“This publication confirms that the medical efficacy of the Ozilia treatment is on par with conventional drug-based alternatives for the preventive treatment of chronic migraine, a market estimated at approximately USD 8 billion in sales globally, with strong growth,” says Anders Weilandt, CEO of Chordate.

The publication signifies that the article and the study’s results have undergone a peer review by an independent expert panel. The journal’s review has given the study’s methodology and results the highest classification, Class I, as evidence that intranasal kinetic oscillation stimulation is associated with a reduced number of headache days per month in patients with chronic migraine.

In the article, the authors write about Ozilia (formerly K.O.S):

"The Chordate System provides significant benefits to patients with Chronic Migraine by reducing the number of Monthly Headache Days. The nonpharmacologic nature of the treatment option positions K.O.S as a valuable addition to the current therapeutic portfolio for the management of Chronic Migraine.”

The article, titled “Kinetic Oscillation Stimulation for the preventive treatment of chronic migraine – a randomized, double-blind, sham-controlled trial,” reports that the primary efficacy measure in the PM007 study demonstrated a significantly greater reduction in average monthly headache days (MHD) during the measurement period with active treatment (-3.5 days, n=67) compared to sham/placebo treatment (-1.2 days, n=65, p=0.0132). Compared to the sham treatment, active treatment also consistently resulted in a significant reduction in MHD during the follow-up period (-2.7 days [-4.3; -1.0, p=0.0014]). Similarly, the key secondary efficacy measure, average monthly migraine days (MMD), showed a significant reduction during both the measurement period (-2.4 days [-4.1; -0.7, p=0.0048]) and the follow-up period (-2.9 days [-4.5; -1.2, p=0.0008]).

“It is rare for medical technology in a clinical study to demonstrate this level of clarity and significance, and the importance of this publication for the company’s value can hardly be overstated,” says Anders Weilandt.

The PM007 study was registered on clinicaltrials.gov (NCT03400059) on January 17, 2018. The first patient was recruited on March 22, 2018, and the last patient completed the study on October 1, 2022. Five clinics in Germany and four in Finland recruited the study’s 132 patients, all diagnosed with chronic migraine. Half of the patients were randomized to active Ozilia treatment, while the other half received sham/placebo treatment. No treatment-related serious adverse events were observed.

Patients are diagnosed with chronic migraine if they have experienced more than 15 headache days per month, including at least 8 migraine episodes, for a minimum of three months.

The full article is available via open access at: https://www.neurology.org/doi/10.1212/WNL.0000000000210220

"The PM010 study is progressing well, with approximately 40 percent of the maximum number of patients currently recruited. One of the study's goals is to obtain as broad an overview as possible of different markets and healthcare models, which is why it is important that our new focus market, Switzerland, is also represented in the study. Inselspital in Bern is also an important reference clinic for Neurolite, our Swiss distributor," says Anders Weilandt, CEO of Chordate.

PM010 is an ongoing open clinical post-market surveillance to monitor long-term outcomes and safety of Ozilia® in patients with chronic migraine under routine clinical care. The study is designed to recruit up to 200 patients and is being conducted at 12 clinics across four European countries, with a follow-up period of 12 months. Data from this study will be reported at intervals and also be used to refine recommendations for the clinical treatment regimen.

“The revenue potential a buyer sees in the Ozilia treatment technology will determine the price they are willing to pay, likely in competition with others aiming to add Ozilia to an existing product portfolio,” says Anders Weilandt, CEO of Chordate Medical.

Chordate Medical holds 79 granted patents across 9 patent families, spanning 32 countries. These patents provide intellectual property protection for the inventions underlying the company’s products for treating chronic migraine and rhinitis. Each family includes one or more patents, registered in the EU and several other key markets, collectively describing various unique aspects and potential variants of the company’s technology and clinical efficacy. Currently, one patent application is in the review phase and has yet to be granted.

“It’s reasonable to assume that a potential buyer of the business will want to establish a global product sales strategy under patent protection for quite some time. The patents are a fundamental factor in the company’s sales value when a buyer calculates how long they can invest in sales growth with minimal disruption from direct competition,” says Anders Weilandt.

Chordate’s exit strategy focuses on demonstrating market penetration in selected markets. The company’s value is built on three pillars: robust scientific evidence from clinical studies, demonstrating sales success in a number of selected markets, and a comprehensive portfolio of intangible assets, such as patents and trademarks. Since October 2024, Chordate has engaged Partner International Switzerland GmbH as an advisor to find an international buyer for its operations.

“The availability of Ozilia as a treatment option for chronic migraine and chronic rhinitis in these markets adds significant value to the business for a potential acquiring company,” says Anders Weilandt, CEO of Chordate.

Chordate's focus markets stand out in two distinct ways. First, they have a well-developed private healthcare sector with an insurance system that, over time, could allow treatments like Ozilia to secure reimbursement codes. Second, the regulatory pathway for obtaining market approval for medical devices like Ozilia is considered favorable.

Germany

Ozilia is currently offered as a migraine treatment at six clinics in Germany.

In November 2023 and January 2024, Chordate Medical signed agreements with two specialist clinics in Hamburg and Munich for Ozilia. In addition to these two clinics, Ozilia is available as a migraine treatment at four other clinics, including those in Freiburg and Frankfurt.

Since August 2022, Chordate has been in partnership with MedTech Innovation Germany (MTIGER) to introduce Ozilia to key opinion leaders in neurology across both private and public healthcare sectors in Germany.

Saudi Arabia

Ozilia is currently offered as a rhinitis treatment at nine clinics in Saudi Arabia.

In September 2024, Chordate received its first order for Ozilia migraine treatment in Saudi Arabia. Shortly thereafter, the Saudi Food and Drug Authority (SFDA) approved the market authorization application for the migraine indication. This enabled Chordate and its partner, Janin Medical, to commence a broad market launch of Ozilia as a migraine treatment in the country. Clinical evaluation with patients is currently ongoing or scheduled at three public hospitals and a major private clinic.

In mid-2023, Chordate received its first order for Ozilia for chronic rhinitis via its new distributor in Saudi Arabia, Janin Medical. The customer was the private healthcare company Nahdi Care Clinics, which operates four hospitals in the country’s second-largest city, Jeddah. Altogether, Ozilia is offered as rhinitis treatment at six clinics in Jeddah and three in Riyadh. Clinical evaluation with patients is also underway at two additional public hospitals, and a demonstration has been scheduled at a private hospital chain in Jeddah.

Italy

Ozilia is currently offered as a rhinitis treatment at eleven clinics in Italy.

Since 2019, Chordate Medical's distributor, Vedise Hospital, has been treating patients with chronic rhinitis using Ozilia. While Ozilia has been in use as a rhinitis treatment for five years, Vedise is actively working on introducing the migraine treatment to the Italian market.

Switzerland

Ozilia is currently undergoing clinical evaluation for migraine treatment at three clinics in Switzerland.

In June 2024, Switzerland was added to the list of focus markets. At the same time, Chordate signed a partnership agreement with Neurolite AG. Neurolite has specialized for many years in delivering cutting-edge medical technology solutions in neurology to hospitals and private clinics. Shortly after the signing of the partnership agreement, Neurolite placed its first order for Ozilia products with a value of approximately SEK 370,000.

Finland

As four of the nine trial clinics in the pivotal PM007 registration study for migraine were located in Finland, it has also been designated a focus market. Chordate is working to initiate clinical use at three of the trial clinics and believes this is likely to happen.

"Securing global trademark protection is valuable and important for creating long-term opportunities, even though Japan is not currently one of our focus markets. Having registered trademarks in key markets makes the business more attractive to potential buyers," says Anders Weilandt, CEO of Chordate Medical.

Ozilia was introduced in September 2023, replacing K.O.S as the brand name across all markets where Chordate operates. The rebranding aimed to simplify and harmonize the company's global market presence while enhancing awareness of its technology and treatments.

The registration in Japan is part of Chordate Medical's ongoing efforts to safeguard intellectual property rights in strategic markets worldwide.

Chordate's exit strategy involves demonstrating clear market penetration in selected markets. The company’s value is built on three pillars: robust scientific evidence from clinical studies, demonstrable sales success in several selected markets, and a comprehensive portfolio of intellectual property assets such as patents and trademarks. Since October 2024, Chordate has engaged Partner International Switzerland GmbH as an advisor to identify an international buyer for the business.