Clinica's MedTech Ventures: Glyconics

Specialty area: Respiratory disease diagnostics
Based in: Swansea, UK
Founded in: 2013
No. of employees: Three
Total investment received to date: None so far
Investors: N/A

Chronic obstructive pulmonary disease (COPD) is expected to be the third leading cause of death and the fifth commonest cause of disability worldwide by 2021. It is also a big drain on resources. In the UK alone, where it affects around six million people, COPD costs nearly £4bn ($6.7bn) per year from reduced productivity and hospitalisation.
Diagnosing the disease earlier, and monitoring patients to help prevent exacerbations, could therefore reduce the number of deaths from the disease as well as cutting healthcare costs.
However, identifying COPD patients is currently a problem, and the disease is often mistaken for asthma or other respiratory disorders. One reason is that there is no specific test for COPD. The main method of diagnosis is spirometry, a breathing test that assesses the total amount of air a person can breathe out (forced vital capacity, FVC) and the volume of air they can breathe out in one second (the forced expiratory volume in one second, FEV1). Other tests such as a chest X-ray or peak flow test can also be used.
But these all pick up general breathing difficulties, not just COPD. It is estimated that only around 50% of COPD patients are properly diagnosed.
UK firm Glyconics believes it has come up with a solution, with a handheld device that analyzes sputum using infrared spectroscopy. The company has found that the sputum of COPD patients differs from healthy people, with altered sugars giving sufferers a signature pattern.
As well as diagnosing COPD, Glyconics believes the technology could also give an early indication of which COPD patients are about to experience an acute worsening of symptoms called an exacerbation, meaning it could be used for early therapeutic intervention. The latter indication will involve a longer path to approval, as the firm will need to carry out a prospective study.
The technology, which was developed for medical indications by Paul Lewis and colleagues at Swansea University, is currently used in multiple industrial applications and the device that Glyconics is developing is already CE marked for sale in Europe.
Glyconics, which was spun out of the Welsh university in October 2013, has so far not raised any equity financing. Soon after forming, the firm won a £100,000 contract with Small Business Research Initiative for Healthcare (SBRI Healthcare), an NHS England initiative, to carry out a feasibility study of its device. If the six-month trial goes well, the firm will carry out a larger validation study, expected to start in late-2014.
This validation study will support CE marking of the COPD diagnostic product which could happen as early as mid-2015, estimates CEO Berwyn Clarke. Obviously, this hinges on the success of the upcoming trials.
“It’s different to most other companies I’ve been involved in, where development can take a long time,” says Dr Clarke, who was previously chief scientific officer of UK molecular diagnostics firm Lab21. “With Glyconics, it’s binary – when the feasibility study results come in, it will either be a no-go or will open the door to a major global market.”
But this doesn’t mean that the firm won’t go down the VC route, and Glyconics is currently looking for financing which will allow it to accelerate its programmes and build its international market. Unusually for a start-up company there is already significant VC interest and this is likely to grow assuming the feasibility study is positive. “The interest in investment in the company is testament to the potential clinical importance and market size in COPD,” the CEO says.
The device itself is around twice the size of an iPhone and provides results in around five minutes, making it ideal for point-of-care use. The firm has also developed software and a disposable in the form of a cartridge in which the sample is placed, giving it another revenue stream.
Dr Clarke estimates that, for high-volume testing, Glyconics will use a razor/razorblade model, giving the hardware away, while charging a monthly license fee for the software and a low-cost consumable.
The cost to the NHS will be worth it, he believes, saying the test could make significant cost-savings to reduce the £1bn per year hospitalization costs for COPD patients. The firm is currently carrying out a health economics analysis to confirm this as part of the SBRI contract.
But although the UK and European market is “ready-made,” getting US FDA approval will be more challenging. One solution could be to provide a lab-testing service under CLIA regulations, or supply the device to companies that specialize in this area.
Glyconics is also aiming to partner with pharmaceutical companies, as the test could be used to potentially improve clinical trial outcomes by ensuring patients enrolled actually have COPD; and, further into the future, guiding the treatment of exacerbations.
Although not many COPD drugs are currently available, there are several in the pipeline, according to Dr Clarke, who says Glyconics is in early-stage discussions with pharma companies. Players in the COPD sector include GlaxoSmithKline, Verona Pharma and Astellas.
The CEO does not see any direct rivals to Glyconics on the horizon. “I’m not aware of anyone doing anything as advanced as we are,” he says, adding that some firms are investigating biomarkers, but this is not the same as Glyconics’ technology.
Further into the future, the firm’s device could have uses in other respiratory disorders, such as cystic fibrosis or asthma, Dr Clarke believes. Glyconics has also already identified lung cancer signatures and, potentially, could develop a test for early diagnosis. If successful, it could be onto something even bigger.
Berwyn Clarke, CEO.
Tel: [phone]
Email: [email protected]
Address: Haywood House, Dumfries Place, Cardiff, CS10 3GA
www.glyconics.com