CorMatrix Cardiovascular Secures Fifty-six (56) Patents in 2016 Expanding Patent Protection for Extracellular Matrix (ECM®) Based Implantable Devices

(Roswell, GA –Jan 19, 2017) – CorMatrix® Cardiovascular, Inc., (www.cormatrix.com) a leading developer of biomaterial compositions and medical devices for regenerative medicine, today announced the issuance of 56 patents in 2016.  The ongoing expansion of this patent portfolio continues to support the Company’s development of novel extracellular matrix (ECM®) based devices and compositions. Of the fifty-six patents, 19 were obtained internationally. CorMatrix currently holds 13 trademarks related to its Extracellular Matrix products and the Company has secured some 128 patents affording significant intellectual property protection in the area of regenerative medicine. CorMatrix ECM is a naturally occurring bioscaffold that remodels over time into healthy, organized tissue that is site specific.

“CorMatrix’s intellectual property portfolio is outstanding. We have very comprehensive coverage of not only the ECM devices we provide to our core markets, but also of the innovations that can find applications in other important areas of regenerative medicine,” said Robert Matheny, MD, CSO of CorMatrix. “From the beginning, we recognized the importance of developing and then protecting our technology. As a pioneer in the field of regenerative science since 2001, having our patents recognized by offices around the globe (United States, Europe, South America, Australia and others) is a source of pride for the entire Company, our Partners, and our Investors.”

Extracellular matrix has been used as a biologic scaffold in many different surgical applications including cardiac and vascular repairs, pelvic floor reconstructions, dental surgery, and veterinary medicine to identify a few. A steady production of both preclinical and clinical data support the need for organs and tissues to have an inductive scaffold for the cells, particularly stem cells, to be retained, restored, and to function normally.

Among the patents issued this year, CorMatrix secured US 9,352,070 for use as a tissue prosthesis which can be engineered into a variety of shapes and used to repair, reconstruct or replace damaged or diseased tissue and the associated biological structures. This includes seamless tubular uses (for vein and arterial replacements), heart valves, myocardium, pericardium and other significant aortic structures. Use of ECM as a prosthetic also could also be extended to esophageal, tracheal, and bronchial anatomy. The Company currently has 510(k) clearances for their implantable ECM devices used in adult and pediatric cardiac tissue repair, pericardial reconstruction, and vascular repair.

Two additional patents, US 8,980,296 and US 8,877,224; along with the issuance of European patent No. 2398502, may significantly address issues surrounding the prevention, reduction, and treatment of myocardial damage and arrhythmic sequelae. Atrial fibrillation, (AFib or AF) is the most common type of heart arrhythmia and affects an estimated 3-6 million people in the United States. More than 750,000 hospitalizations occur each year because of AFib and costs the United States approximately $6 billion each year. Through these patents, micronized extracellular matrix (with or without stem cells) is delivered via intra-myocardial injection into the area of infarct enabling regrowth and restoration of the native cardiac function. Medical costs for people with AFib are almost $9K higher per year than for people who do not have AFib.1, 2 

“Our CorMatrix technology backed by the Company’s patents is harnessing the potential of stem cells and matrix factors working together to regenerate site specific tissue,” said Andrew Green, CEO of CorMatrix.  “We now have preclinical and human evidence of regenerating heart muscle after myocardial infarctions and myocardial tissue replacement treatments. No other company, stem cell based or otherwise, has been able to demonstrate this concept. Now our goal is to make it available around the world.”

1  January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. Journal of the American College of Cardiology. 2014; 64(21):2246–80.

2 Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015; 131:e29–e322.

CorMatrix Cardiovascular, Inc. Named as One of Six Innovative Pediatric Medical Device Projects Selected for Seed Grant Awards by Atlantic Pediatric Device Consortium (APDC)

Atlanta, GA:  A device to measure a child’s pain. A video game to treat lazy eye. A tool that assesses concussions in real time. These are just some of the innovative medical device projects that were selected to receive critical seed funding when the Atlantic Pediatric Device Consortium (APDC) hosted its sixth annual innovation competition in September at the Petit Institute for Bioengineering and Bioscience. Six projects in all, designed to improve the healthcare options for children, emerged as the big winners in the annual competition, an opportunity for the scientific and business community (entrepreneurs, clinicians, scientists, businesses, academic researchers, graduate and undergraduate students) to develop and commercialize a pediatric medical device.

The winners which included Michelle LaPlaca, Petit Institute researcher and associate professor in the Wallace H. Coulter Department of Biomedical Engineering, were selected from 11 finalists who presented their projects in front of a review committee, the APDC Executive Board, and an audience of their peers, during September’s event. The six awardees represent a wide range of projects. The winners are:

Project: Brain Buddy/VR Detect, multimodal concussion assessment in children using virtual reality
Principal Investigator: Michelle C. LaPlaca
Company: Georgia Institute of Technology / Emory University (Atlanta, GA)
The Device: This is a multi-modal tool for objective concussion assessment that can be deployed in real-time to aid in medical decision-making in non-traditional environments. In contrast to currently marketed technologies, this tool incorporates the three key pillars of concussion assessment (neuropsychological, balance, and oculomotor testing) within a single unit that is portable, rapid, and simple to use.

Project: In vivo regenerating tubular mitral valve device for neonates and infants
Principal Investigator: Robert Matheny
Company: CorMatrix Cardiovascular, Inc. (Roswell, GA)
The Device: Based on proven CorMatrix products and technology, this regenerating tubular Extracellular Matrix (ECM) mitral valve replacement remodels into a patient’s own tissue by the attraction of host cells and stem cells to the matrix. Over the course of several months the valve matrix will be infiltrated with host cells that will slowly remodel it into a functional mitral valve with growth potential.

Project: Binocuclear, a binocular medical device for the treatment of amblyopia
Principal Investigator: Joseph Koziak, Robert Derricotte, and Vidhya Subramanian
Company: Amblyotech Inc. (Marietta, GA)
The Device: Binocuclear is a novel and patented medical device for the treatment of amblyopia, an ocular disorder also known as “lazy eye” that develops in infancy or early childhood. The binocular game is pre-loaded in a gaming device (iPad or a similar tablet device) and prescribed by a physician.

Project: LifeFlow, a novel rapid infusion device for pediatric resuscitation
Principal Investigator: Mark Piehl
Company: 410 Medical Innovation (Durham, N.C.)
The Device: Umbilical catheterization is  important for delivering medication and nutrition to critically ill newborns.  The proposed product standardizes and simplifies umbilical catheter securement, enhances protection of the umbilical stump, and minimizes translation of the catheter. LIFEbubble targets the major sources of infection and works to prevent infections by protecting against bacteria and bacteria migration, and stabilizing the umbilical catheter.

Project: AlgometRx, a novel device and method for the objective measurement of pain and analgesic drug effect in children
Principal Investigators: Julia C. Finkel and Dan Gura
Company: Children’s National Medical Center (Washington D.C.)
The Device: AlgometRx integrates a novel smartphone-based pupillometer and a specific neuro neuro-stimulator. The device measures objective pupillary constriction and dilation to gather vital data about a patient’s pain experience or drug effect that can be recorded, characterized and assessed.

Project: LIFEbubble, a standardized device that protects and stabilizes umbilical catheters to reduce central line-associated bloodstream infections in the neonatal intensive care unit
Principal Investigator: Eric Chehab, Carl Dambkowski, Eric Johnson, Shivani Torres, James Wall, and Ross Venook
Company: Stanford University (Stanford, CA)
The Device: Umbilical catheterization is a lifeline for delivering medication and nutrition to critically ill newborns.  The proposed product standardizes and simplifies umbilical catheter securement, enhances protection of the umbilical stump, and minimizes translation of the catheter. LIFEbubble targets the major sources of infection and works to prevent infections by protecting against bacteria and bacteria migration, and stabilizing the umbilical catheter.

The APDC Innovation Competition Review Committee (comprised of pediatricians, engineers, business professionals and venture capitalists) selected winners based on the following factors: 1) clinical significance of the pediatric device, 2) approach to product development, 3) likelihood for marketing success, 4) project team, environment, and resources, and 5) potential for additional funding. The six projects that were awarded seed grants are placed under contract to APDC to complete a specific set of tasks that move their pediatric medical device project along the product development pathway – a route to market defined by the Food and Drug Administration (FDA) as concept to prototype to pre-clinical to clinical to manufacturing to marketing, right on to commercial use. The APDC monitors project progress and offers assistance with device development, prototyping, biostatistical consulting and trial design, selection of manufacturing partners, determining regulatory strategy, and business development and planning.

With funding from the FDA Office of Orphan Products Development, the APDC’s mission is to enhance the lives of children through the development of novel, safe, and effective pediatric medical devices. The consortium fosters an environment of creativity, where innovative ideas are reviewed, tested, and developed by a multidisciplinary team of experts from Georgia Tech, Emory, Virginia Commonwealth University, and Children’s Healthcare of Atlanta.

CONTACT:
Jerry Grillo
Communications Officer II
Parker H. Petit Institute for Bioengineering and Bioscience

CorMatrix® CanGaroo® ECM® Envelope Receives CE Mark Approval

(Roswell, Georgia – June 28, 2016) – CorMatrix® Cardiovascular Incorporated, a company specializing in its extracellular matrix (ECM®) technology announced today that it has received CE mark approval for its CorMatrix® CanGaroo® ECM® Envelope.  It is intended for use with cardiac implantable electronic devices (CIED’s) including pacemakers and implantable cardioverter defibrillators (ICD’s).  The company received U.S. FDA clearance to market the device in August of 2014. CorMatrix® ECM® acts as a scaffold into which a patient’s cells migrate and integrate, stimulating natural wound healing mechanisms.

In recent world surveys of cardiac pacing 1,2,3,4 most European countries showed an increase in new CIED implants per million population compared with previous years. “With data trending toward increases in the number of implants in Europe, we’re excited to make this device available to the Electrophysiology communities of Europe.” said Andrew Green, President and Chief Operating Officer of CorMatrix.

The CanGaroo® differs from other device pockets on the market because it’s made from porcine derived extracellular matrix (ECM); not synthetic materials. When synthetic material is implanted, inflammatory “M1” macrophages are triggered5, 6 which can result in fibrotic scar formation. Alternatively, the CorMatrix CanGaroo is made from ECM—a natural biologic that triggers a healing, regen­erative “M2” response 5, 6 allowing it to remodel into neo-vascularized tissue that is systemically connected. Other benefits of the device include stabilization, support and reinforcement of the pocket which may reduce the risk of device migration and erosion. It conforms to CIEDs and may ease their removal during exchanges or revisions. In addition, the CanGaroo® is soft and supple, with no sharp edges which may enhance patient comfort.

The CorMatrix® CanGaroo® envelope is available in four sizes to fit an array of device types and sizes. The company will make the CanGaroo available via its international distributors.

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Mond HG, Irwin M, Morillo C, et al. The world survey of cardiac pacing and cardioverter defibrillators: calendar year 2001. Pacing Clin Electrophysiol 2004; 27(7):955-64

2   Mond HG, Irwin M, Ector H, et al. The world survey of cardiac pacing and cardioverter defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol 2008; 31(9):1202-12.

3 Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators:  calendar year 2009–a World Society of Arrhythmia’s project. Pacing Clin Electrophysiol 2011; 34(8):1013-27.

4 Ector H and Vardas P. Current use of pacemakers, implantable cardioverter defibrillators, and resynchronization devices: data from the registry of the European Heart Rhythm Association. Eur Heart J (2007): 9(suppl I), 144-149.

ECM-Based Materials in Cardiovascular Applications: Inherent Healing Potential and Augmentation of Native Regenerative Processes Anna V. Piterina, Aidan J. Cloonan, Claire L. Meaney, Laura M. Davis, Anthony Callanan, Michael T. Walsh and Tim M. McGloughlin;  Int. J. Mol. Sci. 2009, 10(10), 4375-4417; doi: 10.3390/ijms10104375

6 Exploring the full spectrum of macrophage activation David M. Mosser and Justin P. Edwards, Department of Cell Biology and Molecular Genetics and the Maryland Pathogen Research Institute, University of Maryland, College Park, Mary­land 20742, USA. Nat Rev Immunol. 2008 December; 8(12): 958–969. doi: 10.1038/nri2448.

CorMatrix® Cardiovascular, Inc. Treats First Patients with New Tyke® Product for Neonates and Infants

Extracellular Matrix (ECM®) Now an Alternative for Congenital Heart Defect Repairs in Smaller Structures

(Roswell, GA – June 21, 2016) – CorMatrix Cardiovascular, Inc., a leading developer of biomaterials and medical devices, today announced the treatment of the first patients using its CorMatrix® Tyke®, a product specifically designed and cleared for cardiac tissue repairs in neonates and infants.  The product received FDA 510(k) clearance in February 2016.  CorMatrix® Tyke® is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing, and cardiac repair. Tyke® is made of 2 layers of CorMatrix® ECM® as compared to the 4 layers of the current CorMatrix® ECM® for Cardiac Tissue Repair, therefore providing a thinner product for smaller repairs.

Dr. Frank Scholl, Chief, Pediatric & Congenital Heart Surgery and Surgical Director, Pediatric Heart Transplant  and Dr. Steven Bibevski, Pediatric & Congenital Cardiac Surgeon, both at Joe DiMaggio Children’s Hospital in Hollywood, FL  were the first to implant the CorMatrix® Tyke® ECM® device.   The company is implementing a phased commercial launch of the device involving approximately 20 pediatric centers who will be trained and certified to receive the device. Tyke® was developed as an alternative to synthetic grafts or patches, and for complex reconstructive surgeries in neonates and infants with congenital heart defects (CHD).

Dr. Scholl noted “The availability of Tyke and its 2 ply construction will allow us the ability to repair the tiniest structures in the most delicate and tiniest of newborn babies, and achieve a more accurate—and hopefully—more durable repair.  We are excited about the future Tyke provides for our most fragile patients.”

The American Academy of Pediatrics and the Congenital Heart Public Health Consortium (CHPHC) estimates congenital heart defects are the most common birth defects. Nearly 1 of every 100 babies is born with a CHD and each year, approximately 40,000 babies are born in the United States with a congenital heart defect. [Source: CHPHC]. Most CHD-related surgical procedures require the use of prosthetic material for reconstruction of intracardiac and extra cardiac structures. Several different biological and prosthetic materials are commonly used in surgery including autologous pericardium, preserved homograft, bovine pericardium, and polytetrafluoroethylene. None of these alternatives represents the ideal prosthetic tissue, which should be pliable and easy to handle, resistant to calcification or shrinkage. Most importantly, it should have growth potential and should not induce formation of scar tissue.¹

Andrew Green, President and Chief Operating Officer commented, “We are excited to partner with our pediatric cardiac surgeons to deliver Tyke as product developed to address a specific need in the neonatal and infant population.  CorMatrix Tyke is one of the few products commercially available that is specifically designed and labeled for the treatment of neonate and infant cardiac tissue repair.”

About CorMatrix

CorMatrix Cardiovascular, Inc. is a privately held medical device company dedicated to developing and delivering innovative biomaterial devices that harness the body’s own innate ability to repair damaged cardiac and vascular tissues.  CorMatrix® ECM® Technology allows surgeons to restore the native anatomy of cardiac and vascular tissue in need of repair, serving as a superior alternative to synthetic or cross-linked materials. Headquartered in Roswell, Georgia, the Company is currently researching, developing and commercializing a platform technology known as CorMatrix® ECM® for a variety of cardiovascular and other indications, and has U.S. clearance and European registration (with a CE Mark) for its ECM® technology.  Since its launch in 2006, CorMatrix® ECM® Technology has been used at more than 975 hospitals across the U.S. and has been implanted in over 145,000 cardiac procedures.  Visit cormatrix.com for additional information.

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¹ Preliminary Experience with Cardiac Reconstruction Using Decellularized Porcine Extracellular Matrix Scaffold: Human Applications in Congenital Heart Disease Frank G. Scholl, MD¹, Mark M. Boucek, MD¹, Kak-Chen Chan, MD, MBBS¹, Lilliam Valdes-Cruz, MD¹, and Richard Perryman, MD¹

World Journal for Pediatric and Congenital Heart Surgery

CorMatrix® Cardiovascular, Inc. Treats First Patient in Its US Clinical Study for CorMatrix® ECM® Tricuspid Valve at Franciscan St. Francis Health Indianapolis, IN

CorMatrix Cardiovascular, Inc., a leading developer of biomaterials and medical devices, today announced treatment of the first patient to receive their tissue engineered regenerative CorMatrix® ECM® Tricuspid Valve. The operation was performed by Marc Gerdisch, MD, FACS, FACC, Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Health in Indianapolis. The Company received approval for the CorMatrix® ECM® Tricuspid Heart Valve as an early feasibility study approved through the FDA Investigational Device Exemption (IDE).  The trial will demonstrate proof of principle and initial clinical safety of the CorMatrix® ECM® Tricuspid Valve at 8 US centers.  The study will enroll up to 15 patients who are candidates for the surgical management of tricuspid valve disease not amenable to annuloplasty or repair; including tricuspid valve disease secondary to congenital heart disease in pediatric patients (age < 21) and adult patients with tricuspid endocarditis.

In addition to Franciscan St. Francis Health, other clinics participating in the study include the Mayo Clinic (Rochester, MN), Cincinnati Children’s Hospital (Cincinnati, OH), Cleveland Clinic (Cleveland, OH), Duke University (Durham, NC), Florida Hospital (Orlando, FL), Nationwide Children’s Hospital (Columbus, OH), and the University of Iowa (Iowa City, IA). The Principal investigator for the study is Dr. Joseph Dearani, Chair, Division of Cardiovascular Surgery at the Mayo Clinic.

Dr. Gerdisch is the first surgeon globally to use the tricuspid device in the study.  “The past decade has seen an enormous expansion of research in, and subsequently—understanding of extracellular matrix. We have been using CorMatrix for 8 years with remarkable success in reconstructing complex structures of the heart and blood vessels. In 2014, we published the North American experience with complete CorMatrix tubular reconstruction of the tricuspid valve,” said Dr. Gerdisch. “Given the remarkable adaptability and regenerative properties of CorMatrix we recognized the dramatic effect this could have on surgery for tricuspid valve pathology, especially for younger patients. Furthermore, it would serve as a platform for engineering other heart valves. This first FDA study enrollment is a substantial step toward patients avoiding synthetic replacement valves by having the opportunity to regrow their own.”

The CorMatrix® ECM® Tricuspid Valve is a flexible, unstented valve constructed from the CorMatrix® ECM® material. The device is specifically designed to function immediately after implantation as a competent heart valve and to perform efficiently at lower transvalvular pressure gradients as experienced by the normal tricuspid valve. CorMatrix’s unique bioscaffold characteristics enable native cells to infiltrate and remodel over time into a fully functioning tricuspid valve. The implanted, remodeled valve is comprised of the patient’s own tissue and leaves behind no “foreign body” as is the case with all mechanical or prosthetic valve designs. In addition, the CorMatrix® ECM® Tricuspid Heart Valve does not require the long-term anticoagulation therapy associated with the implant of mechanical valves.

Other unique features of the device include: mechanical resemblance to the native tricuspid valve, conformity of the normal annulus rather than a stiff prosthetic, maintenance of the subvalvular connection to the right ventricle, ability of the device to become lined with native endothelium during remodeling, and ease of surgical implantation.1 In an ovine model, tubular SIS-ECM TV bioprostheses demonstrated “growth”.2

Valve diseases affect up to 5 million Americans each year3 and while some types are not serious, others can lead to major complications including death.  When valve disease is severe, it may be necessary to repair or replace the diseased valve. There are no valves on the market that have been specifically designed for adult and pediatric tricuspid replacement. Lack of availability of FDA-approved products for the tricuspid valve has resulted in non-indicated devices being used to replace irreparable valves in adult and younger patients.  In pediatric patients, some are left with limited or no surgical repair options.

CorMatrix Chief Executive Office, David Camp commented, “The treatment of the first patient in our study represents a major milestone for CorMatrix and strengthens our leadership in the field of regenerative medicine.  This study actively addresses the need for a tricuspid valve replacement that improves clinical outcomes in pediatric and adult patients who may not otherwise have an option.  The development of this application of CorMatrix® ECM® Technology truly has the capacity to lengthen people lives and furthers our pursuit of developing the best possible medical devices for surgeons and the patients they treat.”

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Physiological Growth, Remodeling Potential, and Preserved Function of a Novel Bioprosthetic Tricuspid Valve Tubular Bioprosthesis Made of Small Intestinal Submucosa-Derived Extracellular Matrix.  Farhan Zafar, MD,* Journal of the American College of Cardiology Vol.66, No.8, 2015 Issn 0735-1097
Functional and Biomechanical Performance of Stentless Extracellular Matrix Tricuspid Tube Graft: An Acute Experimental Porcine  Valuation. Diana M.Ropcke, MD Ann Thorac Surg 2016; 101:125-32
3 F Nkomo V, Gardin M, Skelton T, et al. Burden of valvular heart diseases: a population-based study (part 2). Lancet: 2006:1005-11.

CorMatrix Names Andrew M. Green President and Chief Operating Officer

New Organizational Appointments Made for Future Growth

CorMatrix® Cardiovascular, Inc. a leading developer of biomaterial compositions and medical devices for regenerative medicine, announced effective January 1, 2016 it has appointed Andrew M. Green as President and Chief Operating Officer and Patrick R. Ferguson as National Sales Director. Mr. Green will have responsibility for the Company’s worldwide product lines and operations, reporting to David Camp, CorMatrix’s Chairman and Chief Executive Officer. Mr. Ferguson will have responsibility for US Sales and Marketing, and will report to Mr. Green.

Mr. Green joined the company in July 2013 as Vice President Regulatory, Clinical and Quality Affairs and prior to January 1 served as Executive Vice President of Operations. He is credited with consolidating CorMatrix’s operations and expediting its product pipeline, including FDA clearance for 3 new products and initiation of clinical trials for 2 product pipelines, while also positioning the business for future growth.

“Drew Green’s 23 years of demonstrated leadership experience in the medical technology industry have prepared him well to assume the expanded responsibilities of his new role,” said Mr. Camp. “Since joining CorMatrix, Drew has rapidly gained the organization’s respect as he moved decisively to strengthen the company’s franchise. He also has been involved in a number of corporate initiatives that have given him exposure to various parts of the business and geographic operating entities. I’m extremely pleased to have an executive of Drew’s caliber taking an even greater role in helping to build CorMatrix’s future.”

Prior to joining CorMatrix, Mr. Green held various executive roles in public and private companies including the VP of Regulatory and Clinical Affairs at Halscion, Inc., President and CEO for Oncologix Tech, Inc., principal in NeoMedica, LLC,  and Vice President of Scientific Affairs at Novoste Corporation. He started his career as a Scientific Reviewer for the FDA, where he was responsible for the review of scientific, technical, pre-clinical and clinical data submitted in support of the safety and effectiveness of both interventional and general cardiovascular devices. Mr. Green holds a BS degree in Biological Sciences and an MS degree in Bioengineering, both from Clemson University, where his research focused on characterization and use of materials in a biological environment.

Mr. Ferguson Joined CorMatrix as an Area Sales Director in November 2012. Bringing over 18 years of leadership and sales experience, he has been instrumental in delivering strategic vision, culture development, and sales excellence to CorMatrix.  Since joining the Company, he served as Eastern Area Director and played an integral part in launching the CorMatrix Vascular and Electrophysiology product lines. In addition, Patrick spent 12 years with Medtronic as a District Manager and Senior Sales Rep in their CRM division.  His has also held sales roles with St. Jude Medical in their CRM division.  Mr. Ferguson received his Bachelor of Science degree from the University of Florida.

“Patrick has demonstrated success in sales and sales management over the years and especially at CorMatrix. We’re pleased to expand his responsibilities to include direct leadership of our US Sales and Marketing efforts,” said Mr. Green. “We are truly excited about the future growth of CorMatrix and with Patrick’s leadership, we’re already seeing the initial results of his work.”

CorMatrix Cardiovascular Inc. Launches New Corporate Website Cormatrix.com

Site Focused on Reinforcing the Benefits of ECM and Enhancing User Experience

CorMatrix® Cardiovascular, Inc. a leading developer of biomaterial compositions and medical devices for regenerative medicine, today announced deployment of their new corporate website www.cormatrix.com. The site was developed and designed by Smith & Jones, a marketing communications agency exclusively focused on hospitals and health systems. Cormatrix.com is dedicated to reinforcing and re-educating the market of the benefits extracellular matrix (ECM) offers cardiac and vascular patients. It also seeks to continue supporting and elevating awareness of the CorMatrix brand.

“We’re thrilled to be launching the new CorMatrix corporate website,” said Patricia Cuomo, Director of Marketing for CorMatrix. “Our main goals for the site included improvements to key features such as intuitive navigation, a more streamlined design, an enhanced user experience, data capture and increased optimization for mobile device viewing. We accomplished these goals by re-organizing content and including additional content types. These improvements will allow us to effectively communicate with all of our audiences—from surgeons, to administrators—as well as patients and investors.”

“Launch of the new website ensures quick and easy access to essential information. It’s part of our ongoing effort to enhance and improve the quality and availability of our products and tell the world why they are important,” said Chairman and CEO, David Camp. “The design is modern, colorful and clearly identifies who we are, what we do, and the science that supports our ECM devices and technology.”

The CorMatrix site will be updated on a regular basis with industry news, video, newly approved products, the Company’s participation in industry events, published academic articles and clinical data. The website can now be viewed on smartphones, tablets, and other mobile devices.

CorMatrix® CanGaroo™ Secures International Approval for South America CorMatrix Extends Distribution of Its Implantable Device to Buenos Aires Based, Demedic

Roswell, GA—March 18, 2015. CorMatrix® Cardiovascular, Inc., a leading developer of biomaterials and medical devices, has received international approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) to market the CorMatrix CanGaroo™ ECM® Envelope. The CorMatrix CanGaroo™ ECM® Envelope is intended to securely hold an implantable electronic device to create a stable environment when placed in the body.  The devices that may be used with the CorMatrix CanGaroo™ ECM® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices (CIED). The device was cleared for sale by the United States Food and Drug Administration (FDA) in 2014 and is expected to receive a CE mark later this year for distribution in the European Union (EU).

“This international approval for the CanGaroo™ draws us closer to our goal of making life changing technology available to patients around the globe,” CorMatrix’ CEO David Camp said. “We continue to drive the tremendous potential of our ECM® products to affect positive advances in cardiovascular medicine. We look forward to including more countries to the list of international approvals.”

CorMatrix® ECM® is a naturally occurring bioscaffold that enables the patient’s own cells to remodel and regrow new functional tissue structures in the body. The CorMatrix® CanGaroo ™ is a soft, supple pocket having no sharp edges, which conforms to pacemakers and implantable cardioverter defibrillators (ICD) while stabilizing the pocket to restrict migration. The CorMatrix CanGaroo™ pouch vascularizes over time, re-growing a secure pocket, which also facilitates removal or revision during exchange of these CIED’s. CorMatrix’ ECM is also available for pericardial repair and reconstruction, cardiac tissue repair, and vascular repair.

The Company has selected service organization, Demedic as the Argentinian distributor for the CorMatrix CanGaroo device. Demedic is a service company focused on delivering the best and latest biomedical solutions to their clients, helping them improve their productivity and the quality of care they offer.

Founded in 1984, Demedic has worked with leading international companies to bring the best medical technology available to Argentina. Initially the company focused only on Cardiac Surgery products and services, but later expanded the scope of its offerings to other areas such as Temperature Management, Oncology, PE and DVT Treatment. Demedic has built a strong reputation as a trusted company and partner with their customers and other international organizations. The company is headquartered in Buenos Aires, Argentina, and currently centers its efforts on the regional market. 

Demedic’s General Manager, Cecilia Muñoz commented, “It has been a privilege working with a medical device company like CorMatrix. As they continue to be at the forefront of regenerative medicine, we look forward to being the first company to market the CanGaroo pacemaker envelope internationally and to delivering ECM technology through different subspecialties of medicine in Argentina. We also look forward to working with the CorMatrix team in bringing the latest technological developments to the Latin American Market.”

CorMatrix Cardiovascular Inc. Receives 510(k) Clearance for its Tyke™ Implantable Device for Neonate and Infant Cardiac Tissue Repair

Roswell, GA—February 8, 2016 – CorMatrix® Cardiovascular, Inc., (www.cormatrix.com) a leading developer of biomaterial compositions and medical devices for regenerative medicine, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CorMatrix® Tyke™, a biomaterial technology derived from the Company’s ECM® technology platform.  CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing, and cardiac repair. Tyke™ is made of 2 layers of CorMatrix® ECM® as compared to the 4 layers of the current CorMatrix® ECM® for Cardiac Tissue Repair and therefore providing a thinner product for smaller repairs.  Tyke™ was developed as an alternative to synthetic grafts or patches and to enable congenital cardiovascular surgeons to repair complex reconstructive surgeries, in neonates and infants with congenital heart defects (CHD), such as atrial-septal defects and small pulmonary vessels.

According to the American Academy of Pediatrics and the Congenital Heart Public Health Consortium (CHPHC), congenital heart defects are the most common birth defects. Nearly 1 of every 100 babies is born with a CHD and each year, approximately 40,000 babies are born in the United States with a congenital heart defect. [Source: CHPHC]. Most CHD-related surgical procedures require the use of prosthetic material for reconstruction of intracardiac and extra cardiac structures. Several different biological and prosthetic materials are commonly used in surgery for CHDs including autologous pericardium, preserved homograft, bovine pericardium, and polytetrafluoroethylene. None of these above-mentioned represents the ideal prosthetic tissue, which should be pliable and easy to handle, resistant to calcification or shrinkage, and most importantly should have growth potential and should not induce formation of scar tissue.¹

CorMatrix develops biomaterials that harness the body’s ability to repair damaged cardiac and vascular tissues.  In vivo tissue engineering represents a new approach to tissue and organ regeneration and replacement. Specifically, cardiac and vascular tissue engineering is an emerging field that may hold a great promise for advancement in the treatment of CHDs². CorMatrix Tyke now creates a viable choice for pediatric patients with few surgical options that could affect their long term prognosis.

Dr. Robert Matheny, CorMatrix Scientific Director said, “The Tyke product was developed in response to congenital surgeon’s directed needs. It is our stated goal to continue to develop the cardiovascular regenerative products as dictated by the needs of patients and physicians. One size doesn’t fit all applications and the Tyke is a step in the direction of satisfying a particular surgical need. We are currently in clinical trials to apply the technology to Congestive Heart Failure and Heart Valves.

Dr. David Morales, Director of Congenital Heart Surgery, The Heart Institute, Cincinnati Children’s Hospital Medical Center noted, “CorMatrix ECM has been useful in repairing children’s hearts but there were a few areas were a thinner material would even be better. This is why we are excited about the Tyke—we now have an option to perhaps repair even the smallest structures more accurately.”

“FDA clearance further validates CorMatrix ECM technology for creating world class implantable cardiac devices. CorMatrix is proud of this clearance achievement and the potential impact it can have on reducing CHD in children.” Said CEO and Co-Founder, David Camp. “This is but one small step in our ongoing quest to develop and deliver ideal materials for use in reconstructing damaged cardiac and vascular tissues. Tyke™ and other CorMatrix cardiac products will help us extend and improve the lives of those who receive our implants and move toward a global goal of making cardiovascular disease curable.”

Early availability of CorMatrix Tyke™ will begin with up to 15 clinical sites across the United States that will take part in a post-market study. The study is targeted to include up to 150 patients undergoing pediatric cardiovascular procedures. Patients will be enrolled at the time of treatment and monitored at standard follow-up time points with routine collection of data.  Based upon early collection of patient data, broadened commercial availability will be scheduled, and expansion of the product extended to additional centers under normal launch conditions.

¹ Preliminary Experience with Cardiac Reconstruction Using Decellularized Porcine Extracellular Matrix Scaffold: Human Applications in Congenital Heart DiseaseFrank G. Scholl, MD¹, Mark M. Boucek, MD¹, Kak-Chen Chan, MD, MBBS¹, Lilliam Valdes-Cruz, MD¹, and Richard Perryman, MD¹ World Journal for Pediatric and Congenital Heart Surgery

² Londono R, Badylak SF. Biologic scaffold for regenerative medicine. Mechanisms of in vivo remodeling. Ann Biomed Eng. 2015; 43: 577–92.

Lovell Government Services Award a VA FSS Contract for CorMatrix® ECM® Surgical Implants

Roswell, GA, August 18, 2015– CorMatrix® Cardiovascular Inc. is pleased to announce its first Veterans Health Administration Contract Award through its Federal distribution partner, Lovell Government Services LLC (LGS). The Contract award number #V797D‐50450 enables the VA and other federal organizations to purchase any of the CorMatrix® products at pre‐approved pricing via the Veterans Administration’s FSS Online Schedule.

“CorMatrix produces life‐changing medical devices and technology that are now available via the online VA Federal Supply Schedule. I’m honored that CorMatrix selected LGS as their partner to help make these life‐saving products readily available to the Veterans Healthcare System,” said Chris Lovell, President of LGS.

CorMatrix is approved for Cardiac Tissue Repair, Vascular Repair, Pericardial Repair and Reconstruction, and the CorMatrix CanGaroo™. CorMatrix products are made from decellularized porcine small intestinal submucosa. Extracellular matrix (ECM®) is the naturally occurring bioscaffold that surrounds cells in almost all tissues. CorMatrix acts as a scaffold into which the patient’s stem cells migrate and integrate — stimulating natural healing mechanisms which mature to form a strong, permanent tissue repair.

“While our primary focus has been in furthering the development of CorMatrix ECM technology and devices, we’re also focused on the need to ensure medical and surgical resources are made available to those who have served. We reached out to LGS in our effort to simplify and streamline Federal Contracting sales channels,” said CorMatrix CEO, David Camp. “We’re grateful to Chris for his service to our country and his desire to continue to serve by providing specialty devices such as CorMatrix to the Veterans  Administration Hospital System and the U.S. Military Medical Networks.”

“By partnering with experts like LGS, we can help ensure CorMatrix products are being made available to our Veterans through the benefit network of the FSS and the hospitals that comprise the Veterans Health Administration,” added CFO of CorMatrix, John Thomas. “Mr. Lovell and his team will help us move toward our goal of making CorMatrix products a standard of care—not only for the brave men and women who have served, but for every patient who undergoes a vascular or cardiac procedure.”

About Lovell

Lovell Government Services LLC (LGS) is a VA Certified Service Disabled Veteran Owned Small Business whose mission is to make leading edge Surgical and Medical resources more quickly and easily available to the Veterans Administration Hospital System and the U.S. Military Medical Networks via preferred Federal Contract Vehicles. If you would like more information regarding LGS, LLC please contact Chris Lovell at 850.684.1867 or email at chris@lovellgov.com