Stem Cell Stock Alert: BioRestorative Therapies (OTCBB: BRTX) Provides Company Updates with Shareholder Letter

JUPITER, Fla. - August 1, 2013 (Investorideas.com Newswire) BioRestorative Therapies Inc. ("BRT" or the "Company") (OTCQB: BRTX), a life sciences company focused on stem cell-based therapeutics, today announced the issuance of a shareholder letter by Chief Executive Officer, Mark Weinreb, providing an update to shareholders on the Company's progress.

The shareholders were advised as follows:
Over the past 12 months, BRT's substantial investment in research and development has allowed the Company to continue executing on its growth strategy. There have been many developments, both operationally and scientifically, that have positioned the Company well as a growing stem cell biotechnology company with a specific focus on cellular treatments and therapies for certain medical applications.
Below are some of the Company's accomplishments and activities over the past 12 months:

• In the latter part of 2012, BRT appointed Wayne A. Marasco, M.D., Ph.D. as Chairman of its Scientific Advisory Board. Dr. Marasco currently serves as an Associate Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute. He is head of Marasco Labs, an accomplished research laboratory at Dana-Farber Cancer Institute known for discovery and therapeutic human monoclonal antibody development and for constructing and validating various human-mouse chimeric models in the area of cancer, infectious disease immunotherapy, regenerative medicine and tissue engineering. Dr. Marasco is a Principal Faculty Member of the Harvard Stem Cell Institute and has extensive experience in the field of stem cells.
• Late last year, the Company announced that its common stock had begun trading on the OTC Bulletin Board. The company went through a very thorough and diligent review process by FINRA to attain the Bulletin Board listing. The Bulletin Board trading platform allows for more potential investors interested in purchasing the Company's stock. The Company is extremely pleased to provide investors increased visibility and transparency that this regulated quotation service provides.
• In late November, BRT launched its new website available at www.biorestorative.com. The new site highlights the Company as an innovator and pioneer in the adult stem cell industry. The Company's primary programs are highlighted in more detail on the website, along with rich imagery and information about therapies being developed.
• At the start of 2013, the Company was invited to present at the Adipose Tissue Biology conference of the Keystone Symposia conference series. Chief Scientist and Vice President of Research and Development, Francisco Silva, presented the Company's research on "Human Metabolically Active Brown Adipose Tissue Derived Stem Cells." This research is a result of the scientific work the Company has been performing pursuant to its ThermoStem® Program, which is in the pre-clinical stage and which focuses on treatments for metabolic disorders (particularly focusing on Type 2 diabetes) and obesity and uses adult derived stem cells from brown adipose (fat) tissue stem cells.
• On April 13th, Dr. Marasco spoke at the Second International Vatican Adult Stem Cell Conference: Regenerative Medicine -- A Fundamental Shift in Science and Culture. The event was held in Vatican City from April 11th to April 13th. Dr. Marasco spoke during the session entitled "Stem Cells, Cancer and Aging — A Search for Solutions." His talk was titled "What Questions Haven't Been Addressed with Respect to Stem Cells, Cancer and Aging?"
• In April, the Company was invited to present at the 5th International Congress on Prediabetes and the Metabolic Syndrome in Vienna, Austria. Mr. Silva presented the Company's research on Human Metabolically Active Brown Adipose Tissue Derived Stem Cells. This research is a result of the scientific work the Company has been performing pursuant to its ThermoStem® Program.
• The Company hired ProActive Capital in mid-April to help increase awareness of the Company among the investment community. ProActive Capital is also helping to increase exposure through the use of social and digital media.
• In mid April, the Company implemented a 1-for-50 reverse stock split which reduced its outstanding shares from 820,641,011 to 16,412,820. 94% of the shares voted were in favor of the proposal. The Company believes the reverse split will help attract a new base of shareholders as well as new institutional and retail support in the market.
• In mid May, the Company signed an agreement with Dexterity, Inc., a product design and bioengineering firm, to further the development and production of its brtxDISC™ (Disc Implanted Stem Cells) stem cell therapy device. This device plays an integral role in delivering stem cells for its proprietary bulging/herniated disc therapy.
• In May, the Company once again presented its investment thesis at the Marcum MicroCap Conference. To listen to the webcast, please visit http://wsw.com/webcast/marcum/brtx. The event hosted nearly 100 publicly traded companies with capitalizations under $500 million and attracted more than 1,000 people, including senior personnel from the presenting public companies, leading institutional investors, directors, bankers and service providers to the microcap marketplace.
• At the end of May, the Company formally launched its "brtx-C Cosmetic" Program. The Company announced that it has developed a human cellular-derived extract that, per initial in vitro studies, when applied to skin cells, appears to cause a significant increase in collagen and fibronectin production (proteins that are essential for combating the aging of skin). The Company plans to conduct additional in vitro studies to better understand the extract's mechanism of action and human cellular activity and is actively seeking collaborations with other parties to commercialize the product.
• In mid June, financial personality and founder of NBT Equities Research, Tobin Smith, interviewed CEO Mark Weinreb with regard to the Company's hybrid business model and what it is currently doing that will help change the biotechnology landscape. Click here for the full interview: http://direct.nbtequitiesresearch.com/video/nbt-biorestorative-1
• In late June, the Company expanded its ThermoStem® Program by collecting 150 samples of human brown adipose tissue. This strengthens its R & D platform for the development of treatments for metabolic disorders and obesity. For the past year, through strategic collaboration and internal efforts, the Company has grown a large library of human brown fat stem cells. The compilation of a large number and variety of brown fat derived stem cells allows it to study and identify potential cell lines to be used in developing therapies.
• In mid July, the Company was featured in the industry publication, "The Life Sciences Report." In the interview included in the report, CEO Mark Weinreb described how the Company's cell therapy process could possibly keep disc disease treatment out of the operating theater. Link to full interview: http://www.thelifesciencesreport.com/pub/na/15470
• Since 2011, the Company has raised approximately $9 million, which has enabled it to achieve clear milestones as it continues to build momentum on its growth strategy.

"Based on these accomplishments, we are excited for what lies ahead in the near and long term," states CEO Mark Weinreb. "We continue to make speedy and efficient progress with our programs and look forward to further advancements regarding each of our exciting initiatives. I would like to thank all of our shareholders for their continued support. We will continue to work diligently to further execute our growth plan so that BioRestorative Therapies will be able to mature into a prominent life sciences company."
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. ("BRT"), www.biorestorative.com, develops medical procedures using cell and tissue protocols, primarily involving adult stem cells, designed for patients to undergo minimally invasive cellular-based treatments. BRT is developing the following scientific initiatives:

• brtxDISC™ Program (Disc Implanted Stem Cells), a non-surgical treatment for bulging and herniated discs that addresses the gap between non-invasive and invasive back procedures. This research is still in the non-clinical, investigational stage.
• ThermoStem® Program, a treatment for metabolic disorders (diabetes, heart disease, etc.) and obesity using brown fat stem cells. Initial non-clinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels in the body.
• brtx-C Cosmetic Program, based on the development of a human cellular extract that, per initial in vitro studies, when applied to human skin cells, appears to cause an increase in the production of collagen and fibronectin, which are proteins that are essential to combating the aging of skin. Potential cosmetic uses are being explored with third parties.

The Company also offers plant stem cell-based facial creams and beauty products under the Stem Pearls® brand at www.stempearls.com.
This press release and the interview contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
Investor Contact:
Adam Holdsworth
ProActive Capital
646.862.4607
adamh@proactivecapital.com
Media Contact:
Sandra Lee
ProActive Capital
646.862.4608
slee@proactivecapital.com
Disclaimer /Disclosure: The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk.
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This site is currently compensated by featured companies, news submissions and online advertising. Disclosure: BioRestorative has compensated Investoridea for a six month news program ( five thousand ) to be published on Investorideas.com newswire and syndication and social media partners.
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894

Stem Cell Stock Alert: BioRestorative Therapies (OTCBB: BRTX) CEO Mark Weinreb Interviewed by The Life Sciences Report

SAN FRANCISCO, CA - July 25, 2013 (Investorideas.com Newswire) "Millions of people suffer back pain caused by herniated and bulging disc disease. When conventional medical therapies fail, they often resort to surgery for relief, a costly and time-consuming solution for both patients and the medical system. In this interview with The Life Sciences Report, Mark Weinreb, president, CEO and chairman of BioRestorative Therapies Inc. (OTCQB: BRTX), describes how his company's cell therapy process could keep disc disease treatment out of the operating theater.

The Life Sciences Report: Mark, what disease indication are you exactly going after for patients suffering with back pain?
Mark Weinreb: We have developed a novel cellular therapy and therapeutic delivery device for the treatment of bulging and herniated disc disease. We believe we can effectively and safely treat patients using a nonsurgical, minimally invasive procedure that can be performed routinely in a physician's office. This technology could effectively bridge the gap between noninvasive and surgical back procedures. There are at least one million people, annually, in the U.S. who could benefit from this type of procedure with the promise of avoiding surgery. We elected to pursue this market because of the early success we have seen in several patients who have received this treatment.
TLSR: Can you very briefly describe the technology?"
Continue reading this interview with Mark Weinreb: "BioRestorative Therapies Inc. Develops Plug-and-Play Therapy for Bulging and Herniated Disc Disease."
Read more about cell therapy and BioRestorative Therapies Inc. in The Life Sciences Report's in-depth interview with Jason Kolbert of Maxim Group: "Is Cell Therapy the 'Future of Medicine'?"
About Streetwise Reports - The Life Sciences Report
Investors rely on The Life Sciences Report to share investment ideas for the biotech, pharmaceutical, medical device, and diagnostics industries. Our exclusive interviews with leading industry experts and analysts provide a clear picture of the causes of macro-economic shifts and the strategies that will help you capitalize on these developing trends. This valuable insight is integrated with in-depth company information, summaries from the latest research and news that will help you make smart investment decisions.
Contact:
Streetwise Reports, LLC - The Life Sciences Report
Brandon Fung
Tel: 707-981-8107
Disclaimer /Disclosure: The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk.
http://www.investorideas.com/About/Disclaimer.asp
This site is currently compensated by featured companies, news submissions and online advertising. Disclosure: BioRestorative has compensated Investoridea for a six month news program ( five thousand ) to be published on Investorideas.com newswire and syndication and social media partners.
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894

Battelle Team (NxStage Medical(NASDAQ: NXTM) and Aethlon Medical (OTCQB: AEMD) Wins DARPA Contract to Build Medical Device to Treat Sepsis

COLUMBUS, OH - July 24, 2013 (Investorideas.com newswire) At Battelle, supporting America's military personnel is woven into the fabric of its business. In that pursuit, a team consisting of Battelle, NxStage Medical (NASDAQ: NXTM), Inc. and Aethlon Medical (OTCQB: AEMD) has won a contract from the Defense Advanced Research Projects Agency, or DARPA, to develop an innovative, new medical device that may save the lives of soldiers -- and civilians as well -- by treating sepsis.

The problem to be confronted is more severe than is commonly known -- as many as 10 percent of combat wounds result in life threatening infections that ultimately lead to septicemia and/or sepsis. "This device could not only save many of our soldiers' lives, it could be profoundly important in saving thousands of civilian lives each year in the United States alone," said Martin Toomajian, President of Battelle Energy, Health and Environment.
DARPA created the Dialysis-Like Therapeutics (DLT) program to develop a portable device that creates a holistic treatment for sepsis. The device is intended to remove blood from the body, separate harmful "dirty" agents from the blood and return "cleaned" blood to the body in a manner similar to dialysis treatment for kidney failure. DARPA has made significant investments in its DLT effort to date to multiple contractors for the development of key blood purification and diagnostic technologies that could contribute to the ultimate device.
This contract -- which is funded in phases and could be as large as $22.83 million and last as long as four years -- is for leading one of DARPA's DLT System Integration projects. The project calls for Battelle and key subcontractors, NxStage and Aethlon, to design, develop, test and validate an advanced, portable medical device that exhibits the technical innovation for which DARPA projects are known, and to coordinate integration of key technologies developed during the overall DLT program. This funding does not include human clinical trials that may be required prior to military use and/or United States Food and Drug Administration clearance for sepsis-treatment technologies.
Beyond the military need for sepsis therapies, the DLT device may play an important role in saving the lives of civilian patients, as infection leading to sepsis is a significant cause of mortality. When sepsis is complicated by shock, approximately half of patients do not survive for 30 days, even if effective antibiotics are used.
Because of the interdisciplinary nature of the program, it will draw experts from many scientific and engineering segments at Battelle and its development team members. "This program will utilize a highly diverse set of resources, ranging from medical device design to biological testing to meeting the exacting needs of the military-medical environment," said Steve Kelly, President of Battelle National Security. "Battelle is exceptionally qualified, together with the collaboration of NxStage and Aethlon, to bring the necessary diversity of expertise to this complex program."
Battelle will lead a project team focusing on military user needs, systems engineering, integration of DLT technologies and pre-clinical testing. Working closely with Battelle, NxStage will design, develop and ultimately manufacture and distribute the medical device upon regulatory approval. Aethlon is developing and plans to distribute key blood separation component technologies for the DLT system.
"NxStage is pleased to be chosen as part of this team based upon our recognized expertise in developing and commercializing innovative, portable technology for the purification of blood, which includes use of the System One in the military environment," said Jeffrey H. Burbank, Chief Executive Officer of NxStage Medical, Inc. "We are confident that our leadership in device design will lead to a good outcome for this important DARPA project, ultimately benefitting military personnel and civilians alike."
"We are honored to be part of the DLT System Integration team and appreciate the continued opportunity to innovate an effective therapeutic solution to address sepsis," said Aethlon Medical Chairman and CEO Jim Joyce. Aethlon is the previous recipient of a $6.8 million DARPA DLT contract.
About Battelle
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.
About NxStage Medical, Inc.
NxStage is a medical device company, headquartered in Lawrence, MA, USA, which develops, manufactures, and markets innovative systems for the treatment of end-stage renal disease (ESRD), and acute kidney failure. The System One™ home hemodialysis device developed by NxStage is the only FDA approved portable hemodialysis machine cleared for home use. For more information on NxStage, or NxStage® products, visit http://www.nxstage.com.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices that provide rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, the Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
For more information contact
Katy Delaney
(614) 424-7208
T.R. Massey
(614) 424-5544
Published at Investorideas.com newswire
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Medical Technology Stock Trading Alert: Aethlon Medical (OTCQB: AEMD) Gains 16%

Point Roberts, WA, New York, NY - July 22, 2013 (Investorideas.com newswire) Investorideas.com, an investor research portal specializing in investing ideas in leading sectors including biotech and medical technology stocks, issues a trading alert for Aethlon Medical, Inc. (OTCQB: AEMD), The stock is trading at $0.13, gaining 0.0180 or 16.07% 10:30AM EDT on over 460,000 shares.

Last week Brian Marckx, CFA from Zacks Small Cap Research Issued an updated on the company entitled, “AEMD: Recent Progress Helps De-Risk Aethlon” and increased his price on the stock.
The company also recently reported FDA approval of an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the United States. The Hemopurifier ® is a first-in-class medical device that targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
Under the feasibility study protocol, Aethlon will enroll ten end stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease conditions.
Full Zacks research news: http://finance.yahoo.com/news/aemd-recent-progress-helps-risk-110000781.html
About Aethlon Medical (OTCQB: AEMD)
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT product pipeline includes the Aethlon Hemopurifier to address infectious disease and cancer, and a medical device being developed under a 5-year contract with DARPA to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
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Research Alert: Zacks Small Cap Research Increases Price Target for Aethlon Medical (OTCQB: AEMD)

Point Roberts, WA, New York, NY - July 19, 2013 (Investorideas.com newswire) Investorideas.com, an investor research portal specializing in investing ideas in leading sectors including biotech and medical technology stocks, issues a research alert for Aethlon Medical, Inc. (OTCQB:AEMD), Yesterday Brian Marckx, CFA from Zacks Small Cap Research Issued an updated on the company entitled, “AEMD: Recent Progress Helps De-Risk Aethlon.” In his report he noted, “based on our DCF model AEMD is valued at about $0.15/share."

The company recently reported that the FDA has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the United States. The Hemopurifier ® is a first-in-class medical device that targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
Under the feasibility study protocol, Aethlon will enroll ten end stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease conditions.
Excerpt from Zacks Small Cap Research, Brian Marckx, CFA:
Since initiating coverage of Aethlon Medical back in March 2012 we listed several risks and concerns, some of which we felt precluded us from assigning a reasonable value on the company. Among the greatest concerns, which we felt had the potential to essentially stop the company in its tracks, were AEMD's outstanding and non-performing debt as well as the real uncertainty of whether FDA would ever green-light the company to run U.S. human trials. And while the debt issue remains an overhang, we feel that the company's success in continuing to raise financing (particularly financing that is subordinate to the debt) and ongoing progress with converting some debt to equity, provides us much more comfort that their still tattered balance sheet can continue to meaningfully improve. We also view, as we explain below, the IDE approval as major positive and while this does not necessarily get the company substantially closer to eventual U.S. commercialization, it removes the most near-term hurdle that AEMD had to clear for that to happen and one that had it not happened, in our opinion could have doomed the company.
For those reasons, we now feel the company's future is less uncertain (or near-term risks are at least meaningfully mitigated) and believe it's now appropriate to use a discounted cash flow model to value the company. We continue to expect somewhat insignificant revenue in the near-to-mid term, largely from the DARPA contract and the subcontract with Battelle. We also think there may be a small revenue contribution from compassionate use of Hemopurifier in India. But, as we noted in our previous updates, a favorable decision by the FDA on the IDE application to begin <_st13a_country-region _w3a_st="on"> U.S. studies would potentially provide some upside to our current financial estimates over the longer term. We have now built a 10-year DCF model through fiscal 2024. Our relatively lofty 15% discount rate is appropriate given our remaining concerns, and risks and hurdles that company will need to clear as well as the potentially lengthy runway until AEMD begins to generate meaningful commercial sales, which we still believe is contingent on launching Hemopurifier in the <_st13a_country-region _w3a_st="on">U.S. Based on our DCF model AEMD is valued at about $0.15/share. We are maintaining our Neutral recommendation. We feel that continued progress in hitting operational and financial milestones would provide additional de-risking and potentially further upside to the value of the company.
Full Zacks research news: http://finance.yahoo.com/news/aemd-recent-progress-helps-risk-110000781.html
About Aethlon Medical (OTCQB: AEMD)
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT product pipeline includes the Aethlon Hemopurifier to address infectious disease and cancer, and a medical device being developed under a 5-year contract with DARPA to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
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Medical Technology Stock Breaking News: Aethlon Medical (OTCQB: AEMD) Recent Progress Helps De-Risk Aethlon

July 18, 2013 (Investorideas.com newswire) We have updated our report on Aethlon Medical (OTCBB:AEMD) for their 10-K filing as well as other recent events. See below for access to the full report.

10-K Filed for Fiscal 2013 (ending 3/31/2013)
Aethlon (AEMD) filed their 10-K for the fiscal year ending 3/31/2013 on July 15th. Results (excluding non-cash change in derivative liability expense) remain very much in-line with our estimates. AEMD booked $404k in DARPA contract revenue in Q4 compared to our $380k estimate. Revenue relates to the tenth and eleventh milestones under the DARPA contract (the second and third milestones under the year-2 contract). Subsequent to (in April 2013) the end of fiscal 2013 AEMD booked another $196k related to the twelfth milestone.
These three milestones are (per AEMD's 10-K):
Milestone 2.3.2.1 – Demonstrate the effectiveness of the prototype device in vivo in animals preventing platelet activation or clotting in at least a 2 hour blood pumping experiment at 75 mL/min blood flow. The milestone payment amount was $195,581. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. The prototype device was successfully used in vivo in animals preventing platelet activation or clotting in at least a 2 hour blood pumping experiment at 75 mL/min blood flow. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Milestone M4 – Target capture > 50% in 24 hours for at least 5 targets in blood or blood components. The milestone payment was $208,781. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We demonstrated that we were able to capture > 50% in 24 hours for at least 5 of the agreed targets in blood or blood components. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Milestone 2.3.2.2 (booked in fiscal Q1 2014) – Formulate initial design based on work from previous phase. Begin to build and test selected instrument design and tubing sets. The milestone payment amount was $195,581. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We demonstrated that we had begun to build and test selected instrument design and tubing sets. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Through April 2013 AEMD has booked approximately $2.8 million in DARPA revenue and had approximately $790k remaining to invoice under the year 2 contract. As a reminder, DARPA has the option of entering into the remainder of the proposed contract for years three through five, which would pay Aethlon up to an additional $3.2 million, annual payments under which would range between $775k and $1.6 million.
Q4 operating expenses were $1.3 million, just slightly higher than our $1.2 million estimate. Q4 net income and EPS of ($2.8) million and ($0.02) were below our ($1.0) million and ($0.01) due to a non-cash change in derivative liability expense.
Cash
Aethlon exited fiscal 2013 with $125k in cash and equivalents, compared to $108k at the end of the prior quarter (12/31/2012). Subsequent to fiscal year end the company raised an additional $128k from the sale of equity, entered into $400k in loans from directors of the company and collected $404k from the DARPA contract.
Cash used in operations was $522k in Q4 ($2.1 million in 12 months ending 3/31/13), compared to $662k in Q3 and $1.8 million in fiscal 2012. AEMD continues to be successful in raising operating capital, raising over $2.1 million from the sale of common stock in fiscal 2013.
Along with their ongoing ability to continue to raise operating capital, we have been encouraged, from the standpoint of strengthening their financial position and balance sheet, by the success of converting some of their outstanding debt to stock. While a substantial portion of debt remains in default, the company continues to make progress on cleaning up their balance sheet, which we view as meaningful from a de-risking perspective. We reiterate, however, as we have in the past, that Aethlon will need to raise a substantial amount of cash, enter into partnering arrangements or score additional valuable contracts/grants in order to complete the recently announced <_st13a_place _w3a_st="on">U.S. safety study and to be able to maintain operations for the longer-term. Nonetheless, we believe management's recent progress should not be marginalized.
Using DCF To Value AEMD
Since initiating coverage of Aethlon Medical back in March 2012 we listed several risks and concerns, some of which we felt precluded us from assigning a reasonable value on the company. Among the greatest concerns, which we felt had the potential to essentially stop the company in its tracks, were AEMD's outstanding and non-performing debt as well as the real uncertainty of whether FDA would ever green-light the company to run U.S. human trials. And while the debt issue remains an overhang, we feel that the company's success in continuing to raise financing (particularly financing that is subordinate to the debt) and ongoing progress with converting some debt to equity, provides us much more comfort that their still tattered balance sheet can continue to meaningfully improve. We also view, as we explain below, the IDE approval as major positive and while this does not necessarily get the company substantially closer to eventual U.S. commercialization, it removes the most near-term hurdle that AEMD had to clear for that to happen and one that had it not happened, in our opinion could have doomed the company.
For those reasons, we now feel the company's future is less uncertain (or near-term risks are at least meaningfully mitigated) and believe it's now appropriate to use a discounted cash flow model to value the company. We continue to expect somewhat insignificant revenue in the near-to-mid term, largely from the DARPA contract and the subcontract with Battelle. We also think there may be a small revenue contribution from compassionate use of Hemopurifier in India. But, as we noted in our previous updates, a favorable decision by the FDA on the IDE application to begin U.S. studies would potentially provide some upside to our current financial estimates over the longer term. We have now built a 10-year DCF model through fiscal 2024. Our relatively lofty 15% discount rate is appropriate given our remaining concerns, and risks and hurdles that company will need to clear as well as the potentially lengthy runway until AEMD begins to generate meaningful commercial sales, which we still believe is contingent on launching Hemopurifier in the U.S. Based on our DCF model AEMD is valued at about $0.15/share. We are maintaining our Neutral recommendation. We feel that continued progress in hitting operational and financial milestones would provide additional de-risking and potentially further upside to the value of the company.
FDA Grants IDE, Approving Human Study With Hemopurifier
After a years-long quest, Aethlon Medical (AEMD) cleared what we view as a major milestone, announcing in late June that they received IDE approval to initiate a human feasibility study with Hemopurifier. Whether FDA would approve an IDE was an ongoing question in our mind and, given that such an approval would be required as a first step towards potential U.S. commercialization (where we believe the bulk of potential opportunity lies) of the device, was something that could have been highly detrimental to AEMD had FDA denied the IDE request.
As a reminder, in early January 2013 AEMD announced that they submitted an IDE to the FDA seeking approval to commence a 10-patient safety and effectiveness feasibility study of Hemopurifier. Included in the submission was data from the recent and ongoing studies at hospitals in India as well as HCV capture data, the latter which that the FDA had requested at a pre-IDE meeting in 2011. Then in late-March, following response from FDA which included comments and study design considerations, AEMD resubmitted the IDE.
FDA subsequently communicated that they were withholding clearance of the IDE until AEMD addressed the agency's safety concern, namely that the company detail their training and monitoring procedures for heparinization - the anticoagulant used during dialysis and with the Hemopurifier. AEMD noted in early May that they were gathering the requested information and expected to have it submitted to FDA in the coming week (i.e. - by mid-May). Given this recent news of the approved IDE, FDA's safety concerns have clearly been satisfied.
The feasibility study will enroll 10 end stage renal disease patients infected with HCV to demonstrate safety of Hemopurifier therapy. The patients, which must not have received any HCV drug therapy for at least the preceding 30 days, will receive three treatments of standard dialysis in the first week (i.e. - control phase), followed by a total of six dialysis treatments using Hemopurifier over the next two weeks. The rate of adverse events during the control and Hemopurifier treatments will be compared. Viral load changes will also be measured in order to provide an indication of efficacy. AEMD also notes that they may also collect HCV capture data (another efficacy metric with positive results in trials in India and which FDA had previously indicated interest in). AEMD had previously announced that the study is expected to be conducted by the Renal Research Institute, a partnership between Fresenius Medical Care (FMS), a leader in dialysis products and services, and <_st13a_placename _w3a_st="on">Beth Israel Medical Center in NYC. AEMD is now in the process of preparing for the study.
Assuming positive results, the expectation is this will lead to larger U.S. studies to support an eventual FDA approval filing. And while we do not expect U.S. commercialization to be a near-term event, IDE approval to conduct human studies is a huge positive, meaningful hurdle that's now cleared and significantly increases the likelihood of initiation of larger studies to support an eventual FDA filing.
Cancer / Infectious Disease Presentation
Dr. Annette Marleau, AEMD's Director of Tumor Immunology, made a poster presentation titled, "Extracorporeal Exosome Removal: A Therapeutic Strategy to Address an Evolutionary Survival Mechanism Shared by Cancer and Infectious Viral Pathogens" in April at the 2013 International Society of Extracellular Vesicles conference in Boston.
The presentation addressed cancer-secreted exosomes and the role these exosomes play in cancer progression. Aethlon's Hemopurifier directly targets exosomes in infectious diseases and is also being investigated to target cancer-secreted exosomes, something that current cancer drugs fail to sufficiently address. Pre-clinical studies with the Hemopurifier have shown that it can capture exosomes of various cancers including breast, melanoma, ovarian and colorectal.
While cancer currently remains somewhat of a back-burner application for AEMD, the company has been fairly active in pursuing additional research into the role Hemopurifier could play in cancer therapy. Aethlon's focus with cancer had until recently been mostly in the treatment of HER2 breast cancer, although they are also seriously looking at other cancers including melanoma, ovarian, colorectal and lymphoma as they believe their device could also have potential utility with targeting different pathogens and with treating other types of tumors. In particular and based on recent research, melanoma may hold promise for treatment with the Hemopurifier which Aethlon may also pursue in the near future. Furthering AEMD's quest towards application of Hemopurifier in treatment of cancers, in October 2012 the company announced that a U.S. patent was issued to them entitled "Extracorporeal Removal of Microvesicular Particles" which gives AEMD the exclusive right to remove immune suppressive microvesicular particles, which include but are not limited to exosomes from the circulation of treated patients.
Relative to melanoma Aethlon noted in a press release in June 2012 that based on findings from a study led by Cornell University and published in the (online version) journal Nature, that the company may pursue a melanoma treatment study that has been proposed by a (unnamed) U.S. cancer research institute.
The Cornell study found that exosomes released by melanoma cancer cells facilitated the spread of the disease throughout the body and to other organs and bones. There was also a predictive relationship between exosome levels and severity of cancer with late-stage (IV) patients presenting with much greater exosomes levels compared to earlier stage patients. This indicates that removal of exosomes from circulation could reduce progression of the deleterious effects of melanoma to other parts of the body and potentially improve patient outcomes. Aethlon has previously demonstrated in pre-clinical testing that their Hemopurifier can capture exosomes from patients with late stage melanoma.
Melanoma, the incidence of which is growing rapidly, is the most deadly form of skin cancer, accounting for approximately 4% of all skin cancer cases. Melanoma can be lethal, especially if it penetrates the lowest skin layer and enters the lymph system. Statistics show that five-year survivability is as high as 97% if melanoma if diagnosed and treated at its earliest stage (IA) but this drops precipitously as the disease progresses. As such, a device that could effectively treat these late-stage melanoma patients would have massive appeal, not just in the U.S. but worldwide.
As a melanoma study is still in the early proposal stage and Aethlon remains focused on the near-term opportunities with HCV and the DARPA contract, management does not currently have a timeline when a melanoma or other cancer study may commence. This proposed melanoma study could potentially speed Aethlon's cancer program along, although still likely to be more of a back-burner application as Aethlon pursues their near-term endeavors. Nonetheless, we view this as a positive development, potentially offering another opportunity for Aethlon and their Hemopurifier.
In September 2012 AEMD made a presentation at the MD Anderson Cancer Center in Houston entitled, "The extracorporeal removal of tumor-secreted exosomes: An adjunct strategy to reverse immune suppression and inhibit metastases in melanoma". The presentation focused on the potential of the Hemopurifier to be combined with chemo and immunotherapies as a strategy to improve melanoma treatment outcomes.
Battelle Subcontract
In mid-April AEMD announced that they have been selected as a subcontractor by Battelle Memorial Institute under Battelle's $22.8 million systems integrator contract with DARPA related to the sepsis DLT program. The systems integrator is responsible for integrating the various component technologies developed under the DLT program by the various participating organizations, including AEMD. The contract will pay AEMD on a cost (time and materials) plus margin basis so the total that AEMD will eventually bill will not be known until their work is completed. AEMD noted that they began work on this subcontract in early April.
AEMD's Bioterror Program Potentially Revitalized
Another somewhat back-burner application for AEMD's technology has been bioterrorism. Earlier in vivo studies conducted by Aethlon and in conjunction with other organizations, including the Centers for Disease Control and Prevention (CDC), have shown the Hemopurifier was able to rapidly clear viral particles and remove glycoproteins in cell cultures fluids. Pre-clinical studies have shown success with the capture of several Category A (i.e. most serious) pathogens including the Ebola virus, Dengue virus, Lassa virus, West Nile virus, Monkeypox virus, H5N1 Avian flu virus and the H1N1 Swine flu virus.
Aethlon, in collaboration with the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and other organizations, have worked in the past to validate Hemopurifier for use against Category A threats. Studies have yet to move forward, however - possibly as enrolling for a trial with Ebola infected patients would present serious challenges. As a result, Aethlon's bioterror program had been in somewhat of a holding pattern.
AEMD's bioterror program could potentially be revitalized, however, and sparked by renewed federal funding for bioterror countermeasures (including medical countermeasures) through the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013. The CBO estimates that $11 billion will be spent on PAHPRA from 2014 to 2018. Included in the scope of the program is countermeasures against the new strains of bird flu. Given Hemopurifier's success in pre-clinical studies in capturing the H5N1 Avian flu virus and the H1N1 Swine flu virus, AEMD may be in a solid position to pursue any grant funding targeting the new strains of bird flu.
A copy of the full research report can be downloaded here >> Aethlon Medical Report
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Medical Technology Stock Breaking News: Aethlon Medical (OTCQB: AEMD) Announces the Appointment of Chetan S. Shah, M.D. to its Board of Directors

SAN DIEGO - July 12, 2013 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCQB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today announced the appointment of Chetan S. Shah, M.D. to its board of directors. "We are honored to have Dr. Shah join our board. His wealth of medical and business experience will be instrumental in guiding the future growth and achievement of our organization," stated Aethlon Chairman & CEO Jim Joyce.

Dr. Shah is a board certified Otolaryngologist. He is an Advisory Board Member at The Bank of Princeton, and a founder, partner and Board member of the Surgery Center at Hamilton as well as Physician Management Systems and Princeton Eye & Ear. Dr. Shah serves on the board of two other private companies. He holds teaching positions and serves on multiple hospital committees in the area and is on the Audiology and Speech Language Pathology Committee for the State of New Jersey. Dr. Shah received his Bachelor's degree and Medical Degree from Rutgers University and Robert Wood Johnson Medical School.
"Aethlon Medical's Hemopurifier® is first in class therapeutic device that is a game changer in both the infectious as well as cancer treatment regimen. As a physician, I am excited at the prospect of being able to help millions of patients worldwide. As a director, I look forward to building value for all who have patiently supported the company over the past decade," stated Dr. Shah.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com newswire
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