In the arena of oncology, one form of cancer treatment has seen a resurgence of interest from the medical community and patients in recent years. Due to a combination of improving technology and increasing awareness of the technique’s effectiveness, brachytherapy has become a popular method of cancer treatment, and is projected to grow to an $8 billion market by 2017. The treatment is a form of precision radiotherapy that targets tumors from within the body. Cancer physicians are very positive on the treatment, because It’s minimally invasive, very cost effective and requires a significantly shorter recovery time than other forms of treatment.
That said, the current radioisotope technology on the market today still has ample room for improvement. Advanced Medical Isotope Corp. (ADMD) believes its lead product Y-90 RadioGel™, which is currently seeking FDA clearance as a Class II medical device, offers several advantages over current competitors. In fact, the company doesn’t shy away from what exactly it wants to be for the industry.
“Many believe that we are the next generation of brachytherapy,” ADMD’s Co-Founder and CEO James C. Katzaroff told Equities.com. “We are very comfortable agreeing with that. The most simplistic way to put it is that our Y-90 RadioGel™ is injected into inoperable tumors and then hardens, effectively stopping the spread of cancer, with the radioactivity effectively killing the cancer cells, and focusing all the therapeutic dose to the affected area. There’s nothing in the market that is remotely similar.”
There are a few reasons for Katzaroff’s confidence in Y-90 RadioGel™, which he calls “a massive paradigm shift in a 100-year-old industry.” For one, it has a significantly shorter half-life of 2.7 days, as opposed to a half-life of 10 to 65 days for current treatments, meaning it exposes patients and healthcare workers to a fraction of the radiation. It also uses a bioresorbable (biodegradable) polymer gel as the application as opposed to the permanent radioactive metal or glass seed implants that other forms of brachytherapy use to target tumors. Most importantly, Y-90 has an extremely high therapeutic index, according to the company, meaning that it is very effective at destroying cancer cells in relationship to other marketplace isotopes.
The technology is primarily based on ADMD’s exclusive licenses to patents from the renowned Battelle Memorial Institute in Washington state.
The Next Generation of Brachytherapy
“The demands for radioisotopes is continually increasing,” Katzaroff said. “Radiotherapy can be used to treat all sorts of medical conditions, especially cancer, because it's proven that radiation either weakens or destroys targeted cells. There are tens of millions of nuclear medicine procedures performed each year. In fact, there are over 10,000 hospitals worldwide using radioisotopes in medicine today.”
Y-90 RadioGel™ is one of three products the company has in its pipeline, all of which are based on the Yttrium-90 isotope. “Yttrium- 90 is really a wonderful isotope to utilize,” Katzaroff said. “Not only is it in good supply and inexpensive relative to others, but it also has only a 2.7-day half-life. It’s a beta emitter with very short and very powerful wavelengths, averaging 4 to 9 mm. It's really great for a targeted tumor.”
The other two products in development are the Y-90 Fast-Resorbable Polymer Seeds, which is a brachytherapy seed using bioresorbable polymer as opposed to permanent titanium or glass seeds; and the Y-90 Polymer Topical Paste, which is to be applied to tissue surfaces after surgical tumor removals to treat residual tumor cells.
FDA Clearance for Y-90 RadioGel™
Currently, the company is focused on getting FDA clearance for the Y-90 RadioGel™ as a Class II medical device. The advantages of Y-90 RadioGel™ being definitively designated as a medical device is that the path to clearance has significantly less red tape than the FDA’s drug approval process, which tend to drag on for years in many cases. Granted, there are no guarantees in matters such as these, but ADMD has been in communication with the FDA to ensure that the company provides all the information that is needed for the review. The company estimates that the process typically takes anywhere from 90 to 120 days.
“It's an advantage for two things,” Katzaroff said. “Number one is time, and number two is capital required. Both of those are big advantages to us, so we’re happy with that obviously.”
The company is targeting pancreatic cancer for its FDA clearance, but the Y-90 RadioGel™ could potentially be applied to all forms of non-resectable tumors—meaning tumors that can’t be cut out by surgery—which translates to a very large market potential for the treatment.
Market Potential for Y-90 RadioGel™
“I don’t want to throw out silly numbers, but if you really look at all the non-resectable tumors…it’s scary,” Katzaroff said. “The market size is very big. As an example, there’s a company called Sirtex out of Australia that generates over $100 million in revenue, much of it in the US, just for liver cancer. It's FDA-approved, so they've got a head start on us, but we're contacted constantly by oncologists that want to be part of what we're doing, and we've had groups of university and private hospitals that want to be part of our trials. We're working towards making a very big splash and a big difference for patients.”
Katzaroff added that while ADMD is in no rush to do so, it is open to exploring partnerships that make sense for the company’s long-term strategic plans. The company continues to receive validation for its work, as evidenced by awards and recognition by the United States Secretary of Energy, the World Council on Isotopes, as well as a number of government grants from the state and federal level.
“What we are all about is making the world a better place, having some fun doing it, and trying to create a lot of shareholder value,” Katzaroff said. “I think the next few months are going to be some of the most exciting time in our company's history. There’s a lot of things happening including we will resubmitlater this year with the FDA and keep on top of that. We’ve got people joining the company from around the globe. We have strategic partnerships that are in the works. We have a lot happening on the manufacturing side that we're working through. All these sorts of slots are being filled one by one and I’ve put together a spectacular team that gets things done. I’m very excited about the future of ADMD and the difference we will make around the globe to patients suffering from cancer.”
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