Approval of the study design was the final formal obstacle for study to be initiated at King's College London. Chordate estimates that the screening process at the earliest can start in the beginning of July 2023.

"PM009 is an important and exciting study with significant potential for us. Any level of positive outcome will likely mean a great opportunity for our company as this challenged patient group has very few options left," says Anders Weilandt, CEO of Chordate.

About PM009

The PM009 study is a planned, open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation (K.O.S) in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway. The study aimed to include 25-30 subjects to investigate the reduction of headache days using the KOS technology. The study is conducted at King’s College in London with three to four referring clinics assisting with the recruitment of suitable subjects for the study.

Chronic rhinitis is a major health problem in the country due to air pollution in larger cities, high prevalence of dust mites and mold spores, combined with constantly changing between high outdoor temperatures and chilled indoor environments.

Healthcare in Saudi Arabia

Healthcare in Saudi Arabia is provided through three main sectors: the Saudi Ministry of Health, which consists of hospitals and primary care centers throughout the country, other government institutions, and the private sector. Publicly funded healthcare is free for all Saudi citizens.

In the early 2000s, Saudi Arabia adopted a new law requiring private employers to provide health insurance coverage to non-Saudi employees. This has contributed to significant changes in how healthcare services are provided and paid for in the country, with a strong growth in the private healthcare sector's capacity and the number of health insurance companies.

Bupa Arabia is the leading health insurance provider in Saudi Arabia, offering health insurance to both companies and individuals. Bupa Arabia is part of the international health insurance and healthcare company Bupa Group, which provides healthcare services to more than 40 million people in 190 countries.

“Saudi Arabia has two very modern national catalog systems that public healthcare providers can use. Therefore, all connected healthcare providers under the Ministry of Health can easily order or request bids for our products. A similar system exists in Sweden, but it is divided among all of our regions”, says Anders Weilandt, Chordate CEO.

Chordates position on the market

Chordate Medical's distributor, Janin Medical, is licensed to offer K.O.S treatment for chronic rhinitis to both private and public hospitals and Chordate received an insurance code for insurance payment at the end of 2020. The insurance code means that patients with private health insurance have the costs or part of the costs paid for a treatment. The reimbursement code covers the cost at private hospitals and clinics belonging to the VIP, Class A, and Class B categories in Saudi Arabia. For VIP and Class A, the K.O.S treatment for chronic rhinitis is fully covered by medical insurance, while Class B has a cost sharing of 10 to 15 percent.

Saudi Arabia has 415 public and 127 private hospitals, of which about 30 hospitals belong to categories A and B. In addition to the treatments for chronic rhinitis, Janin Medical is also driving the process of registering a market authorization for K.O.S for chronic migraine, where the processing time is at least two months.

In March 2022, Chordate opened a representation office in Saudi Arabia to increase the chances of a successful market establishment and expand the business to other countries in the Gulf Cooperation Council, GCC. In December 2022, Chordate entered into an agreement with Janin Medical, one of Saudi Arabia's leading medical equipment companies, to function as new exclusive distributor in Saudi Arabia and Bahrain for both migraine and rhinitis indications from the turn of the year. The company is a pure importer and distributor of advanced medical technology products in neurology, pulmonology, cardiology, speech therapy/audiology, and urology. Janin Medical also has the status of offering public procurement, currently supplying medical devices to Saudi Arabia’s government biddings, so called Nupco tenders (National Unified Procurement Company, Saudi Arabia’s largest centralized health care procurement, storage, and distribution organization for pharmaceuticals, medical equipment, and supplies).

Chordate assesses that there is potential for expanded market activities in the GCC area – not least in the United Arab Emirates and Qatar.

“The healthcare company has evaluated K.O.S for some time and treated approximately 30 patients. They have now placed a small initial order worth around SEK 120,000 for one of their hospitals, and we expect that they will shortly place orders for two more of their four care facilities. In most cases, the treatments at NadiCare are reimbursed by insurance from the private healthcare insurance company BUPA Arabia. One can roughly expect that a patient in Saudi Arabia means an average annual revenue from end-user sales stage of around SEK 10,000”, says Anders Weilandt, CEO of Chordate.

Three publicly owned hospitals in Jeddah, Makkah and Dammam have also evaluated K.O.S and Janin Medical expects incoming orders from all three. In addition to incoming orders for K.O.S for rhinitis, Janin Medical is also driving the process of registering a market authorization for K.O.S for chronic migraine, where the registration process will take at least two months.

“Since we’ll receive more and more orders for the rhinitis treatment, the road to a market permit for the migraine indication is shorter and less difficult than before.”

The Saudi Food and Drug Authority (SFDA) has previously approved Janin Medical as Chordate's new authorized representative in the country, and transfer of the market authorization for the rhinitis treatment to Janin.

Chronic rhinitis in Saudi Arabia

The prevalence of chronic rhinitis is high in Saudi Arabia due to air pollution in major cities, high incidence of mites and mold spores, combined with constant alternation between high outdoor temperatures and cold indoor environments. Chronic rhinitis is considered a major health problem that has been given a lot of attention. The overall picture is that treatment should be given 2-3 times more often than in Northern Europe due to the low air quality. Excessive long-term use of nasal spray is also very common and is seen as a very urgent problem to overcome, even here the K.O.S treatment is seen as a valuable therapeutic tool.

”The headache days were significantly reduced when comparing the real internasal stimulation to sham stimulation. The side effect profile is very different. K.O.S mostly gives side effects during those 20 minutes when you receive the treatment, but the rest of the week you’re “free to go” so to speak. Currently, available treatments for migraine prevention include medication mostly. So, we have blood pressure medication, anti-depressants, and anti-epileptic drugs available for most patients. While they can be effective for some individuals, they’re not always successful in reducing migraine days or the severity of the attacks, and they may also have unwanted side effects. It is actually quite common that the side effects prevent use of those treatments”, says Dr. Emilia Tauriala in the interview.

Watch the interview with Dr. Emilia Tauriala, Specialist in neurology and CMO at Terveystalo.

The primary final results from Chordate Medical's PM-007 study will be presented at the American Headache Society's Scientific Meeting in mid-June. The results show that K.O.S has a significant effect in the preventive treatment of chronic migraine. Chordate CEO Anders Weilandt has previously commented on the study results:

"The fact that AHS invites the researchers in the study to present the study results in a lecture format confirms the importance of the study results, which show that K.O.S has a significant clear effect for the preventive treatment of chronic migraine. We see the customary publication of the abstract as very positive because it will contribute to the knowledge about the treatment method spreading faster both in the USA and the rest of the world," says Chordate CEO Anders Weilandt in a Biostock article.

Read more about The migraine market in Finland and Chordate’s outlook