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    the Myotech Circulatory Support System (CSS) - was geht? - 500 Beiträge pro Seite

    eröffnet am 12.08.07 23:38:07 von
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      schrieb am 12.08.07 23:38:07
      Beitrag Nr. 1 ()
      The Committee will also formulate the Company's strategies for commercial success in the highest potential underserved markets. These include the Myotech Circulatory Support System (CSS), the visible stent project, the projects of Biophan Europe, and the Company's other technologies and products in development. The Executive Committee will also be tasked with formulating strategies for funding these initiatives through strategic partnerships, licenses, and institutional investors. The Company's sales, sales strategies, and financing for both its licensing and it product development efforts are included in the scope of the Executive Committee. We look forward to reporting our progress on these and other areas in the future,” Jaensch concluded.
      Avatar
      schrieb am 14.08.07 12:48:08
      Beitrag Nr. 2 ()
      City Newspaper Archives - 4/2007TECH: Pittsford firm's work could help heart patients
      Published by Steve Jacobs on Apr 11, 2007
      Today's hi-tech medical world has an array of support technologies sometimes referred to as "bridge" technologies. These solutions are not meant to be permanent; they're designed to address an urgent medical need and keep patients alive until, hopefully, a more definitive solution can be delivered.

      One example is dialysis. Patients with kidney failure are able to use dialysis machines to stay alive until another, more permanent medical solution can be found. For some types of heart failure, a Ventricular Assist Device, or VAD, can be an appropriate bridging technology. Unfortunately, VAD's are a high-cost, high-risk solution. The Pittsford-based biotech company Myotech and its distribution partner Biophan are well down the road to offering a simpler, cheaper, less intrusive solution.

      Current VAD technology requires that tubes physically pierce into the heart itself. The tubes need to do this because the VAD passively drains the blood that tends to fill up a weakened, damaged heart. The VAD's tubes connect to an electromechanical device that helps the heart drain. Because the tubes pierce the heart tissue and come into direct contact with blood, VAD patients often experience complications such as clotting and stroke, bleeding, and infection. An MD friend of mine has called VADs "medieval torture devices." Jeffery L. Helfer, president of Myotech and of Biophan Technologies' cardiovascular division, is more charitable. "Current VAD technology originally showed great promise 20 years ago," he says, "but has not been able to deliver on that promise."

      The approach of Myotech's MYO-VAD is to provide support for the heart and help it do the full cycle of pumping that it's supposed to do. Where current VAD's work passively, on a single ventricle, the MYO-VAD actively works with the whole heart. The core of the MYO-VAD is a polymer cup similar in shape to a wine glass or an eggcup. Air pressure is raised and lowered to allow the inside of the cup to move. This in turn gently expands and contracts on the heart, allowing it to pump more efficiently. To visualize the effect, imagine holding a water balloon in your hand and gently squeezing it. Since the heart isn't punctured, most general or emergency-room surgeons can install and remove it in just a few minutes.

      Myotech currently has five employees, focused mainly on bringing the MYO-VAD through the FDA processes and clinical trials to get approval for regular clinical use in humans. Both Helfer and John Lanzaflame, CEO of Biophan, anticipate that once that's achieved, Myotech will bring on a much larger medical and clinical workforce to continue to develop the MYO-VAD technology for a variety of clinical applications.

      In Helfer's last six years working with the technology, he's seen new opportunities for the application of the medical technology "Current VAD technology performs best for adults around 5' 11" tall weighing about 180 pounds," Helfer says, "due to the size and requirements of the technology." That means most women are too small for them. Because the MYO-VAD's main component is a rubber-like cup, it can be molded into a variety of sizes. And since it can be installed quickly and easily by doctors with emergency medical training, the MYO-VAD is of interest to the military. It could be used in field medical units, for example, to stabilize wounded soldiers during transport to a hospital. Myotech is one of the recipients of a $1 million federal grant for high-tech medical research in Rochester. MYO-VAD technology is also a good candidate for use outside of the US, since its costs are dramatically lower than current VAD technology.

      The company has seen the technology through a range of animal tests with great success. The FDA hasn't yet approved the technology for trials in humans. (Generally, years of animal trials are required before limited human trials are allowed.) But the MYO-VAD has been used five times in emergencies where lives were threatened and nothing else would allow the person to live long enough to benefit from more traditional treatment. In each of those cases, the MYO-VAD worked flawlessly in FDA emergency exceptions cases. Formal human trials are expected to begin in the next 18 months, and the product could be approved by the FDA for use in 2009.
      Avatar
      schrieb am 14.08.07 15:56:38
      Beitrag Nr. 3 ()
      @zuchtfreund - danke

      hier noch mal was zum Nachschlagen, für die, die wie ich als es losging auch noch nicht volljährig waren :)

      Q- 10 vom 30.11.2005

      http://www.sec.gov/Archives/edgar/data/1084000/0001144204060…

      Effective November 30, 2005, we entered into a Securities Purchase Agreement for
      the acquisition of an initial 35% interest in Myotech, LLC ("Myotech"), a New
      York limited liability company, whereby we exchanged 4,923,080 shares of our
      common stock, par value $.005, for 3,768,488 Class A (voting) units of Myotech.
      Under the Securities Purchase Agreement, we will also purchase for cash
      consideration of $2.225 million an additional 811,037 Class A units of Myotech
      over a six-month period. We are obligated to issue the shares and fund the
      investment amount, subject to certain conditions. This acquisition will be
      accounted for under the equity method.

      Further, at our discretion, we may purchase up to an additional 3,563,097 Class
      A units of Myotech for aggregate cash consideration of $9.775 million upon
      achievement of certain milestones satisfactory to Biophan measured over a
      24-month period. Upon the consummation of these additional elective milestone
      investments, we would hold a majority interest in Myotech



      Presseerklärung zum 10 – Q vom 25.01.2007

      http://www.biophan.com/index.php?option=com_content&task=vie…

      The Company has recently re-evaluated the accounting treatment of its investment in MYOTECH. In order to comply with FASB FIN 46(R), the Company has consolidated MYOTECH from the date of acquisition, November 30, 2005. In order to accomplish this consolidation, the Company had the patents held by MYOTECH appraised by a nationally-recognized, independent, outside valuation firm.

      The patents that MYOTECH holds were appraised at $26 million, which is now included in the Company’s consolidated balance sheet.
      Avatar
      schrieb am 27.08.07 11:08:18
      Beitrag Nr. 4 ()
      FOR IMMEDIATE RELEASE: June 22, 2007

      Schumer, Clinton Announce Key Senate Panel Approves $1.3 Million For Community Projects In The Greater Rochester Region

      Rochester Area Colleges Center For Excellence, Rochester General Hospital and Catholic Family Center Awarded Federal Funding As Part Of the LHHS Bill

      Federal Funds Will Also Be Awarded Seneca Knitting Mill As Part of the Interior Bill

      Senators Worked Closely With Committee To Include Funding In Spending Bill

      Bill will now be sent to the Senate Floor



      U.S. Senators Charles E. Schumer and Hillary Rodham Clinton today announced that the full Senate Appropriations Committee has approved the Labor, Health and Human Services and Education FY08 Appropriations Bill which includes $600,000 for the Rochester Area Colleges Center for Excellence in Math and Science; $250,000 for the Rochester General Hospital; and, $250,000 for the Catholic Family Center. The Appropriations Committee also approved the Interior, Environment, and Related Agencies which includes $250,000 for the Seneca Knitting Mill. The bill will now proceed to the Senate Floor as the next step in the appropriations process. Schumer and Clinton worked closely with members of the Appropriations Committee to include funding for the project in this year’s spending bill.



      “This is great news for the Rochester area,” said Schumer. “From the Catholic Family Center to Rochester General, these projects will improve medical services in the area and improve educational and cultural opportunities. With this funding, Rochester can take their reputation as a center of math and science teaching to a new level. The Center for Excellence in Math and Science Teaching will become the crown jewel in the Rochester education community.”



      “These are incredible investments in the Greater Rochester Region. The Center for Math and Science will be critical in the promotion of math and science studies, building a new generation of scientists and engineers as the region continues to develop as a center for technology research and development and the MYOVAD units will help a local company doctors treat patients in rural areas,” Senator Clinton said. “I have long pushed to secure better support services for kinship caregivers - grandparents and other relatives – who are making great personal sacrifices to provide safe and loving homes for the children in their care so I am very pleased that the Catholic Family Center will be receiving these funds to continue their important work. I am particularly pleased that we have secured these funds to support the expansion of the National Women’s Hall of Fame and help it realize its incredible potential as a world-class tribute to women and tourist attraction.”



      Rochester Area Colleges, which include nineteen institutions like Nazareth, RIT, U of R, St. John Fisher, SUNY Geneseo, SUNY Brockport, Hobart & William Smith, Keuka, will use the $600,000 in federal funding to continue development of the Center for Excellence in Math and Science. The Center will become a national base for preparing college students in the areas of math and science. Funds will be used to promote collaborations that contribute to a deeper understanding of the crisis and its possible solutions at the national and local levelsAdditionally, funding will be used to design national and local programs that will increase the number of students who pursue careers in math, science and related fields while increasing the national and local pool of math and science teachers at the K-12 levels. Retention of these teachers will enhance the quality of math and science education at the elementary, secondary, and college levels. Nazareth College played a special role in developing this concept.



      Rochester General Hospital (RGH), in partnership with MYOTECH, LLC, will use the $250,000 in federal funds to institute new heart failure treatment technology. They will bring a new generation of minimally-invasive cardiac assist devices, called MYOVADs, to patients in rural and community hospitals in the Greater Rochester area. This new technology has higher success rates with fewer complications than existing devices at one-third of the cost. RGH will also use the funding in final product development, development of manufacturing and medical support facilities in New York State, and to train New York State rural health care providers in its use. Existing cardiac assist devices are limited to patients of a few specialized health providers. The new generation technology can easily and safely be used in virtually every hospital including small rural health care providers.



      The Catholic Family Center will use $250,000 in federal funds to support their Kinship Care Resource Center. The Kinship Care program serves families through the 6-agency partnership CFC has created to provide a continuum of services for caregivers who are raising another relative’s child. Services that are provided include: case management; support groups, both educational and therapeutic; self-esteem building workshops for the children; educational workshops for both children and caregivers; counseling; and legal consultation and assistance.



      Seneca Knitting Mill will use $250,000 in federal funding for the restoration of the historic Seneca Knitting Mill, the future home of the National Women's Hall of Fame in Seneca.



      Now that the bill has been approved by the full Senate Appropriations Committee, it will be sent to the Senate floor. Following approval by the Senate, the bill will move towards Conference with the House and then to the President for signature.

      http://www.senate.gov/~schumer/SchumerWebsite/pressroom/reco…
      Avatar
      schrieb am 05.10.07 20:53:17
      Beitrag Nr. 5 ()
      biophan erwirb Mehrheit über den ursprünglich vorgesehenen 54 % und bestimmt wo`s lang geht

      http://www.biophan.com/index.php?option=com_content&task=vie…

      Biophan Technologies, Inc. holds a 68% interest in Myotech with rights to acquire additional equity, and is leading Myotech’s business development efforts.


      und jetzt die spannende Frage, wie weiter?? will man später über die mehr Anteile ordentlich absahnen oder werden sie für das Geschäftsmodell myotech benötigt - hier könnte es wieder Spass machen zu spekulieren!!

      hier noch mal ein Auszug aus meiner lieblings-News (Managementewechsel vom 08.05.2007)
      http://www.biophan.com/index.php?option=com_content&task=vie…" target="_blank" rel="nofollow ugc noopener">
      http://www.biophan.com/index.php?option=com_content&task=vie…

      “The Committee will also formulate the Company's strategies for commercial success in the highest potential underserved markets. These include the Myotech Circulatory Support System (CSS), the visible stent project, the projects of Biophan Europe, and the Company's other technologies and products in development. The Executive Committee will also be tasked with formulating strategies for funding these initiatives through strategic partnerships, licenses, and institutional investors. The Company's sales, sales strategies, and financing for both its licensing and it product development efforts are included in the scope of the Executive Committee. We look forward to reporting our progress on these and other areas in the future,” Jaensch concluded.


      ich hab mich doch schon ein paar mal gefragt, wie die das mit knapp 50 Prozent machen wollen, ohne auf die mehrheit zu verzichten - so hat man erst mal eine reserve von 17 % oder mehr - ich bin mal wieder überrascht worden - und ich denke hier ist die stelle, wo das Neue zu finden sein sollte (außer natürlich visible stent, Batteri ...wo wir alle nichts wissen dürften)

      vielleicht kommt ja jetzt erst mal ein ordentliche Internetauftritt von myotech

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      schrieb am 19.10.07 16:51:02
      Beitrag Nr. 6 ()
      http://biz.yahoo.com/iw/071019/0317351.html

      Press Release Source: Biophan Technologies, Inc.

      Biophan Announces Myotech CSS Data Presented at the Cleveland Clinic
      Friday October 19, 7:30 am ET

      Animal Study Results Presented at the 21st Century Treatment of Heart Failure Conference

      PITTSFORD, NY--(MARKET WIRE)--Oct 19, 2007 -- Biophan Technologies, Inc. (OTC BB:BIPH.OB - News), a developer of next-generation biomedical technology, today announced a presentation of animal study data on the Myotech Circulatory Support System (CSS) at the Cleveland Clinic's 21st Century Treatment of Heart Failure Conference. The data presented indicates that the Myotech CSS holds promise to vastly improve outcomes for patients with Congestive Heart Failure (CHF).

      Congestive Heart Failure affects an estimated 4.8 million Americans, and half of all patients diagnosed with CHF will die within five years. There are over 200,000 deaths per year related to CHF. Due to the poor prognosis for patients with CHF, the search for better treatments is critically important.

      The Myotech CSS consists of a flexible polymer cup that slips over the heart and connects to an external drive unit to pump the heart and restore normal blood flow. It can be installed in approximately three minutes through a small incision to provide immediate, life-saving support in emergency situations. Since it has no contact with circulating blood, the Myotech CSS also promises to reduce the risk of patient complications, such as clotting and stroke, bleeding, and infection.

      In the recently presented small-animal study, Myotech Chief Medical Officer Dr. Mark Anstadt and his colleagues at Wright State University demonstrated that the Myotech CSS effectively supported cardiac function when CHF had been artificially induced. They also found evidence that the Myotech CSS may one day revolutionize CHF treatment. One bio-marker that tracks cell damage which might have been caused by the device was unchanged, indicating the safety of the device to the heart muscle. Another marker that tracks the gradual weakening of heart muscle as CHF progresses was drastically reduced by use of the Myotech CSS, showing that this system could actually reverse the course of CHF.

      "This study indicates the tremendous potential for the Myotech CSS to treat multiple forms of heart disease," stated John Lanzafame, Biophan CEO. "Our initial focus is on acute circulatory support, which will be the initial application of the technology, but this study shows that the Myotech CSS may also be effective in treating CHF, and improving the quality of life for thousands of patients. We are very excited about the long term potential of this technology platform."
      Avatar
      schrieb am 23.10.07 16:53:27
      Beitrag Nr. 7 ()
      Cardiac arrest? Your best hope is to reach for a wine glass
      By ROGER DOBSON - More by this author »

      Last updated at 11:27am on 23rd October 2007

      Comments

      A wine glass-shaped device that works by squeezing the heart may be a safer and faster way to treat cardiac arrest patients.

      A sudden cardiac arrest occurs when the heart's electrical system malfunctions and it stops beating.

      It can often occur after a heart attack, which is caused when a blood vessel becomes blocked, interrupting blood flow and damaging the heart muscle.

      While resuscitation techniques and defibrillation can often get the heart beating again in an emergency, keeping the heart going can be a problem.

      In some cases the patient may need an artificial heart pump to power blood around the body.

      This requires specialist cardiac teams.


      The new device - the Myotech Circulatory Support System - can both restart the heart and keep it going.

      It also does not need a cardiac specialist to install it.

      Once wrapped around the heart, the soft inner lining of the device is inflated - securing it in place by suction - and an external computer and control system alternately compresses and expands the lining.


      The new device is said to be less risky and easier to put in place than a conventional heart pump.

      Implanting a conventional pump involves connecting it directly to the blood vessels and the surgery carries risks of bleeding, clotting, and infection.


      The new device, which is inserted through an incision between the ribs, doesn't come into contact with circulating blood, so there is a lower risk of these problems, says John Lanzafame, chief executive of US-based developers, Biophan.


      It can also be implanted much more quickly - in just three minutes, compared with the 45 minutes to two hours it takes for conventional pumps - and that, say the developers-could be a life- saving difference.


      Its small size makes it especially suitable for women for whom some current pumps are too big.


      An early version of the technology has already helped to save lives in emergency situations in America and a newer model will be tested on patients in a clinical trial next year.

      In one case, a teenage girl whose heart stopped beating was given a research version of the device in a procedure that took less than three minutes.

      It kept her alive for seven days while her heart recovered.


      The simplicity and expected low cost of the device means it can be installed by a general surgeon at any hospital with an operating room, rather than only at specialised transplant or cardiac centres.


      While the first use is likely to be in emergency cases of sudden cardiac arrest (there are around 275,000 heart attacks in the UK each year), the device could also be used for chronic heart failure patients, the fastest growing group of heart disease patients - more than a million people in the UK have heart failure.

      Its developers say the technology has potential in a number of other areas, including so-called "bridge to recovery" - short-term support while the heart heals itself.

      Destination therapy, where a device is installed permanently, is also being looked at.

      Other potential uses include keeping patients alive until a transplant become available.


      "It is a very simple and neat idea, and these kind are often the best," says Dr Chris Morley, consultant cardiologist at Bradford University teaching hospitals.

      "There is considerable and growing interest in physical therapies like this rather than medical therapies."

      http://www.dailymail.co.uk/pages/live/articles/health/thehea…
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      schrieb am 23.10.07 16:58:20
      Beitrag Nr. 8 ()
      Antwort auf Beitrag Nr.: 32.122.380 von zuchtfreund am 23.10.07 16:53:27
      Avatar
      schrieb am 26.10.07 17:25:53
      Beitrag Nr. 9 ()
      aus dem S-1


      betr. 38.102.868 shres, maximum offering price per share 0,145, proposed maximum aggregate offering price 5,524,916 $

      Fußnoten siehe sec Meldung

      http://www.sec.gov/Archives/edgar/data/1084000/0001144204070…

      weil hier bei Myotech thread - was für mich interessantes aus dem S -1

      ...Thereafter, upon the satisfaction of certain conditions, we would purchase an additional 6,180,000 Class A Membership Units of Myotech for a purchase price of $2,000,000. As a result of this investment the Company’s holdings in Myotech will increase to approximately 75% and provide Biophan with control of a majority of the Board of Directors of Myotech....

      Hinweis was als nächstes kommt - Hinweise zur Besetzung der direktorenposten in den Vereinbarungen mit den Investoren vom Oktober 2006 zur Genehmigung der Transaktion mit medtronic - es geht weiter !!


      neben fachlicher Fortschritte sollte man auch hierauf ein Auge werfen - in diesem Jahr bin ich bisher noch nicht von den Aussagen des Management enttäuscht worden!

      It is anticipated that the Gen-1 Myotech CSS could enter into clinical studies in fiscal year 2009. The Myotech CSS is targeted to be marketed and distributed by entering into a strategic relationship with a major medical device company.
      Avatar
      schrieb am 01.11.07 13:17:30
      Beitrag Nr. 10 ()
      Biophan Announces Myotech Board of Directors
      Biophan Technologies, Inc. (OTCBB: BIPH), a developer of next-generation biomedical technology, today announced the composition of the new board of directors of its subsidiary, Myotech. Under the terms of the new deal announced on October 5, in which Biophan now owns 68% of Myotech, a new board of directors has been put in place for the subsidiary with three of the five members appointed by Biophan.

      The new board of directors will consist of the following five individuals:

      Peer M. Portner, PhD, FACC, FAHA, FAIMBE, developer of the first permanently implanted mechanical cardiac assist system, is Consulting Professor of Cardiothoracic Surgery at the Stanford University School of Medicine (on the faculty since 1976). Dr. Portner was President, CEO, and founder of Novacor Medical Corporation in Oakland, California. Following its acquisition in 1988 by Baxter Healthcare Corporation, he was President, then Chairman, and until mid-2000 Chairman Emeritus of the Novacor Division of Baxter.

      Bonnie Labosky is a former Medtronic Vice President and General Manager of the Heart Failure Division. She is currently President and CEO of Cardiac Concepts, Inc., a Minneapolis-based company with venture capital backing, developing new medical device technologies. Prior to joining Cardiac Concepts, Inc., Ms. Labosky was Group Vice President for Welch Allyn, a provider of innovative medical diagnostic devices, patient monitoring systems, and external defibrillators.

      Mark P. Anstadt, M.D. FACS is Myotech's Chief Medical Officer and Associate Professor in the Department of Surgery, Wright State University School of Medicine and Chief of Cardiothoracic Surgery and Medical Director of Cardiothoracic Surgery Services at Miami Valley Hospital. He has served as Chief of Cardiothoracic Surgery and Director of the Cardiothoracic Training Program at the Medical College of Georgia and Assistant Professor, Cardiothoracic Surgery at Baylor College of Medicine.

      Stan Yakatan is the Chairman of Katan Associates, a consulting/advisory group, through which he has served as a senior advisor to various healthcare companies over the last ten years. Previously, Mr. Yakatan was CEO and co-founder of several companies including Quantum Biotechnologies Inc.; CryoSurge; Cystar, Inc.; Proteine Performance; New Brunswick Scientific; BioSearch, and Unisyn Technologies. Mr. Yakatan also served as a senior executive with New England Nuclear ICN Pharma, and EI Dupont.

      John Lanzafame is currently CEO of Biophan Technologies. Mr. Lanzafame has over fifteen years experience in the medical device industry. Prior to joining Biophan, he was president of STS Biopolymers, Inc., a privately held medical device company that marketed high performance polymer-based coatings for the medical device industry. STS Biopolymers was sold to Angiotech Pharmaceuticals in 2003.

      "We're very excited to have such an experienced board, with broad clinical and business backgrounds, to help focus the development of the Myotech Circulatory Support System," stated Biophan CEO John Lanzafame. "Their experience in building successful businesses, and in launching new product categories in the heart failure / cardiac support space, will help to ensure the success of the Myotech CSS."

      About Biophan Technologies, Inc.

      Biophan is dedicated to providing technologies that offer innovative and competitive advantages to the medical device industry. The Company is helping to commercialize the Myotech Circulatory Support System, which has significant potential to improve the treatment of acute heart failure. Biophan Technologies, Inc. holds a 68% interest in Myotech with rights to acquire additional equity, and is leading Myotech's business development efforts. Biophan is traded on the OTC market under the symbol BIPH, and is also listed on the Frankfurt Stock Exchange under the symbol BTN. For more information on Biophan, please visit our website at www.biophan.com.
      Avatar
      schrieb am 11.11.07 16:00:26
      Beitrag Nr. 11 ()
      aus Mitteilung Senator Charles E. Summer zum Stand der 250.000 $ für Rochester General Hospital / Myotech vom 06.11.2007

      http://schumer.senate.gov/SchumerWebsite/pressroom/record.cf…

      Bekanntes zu Vorteilen, Kostenersparniss ... + Informationen New York
      Avatar
      schrieb am 14.11.07 10:53:33
      Beitrag Nr. 12 ()
      biophan verkauft für 11 Mio seine MRI-Sicherheitslösungen an medtronic

      mit diesen Mitteln ist biophan in der Lage die bestimmende Mehrheit an myotech zu erwerben (von ca. 44 auf 68%)

      in Übereinstimmung mit den Vereinbarungen zum Verkauf der MRI Sicherheitslösungen vom 05.10.2007, wird am 01.11.2007 die neue Zusammensetzung des Board of Directors von myotech durch biophan bekanntgegeben

      http://www.biophan.com/index.php?option=com_content&task=vie…

      a new board of directors has been put in place for the subsidiary with three of the five members appointed by Biophan.

      jetzt braucht man eigentlich nur noch auf den nächsten Schritt zu warten (außer man ist blind und erkennt nicht, dass diese Entwicklungslinie schon seit vielen Monaten konsequent durchgezogen wird)

      und was wird der nächste Schritt sein - das neue board muss natürlich auch erst mal tagen und Beschlüsse fassen :) - etwas anderes wäre ja wohl rechtlich nicht korrekt!!

      jetzt erwarte ich Entscheidungen und Aussagen zum / vom Management - wer wird Myotech als CEO führen und vielleicht bleibt Darryl Canfield CFO (wenn ja dann würde ich ein gutes Gefühl haben, denn dann hat er seinen Posten bei biophan wirklich nur aus Kostengründen abgegeben und möglicherweise eine gute Arbeit geleistet und setzt diese nun bei myotech vielleicht schon fort?? - oder auch nicht, dann war die entscheidung wohl auch o.k.)

      auch hier steht nun schon ziemlich lange ... comming soon, da sollte sich doch wohl auch bald was tun!!!

      http://www.myotechllc.com/pr/index.html
      Avatar
      schrieb am 14.11.07 11:12:08
      Beitrag Nr. 13 ()
      Antwort auf Beitrag Nr.: 32.420.363 von guztaw am 14.11.07 10:53:33Entschuldigung - "coming" unkorrekt zitiert - bin wohl auf dem m eingeschlafen
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      schrieb am 08.01.08 23:05:19
      Beitrag Nr. 14 ()
      Avatar
      schrieb am 15.01.08 09:57:52
      Beitrag Nr. 15 ()
      Antwort auf Beitrag Nr.: 32.381.976 von guztaw am 11.11.07 16:00:26wenn die 250.000 Dollar Teil des H.R. 3043 (ein umfangreiches Packet von Maßnahmen bei forschung , gesundheitswesen und bildung) sein sollten - wie mir scheint, ist es damit seit dem 15.11.2007 vorbei - das Veto des Präsidenten der USA konnte nur knapp durch eine entsprechende Mehrheit von Demokraten und Republikanern nicht überstimmt werden (aber das wissen die, die sich mit biophan beschäftigen sicherlich schon länger, auch nichts neues, dass in der politik solche programme an machtspielchen mit anderen betreff scheitern können - ich glaube da gab es schon mal hoffnungen über 400.000 dollar , wobei mit den 1 mio vom Verteidigungsministerium wird schon gearbeitet - auf jeden Fall scheint dieses projekt im Focus von Politikern zu stehen!!!)

      http://www.govtrack.us/congress/bill.xpd?bill=h110-3043
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      schrieb am 15.01.08 10:04:50
      Beitrag Nr. 16 ()
      http://www.biophan.com/index.php?option=com_content&task=vie…

      Schritt für Schritt

      biophan ernennt (Interims) president

      was wird seine nächste Aufgabe sein / hat das neue board of directors schon getagt , gibt es schon einen neuen CEO? / sind strategische partnerschaften von myotech möglich / warum soll der Anteil von biophan an myotech noch auf 75% durch barzahlung erhöht werden / wie wird FDA Prozeß gestaltet / wie ist der stand der medizinischen tests - Planung in Europa??
      Avatar
      schrieb am 15.01.08 10:10:19
      Beitrag Nr. 17 ()
      Neues Jahr - neues ....?

      endlich hat man den alten Schrott entsorgt - und man bastelt womöglich an was neuem - nichts was so nicht zu erwarten war - nur mal sehen wie man es uns bis zur Marktreife dosiert??

      http://www.myotechllc.com/
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      schrieb am 07.02.08 17:42:56
      Beitrag Nr. 18 ()
      gegeben:

      - patentierte, konkurrenzlose myotech-Technologie / Bewertung ca. 26 Mio dollar, klinische studien 2009 in europa, Mutter biophan im november 2007 ca. 26 monate workinhg capital

      - myotech mit einem interessanten neustrukturierten Board of directors

      - neuer CEO und Mitglied board of directors von biophan - J. Lanzafame

      - Stan Yakatan seit Januar 2008 Chairman of the Board of directors von biophan

      - Biophan Names Travis E. Baugh to Board of Directors

      http://www.biophan.com/index.php?option=com_content&task=vie…

      Mr. Baugh is currently the founder, president and chief executive officer of Lifecap Resources, LLC, a consulting firm providing early stage life sciences companies with expertise in a wide range of areas, including capital formation, accounting and finance, evaluation of new technologies, formulating FDA strategy / clinical trial design, and international regulatory strategy.

      In 1995, he co-founded MicroMed Cardiovascular, Inc., a medical device company focused on the development and marketing of a miniaturized blood pump known as the DeBakey VAD® that is used to treat congestive heart failure. As CFO, Mr. Baugh raised seed funding, venture capital, and bank financing totaling over $60 million. In 2005, he became CEO and took the company public, raising an additional $25 million through three secondary PIPE transactions. Mr. Baugh has served on numerous boards and is currently serving on the board of DFB Pharmaceuticals Inc., a private diversified pharmaceutical company based in Texas.



      John Lanzafame stated, “I am extremely excited to welcome Travis to our board. We're fortunate to have the benefit of his medical device and financial expertise. His experience with MicroMed Cardiovascular will be particularly helpful as we move forward to bring the Myotech technology to market.”


      - noch im Mai 2007 genehmigte 250 Mio biophan Aktien / derzeit ca 125 mio im Umlauf plus bestehende Aktienprogramme

      - Anteil von biophan an myotech 68 % / weitere anteile können erworben werden (geplant waren wohl mal nur 54 % ?)



      ges:

      Finanzierung ???

      Marktreife ???

      na dann mal los / auch Mr. H. Gubnitzky

      http://www.biophan.com/index.php?option=com_content&task=vie…
      Avatar
      schrieb am 27.02.08 15:42:07
      Beitrag Nr. 19 ()
      Zitat aus dem Lanzafame Brief vom 16.01.2008

      http://www.biophan.com/index.php?option=com_content&task=vie…





      We now have the opportunity to develop, with an eye toward commercializing, a number of technologies covered by Biophan's existing 45 issued patents, as well as numerous pending patent applications. In addition, Biophan has become the majority shareholder in Myotech, which is developing the Myotech Circulatory Support System (CSS) - a novel medical device designed to quickly restore full cardiac output to an arrested heart.


      In terms of the Myotech CSS, it is important to fully understand the scope of this unmet medical need and the large market opportunity that is crying for a solution.

      Over 260,000 patients suffer in-hospital cardiac arrest every year, and about 80% of those patients do not survive. The Myotech CSS is capable of returning full cardiac output to an arrested heart in under three minutes, doing so without any contact with circulating blood. We believe this approach is superior and will dramatically improve outcomes for this patient population.



      On November 1, 2007, we named a number of seasoned professionals to the Myotech Board of Directors, whose experience in and understanding of our industry can provide solid counsel and direction as we move down the regulatory path toward approval.

      On December 18th, James Goldberg, a respected executive with vast experience in all areas of running early- and mid-stage healthcare companies, agreed to become President of Myotech. His experience and contacts within the industry will provide steady leadership.

      In a few short months we have sharpened our focus, strengthened our financial position, and named a solid leader and a strong Board of Directors for Myotech. Our goal is to begin clinical trials in Europe for the Myotech CSS in 2009.

      What can our shareholders look for in 2008 to indicate we are making solid progress and gaining traction in reaching that goal?

      We will continue to build an operational team at Myotech with the requisite experience and expertise to navigate the various clinical and regulatory hurdles. We should be making a number of organizational announcements in the first half of 2008.

      This team will undertake a number of important steps in moving toward our goal to initiate clinical trials in 2009. We will be laying out a detailed plan and milestones, including timelines for further animal testing for the Myotech CSS, initial meetings with the FDA regarding the regulatory pathway for the device, plans for engaging with development partners to finalize and enhance the design of the Myotech CSS, and ultimately for filing for regulatory approval.

      Our 2008 progress can be measured as we grow and strengthen our operational team, prudently manage our costs-including funding our emerging technologies through grants and partnerships-and most importantly, reach critical milestones in the development of the Myotech CSS.

      Strengthened by a focused strategic direction and more solid financial footing, Biophan has a renewed purpose and vitality. 2008 should prove to be an eventful and productive year for our company.



      Sincerely,



      John Lanzafame
      Chief Executive Officer




      ein neuer Schritt und der nächste wird nicht auf sich warten lassen!! (wobei für mich nicht der Einzelschritt , sondern die Deutlichkeit des strukturierten Auf- und Weiterbaus!!)

      Jeanne Lesniak

      http://www.biophan.com/index.php?option=com_content&task=vie…
      Avatar
      schrieb am 27.02.08 19:20:35
      Beitrag Nr. 20 ()
      Hey Leute,

      hoffe ihr wisst was die meldung zu bedeuten hat.
      Jeanne Lesniak war in Ihrer vorigen Tätigkeit zuständig für
      FDA liason und Zulassung.
      D.h. Produkte von Biophan müssen kurz vor der Zulassung durch
      FDA stehen. Sonst hätte Biophan Jeanne Lesniak nicht eingekauft.

      WIR WERDEN ALSO SEHR GUTEN TAGEN ENTGEGEN SEHEN UND DER ZEITPUNKT FÜR EINE ERNORME KURSSTEIGERUNG IST JETZT SICHERLICH DA.
      ALSO SCHÖN AM BALL BLEIBEN, UND STELLT NEWS HIER REIN. JE MEHR SICH NATÜRLICH FÜR DIESEN WERT INTERESSIEREN, JE BESSER STEHEN DIE CHANCEN FÜR EINE STABILISIERUNG DES KURSES.
      GRUSS





      SOURCE: Biophan Technologies, Inc.

      Feb 27, 2008 07:00 ET
      Biophan Announces Appointment of Jeanne Lesniak as Advisor for Regulatory and Clinical Affairs for Myotech
      PITTSFORD, NY--(Marketwire - February 27, 2008) - Biophan Technologies, Inc. (OTCBB: BIPH), a developer of next-generation biomedical technology, today announced the appointment of Jeanne Lesniak as one of two advisors for Regulatory and Clinical Affairs for Myotech, LLC, effective immediately. Myotech is a majority-owned subsidiary of Biophan Technologies, Inc.

      For the past 16 years, Ms. Lesniak has served as President and CEO of Lesniak & Associates, a medical device consulting firm focused on business and market development for emerging technologies. In this capacity Ms. Lesniak has acted as an FDA liaison for new medical device product development, clinical research, product approval strategies, and product classifications/designations. She is also experienced in the design and implementation of clinical research studies and investigational plans. Ms. Lesniak is an acting Vice President at several early stage medical device companies.

      Previously, Ms. Lesniak has served as Director of Regulatory Affairs and Quality Assurance for Thermo Cardiosystems, Inc. From 1989 to 1991 she was the Director of Corporate Regulatory Affairs at Boston Scientific Corporation. She has occupied numerous consulting roles implementing new product approval strategies and conducting clinical investigations.

      Ms. Lesniak received her B.S. in Biomedical Engineering from Boston University.

      The Myotech Circulatory Support System (CSS) consists of an external drive unit and flexible polymer cup that slips over the heart and provides the energy that enables the heart to restore normal blood flow. It can be installed in approximately three minutes with a small incision to provide immediate, life-saving support for use in resuscitation and insufficient cardiac output indications. Since it has no contact with circulating blood, the Myotech CSS also has been demonstrated to reduce the risk of patient complications, such as clotting and stroke, bleeding, and infection.

      About Biophan Technologies, Inc.

      Biophan is dedicated to providing technologies that offer innovative and competitive advantages to the medical device industry. The Company is helping to commercialize the Myotech Circulatory Support System, which has significant potential to improve the treatment of acute heart failure. Biophan Technologies, Inc. holds a 68% interest in Myotech. Biophan is traded on the OTC market under the symbol BIPH, and is also listed on the Frankfurt Stock Exchange under the symbol BTN. For more information on Biophan, please visit our website at www.biophan.com.

      Cautionary Statement Regarding Forward-Looking Statements

      Certain statements included in this press release may constitute forward-looking statements within the meaning of applicable securities laws. These statements reflect what Biophan anticipates, expect, or believe may happen in the future. Biophan's actual results could differ materially from the outcome or circumstance expressed or implied by such forward-looking statements as a result of a variety of factors including, but not limited to: Biophan's ability to develop its technologies; the approval of Biophan's patent applications; the successful implementation of Biophan's research and development programs; the ability of Biophan to demonstrate the effectiveness of its technology; the acceptance by the market of Biophan's technology and products incorporating such technology; the ability of Biophan to effectively negotiate and enter into contracts with medical device manufacturers for the licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its operating and research and development activities until it generates revenues sufficient to do so; and the timing of projects and trends in future operating performance, as well as other factors expressed from time to time in Biophan's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with Biophan's periodic filings with the SEC, which are incorporated herein by reference. The forward-looking statements contained herein are made only as of the date of this press release, and Biophan undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
      Avatar
      schrieb am 17.05.08 21:49:37
      Beitrag Nr. 21 ()
      hier Zugang scheinbar zu einem Angebot für Leute, die Anregungen für ihre Gedanken suchen

      http://www.biophan.com/index.php?option=com_content&task=vie…
      Avatar
      schrieb am 17.05.08 21:59:28
      Beitrag Nr. 22 ()
      Antwort auf Beitrag Nr.: 34.117.876 von guztaw am 17.05.08 21:49:37Biophan/Myotech CSS simulates cardiac massage for SCA cases
      By LYNN YOFFEE
      Medical Device Daily Staff Writer
      Physicians struggling to save the lives of people suffering
      sudden cardiac arrest (SCA) will, many times, administer
      defibrillation, cardiopulmonary resuscitation, drug therapy
      or they will crack open their chests and massage the
      heart. But these efforts often are fruitless, with at least an
      80% mortality rate.
      Biophan Technologies (Pittsford, New York) has
      taken a cue from the latter technique with the development
      of Myotech CSS, a flexible plastic sheath that slips around
      the heart and literally pumps it back to life.
      The Myotech CSS is based on direct mechanical ventricular
      actuation (DMVA) technology. It consists of a flexible
      polymer cup that can be installed around the heart in as
      little as three minutes via thoracotomy, an incision between
      ribs.
      “It is a mechanical circulatory support device, but it’s
      totally different in design,” John Lanzafame, Biophan’s CEO,
      told Medical Device Daily. “Ventricular-assist devices [VAD]
      are typically blood pumps. They actually pump blood,
      bypassing the heart chamber. Ours is a heart pump. It’s a
      device alternative to doing cardiac massage, but it’s much
      more controlled, it applies uniform pressure, and it can run
      for days.”
      Lanzafame explained that it can be used as a bridge to
      CABG, bypass surgery, heart transplant or even recovery
      because it can both resuscitate a stopped heart and provide
      cardiac support while waiting for additional therapy or
      transplant.
      Incorporating a pneumatically activated liner, the
      Myotech CSS operates by compressing and expanding bidirectionally,
      providing the energy that allows the heart to
      restore blood flow to normal, life-sustaining levels. Because
      there is no contact with circulating blood, it is expected to
      significantly reduce the risk of patient complications, such
      as clotting and stroke, bleeding and infection.
      “Given the unique features of Myotech CSS compared
      to what’s on the market, we think it will position us to
      address an unmet market niche,” Lanzafame said.
      In the U.S., there are 263,000 in-hospital sudden cardiac
      arrests every year. There are 70,000 cases per year of heart
      stoppage due to myocardial infarction with cardiogenic
      shock with a 70% mortality rate. He said Myotech CSS will
      address that secondary market as well.
      Biophan’s board of directors has just approved the next
      phase of Myotech’s (also Pittsford) engineering and regulatory
      development program for the Myotech CSS with the
      release of $2 million to be invested in its development.
      Myotech is a majority-owned subsidiary of Biophan.
      Lanzafame said the company is searching for partners
      to commercialize and distribute Myotech CSS and will later
      seek approval overseas.
      Clinical data is as yet unavailable, but a previous version
      of the technology, originally tested at Duke
      University (Durham, North Carolina) has been tested in
      more than 700 animals and the company has anecdotal evidence
      that it has helped to save human lives.
      The company has yet to announce its development and
      regulatory plan, but, “With our current strategy, the
      Myotech CSS could be on the market in the U.S. in 24 to 30
      months,” Lanzafame said. “We are in early-stage discussions
      with a number of distribution and commercialization
      partners.”
      The company has enough funding to move through the
      next stages of development but will seek additional funding,
      “potentially through distribution/commercialization
      relationships,” he said.
      It’s a little early, too, for targeting a cost of the device,
      but Lanzafame said it can easily be priced competitively
      with existing VADs. While the sheath part that fits over the
      heart will be considered disposable, the external console
      that runs the pump is reusable. ■
      Avatar
      schrieb am 17.05.08 22:00:00
      Beitrag Nr. 23 ()
      Antwort auf Beitrag Nr.: 34.117.876 von guztaw am 17.05.08 21:49:37
      Avatar
      schrieb am 25.09.08 16:55:18
      Beitrag Nr. 24 ()
      Mit der gestrigen Meldung könnte man meinen, die Mutter (biophan) ist auf einem gutem Weg der Besserung

      http://www.biophan.com/index.php?option=com_content&task=vie…



      worüber würde ich jetzt nachdenken:

      Erstens: dass Auskommen der Mutter ist wohl eine Weile gesichert


      Zweitens: es gibt ein fast vollständig verändertes Management (mit Yakatan und Lanzafame an der jeweiligen Spitze, eine neue CFO)

      Die Direktoren mehrheitlich durch Aktionäre bestätigt

      http://www.sec.gov/Archives/edgar/data/1084000/0001144204080…


      Drittens myotech wird wohl ein "wenig" mehr finanziellen Spielraum für seine geplante Umsetzung seiner myo-vad Maßnahmen benötigen (hier ist Phantasie angesagt oder Überraschungen vorbereitet) - in den Büchern wurde einiges schon ordentlich geordnet - manche hatten hier damals diese Verzögerungen bei den sec Meldungen sogar als Niedergang gewertet - lächerlich (wie vieles andere auch - aber scheinbar ist die Nase bei einigen so lang, dass man nicht mal sagen kann schaut auf andere von Euch gepushten Aktien und fasst Euch lieber an Eure eigene Nase, was unausführbar ist, weil dazu die eigenen Arme nicht reichen)


      Viertens: die Mannschaft von myotech scheint auch nach bestimmten nachvollziehbaren Kriterien ausgewählt worden sein (mal jemand, der organisieren kann, mal jemand, der cash besorgen kann, mal jemand, der Ahnung vom Fach hat ... (nicht zu vergessen der, der schon immer da war); vielleicht war das die anspruchsvolle Aufgabe, für die Mr. Goldberg relativ kurzfristig da war – da bin ich mir nicht so sicher vielleicht auch Konzeptionsveränderungen (manches kann man in den Jahres- oder Quatalsmeldungen nachlesen, ich erspare mir auf die hinzuweisen, die auch Lohn für ihre Arbeit bekommen, erst mal abwarten was sie so bringen)

      Fünftens. Die Anteile an myotech wurden ordentlich erhöht und zusätzliches Geld locker gemacht – auch hab ich mal in der Mitte gelesen, dass Geld bei früheren Käufen von Anteilen ins Unternehmen gesteckt werden sollten, und nicht in die Taschen der Verkäufer


      Sechstens. Was mich so ein wenig reizt sind immer wieder Formulierungen – wie man spricht von „for sale in the US, in 24-30 months.“
      http://www.biophan.com/index.php?option=com_content&task=vie…
      vielleicht entspricht das sogar der Wahrheit – und es stimmte mit den 24 – 30 monaten in den USA

      was hier gesagt wird – Ende August 2008 – zu anderen Regionen, kann man nicht überlesen / und einiges mehr

      http://www.biophan.com/index.php?option=com_content&task=blo…


      wie gesagt nur Gedanken, also ohne Struktur und Wertung


      einiges was zur Mutter geschrieben wird, kann man mit ein wenig Phantasie auch mit anderen Entwicklungslinien und Aktivitäten in Bezug setzen (da kann auch was neues noch nicht fassbares passieren??)

      http://www.biophan.com/index.php?option=com_content&task=vie…
      http://www.biophan.com/index.php?option=com_content&task=vie…

      das alles nur aus Spass an Spekulationen, und weil ich immer noch an einen Plan glaube, der seit der news zum mangementwechsel konsequent (vielleicht mit einigen erforderlichen korrekturen) umgesetzt wird
      Avatar
      schrieb am 26.09.08 00:27:36
      Beitrag Nr. 25 ()
      Antwort auf Beitrag Nr.: 35.274.621 von guztaw am 25.09.08 16:55:18Jünger, ich gebe dir recht!


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      the Myotech Circulatory Support System (CSS) - was geht?