Category Archives: Market News

BioRestorative Therapies, Inc. (BRTX: OTCQB) | BioRestorative Therapies to Present at 5th Annual Marcum MicroCap Conference

MELVILLE, N.Y., May 31, 2016 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BRT” or the “Company”) (OTCBB:BRTX), a life sciences company focused on stem cell-based therapies, today announced that Mark Weinreb, the Company’s CEO, will present a Company overview at the 5th Annual Marcum MicroCap Conference on Thursday, June 2, 2016 in New York City at the Grand Hyatt Hotel.  The Company’s presentation is scheduled to begin between 10:30 AM – 11:00 AM ET.

The annual Marcum MicroCap Conference is a signature showcase for public companies with less than $500 million in market capitalization. 

Mark Weinreb, CEO of BioRestorative, commented about the Company’s attendance, “The Marcum MicroCap Conference provides a welcome forum to highlight the exciting advancements in our Disc/Spine and Metabolic Programs.  We consider it a privilege to be selected to present the ongoing progress of our business.” 

For more information or to register, please visit the conference website at http://www.marcumllp.com/microcap.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

  • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The BRTX-100 production process involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.  BRTX-100 is then injected by a physician into the patient’s damaged disc in an outpatient procedure. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery.

  • Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical 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. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains “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.

CONTACT:
Tony Schor, President 
Investor Awareness, Inc.
Phone: 847-945-2222 ext. 221
E: tony@investorawareness.com

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Article source: http://www.otcmarkets.com/stock/BRTX/news?id=132954

Blow & Drive Interlock Corp. (BDIC: OTCQB) | BDIC Revenues up 70% From Last Quarter; Releases Shareholder Letter

LOS ANGELES, CA–(Marketwired – May 31, 2016) – Blow and Drive Interlock Corporation (OTCQB: BDIC), an offender monitoring and police-grade alcohol detection device manufacturing and distribution company, releases Quarterly Shareholder Letter, Earned Revenues Increase Nearly 70% over Previous Quarter.

Dear Valued Shareholders:

As you know, BDIC just filed its first quarter disclosure for 2016. The Company is pleased to announce that practically every single machine has been leased to paying customers. These leasing customers have contracts with BDIC for an average of twelve (12) months. Our latest financial statement reflects a scaling business and our earned revenues increased quarter over quarter by 69% with an additional increase in deferred revenue of approximately 44%. These deferred revenues are customers who choose to pay for their entire lease in advance, which under GAAP accounting principles are not considered revenues but rather are accounted for as liabilities. While BDIC has technically incurred accounting liabilities relating to providing criminal monitoring services for the contract of the leases, this practically accounts as immediate revenue that we are deploying in scaling up production of our BDI 747/1 Breath Alcohol Ignition Interlock Device (BAIID).

Our sales continue to outpace our ability to manufacture devices. We estimate that our Company has lost out on approximately $330,000 in this year’s annual sales revenues simply from having a lack of inventory to meet immediate customer demand. Investment and financing dollars we have received have been used to pay for production of the additional inventory of our BDI 747/1 devices. This investment in inventory has been translating into an approximately 45% return on money in the first year. According to our economics estimates, assuming an eight (8) year lifetime of our BDI 747/1 units, this investment in inventory would translate into an internal rate of return (IRR) on investment exceeding 200% annually. This is consistent with our view that our business has already begun the process of scaling to rapidly acquire market share. These efforts resulted in BDIC increasing our equipment assets by 200% and we now have approximately 350 units under active lease. We have an additional 100 units that are being delivered to BDIC headquarters tomorrow. We have additionally begun the process of commencing production of a further additional 100 units, to be delivered to our Los Angeles facility within the next 14 days. We anticipate that we will lease each and every one of these units out by the end of the 2nd quarter, which is not inconsistent with our sales performance last quarter, and which will raise our total number of BDI 747/1 devices under active criminal monitoring leases under the auspices of the nine (9) states in which we have approval, to over 500 units. Further, it should be noted, that our sales efforts have been materially only in five (5) of the nine (9) states in which we have approvals. We didn’t pursue the additional states due to our constraints relating to manufacturing this additional inventory.

To remedy this situation we are in active discussions with a variety of parties to explore financing options to expand our manufacturing and production capabilities. We have contracted with Gnosiis International to provide us with economics and consulting services. Regardless, I want to remind you, that once we accomplish our goal of having over 1,000 paying monthly customers, the company will be in a position to self-finance the production required to meet the demand for national expansion. In the event that we choose to not accept any new financing, at our current rate of growth, by the end of this next quarter, we will be able to self-finance a national expansion by the end of 2016.

That being said, we are actively negotiating with financing and investment banking firms to assist BDIC in properly structured financings. A key barrier to us accepting financing that has been offered so far has been “toxic debt” provisions that I refuse to accept. By “toxic debt” I am referring to convertible debt of a specific nature, or unclear nature, which is commonly offered to companies trading on the OTC Markets. Not all convertible notes are toxic but toxic type of convertible debt can contain terms that can be very detrimental to shareholders. I actually feel so strongly about it that I honestly believe it should be considered predatory lending that harms the reputation of the OTC markets and the shareholders whose support is betrayed by toxic debt financing. Our company is in too strong of a position, with too much potential, to risk assuming any debt of a potentially toxic nature of any kind.

Our cash position may appear weak at first glance, however it is important for our shareholders to understand the importance of spending all our free cash manufacturing devices, which in turn enables the company to strengthen its financial position at the negotiating table with potential lenders.

As is disclosed in the subsequent events in the Company’s 10Q, we were able to secure funding from some traditional lending sources as well as the sale of restricted stock. The restricted stock was sold at a discount to market, however it is restricted for a twelve (12) month period and there are no convertible features or options in conjunction with any of these stock purchase agreements.

I am certain that, until such time that we can secure more traditional and friendlier terms of financing, these sales of restricted stock directly from the company’s treasury and/or short term loans with 100% of the proceeds received directly by the company, will continue to sustain our short term inventory financing needs. It is important to note, that all of our financing activities are being utilized to capitalize the expansion of our market share (as opposed to covering operating expenses, which is already being covered by reoccurring billing from existing leases).

I am sure that interested shareholders are aware that we were approached by the New York State Department of Criminal Justice Services (NYDCJS) to replace an industry leader in Breath Alcohol Ignition Interlock Devices that was recently suspended by the State of New York. The industry leaders each have an estimated 50,000 – 70,000 BAIID’s on the road each and every day in the United States, which equates to a gross market potential of $5 million for each company on a monthly reoccurring basis and growing. The NYDCJS reached out to us by phone inquiring if our company would be interested in applying to serve as a replacement vender for the criminal monitoring services through the NYDCJS. Subsequently, the NYDCJS mailed us the 146 page application and we have already submitted the application back to the NYDCJS. We received telephone confirmation that the state is in receipt of our application. If you remember, this was something I guaranteed we would deliver on and I am proud to announce that, in fact, we indeed have.

BDIC and its management team are as committed as ever to create a sustainable business that consistently increases shareholder value. We are expecting to realize increasingly rapid growth as we move through the phases of our plan for national expansion. We will continue to keep our shareholders well informed on our progress and challenges in all areas of the Company’s business throughout the year.

I would lastly like to make note that we are beginning internal due diligence with regard to necessary efforts to begin pursuing the possibility of up-listing from the OTC Venture Markets Exchange to another more established U.S. National Exchange. We have significant milestones that we still need to achieve but we are confident that these milestones and relevant listing criteria will inevitably be met in the due course of growth for our business. We are therefore commencing preliminary planning efforts, as well as taking some practical steps, to enable implanting this milestone when the time becomes appropriate. I am looking forward to keeping our shareholders updated in this regard in future Shareholder Letters and updates.

On behalf of the Company, I truly appreciate your continued support and patience while we embark on the next phase of the Company’s growth. Every BDI 747/1 BAIID helps keep the roads safe for sober motorists and saves lives. We hope that the Company’s positive outlook and social impact continues to be recognized by its shareholders.

Laurnce Wainer
President CEO
Blow Drive Interlock Corp.

FORWARD-LOOKING DISCLAIMER
This report may contain certain forward-looking statements and information. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of mentioned company to be materially different from the statements made herein.

Article source: http://www.otcmarkets.com/stock/BDIC/news?id=132888

Avita Medical Ltd. (AVMXY: OTCQX International) | Clinical Study in UK to Evaluate ReGenerCell for Diabetic Foot Ulcer Treatment

Clinical Study in UK to Evaluate ReGenerCell for Diabetic Foot Ulcer Treatment

May 30, 2016

OTC Disclosure News Service

Northridge, CA

·        Study will evaluate preliminary safety and effectiveness in a cohort of up to 24 patients

·        Innovative regenerative technology will use patients’ own skin cells to try to close chronic Diabetic Foot Ulcer (DFUs)

·        DFUs represent a significant new potential patient population for Avita Medical

 

Northridge, CA, USA, Perth, Australia and Cambridge, United Kingdom, 31 May 2016 — The first patient suffering from a Diabetic Foot Ulcer (DFU) has been enrolled in a clinical trial in the UK aimed at evaluating the feasibility of the medical device ReGenerCell™ in the safe and effective treatment of this widespread complication of diabetes, Avita Medical said today.

 

Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, said the new research takes Avita into a significant new indication area, after the recent release of positive study outcomes for ReGenerCell™ in the treatment Venous Leg Ulcers (VLUs). The DFU clinical study has now started at Manchester Royal Infirmary, with London’s King’s College and Northwick Park hospitals to join shortly. DFUs are a common and growing complication of diabetes, and can often lead to amputation amongst the UK’s 4 million diabetics, whose condition costs the NHS £10bn a year to treat.[1]

The Company said the first patient had been treated at the Manchester Royal Infirmary and that the study aimed to enroll up to 24 patients with DFUs, who will each be followed over a 26-week evaluation period. The ReGenerCell™ device enables medical professionals to create an autologous suspension of skin cells, which is then applied to the patient’s wound to trigger healing. The treatment will be evaluated as an adjunct to standard care treatments, such as debridement, cleansing, dressings, and offloading. As well as the key outcome measures of incidence of healing and rate of wound closure, the study will also explore patient and physician satisfaction, the Company said.

 

“We are keen to evaluate any treatment that has the potential to improve patient care and at the same time reduce cost,” said Mr Tawqeer Rashid, Chief Investigator and Consultant Vascular Surgeon at Manchester Royal Infirmary. “With this study we will be evaluating the clinical benefits of the ReGenerCell™ treatment for patients whose quality of life is often severely reduced.”

 

The Company said it had embarked on the study following many successful patient outcomes, indicating that the regenerative approach could be a very effective means of treating DFUs, which are typically long-term open wounds resistant to most standard treatments. Pioneering work at a wound clinic in Italy achieved complete wound closure for three DFUs of four within 50 days of treatment[2], and similarly successful outcomes have been shown in DFU patients treated in the UK, notably those treated by Dr Harvey Chant at the Royal Cornwall Hospital, the Company said.  

 

“Clinicians from different parts of the world have found ReGenerCell™ to be an effective treatment of diabetic foot ulcers in their practices. A clinical study will allow us to formalize our understanding of the treatment effect and will serve in the development of the clinical guidance and evidence needed for commercialization,” said Andrew Quick, Avita’s Senior Vice President of Clinical Development.

 

The Company said that diabetes was a growing and significant healthcare problem in many of the markets in which it has approval, including Australia (1.7million)[3] and China, which has 114 million diabetics: 1 in 3 in the world.[4]

 

“Most healthcare authorities around the world are facing an epidemic of diabetes and one of their most expensive challenges is how to treat foot ulcers which, sadly, once started, typically lead to a slow and lingering decline,” said Avita CEO Adam Kelliher. “If our approach can get these ulcers to heal, then it could offer hope to many diabetics around the world.”

 

Using a small sample of skin, the ReGenerCell™ device enables the production of a Regenerative Epithelial Suspension (RES™). The autologous suspension contains the multi-phenotype cells and wound-healing factors essential for natural healthy skin regeneration and healing. The procedure performed at the patient’s bedside takes about 30 minutes from collecting the skin sample to treatment of the affected area. In cases of chronic wounds, including DFUs and VLUs, the suspension is sprayed or dripped onto the skin.  It has been shown to significantly reduce the healing time of wounds and leaves the patient with skin with similar elasticity, texture and pigmentation to surrounding skin, with limited scarring.

 

ABOUT AVITA MEDICAL LTD

Avita Medical develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita’s patented and proprietary collection and application technology provides innovative treatment solutions derived from a patient’s own skin. The company’s lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell® is patented, CE‐marked for Europe, TGA‐registered in Australia, and CFDA‐cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use. To learn more, visit www.avitamedical.com.

 

For information on ReGenerCell™, visit: www.avitamedical.com/products/recell-for-chronic-wounds/

# # #

FOR FURTHER INFORMATION

 


[1] https://www.diabetes.org.uk/About_us/News/Number-of-people-with-diabetes-reaches-over-4-million/

[2] DeAngelis B, Migner A, Lucarini L, Agovino A, Cervelli V. The use of a non-cultured autologous cell suspension to repair chronic ulcers. International Wound Journal 2013; doi: 10.1111./iwj. 12047 [Epub]

 

[3] https://www.diabetesaustralia.com.au/diabetes-in-australia

[4] Yu Xu, Limin Wang, Jiang He, et al. Prevalence and Control of Diabetes in Chinese Adults. JAMA 2013; 310(9): 948-59

This release includes additional documents. Select the link(s) below to view.

Clinical Study in UK to Evaluate RegerCell for Diabetic Foot Ulcer Treatment.pdf

Copyright © 2016 OTC Markets. All Rights Reserved

The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.

Article source: http://www.otcmarkets.com/stock/AVMXY/news?id=132878

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