Everyone. We've been in at Longeveron and trades on the NASDAQ symbol LGVN. At clinical stage, we are a company developing regenerative medicines to address unmet medical needs. Happy to welcome its CEO and Director, Wa'el Hashad. Welcome, Wa'el. What's your update today?
Thank you, Anna. We continue to make good progress on all of our deliverables and progress toward submitting a BLA hopefully next year and get this product and therapy out to the patients that need it, hopefully in 2027. As a reminder, this is our forward-looking statement. You can read the whole statement. It is available on our website. Longeveron is a stem cell therapy company for life-threatening and chronic aging-related conditions. We have our lead asset, Lomecel-B, which has multiple positive initial results in five clinical trials across three indications. In the order of our priority, we have a clinical pipeline available to us for HLHS, hypoplastic left heart syndrome, Alzheimer's disease, and aging-related frailty. I also want to remind everyone that we have received several important designations from the FDA for the HLHS program.
We have rare pediatric disease designation, which comes with a priority review voucher available to us upon approval. We have an orphan drug disease designation and fast-track designation. On the Alzheimer's side, we have two important designations: a regenerative medicine advanced therapy designation. We are the only one that has that designation for Alzheimer's disease. We also have a fast-track designation. We have a cash and cash equivalent that covers us throughout the end of this year. We continue and we have a proven management and scientific and manufacturing team. Our product, for those who are listening to it for the first time, it's an allogeneic medicinal signaling cells, also known as mesenchymal stem cells. We're isolated from bone marrow of healthy young adults, 18 to 45 in age. We expanded from a cultural standpoint in our labs here in Miami.
We produce billions of cells out of this starting points of the bone marrow. This is an off-the-shelf product, meaning that it can be given to any patients who are suffering from any of these conditions, at least in our clinical trial for the time being. We are in, as we said, we finished five clinical trials. We finished two trials in Alzheimer's disease. We finished two trials in aging-related frailty. Both are phase I and phase II, 2a in Alzheimer's, 2B in aging-related frailty. We finished phase I in hypoplastic left heart syndrome. I will call it from now on HLHS. We are almost at the end of wrapping up our phase 2b, which is a pivotal trial for HLHS. This three indications represent a great opportunity.
Hypoplastic left heart syndrome, while the prevalence of disease is about 1,000 patients every year, because it's a rare disease, the pricing model for these products is different. We estimate the opportunity could be up to $1 billion in the US market and maybe equivalent outside of the US. Alzheimer's disease is 6.9 million patients that suffer and continue to be one of the fastest-growing populations. Aging-related frailty is 8.1 million patients and again continue to grow with the aging population, continue to live longer. Both market opportunities are north of $5 billion each. Whereas, how is our progress so far on HLHS, which is our top priority? We presented our five-year post-treatment long-term survival data last year in October at the Congenital Heart Surgeons' Society meetings. We showed 100% survival.
This is compared to the largest data set that was done by the NIH from the National Heart and Lung and Blood Institute. It's called the SVR trial that shows about 83% in a similar timeframe for the patient. We definitely have showed very good progress on this one. That is very promising data. We have not seen any adverse cardiovascular events, MACE. We also have not seen any related safety issues. These findings all were reported, as I said, last year at the CHSS meeting. On the regulatory front, we have continued to move our pivotal trial, the phase II, ELPIS II, phase 2b trial. We are going to give an update on the latest number of enrollment, but we are anticipating to finish this in the first half of this year.
We'll follow up the patients for one year, and then we'll be ready to go for the submission. We also had last year a positive type C meeting with the U.S. FDA. We have a roadmap now toward filing our BLA next year after we finish our trial. On the Alzheimer's disease, we have the results from the CLEAR MIND data that was presented last year in Philadelphia at the Alzheimer's Association International Conference as a featured presentation on the first day of the conference. The results of the trial support the potential for treating the patients with mild Alzheimer's disease and provided evidence about the potential clinical benefit without demonstrating any major serious adverse events. The trial was also presented at the CTAD meeting in Spain last year as well.
The finding again demonstrated the potential mechanistic and clinical insights into the use of Lomecel-B in Alzheimer's patients. The FDA in July granted Lomecel-B an RMAT designation. We are the only drug that we are aware of that has that designation for Alzheimer's disease. We have also received a fast-track designation. We are planning to meet with the FDA in the first quarter of this year to demonstrate the next steps in the development of Alzheimer's disease. Other milestones, we have also received the World Health Organization International non-proprietary name for the product. From now on, you're going to hear about the word lomestrocel, which is, again, this makes it a unique product compared to any other stem cell therapy products. Our HLHS completion of enrollment, as I mentioned, we anticipate it in the next few months.
Alzheimer's disease, we anticipate meeting with the FDA in the first quarter of this year. We continue to make good milestones on this one. With that, I will give it back to you, Anna, and happy to take any questions that you may have.
Wonderful, Wa'el. Thank you so much. We are out of time, but we will send you these questions so you can answer our viewers on your own. Thank you . Begin real soon.
All right. Thank you, Anna.
All right.