SEOUL – It may be the most gruesome disease you have never heard of.
Somewhere in the world, every 1-2 seconds, a diabetic gets a foot ulcer. Half of these ulcers become infected – a process that takes only one to three days – and the infection eats deeply into the flesh.
The resultant huge, gangrene-like abscess is the diabetic foot ulcer. It is one of the most feared skin conditions on the planet.
Treatment is necessarily drastic. There is a related lower-limb amputation around the world every 20 seconds. Making matters worse, half of those who undergo these amputations die.
Now, a South Korea-based medical startup, ROKIT Healthcare, has come up with a radical regenerative solution.
First, the wound is digitally scanned, a process that can be done remotely. Then, liposuction harvested from the patient’s healthy abdominal fat is used to create “bio ink.” Next, using the bio ink, a bioprinter generates a patch of tissue to fill in the ulcer. Within 4-8 weeks, the healthy tissue grows in, without a need for surgery or drug regimens.
As the treatment is “autologous” – the implanted tissue is sourced from the patients’ own cells – there is no rejection. The procedure takes only 30 minutes, rather than the months of hospitalization required for current treatments.
Though only 300 procedures have so far been carried out worldwide, the success rate is 100%. The procedure, says Dr David G Armstrong, a professor of surgery and director of the Southwestern Academic Limb Salvage Alliance, or SALSA, will “make the world a little better and keep a few more legs on a few more bodies.”
But that is only one disease. The “regenerative niche” concept behind the treatment does not stop at diabetic foot ulcers. It is now being applied to knee cartilage regeneration and is in the experimental stage of regenerating donated kidneys.
And this opens the door on tomorrow. Regenerative niche medicine potentially offers a universe of autologous applications for multiple skin, bone and organ conditions.
Brains behind the company
The company behind these technologies is ROKIT Healthcare. And the man behind ROKIT is CEO and Chairman You Seok-hwan.
At ROKIT’s office in southern Seoul’s Gasan Digital Complex – a combined retail and startup neighborhood – You, dressed in black and white pinstripes, does not look like a scientist or a doctor.
That makes sense: The youthful-looking 63-year-old is neither.
You – who also goes by the English name Steve – was originally in automotives, where he rose to vice-president of innovation and executive director of the European headquarters of Daewoo Motor.
Daewoo was the most ambitious, fastest accelerating South Korean conglomerate of the 1980s and 1990s, storming into every sector from ships to chips. Motor was the crown jewel of the group.
“Daewoo had a certain spirit of challenge – of innovation,” You, recalled. So You – like thousands of his colleagues – was astounded when, amid the Asian financial crisis, a multi-billion dollar hole was discovered in Daewoo’s accounts.
In 1999, Daewoo imploded in the world’s then-largest bankruptcy. Its chairman went on the run; the group was broken up and sold off. When GM took over Daewoo Motors, “I found they were very slow-moving, I felt the Daewoo spirit of challenge would disappear,” You said. “I quit.”
Advised to expand his experience in global management, he took a job with multinational fire and security systems firm Tyco. There, he gained experience in capital flows and capitalist behavior.
“I learned how global business was controlled by guys in Wall Street and London,” he said. “It was a money game.”
With Tyco on an acquisition binge, You, as senior vice-president for Asia-Pacific in Singapore, found himself wielding the ax. “I hated firing people – we often lost 10-20% of employees,” he said. “It was very stressful, but everyone said, ‘That’s the way.’”
Armed with a spirit of “innovation and challenge” from Daewoo and financial and management nous from Tyco, You became more interested in corporate regeneration than payroll surgery.
Bouncing into bio
Asking himself what the industries of the future would be, he returned home to bio-pharmaceutical venture Celltrion. The company was founded by another ex-Daewoo Motor alumnus, Seo Jung-jin – now one of South Korea’s richest entrepreneurs.
As CEO of Celltrion Healthcare, You took on global sales of Celltrion’s bio-similars. There, he learned the pharmaceutical business, and the huge financial burdens and risks of clinical trials, which, he said, take years and cost approximately US$1 billion.
Stresses were high. “There are many unforecastable risks in clinical trials,” he said. “I had to fly, I had to go to over 100 countries to resolve problems.”
Suffering health issues, You exited Celltrion and mulled his own future – and that of the world.
“People live longer, and need different solutions as governments have no money,” he mused. “Complex diseases usually start after 50, and after 60, people’s medical expenses increase 50% every five years.”
Using an automotive analogy, he noted: “It’s like an old car – you have to go to maintenance every month for tires, for suspension and so on. Aging is a disease.”
You was struck by the one-size-fits-all strategy that dominates pharmaceutical science. Though there are more than 200,000 identified diseases globally, pharmaceutical firms have, over the last 100 years, focused largely on illnesses affecting the highest numbers of patients.
“It is a very high-risk business – huge costs. Huge data,” You said. “Even if [drugs] are developed for just 10 people, that costs $1 billion.”
Moreover, the success rate of new drugs is only 1%. And a related issue is imprecision.
“Large production – one drug to treat 1 million people – has been the paradigm of the pharmaceutical industry for the last 100 years,” he said. “It’s economical but imprecise.”
Due to differences in DNA, bodily composition and personal health, bespoke treatment is the ideal. But like bespoke tailoring in fashion, it is prohibitive. “Everyone needs personal treatment, but it’s too expensive,” You said. “Precision medicine is only for the rich.”
Haunted by his experiences at Daewoo and Tyco, another issue on his mind was the longevity of employment. You decided to jump into bio – but not bio-pharmaceuticals.
Aiming at both regenerative healthcare and sustainable business, You founded ROKIT Healthcare in 2012.
Medical expertise was needed and it arrived in the form of Kim Jee-hee, a biologist, who was lured away from LG Chem to lead ROKIT’s R&D.
Engaged in stem-cell research, she learned of the then-emergent science of bioprinters and met You by chance – “a great opportunity.” You already had ideas and he pushed Kim to stop meeting scientists and instead talk to doctors.
That led to successful data collection, but there was a bigger aim. “At the start, my goal was tiny – to finish safety and efficacy tests,” she said. “Now, the goal is the platform business – to give the platform to the patient.”
You was determined to leapfrog medical imprecision. “I wanted to go to precision medicine, it is a totally different business model,” he said. Autologous medicine is precise to the patient – and due to this factor, ROKIT is on a regulatory fast track, obviating the irksome and expensive clinical trials required for drugs.
ROKIT’s core concept is the “regenerative niche” used to combat diabetic foot ulcers. ROKIT focused on the poorly known ailment for a simple reason.
“We had started with skin regeneration, targeting cosmetic surgery,” Kim said. “But we realized diabetic foot ulcers are the most complex skin problem. Steve said, ‘Let’s start with the most difficult thing first.’”
ROKIT’s approach is deeper than common skin grafts. “Skin grafts do not call in stem-cell reinforcement,” You said. “This is what we call the ‘regeneration niche’ – it generates a signal to the stem cells.”
Given that ulcers destroy blood vessels and neurons, affected tissue is “a kind of desert – there is no soil, no water,” You said. “Our process brings back the eco-system.”
Skin is comprised of tens of thousands of chemicals – proteins, cytokines, growth factors – of which 2-3% differ from person to person. So the patient’s own (healthy) tissue is used to combat the invasive ulcer. “It’s like the Normandy invasion!” You said.
“Traditional medicines target one kind of disease and they are artificial,” added Kim. “Our concept starts with autologous systems – our platform triggers the patients themselves.”
The treatment ROKIT is pioneering with Diabetic foot ulcers potentially extends to multiple other skin or tissue conditions.
It has already been used to treat burn victims in Turkey and in cosmetic surgery in the UAE. In the latter case, a patient rejected silicon following breast treatment. Using ROKIT’s technology, the breast was successfully implanted with living tissue – “total regeneration,” said Kim.
Similarly, ROKIT is extending its “regeneration niche” concept beyond tissue to deal with bone and organ conditions.
In the former case, knee cartilage treatments for osteoarthritis are being undertaken. The process is similar to that used to transplant bio-printed tissue to the ulcers of diabetic foot patients, but instead of using abdominal fat, the regenerative material – which is virtually identical in biological properties to knee cartilage – it is sourced from the patient’s rib.
In the latter case, kidney transplants are being undertaken, though this process is more complicated. Organs are hugely complex, and bio printers, at present, cannot reproduce the labyrinth of capillaries therein. So a donated organ is “washed” of its donor’s DNA and re-implanted with DNA from the patient, meaning it will not be rejected.
“Any kidney can be transferred to any living person,” You claimed. “Once a kidney has less than 30% function, you need dialysis, but we can improve that functionality to over 40%. ‘Washing’ a kidney is the regeneration niche.”
Trials on the cartilage solution started in November 2019, on human patients in Massachusetts and Egypt, as well as on several hundred animal tests at Harvard Medical School.
The kidney process has, so far, only been carried out on pigs, but safety and efficacy tests are set to begin in April. You admits those April tests will be “challenging,” but is bullish about expanding.
“This technology can be applied to the heart and liver,” he insisted. “It’s a hybrid concept.”
ROKIT has already registered its “Dr Invivio” bioprinter with the US Food and Drug Administration as a medical device. Its diabetic foot ulcer and cartilage procedures have been categorized as Non-Advanced Therapy Medicinal Products by the European Medical Agency.
“Each country needs its own approval from their regulatory authorities,” You said, but noted that many countries follow the lead set by the FDA and EMA
The pandemic has put ROKIT’s plans back between six and nine months, but matters are proceeding regardless. A “Regenerative Center,” operating the diabetic foot ulcer regeneration platform developed by ROKIT, opened in Al-Qassimi Hospital in Sharjah, UAE, on January 27 this year.
You’s business model is to provide the hardware and software package that comprises his “Dr Invivo” bioprinters free of charge to hospitals, clinics and medical professionals. ROKIT will generate revenues by selling the patient kits for each treatment. Though prices have not yet been set, Asia Times understands that costing will fall inside the US$600-1,500 range.
The boxed kits include disposable accessories for the treatment process, and include dispensers, bio polymers, dressings, film and tools to handle tissue. The boxes themselves are inscribed with a quote from SALSA’s Armstrong.
The de-cell, re-cell machine for “washing” organs and replacing them with patients’ DNA should be ready for operational use in April, You reckons.
Unlike South Korean conglomerate offices – with their ranks of grey cubicles – ROKIT’s office is fully open plan. Casually dressed staff work at shared-use, rather than individual, desks.
The meeting zone is right in the center of the office and lab space is at the back. Plastic superhero figures stand on the window frames and a gruesome plastic model of an ulcerated foot stands on a bioprinter. A $500,000 DNA scanner is prominent in the glassed off, sanitized lab.
ROKIT now has about 300 patents and approximately 100 staff, of whom approximately 20% hold PhDs. Everyone has stock options.
“I call it talent capitalism,” You said. “If we succeed in the diabetic foot ulcer space, we can be a billion-dollar company.”
According to the International Diabetes Federation, the number of diabetic patients worldwide has exceeded 462 million, a number expected to increase up to 600 million in the next decade.
It is estimated that up to one-third of diabetic patients worldwide will develop a diabetic foot ulcer – hence ROKIT is targeting approximately 77 million patients worldwide, a market worth approximately $77 billion for its kits.
And with the technology being applicable to serious burns, ROKIT is banking on a market of approximately $119 billion in 2025.
This is one of the reasons You plans to offers his bioprinters for free. That will help to win the technology economy of scale, while creating a community of users, who can share data, via open platforms, and advance treatment protocols beyond those ROKIT is developing.
A more distant goal is to create a medical insurance company.
“We know DNA, so we can say to a patient, ‘You have a high possibility of Alzheimers, we can provide a monthly medical check-up for those symptoms,’” he said. “People are living longer – that is the fundamental issue – and this will reduce medical expenses.”
South Korea’s startup scene is frothing with liquidity and the G12 economy hosts the world’s 5th largest flock of unicorns. Amid this, ROKIT has secured startup capital of $110 million from Boston-based life sciences venture fund DRADS Capital and local VCs.
On the business front, it has pre-signed some $200 million worth of contracts around the world, You said. Later this year, ROKIT will list on South Korea’s secondary KOSDAQ market.
Looking further ahead, You is aiming at leveraging the micro-scanning technology embedded in his printers to create a 4D laser cutter that could, potentially, replace human surgeons. “We already have the AI to do this,” he said.
Much of the above may read like science fiction. But Kim is upbeat. “We are like a rocket – we go very fast,” she said. “We want to change things for the better.”
And You is convinced that his maximum-challenge strategy provides an express route over the horizon.
“The most difficult skin regeneration is diabetic foot ulcers, the most difficult bone regeneration is cartilage, the most difficult organ regeneration is the kidney,” You said. “Our culture is not step-by-step, it’s a quantum jump – we don’t want to take 30 years.”