Existing Treatments

Arch can transform the landscape. The competition has limitations

“Surveys of general, vascular, thoracic, and neurosurgeons affirm the need for products that will work within one minute (preferably 15-30 seconds), remain effective for 10-14 days, and absorb within 8 weeks…”

Surgical “biomaterials” for hemostasis and sealant are out of date. Surgical (and trauma) patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluids. While surgical techniques, instrumentation and technology have made tremendous strides over the last couple of decades, the majority of hemostatic agents and sealants that surgeons rely on to help stop bleeding and seal leakages have not kept up. Even though some companies have made incremental improvements on first-generation hemostatic products (example: a recombinant version of thrombin to eliminate adverse effects associated with animal-derived blood products), revolutionary advances have been elusive because the underlying technologies have basic limitations.

Fortunately, thought leaders have been vocal about what is missing, and that is where Arch steps in. Surgeons agree that the ideal agent to stop bleeding or leaking does not currently exist. Surveys of general, vascular, thoracic, and neurosurgeons affirm the need for products that will work within one minute (preferably 15-30 seconds), remain effective for 10-14 days, and absorb within 8 weeks, among other needs. A product exceeding these customer expectations should achieve a high level of success. If it possesses both sealing and hemostasis crossover potential, the opportunity should be further enhanced.

Starting with surgical hemostasis, Arch intends to transform the landscape of interventional care. Whether due to surgery or trauma, burn or biopsy, any hole made in the body must be properly sealed and managed. Customers desire a democratic, multipurpose technology to seal and protect that hole without interfering with normal healing.

While surgeons and trauma care providers have available products to stop bleeding, they are often “me-too” products that are largely variations on relatively narrow and very old themes or classes. These possess significant drawbacks. The underlying technologies confer inherent performance limitations, with implications for the surgeon and the patient.

Drawbacks of these products can include a combination of the following:

  1. Unreliable, slow onset of action
  2. Does not stop bleeding
  3. Foreign body reaction, adhesion, granuloma formation, delayed healing
  4. Infection
  5. Difficult to prepare and use
  6. Intact clotting cascade required
  7. Animal/human sourcing
  8. Must be kept dry or wet surface causes poor performance
  9. Removal required
  10. External application only
  11. Toxicity potential
  12. Narrow indications
  13. Glue-like

Competitive Limitations

CategoryCompositionDrawbacksProducts
Fibrin/Thrombin,
Collagen/Gelatin
Proteins mostly from
animal or human
  • Unreliable, slow onset of action
  • Foreign body reaction, adhesion, infection
  • Difficult to prepare and use
  • Intact clotting cascade required
  • Animal/human sourcing
Tisseel, Evicel,
Evithrom, Thrombin,
SurgiFoam, Floseal,
Avitene, Cellerate
Cellulose/polymer hydrogels Plant cellulose,
Polymer hydrogels
  • Unreliable
  • Granuloma
  • Poor adhesion and clotting
Surgicel
Others
Desiccants/Concentrators Clay, chitin, starch
powders
  • Must be kept dry
  • Removal required
Perclot
QuikClot -Field trauma
Of Peripheral Interest:
Cyanoacrylates Cyanoacrylates
  • Wet surface poor performance
  • External application; Toxicity potential
  • Does not stop bleeding
Dermabond
Omnex
Neucrylate
PEG Polyethylene Glycol
  • Wet surface poor performance
  • Delayed healing
  • Narrower indication
Duraseal
Coseal
RTP