By leveraging a breakthrough discovery and developing an innovative solution that builds and enhances the body’s own natural protective capabilities, Covira Surgical is redefining post-operative infection prevention with a USA total available market of $8.2 billion.

The medical industry is rife with companies claiming to provide technology marketed with touch phrases such as Artificial Intelligence in an effort to demonstrate their futuristic nature and attract attention. Very few however are taking the approach of combining cutting edge innovation to amplify the body’s natural protective capabilities to resist complications following major medical interventions. In this regard, Covira Surgical is unique in its approach. 

Covira’s approach is based on leveraging the power of the gut microbiome – something that patients, medical professionals and the whole sector is excited about. Yet rather than adding onto, eliminating or replacing one’s gut microbiome, Covira seeks to develop compounds that maintain and enhance one’s own microbiome- the very microbiome that has served to promote good health over one’s lifespan. The idea is to leverage the “home field advantage” and “homegrown” aspect of one’s own unique microbiome and allow it to continue to properly function when subjected to invasive surgical procedures, antibiotics, polypharmacy and prolonged hospitalization. 

An early-stage biotech company, Covira’s work focuses on maintaining the balance and function of one’s own microbiome over the course of complex medical interventions such that it can maintain and enhance immune tone, drive recovery and prevent postoperative (surgical) infections. This method is based on the work of Dr. John Alverdy, MD, a professor of surgery, practicing gastrointestinal surgeon and world authority on the role of the microbiome in surgical infections, and Founder & Chief Scientific Officer of Covira.

Spun out of the University of Chicago, Covira’s innovative biological approach and  proprietary lead compound Pi-PEG (phosphorylated polyethylene glycol) not only has the potential to save the healthcare industry significant cost (healthcare expenditures), but more importantly, it can save hundreds of thousands of lives.

Postoperative infections can be disabling, costly and devastating

Although framing postoperative infections in this manner may sound dramatic, when you are the victim despite your surgeon and hospital doing all the right things, Covira’s novel approach is compelling. 

Despite the many advances in preparing patients for surgery with antibiotics and sterility precautions, postoperative infections remain a clear and present danger to patients. Whether it’s prolonged hospitalization, readmission or an increased risk of Sepsis and, in some cases death, postoperative infection can cause a range of issues.

As a result of a number of factors, including a generally aging population subjected to ever more invasive life-saving measures, surgery rates around the world are increasing and in turn, the number of patients suffering complications following those procedures is on the rise.

In the USA alone, over 270,000 people die every year from Sepsis and the USA Healthcare system loses over $34 billion due to Surgical Site Infections (SSI) and Sepsis. Meanwhile SSI are the leading cause of death in hospitals and are the most frequent complication with surgical patients, causing over 38% of all infections. If this reflects the issue in the USA, one of the most advanced healthcare providers in the world, imagine the situation around the world.

There are efforts being made by pharmaceutical companies to create more effective antibiotics, but Covira believes that not only can this approach on its own not work, it is arguably going to make the situation worse as emerging and increasing antibiotic resistance is a global public health concern that many countries are facing already.

Helping the body to help itself

The elegance of Covira’s approach is the simplicity of its underlying premise – that the body already has the foundations of what it needs to protect itself. Covira views its role as developing products that allow the body to heal itself by collaborating with the gut microbiome- a key factor in promoting immune health and recovery from infection. 

The microbiome is composed of communities of bacteria that have a greater complexity than the human genome itself. It can almost be thought of as another organ of the body and helps with a number of functions including development of immunity, defense against pathogens, energy metabolism and even human behavior.

Covira’s proprietary technology (Pi-PEG) is a prescription medicine that patients mix with water and then drink before and after their surgery. It coats the intestinal tract and works with the microbiome to prevent postoperative infections.

This concept of working in collaboration with the microbiome is crucial. The Pi-PEG approach does not negatively impact the gut microbiome, but instead works with it-  supporting patients in a much more effective manner than the indiscriminate use of antibiotics. Covira’s approach is both effective and biologically sustainable.

The treatment is the culmination of 30-years of work from Dr. Alverdy, MD and the patent protected proprietary technology (Pi-PEG) has been proven to be safe and effective in a larger number of pre-clinical small animal studies. Furthermore, the approach has led to 225 peer-reviewed publications in high-impact journal and three patents (one issued and two pending).

From a financial point of view, the potential value of Pi-PEG is substantial to the field. When you consider that the average cost to a hospital of each Surgical Site Infections is $39,000 ($175,835 Anasomotic Leaks – lead indication) and that the cost of Pi-PEG is projected to be less than $700 per patient/per surgery, it’s easy to see why the healthcare industry is watching Covira’s progress so closely.

A team of experts 

At the heart of Covira is a leadership team that combines scientific and business expertise – all of whom are passionately aligned with the company’s vision of serving patients by transforming the promise of science into innovative treatments and saving lives.

Dr. Alverdy has dedicated over 30-years to this area of research and development and has a truly impressive international reputation. He previously served as President of Surgical Infection Society and has had over 20 years of continuous NIH (RO1) funding. As a practicing surgeon he genuinely understands the complexity and importance of the problem that Covira is trying to solve. 

As the Sarah and Harold Lincoln Thompson Professor of Surgery and the Executive vice-chair of surgery at the University of Chicago, Dr. Alverdy is at the forefront of both research and implementation making him the perfect person to hold the position as Chief Science Officer for Covira.

Partnering closely with Dr. Alverdy is Covira’s CEO – Peter Farmakis. With more than 25 years in the Biotech/Pharma, Medical Devices, and Molecular Diagnostics industries, Peter has the expertise and credibility to lead an innovative biotech company like Covira. His commercial experience is just as impressive with senior roles at Johnson & Johnson and Abbott Laboratories as well as four prior successful start-up experience where he’s led the launch and scale up of a number of businesses culminating in two successful biotech exits. 

As well as being supported by a talented Management and Medical Research team, Dr. Alverdy and Peter Farmakis have brought together a group of valuable partners to support Covira’s aspirations. These include the likes of Polsky Center for Entrepreneurship and Innovation at The University of Chicago, Pritzker School of Molecular Engineering, Argonne National Laboratory, SmartHealth Catlayzer, Helix51 and IQVIA Biotech.

Exciting growth potential
With an exciting and effective solution in development and such an experienced leadership team, Covira is excited about the opportunity that sits in front of them. 

From a market point of view, the stakes are extremely high. The company believes the peak projected opportunity for Covira’s top three prioritzed indications to be in the region of $2.2 billion by 2037 in the USA alone with Pi-PEG having an addressable population of 28.9 million patients today, increasing to approximately 30.9 million patients by 2040, and an overall total available market in the US of $8.2 billion.

As a result of the strong networks, relationships and credibility that the leadership team have established over the past few decades, Covira is able to take advantage of a three pronged go to market approach that should be able to deliver immediate growth. The approach is made up of gaining insurance support, selling directly to Health Systems/Hospitals and Surgery Centers, and educating surgeons and surgical support staff directly.

Building a successful future on great momentum

The impressive progress so far has provided a strong foundation for Covira to build upon as they work towards full FDA approval over the next 5-years. 

After $7.7 million of non-dilutive funding, the company is now seeking to raise an additional $5.0 million and has a busy next couple of years planned including completing human trials, scaling operations and then potentially a further round of funding.

Given that the cost of antibiotic-resistant infection treatment have doubled in the last 19 years and now exceed $2.0 billion per year, it seems as if the timing is perfect for a cost effective and medically effective approach such as Covira’s proprietary Pi-PEG to thrive and dramatically improve the well-being of patients.

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