Colombian biotechnology start-up heals wounds
By Philip Stevens
For those unlucky enough to suffer a serious burn or wound, a skin graft is one of the few tools at the disposal of surgeons.
Skin grafts are neither easy nor pleasant. Under a general anaesthetic, a large slice of healthy skin is taken from elsewhere on a patient’s body, and “grafted” over a large wound or burn — a complex and expensive surgical procedure that that can lead to severe pain, scarring, months of recovery and even rejection by the patient’s body.
In 2008, company Keraderm was set up in Bogotá by a group of Colombian plastic surgeons, convinced they could find a better way to treat tissue loss resulting from burns, ulcers, tumours and trauma.
Keraderm is a story of Latin American innovation that will have global implications, that could not have got so far without the protection provided by patents.
After several years of work, Keraderm’s scientists refined a technique that involves taking a one centimetre-square sample of healthy skin from behind a patient’s ear and allowing the skin cells to reproduce over a period of five to seven days in a sample of the patient’s blood in a laboratory. The skin cells are then implanted on a collagen sheet about four times the size of a business card. This new sheet takes the place of the traditional skin graft.
“It starts to heal the injury by accelerating the growth of healthy skin cells,” said Jorge Soto, the company’s chief financial officer. “In 20 to 40 days, the wound is completely healed.”
This procedure, now patented in several countries including the United States, removes the need for a sterile operating room and anaesthesia, slashes recovery times, reduces pain and scarring, and eliminates entirely the risk of rejection.
A 10-centimetre square sheet of skin costs US$550, many multiples less than a skin graft operation.
Keraderm is a story of Latin American innovation that will have global implications, that could not have got so far without the protection provided by patents.
The problem
Severe burns impact 1% of the world’s population at some point in their lives. In Colombia alone, 50,000 people suffer burns each year, with 5,000 of those requiring hospitalisation.
But it’s not just burns that disfigure skin. Chronic wounds caused by for example diabetic, venous and pressure ulcers are a silent epidemic that affect between 1 and 2 percent of the population of developed countries at some point during their lifetime, a problem that will get worse as populations age. Complications of chronic wounds include infection, gangrene and amputations and can seriously undermine overall health and quality of life through pain, loss of function and mobility, depression and prolonged hospital stays.
The economic impact of chronic wounds is enormous, with the United States spending over USD$25 billion each year on treating wound-related complications.
And while synthetic skin replacement products have emerged as alternatives to skin grafts in recent years, they are costly and often do not resemble native skin.
The solution
“The story goes back to when I was finishing my specialization”, says Jennifer Gaona, scientific director of Keraderm and specialist in plastic and reconstructive surgery.
“We started looking for a method of covering wounds that was not so traumatic. During our search, we came to the standardization of a skin cell culture method. Our solution was Keraderm, a process of growing skin cells where a very small sample is taken behind the ear, taken to the laboratory, cultivated in the patient’s own blood, from which 10 square centimetre skin membranes are made to put on top of the patient’s wound.”
“This has huge advantages for all patients, because not only does it not need surgery, it does not create pain or additional scarring,” she adds.
Furthermore, the procedure can be conducted anywhere by nurses and physicians of any speciality, removing the need for using the operating theatre. Keraderm is therefore a solution particularly suitable for developing countries, where burn prevalence is high and clinical infrastructure is minimal.
Growing pains
Keraderm’s road from laboratory to marketplace is not yet complete, but it would not have come so far without the credibility and protection afforded by its intellectual property portfolio, including patents awarded by the United States, Canada, Mexico and China.
Once the initial concept had been proved on ten patients in 2008 and the results published in a Colombian medical journal, the team quickly moved to gain patent protection for the procedure, with an application filed in late 2009 via the World Intellectual Property Organization’s (WIPO’s) Patent Cooperation Treaty. This acts as a “one stop shop” for inventors, removing the need to file a different patent for each country.
Keraderm’s road from laboratory to marketplace is not yet complete, but it would not have come so far without the credibility and protection afforded by its intellectual property portfolio, including patents awarded by the United States, Canada, Mexico and China.
Once the patents were granted, the Keraderm scientists designed and undertook a clinical trial in Bogota with 48 patients. Success here allowed the company to raise an additional $300,000 from angel investors, giving them resources to open a lab in Bogota that June.
A further boost came in 2013, when the company won $50,000 from Boston start-up accelerator MassChallenge.
Keraderm’s technique has been proven in small scale clinical trials in Colombia. But to bring it to a global market, including the United States, it would need to be tested in clinical trials amongst large numbers of volunteers to gain regulatory approval. That would be a risky and resource-intensive programme beyond the resources of Keraderm, which currently has fewer than ten employees.
Small start ups with promising technologies typically look for alliances with larger companies to take their ideas through the expensive process of commercialisation. Here, intellectual property rights are key. The existence of a patent allows the start-up to license the technology to another company for commercialisation, or sell it outright.
Either option would allow the technology to go through the process of clinical trials and eventually come to the market, providing a source of income to the inventor in the form of royalties or sale of the company, while benefitting society at large through the introduction of an innovative product.
This is the strategy being deployed by Keraderm. “We are thinking of taking it specifically to Canada and Spain, which is where besides having patents, we can have contact with companies that are interested in buying Keraderm. Recently also an Arizona company expressed interested in an alliance with Keraderm” says Gaona.
Given its advantages over existing skin reconstruction technologies, Keraderm will no doubt soon find a partner or buyer, and eventually find its way into the reconstructive surgery toolkit. As with all inventions, inspiration and perspiration have been key, but without patents that effort would be wasted.
