The usage of OCT device in the hospital in diagnostics setting

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The usage of OCT device in the hospital in diagnostics setting:

In 1991 Prof. Fujimoto and Mr. Swanson from MiT (Massachusetts Institute of Technology) first came with the Optical Coherence tomography (OCT) for noninvasive cross-sectional imaging in biological systems. Ophthalamology, studying the anatomy, physiology and diseases of the eye, was the first commercial application of OCT.

It is estimated that annually more than 40 million OCT diagnostic procedures are performed worldwide (2012). This is about one OCT procedure per second somewhere around the world.This number can and will substantially increase, because in the last 20 years OCT has grown from a new invention to a greatly developed technology and received (e.g. FDA) approval for application in a number of medical markets: cardiovascular, gastroenterology, dermatological, oncology and dentistry.

Carl Zeiss Medtec controlled over 95% of the OCT-market in 2005. But Carl Zeiss’ market share declined over the past five years as many other companies gained FDA approval and brought their products to market.

Even though OCT cannot image as deeply into the tissue as in ultrasound, MRI and CT, the main advantage of OCT is the high resolution of the images in the morphologic tissue. Also, OCT does not require physical contact with the sample, and uses non-ionizing radiation at biologically safe levels, allowing for long exposure times. The point-scanning nature of OCT technology allows it to be implemented in fiber optics, which makes endoscopic and catheter-based imaging possible. Further, a major advantage of using OCT includes operator safety, patient comfort and patient safety.

Competitors

At the moment more than 36 companies are developing and/or marketing OCT systems in eight medical specialties. This means that there is a big market in OCT devices. This rises the question what is the potential for our invention in this big medical market?

The (small) optical fiber in our invention is, as described in the NTNU invention disclosure form, ‘ideal for intracranial and coronary vessel imaging’. Since detection in the brain has not been described before, it is possible to compare how the market has developed around cardiovascular OCT imaging and to see how it can potential go in the field of the brain, concerning OCT imaging. Cardiology is an other area of use for OCT and can have a major impact on medical device industry and on health care. Intravascular OCT may play an important role in identifying and guiding the treatment of coronary artery diseases and provide a diagnostic tool for performing clinical studies.

Today there are three key players in the field of Cardiovascular OCT systems: LightLab Imaging/St. Jude Medical, Volcano Corporation and Terumo.

In May 2010, LightLab Imaging was the first to get the FDA's approval for a clinical OCT system to be used in cardiovascular imaging.

In July 2010, St Jude Medical Inc acquired LightLab Imaging. St. Jude Medical develops, manufacture and distribute cardiovascular medical devices. The company is the structural heart market leader with the broadest product portfolio in the industry. They sell their products in more than 100 countries around the world with largest geographical markets in USA, Europe, Japan and Asian Pacific. Already, over 40,000 patients have been imaged with Lightlab clinical instruments.

Volcano acquired its initial OCT technology in December 2007 when the company purchased CardioSpectra,Inc. for $63 million. Volcano develops, manufacture and commercializes devices designed to facilitate endovascular procedures, enhance the diagnostics of vascular and structural heart diseases and guide optimal therapies The company is developing OCT products to complement their existing products (IVUS) and their early model OCT system has been used in several clinical settings in Europe and South America. Vulcano, the leader in intravascular ultrasound (IVUS) devices, is far on there way to commercialize a combination of IVUS and OCT. Volcano got the receipt of CE mark for their OCT imaging system and catheter in January 2010. Because of litigation with LightLab Imaging, their commercial launch of the OCT imaging systems may be dalayed

Terumo has become a global leader in the medical device industry. In 2012 Terumo Corporation received CE certificate for commercial sale of their OCT system and catheter for imaging and inspecting of coronary artery lumen and vessel surface layer. It is currently sold in more than 30 countries in Europe. The company announced that a Japanese launch of the OCT system and catheter began from April 2013 in which Terumo aims to achieve the revenue of approximately 17,2 USD in fiscal year 2013. ( http://www.terumo.com/about/pressrelease/2013/20130417.html ). By adding the sales in Japan, the company aims for 35,2 M USD in fiscal year 2014 from their OCT systems and catheter.

A new player, Wasatch Photonics. Info.. cardio

2011: Wasatch Photonics Received $149,773SBIR Phase I from the NSF Division of Industrial Innovation and Partnerships for work on High-speed Low-cost Spectral Domain Optical Coherence Tomography System for Intravascular Imaging Applications.

2013: Wasatch Photonics received a two-year Small Business Innovation Research (SBIR) Phase II grant for $498,325 from the NSF. The grant provides funding to continue developing the intravascular optical coherence tomography system.

Wasatch Photonics:

Phase I, 2011: http://www.octnews.org/articles/2886186/wasatch-photonics-receives-sbir-phase-i-for-high-s/ redusere kostnadene.

Phase II: 2013: http://www.octnews.org/articles/4465728/imaging-technology-could-lower-coronary-disease-mo/

There are also competitors in fields adjacent to the cardiovascular market. Avinger Inc. develops next-generation catheter-based technologies for treatment of Peripheral Artery Disease (PAD). In November 2012 the company received FDA approval for their OCT system and catheter for crossing chronic total occlusions in patients with PAD, and are globally marketing it. In December 2012 the company got FDA clearance to market a smaller profile and longer catheter to treat more patients with smaller arteries.

Markets

To increase the likelihood that the invention is commercialized there is a need for ‘market orientation’, meaning that it is important to know the needs certain people and markets have. The more ‘useful’ the invention is, the more investors and companies are willing to pay for it For our OCT-device invention we want to both enter the diagnostic (hospital) and research market. Hospitals will be the main market for our product release. But we believe with entering the research market we could gain revenues at an earlier stage.

Hospital

Many OCT diagnostic procedures are performed on a yearly basis, in different parts of the medical field. By giving the medical field an improved OCT-device that protects the patient by reducing tissue damage and protect the optical fiber of the OCT-device reducing the costs of replacing the OCT-devices, we believe our device can be interesting for hospitals to use.

Since the OCT-device in the invention of Tomolux can reach the blood vessels in de brain and this has not been described before, we will use the developed market around cardiovascular OCT imaging to look at the commercial potential in the field of brain imaging in hospital use. Over the past decade OCT has extensively been applied to the field of cardiology. OCT can replace the IVUS to provide higher resolution, and when used in combination with catheters high-speed data-acquisition. In this way, cardiovascular OCT-imaging can for example be used to visualize the vulnerable plaques in the coronary arteries, often leading to cardiovascular disease.

In may 2010 LightLab Imaging received as mentioned a first clearance from the FDA for a clinical-OCT system to be applied to cardiovascular imaging; the first time that American clinicians have access to OCT for an application other than eye care. This OCT system had previously been approved in more than 35 countries in Europe and Asia, where it has been used by leading hospitals to perform high-resolution imaging in thousands of coronary interventions.

Besides that LightLab imaging received an FDA approval, the global medical device company St. Jude Medical, Inc. acquired LightLab imaging for approximately $90 million in cash. This acquisition "provides St. Jude Medical with a product platform to compete in and potentially expand the $500 million coronary imaging market." St. Jude Medical contributed to the OCT platform an additional $20 million in revenue to its cardiovascular business during the second half of 2010. St. Jude Medical keeps improving and researching OCT-devices for diagnostic use.

In response to the acquisition, the president and CEO of one of the competitors of LightLab imaging, Volcano Corp, mentioned that their second-generation OCT system is under regulatory trial in the US. Volcano Corp. wants to commercialize their line of OCT systems as soon as possible in the US and in may 2010 they received a CE-mark for the EU.

Research

The implementation of the device into the hospitals and clinics will be slow because of the different regulation approvals needed. The device needs to be both FDA and CE approved for use in the US and EU, respectively. Since the process of getting these approvals may take some years, our strategy includes selling to research institutes. The device is especially well acquitted for use in the intracranial and coronary vessels, and this is a field where a lot of research is done. Cardiovascular and brain diseases, for example cancer and Alzheimer’s disease (MAYBE ADD NUMBERS), is an attractive field of research and it makes it interesting as a potential market opportunity. Many universities and other research institutions do research on these fields. The number of universities doing this kind of research is estimated to be 3000, based on the number of technical universities. Many of these institutions use animals in their research. Since our device is applicable for use in animals, there is a possible market in selling the device to these institutions. This is an opportunity to gain revenue before starting selling to hospitals. Further on, there are also other research institutions besides the universities that may be potential buyers. To show the potential of our device to this market/institutions we will use the help of CROs, to gain data that can prove the greatness of Tomolux’s OCT-device. CROs (contract research organizations) are organizations which provide support for companies with drug development, clinical trial management and testing of medical devices. This small investment in the hiring of CROs will result in higher revenues on the long-term.

In the OCT-industry, a clear tendency of acquisitions and merging of companies are seen. It’s been reported that four large companies are expected to generate 48 % of the revenues in this industry in 2012. This indicates that there are a few large companies that are dominating in this field. A lot of the bigger companies are buying the smaller companies, to expand their business and to obtain the newest technologies. For these companies, the most profitable time to acquisition the small operators, is when they have gotten their FDA approval or is close to getting it. If the acquisition happens before this, it means that the companies must spend more resources on developing the technology and getting it ready for the market.

For small start-up companies, it is difficult to make to the market without financing. Tomolux has a potential partner in Johnson & Johnson, since one of the inventor is an employee there. Hospitals tend to buy devices from the established operators because these are known and have a good reputation in the industry. By partnering with Johnson & Johnson or maybe a similar company, it will increase our chances of getting the technology out on the market easier and probably quicker. It could also be a possible exit opportunity for Tomolux. Once our OCT-device is approved for the US and EU market, the company will increase its value significantly.

Concluding remarks

Looking at the competition, and the speed of regulatory approvals in the last years, it shows that the OCT-market is a moving-marked where a lot of progression is made in a fast paste. This means that improved OCT-systems are potentially a great investment for large companies and can contribute to high revenues. With the improvements in the probe and optical fiber in our invention, we can make a difference in the OCT-market. As a small start up company we will probably be sold out by a larger company, preferably by Johnson&Johnson or a company as St. Jude Medical. The in 1998 founded company LightLab imaging got sold to St. Jude Medical for $90 million after they got a FDA approval. Since LightLab was the pioneer and leader in the development of OCT we believe that we will get less if we exit after FDA/CE approval. This is because our start-up company is not a pioneer in the OCT market and we improved an already existing OCT technology. We expect to be sold out for an amount between $40-50 million, since we do have an invention that reaches new areas in the body and is safe for patients. Also, since our OCT device is able to reach the vessels in the brain, we believe that we also get interest from the large brain monitoring devices market. The global brain monitoring devices market is valued at $1.08 billion in 2012, and is poised to grow and reach $1.63 billion by 2017.

This is causing an increased potential for commercialization of our OCT-device.

And since our invention is also useable in other areas of the body (e.g. cardiovascular), in a safer way, this further increases the commercialize potential in the medical field.

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