Medical devices on trial

Medical technology company Rhinomed (ASX:RNO) is using their BreatheAssist technology platform to develop nasal devices for sport, snoring, sleep apnoea and drug delivery.

The first of Rhinomed’s products, which is aimed at treating night-time nasal congestion (snoring) and sleep quality, will be launched later this year as an over-the-counter nasal device.

Rhinomed successfully launched its first nasal and respiratory device, the Turbine, earlier this year.

The Turbine widens the nasal passages and increases airflow through the nostrils, resulting in improved power output for athletes. For example, wearing the Turbine enables cyclists to travel further when compared to not wearing the device. The device is now being used by pro and amateur cyclists, including last year’s Tour de France winner - British Team Sky rider Chris Froome.

Alleviating nasal congestion

Rhinomed’s sleep device also inserts into the nostrils but is a different design to the Turbine.

“The sleep device needs to stay in the nose for eight hours or more,” said Rhinomed CEO Michael Johnson. “It is more comfortable and opens the nostrils in a slightly different way.”

Johnson said the company has gone through an extensive design phase before finalising version 1.0 of the sleep technology.

Early qualitative evidence showed that the device alleviates nasal congestion and appears to have an impact on snoring intensity - a hypothesis that is currently being tested in a user and partner trial.

Treating sleep apnoea

The company is also setting up a clinical trial program to look at how the technology can be adapted to help patients suffering from mild to moderate sleep apnoea.

The treatment of choice for people with sleep apnoea is continuous positive airway pressure (CPAP). This involves using a CPAP machine at night to maintain continuous pressure to the airway during sleep to prevent airway collapse and consequent blockage of the airway.

The Rhinomed device inserts into the nose, opening the nasal passages and regulating inhalation and exhalation.

“The aim is to impede exhalation,” explained Johnson. “A CPAP device uses mild air pressure to maintain inflow and outflow of air. We want to maintain air pressure in the upper airways when people are exhaling - EPAP [expiratory positive airway pressure]. There are some existing EPAP therapies which are gaining traction due to their less-invasive nature. We believe there is a meaningful role for our technology in this setting.”

The clinical trial program on patients with sleep apnoea will commence in early 2015 to assess how the technology could be used as a stand-alone therapy and as a companion therapy; for example, as a conjunct therapy which could improve the efficacy of a dental plate.

“Dental plates pull the jaw forward to avoid collapse of the palate,” said Johnson, “so while they physically stop the jaw from collapsing the throat, we believe our device can assist with airflow into the upper airways.

“Most sleep apnoea patients report poor sleep quality. We are hopeful that our technology will not only be able to deliver some meaningful clinical end points but also improve a patient’s all-important, but often neglected, sleep quality. If we can deliver this, we will have a significant impact on the level of adherence and compliance within this market.”

Drug delivery through the nose

Another area Rhinomed is pursuing with its nasal device technology is the delivery of drugs for migraines and allergies. The first cab off the rank as a proof-of-concept or pilot study involves the migraine medicine sumatriptan.

“I was acutely aware of the value of novel delivery methods through my work with Melbourne-based advisory firm Cogentum,” said Johnson. “When we looked at the challenges facing existing nasal sprays, of particular interest was the observation that the sprays often fall out - either through the nostrils or down the back of the throat. So we developed the concept of delivering drugs and keeping them in situ through our nasal devices.”

The nose as a site to deliver drugs is very effective. It is safe, uptake is highly efficient and delivery into the blood is relatively direct - unlike taking a pill that can be inefficiently absorbed through the gut wall.

Nasal drug delivery also enables the dose of a medicine to be adjusted relatively quickly. The device can be removed and drug delivery stopped once enough has been taken up - unlike tablets, injections or the application of a cream where the dose is given whether it is needed or not.

“We are currently running a bio-equivalency trial,” said Johnson. “In this way we can benchmark the ability of our technology to deliver the drug against delivery via a nasal spray. We need to determine efficacy within a relevant time frame and show equivalency to current modes of drug delivery.”

The pathway to commercialisation

Johnson said the program has commenced with stability trials and a bio-equivalency trial will be conducted through local pharmaceutical manufacturing company IDT’s CMAX subsidiary at the Royal Adelaide Hospital. Rhinomed anticipates reporting results in early to mid 2015.

“We have specifically chosen sumaptriptan because it’s now a generic,” said Johnson. “In addition, safety and efficacy within the nose has been established, the pathway is clear and our trial more easily managed and contained.

“Commercially, our focus has switched to creating differentiation within a competitive marketplace through novel delivery methods. If we can show that our delivery method works, and that it solves clear unmet patient and clinician needs, we believe we have a very attractive proposition to the current players in this market.”

The potential applications and the range of drugs that could be delivered using this type of delivery method are significant, from acute rhinitis drugs through to more complex applications like pain management.

“In settings where getting a drug into someone quickly and where either oral or even injection delivery is problematic, the nose is a great site,” said Johnson.

Another market with potential for the device is with people suffering from dysphagia. The number of people who have difficulty swallowing is growing - in large part due to the ageing population - so giving drugs via the nose instead of in tablet form provides a good option for these people.

Assuming positive outcomes from the trial program, the company plans to partner with a bigger company to take the drug-delivery program through to commercialisation.

Image credit: ©iStockphoto.com/duncan1890