Prisyna Secures $6M in Financing
Top-line data on Moistagen for dry mouth demonstrates statistically significant outcomes.
Funding to support completion of clinical studies of multiple products, FDA device market clearance process and marketing efforts in support of the pending product launches.
April 28, 2016 07:30 AM Eastern Daylight Time
CLAREMONT, Calif.–(BUSINESS WIRE)–Prisyna, an oral care business unit of Synedgen, Inc., announced today that the company secured a $6 million growth equity investment. The financing was led by Andrew Miller through a private investment. Prisyna plans to use the funding for the advanced development, regulatory approval and marketing efforts for the expansion of its pipeline and in support of current products. Prisyna combines breakthrough, propriety glycomics technology, with natural materials and innovative polysaccharides to create advanced rinses for the mouth that support a healthy oral cavity. The company’s investigational products include Moistagen®, a potential treatment for the symptoms of dry mouth, and a new formulation to relieve the symptoms of oral mucositis due to chemotherapy or radiation treatments. Prisyna currently offers two oral rinse products — Synedent® Oral Care and Synedent Plus Oral Care with fluoride.
“It is a rare and privileged opportunity to provide support to such an exciting technology and a portfolio of products that will enable new treatment options for patients,” said Andrew Miller. “As a revenue positive company with commercial product sales, this current funding round will help accelerate Prisyna’s growth and R&D efforts. I look forward to being part of their continued success.”
In a multi-center, clinical evaluation of Moistagen, the product demonstrated statistically significant reductions in 15 of 33 symptoms associated with dry mouth. The study was conducted at two sites; a private practice in Los Angeles and Tufts University School of Dental Medicine in Boston. The study design was a pre-test post-test prospective cohort within-subject study on 57 patients with significant dry mouth symptoms. Participants used Moistagen rinse twice daily with as desired optional Moistagen spray for seven days, and then self-reported changes in their oral symptoms and function. The results showed positive outcomes based on a variety of metrics and will be presented in an upcoming manuscript.
“The pain, discomfort and quality of life issues associated with dry mouth negatively impact millions of patients in the U.S. and I welcomed the opportunity to evaluate a new technology to address this oral health challenge,” said Joel Epstein, DMD, MDS Medical-Dental Staff, Cedars-Sinai Medical Center. “The results of the Moistagen study showed the product’s excellent ability to safely address the issues associated with dry mouth, especially among those patients who have pain and complications due to the accumulation of sticky mucus deposits. The product use was convenient and easily used as directed with twice daily rinsing and oral spray as needed.”
With this financing, Prisyna will operate as an independent, oral care business unit within Synedgen, a pioneering biotechnology company using the science of glycomics to discover and develop polysaccharide-based drugs. The Prisyna pipeline of oral care products provides a distinct business unit from the pharmaceutical programs. The advanced design capabilities of the Synedgen Glycomics Platform coupled with an experienced knowledge of medical targets, enabled the successful application of the technology into such complementary areas as oral health while serving as a distinct business unitfrom the pharmaceutical programs. Prisyna is currently lead by co-founders William Wiesmann, M.D. and Shenda Baker, Ph.D. Prisyna will be announcing an expanded leadership team in the coming months.
“Our proprietary technology and novel approach to enhanced oral care offers tremendous breadth and promise for the treatment of a variety of challenging yet common conditions in the mouth,” said Dr. Wiesmann. “We appreciate the support and confidence demonstrated by our new and existing investors. We believe that daily use of the Prisyna line of oral care products has the potential to change the course of oral healthcare and the lives of patients who suffer from the symptoms of dry mouth and the debilitating effects of oral mucositis.”
About Dry Mouth
Xerostomia, or dry mouth, is a frustrating oral health care issue that affects up to 20 percent of the adult population and nearly 50 percent of the elderly in the US today. The complications of dry mouth can be caused by more than 1,800 commonly used medications, radiation therapy for head and neck cancer, Sjogren syndrome and other conditions. Dry mouth significantly impacts patient quality of life, causing difficulty chewing, swallowing and speaking, wearing of dental prosthesis, dried thick oral mucus, painful dry oral tissues, affecting taste and causing bad breath, and may cause sleep disturbance.
Moistagen is specially formulated oral rinse currently under evaluation to relieve the symptoms of dry mouth using cutting-edge lubricants that coat the surface of the mouth to protect and may hydrate dry and irritated oral tissues. These components also have the potential to loosen sticky, dry mucus and help moisten oral surfaces. Moistagen is anticipated to be cleared for marketing by the FDA in the second half of 2016.
Prisyna is an oral care business unit of Synedgen, focused on the development of consumer products that clean teeth and gums, freshen breath and moisten mouths without the burn or irritation of abrasive oral care products. The company combines breakthrough, propriety glycomics technology, with natural materials and innovative polysaccharides to create advanced rinses for the mouth that support a healthy oral cavity. Based in Claremont, Calif., Prisyna currently offers two mouth cleansers – Synedent Oral Care and Syndent Plus Oral Care – available for purchase online at www.synedent.com or through leading dentists. To learn more about Prisyna please visit: http://www.prisyna.com/
Shenda Baker, Ph.D., 909-447-6858
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Maureen L. Suda, 585-387-9248