Showing posts with label Autologous Products. Show all posts
Showing posts with label Autologous Products. Show all posts

Friday, October 8, 2010

Cytomedix Secures $13 Million in Committed Funding

GAITHERSBURG, Md., Oct 8, 2010 (GlobeNewswire via COMTEX) -- Cytomedix, Inc. (GTF 0.44, -0.03, -5.75%), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced today that the Company has secured approximately $13 million in current and future funding via a registered direct offering and commitments under two separate equity purchase agreements.
The Company has entered into a securities purchase agreement with certain existing shareholders and a new institutional investor for the sale of 3,727,677 shares of its common stock in a registered direct offering priced at $0.40 per share for non-affiliates and $0.53 for affiliates. In addition, warrants to purchase an aggregate of 1,863,839 shares of common stock will be issued to the investors. The warrants are exercisable beginning April 6, 2011, expire five years after initially exercisable and have an exercise price of $0.60 per share. Lincoln Park Capital Fund, LLC ("LPC" or "Lincoln Park") led the transaction with a $500,000 investment in this registered direct offering. Gross proceeds of the offering, before agent fees and offering expenses, are expected to be approximately $1.50 million. Subject to customary closing conditions, this transaction is expected to close on or before October 11, 2010. These securities were offered through a prospectus supplement pursuant to the Company's effective shelf registration statement and base prospectus contained therein.
"We are pleased to have secured this funding as it provides us with the immediate capital to honor our commitment to the Sorin Group and provides us incremental capital to pursue our business strategy," said Martin P. Rosendale, President and Chief Executive Officer. "Over 35% of the capital raised came from significant shareholders, insiders, and employees. We appreciate the continued support of these existing shareholders and welcome our new ones. "
In addition, the Company entered into two separate purchase agreements with Lincoln Park. The first is for $10 million for which a new registration statement will be filed and the second is for $1.5 million using the existing shelf registration. The pricing terms, maturity, and other relevant economic terms are consistent across the two agreements.
Under the existing shelf registration statement, in the case of the $1.5 million purchase agreement, and after the SEC has declared the registration statement effective, in the case of the $10 million purchase agreement, the Company has the right over the 25 month period to sell 150,000 shares of common stock to LPC every other business day. The Company will control the timing and amount of any sales of shares to LPC and in neither agreement, is the Company obligated at any time to sell shares to LPC. Should the Company elect to sell shares to LPC under either of the agreements, the purchase price would be fixed on the date of sale and based on the prevailing market prices of the Company's shares for a period immediately preceding the sale.
In consideration for entering into the $10 million purchase agreement, the Company issued 305,944 of unregistered shares of common stock. The Company further agreed to issue up to 428,322 shares of common stock on a pro-rata basis as commitment shares in connection with LPC purchases up to $7 million of the aggregate $11.5 million commitment amount. Sale or transfer of the commitment shares, when they are issued, is prohibited until the expiration of the term or Company termination of the agreement. There are no warrants associated with any purchases under the agreement and the agreements prohibit any shorting or hedging by LPC.
The net proceeds from these financings will be used for continuing product development, sales and marketing, and general corporate purposes.
Mr. Rosendale further commented, "We are pleased by the commitment from Lincoln Park, a fundamentally oriented investor. We are under no obligation to utilize the facility, but plan to use any proceeds to support and accelerate the development of our regenerative therapies and to expand our marketing efforts."
A more detailed description of the agreements with Lincoln Park is set forth in the Company's current Report on Form 8-K, as filed earlier today with the SEC.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

Wednesday, June 2, 2010

Cytomedix to Present at Sixth Annual Noble Financial Equity Conference


ROCKVILLE, Md., June 1, 2010 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will participate in the Sixth Annual Noble Financial Equity Conference taking place June 7-8, 2010 at the Seminole Hard Rock Hotel in Hollywood, Florida.

Martin Rosendale, President and CEO of Cytomedix, will present a corporate update on Tuesday, June 8, 2010 at 1:30 p.m. ET in which he will provide an overview of Cytomedix, including an update on the integration of its recent acquisition of the Angel® Whole Blood Separation System and the activAT® Autologous Thrombin Processing Kit from the Sorin Group.

Company management will be available for one-on-one meetings with investors participating in the Noble Financial Equity Conference. For those who would like to schedule an appointment with Cytomedix's management, please contact Anne Marie Fields, Lippert/Heilshorn & Associates, Inc., at 212-838-3777 or at afields@lhai.com or contact your Noble Financial representative.

The presentation will be video webcast live at www.cytomedix.com where it will also be archived for 90 days.

About Cytomedix

Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP") in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from platelet poor plasma. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its products. Cytomedix is also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Most notably is its anti-inflammatory peptide (designated "CT-112") that has shown promise in pre-clinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.

Thursday, April 22, 2010

Sorin Group Sells Angel(TM) Whole Blood Separation System and activAT(R) Autologous Thrombin Processing Kit to Cytomedix

MILAN, Italy, Apr 12, 2010 (BUSINESS WIRE) -- Sorin Group, (MIL:SRN), a global company and a leader in the treatment of cardiovascular diseases, announced today that it has completed the sale, for $7 million (EUR5.25 million) in cash paid in installments over two and a half years, of the Angel(R) Whole Blood Separation System ("Angel(TM)") and activAT(R) Autologous Thrombin Processing Kit ("activAT(R)") product lines to Cytomedix, Inc. (GTF 0.90, -0.05, -5.26%), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis. Together these products had sales of approximately $5 million (EUR3.75 million) in 2009.

Angel(TM) consists of a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP"); activAT(R) is designed to produce autologous thrombin serum from platelet poor plasma, providing a completely autologous, safe alternative to bovine-derived products.

"We are pleased to enter into an agreement to sell these non-core assets to Cytomedix, and we count on Cytomedix to maintain the same high level of customer service, support and product excellence that our customers have come to expect from Sorin", said Michel Darnaud, President, Cardiopulmonary Business Unit.

Sunday, August 9, 2009

Blood transfusions increase fatal infections in heart surgery

The risk of dying during heart surgery is increased five-fold by infections carried in blood transfusions, according to research published in the journal BMC Medicine.

The Research (click Thumbnail below) reports a 0.13% increase in predicted infection rates for every 1% increase in the frequency of blood transfusions.

Infections included those of the urinary system, lungs, bloodstream, digestive tract and skin, as well as a significant number of Clostridium difficile cases.

The small minority of patients receiving ‘autologous’ transfusions - their own stored blood - fared far better, as did those who had no blood transfusion at all.

Says study leader Dr Mary Rogers, from the University of Michigan: ‘The safety of patients undergoing a coronary artery bypass graft (CABG) will likely be improved if hospitals … institute interventions to reduce inappropriate use of blood transfusions.’

The infection rate among those receiving donor blood was 18% compared with 9.7% of patients only receiving their own blood, and 6.6% when no transfusion was carried out. Overall, 16.2% suffered a hospital infection.

Tuesday, January 6, 2009

Vivostat


The Danish medical device company Vivostat A/S (formerly known as Vivolution) announced the formation of a new management team to support the aggresive growth plans for the company’s Vivostat product lines.
During the last year the Alleroed-based company has completed a range of cross-organisational projects in order to prepare the company for the future. The outsourcing of the disposable production to a low-cost country, the re-branding of the Vivostat product lines and the establishment of direct sales organisations in major European markets, just to mention a few of the projects.
“The formation of the new management team is an important step in the process of preparing our company for the exciting challenges that lie ahead”, explains Tom Bjerg Laurizen, CEO at Vivostat.
Tom Bjerg Lauritzen continues: “During the last five years Vivostat has expanded from being a R&D focussed company into a significant commercial player in the surgical sealant and wound care markets. The establishment of the new management team reflects this change and lays a strong foundation for the company’s aggressive growth plans in the future”.
Together the new management team represents many years of medical device experience within sales, marketing and regulatory/medical affairs. Besides Tom Bjerg Lauritzen, the group consists of Anne KlitgƄrd, VP of Regulatory and Medical Affairs, Henrik Vester-Andersen, VP of Sales, and Martin Poulsen, VP of Marketing.
Vivostat is already a well-established player in the European surgical sealant and wound care markets with sales of its products in 19 countries. To continue the expansion the company recently initiated the US approval process for the newest member of the Vivostat product family, Vivostat PRF - a second generation growth factor product used for the treatment of chronic wounds.
Chronic wounds are a serious problem for many diabetic patients and there is currently very little success with conventional treatment methods.
The Vivostat® System is an automated system for the on-site preparation and application of patient-derived fibrin sealant or platelet rich fibrin (PRF®). It incorporates a unique and patented biochemical process that produces an autologous sealant from 120 ml of the patient’s own blood in only 23 minutes. The sealant has biophysical properties that outperform most sealants on the market today and a delivery system that enables unparalleled control in the application during surgery.The system comprises three components: A Processor Unit for the preparation of fibrin sealant or PRF®, an Applicator Unit to control the delivery of fibrin sealant/PRF® and a disposable kit comprising all components required to collect blood and apply the sealant to the surgical site.

Saturday, June 14, 2008

Autologous Products

Scandanavian company Vivolution sells their product range the Vivostat® System in Europe comprising two groups of products that utilize the same patented technology. The Vivostat®System is an automated system for the on-site preparation and application of patient-derived fibrin sealant or platelet rich fibrin (PRF®). It incorporates a unique and patented biochemical process that produces an autologous sealant from 120 ml of the patient’s own blood in only 23 minutes.
Vivostat® autologous fibrin sealant is used during surgery to prevent and stop bleedings and oozing of body fluids.
Vivostat® PRF® autologous platelet rich fibrin is used to promote cell growth for a range of procedures e.g. orthopaedic surgery and wound healing.



PlasmaSeal has designed three devices (called Cebus, Ateles, and Proteus) that produce Platelet Plasma Concentrate from the patient's own blood. From a regulatory perspective PPC is an autologous blood product. PlasmaSeal PPC technology is remarkably simple to use. Depending on the extent of wounded area 10 to 100 cc of blood is withdrawn from the patient and immediately mixed with standard citrate anticoagulant. The platelet plasma is separated from whole blood by centrifugation, then it is concentrated by removing some of the salt water. This second step can be accomplished in many ways. A simple method, called hollow fiber concentration uses small tubes with special walls, which are porous to salt water but not to the larger proteins and platelets in blood. It is this basic procedure and two step method that is used in all the devices.



Thermogenesis offer the advanced CryoSeal® FS System a new generation of performance for the production of fibrin sealant. The system safely and conveniently extracts high-quality fibrinogen-rich cryoprecipitate and thrombin from a single unit of autologous or allogenic plasma in approximately 60 minutes. Also the advanced Thrombin Processing Device (TPD™) provides busy operating rooms and other fast-paced environments with a rapid, safe, easy-to-use method for producing active human thrombin from either plasma or whole blood.
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Inoteb has developed what it believes to be the world's first fully autologous biological glue. This Autologous Biological Glue is prepared using the patient's own blood, in a closed system, eliminating immunologic problems and the risk of blood-borne disease transmission such as, for example, HIV and hepatitis. In contrast, all surgical glues currently on the market (whether autologous or homologous) require foreign proteins such as thrombin or antifibrinolitic agents. Clinical trials have been done especially for skin replacement and skin grafts eliminating the need for protein based skin grafts.In its use to date in European trials, the Autologous Biological Glue has been shown to be clinically safe and effective. Biocoral, Inc. will continue to push through the clinical trials examining the use of the Autologous Biological Glue for cosmetic applications, utilizing well-known plastic surgeons in Europe and the United States.