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Perfusio’s Certes technology transforms surgical procedures

Traditionally, surgeons have to rely upon educated guesses when accurately assessing patient blood flow.  Now, thanks to Perfusio Corp and its innovative Certes™ MSPV technology, surgeons can ‘see beyond the human eye’ and protect patients even better.

Surgery is a complex process full of potential risks and challenges. Surgeons and their teams are extensively trained to minimise these risks and use their experience to quickly identify potential issues. During any procedure, one of the most crucial areas that a surgical team tracks, is the flow of blood in and around the site being operated on and until now, this has been done using the good, old fashioned human eye.

Surprisingly, in an environment where technology has provided so much advancement and improvement, the visualisation of blood flow has not evolved as much as surgeons would prefer. Perfusio Corp is changing this situation for the better and providing both surgeons and patients with the benefits of cutting-edge visualization and artificial intelligence technology to help surgeons. 

Perfusio, based in Greenville, North Carolina, USA, was founded in 2014 by Bruce Ferguson, MD, and Cheng Chen, Ph.D. and has always focused on using its work in the medical device field to implement solutions that genuinely improve patient lives.

The core area of focus for the company is technology platforms that provide visualisation of actual dynamic blood flow distribution in tissue in immediate real-time. In doing so the team at Perfusio are confident that they can help surgeons identify and fix problems, avoid potential complications, and create a new standard of care for patients.

What’s wrong with trusting the surgeon’s eyes?

Founded by two highly regarded doctors, Perfusio has nothing but respect for the skills and commitment of surgeons and their teams. Dr. Ferguson, an internationally known cardiac surgeon, and co-founder Dr. Chen, a highly regarded optical physicist, both appreciate how crucial accurate visual information is for a successful procedure and patient well-being.

It’s this appreciation of the importance of visual insight that led them to start and grow Perfusio. They had first-hand experience of the fact that a surgeon has historically had to rely upon a visual light view of the site of a procedure and this only shows anatomy – not physiology. This in turn means that even the most experienced, most talented surgeons, are operating with incomplete information. Not something any medical professional wants.

Research has shown that up to 15% of key surgical procedures have major complications. The majority of complications are as a result of suboptimal blood flow in critical tissues that are unable to be recognised by the surgeon using purely visible light illumination. Potential issues aren’t restricted to the operating theatre but can instead lead to repeat surgeries, higher readmission rates, negatively impacted patient care and increased healthcare costs. In the US alone, there are over 400,000 preventable surgical adverse events every year and the cost of preventable medical errors in the US is over $29 billion.

With an increase in the number of surgical procedures the world over and many countries developing a larger, ageing geriatric group, the scale of these problems is increasing at an alarming rate. Until now, there hasn’t been a suitable solution.

Perfusio Certes™ providing a new quality of visualisation and learning

Perfusio have created a cutting-edge technology that enables surgeons to see beyond the human eye and beyond the visible light spectrum. By using multiple wavelength illumination and AI-enhanced analytics to display immediate real-time MSPV (multi-spectral physiologic visualization), Certes™ provides accurate information about the physiology of perfusion and blood flow.

This level of accuracy in itself is a huge step forward in surgical visualisation, but the team behind Certes™ knew that accuracy wasn’t enough – it had to be delivered in real time in order to allow surgeons to identify potential issues before they arose and react quickly. This dynamic aspect of the Certes™ solution isn’t just a nice feature – it’s crucial to help surgeons and protect patients.

Currently, Certes™ is the only technology that provides the surgeon with visualisation of both anatomy and physiology, and objective data of whether perfusion and blood flow have been achieved. Having been granted its FDA approval in 2019, Certes™ now has FDA 510(k) clearance as a Class II device and continues to provide both surgeons and patients with a vastly improved experience.

The “in the moment” nature of Certes™ is incredibly powerful but Perfusio’s innovative nature appreciated that the vast amount of data that Certes™ collects would enable them to provide a broader suite of services to benefit a future generation of surgeons.

This information collected during an operation is then uploaded to the Perfusio-ARMUS Cloud Repository where bespoke machine learning and AI programmes are able to identify potential learnings for future procedures. Not only does this storage allow for valuable post-surgical review but the growing dataset will allow Perfusio to identify insights for the future.

“The potential for the Certes™ platform to visualize, in real time, possible surgical complications, mitigate them and improve patient outcomes is astounding”

Gyula Sziraczky, CEO of ARMUS

A key part of the value proposition of the Certes™ is its versatility. It can be used by all surgical specialists during any procedure where data on perfusion and blood flow would impact decision-making and/or clinical outcomes. This includes a vast range of operations and millions of patients can benefit as a result.

Certes™ – unlike any other real-time surgical imaging

Conventional visualisation methods undoubtedly have their strengths, yet they also come with crucial downsides. The Certes™ solution is non-contact, non-invasive, has no need for dyes or contrast agents, and doesn’t use ionizing radiation. This obviously means it is far less risky for patients. Furthermore, it provides accuracy in real time unlike traditional methods and can be used multiple times during an operative procedure to enhance surgeon judgment and decision-making.

Owing to the data collection and analysis aspects of the solution, information can be accessed and reviewed after a procedure, providing crucial insight for benchmarking, reviews, training, and predictive analytics for future procedures.

From a commercial point of view, providers are able to transition from an episodic care model to cost-efficient, patient-centric, value-based care. Certes™ is able to help reduce preventable surgical errors, reduce costs, and improve outcomes for both providers and patients.

Exciting results achieved already

The latest innovations from Perfusio have focused on how to leverage the power of AI-enhanced technologies to deliver even higher standards of patient care, and in September 2021, the company reached an exciting milestone. Perfusio confirmed at this time that it had captured over 100 patient images in its First-In-person Study (FIRST) into the Perfusio-ARMUS Cloud Repository. This is a crucial step forward and lays a strong foundation for the company’s AI machine learning capability.

This multi-site study currently involves 25 physicians across nine surgical sub-specialties. This level of rigour adds even more credibility to a solution that continually demonstrates its capacity to deliver remarkable value to surgeons, healthcare providers and patients.

A bright future ahead

Perfusio already holds an exclusive licence to 14 patents and has over 20 under review. This breadth of IP combined with the ability of the company’s team to use innovative technology to solve real world problems has enabled it to position itself perfectly for rapid future growth, utilising a range of potential revenue streams. 

Monte B. Tucker, CEO of Perfusio confirmed this potential, explaining that the organisation’s solutions “can now expand at an exponential rate to truly support predictive analytics – in real time – of perfusion and blood flow in the surgical setting.” There are millions of patients and surgeons who will be very grateful that this is the case. Also, as a new and exciting technology we continue to learn new areas where this technology can benefit patients and therefore are always open to collaborating with research hospitals for ongoing research.

For further information on Perfusio, insights into its pioneering technology and its benefits to the healthcare sector, please visit the company website at  https://perfusio.com

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