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5		-= Paragraph 1 =
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7	7	Tenax Therapeutics was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. Effective June 30, 2008, the company changed the domiciliary state of the corporation to Delaware and changed the company name to Oxygen Biotherapeutics, Inc. On September 19, 2014, the company changed the company name to Tenax Therapeutics, Inc.
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15	15	For comparative purposes, an unaudited consolidated statement of operations and comprehensive loss has been included for the year ended December 31, 2015 and for the eight month period from May 1, 2014 to December 31, 2014. The financial information for the year ended December 31, 2015 and the eight months ended December 31, 2014 has not been audited and is derived from its books and records. In the opinion of management, the financial information for the year ended December 31, 2015 and the eight months ended December 31, 2014 reflects all adjustments necessary to present the financial position and results of operations in accordance with generally accepted accounting principles. Prior to the year-end change, its fiscal year ended on April 30 of each year.
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17		-==== Business Strategy ====
	17	+= Business Strategy =
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19	19	The company's principal business objective is to identify, develop, and commercialize novel therapeutic products for disease indications that represent significant areas of clinical need and commercial opportunity. The key elements of its business strategy are outlined below.
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27	27	Enter into licensing or product co-development arrangements in certain areas, while out-licensing opportunities in non-core areas. In addition to its internal development efforts, an important part of its product development strategy is to work with collaborators and partners to accelerate product development, reduce its development costs, and broaden its commercialization capabilities. The company believe this strategy will help it to develop a portfolio of high quality product development opportunities, enhance its clinical development and commercialization capabilities, and increase its ability to generate value from its proprietary technologies.
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29		-==== The company's Current Programs ====
	29	+= Current Programs =
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31		-**Levosimendan Background**
	31	+== Levosimendan Background ==
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33	33	Levosimendan was discovered and developed by Orion Pharma, a Finnish company. Levosimendan is a calcium sensitizer/K-ATP activator developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in over 60 countries for this indication and not available in the United States or Canada. It is estimated that to date over 1,000,000 patients have been treated worldwide with levosimendan.
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45	45	The European Society of Cardiology, or the ESC, recommends levosimendan as a preferable agent over dobutamine to reverse the effect of beta blockade if it is thought to be contributing to hypotension. The ESC guidelines also state that levosimendan is not appropriate for patients with systolic blood pressure less than 85mmHg or in patients in cardiogenic shock unless it is used in combination with other inotropes or vasopressors.
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47		-**Levosimendan Development for Cardiac Surgery Patients**
	47	+== Levosimendan Development for Cardiac Surgery Patients ==
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49	49	Levosimendan is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of LCOS. As noted above, Tenax Therapeutics has the exclusive rights in the United States and Canada to develop and commercialize intravenous levosimendan.
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82	82	Notwithstanding the fact that the trial’s primary endpoints were not statistically significant, and given the statistically significant reductions in the secondary endpoints, the company continue to believe levosimendan is an effective and safe inotrope to increase cardiac output in patients at risk for or with perioperative low cardiac output. Following the announcement of the Phase III LEVO-CTS top-line results, the company held a meeting with the FDA to review the preliminary trial data and discuss a path forward to file a NDA for levosimendan. As a follow-up to this meeting, a pre-NDA meeting has been scheduled with the FDA in the second quarter of 2017 to discuss the data that supports the approval of levosimendan for acute decompensated heart failure. The FDA may not approve levosimendan for this or any other indication, and if Tenax Therapeutics is unable to obtain regulatory approval, the company will be unable to commercialize levosimendan in the U.S.
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84		-**Levosimendan Development for Septic Shock Patients**
	84	+== Levosimendan Development for Septic Shock Patients ==
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86	86	Septic shock is a serious life-threatening condition with high unmet medical need. Small clinical studies suggest that levosimendan may provide important benefits to septic shock patients in the form of improved cardiac function, renal function, organ perfusion, and mitochondrial function. The company announced a collaboration with Imperial College London in August of 2014 which provided supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). The LeoPARDS trial was designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile.
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88	88	On October 5, 2016, Anthony Gordon, M.D., Chair in Anaesthesia and Critical Care, Imperial College London, presented results from the LeoPARDS trial evaluating levosimendan in septic shock at the 29th Annual Congress of the European Society of Intensive Care Medicine (ESICM), held in Milan, Italy. Results presented by Dr. Gordon show that the levosimendan treatment arm did not achieve the trial’s primary endpoint of reducing the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as the pre-specified secondary endpoints. Based upon these results seen, the company do not anticipate undertaking further development with levosimendan in the septic shock indication.
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90		-**Other Products**
	90	+== Other Products ==
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92	92	In addition to levosimendan described above, Tenax Therapeutics has previously developed Oxycyte, a PFC-based oxygen carrier, its Dermacyte® line of topical cosmetic products, which contained its PFC technology and other known cosmetic ingredients to promote the appearance of skin health and other desirable cosmetic benefits, as well as Wundecyte™, a novel gel developed under a contract agreement with a lab in Virginia that was designed to be used as a wound-healing gel. As Tenax Therapeutics has suspended the development of these PFC products while the company evaluate strategic alternatives, the company do not expect that Oxycyte, Dermacyte or Wundecyte constitute a material portion of its business going forward.
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94		-**Suppliers**
	94	+== Suppliers ==
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96	96	Pursuant to the terms of its license for levosimendan, Orion Corporation is its sole manufacturing source for levosimendan.
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98		-**Intellectual Property**
	98	+== Intellectual Property ==
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100	100	The company rely on a combination of patent applications, patents, trade secrets, proprietary know-how, trademarks, and contractual provisions to protect its proprietary rights. The company believe that to have a competitive advantage, the company must develop and maintain the proprietary aspects of its technologies. Currently, the company require its officers, employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, and other advisors to execute confidentiality agreements in connection with their employment, consulting, or advisory relationships with it, where appropriate. The company also require its employees, consultants, and advisors who the company expect to work on its products to agree to disclose and assign to it all inventions conceived during the work day, developed using its property, or which relate to its business.
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118	118	* use of levosimendan in patients undergoing cardiac surgery.
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120	120	Tenax Therapeutics has received U.S. trademark registrations for Oxycyte®. Simdax® is owned by Orion and is licensed to it for sales and marketing purposes in the United States and Canada.
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