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Matrix Surgical USA Featured in GCMI Article - Can You Really Bootstrap a Medtech Company? The Answer Is Yes.

Innovators seeking to enter the world of medtech face a daunting path from concept to commercialization. Design, engineering, prototyping and preclinical testing to prepare a single FDA regulatory submission are just a few examples of the many hurdles medtech innovators must successfully clear before event attempting to realize any revenue.

For John O’Shaughnessy, Founder and CEO of Matrix Surgical USA, the path from concept to commercialization ran successfully through a partnership with GCMI. The result has been the creation of a profitable company in a $250 million market in less than three years since receiving its first 510K. Can you really bootstrap a successful medtech company? The answer is yes, but only if you know where to find the best resources.

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Matrix Surgical USA Donates Surgical Implants to
Reconstruct Children’s Ears through Mending Kids

Atlanta, GA – March 23, 2015 – When John O’Shaughnessy was covering KISS songs in a high school garage band, he never dreamed that one day he would be standing next to Paul Stanley, the band’s guitarist and frontman, at the bedside of a child following microtia surgery.

But that’s exactly where the Founder and CEO of Matrix Surgical USA ended up a few weeks ago as John Reinisch, M.D. used OMNIPORE implants to reconstruct ears for two children with microtia. Microtia is a congenital deformity that occurs in approximately one in 10,000 births, with the child born without outer ears and even ear canals, causing significant hearing loss. Stanley is one of the better-known people to suffer from microtia. The KISS rock star says he knows the loneliness of growing up with microtia and hopes to inspire young patients with his story. Stanley says he was teased and bullied as a kid.

Stanley is a supporter of Mending Kids, a California-based not-for-profit organization that raises money and support for these microtia operations as well as other life-changing surgical care for children worldwide. Over the years, thousands of children have received corrective, transformational surgeries from Mending Kids, giving them a chance at longer, healthier and happier lives.

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Matrix Surgical USA Announces FDA 510(k) Clearance for
Customized High-Density Polyethylene Surgical Implants

Atlanta, GA – May 15, 2014 – Matrix Surgical USA (www.matrixsurgicalusa.com), a leader in the development, manufacturing and commercialization of craniomaxillofacial implants, announced today that it has received a 510(k) clearance to market its High-Density Polyethylene Customized Surgical Implants for use in craniofacial reconstruction and augmentation.

Matrix Surgical USA is currently one of only two companies in the world to have a 510(k) clearance for both off-the-shelf and patient-specific High-Density Polyethylene craniofacial implants.

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Matrix Surgical USA to Become Exclusive Worldwide Licensee
for Patent-Pending Craniofacial Implant System

Atlanta, GA, March 14, 2014 – Matrix Surgical USA, a leader in the development, manufacturing and commercialization of craniomaxillofacial implants, announced today that it has entered into a definitive agreement with Dr. Michael J. Yaremchuk to license a patent-pending craniofacial implant system (US patent application 20120330427).

Under the terms of the agreement, Matrix Surgical USA will use its proprietary technology to manufacture implants designed by Dr. Yaremchuk for use in craniofacial reconstruction and augmentation procedures. Through the collaboration, Dr. Yaremchuk and Matrix Surgical USA will use their complementary clinical and engineering capabilities to develop and manufacture next-generation implant shapes that provide better outcomes for plastic surgeons and their patients.

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Matrix Surgical USA Receives CE Mark and ISO 13485:2003 Certification

Atlanta, GA, December 19, 2012 – Matrix Surgical USA announced today that it has received CE Mark approval as well as certification for ISO 13485:2003 for its OMNIPORE® High-density Porous Polyethylene craniofacial implants for reconstructive and aesthetic craniofacial surgery. Manufactured in the USA, OmniPore Surgical Implants meet the highest standards for quality and reliability, providing surgeons with an expanded range of options to achieve the best possible outcome for their patients.

“We can now provide surgeons in all countries recognizing the CE Mark with OmniPore Surgical Implants. These state-of-the-art sterile devices are of the highest quality and provide a cost-effective solution to the difficult challenges faced by craniofacial surgeons every day,” said John O’Shaughnessy, President and CEO of Matrix Surgical USA. “We believe that our years of industry experience have contributed to reaching these important goals ahead of schedule.”

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John O'Shaughnessy, Founder and CEO of Matrix Surgical USA (left), with Paul Stanley, KISS guitarist and frontman.
Jim Perez (right) of Matrix Surgical USA with Governor Nathan Deal at the GLOBE Awards. Matrix Surgical USA was recently recognized  a GLOBE (Georgia Launching Opportunities By Exporting) Award for entering one or more new international markets in 2014.
Matrix Surgical USA recently announced an agreement to become the exclusive worldwide licensee for the patent-pending craniofacial implant system developed by Dr. Michael Yaremchuk, the author of the acclaimed book, "Atlas of Facial Implants."