Hemostatic device developer Z-Medica this week received a majority investment from private equity firm Linden Capital Partners as the company looks to continue expanding the availability of its QuikClot hemostatic products.
The investment places Linden Capital alongside current shareholders DW Healthcare Partners, who invested in the company in 2012, according to a statement from CEO Stephen Fanning.
“This new investment of financial capital comes at a very good time for our company. It will allow us to significantly expand our U.S. healthcare sales force to support the launch of our recently FDA approved product, QuikClot Control+. We also plan to expand the U.S. MILTAC team and develop a strong international sales team. Additionally, the new investment from Linden Capital Partners will also allow us to develop a better infrastructure at our Wallingford facility to help support our future growth plans,” Fanning said in a statement provided to MassDevice.com.
CEO Fanning spoke to MassDevice.com this summer about the FDA de novo approval the company received in July for its QuikClot Control+ as well as the company’s goals and plans for the future with its hemostasis products.
“We’re involved in the hemostasis business, so we’re all about saving lives by stopping very aggressive bleeding. The business started out in 2002 operating solely with the military, which guided our first generation product. We have subsequently launched 2 new generations of product, and about 99% of our business right now is in our 3rd generational product,” Fanning said.
Z-Medica’s core product family are its QuikClot hemostatic products designed to accelerate the body’s natural clotting ability. The company has produced a number of different versions of the product, with the most recent version winning FDA clearance for internal use.
“Basically what we have is a product that looks like a piece of gauze, but we impregnate kaolin onto the gauze. The product has been the number 1 recommended product in the military for all 5 branches, and we have subsequently moved the business into other sales channels, specifically, the emergency services. So we’ve moved it into EMS, healthcare and we’ve moved it into what’s called the tactical business,” Fanning said.
Fanning said that the product’s ease of use and efficacy has helped the company grow outside its initial military market and helped it address bleeding in a way other products have failed to.
Multiple studies have shown that bleeding-related complications or transfusions due to blood loss increase risk of infection, result in longer hospital says, higher costs and increased postoperative morbidity and mortality.
“The company is now not only involved with the military, but we’re involved in hospitals and trauma surgeons and we’re on the duty belts of any police officers, we’re sold into many schools. Our product is very intuitive to use, and at the end of the day, we have vastly increased the distribution of our product into a significant number of sales channels,” Fanning said.
In July, Z-Medica said it won FDA de novo clearance for its QuikClot Control+ with indications for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding.
The company said the clearance made the QuikClot Control+ the 1st and only non-absorbable hemostatic dressing cleared for the internal organ space in severely bleeding patients, and added that it can also be used to control severely bleeding wounds, including surgical wounds and traumatic injuries.
“Now, with the internal approval that we’ve gotten from the FDA, a surgeon can wrap the liver with our product, stop aggressive bleeding, continue with the procedure, and then come back after the bleeding has stopped and use more expensive products, which are absorbable,” Fanning said.
Fanning clarified that the QuikClot product is non-absorbable, but can be left to control internal bleeding for 24 to 48 hours before its required to be removed.
Beyond clearing the product into the internal space, the FDA de novo approval held other benefits as well, said Fanning.
“The de novo provides us with significant patent protection and significant overall protection in the marketplace versus just getting 510(k) approval,” Fanning said. “So, we have a significant number of opportunities to be a stand-alone product in the marketplace, because of the de novo. And, the fact that we can now use it internally, as I said earlier, we view ourselves as the first line of defense.”
Fanning said that the company has a number of opportunities it can follow with the product now that it’s received de novo approval, including use in the entirety of the torso.
“Quite frankly, the only thing we don’t have approval for right now is in the brain,” Fanning said.
Z-Medica has inked deals with a number of police departments, including New York, Chicago, Los Angeles, as well as school systems and other public facilities, Fanning said. The company is also looking to expand its presence in hospitals.
“Right now we are only in over 400 hospitals. So we have a huge, huge opportunity ahead of us to continue gaining distribution in hospitals and significantly improve our overall footprint, not only just with the trauma surgeons, but with the [internal] indication for QuikClot Control+, we have an opportunity to move into many, many other departments,” Fanning said.
The company is also developing a new product for the military, which includes a second mechanism of action, though Fanning said he couldn’t speak much on the development at this time.
“We have a number of things in the pipeline that we’re working on, but we think first and foremost right now, getting distribution in hospitals with QuikClot Control+ will be critically important to us, and the continued expansion of QuikClot throughout police organizations, schools, airports, and wherever there’s an opportunity to save lives where mass casualty events could occur,” Fanning said. “We literally would like to have our products everywhere, because if you can stop bleeding, you can save lives. And we believe that by having our products available wherever possible, we’ll be able to save more lives.”