Hemostemix’s Patented Technology Based on Over 15 Years of Clinical Data

The Canadian biotech company Hemostemix (TSXV:HEM; FRA:2VF0) has confidently secured the registered trademark “your fountain of youth”. What sounds like science fiction or mere marketing is not. Rather, this promise captures the essence of Hemostemix’s stem cell therapy: The company has treated heart patients, diabetic foot patients, and patients with vascular dementia under scientific supervision with statistically proven success!

Today, all those who need stem cells to regenerate their circulatory system can receive them. Soon, according to the company’s forecast, it will offer its therapy as naturally and regularly as one is accustomed to from an annual spa visit. Who wouldn’t want to maintain the clear mind and quality of life we enjoy in our 40s and 50s well into our 80s and 90s?

Hemostemix has treated 498 individuals with complete safety and statistically significant results. The company has published its scientific data from seven clinical trials with 318 subjects in leading journals, including Stem Cell Research and Science. The company’s therapy is both safe and effective in regenerating blood flow where the body signals a need. As with any medical innovation that becomes commonplace (think of slimming pills), the demand is high.

Consider the treatment of chest pain (angina), a treatment for the heart after a heart attack, or the treatment of circulatory disorders in toes, feet, and legs. Hemostemix has completed and published seven clinical trials showing that it treats each of these conditions in patients for whom there were no other treatment options. A patient without treatment options is typically in the end stage of their disease process. They are very ill and have exhausted all surgical, medical, and pharmaceutical options. Take, for example, a typical heart patient who has received stents and bypass surgery, is on maximum medication, and has no further options. These are Hemostemix’s patients to date.

Hemostemix’s stem cell therapy is made from the patient’s blood. The company offers its treatment to eight patient groups who have exhausted all surgical, medical, and pharmaceutical options, or to individuals who conclude: Why wait until I run out of options? For example, Hemostemix treats patients at risk of limb amputation (chronic limb-threatening ischemia, CLTI), those suffering from peripheral arterial disease, or chronic limb pain. For heart patients, special access programs treat angina, ischemic cardiomyopathy (plaque buildup), dilated cardiomyopathy (thickening of the heart wall), congestive heart failure, and vascular dementia.

Diabetics who become CLTI patients without treatment options have a 60% mortality rate within five years. In Hemostemix’s Phase II study, the University of Toronto and the University of British Columbia found that 83% of patients observed for up to 4.5 years had their limbs saved, ulcers healed, pain stopped, and no mortality was recorded.

In its third study on treating heart disease without treatment options, published in Stem Cell Research Therapy in November 2023, Hemostemix confirmed the results of two previous independent studies: The therapy improved 27% of the blood volume ejected with each heartbeat in patients suffering from ischemic cardiomyopathy, and improved the blood volume ejected with each heartbeat by up to 47% in patients suffering from dilated cardiomyopathy. These results were statistically as significant as in the first study with 41 patients and the second study with 106 patients.

With its proprietary stem cell therapy, Hemostemix is addressing these debilitating conditions earlier in the disease process to generate revenue. In this respect, Hemostemix is no longer a startup. The company was founded 21 years ago. Since then, more than CAD 45.8 million has been invested, including more than CAD 9.1 million by management and directors since 2020.

Hemostemix was awarded the ‘Technology Pioneer Award’ at the World Economic Forum in Davos in 2005 for scientifically demonstrating that 250 ml of a patient’s blood contains enough stem cells to develop a therapy from it.

However, the path from a good idea to revenue realization is long and rocky. It speaks for the company that it is still bringing its therapy to market after such a long time. The management has made significant progress, persevered, and together with the board has invested about $9 million since January 2020.

Clear Path to Revenue Ahead

During the clinical Phase II study, the company chose not to focus on revenue to minimize risks. However, given the results of Phase II and Hemostemix’s ability to treat patients without treatment options through special access programs, management negotiated a contract to manufacture its therapy at CytoImmune Therapeutics Inc.

Now the company is focusing on selling its therapy to patients who have no other treatment options, and to wealthy individuals seeking improved quality of life and longevity or improved cognitive abilities (vascular dementia). These treatments are planned with specialists who have already treated patients with the Hemostemix therapy, including three cardiologists who have treated more than 200 cardiac patients.

The company is starting with 20 batches per month and aims to double to 40 batches per month by 2026. At the same time, the company is developing an automated production system. Using robots, the company will simulate the production process to enable scaling up to 240 treatments per month. At 20 treatments per month, the company projects annual revenue of $8,800,000.

Two Types of Stem Cells

To understand Hemostemix’s special position compared to its competitors, it’s important to know that there are two main types of stem cells. There are stem cells that come from the patient’s body (autologous), and there are stem cells that come from a donor’s body (allogeneic). Intuitively and scientifically, it’s advantageous to use one’s own stem cells, as they are completely safe and can better utilize the body’s natural healing processes. For example, Hemostemix’s therapy navigates to the site of need using a GPS-like mechanism, nests there, creates new circulation, and recruits other stem cells to support regeneration of the area of need.

The market for heart disease is estimated at $5.7 billion and the market for critical limb ischemia at $3.5 billion. Worldwide, about 126 million people suffer from a heart condition known as ischemic cardiomyopathy. About 236 million people worldwide suffer from peripheral artery disease, which affects blood flow to toes, feet, and legs. About 23 million degenerate to CLTI, and about 5 million are CLTI patients with no treatment option facing limb amputation.

Strictly speaking, Hemostemix’s angiogenic cell precursors (ACP-01) are just one of three products that Hemostemix can produce from the patient’s blood. Neuronal cell precursors (NCP-01) and cardiomyocyte cell precursors (CCP-01) are also derived from the patient’s blood. In this context, Hemostemix is a platform technology. NCP and CCP are not yet commercially available. However, the potential here is also considerable: NCP could be ideal for a still young technology in which electrodes are implanted in the brains of tetraplegics. This approach has become known primarily through Neuralink (), a company founded by Elon Musk. Hemostemix believes that NCP, together with ACP, will improve signal transmission between the brain and electrode and increase the longevity of the implant, potentially reducing the need for additional surgeries.

The cardiomyocyte cell precursor is a heart cell precursor. Imagine your own heart stem cells beating in a dish. In the future, it could be fused with a bioscaffold to create a heart patch.

ACP is very easy for doctors to use as it fits into their existing practice. For example, on the first day, the nurse takes blood from the patient and sends it by courier to Hemostemix, where it is centrally processed. After the blood draw, the nurse schedules an appointment for the patient in seven days. The doctor receives ready-to-use syringes. When there is no other option to treat critical limb ischemia, the doctor injects the therapy into the patient’s leg in an outpatient procedure. For heart treatment, the cardiologist and patient are in a catheter lab, where the cardiologist injects the stem cells directly into the collateral arteries that supply the heart. This is a routine catheter procedure.

Increase production from 20 to 240 batches per month

Hemostemix is now ready for the Phase III study on critical limb ischemia. The company plans to finance the study from the cash flow generated by treating patients without treatment options.

The company plans for CytoImmune to perform 20 treatments per month with a team on one shift, generating annual revenue of $8,800,000. By expanding to two or three shifts, revenue can be doubled and tripled. After that, a larger volume (12-fold) is to be achieved through automation of production processes. Hemostemix expects to generate cash by the fourth quarter of 2025 and achieve positive cash flow in 2026. To achieve this, Hemostemix will increase revenue in the coming months.

Conclusion: Hemostemix is what is known on the stock market as a ‘fallen angel’. This is precisely why we also see the company as a ‘blue sky trade’. Hemostemix shares were traded at over CAD 20 equivalent at the IPO in 2014! Today, the share price is in the penny stock range and the market capitalization reflects only a fraction of what has already been invested in the company. However, the medical uncertainties are much lower today than they were a few years ago. Clinical studies show that Hemostemix offers groundbreaking treatment for heart disease and chronic limb-threatening ischemia. There is no risk to the patient as the therapy consists of the patient’s DNA. Therefore, there are no ethical concerns regarding the origin of the stem cells. The therapy is safe and effective. The process is patented, scalable, and profitable. With the completion of a successful FDA Phase III clinical trial, Hemostemix will become a highly sought-after takeover target. We consider Hemostemix an exciting investment in biotechnology for the treatment of cardiovascular diseases. From now on, we will report on the company’s progress here.

[1] Your Fountain of Youth is an international brand owned by Hemostemix. In short, Your Fountain of Youth describes the results of the therapy: the reversal of cardiovascular diseases in the heart, limbs, and brain (vascular dementia) of patients