Sometimes, success in healthcare comes down to simply discovering the right solution at the right time. More often than not, however, it comes down to foreseeing how that solution will be rolled out.
After all, it’s not always the company that initially develops a therapy or drug that achieves the most profit, it’s the one that rolls it out to market. It’s a common story in the healthcare sector; a company with patented therapies succeeds in trials and makes a pretty penny, but the partner that sells and distributes it makes enough to run a whole business.
That’s why the perfect mix of a healthcare company that both develops breakthrough therapies and has the capacity to scale and produce them is worth every investor’s time. When those therapies can help more than 10 million people worldwide, like those of
Hemostemix Inc. (
TSX-V:HEM,
OTC:HMTXF,
Forum), that time can quickly become money.
As alluded to above, the Canada-based Hemostemix is a rare type of healthcare play. The clinical-stage company develops blood-derived stem cell therapies for critical limb ischemia (restriction in blood flow) and other types of vascular diseases, and works to manufacture and commercialize those therapies at the same time. Unlike other clinical-stage developers, however, Hemostemix has already found success. Now it is working to turn that success into profit.
The key to understanding how Hemostemix stands out is in the Company’s history of success, scalable business model, and seriousness of its target diseases and market. Stockhouse recently spoke with the management team of Hemostemix, including the Company’s President, CEO & Co-Founder Thomas Smeenk and Chairman Peter Lacey, and it was immediately clear just how impressive their therapies are. According to Smeenk, they were overwhelmed by the results.
“Our space is in stem cells created from the patient's own blood to address lack of blood flow, whether that's to the feet and legs or to the heart (angina), and the results have been nothing short of astonishing. Heart patients that were suffering from a class 2-3 angina with a lot of chest pain were improving to a class 1 of angina with very little chest pain, if any at all. For cases of critical limb ischemia, up to nine of 10 patients were actually saving their limb from amputation.”
(Image via Hemostemix)
The results for Hemostemix are impressive on their own, but more so when you consider the market. The Company’s patented ACP-01 treatment has been studied and clinically trialled for five different indications of ischemia, including critical limb ischemia, peripheral arterial disease, angina, and both dilated and ischemic cardiomyopathy. By itself, critical limb ischemia affects 10-12 million people around the world, with estimated total costs of up to US $248 billion. When you factor in the approximately 10 million people in North America that suffer from angina, and that the Company’s other developing treatments have the potential to assist the
one-in-three that suffer from cardiovascular diseases in general, the massive market scope is clear.
And as Smeenk highlighted, the Company’s ACP-01 doesn’t just treat patients with ischemia, it saves them from potential amputations. Restricted blood flow to limbs is the most common reason for amputation because of the damage done to peripheral arteries, to the point that there are more than three million amputations worldwide each year. The stem-cell based ACP-01 uses a patient’s own extracted blood to harvest and enriches the cell population before reinjecting it to form new blood vessels, all within the span of seven days.
Right now, Hemostemix is in a great spot with ACP-01. Early abstract results showed improvement in 83% of patients tested. The treatment was just announced as having reached the midpoint analysis of its safety and efficacy, based on 65 patients who have been followed for a minimum of 26 weeks. With 20 sites on-boarded and 65 patients enrolled, the Company is on the precipice of ACP-01 reaching a tipping point.
(Image via Hemostemix)
Of course, the Company’s success with ACP-01 has spurred the development of additional therapies, including the early-stage NCP-01. Though still in development, the scientific advisors of Hemostemix are already seeing what indications they want to tackle with the therapy, including the possibility of treating strokes.
Yet the most impressive thing about Hemostemix is not ACP-01, or even NCP-01; It’s the 91 patents issued worldwide for the therapies and their production. In their interview with Stockhouse Editorial, Smeenk recalled that when the Company was faced with the breadth of their solutions and the markets they affect, they quickly saw that what was needed wasn’t a simple treatment, but a scalable manufacturing platform.
“The numbers become daunting when you look at the process of turning blood into a therapeutic within a week and getting it back to the patient. If you have to do that 20 times a week that’s one thing, but if you have to do it 15,000 times a week, that’s quite a different scale. With 10 million people suffering from angina and millions of limbs lost to amputation every year, we recognized early on that the veracity of our treatment was overwhelming, but that it needed to be scaled.”
The solution?
A patent family that is at its core a manufacturing platform technology. After hiring an engineering firm to conduct a feasibility analysis for a device made from off-the-shelf components that could manufacture up to 150 batches per week per machine (15,000 per week from 100 machines), Hemostemix had a blueprint and a patent for automated production. They saw that the key wasn’t only in the derivation of ACP-01 and additional stem cell therapies, it was in the manufacturing and scalability of the products.
(Image via Hemostemix)
What that means for Hemostemix, and why it stands out from so many different innovators in healthcare, is that it is an effective business-model approach to market. With the scalable machine design already secured, and one machine capable of producing 150 units/week, treating and saving a million limbs from amputation worldwide doesn’t seem so farfetched. In fact, it would only take 130 machines.
Speaking to where their taking Hemostemix in the future, the Company’s Chairman Lacey stressed that they’re already at a good place with both ACP-01 and their patent portfolio. Unlike competitors developing treatments, Hemostemix is looking to capitalize
now.
“Once we've got the phase two data for ACP-01, that could actually be commercial in a very short period of time. So we're not looking at a three year window before we can make create any revenue. On the contrary, that could be the second half of this year even.”
Lacey understands fully well how important the Company’s work is in the field of ischemia. The Chairman has been invested in Hemostemix since 2014, as early on a relative of his needed surgery to transplant a vein into an artery, and lost the limb due to an infection. He’s seen firsthand that the Company’s therapies are needed in the field, and because ACP-01 has treated CLI and peripheral arterial disease, and earlier form of CLI, ACP-01 faces an easier time of adoption.
(Image via Hemostemix)
And the more people learn about Hemostemix’s many therapies and their efficacy, the more directly they can enter the market. Thanks to the right-to-try law in effect in the USA, patients are allowed to try a therapeutic they believe will save them. Similarly, in Canada, a medical exemption can be granted by a physician or surgeon who understands ACP-01 can enable the same outcome.
Meanwhile, though a successful Phase II clinical trial might not lead to immediate sales in North America, it can be used to start commercially treating in many Asian markets. As Hemostemix has built up its Board of Advisors and Directors, it has made sure that the right people in each market are on their team. For example, the recent April 21 appointment of
renowned private equity investor Timothy Chang, who brings a track record of investments throughout the Asian region and experience as the former Managing Director of Citigroup’s Asian venture capital firm in Hong Kong, tracks directly with the Company’s future roadmap.
It’s all because the team at Hemostemix is focused on not just developing effective therapies, but getting them in the right hands. Investors will want to learn about the Company and the seriousness of ischemia, but for the first time the picture becomes simplified. The market needs solutions for the millions of people who are affected, who lose a limb, and the billions of dollars depleted by ischemia and other vascular diseases. Hemostemix has management team, independent board of directors, scalable business and the therapeutic-innovations to see them come to fruition.
FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.