was made by Deeter and Mayer to relocate the business from Red Bank, New Jersey to its current location at 210 North Buffalo St. in Warsaw allowing for planned future growth.

Nextremity Solutions brings advanced technology to one of the fastest growing segments of the foot and ankle market by primarily focusing their efforts on the development of proprietary solutions to treat foot and ankle deformities.

“It’s an honor to be a part of this team of dedicated and talented professionals. We work closely with our founding surgeons to ensure that Nextremity Solutions continues to provide innovative solutions for our surgeon customers,” said Nick A. Deeter, CEO and Chairman of the Board for Nextremity Solutions, Inc.

“The team at Nextremity Solutions, Inc. should really be proud. Entrepreneurship can be challenging at times, especially in this space. But, each member of our team brings a unique set of skills that allow us to be a strong and united family. Nextremity Solutions is committed to serving our surgeon partners with excellence. I look forward to seeing this company continue to build our business together one relationship at a time,” commented Rod K. Mayer, President of Nextremity Solutions, Inc.

Through innovation and product design Nextremity Solutions has gained acceptance in the market by providing precise and repeatable outcomes in orthopedic foot and ankle surgery, Worldwide.

Nextremity Solutions, Inc. and BESPA Finalize Strategic Alliance

Warsaw, Indiana, January 21, 2016 — Nextremity Solutions, Inc., a pure-play foot and ankle orthopedic implant company located in “The Orthopedic Capital of the World” Warsaw, IN, has finalized a strategic alliance with BESPA. BESPA is a pioneer in partnering industry with medical professionals to provide solutions that improve patient outcomes.

“Nextremity Solutions, Inc. will be a global industry partner with BESPA; commercializing products and surgical techniques in the foot and ankle segment of the orthopedic market place on a worldwide basis,” said Nick A. Deeter, CEO and Chairman of the Board for Nextremity Solutions, Inc.

This strategic alliance provides Nextremity Solutions, Inc. the opportunity for an immediate and a single-resource access to highly-trained surgeon specialists in research, product ideas, intellectual property, product design, and testing of new technologies.

“We are thrilled to finalize this strategic alliance. As a surgeon-driven company, we are truly grateful for the opportunity to work closely with this premier network of fellowship-trained foot and ankle surgeons. Through the relationships with these talented surgeons, we will be able to continue to provide innovative solutions for the foot and ankle, as well as provide educational programs that are facilitated by surgeons for surgeons,” commented Rod K. Mayer, President of Nextremity Solutions, Inc.

Gregory Pomeroy, MD, CEO and Managing Partner of BESPA stated, “We chose this alliance with Nextremity Solutions, Inc. because we feel they are positioned to both develop new products and to bring these products to market successfully – in this ever changing Healthcare environment.”

Nextremity Solutions, Inc. co-founder and Section Chief, Foot and Ankle Orthopedic Surgery for Lenox Hill Hospital (New York, New York), Stuart D. Katchis, MD stated, “As one of the founders of Nextremity Solutions, Inc., our goal was always to develop innovative products that solved challenges surgeons had with existing technologies and techniques. Through this alliance with BESPA, we can continue to tap into a network of like-minded surgeons and continue to develop innovative solutions that will provide a positive impact on both surgeons and patients.”

Nextremity Solutions, Inc. will also have access to third-party product evaluation of new and existing products, educational programs and training with emphasis on “best-in-class” surgical outcomes, as well as products for patients with foot and ankle problems.

 

About BESPA

BESPA is the pioneer in joining industry and healthcare providers together to develop innovative products, bring these products to market faster, at a lower cost than traditional methods, and educate industry professionals on the products and strategies that will improve patient outcomes.

BESPA offers Medical Professionals an opportunity to be part of the world’s most skilled physician’s network, inspiring talent and innovation around the globe, and improving patient care.

BESPA offers Client Companies access to world renowned HCP’s in many fields. BESPA is driven to provide the medical industry with improved ways to deliver new product solutions through R&D, education, product evaluation and/or design. BESPA consultants are vetted to ensure no cross contamination of ideas or confidentiality issues occur.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies 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. Receives FDA 510(k) Approval for the Axi+LineTM Proximal Bunion Correction System

Warsaw, Indiana, December 22, 2015 — Nextremity Solutions, Inc., a surgeon-driven, pure-play foot and ankle orthopedic company located in Warsaw, Indiana, announced it has received 510(k) approval by the Food & Drug Administration to market its upcoming Axi+Line™ Proximal Bunion Correction System.

“The Axi+Line™ Proximal Bunion Correction System represents a significant advancement in the treatment of moderate to severe hallux valgus and is complementary to our Re+Line® Bunion Correction System. The Axi+Line™ system leverages the recognized benefits of the Mau osteotomy, while allowing our surgeons to have confidence in their operative technique. As with our other products, the final repair is very stable thanks to the innovative plating system, giving surgeons peace of mind and patients the potential to quickly get back to their daily activities,” said Director of Product Development, Ryan Schlotterback.

Rod K. Mayer, President of Nextremity Solutions said, “We are very excited to receive 510(k) approval from the FDA for this new and innovative treatment option for patients. I’m extremely proud of our team and their efforts to produce yet another state-of-the-art device for the treatment of deformities in the forefoot. We look forward to taking the next steps to release this product into the hands of our surgeon consultants in our upcoming beta launch.”

The Nextremity Solutions Axi+Line™ Proximal Bunion Correction System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot. An application for a CE mark is pending.

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies 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. Signs Exclusive Agreement with Biotech Company Molecular Matrix, Inc.

Warsaw, Indiana, October 30, 2015 — Nextremity Solutions, Inc., a pure-play foot and ankle company located in Warsaw, IN, recently signed an exclusive agreement with California-based biotechnology company, Molecular Matrix, Inc. (MMI) The agreement will give Nextremity Solutions worldwide exclusive rights for use of Molecular Matrix’s GroCell-3D™ technology, as well as any new musculoskeletal technologies developed by Molecular Matrix for use below the knee.

GroCell-3D™ is an innovative technology for growing mammalian cells and tissues on a three dimensional scaffold. The GroCell-3D™ scaffold has been shown to support the growth of bone, cartilage, heart, nerves, liver, and stem cells among others.

GroCell-3D™ is a 3-dimensional cell scaffold that is safe, highly porous (97% porosity), biocompatible, and biodegradable. Cells cultivated using the GroCell-3D™ scaffold have shown exceptional compatibility and growth. The primary focus in the utilization of the scaffolds unique properties (biocompatible, biodegradable, and osteogenic) is to develop a superior and more cost-effective bone-void filler.

Molecular Matrix founder and inventor of the GroCell-3D™ technology, Charles Lee, Ph.D. said, “As an inventor, I am intrigued to see how this technology is able to be used in real-world situations. Through this partnership, we are able to combine Molecular Matrix’s expertise in biotechnology with Nextremity’s expertise and worldwide surgeon relationships in the foot and ankle market to develop innovative treatment options that will help patients.”

“When I first heard about this technology I knew Nextremity Solutions needed to find a way to work with Molecular Matrix. When you really think about all of the ways this technology could be used in the treatment of foot and ankle degenerative diseases and deformities, you realize that this industry is about to change. We are privileged to partner with the amazing and innovative team at Molecular Matrix,” commented Nick Deeter, CEO and Chairman of Nextremity Solutions, Inc.

Deeter went on to say, “We are so excited about what MMI can do in the musculoskeletal area throughout the human body, that Nextremity has invested in MMI and our CFO, Frank Patton, will be joining their Board of Directors.”

Nextremity Solutions is expected to launch this technology as part of its product portfolio in 2016.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

 

Nextremity Solutions, Inc. Acquires Foot Fusion Technology from Del Palma Orthopedics

Warsaw, Indiana, October 22, 2015 — Nextremity Solutions, Inc., a pure-play foot and ankle company located in Warsaw, IN, has completed the acquisition of a highly innovative foot fusion technology from Del Palma Orthopedics (DPO) that had previously gained the interest of a larger orthopedic company. DPO, located in Columbia City, IN, is an orthopedic company that focuses on the development of global upper and lower extremities medical devices.

The purchase consists of multiple issued and in-prosecution utility and design patents, associated intellectual property, and partially developed foot fusion devices. The foot fusion technology has immediate applications throughout the foot and ankle, expanding Nextremity Solutions’ product offering. Nextremity also believes this technology also has other applications within other orthopedic market segments.

Ryan Schlotterback, Director of Product Development for Nextremity Solutions said, “The acquisition of this technology not only strengthens our IP portfolio, but also further prepares us as we continue to expand our product development efforts beyond the forefoot to the midfoot and hindfoot.  We believe this technology has the potential to play a role in a number of different procedural applications.”

DPO CFO, Brian More commented, “Del Palma along with key influential surgeons had a vision for a unique system to treat certain conditions in the foot, ankle, hand, and wrist; a system that lowers inventory requirements and increases procedural repeatability that provides for better outcomes.  We are excited to find the right partner in Nextremity Solutions to finish the development and commercialization of the system.  It a privilege to work with partners where goals are aligned; to provide better outcomes for patients and surgeons.”

“The acquisition of the Del Palma technology is another step in Nextremity’s journey to being recognized as the leader in innovation within the foot and ankle market.  Given the interest in this technology by others in the foot and ankle marketplace, Nextremity is excited about obtaining this IP and the opportunity to bring this technology to foot and ankle surgeons in order to improve their patient outcomes,” concluded Frank Patton, CFO for Nextremity Solutions, Inc.

Nextremity Solutions anticipates to launch this technology as part of its product portfolio in the next 12-18 months.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

 

Nextremity Solutions, Inc. Announces the Issuance of Seven Patents for Use in Foot and Ankle

Warsaw, Indiana — The U.S. Patent and Trademark Office (USPTO) recently awarded Nextremity Solutions, Inc. with seven additional patents. The patents are a mix of design and utility patents related to medical devices specific to the treatment of foot and ankle deformities.

Director of Product Development, Ryan Schlotterback stated, “We are pleased with the Nextremity Intellectual Property that was issued recently and feel that it is indicative of the hard work and talent of our surgeon partners and product development staff.  We are proud of our unique product portfolio and are committed to developing innovative solutions that continue to advance the standard of care in the Foot and Ankle market.”

Some of the patents relate specifically to current implants that Nextremity Solutions markets, including the Nextra® Hammertoe Correction System, as well as the MSPTM Metatarsal Shortening System. Additional products in the Company’s product pipeline are also utilizing the technology developed in the issued patents.

“As surgeons, we start with a concept. When these visions become products and procedures that allow surgeons to offer their patients a unique and better solution, we as doctors have achieved something special,” said Nextremity Solutions founder Lon S. Weiner, MD.

Co-founder Stuart D. Katchis, MD noted, “All of our work at Nextremity Solutions has been focused on designing unique products that make complex foot and ankle surgical procedures more consistently successful.  The issuance of these patents and the success we have seen clinically, confirm the value of our products to surgeons and patients alike.”

“The issuance of these patents by the USPTO is definitely exciting for us as a company. It truly speaks to the fact that we, as a pure-play foot and ankle company, are committed to working closely with our foot and ankle surgeon partners to develop innovative solutions in the foot and ankle market,” commented Rod K. Mayer, President of Nextremity Solutions.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies 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. Receives FDA 510(k) Approval for the Arcus™ Staple System

Warsaw, Indiana, September 8, 2015 — Nextremity Solutions, Inc., a pure-play foot and ankle company, recently received 510(k) approval by the Food & Drug Administration to market its upcoming ArcusTM Staple System.

“We are excited about the recent 510(k) approval of Nextremity’s new ArcusTM Staple System.  The unique design of our new staple generates excellent compression and is indicated for use throughout the foot and ankle.  Our testing has shown that the ArcusTM Staple performs better at maintaining compression over time when compared to the competition.  We look forward to the first implantations later this year,” said Director of Product Development, Ryan Schlotterback.

Rod K. Mayer, President of Nextremity Solutions said, “I’m extremely proud of the hard work our product development team has put into this product line. By working closely with our surgeon partners, we have developed a truly unique staple that will provide for more stable fixations in foot and ankle deformity correction, as well as trauma applications and other uses. We look forward to getting this product into the marketplace.”

The Nextremity Solutions Arcus™ Staple System is indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. This includes, fixation of bone fragments or small bones fractures, as well as fracture management in the foot and hand. An application for a CE mark is pending.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies 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 574-635-3023.

U.S. Congressman Todd Rokita Visits Nextremity Solutions, Inc.

Rokita

(Pictured L to R) U.S. Congressman Todd Rokita
and CEO & Chairman Nick A. Deeter

Warsaw, Indiana, August 13, 2015 — US Representative, Congressman Todd Rokita (Indiana 4th District) visited Nextremity Solutions, Inc. on Thursday. The purpose of the visit was to learn more about Nextremity Solutions and how it is impacting the orthopedic foot and ankle market, creating jobs in Indiana, and what its plans are for the future.

Nextremity Solutions, headquarted in Warsaw, IN, is a pure-play foot and ankle company that was originally located in Red Bank, NJ. It was decided in February 2015 that Nextremity Solutions should move its operations to Warsaw, the orthopedic capital of the world. The move to Warsaw, according to CFO Frank Patton, was because it has the right address for the orthopedic industry and has the orthopedic talent pool needed to grow the Company.

“It’s exciting for me to see growing companies like Nextremity Solutions, flourishing in the state of Indiana. They are positively impacting Indiana’s economy by creating jobs for talented individuals and developing innovative products that benefit the global healthcare industry,” said U.S. Congressman Rokita.

“There is nothing I love more than sharing with the leaders of this state, the passion that Nextremity Solutions has for creating innovative solutions for today’s patients. We are proud to be located in Warsaw, IN and are excited to impact this community and state in a positive way,” commented Nick Deeter, CEO and Chairman of Nextremity Solutions, Inc.

 

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies 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 574-635-3023.