MEDdesign

Building a Better Hemostatic Device: Why Collaboration Is Key

By Terrence W. Norchi, M.D.
December 5, 2016


• Categories: 04-Product Design & Development, Combination Products, Market Access, MEDdesign, RC - Device Design & Manufacturing

Over the last decade or so, advances in technology have resulted in a significant increase in biomaterials that are available to the modern surgeon for a range of uses.¹ Yet as many have realized, the ideal method for stopping bleeding during surgery, which is one application that biomaterials have tried to address, still does not yet exist. However, once a new technology has been developed, could the key to securing further development and pipeline applications, as well as support for clinical trials, lie in teamwork reaching across national boundaries? Potentially—in fact, I’m involved in just such an effort. Let me explain why.

First, what would “the perfect hemostat” be like? Ideally, it should work quickly, effectively and safely while being easy to use. It should be conformable to a wound, allowing the agent to reach areas that may be difficult to access. It should cause little or no lasting untoward effect to surrounding tissue, appropriately break down over time or be removable from the wound, and not contain unsafe ingredients or components that can spread systemically.² Further, in the trauma setting, it should be lightweight, easy to store and rapidly applied to a hemorrhaging wound.

Companies that successfully invent and commercialize products with those features stand a good chance to reap big rewards. The opportunity is huge: According to MedMarket Diligence, LLC, sealants, hemostatic agents and/or other products can provide benefit in more than 100 million procedures annually worldwide.³ The hemostat and sealant market is projected to achieve $5 billion in 2017 worldwide sales and surpass $7.5 billion in 2022.⁴

And many are trying to carve a niche in this market. The trouble is, each of the existing solutions on the market present their own specific set of drawbacks. Here is just a small sampling of what is out there:

• Gelatin foams should not be used in closed spaces, as significant swelling may compress nerves; their use around brisk arterial bleeding can dislodge a sponge, and it may embolize if in an intravascular compartment.
• Microfibrillar collagen is inadequately effective in patients with thrombocytopenia, sticks to the surgeon’s gloves and may bind to neural structures. Caution needs to be taken with blood scavenging systems, as it can pass through filters.
• Oxidized cellulose cannot not be used in tandem with many other biologic hemostatic agents because of low pH, which may increase inflammation in surrounding tissue. Caution must also be taken when using it in close proximity to the spinal cord.
• Thrombin, which can be unreliable, is best used in combination with other products
• and depending on the source, may lead to life-threatening immune responses.
• Fibrin sealants can be unreliable and challenging to use.

As the CEO of a company developing its own approach to a new hemostatic device, I believe that many heads are better than one when it comes to progress. That is why, in mid-2015, my Massachusetts-based company initiated a research and development collaboration with the CÚRAM Center for Research in Medical Devices, a new center of excellence for research based in Galway, Ireland. The technology was initially created at the Massachusetts Institute of Technology and licensed by Arch for development and eventual commercialization. When considering a range of R&D options and our eventual push into the EU marketplace, we focused on Ireland as a potential location to establish a footprint. A CÚRAM partnership was appealing in that it would provide R&D support and resources. Together, we intend to deploy our resources in Ireland on a range of activities from early-stage research to late-stage development for diverse pipeline projects.

Our collaboration—as well as others being undertaken by companies here and abroad—encompasses a direct, forward-looking approach to the changing global dynamic of both industry and academic R&D. It represents a trend that promises mutually beneficial opportunities for companies and research centers alike. In our case, my company benefits by obtaining access to financial, infrastructural and expert human resources for our planned work; CÚRAM benefits by being provided access to collaborate on our technology; and Ireland benefits from the shift of some of our financial and labor resources to the country as well as the growing footprint of a non-Irish company into the country.

I believe an ideal hemostatic device can be created with our synthetic peptide in the form of a clear liquid that can be squirted or sprayed onto a wound, resulting in a physical/mechanical barrier that stops bleeding promptly, even in the presence of antithrombotics, also known as blood thinners. Surgeons should be able to see and operate through it; it should be bioabsorbable and enable normal healing. This is the approach that my company has been pursuing with our own and our licensed technology, and recently with the support of CÚRAM.

We have already met with encouraging results. We recently reported data from a study indicating that treatment with our synthetic peptide, called AC5, achieved median time to hemostasis 41% faster than the standard of care during a dermatology procedure. Additional clinical data indicated that for a group of patients who were taking antiplatelet therapy, median time to hemostasis was also significantly reduced. In fact, in both groups, the time to hemostasis for wounds treated with our product was less than 30 seconds.

If building the perfect hemostatic device were easy, a single company might have accomplished the feat by now—and reaped the rewards. In reality, just as in so many other scientific endeavors, the key to success may lie in collaboration between far-flung partners—with the potential glory to be shared on many shoulders.

References

1. Achneck HE, Sileshi BS, Jamiolkowski RM, Albala DM, Shapiro ML, Lawson JH. A comprehensive review of topical hemostatic agents: efficacy and recommendations for use. Ann Surg. 2010 Feb;251(2):217-228.
2. Stuke LE. Prehospital topical hemostatic agents: a review of the current literature. National Association of Emergency Medical Technicians.
3. MedMarket Diligence, LLC, Report #S290, “Worldwide Markets for Surgical Sealants, Glues, and Hemostats, 2015-2022.″
4. MedMarket Diligence, LLC; Report #S290, “Worldwide Markets for Surgical Sealants, Glues, and Hemostats, 2015-2022.”