Citius Announces Completion of Private Placement Financing

Source:  Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc.,"Citius" (OTCQB: CTXR) today announced that the Company has completed the final phase of its private placement offering of 7.6mm units for net proceeds of $4.1mm dollars. Each unit consists of one share of common stock and one warrant to purchase a share of common stock for $0.60 per share. As a result of the completion of this offering, the Company now maintains 73 million common voting shares outstanding. Citius intends to use the proceeds of this offering for product development and general working capital purposes. 

About Citius Pharmaceuticals, Inc.

Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with primary focus on anti-infectives and adjunctive cancer-care drug products using innovative, patented or proprietary formulations of previously approved pharmaceuticals. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs. By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches.

Citius Pharmaceuticals Completes Acquisition of Leonard-Meron Biosciences

Source:  Citius Pharmaceuticals, Inc.

-Acquisition provides Citius with a phase 3 ready critical care product

-Myron Holubiak appointed as President and Chief Executive Officer of Citius

-LMB's senior executives join Citius and enhance management team

-Merger creates numerous opportunities for growth

Citius Pharmaceuticals, Inc. (OTCQB: CTXR) ("Citius") today announced completion of the acquisition of Leonard-Meron Biosciences, Inc. ("LMB"). Pursuant to the acquisition, Citius acquired all of the outstanding shares of LMB common stock in exchange for shares of Citius common stock.

LMB is a private, late-stage specialty pharmaceutical company focused on the development and commercialization of critical care products with a concentration on anti-infective drugs. LMB's leading drug candidate, Mino-Lok™, is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections ("CRBSIs"). Mino-Lok™ is a patent-protected, novel solution containing minocycline, edetate (disodium EDTA), and ethyl alcohol, which act to break down bacterial biofilm, eradicate the bacteria, provide anti-clotting properties to maintain patency, and salvage the indwelling central venous catheter ("CVC"). Mino-Lok™ is entering phase 3 trials after demonstrating safety in its phase 2b trial conducted at the MD Anderson Cancer Center in Houston. Recently, the U.S. Food and Drug Administration ("FDA") granted a Qualified Infectious Disease Product ("QIDP") designation for Mino-Lok™.  Receiving QIDP designation means that Mino-Lok™ is now eligible for Fast Track designation, Priority Review, and a five-year extension of market exclusivity.  

"Management is excited with the acquisition which has provided us immediate access to Mino-Lok™, a phase 3 ready program in a billion-dollar industry," said Mr. Leonard Mazur, Chairman of the Board of Directors of Citius.  "We are especially pleased with the expansion of our management team to include industry veteran, Mr. Myron Holubiak, who has assumed the position of our Chief Executive Officer and is now directing all of our business and development programs including our prescription hemorrhoid treatment. Mr. Holubiak has an extensive background in pharmaceutical general management, having been president of Roche Labs Inc., and also in a number of related disciplines including health economics, an increasingly important perspective in healthcare today. We are now prepared to seek additional opportunities to expand our product pipeline in critical care and associated treatment areas while conforming to our growth philosophy of developing and introducing drug products that address unmet medical needs and provide cost-effective solutions in today's healthcare world.  We are at the forefront of an exciting time for Citius". 

Prior to the acquisition, Mr. Leonard Mazur was the Chief Executive Officer and Chairman of the Board of Directors of Citius and a principal stockholder of LMB; and, Mr. Myron Holubiak was the President and Chief Executive Officer of LMB, a significant stockholder of LMB, and a director of Citius.  Pursuant to the acquisition, Mr. Holubiak assumed the role of President and Chief Executive Officer of Citius and will continue as a director of Citius, and Mr. Mazur will remain as the Chairman of the Board of Citius.  All key employees of LMB joined the combined company in their respective roles pursuant to the acquisition. 

About Citius Pharmaceuticals, Inc.

Citius is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for healthcare markets where there are unmet needs using innovative, patented or proprietary formulations of pharmaceutical products.  Citius seeks new and expanded indications for previously approved pharmaceutical products as a means to achieving leading market positions or potential market exclusivity.  By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development. We seek to achieve these objectives by utilizing the FDA's 505(b)(2) pathway for our new drug approvals. We believe this pathway is comparatively faster, lower risk and less expensive than the FDA's traditional new drug approval pathway. In addition, we focus on obtaining intellectual property protection with the objective of listing relevant patents in the FDA Orange Book in order to limit generic competition. 

About Leonard-Meron Biosciences, Inc.

LMB is a private, late-stage specialty pharmaceutical company focused on the development and commercialization of critical care products with a concentration on anti-infective drugs. LMB is developing Mino-Lok™, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections that is entering phase 3 trials.  Recently, the FDA granted a Qualified Infectious Disease Product designation for the antibiotic lock solution, Mino-Lok™.  Receiving QIDP designation means that Mino-Lok™ is now eligible for additional FDA incentives in the approval and marketing pathway, including Fast Track designation and Priority Review, and a five-year extension of market exclusivity. 

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute ("NCI"). MD Anderson is ranked number1 for cancer care in U.S. News & World Report's "Best Hospital's" survey. It has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Citius Pharmaceuticals Announces Significant Equity Investment from Chairman and CEO

Source:  Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc.,"Citius" (OTCQB: CTXR) or the "Company", today announced that Chairman and CEO Leonard Mazur has purchased 5 million of its restricted shares from the Company for $3 million dollars.  This substantial investment will enable the Company to continue its development efforts across its product portfolio, and to build the infrastructure necessary to support multiple product development efforts.

"I am extremely excited about the prospects of the Company, and believe that we have a strong portfolio in different, progressive stages of development," said Mr. Mazur. "Going forward, Citius will use the proceeds to assist operations and develop specialty pharmaceuticals that address unmet medical needs. In some cases, we will be the only drug product being developed in its respective area Citius now has the team and the assets in place to execute on our strategic business plan."

About Citius Pharmaceuticals, Inc.

Citius is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets using innovative, patented or proprietary formulations of previously approved pharmaceutical products.  We seek new and expanded indications for previously approved pharmaceutical products as a means to achieving leading market positions or potential market exclusivity.  By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development. We seek to achieve these objectives by utilizing the U.S. Food and Drug Administration's, or FDA's, 505(b)(2) pathway for our new drug approvals. We believe this pathway is comparatively faster, lower risk and less expensive than the FDA's traditional new drug approval pathway. In addition, we focus on obtaining intellectual property protection with the objective of listing relevant patents in the FDA Orange Book in order to limit generic competition.

Citius Pharmaceuticals Signs Letter of Intent to Acquire Leonard Meron Biosciences

Source:  Citius Pharmaceuticals, Inc.

- Merger expands Citius' product portfolio to include a phase 3 ready critical care product

- Addition of accomplished pharma executives enhances management presence

- Merger creates numerous opportunities for growth

Citius Pharmaceuticals, Inc.,"Citius" (OTCQB: CTXR) today announced that the Company has entered into a non-binding letter of intent to acquire all of the outstanding shares of Leonard Meron Biosciences, Inc. (LMB). LMB's lead drug candidate, Mino-Lok™, is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections, or CRBSIs. Mino-Lok™ is a patent-protected, novel solution containing minocycline, edetate (disodium EDTA), and ethyl alcohol, which act to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. Mino-Lok™ is entering phase 3 trials after demonstrating safety in its phase 2b trial conducted at the MD Anderson Cancer Center in Houston. Recently, the U.S. Food and Drug Administration (FDA) granted a Qualified Infectious Disease Product (QIDP) designation for Mino-Lok.  Receiving QIDP designation means that Mino-Lok™ is now eligible for Fast Track designation, Priority Review for development, and a five-year extension of market exclusivity.  The Company believes that the commercial target for Mino-Lok™ represents a significant opportunity in the multi-billion, critical care market.

"We are excited with this merger which we believe will provide us immediate access to Mino-Lok™, a phase 3 ready program in a billion-dollar industry," said Mr. Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals, Inc.  "We are especially pleased with the expansion of our management team to include industry veteran, Mr. Myron Holubiak, who will manage and direct all of our development programs including our prescription hemorrhoid treatment. Mr. Holubiak has an extensive background in pharmaceutical general management, having been president of Roche Labs Inc., and health economics, an increasingly important discipline in healthcare today. After the merger, we will be prepared to seek additional opportunities to expand our product pipeline in critical care and associated treatment areas while conforming to our growth philosophy of developing and introducing drug products that address unmet medical needs and provide cost-effective solutions in today's healthcare world.  We are at the forefront of an exciting time for Citius". 

Closing of the acquisition is subject to due diligence, definitive merger documentation, and closing of additional financing and other customary formalities.  Citius is expected to issue shares of its stock in exchange for shares of LMB in which, after the completion of the transaction, all prior common shareholders of LMB will retain approximately 49% of the common stock in Citius.  Additionally, no preferred shares or notes convertible into common stock will be outstanding in the newly combined company.  Citius will reserve shares for any non-extinguished obligations of LMB at the closing, in the form of warrants and options, and will also assume certain liabilities created in the ordinary course of business.  Mr. Leonard Mazur, Citius' Chief Executive Officer is the Chairman and Principal Stockholder of LMB.  Mr. Myron Holubiak, a director of Citius is currently the President and CEO of LMB and is a significant stockholder of LMB.  Myron Holubiak, CEO of LMB, will assume the role of CEO for the combined company, and Leonard Mazur will assume the role of Chairman of the Board.  All key employees of LMB will also join the combined company in their respective roles. 

About Citius Pharmaceuticals, Inc.

Citius is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets using innovative, patented or proprietary formulations of previously approved pharmaceutical products.  We seek new and expanded indications for previously approved pharmaceutical products as a means to achieving leading market positions or potential market exclusivity.  By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development. We seek to achieve these objectives by utilizing the U.S. Food and Drug Administration's, or FDA's, 505(b)(2) pathway for our new drug approvals. We believe this pathway is comparatively faster, lower risk and less expensive than the FDA's traditional new drug approval pathway. In addition, we focus on obtaining intellectual property protection with the objective of listing relevant patents in the FDA Orange Book in order to limit generic competition. 

About Leonard Meron Biosciences, Inc.

Leonard Meron Biosciences, Inc. (LMB) is a private, late-stage specialty pharmaceutical company focused on the development and commercialization of critical care products with a concentration on anti-infective drugs. The Company is developing Mino-Lok™, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections, or CRBSIs.  Recently, the U.S. Food and Drug Administration (FDA) granted a Qualified Infectious Disease Product (QIDP) designation for the antibiotic lock solution, Mino-Lok.  Receiving QIDP designation means that Mino-Lok™ is now eligible for additional FDA incentives in the approval and marketing pathway, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report's "Best Hospital's" survey. It has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Citius Pharmaceuticals Announces Results from Phase 2a Trial of Hydrocortisone and Lidocaine Combination Cream in Patients with Grade I and II Hemorrhoids

Source:  Citius Pharmaceuticals, Inc.

-- Company advances commercialization of product into $1 billion industry

-- Combination product demonstrates positive directional improvement compared to placebo in Global Score of Disease Severity and the onset of symptom relief

-- Data demonstrate an excellent safety profile

-- Company plans to conduct future studies

Citius Pharmaceuticals,  Inc. (OTCQB: CTXR) today announced top line data from the first Phase 2a clinical trial of hydrocortisone acetate (HC) and lidocaine hydrochloride (L) as single agents and in combination (HC+L)  in patients with grade I and II hemorrhoids.  Citius' hydrocortisone and lidocaine cream is targeting to become the first FDA –approved prescription product to treat hemorrhoids in the U.S.

In this randomized, double blind study of topical formulations of hydrocortisone, lidocaine and hydrocortisone + lidocaine were tested in patients with Grade I and II hemorrhoids.  There have been no historical randomized, placebo-controlled studies of these two drugs used either individually or in combination to treat hemorrhoids.  Therefore, this study's objective was to obtain data to inform the design of future studies.  In this study, 210 patients were treated twice daily for 14-days with either placebo or one of the six active drug treatments (i.e., two concentrations of each HC, L and HC+L).  Patients kept a diary of their symptoms. Additionally, there were 4 physician assessments during which patients were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on the individual signs and symptoms of hemorrhoids such as bleeding, pruritus and overall pain and discomfort, and time to the onset of symptom relief.  

Within the first few days of treatment the highest concentration of the hydrocortisone + lidocaine product was directionally superior to the placebo as measured by the number of subjects experiencing a minimum of 2 levels improvement from baseline according to the GSDS scale.  This study was not powered to obtain statistical significance; however the data suggest that the combination product may also perform better than the HC or L alone.  The trend of HC+L superiority over placebo was also generally consistent for the treatment of individual signs and symptoms of hemorrhoidal disease – bleeding, itching, pain and overall discomfort.  In addition, no safety signal of note was recorded in the trial.      

"We are pleased with the results of this study which was intended to test the hypothesis that a steroid and anesthetic drug combination can be an effective way to reduce the symptoms of hemorrhoids," said Mr. Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals, Inc.  "As expected, the data provides a positive directional signal and also indicate early reduction of symptoms. We look forward to submitting these results to the FDA as we move toward commercialization of our product within this $1 billion market with unmet need. "

About Hemorrhoids

Hemorrhoids are a common gastrointestinal disorder, characterized by itching, pain, swelling   and tenderness and bleeding.  In the U.S., hemorrhoids affect nearly 5% of the population, with approximately 10 million persons annually admitting to having symptoms of hemorrhoidal disease. Of these afflicted persons, approximately one third visit a physician for evaluation and treatment of their hemorrhoids. The data also indicate that for both sexes a peak of prevalence occurs from age 45 to 65 years with a subsequent decrease after age 65. Caucasian populations are affected significantly more frequently than African Americans, and increased prevalence rates are associated with higher socioeconomic status in men but not women. Development of hemorrhoids before age 20 is unusual. In addition, between 50% and 90% of the general U.S., Canadian and European population will experience hemorrhoidal disease at least once in life. Although hemorrhoids and other anorectal diseases are not life-threatening, individual patients can suffer from agonizing symptoms which can limit social activities and have a negative impact on the quality of life.  We believe that currently there are no FDA approved products for the treatment of hemorrhoids. 

About Citius Pharmaceuticals, Inc.

Citius is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets using innovative, patented or proprietary formulations of previously approved pharmaceutical products.  We seek new and expanded indications for previously approved pharmaceutical products as a means to achieving leading market positions or potential market exclusivity.  By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development. We seek to achieve these objectives by utilizing the U.S. Food and Drug Administration's, or FDA's, 505(b)(2) pathway for our new drug approvals. We believe this pathway is comparatively faster, lower risk and less expensive than the FDA's traditional new drug approval pathway. In addition, we focus on obtaining intellectual property protection with the objective of listing relevant patents in the FDA Orange Book in order to limit generic competition.

BioSig Technologies, Inc. (BSGM) Completes Private Placement

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing the PURE EP System, a proprietary platform designed to improve the clinical outcomes of electrophysiology procedures, today announced the Company closed a private placement with net proceeds of $4,504,524. Laidlaw & Co (UK) Ltd. in New York served as the sole placement agent.

The Company issued 3,003,016 common shares at a price of $1.50 per share and a half warrant with a 3-year expiration at a cash exercise price of $1.95.

Kenneth L. Londoner, Chairman, stated, “We are pleased to have closed on this growth capital, which will drive our clinical, technology, and commercialization efforts forward. Our shareholder base has now surpassed 650 shareholders of record and the Company continues to deliver on its milestones as we advance toward commercial launch of the PURE EP System.”

James Ahern, Laidlaw Managing Partner and Head of Capital Markets commented, “Laidlaw has been with BioSig as placement agent since its A round over five years ago and is very pleased with the progression of the technology and management.  Laidlaw looks forward to future milestones and inflection points.”

About BioSig Technologies
BioSig Technologies is a medical device company that is developing a proprietary technology platform designed to improve the $4 billion EP marketplace (1) (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP^™ System.

The PURE EP System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system engineered to assist electrophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the electrophysiologists in identifying ablation targets - areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia).

Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019(1), making it one of the fastest growing medical device segments. Just in the US, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017(2).

BioSig has partnered with Minnetronix on technology development and is working toward a FDA 510(k) clearance for the PURE EP System. The Company has achieved proof of concept validation and tested its prototype at the University of California at Los Angeles (UCLA) Cardiac Arrhythmia Center; and, has performed pre-clinical studies at Mayo Clinic in Minnesota. Additionally, an Advanced Research Program at Mayo Clinic will launch in June 2016. The Company is also collaborating with other prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UH Case Medical Center in Cleveland, Ohio and Mount Sinai Medical Center in New York.

(1) Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019

(2) HRI 2013 "Global Opportunities in Medical Devices & Diagnostics" report; triangulation of multiple sources; AF includes left atrial tachycardia, left WPW, left atrial flutter.

BioSig Technologies Announces Advanced Research Program with Mayo Clinic

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM) today announced the establishment of an advanced research program with Dr. Samuel Asirvatham at Mayo Clinic in Rochester, Minnesota.
This program has been designed to build upon the initial studies conducted at Mayo Clinic in March, June and November 2015 through a tripling of investment to fully characterize and develop novel features discovered during this prior preclinical work. These features have the potential to make a significant impact in the treatment of complex arrhythmias.

“We are extremely pleased to continue our sponsored research activities with Dr. Asirvatham and his colleagues at Mayo Clinic,” said Greg Cash, President and CEO of BioSig Technologies. “The previous studies confirmed the potential of PURE EP to improve the clarity of cardiac signals while minimizing electrical noise in the cardiac electrophysiology laboratory.”


About BioSig Technologies

BioSig Technologies is a medical device company that is developing a proprietary technology platform designed to improve the $4 billion EP marketplace(1) (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP System.


The PURE EP(TM) System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system  designed to assist electrophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the electrophysiologists in identifying ablation targets - areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia).


Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019(1), making it one of the fastest growing medical device segments. Just in the US, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017(2).

BioSig intends to seek FDA 510(k) clearance for the PURE EP System. The Company has achieved proof of concept validation through UCLA labs, and has performed pre-clinical studies at the Mayo Clinic in Minnesota. The Company is collaborating with several of the nation's most prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, and Mayo Clinic.


(1) Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019


(2) HRI 2013 "Global Opportunities in Medical Devices & Diagnostics" report; triangulation of multiple sources; AF includes left atrial tachycardia, left WPW, left atrial flutter.

BioSig Technologies Initiates Technology Development with Minnetronix

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM) today announced it has signed an agreement to initiate development of its PURE EP^TM high fidelity cardiac electrophysiology (EP) signal acquisition and analysis system with Minnetronix, an award-winning medical technology development and manufacturing firm.

Greg Cash, President and Chief Executive Officer of BioSig Technologies, stated, “We are very pleased to begin this relationship with Minnetronix, who has proven to be a leader in taking innovative medical technology through the development process and into manufacturing in a timely manner. It is our goal to help patients through positively impacting the diagnosis and treatment of complex cardiac arrhythmias as soon as we possibly can.”

“We are excited to work with an advanced cardiac electrophysiology company like BioSig,” said Jeremy Maniak, Minnetronix Chief Operating Officer. “Minnetronix has developed numerous technologies in the electrophysiology field, including mapping and ablation, which positions us well to bring leading-edge technologies like the PURE EP System to the market quickly.”

About BioSig Technologies
BioSig Technologies is a medical device company that is developing a proprietary technology platform designed to improve the $3 billion EP marketplace¹ (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP System.

The PURE EP System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system designed to assist electrophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the electrophysiologists in identifying ablation targets - areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia).

Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019¹, making it one of the fastest growing medical device segments. Just in the US, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017².
BioSig intends to seek FDA 510(k) clearance for the PURE EP System. The Company has achieved proof of concept validation through UCLA labs, and has performed pre-clinical studies at the Mayo Clinic in Minnesota. The Company is collaborating with several of the nation's most prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, and Mayo Clinic.

¹Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019

²HRI 2013 "Global Opportunities in Medical Devices & Diagnostics" report; triangulation of multiple sources; AF includes left atrial tachycardia, left WPW, left atrial flutter.

About Minnetronix
Minnetronix is a medical technology and innovation company with deep expertise in electronic and electromechanical devices. Founded in 1996, the company creates new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies. Minnetronix is FDA Registered and ISO 13485 Certified.

Relmada Therapeutics Announces Results of In Vivo Study Showing d-Methadone has Antidepressant-like Effects

Source:  Relmada Therapeutics, Inc.

Data show that d-Methadone produces antidepressant activity comparable to ketamine after single dose administration in a well-validated model.

Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced the results of an in vivo study showing that administration of d-Methadone (REL-1017), a N-methyl-d-aspartate (NMDA) receptor antagonist, results in antidepressant-like effects.  Results are shown to be comparable to those achieved in similar treatment models using ketamine.

"This study is the first to clearly demonstrate that d-Methadone exhibits antidepressant-like effects in a well-validated treatment model to predict antidepressant activity," said Richard Mangano, Ph.D., chief scientific officer of Relmada.  "Ketamine, also a noncompetitive NMDA receptor antagonist, has been thoroughly characterized in this model and has demonstrated rapid onset of activity in several clinical studies, but has also been shown in multiple studies to present a high risk of toxicity. Combined with the results of our recent Phase I single and multiple ascending dose studies, the encouraging results of this in vivo study support our belief that d-Methadone warrants further evaluation in a Phase II study as an effective treatment for depression."

The purpose of this study was to determine whether d-Methadone elicits antidepressant-like effects after a single administration in a well-validated animal model to predict antidepressant effects, the forced swim test. In the study, male Sprague Dawley rats were administered single doses of vehicle, ketamine, or d-Methadone on day one (after habituation; 24 hours prior to forced swim testing). At all doses tested, d-Methadone significantly decreased immobility of the rats compared to the vehicle, suggesting antidepressant-like activity. In addition, the effect of d-Methadone on immobility at the two highest doses tested was larger than the effect seen with ketamine. Importantly, the effects of d-Methadone in the forced swim test were not confounded by any changes in the locomotor activity of the rats.

About d-Methadone (REL-1017)

As a single isomer, d-Methadone (REL-1017) has been shown to possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA receptors has been associated with neuropathic pain and it is expected that REL-1017 will have a role in pain management by blocking this activity. In contrast, racemic methadone is a long-acting narcotic used in the treatment of various pain states and as a substitution therapy in opioid addiction and associated with typical opioid side effects.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage, publicly traded specialty pharmaceutical company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of pain. The Company has a diversified portfolio of four products at various stages of development, including d-Methadone (REL-1017), an  N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain; topical mepivacaine (REL-1021), an orphan drug designated topical formulation of the local anesthetic mepivacaine; oral buprenorphine (REL-1028),an  oral dosage form of the opioid analgesic buprenorphine; and LevoCap ER (REL-1015), an abuse resistant, sustained release dosage form of the opioid analgesic levorphanol. The Company's product development efforts are guided by the internationally recognized scientific expertise of its research team. The Company's approach is expected to reduce clinical development risks and costs while potentially delivering valuable products to address areas of high unmet medical needs. For more information, please visit Relmada's website at: www.relmada.com. 

Relmada Therapeutics Announces Publication of Full Results from Phase I Study Showing Treatment with d-Methadone to be Safe and Well Tolerated

Source:  Relmada Therapeutics, Inc.

Results Indicate d-Methadone Tolerability Shows Potential in Treatment of Wide Spectrum of Pain Syndromes

 Relmada Therapeutics, Inc. (OTCQB: RLMD) ("Relmada" or the "Company), a clinical-stage company developing novel therapies for the treatment of neuropathic and chronic pain, announced today the publication of the full results from a safety and tolerability Phase I trial of d-methadone (dextromethadone, REL-1017) in patients suffering from chronic pain. Results published in the Journal of Opioid Management[1] demonstrated that d-methadone appears to be safe and well tolerated. The design of the Company's Phase II proof-of-concept study in neuropathic pain will be based in part on this study's findings as well as Relmada's recently completed Phase I single and multiple ascending dose studies (SAD and MAD) conducted in healthy subjects.  

"The publication of these data in a leading pain research journal reflects the importance of our planned proof of concept study for d-methadone," said Sergio Traversa, CEO of Relmada Therapeutics. "Given the high level of need for more effective and better-tolerated therapies for chronic neuropathic pain, we remain committed to advancing d-methadone with the goal of providing a novel treatment option with virtually no opioid-related effects for patients suffering from a wide range of pain syndromes."

The aim of the prospective Phase I open label study was to evaluate the safety of d-methadone 40mg PO BID administered to patients with chronic pain. The study was approved by the Memorial Sloan Kettering Cancer Center (MSKCC) Institutional Review Board (IRB#01-017) and performed at a comprehensive cancer center in New York City. Patients with chronic pain were screened in the Pain and Palliative Care and Anesthesia Pain outpatient clinics and, if found eligible, were offered enrollment in the study.

"Studies have suggested that NMDA receptor antagonists have the potential to treat many neurological and psychiatric disorders such as neuropathic pain and depression. Clinical trials have had limited success thus far because the antagonists evaluated have demonstrated unacceptable neurobehavioral side effects," said Richard Mangano, CSO of Relmada Therapeutics. "This study and our recently conducted SAD and MAD studies in healthy subjects demonstrate that potentially therapeutic doses of d-methadone can be administered without eliciting mu-opioid or ketamine-like side effects."

About d-methadone (REL-1017)
As a single isomer, d-methadone (REL-1017) has been shown to possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA receptors has been associated with neuropathic pain and it is expected that REL-1017 will have a role in pain management by blocking this activity. In contrast, racemic methadone is a long-acting narcotic used in the treatment of various pain states and as a substitution therapy in opioid addiction and associated with typical opioid side effects.

About Neuropathic Pain
Neuropathic pain is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The term neuropathic pain is used to describe a wide range of pain syndromes, including painful diabetic neuropathy, postherpetic neuralgia, and trigeminal neuralgia. According to the Neuropathy Association, neuropathic pain is estimated to affect more than 20 million people in the United States alone. The main classes of drugs used to treat neuropathic pain conditions are anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications less than 50% of patients respond to treatment with currently available therapy options and currently available medications are poorly tolerated.

About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded specialty pharmaceutical company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of pain. The Company has a diversified portfolio of four lead products at various stages of development including d-methadone (REL-1017) its N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain; topical mepivacaine (REL-1021), its orphan drug designated topical formulation of the local anesthetic mepivacaine; oral buprenorphine (REL-1028) its oral dosage form of the opioid analgesic buprenorphine; and LevoCap ER (REL-1015), its abuse resistant, sustained release dosage form of the opioid analgesic levorphanol. The Company's product development efforts are guided by the internationally recognized scientific expertise of its research team. The Company's approach is expected to reduce clinical development risks and costs while potentially delivering valuable products in areas of high unmet medical needs. For more information, please visit Relmada's website at: www.relmada.com. 

 

Relmada Therapeutics, Inc. Provides Update on Nasdaq Up-Listing Process

Source:  Relmada Therapeutics, Inc.

Relmada Therapeutics, Inc. (OTCQB: RLMD) a clinical-stage company developing novel therapies for the treatment of chronic pain, today provided investors with an update regarding the Company's qualification for up-listing to The Nasdaq Capital Market ("Nasdaq"). As previously disclosed, the Company submitted an initial listing application with Nasdaq in the second half of 2015. The Company now believes that it satisfies each of the exchange's applicable listing requirements, with the exception of the $4.00 bid price requirement. In accordance with the Nasdaq Listing Rules, the Company's stock price must close at or above $4.00 per share for 30 of the most recent 60 trading days in order for the Company to be eligible to list.

Sergio Traversa, the Company's Chief Executive Officer, stated, "The up-listing of RLMD to Nasdaq would be a significant milestone for the Company, providing investors with increased liquidity, and generating a higher level of visibility for the Company."

Although the Company believes it will ultimately list on Nasdaq, the Company can provide no assurance that Nasdaq will approve the Company's application for listing.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage, publicly traded specialty pharmaceutical company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of pain. The Company has a diversified portfolio of four lead products at various stages of development including d-Methadone (REL-1017) its N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain; topical mepivacaine (REL-1021), its orphan drug designated topical formulation of the local anesthetic mepivacaine; oral buprenorphine (REL-1028) its oral dosage form of the opioid analgesic buprenorphine; and LevoCap ER (REL-1015), its abuse resistant, sustained release dosage form of the opioid analgesic levorphanol. The Company's product development efforts are guided by the internationally recognized scientific expertise of its research team. The Company's approach is expected to reduce clinical development risks and costs while potentially delivering valuable products in areas of high unmet medical needs. For more information, please visit Relmada's website at: www.relmada.com.