Organovo 2.0: Nächster Organplayer im Bereich der regenerativen Medizin? - 500 Beiträge pro Seite

[Ghoststock]

Nachdem uns Aktien wie Organovo bereits in den letzen 2 Jahren begleitet haben, eröffne ich mal das Forum für HART: Harvard Apparatus, einem Spin-Off der renommierten Harvard University, IPO war November 2013. Im Wesentlichen geht es um die Regenerierung von Organen zu Transplantionszwecken, die Details sind in dieser Präsentation zu finden:

http://www.harvardapparatusregen.com/media/wysiwyg/HART/PDFs…

Ich bin seit einiger Zeit dabei und es ging schon ordentlich nach oben. Mal sehen, wie es weitergeht.

Diskussionen und Anregungen sind sehr willkommen!

[Popeye82]

Antwort auf Beitrag Nr.: 46.590.619 von Ghoststock am 08.03.14 16:13:06

So auf Deine 3 Zeilen hin -interessant. Was man ethisch auch von halten mag.
So ein Unternehmen wie Organovo dürfte, von dem was ich weiss, auch nicht nur "irgendeine Bude" sein, sondern die dürften in Ihrem Bereich meiner Meinung nach wirklich eine Zeitenwende einläuten.

Gruß
P.

[Ghoststock]

Antwort auf Beitrag Nr.: 46.590.685 von Popeye82 am 08.03.14 16:36:02

Hi zusammen,

anbei ein deutscher Beitrag zum dem Thema. Ist jüngst erschienen und dort wird das Prinzip der Firma und deren Produkte und Visionen gut erklärt:

http://www.deutsche-mittelstands-nachrichten.de/2014/02/5939…

Echt abgefahren...

[Popeye82]

Habe keine Aktien.

Harvard Apparatus Regenerative Technology Spotlighted by Fast Company Co.Exist, titled “Lab-Grown Organs Are Out In The Wild, +More Are Coming Soon” recounts the Company’s success to date in regenerating tracheas +the technology involved. It additionally notes the Company “sees a booming business in lab-grown organs - Mar 21, 2014
www.fastcoexist.com/3027468/lab-grown-organs-are-out-in-the-…

[Popeye82]

Harvard Apparatus Regenerative Technology Collaborator Successfully Transplants Regenerated Esophagus, into Rat; Study Results by Dr. Paolo Macchiarini +Research Team Published in Nature Communications, Research to Be Presented @the American Association for Thoracic Surgery(AATS) Annual Meeting 2014 in Toronto - FY/N.com/KI, HOLLISTON - Apr 15, 2014
http://finance.yahoo.com/news/harvard-apparatus-regenerative…
www.nature.com/ncomms/2014/140415/ncomms4562/full/ncomms4562…

"Harvard Apparatus Regenerative Technology, Inc. (HART), a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, announces that a research team led by Paolo Macchiarini, MD, PhD at Karolinska Institutet in Sweden has successfully transplanted a regenerated esophagus into a rat using a bioreactor developed by HART. Dr. Macchiarini has previously overseen several successful regenerated trachea transplants in human patients using a bioreactor developed by HART.

The research detailing the new procedure, “Experimental orthotopic transplantation of a tissue engineered oesophagus in rats,” was published today in Nature Communications and is available to read at http://dx.doi.org/10.1038/ncomms4562.

This research will also be presented at the American Association for Thoracic Surgery (AATS) Annual Meeting 2014 to be held April 26-30 at the Metro Toronto Convention Centre in Toronto, Canada.

David Green, CEO of Harvard Apparatus Regenerative Technology, said, “We congratulate Professor Macchiarini and his research team for this breakthrough in the development of a regenerated esophagus for transplant. We are honored to have been able to support this work by adapting our trachea regeneration bioreactor specifically for the regeneration of the esophagus. We look forward to continuing our collaboration with Professor Macchiarini in developing this technology with the goal of performing the first human transplant of a regenerated esophagus.”

Despite several attempts, it has been proven difficult to grow tissue to replace a damaged esophagus. In this new study, the researchers created the bioengineered organs by using esophagi from rats and removing all the cells. With the cells gone, a scaffold remains in which the structure as well as mechanical and chemical properties of the organ are preserved. The produced scaffolds were then reseeded with cells from the bone marrow. The cells adhered to the biological scaffold and started to show organ-specific characteristics within three weeks.

The cultured tissues were used to replace segments of the esophagus in rats. All rats survived and after two weeks the researchers found indications of the major components in the regenerated graft: epithelium, muscle cells, blood vessels and nerves.

“We believe that these very promising findings represent major advances toward the clinical translation of tissue engineered esophagi,” said Dr. Macchiarini.


About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our technology has been used in eight human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing. On November 1, 2013, HART was spun-off from Harvard Bioscience. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, who has licensed the right to use such trademark from Harvard University.


Forward-Looking Statements

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the planned commercialization efforts and marketing approvals of HART’s products as well as the success thereof and the availability of a market for the HART securities. These statements involve risks and uncertainties, including among other things, market conditions that may cause results to differ materially from the statements set forth in this press release. The forward-looking statements in this press release speak only as of the date of this press release. Harvard Apparatus Regenerative Technology expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.


Contact:

Harvard Apparatus Regenerative Technology
David Green, President and CEO
[e-mail]
or
Tom McNaughton, CFO
[e-mail]
or
Investor Relations:
Dian Griesel Int’l.
Cheryl Schneider, 212-825-3210
or
Public Relations:
Dian Griesel Int’l.
Susan Forman or Laura Radocaj, 212-825-3210 "

[Popeye82]

Harvard Apparatus Regenerative Technology Names Saverio La Francesca, MD as its Chief Medical Officer - Apr 16, 2014
http://app.quotemedia.com/quotetools/newsStoryPopup.go?story…

"Harvard Apparatus Regenerative Technology, Inc. (NASDAQ:HART), a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, has hired Saverio La Francesca, MD, a veteran cardiothoracic surgeon and leading organ transplant physician, as the Company’s first Chief Medical Officer, effective April 14.

Dr. La Francesca has a unique combination of experience that features more than 25 years of academic clinical surgical practice and innovative research, with a foundation in the cardiovascular, thoracic transplantation, cardiac assist device and regenerative medicine fields. He joins HART from the Department of Cardiovascular Surgery and Transplantation at the DeBakey Heart and Vascular Center at the Houston Methodist Hospital, where he developed the current surgical and perfusion techniques for thoracic organ procurement and preservation and where he was also the Director of the Exvivo lung perfusion laboratory. Previously he was an attending surgeon at the Department of Cardiopulmonary Transplantation at the Texas Heart Institute in Houston, Texas. He also previously held an appointment as Associate Professor of Surgery at the “Sapienza” University of Rome in Rome, Italy.

Dr. La Francesca received his MD in medicine and surgery in 1985 at the University of Palermo. He did his Residency in Cardiovascular Surgery in the Department of Cardiovascular Surgery at the “Sapienza” University of Rome. He then completed his postdoctoral training with fellowships at the Texas Heart Institute under the supervision of pioneer heart surgeon Denton Cooley. He was also a Clinical/ Research fellow at McGill University in Montréal, Québec, Canada and at the Baylor College of Medicine in Houston. He holds UNOS certifications as heart transplant surgeon and lung transplant surgeon. He is also certified as surgeon for the use of the HeartMate and the Jarvik 2000 left ventricular assist devices.

Dr. La Francesca said, “I am very excited to be joining HART at a time when regenerative medicine is experiencing unprecedented growth. I am especially impressed that HART has developed technology that will allow it to pursue the first-ever clinical trial for a bioengineered human organ for transplant. As a cardiothoracic surgeon, I am keenly aware of the need for replacement organs, as well as the advantages of regenerated organs that do not require the use of immunosuppressive drugs. I am looking forward to being part of the HART team as we progress to the clinical trial stage for our HART-Trachea and potentially other regenerated organs.”

David Green, Chief Executive Officer of Harvard Apparatus Regenerative Technology, stated, “I am honored that Dr. Saverio La Francesca will be joining HART as our first Chief Medical Officer. Over the course of his career, Dr. La Francesca has participated in more than 1,000 organ transplants in both the United States and European Union, and has personally performed more than 200 heart and lung transplant procedures himself. Additionally, he has been an investigator in several FDA clinical trials of artificial heart products. Dr. La Francesca has also been a co-investigator in clinical trials for the use of stem cells for severe cardiovascular disease. This experience makes him superbly well qualified to lead the clinical development of the HART-Trachea, and to work with the trachea transplant community to ensure the HART-Trachea meets the needs of both the Food and Drug Administration and European Medicines Agency as well as the needs of surgeons. We also look forward to his contributions as HART works with leading medical research institutions to assist in the advancement of their research in regenerating other organs.”


About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our technology has been used in eight human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing. On November 1, 2013, HART was spun-off from Harvard Bioscience. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, who has licensed the right to use such trademark from Harvard University. "

[Popeye82]

Harvard Apparatus Regenerative Technology Reports Operating Results for 2nd Quarter Ended Jun 30, '14, Conference Call To Be Held @11:00 AM ET Today - Aug 8, 2014
http://investor.harvardapparatusregen.com/press-release/harv…

"HOLLISTON, Mass.--(BUSINESS WIRE)--

Harvard Apparatus Regenerative Technology, Inc. (HART), or HART, a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, reports unaudited financial results for the three and six months ended June 30, 2014.


The Company reports the following operating highlights for the second quarter:

- A sixth human tracheal transplant was performed using the Company’s HART-Trachea product on June 3, 2014 at Krasnodar Regional Hospital in Russia. The patient was a 24-year-old male suffering from extensive tracheal damage following an automobile accident. The surgery was a success and the patient was recovering well in the days following the procedure.

- In June, HART responded to the information request by the U.S. Food and Drug Administration (FDA) following its initial review of the Company’s application for an orphan drug designation for its HART-Trachea product. The Company expects this additional submission to be sufficient for the FDA to determine whether or not it will grant orphan drug designation to the HART-Trachea.

- The European Medicines Agency (EMA), through its Committee for Advanced Therapies (CAT), informed HART of CAT’s conclusion that the Company’s HART-Trachea product is classified as a tissue-engineered, advanced therapy medicinal product, or Combined ATMP. This classification grants the Company a pathway to clinical trials on a European Union-wide basis, although clinical trials are managed through individual countries’ regulatory agencies.

- The Company met with the Medicines and Healthcare Products Regulatory Agency of the U.K. (MHRA) to discuss the HART-Trachea product and the MHRA’s views on certain preclinical studies, as well as the Company’s planned approach to clinical studies. The Company was very pleased with the feedback it received from the MHRA, and reiterates its previously disclosed statement that it expects to enter clinical trials in Europe earlier than in the U.S.

- For the first six months of 2014, the Company used $3.8 million of cash in operating activities and ended the second quarter with $10.1 million of cash on-hand.


David Green, President and CEO of Harvard Apparatus Regenerative Technology, commented, “Our Company had a very productive second quarter. We were glad to receive the EMA’s classification of our HART-Trachea as a Combined ATMP. We were also very encouraged by our first meeting with the MHRA. We chose the U.K. to approach first in Europe due to the MHRA’s familiarity with cell therapies, and the availability of surgeons and hospitals there that are already familiar with early progress in tissue-engineered products. Based on that discussion we continue to see a path to clinical trials in Europe prior to the United States. Domestically, although we submitted our responses to the FDA’s request for additional information regarding our orphan designation application later than we expected during the quarter, we anticipate the information we provided will result in the FDA ruling on our application in the next several weeks. Further, our management team was strengthened with the onboarding of Dr. Saverio La Francesca, our new Chief Medical Officer, at the beginning of the quarter.”

Mr. Green continued, “In addition to pursuing our HART-Trachea program we continue to work closely with a number of leading researchers on their efforts to regenerate other organs as well. We continue to believe that our approach to trachea transplant could someday be translated to other tubular organs in the body.”


Second Quarter Reported Results

During the second quarter of 2014, we recognized revenues of $23,000 from the sale of bioreactor systems for organ regeneration research. Prior to our spin-off from Harvard Bioscience on November 1, 2013, we did not record revenues on the sale of research systems. Thus, revenues were first recorded during the fourth quarter of 2013.

Net loss was $2.5 million, or $0.32 per diluted share, for the three months ended June 30, 2014 compared to a $2.1 million net loss, or $0.27 per diluted share, for the same period in 2013. The unfavorable year-to-year quarterly net loss comparison was primarily due to an increase in general and administrative expenses related to the fact that the Company became an independent, publicly traded entity in November 2013.

At the time of the spin-off on November 1, 2013, Harvard Bioscience contributed the assets of its regenerative medicine business and cash of $15 million to HART. At June 30, 2014, HART had cash on hand of $10.1 million, and had no debt.


Conference Call Information:

HART will host a conference call today at 11:00 AM ET to discuss its second-quarter financial results and the Company’s operations. On that call, management may respond to questions from the audience on any of a number of topics related to the business, including clinical and preclinical research, operations, plans and outlook. The live conference call is accessible by dialing toll-free 888-455-2260, or toll/international 719-325-2484, and referencing the pass code "9685223".

A replay of this conference call will be available from approximately 2:00 PM (Eastern Time) on August 8, 2014 through 2:00 PM (Eastern Time) on August 15, 2014 and will be accessible by dialing toll-free 888-203-1112, or toll/international 719-457-0820, and referencing the pass code "9685223".


About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our trachea scaffold technology has been used in five human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing. On November 1, 2013, HART was spun-off from Harvard Bioscience. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, who has licensed the right to use such trademark from Harvard University. "

[Popeye82]

Harvard Apparatus Regenerative Technology Obtains Orphan Drug Designation from U.S. Food, +Drug Administration, for HART-Trachea - Sep 5, 2014
http://investor.harvardapparatusregen.com/press-release/harv…
www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_…

"Harvard Apparatus Regenerative Technology, Inc. (NASDAQ:HART), or HART, a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the HART-Trachea, which is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma.

David Green, President and CEO of HART, said, “We greatly appreciate the FDA’s support of our efforts to develop our first product, the HART-Trachea, to help patients who require a replacement trachea. Orphan designation is the first step toward clinical trials whose successful completion will be necessary to obtain FDA approval for use of the HART-Trachea in the U.S.”

Mr. Green continued, “We informed the public at the time of our first quarter earnings release that although the FDA was satisfied with the market size, they requested additional information about the clinical results for the five humans treated as of the time of the request of the indication included in our application. It was based on their review of these human clinical data that FDA rendered their favorable judgment and approved the orphan drug designation for the HART-Trachea. This designation provides us added confidence for our clinical development pathway.”

In order to receive orphan drug designation, a company must first demonstrate that the disease or condition that will be addressed by the drug or biologic affects less than 200,000 persons in the U.S. Second, the company must provide the FDA with sufficient information about the drug or biologic, or the disease or condition for which it is intended, to establish a medically plausible basis for expecting that their product will be effective for the treatment of that disease or condition.

Orphan drug designation entitles HART to a seven-year period of marketing exclusivity in the United States, if the HART-Trachea is approved by the FDA, and enables the Company to apply for research funding, tax credits for certain research expenses and a waiver from the FDA’s application user fee.

The FDA’s orphan designation for the HART-Trachea was published at the following link on the FDA website: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_R…


About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our technology has been used in eight human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing. On November 1, 2013, HART was spun-off from Harvard Bioscience. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, who has licensed the right to use such trademark from Harvard University. "

[biowonder]

http://investor.harvardapparatusregen.com/press-release/feat…

Zwar schon ein paar Tage alt, aber dennoch relevant, wie man am endlich mal wieder positiven Kursverlauf der letzten Tage sehen kann.

Public Company Information:
NASDAQ:HART
HOLLISTON, Mass.--(BUSINESS WIRE)--Harvard Apparatus Regenerative Technology, Inc. (NASDAQ: HART), a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, today announced the pricing of its previously announced underwritten public offering. HART is offering 1,800,000 registered shares of its common stock at a price to the public of $1.75 per share, and 695,857 registered shares of its Series B Convertible Preferred Stock (“Series B”) at a price to the public of $8.75 per share, for expected gross proceeds of approximately $9.2 million. At the option of the investor, the Series B is convertible into five shares of common stock of the Company, and will vote with the common stock on all matters on an as converted basis. The Series B has no preference to the common shares in respect of dividends, voting, liquidation or otherwise. In connection with the offering, HART has also granted the underwriter a 30-day option to purchase up to an additional 270,000 shares of common stock offered in the public offering to cover over-allotments, if any. HART intends to use the net proceeds from the offering primarily for research and development, including funding pre-clinical and clinical trials relating to the HART-Trachea, business development, sales and marketing, capital expenditures, working capital and other general corporate purposes.

The offering is expected to settle and close on February 18, 2015, subject to the satisfaction or waiver of customary closing conditions. National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (OTCBB: NHLD) is acting as sole book runner in the offering and Summer Street Research Partners is acting as co- manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-200926), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on December 29, 2014. A final prospectus supplement describing the terms of the offering will be filed with the SEC. Any offer will be made only by means of a prospectus supplement and accompanying base prospectus forming a part of the effective registration statement. Before investing, you should read the prospectus supplement and the accompanying base prospectus, and other documents that HART has filed or will file with the SEC, for information about HART and this offering.

Once filed, copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, by contacting National Securities Corporation at the following address:

National Securities Corporation
410 Park Ave, 14th Floor
New York, NY 10022
Attn: Kim Addarich
Telephone: [phone]
Email: [e-mail]

Investors may also obtain these documents for no charge by visiting the SEC's website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of HART and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our HART-Trachea technology has been used in six human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing. On November 1, 2013, HART was spun-off from Harvard Bioscience. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, who has licensed the right to use such trademark from Harvard University.

Forward-Looking Statements

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, HART’s expectations regarding the completion, timing and size of its proposed public offering, whether expressed or implied, statements relating to the success with respect to any regulatory filings and approval pertaining to the HART-Trachea or any other HART products, by the FDA, MHRA, European Medicines Agency, or otherwise, which such filings or approvals may not be made or obtained on a timely basis or at all, and success with respect to clinical trials, commercialization efforts and marketing approvals of HART’s products, including our HART-Trachea product, which such success or approvals may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, HART’s ability to complete the offering, as well as the actual size and terms of the offering and its ability to raise additional capital, as well those factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. HART expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.