April 2020
Vol 7 | Issue 302

Q&A with Larry Tiffany of Medcura

CEO

Principle Series:

Medcura is the next great advanced materials Company to enter the medical device industry. The Company has developed a line of FDA cleared hemostatic products for clinical and consumer applications, the first of which will be available in CVS early next year. With an initial focus on topical delivery for external injuries and clinical applications, Medcura combines the use of safe, inert ingredients with proprietary chemistry to design products that treat all types of bleeding even when caused by military conflict or traumatic accidents. To provide perspective on Medcura’s patented high-performance platform, the US FDA recently designated its first internal product as a “Breakthrough device”. This important new product was designed through a grant-supported collaboration with the US Military resulting in an injectable foam that can decisively treat internal non-compressible bleeding that is currently the largest source of in-combat death. The performance of our initial sprayable foam formulations in such a challenging injury model demonstrates the military and civilian utility for both emergency medicine as well as routine open and minimally invasive surgery.

The Company relies on a lean approach to building and scaling our business. Medcura has advanced our business to the point of first commercialization using $3M in investor capital and $3.5M in grants. This was done through leveraging our versatile and proprietary technology platform across numerous clear market needs, developing disruptive high-performance and cost-effective products, achieving their regulatory clearance to market and then demonstrating their clinical and economic advantages to clinicians, hospitals and patients. Medcura has targeted markets where our disruptive products provide benefit to potential commercial partners that historically spend very little on R&D and require the eventual acquisition of new products and technologies to support their P&Ls.

Medcura’s products are designed to manage even severe bleeding in a safe, effective healing environment in comparison to the current standard of care and known competitors (see below):

Traction
√ Multiple published studies with head-to-head comparisons to best in class.
√ Multiple FDA clearances including “Antibacterial” and “non-sterlie preparation” claims.
√ Recent clinical results from the University of Chicago (UCM) demonstrating superior clinical performance to the current standard of care.
√ Execution of a commercial partnership with the North American market leader in 1st Aid products (~4B adheisve bandages sold/yr) to commercialize Medcura’s OTC product line.

Safety
√ Multiple successful submissions, review and marketing clearance by the US FDA, including biocompatibility, immungenicity and sensitivity of bandages, gels and sponges
√ Recent clearance of antibacterial label expansion and non-sterlie preparation for OTC products.
√ No reported adverse events or unacceptable evidence of immunogenicity from implantation studies in well-established animal models.                                                                                                                                 √ No adverse events reported in recent study from UCM (e.g. no radial artery occlusion, skin inflammation or discomfort, re-bleeding or significant bruising.

Watch video the BBC did on Medcura for the Stephen Hawking series, “Top Innovators”

 


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Why does your technology work better than other approaches to manage bleeding and treat wounds?

Our materials are application-designed to provide high-performance biological seals and barriers. When delivering our technology, regardless if it is in a bandage, gel, foam or powder, it will rapidly adhere to the wound or surgical incision even if this is non-uniform (e.g. jagged). This allows the patient's own coagulative factors to concentrate and form a strong clot (even if they are taking strong blood thinners), indeed some of our material becomes integrated into the clot to improve strength and durability. As blood flows out of the wound/incision and makes contact with our material, it causes a visco-elastic barrier to form which is antibacterial and maintains a safe, moist healing environment for the wound site. Generally, the current standard of care for most applications do not provide this same advantages, and even in circumstances like surgery, where very high-performance options are used, they are very expensive and require significant preparation/anticipation of use.

Why is this a good business?

No one likes to bleed and there is no procedure or engagement with any level of healthcare professional where bleeding management is not required prior to discharge. Medcura believes that it can build a de-risked business by leveraging a common technology and manufacturing core to support multiple franchises and revenue streams. These applications also have overlapping value, as the recent demonstration of dramatically reducing the time to clotting (after routine angiography) coupled with the successful treatment of severe/traumatic wounds using the US military's required model, piqued the interest of our consumer products partners. Medcura's layering of revenue streams across multiple independent markets provides a path to positive cash flow, and multiple opportunities to monetize our business.

How does the recent COVID-19 pandemic impact your business?

Like most businesses, we've been challenged with access to some of our clinical partners who have appropriately prioritized treating the sick as compared to working on new technology projects like ours. We were very fortunate to move into our new purpose-built HQ on March 2 and since we are an Essential business, have been able to stagger our team's access to allow us to set up our new labs and manufacturing space so that we can maintain our timelines for first commercial deliveries in Q4 2020. We've also seen an increase in the interest in our consumer products, given the protective aspects of our materials (e.g. interest in developing multiple SKUs now for both retail and industrial first aid). In summary, our military program will be delayed by ~ 90 days, however the US Military has graciously extended the window for our grant, and has even suggested that we expand our work on this program through a series of new RFPs that can provide $Ms in new grants.


Larry Tiffany of Medcura

Larry Tiffany is Chief Executive Officer and Director of Medcura. Larry is a serial entrepreneur having most recently founded and led to the sale of the neuro-molecular testing company DioGenix. While at the helm of DioGenix, Larry raised over $12M from early stage investors while garnering another $2M in non-dilutive sources (e.g. the National Multiple Sclerosis (MS) Society) to support the clinical development and prospective validation of the first new diagnostic for MS since the late 50’s, MSPrecise®. Prior to DioGenix, Larry held positions in Sr. Management at Ore Pharmaceuticals (CBO), Gene Logic (SVP & GM, Genomics) and Genetraks (US President). He holds a JD from Franklin Pierce Law Center in Concord, New Hampshire (specializing in intellectual and commercial law); a MS in Biotechnology from Johns Hopkins University in Baltimore, Maryland; and a BS in Biochemistry from Nazareth College in Rochester, New York. Contact Larry  ltiffany@medcurainc.com  

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