StopsBleeding TM is registered with The Pharmacy and Poisons Board in Kenya. Overview
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1 StopsBleeding TM is an ISO Certified and FDA approved medical device for control of bleeding in both minor and major lacerations. This is a novel molecule that consists of natural plant based modified amylopectin. StopsBleeding TM promotes coagulation in two ways; it acts as a scaffold and promotes the extrinsic pathway of coagulation and secondly through it's osmotic action which dehydrates the blood thus increases the concentration of coagulation proteins and platelets. StopsBleeding TM is registered with The Pharmacy and Poisons Board in Kenya. Overview StopsBleeding TM is particularly useful in surgical and invasive vascular procedures as an adjunctive or alternate hemostatic agent in the control of bleeding when traditional methods of stopping bleeding (pressure, ligature, heat) is ineffective. StopsBleeding TM is modified amylopectin powder, absorbable, non biological and hypoallergenic, non toxic thus can be left in the body. StopsBleeding TM is particularly effective in control of bleeding when the edges are rough and area of bleeding is broad and should be applied generously. StopsBleeding TM is used for liver and spleen injuries, major vascular (venous and arterial) and accelerates body s natural ability to form a clot in traumatic injuries. StopsBleeding TM requires compression or applying heavy pressure long enough to see the bleeding has stopped for both minor and major injuries. StopsBleeding TM is packed in sterile package which requires NO special storage conditions and can handle extreme temperatures. StopsBleeding TM activates both the intrinsic and extrinsic pathways
2 While control of bleeding from trauma and minor abrasions is the largest use of this product, we want to emphasize that we have completed several preclinical studies with blood thinners and we have been approved for use in patients with blood thinners and coagulopathies. We have a special indication for use in patient with long term deep in dwelling vascular lines. This would encompass an expansive area of medicine including dialysis access, vascular procedures in the fields of cardiology, radiology and neurology. With near complete automation, our price is highly affordable compared to the closest hemostatic agent in the market. Combined with its superior technology and affordable price, we hope to introduce this disruptive technology to the entire world, impacting mankind positively. Below is the summary of the pre clinical study and a link for full study, videos, and press release documents shall be provided. We have published an animal study that shows a transection of the femoral artery in a pig model; all the animals treated with StopsBleeding TM survived while those animals where standard manual compression was utilized died no study gets better than this. Several samples have been used locally by several medical practitioners including surgeons and Obstetrician/Gynecologists. Pig Model: OBGYN: Hemostatic Efficacy of Modified Amylopectin Powder in a Lethal Porcine Model of Extremity Arterial Injury Hemostatic Efficacy of Modified Amylopectin Powder in a Lethal Porcine Model of Extremity Arterial Injury Annals of Emergency Medicine, Volume 53, Issue 6, Pages Michael Kilbourne, Kaspar Keledjian, John R. Hess, Thomas Scalea, Grant V. Bochicchio
3 STUDY: Hemostatic Efficacy of Modified Amylopectin Powder in a Lethal Porcine Model of Extremity Arterial Injury Study objective Rapid hemostasis is crucial in controlling severe extremity hemorrhage. Our objective is to evaluate the hemostatic efficacy of a newly modified amylopectin powder in a model of severe extremity arterial hemorrhage. Methods Anesthetized pigs underwent severe, reproducible femoral artery injuries. Animals were randomized (non blinded) to either modified amylopectin powder (n=10) or standard gauze application (n=6). Each hemostatic agent was applied through a pool of blood with manual compression for 3 minute intervals until hemostasis was achieved. Fluid resuscitation was infused as necessary to reestablish a mean arterial pressure within at least 80% of the preinjury mean arterial pressure if possible. The primary measured outcome was total blood loss. Secondary endpoints were survival, time to hemostasis, resuscitation mean arterial pressure, and resuscitation volume. Results Pretreatment blood losses were similar in both groups. Median (absolute average deviation of the median) post treatment blood loss was significantly less in the modified amylopectin powder group than in the gauze group, 275 (108) ml versus 1,312 (171) ml. Resuscitation mean arterial pressure at 180 minutes after injury was 68% of pre injury mean arterial pressure in the modified amylopectin powder group and undetectable in all control animals. Fluid volume required for resuscitation was 1,962 (258) ml in the modified amylopectin powder group and 2,875 (150) ml in the gauze group. Time to hemostasis was 9.0 (2.1) minutes in the modified amylopectin powder group. Hemostasis was not achieved in any animal in the gauze group. Survival was 100% in the modified amylopectin powder group, whereas no animals survived in the gauze group. Conclusion Modified amylopectin powder demonstrates the ability to control major vascular bleeding in a lethal arterial injury model during a 3 hour period.
4 Testimonials Whatever walks through that door, with SB, I am ready Trauma Surgeon. IRAQ With SB taking care of bleeding in the field is as easy as ABC Paramedic, Texas USA My son Alex was saved from bleeding out after sustaining a deep leg laceration at home. I was lucky I had SB at home. Parent, USA I am amazed by the way SB took care of bleeding in my tumor bed Gyneacologist, INDIA My CT surgeries now require less blood transfusion Cardiothoracic Surgeon, NIGERIA I tried SB and it is amazing Obstetrician/Gynecologist and Fetal Medicine Specialist, KENYA In this tough economy, I finally have an efficacious and truly affordable topical hemostatic agent for my procedures Neurosurgeon, NIGERIA
5 PACKAGE SIZE StopsBleeding TM 20g Recommended for home use and first aid box StopsBleeding TM 60g Recommended for institution use such as hospitals, operating rooms and general us StopsBleeding TM 200g Recommended for mass casualty, trauma centers, Universities and military operations Distributed by: OAKMED LTD, OAKDOOR OFFICE The Office Park, Riverside Drive P.O. Box , Nairobi T: , F: , Mobile: ,
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