This investment comes alongside a commitment from Cook Biotech Inc. (CBI) of West Lafayette, Ind., to manage the Xcede Patch first-in-human clinical study on behalf of Xcede in exchange for secured loan considerations of up to $1.5m.
In addition, Peter Sulick, Dynasil Chairman and CEO, and members of his family made an additional investment of $450,000.
It is anticipated this $3.15 million funding will be sufficient for Xcede to complete first-in-human clinical trials and related preclinical tests. The preclinical studies are anticipated to begin in 2016 and the trial in 2017.
The Xcede Patch is intended to be used during surgical procedures to stop bleeding (hemostasis). Preclinical testing to date indicates this product promotes hemostasis within 60 seconds, a time that is faster than currently approved hemostatic patches, which take approximately three minutes to stop bleeding.
Worldwide, the topical hemostatic market is estimated to be in excess of $1 billion in revenue. In addition, Xcede believes that the ease of use and potential price point for this product will be compelling reasons for practitioners to adopt the patch once it is approved for use as part of their regular surgical practices.
Because the patch promotes hemostasis quickly, it is also under development for severe, traumatic bleeding as a follow-on indication for use.
Xcede Technologies, a subsidiary of Dynasil Corporation of America ("DCA"), is based in Rochester, MN and Seattle, WA and began operations in October 2013 following a technology transfer from Dynasil Biomedical, a subsidiary of DCA. Xcede is committed to the development and manufacture of innovative hemostatic and sealant products to control bleeding in surgical applications based on its innovative adhesive technology.
The Xcede Patch is expected to be the first of these ground breaking products. Following this latest round of financing, Dynasil will own approximately 54% of Xcede.
"We are excited to announce this investment in Xcede, which underpins our continued commitment to this technology," said Peter Sulick, CEO of DYSL.
"Those of you following the company closely know that this has been a lengthy and complicated process. We are very thankful for the ongoing support of our development partner, Cook Biotech Inc. CBI has agreed to provide yet another level of support for this extraordinary product, one component of which is CBI's core technology. Once in commercial production, we believe the product will greatly improve operation room efficiencies and patient outcomes." Linda Zuckerman, PhD, Xcede president and CEO concurs.
"Dynasil's investment combined with Cook's extensive experience in medical device development and clinical trial execution will continue to move the Xcede Patch forward towards licensure. We are on a timeline to get the product in the marketplace within the next several years."
Umesh Patel, PhD, Vice President & General Manager of CBI, states, "Cook's extracellular matrix technology combined with Xcede's adhesive technology provides an excellent foundation for Xcede's first product. We look forward to helping move this technology into the clinical phase of development."
Dynasil Corporation of America develops and manufactures detection and analysis technology, precision instruments and optical components for the homeland security, medical and industrial markets.
