Runner-Up PPM Technologies LLC
By Kendall Jones
At first glance, it sounds like a Biolife copycat, but it's not. PPM is in the same business as Biolife - finding innovative, faster ways to stop bleeding and close wounds - but with a very different product.
Biolife's product, QR, absorbs the blood and chemically reacts with it to create an instant scab. PPM's yet-to-be-named innovation has completely different chemical properties, and it works differently to seal wounds. The lattice technology in PPM's product forms an immediate airtight web, or scaffold, when it comes into contact with a liquid such as blood. When applied to a bleeding wound, the web will form instantly over the wound, sealing it.
"Our product is a giant leap forward (from Biolife's QR)," says Dr. Caroline Popper, one of the founders of PPM, a three-month-old company still in its clinical trial phase prior to marketing. The product is about a year away from appearing on drug store shelves.
"You know how Robitussin has several different formulations, depending on the symptoms? This will be like Robitussin," explains Popper. "We will have the basic formula, plus additives, depending on the need. For gushing wounds, we will add a water absorber. For people who need extra clotting, we will have a formula with clotting accelerant. Other additives can be included for inhibition of bacteria, for example. There are a lot of options. Ours can be offered as a powder - a 'dry bandage,' which is an improvement over current two-step liquid bandages - and it can also be offered as an adhesive coating, an aerosol, a liquid, or a gel."
Popper says the patent has already attracted a lot of attention from the U.S. Department of Defense, and PPM is in negotiations with three major multi-national companies to partner with PPM for future clinical trials.
"We've been putting all of our resources into research and development and patent protection," says Popper. "We're actively developing all versions of the product and we're entering our clinical trials. We've already been approached by strategic partners."
The product could already be manufactured and sold on the consumer market for superficial wound closure because that does not require FDA approval. But PPM, with its founders' medical background, has more intense goals. Popper, PPM's chief executive officer, has been an emergency medical physician for 20 years, with 15 years' experience working with Fortune 500 diagnostic device and therapeutics companies. Co-founder and company president Dr. Allan Pronovost has been head of research at the largest research lab in the nation and has been head of research and development at several diagnostic companies. Three-time successful entrepreneur Michael Miville rounds out the trio of founders.
It's the inclusion of additives in the product such as clotting catalysts and anti-bacterials that require FDA approval. The simple wound sealant alone, even with a liquid absorber is considered a "device" by the FDA - Biolife's current product is a device. But the additives PPM wants to include take the product from a device to a drug in the eyes of the FDA, and that requires clinical trials.
PPM sees two major product categories for its innovation. One will be the consumer product, which, like Biolife's QR, will be used for simple vascular bleeding from minor cuts and abrasions, targeting a $1 billion, annual, worldwide consumer market. Though they work differently, both the Biolife product and the PPM product are stable products with long shelf lives. Neither use human or animal products, like existing wound sealant alternatives, minimizing adverse reactions and allergies. Both will work for recurrent bleeding and people with bleeding disorders or those taking blood-thinning medication. The primary differences are in the wound sealant method and PPM's additives.
"One day we will talk about a Band-Aid impregnated with PPM," predicts Popper.
But PPM's aim of FDA approval is really for its other product category, the clinical product. PPM's clinical product, for professional use, will treat deep wounds and even internal bleeding. It consists of a bridging agent as a clot accelerant and includes thrombolytic factors to trigger a blood coagulation cascade.
There are numerous market opportunities for the clinical product. The professional topical wound closure market, for control of bleeding in topical skin lacerations and surgical incisions, is useful for physicians, nurses, emergency medical technicians, nursing homes, etc. It's a $2.6 billion market, annually. The professional internal wound care market, for wound closure and wound care inside the body, is a market worth $9 billion annually.
"The wound sealant market is a $40 billion market," says Popper. "Our product addresses 30% to 40% of that market, so it's a $15 billion opportunity. Of course, the wound sealant market includes sutures, which are often irreplaceable. If you have a caesarian section, for example, you want sutures."
But PPM is not limiting itself to these more traditional medical markets. It anticipates entering the $30 million veterinary wound care market, and it seeks a place in military applications as well, especially on the battlefield. For example, a soldier seriously injured by shrapnel could have the PPM clinical product applied to stop bleeding in deep, life-threatening wounds in order to stabilize him for transport to a medical facility for treatment.
"Our product has a very long shelf life. It's stable. It requires no special handling. It's easily applied in the field," says Popper. Determining how long the PPM product will hold on what intensity of injury is one of the questions the clinical studies hope to answer.
Pronovost is the actual inventor of the product, but he has little practical understanding of the regulations involved or the market penetration issues. Popper, with her understanding of the regulatory strategy and market requirements, and Miville, with his startup experience, will take the product through clinical testing and into the marketplace.
The trio of founders has recently been joined by Sarasota entrepreneurial investor Norm Worthington, currently known for his affiliation with CopyTalk, another 2003 Innovation Award nominee. This is Worthington's first investment in the life sciences industry, and Popper says he has been very involved in the strategic development of the product.
In the meantime, Pronovost, Popper and Miville already have another breakthrough medical testing product in development. They are in the patent application process with this product, and they don't intend to publicize it until the patent is secured. Popper expects the three of them to develop and market even more medical products in the future.
PPM Technologies is a testament to the success of Sarasota-based StartupFlorida as a business incubator. Pronovost, Popper, Miville and even Worthington were brought together through StartupFlorida. Popper says she will owe Rich Swier, a managing partner of Startup Florida, for the rest of her life.
Asked about the presence of Biolife, Hemacure and other relatively new Gulf Coast competitors in the next generation wound sealant market, Popper expresses nothing short of utter delight. "I think it's exciting," she says. "It shows a kind of momentum in development of the life sciences in this area. Companies like these help open up a new market, and I think it's wonderful that several of them getting recognition are in this area."