Hydromer (HYDI)

[zenvesting]

Should be seeing an update on the N8 Medical CeraShield® Endotracheal Tube before year end, the study has an estimated completion date of October 30, 2019.

This has been slow to develop and has flown under the radar, but could bring some excitement before year end.

For background, in June of 2012 Hydromer announced a Strategic Development Agreement with N8 Medical (1) to co-develop a new antimicrobial coating technology using Hydromer’s coating technology in combination with N8’s Ceragenins, a new class of antimicrobial agents developed at Brigham Young University designed to mimic the broad spectrum activity of the human innate immune system. The terms of the agreement were not specified in the PR or subsequent SEC filings, however, the discussion of the relationship appears to be more than Hydromer’s typical “Stand-still Agreements” and “Supply and Support Agreements” they have engaged in with more than three dozen partners with in the past.

Then in May 2017 N8 Medical announced the FDA granted N8 Medical’s CeraShield Endotracheal Tube (ETT) a “Breakthrough Device” designation, due to the significant threat of infection intubation causes for more than four million healthcare patients in the U.S. each year (2) N8 Medical supported its filing with the FDA with recent data from the U.S. Centers for Disease Control and Prevention (CDC) demonstrating that the antimicrobial compound contained in the CeraShield™ Endotracheal Tube inhibited growth of all 100 strains of Candida auris—an emerging, highly-lethal fungal infection. Further, the May 2017 PR stated: “The CeraShield™ medical device coating technology is applicable to a broad range of medical devices commonly colonized with pathogenic bacteria and fungi, including devices for urology, vascular access, cardiology, orthopedics, and ear nose and throat (ENT), as well as other respiratory devices such as tracheostomy tubes. N8 Medical is working to pursue broad application of its CeraShield™ coating technology to create best-in-class antimicrobial medical devices designed to reduce the morbidity and, mortality and high costs and use of resources associated with hospital-acquired infections worldwide—both through independent commercialization efforts and through collaboration and partnering opportunities.”

N8 does not mention the association with Hydromer in their May 2017 PR, but does identify Hydromer as the supplier of the “optimized CeraShield hydrogel coating containing CSA-131” in a very compelling November 2017 PR (3) that goes on to state: “The optimized CeraShield™ hydrogel coatings containing CSA-131 provided controlled slow release of CSA-131, with concentrations released of less than 1ug/ml per 24 hours. The eluting CSA-131 prevented fungal and bacterial colonization of coated ETTs exposed to high inocula for up to 14 days, while uncoated ETTs had extensive biofilm growth after 24 hours. CeraShield™ coated ETTs were well tolerated in intubated pigs. The authors also found that the CeraShield™ ETTs also significantly reduced endotoxin levels.”

N8’s November 2017 PR mentions their intention to initiate clinical trials in the first quarter of 2018; however ClinicalTrials.gov indicates the Feasibility Study was scheduled to begin in October 2018 and conclude January 30, 2019, which has been delayed to October 30, 2019 (4).

(1) https://www.biospace.com/article/releases/hydromer-inc-enters-into-a-strategic-development-agreement-with-n8-medical-inc-for-a-new-class-of-antimicrobial-coatings-/

(2) http://n8medical.com/2017/05/17/antidepressant-medication-come-with-dangers-studies-show/

(3) https://www.n8medical.com/2017/11/03/n8-medical-announces-compelling-publication-supporting-its-breakthrough-cerashield-endotracheal-tube/

(4) https://clinicaltrials.gov/ct2/show/NCT03716713