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BIO SmartBrief

Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in nbs (37)

Monday
Jan072013

CONSULTING FOR STRATEGIC GROWTH ANNOUNCES 2013 "TWO STOCK PICKS"

NEW YORK, January 2, 2012 - Consulting For Strategic Growth 1, Ltd. (CFSG1), an investor relations, corporate development agency specializing in domestic and international companies new to American financial markets, today continues its tradition of naming a "Stock Pick" from selected CFSG1 clients and announced today its first stock picks for 2013. With anticipation of strong positive growth in the coming year, CFSG1 is pleased to name Neostem (NYSE MKT: NBS) and Medifocus, Inc. (TSX-V: MFS, OTC: MDFZF) as its first stock picks for the New Year.   

CSFG1 has represented NeoStem, Inc. in various capacities since 2006 and has seen the Company grow under the leadership of its CEO, Dr. Robin Smith, MD, MBA, from a single focus business to an international biopharmaceutical company with multiple revenue streams. Today, Neostem is a clear leader in the development and manufacture of cell-based therapeutics with continued growth opportunities in the future.   

 

NeoStem Ranked Number 1 Fastest Growing Company in the Tri-State Region on Deloitte's 2012 Technology Fast 500(TM)

NEW YORK, Nov. 15, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT: NBS) ("NeoStem" or the "Company"), an emerging market leader in the fast growing cell therapy industry, today announced it ranked number 1 in the Tri-State region and number 7 nationally on Deloitte's 2012 Technology Fast 500(TM), a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America.

Dr. Robin L. Smith, NeoStem's Chairman and CEO, said "We are proud to be recognized for this achievement as we build NeoStem into a top tier biopharmaceutical company and thrilled to be honored alongside such fast-growing, successful companies such as Celgene, LinkedIn, and Google. On behalf of the entire NeoStem team, I would like to thank Deloitte & Touche, LLP for their recognition of our efforts." 

NeoStem is emerging as a market leader in the fast growing cell therapy industry. The Company's multifaceted business strategy combines a state-of-the-art contract development and manufacturing organization (CDMO) with a medically important cell therapy product development program providing for near- and long-term revenue growth opportunities. We focus on developing cell therapy products around a strong IP portfolio. These products target large markets such as cardiovascular disease, autoimmune disorders and regenerative medicine. 

In a challenging economy with risk adverse capital markets, we have fashioned a management team that is both flexible and opportunistic. PCT, acquired in 2011, expands our revenue growth and gives us unique insight into the clinical and commercial cell therapy manufacturing market while we simultaneously develop our own clinical products. This service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. 

NeoStem is focused on organic growth and continuously evaluates strategic opportunities. We look forward to achieving success for our future patients, our PCT clients, employees and shareholders. 

About Deloitte's 2012 Technology Fast 500(TM)

Technology Fast 500, conducted by Deloitte & Touche LLP, provides a ranking of the fastest growing technology, media, telecommunications, life sciences and clean technology companies -- both public and private - in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2007 to 2011. 

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company's operating revenues. Companies must have base-year operating revenues of at least $50,000 USD or CD, and current-year operating revenues of at least $5 million USD or CD. Additionally, companies must be in business for a minimum of five years, and be headquartered within North America. 

About NeoStem, Inc. 

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy industry. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company. 

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic product candidate, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSEL TM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed. 

For more information on NeoStem, please visit www.neostem.com .  

CFSG1 and/or its principals have represented Medifocus, Inc. in various capacities since 2008, and have witnessed the Company's growth under the leadership of Medifocus's CEO, Augustine Cheung, from a clinical, trial level company with a single application to now possessing an approved therapeutic system. Medifocus is currently generating revenue and rapidly advancing its Phase III trial in its original asset.      

 

Medifocus Inc. Announces Update on the Prolieve(R) Acquisition and the Hiring of the Prolieve(R) Management Team

COLUMBIA, MD and TORONTO--(Marketwire - Sep 27, 2012) - Medifocus Inc. (OTCQX : MDFZF ) ( PINKSHEETS : MDFZF ) ( TSX VENTURE : MFS ) is pleased to announce the following update on the recently announced purchase of all the Prolieve® business assets from Boston Scientific Corporation (BSX). 

Prolieve® is approved by the FDA for the treatment of Benign Prostatic Hyperplasia (BPH). Medifocus has successfully begun the transition from a research and development company to a revenue generating business. Medifocus has already begun selling and shipping Prolieve® from its Columbia, MD facility; thus will be reporting revenue in the current quarter for the first time in its history.

To fully capitalize on the Prolieve® business opportunity, Medifocus has hired key personnel to expedite the transition and future revenue growth. Mr. Kurt B. ONeill, CPA was formerly the Business Development Manager for the Prolieve® system at BSX and was hired by Medifocus as V.P. of Sales and Finance. Mr. Timothy P. Heyer, formerly the Prolieve® Business Manager and Rocky Mountain Mobile Services (RMMS) Manager at BSX, was hired by Medifocus as Director of Sales. Ms. Stacey Kjeldgaard, formerly Manager of the RMMS business unit at BSX was hired by Medifocus as the Administrative Manager for the Prolieve® System. Together they bring over 50 years of experience in the industry. 

Prolieve® is a patent protected device that utilizes intra-cavitary catheters to deliver a combination of microwave heating and balloon dilatation of the prostatic urethra which leads to the relief of BPH symptoms. Treatment with Prolieve® is a minimally invasive non-surgical in-office procedure which offers patients clinically documented immediate reduction of BPH symptom scores. Prolieve® is the only microwave device to be randomized to drug therapy during its pivotal trial. The BPH drug market is an $8 billion market and growing. BPH patients can be treated using Prolieve® in urologic offices throughout the United States. In addition, the Prolieve® treatment is also made available to physicians using a nationwide mobile service provider, Rocky Mountain Mobile Services, which was part of the asset purchase. 

Prolieve® was originally developed and commercialized by the current Medifocus management, product development, clinical and regulatory teams. The assets acquired by Medifocus include all Prolieve® hardware inventories, Rocky Mountain Mobile Services and its mobile distribution assets, as well as the intellectual property portfolio associated with the Prolieve® technology. The Prolieve® design is based on a platform technology from which other disposable microwave heating catheters for various deep seated anatomical sites can also be developed. 

About Medifocus 

Medifocus owns a patented microwave focusing technology platform (the Adaptive Phased Array ("APA") technology), which precisely targets and controls microwave energy to cause heating in cancerous tumors anywhere in the body reliably and repeatedly. The ability to target tumors with a precision controlled dose of heat can be used to destroy tumors at higher temperatures, to treat tumors in combination with chemotherapy and/or radiation at moderate temperatures for increased effectiveness and reduced toxicity and to trigger the targeted release of therapeutic drugs and genes at tumor sites at lower temperatures. While the core technology has been licensed from the Massachusetts Institute of Technology, Medifocus has further refined the precision of the microwave focusing and control ability and developed a commercial system dedicated exclusively for the treatment of Breast Cancer. With the acquisition of Prolieve®, Medifocus now owns in addition, a revenue generating commercial BPH heat treatment product generating cash flow to support the development and commercialization of other catheter based or APA based external focused heat systems for targeted thermotherapy of deep seated tumors anywhere in the body. Please visit www.medifocusinc.com  for more details.

About Boston Scientific 

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com .    

About Consulting for Strategic Growth 1, Ltd.

 Consulting For Strategic Growth I, Ltd. ("CFSG1") provides consulting, business advisory, investor relations, public relations and corporate development services to public and private companies. In connection with these services, CFSG1 prepares press releases, corporate profiles, and other publications on behalf of and regarding its clients. Certain statements contained in this press release that are not purely historical are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "plans", "estimates", "could" and similar expressions that convey uncertainty of future events or outcomes identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of CFSG1 or its clients to differ materially from those expressed or implied by these forward-looking statements. CFSG1 receives cash and/or restricted stock/warrants to purchase shares in the future. 

Saturday
Dec082012

Robin L. Smith, M.D., of Neostem on the Vatican, regenerative medicine, and women's empowerment

NeoStem, Inc. (NYSE: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.   

NeoStem, continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift occurring in medicine. We anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy industry.

In this interview, Dr. Robin Smith, CEO of NeoStem and Chairman and President of the Stem for Life Foundation discusses a range of topics including regenerative medicine, stem cell research, the Vatican's involvement with Neostem, and Neostem's potential in developing countries:

 

Monday
Jun182012

NeoStem Signs a Definitive Agreement to Divest its 51% Ownership Interest in Suzhou Erye (NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  ItsJanuary 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.

The Company announced that it has "entered into a definitive agreement to sell its 51% interest in Suzhou Erye Pharmaceutical Co. Ltd. (“Erye”), a China-based generic pharmaceutical company, for  $12,280,000 in cash and the return to the Company of (i) 1,040,000 shares of the Company’s Common Stock and (ii) the cancellation of 1,170,000 options and 640,000 Common Stock warrants, which collectively represent 1.3% of the Company’s fully diluted issued and outstanding shares. The closing of the transaction is subject to the approval of NeoStem shareholders and certain other conditions." The transaction is expected to close by the fourth quarter of 2012.

Chairman and CEO of NeoStem Dr. Robin L. Smith stated,

"We are pleased to have reached this significant milestone in our business. This divestiture will enable NeoStem to bolster its cash position in the United States, reduce its legal and financial reporting expenditures, simplify its financials and become a pure play in the rapidly growing cell therapy industry. Consummation of the transaction will also eliminate significant Erye debt from the Company's balance sheet, which was over $37 million as of March 31, 2012."

NeoStem first gained its interest in Erye in October 2009. At the time, the company was heralded for its innovative business move into the emerging Chinese pharmaceutical industry. In 2011, "the Chinese government imposed new policies affecting price and volume controls of certain pharmaceutical products, including generic antibiotics, which reduced the division’s profitability and positive cash flows. This dampened Erye’s operating results and was the catalyst for NeoStem to begin to evaluate opportunities to monetize its interest in Erye."

The divestiture "will enable NeoStem to focus full time on its goal to emerge as a leader in the cell therapy market. The Company is enrolling patients in its PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack and expanding its cell therapeutic contract manufacturing business, PCT. NeoStem also plans to continue to develop and to build on its core capabilities in cell therapy to capitalize on the paradigm shift that is occurring in medicine."
Tuesday
May222012

NeoStem, Buying a falling knife, dead money of an atrophying model @ Scimitar Equity Blog (NBS)

NeoStem, Inc. (Amex: NBS) is a leader in the development and manufacture of cellular therapies. NeoStem has a  strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company.

At Scimitar Equity Blog, Founder and Director of Research Henry McCusker wrote an article discussing his concerns about NeoStem's financial state. He references a recent NeoStem announcement, which stated that "as of 3/31/12, between its US and China operations consolidated cash and cash equivalents of $21.8M, and an additional $2.5M in cash held in escrow." He then poses the question: "Are they TRUE and legal statements or is 'management fiddling as NBS burns'?

He continues,

"What is the true or real US cash position…in my additions and subtractions and rate of spending (using the KISS principle) NBS (approximating) had Plus (+) or minus (-) $1M in cash pre the recent $6.8M raise through Maxim. If NBS is spending $5M a quarter with April and May gone by, I would project a range of $3-4M as a current balance and NBS should be out of money by July end. Are the Erye pre-sale announcements a desperate 'screen' to prolong a further decline in the share pricing, or are they waiting for a 'miracle'?"

Read more at ScimitarEquity.com

Wednesday
Apr182012

NeoStem to Present at BioCentury Future Leaders in the Biotech Industry Conference - $NBS

NeoStem, Inc. (NYSE Amex:NBS) announced that Company management will present an overview of the Company at the Future Leaders in the Biotech Industry Conference in New York City.

Location: Millennium Broadway Hotel & Conference Center, NYC

Presentation date: Friday, April 20, 2012

Presentation time: 2:00 p.m. ET
 
A live webcast of this presentation will be available and archived for 90 days at: http://www.media-server.com/m/p/3o8w4i2

Tuesday
Apr172012

NeoStem Study indicates Bone Marrow Stem Cells May Preserve Heart Tissue After Heart Attack ($NBS)  

NeoStem (NYSE Amex: NBS) is a leader in the development and manufacture of cellular therapies. NeoStem has a  strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. NeoStem endeavors to be an integrative force in the cell therapy industry. By vertically integrating the collection, storage and processing of cell units and the development, manufacturing, distribution, and delivery of cell therapy products, they are positioned to take advantage of growth in the cell therapy industry as a whole.

Results from the The PreSERVE-AMI Study, sponsored by Amorcyte, LLC, a NeoStem, Inc. company, indicate that stem cells retrieved pelvic bone marrow restore tissue and improve heart function in heart attack patients.  The study evaluated the safety and efficacy of stem cell treatments and focused on patients who had received a stent to open the blocked artery and heart attack injuries caused by a prolonged period of blocked blood supply.  The NeoStem company Progenitor Cell Therapy also assisted this study by processing stem cells in preparation for infusion.  

Vijaykumar S. Kasi, MD, PhD, principal investigator for the clinical trial at Orlando Regional Medical Center, commented,

"Severe heart failure, often the end result of large or multiple heart attacks, is a major health care challenge, impacting more than five million people in the United States and costing more than $35 billion annually. Stem cell therapy is part of the movement from treatment to cure and has the potential to overcome limitations and expenses of heart transplants and offers hope for patients who are desperately praying for another chance at life."

Read the full article here.  

Friday
Apr132012

BioSmart Brief: Highlights NeoStem's PreSERVE Trial $NBS

PreSERVE-AMI tests autologous stem cell treatment for heart attack
Doctors at Orlando Health have started a trial as part of the nationwide PreSERVE-AMI study of pelvic bone marrow stem cells in treating tissue damage after a heart attack. The study of autologous transplant will involve 160 patients at 34 sites. American City Business Journals/Orlando, Fla.

Wednesday
Apr112012

NeoStem Announces the Addition of Jonathan Sackner-Bernstein, MD, Past FDA Official, as Vice President, Clinical Development and Regulatory Affairs (NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.

 The Company announced the addition of Jonathan Sackner-Bernstein, MD, FACC to Neostem as the Vice President of Clinical Development and Regulatory Affairs.

He brings to the Company over 20 years of experience as a clinical cardiologist and medical researcher with leadership in healthcare management. Dr. Sackner-Bernstein will join the team to advance Amorcyte's PreSERVE AMI Phase 2 trial in addition to providing regulatory support for NeoStem's product pipeline.
 

"Jonathan's experience at the FDA and with Clinilabs, coupled with his experience as a cardiologist, make him a perfect choice to develop Amorcyte's AMR-001, in part by leveraging his relationships with clinical investigators and leaders in the cardiology community. In terms of our Amorcyte product under development, a CD34+ cell for the preservation of heart muscle function after a large AMI, we continue to see data in the competitive landscape that supports our notion that this is the right strategy for success. As we are accruing our Phase 2 trial we are noting the incidence of low ejection fraction after a ST segment elevation myocardial infarction. Even with advances in the standard of care that have reduced the adverse events associated with an AMI, a meaningful percentage of patients are being found to have a left ventricular ejection fraction of less than 45 percent several days after an AMI. This is the group at risk for adverse events that AMR-001 is being tested on to determine if it will preserve heart muscle function to prevent adverse events."

Dr. Sackner-Bernstein's past experience includes servings as the Associate Center Director for Technology and Innovation at U.S. Food and Drug Administration's Center for Devices and Radiological Health from 2008 to 2011, and serving as Chief Medical Officer at the clinical research organization, Clinilabs, where he established a Phase 1 research unit from 2006 to 2008. From 1993 to 2003, he was an assistant professor of medicine at the Columbia University College of Physicians and Surgeons.

His academic accomplishments include "contributions to medical therapy of heart failure and patients following heart attack as well as leadership in changing the paradigms of drug development in heart failure. Dr. Sackner-Bernstein also founded ExVivos, LLC, a privately-held company focusing on engineering tissues and organs from human cells for the development of drugs, vaccines and biological products. Dr. Sackner-Bernstein earned his B.S.E. from the Moore School of Electrical Engineering at the University of Pennsylvania and his M.D. from Jefferson Medical College. He completed training in Internal Medicine and Cardiology at Mount Sinai Hospital in New York. In addition, he holds Secret Clearance from the U.S. government."

"Jonathan's clinical experience as a cardiologist, and work at the FDA and Clinilabs, make him a perfect addition to the NeoStem senior management as we focus our resources to execute on our operational business plan which includes developing our most mature asset, AMR-001, enrolling patients in the Amorcyte Phase 2 trial and building our contract manufacturing business, Progenitor Cell Therapy (PCT). NeoStem has successfully repositioned the company through the acquisitions of both PCT and Amorcyte, effectively transforming our company to one that is focused on the development of novel cell based therapeutics and, as such, management is focused on execution to build investor confidence and bring value to our shareholders."