Chordate Medical receives patent approval in the US
Chordate Medical will be granted a fourth patent in the US for the migraine treatment Ozilia. In parallel, work is underway to obtain market approval from the FDA. BioStock reached out to CEO Anders Weilandt to learn more about the opportunities in the US market.
Chordate Medical has developed Ozilia Migraine – a medical device treatment method for chronic migraine. The treatment consists of a catheter and a control unit that creates nerve-stimulating vibrations in the patient’s nasal cavity – this provides a preventive treatment effect. At present, Chordate Medical has 79 patents divided into nine patent families in 32 countries.
– The patent families deal with various aspects of Chordate’s technology and are designed to provide the best possible protection for the inventions that is the basis for the company’s products, the company writes in a press release.
The patent portfolio is a central part of the company’s business development and is highlighted in discussions with potential takers of the Ozilia project.
– One of the three cornerstones of our strategic efforts to build shareholder value is to fulfill our patent strategy. The intellectual property defense of our technology to support our ongoing business development is an essential part of what we consider core values in the company, says Chordate Medical’s CEO Anders Weilandt.
Ongoing work on the FDA application
Another important part of the company’s exit strategy is to obtain FDA approval to enable market launch in the US. The company has previously announced that it does not intend to launch the product on the US market by itself. Instead, the FDA approval serves as another way to add value to the Ozilia project.
CEO discusses the US market
The US is an important market as it dominates the global pharmaceutical market for chronic migraine. In addition, the FDA has approved several medical devices for migraines, not least in neuromodulation.
BioStock reached out to Chordate Medical’s CEO Anders Weilandt to learn more.
How does the American migraine market differ from the European one?
– Apart from the obvious differences, such as a radically different market and healthcare delivery, as well as entirely different reimbursement models, the prevalence of migraines or the range of therapies available does not differ significantly from Europe. The American market is predominantly private healthcare, paid for through individual health insurance plans. Most Americans are insured through their employers. Obtaining prescription codes for a treatment that covers the entire market is currently a time-consuming and costly process.
– In contrast, the European market is a mosaic of various forms of healthcare delivery and payment systems. Spanning between the extremes of solely public healthcare and insurance to predominantly private healthcare and insurance or private direct payment.
How does your Ozilia treatment differ from other neuromodulation treatments in the USA?
– Ozilia is a distinctly preventive treatment performed in clinics. There are a handful of other treatments based on neurostimulation, all of which are represented in the USA. Most of these have chosen to go directly to consumers via e-commerce rather than engaging with the clinical market. We believe that involving the healthcare market and neurology specialists is essential for a sustainable business setup. Direct-to-consumer e-commerce tends to be relatively short-lived.
You recently announced that the US Patent and Trademark Office intends to grant a fourth patent for Ozilia. How long are the patents valid?
– Patents can be valid for a maximum of 20 years from the priority date of the original application, which in this case is 2012.
How is the progress going regarding obtaining FDA approval for Ozilia in the USA?
– The project is currently awaiting the publication of the article from the migraine study PM007. We need to have it in place to take the next step in the FDA project.
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