Expert Scape
Expertise in Anastomotic Leak: Worldwide
Covira Surgical (Biotech)
Post-Surgical Infection Prevention
North Chicago, IL
Biotechnology
Health Tech
Covira is an early-stage biotech company, a spinout from The University of Chicago, focusing on the prevention of post-surgical infections. Covira’s approach to solving post-operative infections can be transformative to the field and even Business Worldwide Magazine named Covira Surgical Among the 2021- Top 20 Most Innovative Companies to Watch. This microbiome-focused company is based on the work of Dr. John Alverdy, MD, a professor of surgery, practicing gastrointestinal surgeon and world authority on the prevention of post-surgical infections. Covira has developed a proprietary solution phosphate (Pi) conjugated polyethylene glycol (PEG) polymer to reduce infection risk and related complications following surgical procedures.
$1,000,558
raised
526
Investors
$9.99M
Valuation
$1.00
Price per Share
$250.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
0
Days Left
This offering ended on April 28, 2022 and is no longer accepting investments.
Reasons to Invest
Market Opportunity: Covira estimates the US total available market for Pi-PEG's top three prioritized indications (Surgical Site Infections, Anastomotic Leak, Sepsis) to be $8.8B. The peak year net revenue forecast is projected to reach $2.5B by 2037 (Source: IQVIA).
Technology Platform: Pi-PEG is an orally administered anti-virulence agent to prevent postoperative infections and their progression to sepsis.
Management Team: Founder is a preeminent surgeon-scientist and world leader in GI surgical infection research, CEO is a proven life science executive from J&J, Abbott and four prior startups including two in the biotech space culminating in strategic sales to larger multinational corporations.
Covira’s Platform Technology (Pi-PEG) is the culmination of 30 years of research and development led by Dr. John Alverdy, MD, Founder & Chief Scientific Officer
Dr. Alverdy has made solving infection-related postoperative complications research his life’s work.
The Alverdy Lab, located at The University of Chicago, is and has been, a continuously funded NIH-funded laboratory that studies the molecular interactions of bacteria and the intestinal mucosa in order to understand how life-threatening infections arise from the gut microbiota following trauma and major surgery and during critical illness.
The Problem
Post-operative Infections continue to increase in incidence, severity and are due to pathogens that are resistant to the antibiotics chosen for prophylaxis.
Despite advances in infection control practices (operating room ventilation, sterilization methods, barriers, surgical technique, antimicrobial prophylaxis) post-surgical infections still occur even within the top-rated hospitals and when surgery is performed by top-rated surgeons. Post-operative infections remain a substantial cause of prolonged hospitalization, readmissions, morbidity and can lead to life-threatening Sepsis or Death.
Prolonged hospitalization (+10 days)
Readmissions (5x more likely)
Morbidity (increased)
Life-Threatening Sepsis or Death (2x as likely)
More than 270,000 Americans die of Sepsis each year. Surgical Site Infections (SSI) and Sepsis combined to cost the US Healthcare system over $34B annually.
Balancing the overuse of antibiotics with the problem of emerging and increasing antibiotic resistance is a global public health concern that Covira continues to address
The Solution
Pi-PEG is prescription medicine delivered as a drink that coats the intestinal tract and works to prevent post-surgical infections.
Pi-PEG is the first-of-its-kind solution to inhibit bacterial virulence without affecting bacterial growth and the balance of the microbiome such that there is a measurable reduction in post-operative infections (SSI, AL) and their progression to Sepsis. Pi-PEG collaborates with the gut microbiome to enhance overall health rather than destroying it in the process of attempting to eliminate threatening pathogens.
Prior to surgery, the patient will receive a prescription for Pi-PEG (powder form to be mixed with water). Patients will drink the colorless and tasteless Pi-PEG solution before and after their surgical procedure.
Covira Surgical’s product, phosphate covalently bonded to polyethylene glycol (Pi-PEG), is under investigation for multiple infection prevention applications
Pi-PEG is a novel, non-antibiotic agent that prevents lethal bacterial infection by enriching the local environment with a key element needed for bacteria to successfully grow and reproduce phosphate. Phosphate-rich environments provide a key universal cue to bacteria to suppress their virulence (harmfulness), feed, grow and reproduce.
In preclinical studies, Pi-PEG has prevented infection and suppressed virulence of multiple drug-resistant bacteria strains
The asset preserves the gut microbiome, reducing the collateral damage to the microbiome when antibiotics are applied.
Pi-PEG coats the intestinal tract and prevents post-operative infections…a microbiome-promoting strategy where bacterial virulence is suppressed, yet bacterial growth and functions are maintained.
The Market
Pi-PEG represents a peak projected opportunity of $2.5B by 2037 in the USA across SSI, AL, and Sepsis
Surgical Site Infection (SSI) represents the largest opportunity due to the number of potentially eligible inpatient & ambulatory surgeries ($1.8 B projected by 2037) and the option for prophylactic use
Pi-PEG, as a prophylactic anti-infective in surgery patients, has an addressable projected population of 25.2M by 2037
Anastomotic Leak (AL) represents a high unmet need area with few options directly analogous to Pi-PEG, though small market size contributes to lower projected revenue
Pi-PEG has an addressable AL patient population of 964K currently and is expected to reach 1.1M by 2040
Sepsis represents a more focused usage for Pi-PEG, with low (but increasing) incidence
Pi-PEG has an addressable population of 2.8M patients currently and is expected to reach 3.0M by 2040
Our Traction
Patent protected technology (Pi-PEG) that has been proven to be safe and effective in multiple pre-clinical small animal studies
We have completed target discovery, lead compound identification, optimization, pre-clinical development and have proven Pi-PEG’s ability to safely and effectively reduce the risk of Surgical Site Infections, Anastomotic Leak, and Sepsis in small animal models.
Dr. Alverdy’s research, discovery, product development, and product testing have led to 225+ peer-reviewed high-impact journal publications and 3 patents (1 issued and 2 pending).
To see Dr. Alverdy’s proof of concept milestone publications go to the Covira website: https://www.covirasurgical.com/proof-of-concept
Our next 2 years will be focused on completing the Pre-IND (Investigational New Drug) work and filing the IND application with the FDA. Followed by Phase I First in Human Proof of Principle.
What We Do
Revolutionizing the prevention of infections following surgery and injury by collaborating with the gut-microbiome
Post-operative infections can occur at multiple locations within the operative site (SSI) and can lead to life-threatening Sepsis. Covira’s Pi-PEG is a novel therapeutic alternative to infection control that is distinct from traditional antibacterial approaches. Pi-PEG suppresses bacterial virulence while allowing bacteria to grow and reproduce normally yet remain harmless. This approach allows a robust and resilient gut-microbiome to function normally to the benefit of the patient.
By covalently bonding Pi with PEG...
Pi is delivered and durably embedded to potential sites of infection where it suppresses bacterial virulence.
PEG enhances the epithelial barrier and physically distances bacteria away from the epithelial surface thus preventing deeper tissue invasion.
The Business Model
A go-to-market strategy that we believe drives early adoption/market share capture, and creates a number of collaboration
Our experience in building, launching, and scaling medical solutions enables us to use our network to target immediate sales leading up to and following FDA approval.
Insurance Support: By demonstrating evidence of cost savings (reduced length of stay, hospital readmissions, mortality, etc.)
Top-Down Selling Strategy: We can focus our approach to Health Systems/Hospitals and Surgery Centers on proving reduction in cost burden through decreased case rate of surgical infections.
Bottom-Up Education: By approaching surgeons and surgical support staff directly, we can educate providers on Pi-PEG and its ability to fit seamlessly into existing surgical practices/protocols simply by including Pi-PEG drink prescription prior to and after surgery.
How We Are Different
Pi-PEG as a non-antibiotic anti-virulent addresses key unmet needs, leading to higher product adoption rates
Our novel approach is a biologically sustainable strategy that will seamlessly integrate with the current perioperative protocols. Our focus is on infection prevention by collaborating with the gut-microbiome - rather than an antibiotic approach that focuses on killing the bacteria.
While a few new drugs have begun to emerge as potential candidates for treating SSI, AL, Sepsis, we stand alone in our biological proactive evolutionary sustainable approach and formulation.
When compared with the average cost of SSI, AL, and Sepsis treatments, Covira’s Pi-PEG has the potential to save hospitals & other surgery providers millions of dollars each year.
Here are the specs behind that estimation:
Cost a hospital on average $39k per SSI ($176k per GI SSI “Anastomotic Leak”).
Total US cost burden for SSI/AL and Sepsis is >$34B per year.
Cost for Pi-PEG is <$700 per patient
The Vision
To be a trusted and acknowledged leader in reducing post-surgical infections
Our mission is to discover, develop and bring to market safe and novel therapeutic options that can preserve the health benefits of a patient’s gut-microbiome yet prevent infection-related post-operative complications.
We strive to serve patients by transforming the promise of science into innovative treatments which have the power to improve health and save lives.
Covira’s Platform Technology (Pi-PEG) has the potential to be used for multiple infection-related complications including:
Local Applications (Future)
Pi-PEG can be developed for local application at the anastomotic site via novel delivery methods or as a “biologic bandage” to protect against SSIs
Coating of Prosthetic Materials (Future)
Surgical prosthetic materials, mesh hernia grafts, aortic replacement grafts and breast implants can also be coated with Pi-PEG to prevent infection
OUR LEADERSHIP
Proven Business Leadership Experience and Strong Scientific Expertise, combined with Industry-Leading Key Partners
Peter Farmakis is a CEO with proven life sciences business and leadership successes from two fortune 100 companies (J&J and Abbott), and four prior startup experiences including two in the biotech space.
Dr. John Alverdy, Founder & Chief Scientific Officer is a preeminent surgeon-scientist and world leader in surgical infection research with a focus on the molecular basis of surgical infections and the gut microbiome. As a practicing gastrointestinal surgeon with over 225 peer-reviewed publications, Dr. Alverdy is the Sarah and Harold Lincoln Thompson Professor of Surgery and the Executive vice-chair of surgery at the University of Chicago.
Why Invest
Market Opportunity: Covira’s peak year revenues are projected to hit $2.5B by 2037 in the US. Given the lack of alternative treatment options, infection prevention, and increasing antibiotic resistance continue to be concerning global public health issues. Post-operative infections cost the US healthcare system over $34B each year. The US total available market for Covira’s (Pi-PEG) top three prioritized indications (SSI, AL, Sepsis) is projected to reach $8.8B by 2037 with a peak year blended market share capture of 26.8% (projected $2.5B by 2037).
Technology Platform: Pi-PEG is a novel agent delivered to potential sites of infection that suppresses bacterial virulence while preserving the health-promoting function of the microbiome. Lead candidate is an orally administered anti-virulence agent to prevent postoperative infections and their progression to sepsis.
Management Team: Founder that is a preeminent surgeon-scientist and world leader in GI surgical infection research (molecular basis of surgical infections and the gut microbiome), CEO with proven life science business and leadership successes from two fortune 100 companies (J&J and Abbott), and four prior startup experiences including two in the biotech space.
THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.
Quick Insert
In the Press
Business Worldwide
20 Most innovative Companies to Watch Awards, 2021
CISION
Covira Surgical Named by Business Worldwide Magazine Among Top 20 Most Innovative Companies to Watch, 2021
Offering Summary
Company | : | Covira Surgical, Inc. |
Corporate Address | : | 3333 Green Bay Road Office L-404, North Chicago, IL 60064 |
Offering Minimum | : | $10,000.00 |
Offering Maximum | : | $1,070,000.00 |
Minimum Investment Amount(per investor) | : | $250.00 |
Terms
Offering Type | : | Equity |
Security Name | : | Common Stock |
Minimum Number of Shares Offered | : | 10,000 |
Maximum Number of Shares Offered | : | 1,070,000 |
Price per Share | : | $1.00 |
Pre-Money Valuation | : | $9,987,500.00 |
Voting Rights of Securities Sold in this Offering
Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.
Time-Based:
Lead Investors
Invest within the 1st week and receive 20% bonus shares.
Friends and Family Early Birds
Invest within the 2nd week and receive 15% bonus shares.
Super Early Bird Bonus
Invest within the 3rd week and receive 10% bonus shares.
Early Bird Bonus
Invest within the 4th week and receive 5% bonus shares.
Amount-Based:
$1,000+ | Tier 1
Invest $1,000+, you will receive 5% bonus shares.
$5,000+ | Tier 2
Invest $5,000+, you will receive 10% bonus shares.
$10,000 | Tier 3
Invest $10,000+, you will receive 15% bonus shares.
$25,000 | Tier 4
Invest $25,000+, you will receive 20% bonus shares.
$100,000 | Tier 5
Invest $100,000+, you will receive 25% bonus shares.
*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.
**All perks occur when the offering is completed.
The 10% StartEngine Owners' Bonus
Covira Surgical, Inc., will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.
This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Common Stock at $1.00 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $100. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.
This 10% Bonus is only valid during the investors eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are cancelled or fail.
Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for.
Irregular Use of Proceeds
The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments. Salary payments made to one’s self, a friend or relative.
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Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$118,858.00
USD
$4,132.00
USD
Cash And Cash Equivalents
$118,858.00
USD
$4,132.00
USD
Accounts Receivable
$0.00
USD
$0.00
USD
Short Term Debt
$212,017.00
USD
$58,841.00
USD
Long Term Debt
$0.00
USD
$0.00
USD
Revenues And Sales
$0.00
USD
$0.00
USD
Costs Of Goods Sold
$0.00
USD
$0.00
USD
Taxes Paid
$0.00
USD
$0.00
USD
Net Income
-$38,932.00
USD
-$52,678.00
USD
Risks
A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.
Updates
$1,000,000 Milestone Achieved
5 months ago
Invest Now...Closing in 3 hours!
5 months ago$978,199 Raised
Opportunity Closing in 3 hours
$950,000 Milestone Achieved (7 Hours Left)
5 months agoCovira's Investment Opportunity is Closing in 7 Hours!
If you are interested to make an investment now is the time...
Two Major Milestones Achieved (Investment Opportunity Closes in 10 Hours)
5 months ago$900,000 Raised
500 Investors
Last Day To Invest (16 hours Left)
5 months agoWe are very close to hitting two milestones 1. 500 Investors (currently at 495), and 2. $900,000 Raised on StartEngine (currently at $866,435).
Thank you from CEO (Closing in 1 day)
5 months agoDear Investors and Followers,
Because of you and your referrals, earlier today we achieved our 1H 2022 goal to raise $1,0M. To date we closed $835,508 via the StartEngine Reg CF Offering and we secured an additional $200,000 from the COVID-19 Economic Injury Disaster Loan, totaling $1.035M.
Tomorrow is the last day to invest. If you have not completed your investment yet, please do so ASAP. If you know of someone that may be interested, please share the Covira investment opportunity with your contact(s).
Thank you for your trust and confidence...I am very happy to have you as part of the Covira Investment Community!
Kind Regards,
Peter Farmakis, CEO
$800,000 Milestone Achieved
5 months agoCovira Achieves 1H 2022 Goal to Raise $1.0M
Capital Raised to Date 100% to Goal
$808k Raised from the current $1.0M Seed Round via Reg CF Offering on StartEngine (1 days remaining, scheduled to close April 27th)
$200k Raised from the COVID-19 Economic Injury Disaster Loan (Jan 2022)
$1.0M Total Capital Raised
$700,000 Milestone Achieved
5 months agoUpdate on Covira's 1H 2022 Goal to Raise $1.0M of Capital
Capital Raised to Date 90% to Goal, Projected to be 110% to Goal
$705k Raised from the current $1.0M Seed Round via Reg CF Offering on StartEngine (2 days remaining, scheduled to close April 27th)
$200k Raised from the COVID-19 Economic Injury Disaster Loan (Jan 2022)
$210k Projection based on verbal expressions of interest/commitments received
$1.1M Total Capital Projected to be Raised
Invest Now - Closing in 2 days!
6 months agoTo See Covira's Investment Opportunity go to StartEngine and filter on
1. "In Progress"
2. "Biotechnology" or "Pharmaceutical" or "Health Tech"
3. "Most Funded"
See Screen Shots Below...
Due Diligence Completed - Read Executive Summary
6 months agoReminder: Covira Investment Opportunity Closes in 3-days
Over the last 6+ months Covira has been working Keiretsu Forum's Midwest Chapter to complete Due Diligence. The Due Diligence Final Report (74 pages) has been completed, please see below Executive Summary.
Keiretsu Forum is a global investment community of accredited private equity angel investors, venture capitalists and corporate/institutional investors. Keiretsu Forum was founded in the San Francisco East Bay in California in 2000 by Randy Williams. Keiretsu Forum is a worldwide network of capital, resources and deal flow with 52 chapters on 3 continents. Keiretsu Forum members invest in high-quality, diverse investment opportunities. The community is strengthened through its involvement in social and charitable activities.
Executive Summary of Due Diligence Findings and Deal Terms
March 2022 | Compiled by Patrick Hennessey, MD
Executive Summary:
Covira Surgical was founded in 2018 to translate Dr. John Alverdy’s research on the interplay between the human microbiome and infection into a clinically viable product to prevent gut derived bacterial infections. Dr. Alverdy is a gastrointestinal surgeon and the Sarah and Harold Lincoln Thompson Professor and Executive Vice Chair of the Department of Surgery at the University of Chicago. In addition to his clinical work, he runs world renowned laboratory that studies the molecular interactions of bacteria and the intestinal mucosa in order to understand how life-threatening infections arise as a consequence of trauma, major surgery, and critical illness.
Dr. Alverdy discovered that certain bacteria in a patient’s intestines, when starved of the vital nutrient phosphorus, respond by expressing virulence genes that increase the chance these bacteria will cause an infection. This insight led Dr. Alverdy to study whether supplying phosphate to the gut could prevent infections in postoperative patients. After determining that standard forms of phosphate repletion could not deliver a sustained level of phosphate to the gut, he and his team at The University of Chicago developed a proprietary, patented compound, CS-0003 for this purpose. This unique drug acts as a sustained source of phosphate to prevent bacterial expression of hypophosphatemia-induced virulence genes, while also acting as a mechanical barrier to prevent bacterial translocation across the gut mucosa.
Covira is focused on entering the FDA approval process for CS-0003 with the goal of gaining approval for the treatment of anastomotic leak (AL), a devastating complication of bowel surgery that results in significant patient morbidity, increased risk of death, increased length of hospital stay, and a high cost burden on the healthcare system. Despite decades of research and development of new antiseptic and surgical techniques, the rate of AL has remained stubbornly high, even when surgery is performed by highly experienced surgeons at top performing medical centers. There is a clear need for new tools to prevent AL, and Covira intends for CS-0003 to be the solution to this daunting problem. Although Covira is primarily focused on gaining FDA approval for treatment of AL, they have also identified surgical site infection (SSI), and sepsis prophylaxis as additional prioritized indications for CS-0003, as well as the potential for strategic partnerships to impregnate CS-0003 into wound dressings and medical devices.
Key Due Diligence Team Participants (the “Team”):
- Patrick Hennessey - Coordinator/Lead, Marketing/Competition, and Site Visit
- Adam Elhofy - Finance
- Valerie (Val) Adegbite-Calloway - Science/Technology
- Park Burrets - Reference Checks
Documentation Checklist:
A review of the primary corporate documents and contracts and deal documents was conducted by Wood & Lamping LLP, and is detailed in this report entitled “Review of Corporate and Deal Documents.” The documents reviewed are listed in the checklist included.
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