Prisyna Launches New Website

-Online presence showcases Prisyna’s innovative science through impactful branding and greater online resources for both professionals and consumers –

CLAREMONT, Calif. – January 23, 2019 – Prisyna, the oral care division of Synedgen, founded to optimize oral health using advanced, proprietary glycomics technology, announced that they have launched a completely new website for 2019. 

“It’s exciting to finally bring alive this beautiful and informative website that effectively showcases the innovative science we offer for oral healthcare practitioners and consumers alike,” said Leo Pranitis, General Manager of Prisyna. “Visitors to our site can expect to see a comprehensive set of resources on oral health, as well as gain a much greater understanding of how our products are addressing that challenge.” 

The new website is designed to create a greater connection to the audience, through testimonials and other proof source, noted Mr. Pranitis. 

“From the home page throughout, visitors will see the level of importance we place on the individual who is looking for a safer and more effective option to improve their oral health. Additionally, the ability to easily view our various product configurations and see the full ingredient list is something I believe will greatly enhance our current customers’ experience as well as provide a welcoming and informative environment for new visitors to the site.” 

Prisyna’s new website can be found at https://www.prisyna.com.

About Prisyna 

Prisyna, the oral healthcare division of Synedgen, is developing and commercializing a new class of oral health care products based on glycomics, a revolutionary approach using natural glycopolymers to target the mucosal interface. Prisyna uses this unique technology to develop oral health care products that clean the mouth, reduce pain and irritation on sensitive mucosal surfaces and improve overall oral health. Prisyna is building a family of environmentally safe products using cutting edge science to promote healthy teeth, gums and oral surfaces. http://www.prisyna.com/ 

Media Contact: 

Leo Pranitis
General Manager, Prisyna 909.477.6858 leo.pranitis@prisyna.com

Synedgen showcased in the Top 10 Cystic Fibrosis Stories of 2018 by CF News Today

Studies led by Synedgen and Keck Graduate Institute show Ion-Sugar Interaction in Airway Mucus Has Implications for CF. This research addresses ion interactions in different kinds of cell surfaces and water-containing gels. Understanding how each type of ion affects the structure, electrical potential, and fluid behavior of the airway-surface layers in the lung has direct implications for designing drug targets that influence pulmonary behavior. Read on Cystic Fibrosis News Today

Synedgen Announces the Launch of Moisyn Rinse to Treat Dry Mouth

CLAREMONT, Calif. – October 10, 2018 –  Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced the market launch of Moisyn™ Rinse for the treatment of the symptoms of xerostomia, or dry mouth. Moisyn Rinse is being distributed by Prisyna, the oral care division of Synedgen.

The Moisyn product line is the first glycomics targeted therapy that has been shown in a clinical study to reduce pain and increase comfort for patients living with dry mouth1. Moisyn products, including Moisyn Mist, the convenient spray formulation, provide advanced relief from the symptoms of dry mouth while moisturizing and lubricating the oral cavity.

“The introduction of Moisyn Rinse is part of Synedgen’s commitment to improving oral health based on the benefits of our glycomics technology,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “The Synedent® and Moisyn family of products demonstrate the value that glycomics can bring to addressing important unmet patient needs. We are bringing that same commitment to addressing other inflammatory and infectious diseases associated with the mucosal interface utilizing the promise of glycomics to improve human health.”

“The commercial launch of Moisyn Rinse is another milestone for Prisyna and our dedicated team,” said Leo Pranitis, General Manager of Prisyna. “Moisyn provides relief for the symptoms of dry mouth, a condition which is associated with tooth decay, disturbed sleep, oral infections and a range of other oral health problems. The glycomicstechnology that differentiates both our Moisyn and Synedent family of products is unique, truly innovative and most importantly, addresses a need that is not currently being fully met by the product offerings on the market.”

About Xerostomia (Dry Mouth)

Xerostomia, or dry mouth, causes dryness in the oral cavity, most commonly the tongue and roof of the mouth. Typically, it is identified by a reduction or absence of oral saliva and can be brought on by a variety of conditions, including aging. Over 1000 prescription and non-prescription medications, including drugs for treating anxiety, depression, high blood pressure, allergies, and cancer are known to alter the production of saliva and cause dry mouth as a side effect.

Common problems stemming from dry mouth include tooth decay, disturbed sleep, dry throat, burning sensation in the throat, gum disease, oral infections, taste change, and difficulty speaking and swallowing.

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.https://synedgen.com/

About Prisyna

Prisyna, the oral healthcare division of Synedgen, is developing and commercializing a new class of oral health care products based on glycomics, a revolutionary approach using natural glycopolymers to target the mucosal interface. Prisyna uses this unique technology to develop oral health care products that clean the mouth, reduce pain and irritation on sensitive mucosal surfaces and improve overall oral health. Prisyna is building a family of environmentally safe products using cutting edge science to promote healthy teeth, gums and oral surfaces.  http://www.prisyna.com/

1Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Jan;123(1):76-83. doi: 10.1016/j.oooo.2016.09.008. Epub 2016 Sep 28.

 

Synedgen’s Senior Scientist Publishes New Research

Study sheds light on S. aureus virulence factor regulation

Claremont Calif. — September 21, 2018 — Research conducted by Synedgen Inc.’s Senior Scientist and colleagues from the University of Arkansas appears in the Journal of Proteome Research.

Allister J. Loughran, PhD, of Synedgen, and Stephanie D. Byrum, Karen E. Beenken, Lisa M. Orr, Aaron J. Storey, Samuel G. Mackintosh, Ricky D. Edmondson, Alan J. Tackett, and Mark S. Smeltzer from the University of Arkansas for Medical Sciences and Arkansas Children’s Research Institute conducted the research described in Label-free Proteomic Approach to Characterize Protease-dependent and Independent Effects of sarA Inactivation on the Staphylococcus aureus Exoproteome.

Staphylococcus aureus is an opportunistic Gram-positive bacterial species that exists as a commensal in a significant proportion of the healthy population. In individuals with a weakened immune system, the bacteria can become pathogenic and are capable of causing a diverse array of serious infections including pneumonia,sepsis, and osteomyelitis.

S. aureus treatment can be difficult with antibiotic resistance rates among isolates of S. aureus being high, new druggable targets are needed. The Staphylococcal Accessory Regulator (sarA), is one such target. Among other things, sarA regulates the level of proteases, proteins that degrade S. aureus virulence factors such as toxins. Without sarA, the bacteria are weakened and do not cause the same damage to the host.

Since this protein increases the degradation of the bacteria’s own proteins and new proteomic approach was needed to identify proteins that are changed as a result of loss of sarA function. Using an expanded dual proteomics approach, the team measured the abundance of proteins and characterized the exoproteome of wild type bacteria, sarA mutant bacteria and sarA mutants that also do not make the proteases. The analysis allowed for the separation of protein changes into two distinct groups, protease mediated changes and protease independent changes.The dual approach of conventional proteomic profiling and the new approach outlined in this publication, allowed for the identification of unique protein profiles from both methods, which provides for more complete and robust characterization of exoproteomes in the presence of proteases.

“This paper presented a comprehensive and robust method to analyze exoproteomes when endogenous proteases can impact the findings and highlights Allister’s expertise in investigating bacterial pathogenesis and host response,” remarked Synedgen President & COO Shenda Baker PhD.

This study was supported by the National Institutes of Health (R01AI119380, R21DA041822, P20GM121293, UL1TR000039, P20GM103625, S10OD018445 and P20GM103429).

The abstract is available at: https://pubs.acs.org/doi/10.1021/acs.jproteome.8b00288

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

 

 

Synedgen Appoints Kaveri Parker, Ph.D. as Chief Business Officer

CLAREMONT, Calif.- September 19, 2018 – Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced the appointment of Kaveri Parker, Ph.D. as Chief Business Officer. In her role, she will lead the business development and commercialization of Synedgen’s inflammatory and infectious disease programs as well as advance strategic partnership opportunities across Synedgen’s wound care product portfolio. Dr. Parker will also assist with business development for the Prisyna oral care division of Synedgen.

“Kaveri is an accomplished business executive with a deep scientific background and we are thrilled to welcome her to our team,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “Her scientific training and business development experience along with her keen and rapid assessment of market opportunity and positioning will play a critical role in our growth strategy as we continue to develop our product portfolio.”

“Synedgen’s glycomics technology platform has the potential to fundamentally change how we treat infectious and inflammatory diseases,” said Dr. Parker. “I am excited to join Synedgen at a pivotal point in this organization’s growth and look forward to working with the accomplished management team to bring several FDA-cleared products to market and leverage our existing technologies for sustained growth.”

With SynePureTM Wound Cleanser and CatasynTM Advanced Technology Wound Hydrogel having received FDA clearance for marketing, Synedgen Wound Care is a leader in applying glycomics to manage and improve wound care. Synedgen Wound Care products are developed to support a healthy environment for healing without the use of harsh chemicals that can cause further pain and inflame damaged tissue.

Prisyna, the oral care division of Synedgen, has received FDA clearance to market Moisyn® to treat symptoms of dry mouth, which adds to the portfolio including Synedent® and Synedent FLX® oral rinses. The goal of Prisyna’s scientifically-driven formulations is to develop oral health care products that clean the mouth, reduce pain and irritation on sensitive mucosal surfaces and improve overall oral health.

Synedgen has other programs in early development that use the company’s glycomics platform in therapeutics to:

  • reduce damage and inflammation due to chemical, radiological or physical damage,
  • manage infection, inflammation and ulcers in the gastrointestinal tract,
  • target the host-pathogen interface utilizing novel mechanisms to reduce the challenge of antibiotic resistance, and
  • provide a barrier to infection and improved healing in the eyes.

Dr. Parker has an extensive background in biochemistry and infectious diseases, as well as years of business development and management experience. Most recently, she served as President and Chief Executive Officer of ID Genomics where she led all aspects of executive management, including investor and media relations, management and scientific team building, strategic and tactical planning, fundraising, and path-to-market strategy. During her tenure, she secured strategic partnerships with 12 major clinical hospital networks across the U.S. and managed ID Genomics’ regulatory and intellectual property development.  Prior to her tenure as President and Chief Executive Officer at ID Genomics, she served as Director of Operations. Dr. Parker earned her Ph.D. in biochemistryat Washington University and a Bachelor of Science in biochemistry at the University of New Mexico.

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

Synedgen Welcomes Student Interns

Synedgen is pleased to welcome 3 student interns for the summer.

Allyson Leicht is a Senior dual major in Chemistry and Economics at Grinnell College, Iowa. At Grinnell she has worked on several research projects including a computational chemistry project to examine the mechanisms of hydrogen and deuterium exchange of arginine containing peptides, and a synthesis project to generate and analyze Ircinin produced from economically priced ingredients. Outside of the laboratory she has run a textbook lending library, worked as a peer tutor, worked at a preschool, and served as Project Manager for Grinnell’s “Alternative Breaks Program”, a student-run organization that offers students the opportunity to travel as members of a fun, safe, and intentional service community during breaks.

At Synedgen, Allyson is working on synthesizing new compounds to help expand Synedgen’s molecular library, including independent synthesis of at minimum one compound, generation of synthesis precursors through alternative synthesis pathways, and characterization of new compounds by FTIR, 1D and 2D NMR, and size exclusion chromatography.

Alyssa Thompson is a third year student at the University of Cincinnati (UC) majoring in Middle Childhood Education with a focus in science and English content areas. After graduating from the University of Cincinnati, she hopes to teach biology while pursuing her Masters of Science in Education, and eventually her PhD in Education. Her ultimate goal is to work in a STEM education department, preparing future science teachers to better teach, excite, and encourage students in the classroom.

Briana Thomas is a rising Junior at the University of Cincinnati majoring in Biological Sciences. During the academic year, she works in a research lab at UC. After completing her degree, she plans to attend medical school for a MD/PhD in Pediatrics with an interest in Neurology. Her hopes are to not only provide the best care to each patient she will eventually treat, but also to make healthcare more accessible to low-income families.

This summer the UC students are interning in the research and development department at Synedgen. They experience hands-on training and active research in the fields of microbiology and cell biology. Their research will aid in the characterization and evaluation of promising new molecules. These new molecules, developed through Synedgen’s glycomic technology platform, will be assessed for their impact on infection, healing and inflammation.

“Our goal is to give the interns hands-on research experience that can’t be learned in a classroom and expose them to real life laboratory challenges,” said Synedgen president Shenda Baker PhD. “The study of our novel molecules gives the students a unique opportunity to perform interdisciplinary research in an emerging field.”

Briana Thomas, Alyssa Thompson, Allyson Leicht

 

Synedgen Receives FDA 510(k) Clearance for Catasyn™ Advanced Technology Wound Hydrogel

May 23, 2018–Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced that it has received 510(k) clearance from the U. S. Food and Drug Administration (FDA) to market its Catasyn™ Advanced Technology Wound Hydrogel both under the direction of a health care professional and over-the-counter (OTC).

“This FDA clearance for Catasyn provides patients with a new option to treat both minor burns and skin lacerations and physicians with an alternative to treat more severe dermal ulcers, post-operative incision sites and second degree burns,” said Shenda Baker, Ph.D., President and Chief Operating Officer of Synedgen. “Catasyn has been developed using our Glycomics Technology Platform to provide a moist wound environment that supports healing. We look forward to making Catasyn commercially available as we continue to develop new products to improve care for oral, dermal and mucosal lesions and wounds.”

When administered by a healthcare professional, Catasyn can be used for the dressing and management of partial to full thickness dermal ulcers including pressure sores, venous stasis ulcers, arterial ulcers and diabetic ulcers, surgical wounds including post-operative incisions and donor sites and superficial and partial thickness (second degree) burns. In its OTC indication, Catasyn can be used for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

“Catasyn development was supported by the U.S. Army with the goal of creating a product that can help speed wound healing and mitigate infection risk in soldiers,” said William Wiesmann, M.D., Chief Executive Officer of Synedgen. “While it was tailored to the needs of the military for indications such as postoperative wounds and traumatic, thermal, chemical and radiation wounds and burns, Catasyn is also applicable for the civilian population.”

Synedgen is developing its wound care portfolio based on the science of glycomics to provide superior wound cleansing and a barrier to infection. Synedgen aims to develop products that support a healthy environment for healing without the use of harsh and abrasive chemicals that can cause further pain and inflammation to damaged tissue. Catasyn is the third marketed product in Synedgen’s wound care portfolio which includes SynePure Wound Cleanser for the cleansing of dermal wounds as well as Synoplex for veterinary indications.

About Synedgen

Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

Synedgen Expands Research Focus to broaden indications for core platform of novel pharmaceuticals — Appoints New Senior Scientist to lead research and discovery team

February 15, 2018–Synedgen announces the appointment of Allister J. Loughran, PhD as Senior Scientist to lead its research operations and to expand research indications for its platform of biologically active glycopolymers in areas of infectious disease, systemic inflammation and the innate immune response to injury or exposure.

“Our research indicates that there are far reaching applications for Synedgen’s family of glycopolymers to reduce microbial invasion and inflammation and enhance innate immunity” stated Dr. William Wiesmann, M.D., Synedgen CEO.  “Dr. Loughran brings us a unique experience and expertise in the models, systems and experimental design that we are expanding to conduct the pre-clinical research necessary to develop these potentially important drugs”.

We are particularly excited that  Dr. Loughran’s training and expertise in bacterial infection and inflammation models will be instrumental as Synedgen develops new products focused on the interplay between bacterial interactions and mucosal or dermal injury with the innate immune system and regenerative processes.  ” said Synedgen President, Dr. Shenda Baker.

“Dr. Loughran will provide scientific leadership and oversight as Synedgen continues its therapeutic product expansion. His experience in designing in vitro assays to predict and direct clinically meaningful in vivo studies will support a broad expansion of our drug development vision,” added  Dr.  Baker.

Dr. Loughran previously served as a Postdoctoral Research Associate at St. Jude Children’s Research Hospital,
Infectious Diseases Department, in Memphis TN, where he investigated a broad range of related infectious and injury models that included the effects of bacterial products released in response to antibiotic treatment on inflammation in developing brains.

Dr. Loughran earned his PhD in Microbiology/Immunology at the University of Arkansas for Medical Sciences, and his BSc. in Microbiology and Molecular biology at Monash University, Australia. 
He conducted his Doctoral Research at the University of Arkansas for Medical Sciences, where he studied  the potential of the Staph aureus gene product , sarA, to become a  drug target in a number of bacterial infections, including sepsis and osteomyelitis.

About Synedgen

Synedgen Inc. is developing a new class of drugs with the ability to suppress inflammation, reduce infection and improve healing in the gastrointestinal tract and pulmonary tree and to reduce damage and inflammation due to chemical, radiological or physical damage using the science of glycomics – the study of complex sugar structure and function. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surface.

Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as inhaled pulmonary drugs, which have been licensed to Synspira with SNSP113 currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

Synedgen Announces Publication of Study Exploring the Role of Biological Ions in Controlling Mucosal Surfaces

— New understanding of role of ions could impact treatment of infectious and inflammatory diseases —

CLAREMONT, Calif.-January 31, 2018–Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory disorders associated with the mucosal membranes of the gastrointestinal tract, today announced that research elucidating the role of complex sugars and ions and their potential role in the treatment of diseases was published in the journal, Macromolecular Theory and Simulation.

The paper, “A Continuum Model of Mucosa with Glycan-Ion Pairing” by Shenda Baker, Ph.D., President and Chief Operating Officer at Synedgen and James Sterling, Ph.D., Professor of Applied Life Sciences at the Keck Graduate Institute, describes the role that differences in ion interactions at the cellular level play in driving diseases affecting the mucosal interface and suggests potential therapeutic approaches. This work follows a 2017 publication by Drs. Baker and Sterling in Colloid and Interface Science Communications, titled “Electro-lyotropic equilibrium and the utility of ion-pair dissociation constants,” which established the feasibility of these models for biohydrogel structure determination.

Complex sugars known as glycans are some of the most negatively-charged molecules in biology and coat cell and mucosal surfaces, most notably in the nose, throat, eyes, lungs and gastrointestinal tract to protect against pathogens. Due to lyotropy, the observation that various positive ions with the same charge have different interactions with a negatively charged ion, glycans interact in unique ways with each type of ion. These differences cause small changes in relative ion concentrations to result in large changes in both the electrical potential and the thickness of the glycan layer that protects cells from pathogen attachment and invasion.

“With this study, we were able to contemplate ion interactions and electrical potentials in a variety of biologically important hydrogels and cell surfaces and calculate specific ion-ion interactions for each ion pair type,” said Dr. Sterling. “Understanding how each type of ion affects the structure, electrical potential and fluid behavior of the mucosal surface layers are effects that could be considered when developing treatments for diseases associated with or affecting the mucosal interface.”

In mucosal surfaces, such as the lung and gastrointestinal tract, the mucus is comprised of negatively charged polyelectrolytes called mucins that are very sensitive to changes in ions. In patients with cystic fibrosis, for example, the genetic defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene reduces ion transport, causing thick and viscous mucus.

“This study shows the impact glycans and ions have on infectious disease and immune response. At Synedgen, we are harnessing this work to develop new glycopolymer-based therapeutics to prevent and treat infections,” stated William Wiesmann, M.D., Chief Executive Officer of Synedgen. “Our first glycopolymer approach is currently being studied in a Phase 1 clinical trial of SNSP113 in cystic fibrosis by Synspira, which has in-licensed our technology for applications in the treatment of pulmonary diseases.”

About Synedgen

Synedgen Inc. is developing a new class of drugs with the ability to suppress inflammation, reduce infection and improve healing in the gastrointestinal tract and pulmonary tree and to reduce damage and inflammation due to chemical, radiological or physical damage using the science of glycomics – the study of complex sugar structure and function. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surface.

Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.

About the Keck Graduate Institute

Keck Graduate Institute (KGI) was founded in 1997 as the first higher education institution in the United States dedicated exclusively to education and research related to the applied life sciences. KGI offers innovative postgraduate degrees and certificates that integrate life and health sciences, business, pharmacy, and genetics, with a focus on industry projects, hands-on industry experiences, and team collaboration. A member of The Claremont Colleges, KGI employs an entrepreneurial approach and industry connections that provide pathways for students to become leaders in bioscience and healthcare. www.kgi.edu

Contacts

MacDougall Biomedical Communications
Amanda Houlihan, 781-235-3060
ahoulihan@macbiocom.com

Synedgen Receives FDA Clearance for its SynePure Wound Cleanser

CLAREMONT, Calif. — August 24, 2015– Synedgen announces U.S. Food and Drug Administration 510(k) clearance to market its SynePureTM Wound Cleanser (K143444). SynePure Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

The SynePure Wound Cleanser is designed as an advanced irrigation technology to cleanse wounds by providing superior wound cleaning with no deleterious effects on wound healing. The development of the SynePure Wound Cleanser was funded by DARPA, the Defense Advanced Research Projects Agency, to meet the immense challenges of cleansing deep, dirty and complicated wounds often incurred by US soldiers in combat. These wounds are frequently full of debris and contaminated, and if not cleansed early, can lead to significant complications such as wound sepsis and failure of the wounds to heal properly.

SynePure Wound Cleanser is specifically designed to provide immediate and effective irrigation of wounds following injury and could become part of the first aid kit carried by all U.S. soldiers. It is packaged for use in a squeezable bottle fitted with a nozzle to direct a focused stream of cleanser with sufficient force to help dislodge debris and contamination. The advanced technology also aggregates particles in the wound to help facilitate their removal. Synepure Wound Cleanser is also suitable for hospital and emergency care use with clearance for both single and multiple use bottles.

“The SynePure irrigation system is easily delivered with one hand to rinse debris and contamination from wounds, allowing self-application at the time of injury. This design is ideally suited for use in the field and pre-hospital environment in both military and civilian environments,” said Shenda Baker, PhD, Synedgen President and COO. “We worked closely with our military sponsor to develop a highly effective and easy to use product that does not impede wound healing. This clearance is a key step in the roll-out of our comprehensive wound care platform.”

“While this cleanser was tailored to the extreme needs of the military, it has equally great application for the cleansing and rinsing of any skin, external wounds, non-healing ulcers, post surgical wounds, severe burns, and lacerations,” said William Wiesmann, MD, Synedgen CEO.

This material is based upon work supported by SSC Pacific under Contact No. N66001- 14-C-4009. Any opinions, findings, conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the SSC Pacific.

Synedgen President Shenda Baker Featured Presenter at the Grinnell-in-Los Angeles: Scientists Making a Difference in the World Conference

Synedgen President Shenda Baker will be a featured presenter at the upcoming Grinnell Scientists: Making a Difference in the World Conference

Continue reading “Synedgen President Shenda Baker Featured Presenter at the Grinnell-in-Los Angeles: Scientists Making a Difference in the World Conference”

Biotech Firm Synedgen Announces Joint Collaborative Research Agreement with Cystic Fibrosis Experts From the Cincinnati Children’s Hospital Medical Center and the University of Alabama at Birmingham

Research Investigates Synedgen’s Promising New Treatment to Help Clear Airways of Cystic Fibrosis Patients

Continue reading “Biotech Firm Synedgen Announces Joint Collaborative Research Agreement with Cystic Fibrosis Experts From the Cincinnati Children’s Hospital Medical Center and the University of Alabama at Birmingham”

Synedgen’s Synoplex® Receives FDA Indexing for use in the treatment of chronic wounds in pachyderms

June 26, 2012 — Claremont CA—Elephants and Rhinoceroses frequently encounter chronic non- healing infected abscesses and cutaneous wounds that become resistant to traditional antibiotics and treatments. Over time, these wounds can have serious long-term consequences such as systemic infections and impaired mobility. Recognizing the difficulty in treating these types of wounds, the FDA’s Center for Veterinary Medicine has recently allowed Synedgen to market Synoplex®, Synedgen’s veterinary wound rinse product, as an FDA Indexed Product to treat infected, chronic and non-infected wounds in elephants and rhinoceroses. Synoplex is intended for the treatment of chronic foot disease (cracked nails, abscesses, lesions, ulcers, fissures) and chronic non-healing dermal or subdermal wounds such as abscesses and pressure sores caused by chronic inflammation or bacterial species. Synoplex® is also intended for use as a regular treatment for non-infected wounds at a lower dose.

Data have shown that Synoplex breaks up established biofilms, flushes the bacteria from the wounds, and inhibits the formation of biofilms, providing a safe, prophylactic and therapeutic treatment for both chronic and acute infections associated with dermal wounds and foot disease in elephants and rhinoceroses. In addition, Synoplex has been shown to encourage wound healing, unlike other topical disinfectants that are damaging to tissue.

“Synoplex provides a breakthrough technology for treating both chronic and acute topical infections by eliminating the need for antibiotics,” stated Synedgen President Shenda Baker. “This product is perfectly suited for large topical wound application in elephants and rhinoceroses, as it is safe for the veterinarian and animal and heals the wound while preventing or treating infection.”

Currently, wounds in elephants and rhinoceroses are treated with systemic or topical antibiotics as well as topical disinfectants, such as chlorhexidine or Betadine. These disinfectants are great at reducing bacteria, but they are very harsh on the wound and can inhibit healing. The cost of systemic antibiotics in these large animal species can be cost prohibitive and disrupt their gut flora. Synoplex can be used for Gram-positive or Gram negative bacterial infections, as well as in non-infected wounds.

An expert panel of renowned veterinarians unanimously concluded that Synoplex is effective and safe for use in the family Elephantidae and the family Rhinocerotidae in December 2011. The panel notes the importance of new treatments for infection in its recommendation, “Often these chronically infected wounds have been treated repeatedly with various antimicrobials resulting in development of multiple drug resistant strains of bacteria. The advantage of treating these infections without use of an antimicrobial is a major benefit to the patients and to the caretakers.” Synoplex Panel Member Head Veterinarian Dr. Ralph Zimmerman of the Albuquerque BioPark remarked, “Synoplex provides a safe, prophylactic and therapeutic treatment for controlling and preventing bacterial biofilms and treating both chronic and acute infections associated with dermal wounds and foot disease. Use of Synoplex has demonstrated effectiveness without any adverse effects. Likewise, there is minimal concern for the veterinarian or other caretakers applying Synoplex to their patients as there have been no known allergic reactions or adverse events reported.”

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) maintains an index of legally marketed unapproved new animal drugs and their designated intended uses for minor species. Synoplex® is legally marketed as an FDA Indexed Product under MIF 900-012.

Biotech Firm Synedgen Reports Promising Research Findings on New Treatment for Radiation Damage to the Digestive Tract and Radiation-Induced Mucositis

Federal agencies are highly concerned about potential dangers to the US population by radiation exposures such as the nuclear incident in Japan or the threat of a terrorist dirty bomb

Continue reading “Biotech Firm Synedgen Reports Promising Research Findings on New Treatment for Radiation Damage to the Digestive Tract and Radiation-Induced Mucositis”