Nvision Biomedical Technologies and Watershed Idea Foundry Launch First 3D-Printed Anterior Cervical Plate

The Quantum Titanium Cervical Plate System showcases the benefits of additive manufacturing in bringing game-changing designs to market that ultimately impact patient care.

SAN ANTONIO – Nvision Biomedical Technologies and Watershed Idea Foundry have received FDA clearance for the first-ever completely additive manufactured titanium anterior cervical plate, the Quantum Titanium Cervical Plate System. Recently cleared, the Quantum system leads the way for game-changing design freedoms which push clinical benefits to new levels and ultimately impact patient care. 

The Quantum system offers multiple specialized features, including a nested assembly in which the screw-locking cover is 3D printed as a single unit inside the anterior cervical plate, and dual-plate finishes with a textured posterior surface and smooth, polished anterior surface. Enhanced screw holes accommodate 30 degrees of cephalad/caudal angulation, which allow the surgeon to use a shorter plate. Additionally, the Quantum system incorporates Structural Encoding® capabilities to address FDA Unique Device Identification (UDI) requirements. This adds up to a more elegant construct design with anatomically optimized placement and increased procedural options and flexibility, which potentially means less time in surgery to benefit both surgeons and patients.

“It has been incredibly exciting for us to realize new product enhancements made possible by additive manufacturing,”


said Nick Cordaro, CEO of Watershed Idea Foundry

“It has been incredibly exciting for us to realize new product enhancements made possible by additive manufacturing,” said Nick Cordaro, CEO of Watershed Idea Foundry. “Combining multiple components into single nested 3D printed assemblies is one example of such an advancement, which can provide supply chain cost and timeline advantages while reducing patient risks of component disassembly. Nvision’s willingness to champion additive manufacturing innovation into a commercial product made for an ideal technology transfer scenario.”

Nvision’s Senior Vice President of Product Development, Tom Zink added, “By additive manufacturing the Quantum system, we leveraged design options that were not available with machined plates. The active locking system is integrally printed within the plates, and therefore never assembled, which means the locks cannot become unassembled in the surgical field. The posterior side of the Quantum plates present texture to allow for osteointegration and is designed to allow the plate to absorb load that with traditional plates is fully on the screws. With the hyper angulation of the screw holes design, the surgeon has the option to place the screws as far away from adjacent levels as possible.”

As sister organizations within the Fountainhead Investment Partners portfolio, Nvision and Watershed have previously collaborated on other innovative projects, such as Structural Encoding and 3D printed wedges and interference screws.

“We understand that speed and efficiency in innovation within the industry is essential,” said Brian Kieser, Founding Partner of Fountainhead Investment Partners. “That is why we set up our organization in a way to allow the sister companies to operate independently, yet still allowing for collaborations on key initiatives to advance timelines around research and development. Because we share a fundamental core culture and infrastructure regarding quality, engineering, and process controls across all entities, we all speak the same language. We believe this structure drives greater innovation that ultimately translates into bringing safer, cutting-edge products to the market faster while reducing costs. Quantum is a perfect example of speed to market as the application of the technology from Watershed R&D to Nvision FDA clearance was less than 18 months.”

“We understand that speed and efficiency in innovation within the industry is essential,”

said Brian Kieser, Founding Partner of Fountainhead Investment Partners

Nvision, founded in 2013, is quickly becoming the largest medical device manufacturer in San Antonio, with 21 FDA-cleared devices across a range of orthopedic specialties. In the last year, Nvision added seven products with FDA clearance to its portfolio, with an additional two currently in FDA review and two more scheduled for submission. Nvision has 18 issued patents with more than 30 in development.

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ABOUT NVISION BIOMEDICAL TECHNOLOGIES
Nvision is a San Antonio-based medical device and implant manufacturer focused on providing surgeons with implants paired with instrumentation and biologics that simplify and improve surgical procedures to help patients get back their quality of life. Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep patients, surgeons, healthcare providers, and distribution partners in mind.

Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the intuitive, intelligent, and integrated concepts. Find out more at www.nvisionbiomed.com

ABOUT WATERSHED FOUNDRY IDEAS  
Watershed is an idea foundry created by Fountainhead Investment Partners that focuses on biomedical growth and innovation, specifically involving additive manufacturing. Watershed offers services ranging from proof of concept and product development to manufacturing demonstration and regulatory consulting. In addition to these services, the Watershed Center of Excellence in Carlsbad, Calif., provides full titanium additive manufacturing through its FDA-registered and ISO 13485 certified facility. Find out more at www.watershedideas.com

Media Contacts

Nvision Biomedical Technologies media contact
Bonnie Caver, bonnie@replighthouse.com, Phone 512-217-5397

Make-A-Wish® Central & South Texas granted a wish to be biomedical engineer and design a medical device with San Antonio medical device and biologics company.

Make-A-Wish® partners with Fountainhead Investment Partners to grant the wish of a 20-year-old engineering student.

SAN ANTONIO (June 7th) – For the last 35 years, Make-A-Wish® Central & South Texas has granted over 5,000 wishes for children with critical illnesses. But we’re not done yet.  We remain deeply committed to granting as many wishes as we can as we can during the health crisis surrounding COVID-19. On Monday, June 7th, Make-A-Wish partnered with the south Texas community to grant 20-year-old Townes’ wish to be a biomedical engineer with a week-long and life-changing internship. 

“We were a wish family so I know how incredibly uplifting and valuable these experiences can be for a family.”


said Lorena Kieser, Make-A-Wish San Antonio Board Chair

With help from Fountainhead Investment Partners and its portfolio companies Nvision Biomedical Technologies and Watershed Idea Foundry, and led by Make-A-Wish San Antonio Board Chair Lorena Kieser and her husband Brian, the founding partner of Fountainhead Investment Partners, Townes worked with the team developing a new medical device. Some of the highlights of the internship included design planning, user needs assessments, concept generation, CAD work and concept model printing, Cadaver lab, and design review with surgeons.

“From the beginning, Fountainhead Investment Partners has been dedicated to inspiring the next generation of scientists and engineers and giving them the tools they need to succeed,“ said Brian Kieser, Founding Partner of Fountainhead Investment Partners. “Make-a-Wish has been special to our family for a long time, so to be able to grant a wish in a way that is part of our organization’s DNA is incredibly exciting.”

“We were a wish family so I know how incredibly uplifting and valuable these experiences can be for a family.” said Lorena Kieser, Make-A-Wish San Antonio Board Chair. “For us to have an opportunity to give back to another family in such a meaningful way is a gift.”

In 2016, Townes, an honor student and marching band enthusiast, went to the doctor after experience vomiting and regular migraines. The MRI scan showed a tumor in his brain, and he was diagnosed with medulloblastoma. Medulloblastoma develops in the cerebellum, which controls motor function and balance. 

Townes went straight into an 8-hour surgery to remove the tumor. After the surgery, Townes was unable walk and see. Throughout his chemotherapy and radiation treatments, Townes was also relearning how to walk, and his vision returned.

“One day you could be walking, and then the next day you wake up and there you are, you’re immobile, and you can’t walk,”

said Townes

“One day you could be walking, and then the next day you wake up and there you are, you’re immobile, and you can’t walk,” Townes said in an interview. “It’s a terrifying thing to think about, but it happens.”

After many months of using a wheelchair and walker, his mom found a device that sends electrical signals into his leg muscles. This device allowed him to better control his movement and most importantly, helped him regain confidence, independence and discover his future career dreams.  

“I think a lot of parents get sad because their kids are growing up and moving on,” Patricia, Townes’ mom, said in an interview at Townes’ graduation. “When you have a child that you might not think would make it, you are very happy when they grow up and move on.”

Townes now attends Texas A&M at Galveston and is majoring in engineering with hopes of developing medical devices to help others recover from illnesses and injuries. His brain surgery created challenges, and this internship will help accelerate his career goal.

“If you go and do it, I mean, you might fail, but you might succeed,” Townes said. 

With COVID-19, new health worries are also present, bringing added isolation and vulnerability for wish kids and their families. While fighting their illness, children are now anxiously counting the days until their wish will be granted. Their families are counting, too. Now more than ever, hope is essential. After a trip to see the Olympics in Tokyo was reimagined due to COVID, Townes converted his travel wish to an opportunity to explore his career goals.

Fountainhead Investment Partners has supported Make-A-Wish Central & South Texas for more than three years, granting wishes and participating in the San Antonio Walk for Wishes as a corporate team. 

“We are grateful to assist U.T.S.A.s’ Medical Engineering Program in the fall. With direct input from surgeons in the field, the students can get a much more hands-on approach. ”

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ABOUT MAKE-A-WISH CENTRAL & SOUTH TEXAS
Make-A-Wish® Central & South Texas creates life-changing wishes for children with critical illnesses. We are on a quest to bring every eligible child’s wish to life, because a wish is an integral part of a child’s treatment journey. Research shows children who have wishes granted can build the physical and emotional strength they need to fight a critical illness. Headquartered in Austin and San Antonio, TX, Make-A-Wish is the community’s leading children’s wish-granting organization, serving children in every community across 40 counties.  For more information about Make-A-Wish, visit cstx.wish.org.

ABOUT FOUNTAINHEAD INVESTMENT PARTNERS
Fountainhead Investment Partners, based in San Antonio, Texas, is a capital investment firm that funds privately held companies in sustainable industries including medical, manufacturing, telecom, environmental, and industrial.   

Originally founded in 2014 as an angel fund by a group of successful medical entrepreneurs, Fountainhead’s focus on partnering with the business owner to take companies to the next level is in its DNA. As the firm has expanded into venture capital and private equity funding models and expanded across industries, this commitment has only grown stronger. Fountainhead’s foundation of accessing innovative technologies from all sectors and applying them to the science of medicine opened the door for industry expansion beyond healthcare. 

By offering a range of capital investment options, Fountainhead provides a continuing path for growth from early-stage concept to lower/middle-market with a side-by-side partnership to maximize the highest potential growth. 

Media Contacts

Nvision Biomedical Technologies media contact
Bonnie Caver, bonnie@replighthouse.com, Phone 512-217-5397

CHRISTUS Santa Rosa Hospital – Westover Hills and Dr. Robert Farber Bring Innovation to Local Patients

CHRISTUS Santa Rosa Hospital – Westover Hills and Dr. Robert Farber Bring Innovation to Local Patients

First surgeries in the nation performed with San Antonio-based Nvision Biomedical Technologies Trigon® Osteotomy Wedge System.

SAN ANTONIO (May 6th) – Robert Farber, DPM of San Antonio Podiatry Associates, performed the first two surgeries utilizing the Trigon® Osteotomy Wedge system developed by San Antonio-based Nvision Biomedical Technologies at the CHRISTUS Santa Rosa Hospital – Westover Hills. The Trigon system provides an innovative use of PEEK-OPTIMA® HA Enhanced, which promotes multi-directional bone healing, improved fixation and enabled unique device identification required by the FDA.

“Our hospital is proud to partner with manufacturers like Nvision that develop technology resulting in better patient outcomes,”

said Patricia Burns, President, CHRISTUS Santa Rosa Hospital – Westover Hills.

The Trigon Osteotomy Wedge is the first osteotomy wedge system made from PEEK-OPTIMA® HA Enhanced, a polymer from Invibio Biomaterial Solutions. The Trigon® Stand-Alone Osteotomy Wedge Fixation System has osteoconductive properties that promote multi-directional bone healing and improved fixation without introducing material-related bio-incompatibility reactions. The Trigon system enables a standard surgical technique that allows direct and exact placement of implant and screws without additional plating. Additionally, the Trigon system utilizes Structural Encoding® to enable the Unique Device Identification (UDI) required by the FDA.

“It is always our goal to deliver high quality health care that improves the health of our community. Being the host of these groundbreaking orthopaedic surgeries is a stellar example of that commitment,” said Patricia Burns, President, CHRISTUS Santa Rosa Hospital – Westover Hills. “Our hospital is proud to partner with manufacturers like Nvision that develop technology resulting in better patient outcomes.”

“It is an ideal situation when you have the opportunity to work with an innovative company locally with products that are more intuitive to utilize in surgery with the patient in mind,” said Dr. Farber. “Nvision is bringing innovation to the San Antonio community through its devices and an in-house cadaver lab, which helps test devices, make adjustments, and accelerate the benefit to patients.”

In the weeks since the initial surgeries, surgeons across the country have made plans to implement the Trigon system into their patient care. To date, 12 surgeries have been performed. Nvision, which was founded in 2013, is quickly becoming the largest medical device manufacturer in San Antonio with 17 FDA cleared devices across a range of orthopaedic specialties. In the last year, Nvision added seven products with FDA clearance to its portfolio with an additional two currently in FDA review.

“From the beginning, our goal with Nvision has been to engage in our community and provide innovative solutions for our families and neighbors and CHRISTUS Santa Rosa Health System has been a supporter of this mission,” said Brian Kieser, Nvision founder. “By collaborating with hospitals like CHRISTUS Santa Rosa Hospital – Westover Hills and local surgeons like Dr. Farber, we are making great strides with bringing healthcare innovation to San Antonio, our home.”

“Nvision is bringing innovation to the San Antonio community through its devices and an in-house cadaver lab, which helps test devices, make adjustments, and accelerate the benefit to patients.”

said Dr. robert farber

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About Dr. Robert Farber
Dr. Robert Farber received his Doctorate of Podiatric Medicine with honors from Temple University School of Podiatric Medicine in Philadelphia. While enrolled, he served as the President of the Student Government. He was also inducted into the national podiatric honor and service societies.

Dr. Farber then completed his residency at Inova Fairfax Medical Campus in Fairfax, Virginia, where he served as Chief Podiatric Resident. While in residency, he performed more than 1,800 procedures from elective bunion and hammertoe surgery to complex rearfoot and ankle reconstruction. He also published multiple podiatric medical and surgical abstracts, resulting in a national award in forefoot surgery.

About Nvision BioMedical Technologies
Nvision is a San Antonio-based medical device and implant manufacturer focused on providing surgeons with implants paired with instrumentation and biologics that simplify and improve surgery procedures to help patients get back to their quality of life. Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patient, surgeons, healthcare providers, and distribution partners in mind. 

Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts. Find out more at www.nvisionbiomed.com

About CHRISTUS Santa Rosa Health System
Founded in 1869 by the Sisters of Charity of the Incarnate Word of Houston and San Antonio, CHRISTUS Santa Rosa is a Catholic, faith-based, nonprofit health and wellness ministry dedicated to extending the healing ministry of Jesus Christ and providing the highest quality medical care and services available. As one of the top health care organizations in South-Central Texas, CHRISTUS Santa Rosa has five hospital campuses. The Children’s Hospital is located in downtown San Antonio. We also have hospitals located in the South Texas Medical Center, New Braunfels, San Marcos, Westover Hills, and a surgical hospital in Alamo Heights. CHRISTUS Santa Rosa Health System also owns a majority interest in CHRISTUS Santa Rosa Physicians Ambulatory Surgery Centers – San Antonio, LLC, a joint venture physician partnership, which is comprised of two outpatient surgery centers in San Antonio with facilities in Stone Oak and the Medical Center. Additionally, CHRISTUS Santa Rosa Health System owns a majority interest in the CHRISTUS Santa Rosa Physicians Ambulatory Surgery Centers in New Braunfels and San Marcos, which are joint venture physician partnerships. For additional information on CHRISTUS Santa Rosa, visit www.christussantarosa.org. Find us on Facebook at www.facebook.com/christussantarosa and follow us on Twitter at http://twitter.com/CSRHS.

Media Contacts

Nvision Biomedical Technologies media contact
Bonnie Caver, bonnie@replighthouse.com, Phone 512-217-5397

Nvision Biomedical Technologies: First FDA clearance for an osteotomy wedge system made of PEEK-OPTIMA™ HA Enhanced

Nvision Biomedical Technologies: First FDA clearance for an osteotomy wedge system made of PEEK-OPTIMA™ HA Enhanced

Growing product portfolio for lower extremities made of the innovative, bone on-growth biomaterial

San Antonio, Texas/ Thornton Cleveleys (UK), October 28, 2020 – Nvision Biomedical Technologies, a San Antonio-based medical device and implant manufacturer, has FDA clearance for the first osteotomy wedge system made from PEEK-OPTIMA HA Enhanced, a polymer from Invibio Biomaterial Solutions (‘Invibio’). The Trigon® Stand-Alone Osteotomy Wedge Fixation System has osteoconductive properties that promote multi-directional bone healing and improved fixation without introducing material-related bio-incompatibility reactions. Additionally, the Trigon system utilizes Structural Encoding® to enable the Unique Device Identification (UDI) required by the FDA.

“Nvision’s Trigon Osteotomy Wedge system, along with the entire foot and ankle line, is incorporating multiple technologies that I believe will be major factors in the future of reconstructive distal extremity surgery,”

said Dr. Kyle Vaughn, founder of Paradise Valley Foot and Ankle in Phoenix Ariz.

The Trigon system, made from PEEK-OPTIMA HA Enhanced, enables a standard surgical technique that allows direct and exact placement of implant and screws without additional plating. Nvision collaborated with Invibio for the FDA 510(k) submission to obtain clearance for the new implant.

PEEK-OPTIMA HA Enhanced provides a potential for earlier fusion/union for foot and ankle implants, a surgeon’s primary goal for fusion surgery. It does so because Hydroxyapatite (HA) is fully integrated within the matrix of Invibio’s PEEK-OPTIMA Natural. As it is integrated, not coated, the HA is available on all surfaces of a finished device. In combination with a modulus of elasticity closely matching that of actual bone, PEEK-OPTIMA HA Enhanced has the potential to promote faster bone ongrowth and healing. Its radiolucent properties result in artifact-free imaging with the ability to easily monitor the healing process.

After initially focusing on spinal implants, Nvision is now applying many of the same advanced technologies to lower extremity surgery, having launched the Vector® Hammertoe Correction System into the market in March 2019. An industry first, the hammertoe system was the initial foot and ankle implant made from the advanced, biocompatible PEEK-OPTIMA™ HA Enhanced. It was also the first lower extremity (Proximal Interphalangeal Joint Arthrodesis) implant to use Structural Encoding, the patented technology platform licensed from Watershed Idea Foundry. Earlier this year, Nvision also launched the Trigon titanium wedge, which utilizes additive manufacturing and 3D-printed medical-grade titanium alloy (Ti-6AI-4V) material.

“The ability to innovate with advanced materials, designs, and manufacturing processes allows us to add products to our portfolio that give surgeons the opportunityto achievethe best outcomes for their patients,”

said Tom Zink, Senior Vice President of Product Development.

With a focus on driving innovation for the foot and ankle segment, Nvision has several new products in the pipeline utilizing PEEK-OPTIMA HA material.

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About Nvision Biomedical Technologies
Nvision is a San Antonio-based medical device and implant manufacturer focused on providing surgeons with implants paired with instrumentation and biologics that simplify and improve surgery procedures to help patients get back to their quality of life. Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patient, surgeons, healthcare providers, and distribution partners in mind. Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts. Find out more at www.nvisionbiomed.com

About Invibio Biomaterial Solutions
Invibio, part of the Victrex plc group of companies, is a global leader in providing high-performance biomaterial solutions to medical device manufacturers.  The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic and dental medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in approximately 13 million implanted devices worldwide.

JUVORA™, INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies.  All rights reserved. Find out more at https://invibio.com/

About Victrex
Victrex is an innovative world leader in high-performance PEEK and PAEK polymer solutions focusing on the strategic markets of automotive, aerospace, energy (including manufacturing and engineering), electronics and medical. Every day, millions of people use sustainable products and applications containing our materials – from smartphones, aeroplanes and cars to oil and gas operations and medical devices. With over 40 years‘ experience, we are developing world leading solutions with PEEK and PAEK-based polymers and selected semi-finished and finished parts which shape future performance for our customers and our markets, deliver environmental and societal benefits, and drive value for our shareholders. Find out more at www.victrex.com

Media Contacts

Invibio Biomaterial Solutions media contact
Miriam Kingsley, Marketing Communications Manager, miriam.kingsley@invibio.com, Phone +44 (0) 1253 898000

Nvision Biomedical Technologies media contact
Bonnie Caver, bonnie@replighthouse.com, Phone 512-217-5397

Victrex media contact
Beate Sauer, PR & Marketing Communications Manager, bsauer@victrex.com, Phone +49 61 92 / 96 49 19

Corporate, Financial Media or Investor Relations Enquiries
Andrew Hanson, Director of Investor Relations & Corporate Communications, ahanson@victrex.com, Phone +44 12538 98121

Victrex plc and/or its group companies (Victrex plc) believes that the information contained in this press release is an accurate description of the typical characteristics and/or uses of the product(s) and is based on information that we believe is reliable.  However, it is provided for information only. It is not intended to amount to advice on which you should rely and should not be construed as, or used as a substitute for other professional or specialist advice. In particular, it is the customer’s responsibility to thoroughly test the product in each specific application to determine its performance, efficacy, and safety for each end-use product, device or other application. Suggestions of product uses should not be taken as inducements to infringe any particular patent. Mention of a product in this document is not a guarantee of its availability. 

Victrex plc reserves the right to modify products, specifications and/or packaging as part of a continuous program of product development. Victrex plc makes no warranties, express or implied, including, without limitation, a warranty of fitness for a particular purpose or of intellectual property non-infringement, including but not limited to patent non-infringement, which are expressly disclaimed, whether express or implied, in fact or by law.

Further, Victrex plc makes no warranty to your customers or agents, and has not authorised anyone to make any representation or warranty other than as provided above. Victrex plc shall in no event be liable for any general, indirect, special, consequential, punitive, incidental or similar damages, or any damages for harm to business, lost profits or lost savings, even if Victrex has been advised of the possibility of such damages regardless of the form of action. The foregoing does not seek to affect our liability in respect of: (i) death or personal injury arising from our negligence; (ii) fraudulent misrepresentation; (iii) product liability or other consumer remedy claims brought by an individual consumer in relation to our products; (iv) nor any other liability which cannot be excluded or limited under applicable law.

Copyright ©2020 Invibio Ltd. INVIBIO™, JUVORA™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

US FDA clears first foot and ankle implant made from PEEK-OPTIMA™ HA Enhanced

US FDA clears first foot and ankle implant made from PEEK-OPTIMA™ HA Enhanced

Innovative implant from Nvision corrects hammertoe, and expands product offering to lower extremitiesSan Antonio, TX (US) / Thornton Cleveleys (UK), March 11, 2019 – The Vector™ Hammertoe Correction System, a bioimplant from Nvision Biomedical Technologies, a medical device and biologics company, has been cleared by the FDA for use in the US. It is the first foot and ankle implant to be made from the advanced, biocompatible PEEK-OPTIMA™ HA Enhanced, a polymer from Invibio Biomaterial Solutions™.It is also the first lower extremity (Proximal Interphalangeal Joint Arthrodesis) implant to use Structural Encoding® to enable the Unique Device Identification (UDI) required by the FDA.From focusing on spinal implants, Nvision is now expanding its product portfolio to lower extremities – with the goal to improve patient quality of life in this segment. “Hammertoe correction is one of the most common foot and ankle procedures, but we realized there are opportunities to improve outcomes,” said Tom Zink, Nvision Senior Vice President of Product Development. “We have seen real patient success with our interbody fusion product line using Invibio’s PEEK-OPTIMA™ Natural polymer. Now with our Vector Hammertoe Correction System, we are utilizing the PEEK-OPTIMA™ HA Enhanced material to translate and expand this innovation in foot and ankle surgeries.”

Strong partnership to transfer bone apposition benefits to lower extremity applications. Nvision has developed the Vector Hammertoe Correction System for Proximal Interphalangeal Joint Arthrodesis to offer innovative features including the potential of early bone ongrowth using PEEK-OPTIMA™ HA Enhanced. In addition, it gives surgeons the ability to correct hammertoe issues with a 100% revisable implant.Invibio closely partnered with Nvision to develop testing, and optimize the manufacturing process, while providing support regarding regulatory requirements for the FDA 510(k) submission to obtain clearance for the new implant. The Vector Hammertoe Correction System is also the first lower extremity implant to incorporate Structural Encoding, a patented technology platform licensed from Watershed Idea Foundry that enables the unique identification of medical devices, by means of permanent direct part marking. The technology is able to embed the entire history of the device, and the data can be read by simple X-ray imaging.”

To date, devices made from PEEK-OPTIMA HA Enhanced have been used exclusively for spinal interventions. Nvision’s Vector system is the first time we’ve seen such a device cleared by the US FDA for other than spinal applications,” noted John Devine, Medical Business Director, Invibio Biomaterial Solutions. “What we’ve achieved here, with Nvision and Invibio working as project partners, is a solution for a relatively common but curiously challenging problem, the curled up, calcified toe. The result is a very small device, but one that for many hammertoe patients could literally shape a better future.”

PEEK-OPTIMA HA Enhanced provides a potential solution for fusion across the joint, a surgeon’s primary goal for hammertoe surgery. It does so because hydroxyapatite (HA) is fully integrated within the matrix of Invibio’s PEEK-OPTIMA Natural. This means the HA is integrated, not coated, and available on all surfaces of a finished device. In combination with a modulus of elasticity closely matching that of actual bone, PEEK-OPTIMA HA Enhanced has the potential to promote bone on growth and healing. Its radiolucent properties result in artifact-free imaging with the ability to easily monitor the healing process. Nvision’s new foot and ankle implant enables a standard surgical technique that allows direct drilling and the exact placement of the implant. In doing so, the Vector Hammertoe Correction System offers considerable advantages over a conventional K-wire implant procedure:

  • It achieves a press fit between the implant and the bone since the cavity is accurately drilled and controlled.
  • The precision instrumentation of the Vector system promotes ease of insertion, further improving the success of the procedure.
  • The Structurally Encoded pin, once pressed into position, allows for a greater pull-out force than other PEEK hammertoe implants.

Nvision realized that the small cross sectional area of the intermediary canal makes PEEK-OPTIMA HA Enhanced, with its potential for promoting osteointegration on the implant, the perfect material for hammertoe correction. Fusion is expected to be stronger, and the patient should be satisfied with the outcome.

AAOS 2019 Annual Meeting, March 13-15, Las Vegas, Nevada: Invibio and Nvision to showcase milestones

Driving innovation for the foot and ankle segment, Nvision is currently exploring the development of additional lower extremity devices using PEEK-OPTIMA HA Enhanced. At the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting – March 13-15, 2019 Nvision will showcase its recent innovations at booth 4861, and Invibio at booth 2829.

For further information about Nvision Biomedical Technologies, visit www.nvisionbiomed.com

For further information about Invibio Biomaterial Solutions, visit www.invibio.com

About Nvision Biomedical Technologies

Nvision is a San Antonio-based medical device and biologics company focused on providing surgeons with implants paired with instrumentation and biologics that simplify and improve surgery procedures to help patients get back to their quality of life. Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patient, surgeons, healthcare providers and distribution partners in mind. Nvision is aligned with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts. Find out more at www.nvisionbiomed.com

About Invibio Biomaterial Solutions

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

INVIBIO™, PEEK-OPTIMA™, JUVORA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved. Find out more at www.invibio.com

About Victrex plc

Victrex is an innovative world leader in high performance PAEK/PEEK polymer solutions, focussed on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With 40 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at www.victrex.com

Media Contacts

Invibio Biomaterial Solutions media contact

Barbara Pasciak, Marketing Communications Manager, barbara.pasciak@invibio.com, Phone 484-342-6041

Nvision Biomedical Technologies media contact

Bonnie Caver, bonnie@replighthouse.com, Phone 512-217-5397

Victrex media contact Beate Sauer, PR & Marketing Communications Manager, bsauer@victrex.com, Phone +49 61 92 / 96 49 19

Victrex corporate, financial media or investor enquiries

Andrew Hanson, Director of Investor Relations & Corporate Communications, ahanson@victrex.com, Phone +44 12538 98121

Victrex plc and/or its group companies (Victrex plc) believes that the information contained in this press release is an accurate description of the typical characteristics and/or uses of the product(s) and is based on information that we believe is reliable. However, it is provided for information only. It is not intended to amount to advice on which you should rely and should not be construed as, or used as a substitute for other professional or specialist advice. In particular, it is the customer’s responsibility to thoroughly test the product in each specific application to determine its performance, efficacy, and safety for each end-use product, device or other application. Suggestions of product uses should not be taken as inducements to infringe any particular patent. Mention of a product in this document is not a guarantee of its availability.

Victrex plc reserves the right to modify products, specifications and/or packaging as part of a continuous program of product development. Victrex plc makes no warranties, express or implied, including, without limitation, a warranty of fitness for a particular purpose or of intellectual property non-infringement, including but not limited to patent non-infringement, which are expressly disclaimed, whether express or implied, in fact or by law.

Further, Victrex plc makes no warranty to your customers or agents, and has not authorised anyone to make any representation or warranty other than as provided above. Victrex plc shall in no event be liable for any general, indirect, special, consequential, punitive, incidental or similar damages, or any damages for harm to business, lost profits or lost savings, even if Victrex has been advised of the possibility of such damages regardless of the form of action. The foregoing does not seek to affect our liability in respect of: (i) death or personal injury arising from our negligence; (ii) fraudulent misrepresentation; (iii) product liability or other consumer remedy claims brought by an individual consumer in relation to our products; (iv) nor any other liability which cannot be excluded or limited under applicable law.

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Nvision Biomedical Technologies Launches Pedicle Screw System at NASS

Nvision Biomedical Technologies Launches Pedicle Screw System at NASS

LOS ANGELES – Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, debuted its focus® Pedicle Screw System today at the North American Spine Society (NASS) Annual Meeting, held at the Los Angeles Convention Center, September 26-29. 

The Nvision focus Pedicle Screw System, which received clearance from the U.S. Food and Drug Administration (FDA) in April, keeps patient safety in mind by focusing on ease and flexibility of use by surgeons. The system offers both minimally invasive and open surgery options with standard double lead thread and midline cortical thread options.

The midline cortical thread has a fast-starting initial thread, which is ergonomically designed and allows the surgeon to move faster in surgery. Additionally, the cortical option provides surgeons the flexibility to utilize a midline approach and not just a pedicle approach. For minimally invasive procedures, surgeons have an option to use a tower attachment or an extended tulip design with break-away tabs. This innovative technology allows for common instruments across procedures giving surgeons a choice without having to worry about specific instrumentation per system. Additionally, focus provides benefits for the hospital and surgical support team as well by streamlining implant delivery; minimizing tray space and limiting the number of instruments.

“As we expand our product portfolio at Nvision, our goal is to create devices and instrumentation that address industry challenges and provide solutions for surgeons,” said Tom Zink, Nvision Senior Vice President of Product Development. The focus Pedicle Screw System was developed through collaboration with surgeons to make their concept of the optimum pedicle screw system a reality.  

The focus Pedicle Screw System, which will be available to surgeons in December, is Nvision’s latest product to enter the market. The company, which was founded in 2013, has several products in the marketplace including four interbody fusion systems ­– the nv line, one anterior cervical plate system – the tangis® line, and a buttress plate system – the boundary® line. The interbody devices have multiple footprints to adapt to the general shape of the vertebral endplates. Each set is available in a variety of heights to accommodate patient variability. Additionally, Nvision offers products with Structural Encoding®, the industry’s most innovative solution for medical device identification with permanent direct part marking, as well as a portfolio of human tissue allograft products including celera birth tissue patches and fluids as well as forma musculoskeletal bone and sports medicine grafts.

About Nvision Biomedical Technologies

Nvision is a San Antonio-based medical device and biologics manufacturing company focused on providing surgeons implants that are paired with instrumentation and biologics to simplify and improve surgery procedures that help patients get back to their quality of life. 

Nvision is committed to developing and manufacturing thoughtfully designed products combined with exceptional service that keep the patients, surgeons, healthcare providers and distribution partners in mind. Nvision aligns with surgeon thought leaders, key researchers, and development engineers from prestigious institutions to design, test, and bring to market the most innovative concepts.

For More Information

Bonnie Caver
512-832-8588

Nvision Biomedical Technologies Receives FDA Clearance for Pedicle Screw System

Nvision Biomedical Technologies Receives FDA Clearance for Pedicle Screw System

Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, has received clearance from the U.S. Food and Drug Administration (FDA) for its focus® Pedicle Screw System.

The Nvision focus Pedicle Screw System keeps patient safety in mind by concentrating on ease and flexibility of use by surgeons. The system offers both minimally invasive and open surgery options with standard double lead thread and midline cortical thread options.

The midline cortical thread has a fast-starting initial thread, which allows the surgeon to move faster in surgery and saves turns of the wrist. Additionally, the cortical option provides surgeons the flexibility to utilize a midline approach and not just a pedicle approach. For minimally invasive surgeries, there is an extended tulip design which provides a break-away tab that eliminates unwanted tower disconnects.
 
“At Nvision, our goal is to create products that address industry challenges and provide solutions for surgeons,” said Tom Zink, Nvision Senior Vice President of Product Development. “The focus Pedicle Screw System is a key product in that portfolio, offering design and features that address surgical needs.”

The focus Pedicle Screw System is Nvision’s latest product to receive FDA clearance. The company has developed and manufactured several products that received FDA clearance, including four interbody fusion systems – the nv line, one anterior cervical plate system – the tangis® line, and a buttress plate system – the boundary® line. The interbody devices have multiple footprints to adapt to the general shape of the vertebral endplates. Each set is available in a variety of heights to accommodate patient variability. Additionally, Nvision offers products with Structural Encoding®, the industry’s most innovative solution for medical device identification with permanent direct part marking, as well as a portfolio of human tissue allograft products including celera patches, fluids, and forma demineralized bone, and sport medicine grafts.

Nvision Biomedical Technologies First to Launch Devices with Structural Encoding®

Nvision Biomedical Technologies First to Launch Devices with Structural Encoding®

Nvision Biomedical Technologies is the first company to launch devices with Structural Encoding® technology developed by Watershed Idea Foundry.  

Structural Encoding is the industry’s most innovative solution for medical device identification with permanent direct part marking. The technology was launched by Watershed in June at the Unique Device Identification (UDI) Conference in Baltimore. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself.

“Structural Encoding incorporates a method that embeds data within any device in a way that is read through medical imaging,” said Watershed CEO Nick Cordaro. “Just imagine the impact this can make for patients, surgeons, and hospitals to have complete knowledge of an implant merely by taking an X-ray – no more tracking down long-lost paperwork to determine origin or history of an implant.”

Nvision has initially launched three devices in the nv line with Structural Encoding. nv is an anterior cervical interbody fusion system; nv is a posterior lumbar interbody fusion system; and nv is an anterior lumbar interbody fusion system. The devices have FDA clearance and are ready for implant.

“When we looked at solutions for UDI compliance in the marketplace, Structural Encoding was by far the most advanced,” said Tom Zink, Nvision Director of Engineering. “Not only is it the best solution for the patient long-term, it requires the least adjustment for the hospital and surgical teams. For a manufacturer like Nvision, Structural Encoding is also one of the quickest solutions to market with minimal design changes or new FDA approvals.”

About Watershed Idea Foundry
Watershed is an idea foundry created by Fountainhead Investment Partners that focuses on biomedical growth and innovation. Watershed’s purpose is to forge promising ideas into viable intellectual property and products ready for the marketplace, ultimately creating profitable businesses, bringing together industry experts from around the world to guide entrepreneurial ideas.

Watershed works with entrepreneurs exploring their ideas as well as companies that require research and development assistance to move their intellectual property forward. Watershed offers services ranging from proof of concept and product development to manufacturing demonstration and regulatory consulting to funding readiness.

Through Fountainhead Investment Partners, the foundry provides an environment where talent and innovation are funded, nurtured, and guided to create a turning point for ideas.

For Nvision Biomedical Technologies
Bonnie Caver
512-832-8588

Dr. Zeshan Hyder Presents on the Surgical Benefits of Structural Encoding at NASS 2017

Dr. Zeshan Hyder Presents on the Surgical Benefits of Structural Encoding at NASS 2017

Earlier this month, renowned spine surgeon, Zeshan Hyder, DO, became one of the first surgeons to perform an implant surgery utilizing medical devices from Nvision Biomedical Technologies with Structural Encoding®. On Wednesday, Dr. Hyder will present on his experience and benefits of using the ground-breaking technology at the 2017 NASS (North American Spine Society) Conference in Orlando, Fla.

Dr. Hyder’s presentation — In Vivo Unique Device Identification and Traceability Through Structural Encoding of Intervertebral Cages — is a part of the Innovative Technology Presentation series at NASS. Structural Encoding is the industry’s most innovative solution for medical device identification with permanent direct part marking. Its immediate benefit is improved accuracy of information to the surgeon, which leads to improved care for the patient says Dr. Hyder.

“As surgeons, we are always looking for innovative technologies to simplify and improve the quality of patient care, and Structural Encoding does both. With this technology, the entire history of the device and the procedure are embedded within the device and marked permanently. A simple X-ray reveals everything the surgeon and patient ever need to know about the procedure.”

Structural Encoding is a patented technology platform developed by Watershed Idea Foundry in San Antonio, Texas. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself, called Unique Device Identification (UDI). Nvision, a medical device and biologics manufacturer also based in San Antonio, is the first company to create devices using the Structural Encoding technology.

About Dr. Zeshan Hyder
Dr. Zeshan Hyder is a partner with Bone & Joint Specialists in Merrillville, Ind. He is a board-certified orthopedic surgeon, who has been voted Best of the Region for Spine Care by The Times for three straight years.

He graduated Cum Laude from the University of Illinois and throughout his medical education has published articles on various subjects related to arthroplasty and spinal surgery. During his fellowship and residency programs he gained valuable expertise in sports medicine, orthopedics and trauma as well as conservative and surgical management of all orthopedic spinal disorders.

About Watershed Idea Foundry
Watershed is an idea foundry created by Fountainhead Investment Partners that focuses on biomedical growth and innovation. Watershed’s purpose is to forge promising ideas into viable intellectual property and products ready for the marketplace, ultimately creating profitable businesses, bringing together industry experts from around the world to guide entrepreneurial ideas.

Watershed works with entrepreneurs exploring their ideas as well as companies that require research and development assistance to move their intellectual property forward. Watershed offers services ranging from proof of concept and product development to manufacturing demonstration and regulatory consulting, to funding readiness.
Through Fountainhead Investment Partners, the foundry provides an environment where talent and innovation are funded, nurtured, and guided to create a turning point for ideas.

For More Information Contact:
Bonnie Caver
512-832-8588

Spine Surgeons in Texas and Indiana Advance Patient Care with Structurally Encoded Devices

Spine Surgeons in Texas and Indiana Advance Patient Care with Structurally Encoded Devices

Zeshan Hyder, DO, of Bone & Joint Specialists in Merrillville, Ind.; Frank K. Kuwamura, III, MD, of Innovative Spine in San Antonio; and Larry M. Kjeldgaard, DO, of Cervical Spine Specialist in Fort Worth are the first surgeons to implant medical devices with Structural Encoding® technology. The Structural Encoding technology advances patient care by providing permanent marking embedded within the device that is accessible through an x-ray image.

“We are always looking for the best technologies available to improve the results for our patients and get them back to their productive and pain-free activity as quickly as possible. Having a clear knowledge of their history helps us create the best plan of care. Structural encoding provides transparency for surgeons and patients that creates a new level of knowledge from patient research to implant integrity, all of which equals better patient care,” said Dr. Hyder.

Dr. Kuwamura agrees, “As surgeons, we take care to understand our patients’ lifestyles and activity level. The more knowledge we have, the better decisions we can make for their care. Patients move, physicians retire, and when we see patients that have had previous procedures with other surgeons, it can be almost impossible to get their records. We spend significant time trying to track that information down, but sometimes we don’t know what has previously been implanted until we are in surgery. Structural Encoding changes all of that. We now have a way to know everything about a device and previous surgeries simply by taking an x-ray.”

Structural Encoding, a patented technology platform developed by Watershed Idea Foundry, is the industry’s most innovative solution for medical device identification with permanent direct part marking. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself, called Unique Device Identification (UDI). Nvision Biomedical Technologies, a San Antonio-based medical device and biologics manufacturer, is the first company to launch devices with the Structural Encoding technology.

“We work with our patients to determine the best outcomes for getting them back to their quality of life and sometimes that means surgery,” said Dr. Kjeldgaard. “If we do determine surgery is the best course of action, the knowledge we have and the more information we can provide our patients, the better. Structural Encoding gives us an advantage in patient care and gives the patient peace of mind for a lifetime.”

Nvision initially launched three devices in the nv line with Structural Encoding. nv is an anterior cervical interbody fusion system; nv is a posterior lumbar interbody fusion system; and nv is an anterior lumbar interbody fusion system. The initial surgeries were anterior cervical discectomy with fusion at one and two levels, with a structurally encoded nvc PEEK interbody implant. 

 “The entire medical device industry is looking to provide UDI compliant devices, but none are as seamless or as user-friendly as those with Structural Encoding,” said Dr. Hyder. “Structural Encoding is self-contained and doesn’t cause any extra steps or paperwork for the surgeon or the hospital, and that alone is good for our patients.”

About Dr. Zeshan Hyder
Dr. Zeshan Hyder is partner with Bone & Joint Specialists in Merrillville, Ind. He is a board-certified orthopedic surgeon, who has been voted Best of the Region for Spine Care by The Times for three straight years.

He graduated Cum Laude from the University of Illinois and throughout his medical education has published articles on various subjects related to arthroplasty and spinal surgery. During his fellowship and residency programs he gained valuable expertise in sports medicine, orthopedics and trauma as well as conservative and surgical management of all orthopedic spinal disorders.

About Dr. Frank Kuwamura
Dr. Frank K. Kuwamura, the founder and chief surgeon at Innovative Spine in San Antonio, Texas, is a board-certified orthopedic surgeon who specializes in emerging technology for spinal care.

A graduate of Boston University Medical School, Kuwamura completed his internship in general surgery and residency in orthopedic surgery at the National Naval Medical Center in Bethesda, Maryland where he earned the rank of Commander in the 3rd Marine Division. He is a member of the American Academy of Orthopedic Surgeons and the Bexar County Medical Society. He has held the title of Diplomat of the National Board of Medical Examiners and served on the American Board of Orthopedic Surgeons, Board Certification.

About Dr. Larry Kjeldgaard
Dr. Larry M. Kjeldgaard, founder and owner of Cervical Spine Center in Fort Worth and Hurst, Texas is a board-certified orthopedic surgeon who specializes in the treatment of the spine, neck and back.

A graduate from the Philadelphia College of Osteopathic Medicine, Dr. Kjeldgaard completed his residency at the Community General Osteopathic Hospital in Harrisburg, PA, and his orthopedic surgery residency training in Pontiac, Michigan. He’s a member of American Osteopathic Board of Orthopedic Surgeons, American Medical Association, the American Osteopathic Academy of Orthopedics and Texas Osteopathic Medical Association.

For More Information:
Bonnie Caver
512-832-8588

Nvision Adds New Senior VP of Business Development

Nvision Adds New Senior VP of Business Development

Industry veteran tabbed to lead Nvision’s next phase of growth and development of surgical device and tissue product sales.

Nvision Biomedical Technologies, a San-Antonio-based medical device and biologics manufacturer, has expanded its executive staff with the addition of industry sales leader, Thomas (Tom) Slott, as Senior Vice President of Business Development.

In this role, Slott will develop the national distribution and sales network, direct the efforts of the surgical sales teams, manage contractual agreements, and lead the customer relations division. Additionally, he will provide strategic and operational direction regarding medical devices and tissue products.

Before joining Nvision, Slott spent more than 20 years in executive sales roles for several companies in the spinal device marketplace and has been actively engaged in the product development and sales of medical devices since 1979. Throughout his career, he has consistently been one of the top revenue producers at each organization for which he has served.

“Tom brings a wealth of experience and a high level of performance accountability to the Nvision team,” said Brian Kieser, Nvision Founder and Managing Partner of Fountainhead Investment Partners. “We are now emerging from a period of product development, and Tom provides both the clinical and analytical expertise needed to drive sales and create the distributions channels necessary for our success.”

Nvision is committed to improving healthcare by creating and delivering solutions to surgeons that support simplification and improvement of surgical procedures and ultimately the outcomes for patients. The company recently became the first manufacturer to launch products with Structural Encoding®, the industry’s most innovative solution for medical device identification with permanent direct part marking. Additionally, Nvision has several new products in the pipeline at multiple phases of development including testing, FDA submissions, and FDA clearance awaiting market launch.

For More Information
Bonnie Caver
512-832-8588

Fountainhead Investment Partners Invests in Nvision Biomedical Technologies

Fountainhead Investment Partners, a San Antonio-based venture capital firm, has made an investment in Nvision Biomedical Technologies. Terms of the transaction were not disclosed.

Nvision, founded in 2013, provides surgeons implants that are paired with instrumentation and biologics to simplify and improve surgery procedures and help patients get back to their quality of life.

“In just a few years, Nvision has made significant strides as a manufacturer of spine systems,” said Brian Kieser, Managing Partner of Fountainhead Investment Partners. “We are excited about the innovation the company has in development as well as the opportunities for growth in new practice areas. Our investment will assist with launching the next line of products into the market.”

Nvision has developed and manufactured several products that received FDA clearance in Fall 2014 and 2016, including four interbody fusion systems ­– the nv line, and one anterior cervical plate system – the tangis® line. The interbody devices have multiple footprints to adapt to the general shape of the vertebral endplates. Each set is available in a variety of heights to accommodate patient variability. Additionally, Nvision offers a portfolio of human tissue allograft products including patches, fluids, demineralized bone, and sport medicine grafts.

Nvision has several new products in the pipeline at multiple phases of development including testing, FDA submissions, and FDA clearance awaiting market launch.

Nvision joins Alaris Biologics Technologies, Watershed Idea Foundry, and StemBioSys in the Fountainhead investment portfolio.

About Fountainhead Investment Partners

Fountainhead Investment Partners is a venture capital firm, based in San Antonio, Texas, that invests in early-stage companies. Fountainhead was originally founded as an angel fund in 2014 by a group of successful healthcare entrepreneurs with a vision to connect advancing technologies to solve some of medicines’ most complex issues.

In 2015, Fountainhead transitioned to a venture capital firm, with initial funds focused on companies that are accessing innovative technologies from all industries and applying them to the science of medicine with the intention of disrupting the industry while also advancing patient care. Fountainhead makes portfolio investments ranging from $250,000 to $1.5 million.

For More Information:
Bonnie Caver
512-832-8588