Honored colleagues, first I must say,
I stand here today before you for two reasons: to introduce you to a new product and to explain briefly what it is about and as a research director on two projects that were initiated based on this new product for the treatment of haemorrhoids. The first clinical trial was done 18 months ago on a group of approximately 50 patients; it was a dynamic type pharmacology study on two groups, a mature group and one on actual patients. After a month and a half of research, the product was classified as a class II medical device in Romania and we received FDA approval to sell it in the USA.
The second stage of the study started about a month ago; it is a study requested by the USA in order to show more evidence of the efficacy of this product. There is also a complementary study carried out with some US products that are similar in components and indications, but with different results.
Very briefly, it is about a product called HemoTreat H, which is destined to treat haemorrhoids. As you may know, at the moment approximately 20-25% of the population suffers from haemorrhoidal disease. I can tell you from my clinical experience, I tried many products over the years, for grade III and IV haemorrhoids the only solution was surgery, and even then, we experienced relapses.
Of course, from a surgical point of view, invasive treatment might be more efficient but for the patient, it is better to treat him without any invasive procedure.
This product has a new and innovative formula and I can tell you based on the clinical trial that we had success in 97% of the cases. What does this “efficiency” mean? We will see a little further on some slides, there was a rating scale for each patient and at the beginning of the study they had to give a rating from 1 to 5 on the following questions:
- What were the symptoms: pain, bleeding, itching, rectal tenesmus, incontinence;
The 97% result refers to the favorable response rate of the patients.
This product is for grade I, II and III haemorrhoids for curative purposes and grade IV haemorrhoids to reverse them to a grade II. In stage IV, when they are generally internal and external, the internal ones are associated with rectal prolapse and we cannot treat them 100%. What are the symptoms of stage IV haemorrhoids? Intense itching, anal bleeding, rectal tenesmus after each stool. Our purpose in this stage is no longer to heal, but to convert the condition to a stage II that can subsequently be resolved with ligatures and no surgery.
We tried to see if it has any effect on anal bleedings. As you know, it is said that each anal bleeding is a satellite to a haemorrhoid. Every time we see anal bleeding, we search for haemorrhoids and we tried to see if HemoTreat H has any effect on them. I can tell you that in many cases it helped anal bleeding to heal. Most of the times, an anal bleeding heals with scarring tissue that may lead to a relapse or other fissures because of the tightening of the orifice. From our research study that we completed almost 12 months ago, we can tell you with certainty that there were no recurrent anal fissures. Of course we need more time, I cannot tell you that 5 years from now it will be perfect but I believe that these anal fissures, by locally restoring collagen levels, will no longer be a problem.