We would like to reassure each of our business partners that Celox products are both safe and effective. It has come to our attention that sales people for a competitor have made many misleading and false claims against Celox products during discussions with our partners, including on 22 May 2016, at the biannual meeting of the Committee for Tactical Emergency Casualty Care in Charlotte, NC.
The theme of this competitor’s misleading campaign is that Celox Rapid contains ingredients used in diapers that are unknown and/or dangerous. These statements are simply false.
Let us reassure you Celox Rapid is Safe & Effective. It contains only substances that the FDA considers safe for the intended use. Specifically:
1. Celox Rapid is FDA cleared and the safety and toxicology of Celox Rapid has been reviewed and accepted by professionals in the US FDA and approved in Europe by BSI for a class 3 medical devices.
2. It does NOT contain any of the poly acrylic acids (“PAAs”) or superabsorbents that are used in diapers.
3. The bioadhesive ingredient that we do use is a proprietary polymer. It is the part that allows Celox Rapid to work so fast and save you critical minutes in emergency situations. It is a widely used pharmaceutical grade ingredient made by a major global company. It is a well-known and widely used in numerous medical and pharmaceutical products. We use it in small amounts because that’s what gives the best performance.
4. The grade of bioadhesive that makes Celox Rapid so effective is a “NF grade” ingredient. This means it is a tightly controlled material that meets the US national formulary requirements to add to pharmaceuticals. It also has an FDA drug master file that allows its addition to pharmaceuticals.
5. Our competitor’s suggestions about a product that they do not manufacture are simply wrong.
Recently many US Dept of Defence, Allied militaries, and law enforcement organizations have selected Celox, particularly Celox Rapid, over all other hemostatics. This product has gained favour over legacy products because of its high efficacy, rapid treatment time, and cost. We believe Celox Rapid is a superior product and for these compelling reasons we have clearly gained significant market preference. We do understand that our competitors are resistant to this change.
Medtrade and our partners are whole-heartedly dedicated to the people who serve our military and civilian communities. We do not sacrifice our ethics for profits. We take greatest care to ensure our products meet the highest safety standards and we work tirelessly with our partners like you to save lives. We take seriously any false allegations that would result in any loss of confidence to our partners.
Our customers, who sacrifice so much, deserve the very best. So please, if you have any questions at all about our products- do not ask our competitors. Please ask us or our international sales team and we will provide any information you require to select your solutions. We look forward to your continued support and want to outline our stance on our life saving products.
Again let us reassure you Celox Rapid is both Safe & Effective.
Medtrade Team