Aphthous stomatitis is a common disorder. Sixty percent of the world’s population has experienced such mouth ulcers at some point during their lifetime. At any given moment (point prevalence), about two percent of the population is estimated to suffer from mouth ulcers.
Pain and difficulty in eating and talking is a major problem reported by patients with aphthous stomatitis. This problem has not been sufficiently addressed by previous treatments available on the market. Immediate pain relief is the main feature of the Mucocort oral patch.
The Mucocort oral patch is developed by a team of experienced experts; Jean Lycke, Business developer, CEO, Mats Jontell, Professor of oral medicine and pathology, Olle Isaksson, Professor Internal Medicine, and Thomas Hedner, Professor of Clinical Pharmacology. The patch is a MDR class II product, which relieves pain and speeds up the natural healing process of the aphthous ulcer.
The primary effect of the patch is hygroscopic, leading to absorption of the “inflammatory soup” in the ulcer when placed over the ulcer.
Absorbs the inflammatory soup in the aphthous ulcer
The Mucocort oral patch covers and stays on the aphthous lesion for about three to four hours. The hygroscopic effect of the patch is very powerful. After applying on the mucosal ulcer, the patch absorbs up to 100 percent of the “inflammatory soup” of tissue fluid, inflammatory compounds, viruses and bacteria in the aphthous ulcer. After application, the patch absorbs 20-25 times its own weight before it turns into a gel. The patch is fully biodegradable and disappears usually within 4-5 hours.
“The patch primarily provides immediate pain relief. We believe the effective pain relief provided by this new treatment will, among other things, drastically reduce the need for cortisone treatment that is currently used to relieve discomfort”, says Jean Lycke.
Mucocort is now preparing an application to the Swedish Medical Products Agency seeking permission for a clinical trial. Once validated and approved by the Ethics Review Board, a clinical study will start in the first quarter of 2023.
“We have already prepared most of the documentation and preparations for the study. All procedures are conducted in accordance with the new, upgraded ISO system MDR and ISO14155”, says Jean Lycke.
Mucocort AB is now teaming up with Aurena Laboratories, a privately-owned company in Karlstad Sweden. By joining forces, the companies will secure manufacturing operations and quality at all levels and retain production and further product development in Sweden. An agreement is signed between Aurena Laboratories, as a minority owner, and Mucocort to work together on the development, production, marketing, and sales, to launch the product on international markets.
“A rare and exciting innovation company”
“Aurena has excellent production facilities and product development, and the company is currently working with the customers that would be potentially interested in that Mucocort aphthous ulcer patch. Importantly, Aurena Laboratories also has all the infrastructure in place that is needed for the European market, including regulatory, production, shipping, orders, and distribution”, says Jean Lycke.
Magnus and Lars Hedman, the owners and chief executives of Aurena Laboratories say they are looking forward to the new collaboration to launch the new aphthous ulcer product.
“We are a Swedish medical technology manufacturing company, collaborating with innovative companies from Sweden. Mucocort is a rare and exciting innovation company. We look forward to establishing the Mucocort breakthrough product on international markets”, says Magnus Hedman.
“Mucocort is, in many respects, a unique company, where the owners work pro bono with a largely virtual business model that focuses on products for topical mucosal diseases”, adds Lars Hedman.
98.5 percent of revenue and capital goes towards product development
Mucocort AB is operating from the Umeå Biotech Incubator (UBI) in Northern Sweden. It is a virtual company that has low or no fixed costs for offices or laboratory facilities but relies on external solutions when necessary. Currently, 98.5 percent of revenue and capital goes towards product development – made possible partly through support from Umeå Biotech Incubator (UBI) and partly thanks to the team’s complementary skills and extensive industry network.
Mucocort AB has a strict focus on developing novel treatments for mucosal diseases. The growth strategy outlined for the company will focus on geographical expansion to reach new markets for current products. Further, the company will also expand its scope of operations to include work on additional mucosal “high medical need” indications such as xerostomia.
“Xerostomia, dry mouth in everyday speech, is an interesting development project that we will continue to work on”, concludes Jean Lycke.
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