EPIEN MEDICAL, INC.
(Note: This IPO is a unit offering – 4,190,476 Units consisting of 4,190,476 Shares of Common Stock and 4,190,476 Warrants to purchase 4,190,476 Shares of Common Stock. The price range is $4.25 to $6.25. This is a NASDAQ listing with the proposed stock symbol of “EPMI” and the proposed symbol for the warrants of “EPMIW”. The company is incorporated in Minnesota. Epien will be redomiciled in Nevada before the IPO.)
We are a specialty medical devices company that is developing products for treatment of oral inflammation and acute and chronic wounds based on our chemical formulations that act as aggressive desiccation and debriding agents. We refer to this proprietary process as Desiccation Shock Technology (“DST”). Eleven published clinical trials have shown that our products reduce and, very often, eliminate the need for antibiotics to treat topical infectious wounds, including oral infections and open infectious wounds. Standard treatments can take months and even years of daily antibiotic use to heal an open infectious wound. In 2021, our HYBENX and ERADX product lines received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”), as a medical device for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures, including scaling and root planing, to aid in the removal of contaminated debris from the sulcus. In 2013, the European Regulatory Agency cleared our HYBENX and ERADX product lines for the same uses. In 2022, we initiated a plan to obtain FDA 510(k) clearance for our REVITY product candidate for treatment of chronic wounds. However, in May, based on discussions with the FDA, we withdrew our 510(k) application for REVITY. Instead, we plan to initiate a “de novo” classification request with the FDA in the first quarter of 2023.
Our DST enables our easy-to-use, topically applied products to desiccate harmful bacteria in seconds. Under existing dental standard of care practices today, antibiotics are typically used to reduce harmful microorganisms. However, over the past fifteen years, serious medical concerns have been raised regarding antibiotic resistance and the overuse of antibiotics. HYBENX and ERADX assist in the removal of these harmful microorganisms and contaminated debris. More importantly, using HYBENX and ERADX avoids use of antibiotics, thereby avoiding the risk of resistance, as DST is a non-biologic formulation to which resistance could not develop.
Our REVITY acute and chronic wound care product candidate also uses our proprietary DST. In wounds, in addition to the wound itself, the colonizing of harmful bacteria causes inflammation, which further weakens the immune system’s ability to naturally fight infectious diseases. DST is a physical mechanism of action that uses a proprietary combination of sulfonated phenols to instantly extract water from all microorganisms. By using REVITY, a clinician can easily eliminate bacteria at a molecular level by debriding the tissue.
Our KONKURE product line also uses our proprietary DST in the oral veterinary market.
HYBENX, ERADX, REVITY and KONKURE are applied directly to the surface of a wound, using a syringe to deliver the product in liquid or gel form in the mouth or on the skin. Treatment times range from five to 60 seconds, depending on the severity of the infection. The products are then simply removed by rinsing with copious amounts of water.
With over ten million treatments of DEBACTEROL, ORALMEDIC and HYBENX sold in the U.S., Canada, Asia and the EU, there have only been approximately 130 instances of side effects reported to us by consumers who have purchased our DST-based products.
We have successfully completed approval processes with the European Regulatory Agency and the FDA over the past 15 years. Our HYBENX and ERADX dental products have been cleared as Medical Devices Class I in Europe and the United States for all indications where infectious conditions persist. Our ORALMEDIC product for oral ulcerations is cleared in 30 countries across Europe, Canada, and parts of Asia.
HYBENX and ERADX each received its latest clearance in September 2021 from the FDA for expansion of our oral products to treat periodontal disease in the U.S. market. This clearance complements the existing indications for use of HYBENX and ERADX to treat root canals by endodontic specialists.
(Note: Epien Medical, Inc. filed its S-1 on Sept. 30, 2022, after submitting confidential IPO documents on Jan. 19, 2022.)
|Industry:||SURGICAL & MEDICAL INSTRUMENTS & APPARATUS|
|Address||600 Highway 169 South, Suite 820 St. Louis Park, MN 55426|
|Phone Number||(651) 653-3380|
|View Prospectus:||EPIEN MEDICAL, INC.|
|Revenues||$1.27 mil (last 12 months)|
|Net Income||$-3.8 mil (last 12 months)|
|Price range||$4.25 - $6.25|
|Est. $ Volume||$22.0 mil|
|Manager / Joint Managers||EF Hutton|
|Expected To Trade:|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|