The Tribune

By NEIL HARTNELL

TRIBUNE Business Editor

nhartnell@tribunemedia.net

THE BAHAMAS was yesterday hailed as the North America “lead” on regenerative medicine by the latest provider approved to operate from this nation, which predicted it may generate “up to $9m” in annual economic activity within five years.

Thomas Smeenk, president and chief executive of Hemostemix, which revealed it has received full approval from Bahamian regulators to conduct first-phase clinical studies of its VesCell treatment for impaired blood flows, told Tribune Business that this nation’s supervisory regime and laws governing regenerative medicine and longevity are second to none when compared to regional rivals.

Signalling that Hemostemix is partnering with Doctors Hospital on its Bahamas plans, he confirmed that it will both establish a physical presence in this nation and hire Bahamians although details and timelines now have to be worked out after receiving final go-ahead from the Longevity and Regenerative Therapies (LARTA) Board that oversees the Act bearing the same name.

Also pledging that Hemostemix will offer its stem cell-based vascular and ischemic disease treatments to Bahamians if proven successful, Mr Smeenk said this nation has “carved out a very compelling footing” in this area of medicine through passage of the LARTA Act in 2024 that is now beginning to attract practitioners to domicile here.

“Well, it really is the Longevity and Regenerative Therapies Act,” he explained, “and the forward-looking footing that The Bahamas has taken in respect of the longevity space and the regenerative medicine space. I found that they have obviously done their homework, and found a very compelling footing that they have carved out for themselves.

“It enables companies like Hemostemix to conduct a commercial clinical trial, and that enables patients from all over the world to access treatment under a clinical trial setting. It really creates a ‘two for one’, if you will, where companies obtain the scientific data and are able to publish the results, and do so from a foundation and trial for commercial sales.”

Asked how The Bahamas’ legal and regulatory regime compares to rivals in the commercial and regenerative medicine space, Mr Smeenk told this newspaper: “I think it’s very competitive globally, uniquely positioned in North America. Generally speaking, there are other jurisdictions such as South Korea and others that enable stem cell therapy treatments in an environment like this but, for North America, The Bahamas is really in the lead.”

He spoke out after Hemostemix announced it had received full approval from the LARTA Board, including its ethics committee, to conduct a first-phase study of VesCell, which is designed to treat angina, vascular dementia and associated pain. Angina is chest pain or discomfort that happens when the heart muscle does not get enough oxygen-rich blood, while vascular dementia results from a decline in thinking cells caused by reduced blood flow.

Mr Smeenk said Hemostemix will now have to determine set-up and launch timelines, and find a suitable physical location in The Bahamas, but added: “We’ll be working very closely with Doctors Hospital and the staff there to treat and welcome patients to The Bahamas.”

He added that staffing in The Bahamas will gradually ramp up as Hemostemix’s activities, and the number of patients that visit, increase. Mr Smeenk said it will immediately need at least six persons to provide “concierge type services” in transporting patients from the airport to their hotel, and then to Doctors Hospital and other locations that Hemostemix may be using.

“I think if you take a longer term view over five years, when we are successful, in terms of our business plan we would be generating say $6m, up to perhaps $9m, a year in activity,” Mr Smeenk told Tribune Business. “I think that, longer term, there’s a significant opportunity to perhaps produce our product in The Bahamas and thereby employ the biotechnology-educated type of individual to produce that certainly in The Bahamas.

“These are early days, but that is an opportunity.” Asked about the economic opportunities that the regenerative medicine industry offers The Bahamas, Mr Smeenk said studies suggest there are up to 25 million wealthy individuals globally seeking the kind of treatments the sector provides.

“I think that it is a multi-million, approaching a billion dollar, industry and sector,” he added. “Even if you look at it from the perspective, and I would be conservative, of one patient a day being treated - to build from one per day to two per day, four per day and ten per day - in our modelling there are some 23 million or 25 million high net worth individuals globally who are seeking what Hemostemix offers and what other companies in the longevity space offer.”

Hemostemix’s website lists Dr Desirée Cox, a Bahamian Rhodes Scholar and Cambridge University graduate who played a key role in establishing the LARTA Act, on its Board of Directors. It describes her as a “physician, scientist, bioethicist” who has worked in medicine, ethics, public policy and regenerative medicine.

“For more than a decade, Dr Cox has led regenerative medicine ethics and governance in The Bahamas, chairing the National Stem Cell Ethics Committee and helping build the legislative framework behind the country's Longevity and Regenerative Therapies Act (LARTA) — positioning The Bahamas as a hub for responsible longevity science,” Hemostemix said.

“She is the founder of HEALinc, a global health innovation platform working to make regenerative, longevity-enhancing technologies more accessible.” Hemostemix will now join Ocugen, a US-based provider of gene therapies for blindness, and Neurogen Brain & Spine Institute, the Indian operator that treats “incurable neurological disorders”, among the regenerative providers attracted to The Bahamas and moving through the approvals process.

Mr Smeenk said Hemostemix’s treatment is “unique” in that it uses stem cells, originating from the patient themselves and their DNA, to create new blood flow and circulation wherever there is “inflammation” in the body through “creating a natural bypass” around whatever vascular obstacles and restrictions exist. He added that this enables the heart to beat faster, and prevents the loss of limbs due to amputation as a result of blood flow restrictions.

The Hemostemix chief said initial tests had shown that its products “saved 60 percent of limbs in the first stage trial that would otherwise have been amputated”. He added that, after three months, there were “zero amputations” in the patient group receiving its treatments but six among those who did not.

And, two years later, testing revealed that there were no deaths among the Hemostemix treatment group, with “70 percent of limbs saved”, compared to a 20 percent mortality rate among those who did not take its drugs. Mr Smeenk said the company was also running a clinical trial with Doctors Hospital on vascular dementia which showed its treatments resulted in an improved cognitive state for patients.

Dr Michael Darville, minister of health and wellness, recently told Tribune Business that he soon plans to bring reforms to the governing Longevity and Regenerative Therapies Act 2024 to Parliament in a bid to strengthen the legislation and make it even more user-friendly.

The legal amendments, he added, will be joined by completion of the Act’s accompanying regulations and implementation of a “very robust digital platform” that will allow the authorities to more efficiently monitor and oversee the regenerative medicine industry’s impact on The Bahamas.

“We’ve learned a lot since the passing of the Act. These things are moving so rapidly we have to race behind and keep up as it relates to those in the world of longevity and regenerative medicine,” Dr Darville said. “This is the first amendment brought to Parliament.

“It will allow us further efficiency, and to implement a digital platform so we are actually more efficient in monitoring and collating the impact in the country. We have a very robust digital platform that we are about to finalise along with the regulations and amendment to the LARTA Act that’s already making waves internationally, and attract really good people to our jurisdiction - not only for the treatments, but medical tourism for The Bahamas.”

Asked about the economic potential that regenerative therapies hold for The Bahamas, and the likely impact if a local industry develops, Dr Darville described it as a multi-billion dollar global sector with the largest market on this nation’s doorstep.

“The Bahamas, with its close proximity to the US, which is the largest market for individuals seeking these types of therapies, we anticipate getting a big chunk of the medical tourism market,” the minister said, while not placing a dollar figure on the value.

“It opens, for the first time in the country’s history, it opens a medical tourism industry. We have a real medical tourism product that we can benefit from - the travel as well as the presence of this new industry in the country” that could offer new and innovative treatments for Bahamians too.