We achieved the design freeze of the wound dressing, including overcoming the quality challenges (such as variation of metal concentrations in different batches) within the planned timeframe. More specifically, we adjusted electrospinning parameters for temperature and humidity resulting in reduced batch-to-batch variation of metal content. Among other improvements, we tested different substrate materials to improve the attachment of the electrospun wound contact layer to the substrate and achieved good results with 3-dimensional low-density polyethylene (LDPE).
We tested extensively improved prototypes of the wound dressing for absorbing properties, antibacterial properties, stability, metal release and compared them with competing wound dressings. The results showed that our improved wound dressing was superior to the wound dressings of competitors (MedCu, Sorbact, Mölnlycke, Suprasorb, B.Braun Silvercer and Maxiocel products) in antibacterial tests in vitro.
We established the first version of our quality management system (QMS) documents according to ISO13485 and performed most of the regulatory tests needed to receive CE marking.
We completed the pilot clinical trial of our wound dressing with outstanding results. A randomized controlled trial of developed wound dressing carried out on 30 patients with infected diabetic foot ulcers showed no wound dressing-related adverse events and consistently better results in nearly all relevant efficacy endpoints, such as the wound area size (WAS), the wound bacterial load and quality of life scores compared to competing widely used Ag ion-based wound dressing.
Based on the outcomes from this small trial, we compiled the protocol of the large clinical trial taking into account health economics, reimbursement, and regulatory aspects. The application for approval of this trial has been submitted to the Ethical Committee of Spain in February. The protocol was prepared in collaboration with renowned experts in the wound management field: Dr. José Luis Lázaro Martínez, a Council Member of the European Wound Management (EWMA); Dr. David Russell, a vascular surgeon and Associate Professor, as well as a member of the International Working Group on the Diabetic Foot and Dr. Helen Ilumets, Head of the Therapeutic Department at the North Estonia Medical Centre and Principal Investigator in the pilot study, among others.
We submitted 2 new patent applications: Application No 18/490,294, filed with the U.S. Patent and Trademark Office in the name of the Company on 19 October 2023 and Application NO 22721125.7 filed with the European Patent Office in the name of the Company on 25 October 2023.
We drafted the business plan and initiated contacts with distributors. Nanordica has met with 132 distributors on conferences and exhibitions and their contacts have been entered into Distributor’s database on Pipedrive platform. 14 of the distributors have been qualified as a good fit to Nanordica having experience in bringing novel innovative concepts to the market. With two distributors, we signed the letter of intent (LOI).
