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I believe it is time to by this one. The company had trouble in the past, but they have resolved all the issues.
Updated: 09:17 AM EDT CryoLife, Inc. to Present at Medtech Insight's Dallas, TX ``IN SPINE & ORTHOPEDICS: Strategic Partnering and Investing in Musculoskeletal Technology'' Conference
DALLAS--(BUSINESS WIRE)----CryoLife, Inc. (NYSE:CRY) has announced that it will be a presenter at Medtech Insight's "IN SPINE & ORTHOPEDICS" Conference, taking place November 2-3, 2005 at The Westin Stonebriar Resort in North Dallas, TX.
Founded in 1984, CryoLife, Inc., a biomaterials and biosurgical device company, is dedicated to improving health and quality of life through the transplantation of human tissues and bio-surgical devices. CryoLife is the pioneer and a leader in processing, preserving, and distributing human tissues for use in reconstructive cardiac, vascular, and orthopedic surgeries.
CryoLife markets BioGlue(R) Surgical Adhesive, an innovative biosurgical device that is approved in the U.S. for use in adult patients as an adjunct to standard methods, such as sutures and staples, to help control bleeding in open surgical repair of large vessels. It is approved in the European Community and Canada as an adjunct to surgical repair for soft tissues such as vascular, cardiac, dura, pulmonary, and gastrointestinal and approved in Australia for use in vascular and pulmonary sealing and repair.
CryoLife has been developing several products based upon its Protein Hydrogel Technology (PHT) platform. One of these products is the BioDisc(TM) NPR, which is a patent pending nucleus replacement system.
BioDisc NPR is a protein-based hydrogel device that is proposed for use in post-discectomy patients for preservation of disc height, prevention and reduction of lumbar motion segment instability, and prevention of recurrent disc herniation. BioDisc NPR is intended to fill the void space within the spinal disc annulus following removal of the nucleus pulposus (discectomy) in the treatment of lumbar intervertebral disc herniation. Following a discectomy, the device delivery tip is placed directly into the disc space through the annulotomy and the implant material is easily dispensed into all areas of the nuclear void. The mixed components of BioDisc NPR begin to polymerize immediately, creating a flexible, viscoelastic hydrogel implant that is secure and adherent to the annulus within two minutes.
CryoLife has initiated a BioDisc feasibility human clinical trial in Europe. The feasibility study will gather basic safety and effectiveness information in a very small series of approximately ten patients, to be followed closely and evaluated for a period of two years. Data obtained from this study will support regulatory filings both in the United States and abroad.
The Company's R&D efforts are focused on the PHT platform and include the following products: BioFoam(TM), for recalcitrant Type II endoleaks and for rapid hemostasis for penetrating wounds and severe trauma; and BioLastic(TM), a biological pericardial replacement membrane that is intended to reduce sternal adhesions following open heart surgery.
Updated: 09:35 AM EST CryoLife Updates Status of BioDisc(TM) Spinal Disc Repair System at MedTech Insight's In Spine & Orthopedics Conference
ATLANTA, Nov. 2 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials and biosurgical device company, announced today at the MedTech Insight In Spine & Orthopedics Meeting in North Dallas, Texas that BioDisc(TM) Spinal Disc Repair System, a nucleus pulposus repair device, has been successfully implanted in four patients. The implants are part of a 10 patient feasibility study conducted at a hospital located in the United Kingdom. The study, targeted to address spinal disc herniations at the L4/L5 and L5/S1 levels, is designed to gather basic safety and performance data. The early clinical course of these patients is proceeding as expected.
"We are pleased with the early preliminary results in these first BioDisc patients. BioDisc has the innovative potential to provide spinal stability and preserve range of motion for thousands of patients suffering from herniated discs. Early patient followup indicates that the patients are pain free after the surgery. We expect to increase patient enrollment and the number of clinical sites over the next several months. We hope to file for CE Mark approval sometime during late 2006, and eventually file an Investigational Device Exemption to begin clinical trials in the U.S.," stated Steven G. Anderson, President and CEO of CryoLife, Inc.
The spinal disc is comprised of the nucleus pulposus and the surrounding fibrous tissue, known as the annulus. The nucleus pulposus is composed of a gelatinous-like material that acts as a cushion or shock absorber to the spinal column. Through either the natural process of aging or an injury, the spinal disc may weaken, resulting in a herniation. The herniation may occur adjacent to a nerve, resulting in debilitating back or leg pain. The herniation may be removed via a surgical procedure known as a discectomy, which leaves an empty void within the spinal disc.
The implantation of BioDisc into this void may prevent or reduce spine instability, preserve disc height, and prevent recurrent disc herniation. BioDisc is designed for easy, simple delivery into the void and the material quickly sets in just a few minutes. Presently, over 300,000 discectomies are performed in the U.S. each year and approximately 120,000 are performed each year in Europe. CryoLife is one of few companies in the world with a nucleus pulposes replacement device. The worldwide market for this device is estimated at about $800 million.
About CryoLife
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiovascular, vascular, and orthopaedic surgeries throughout the United States and Canada. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE marked in the European Community and approved in Canada for use in soft tissue repair and approved in Australia for use in vascular and pulmonary sealing and repair. The Company also distributes the CryoLife- O'Brien(R) stentless porcine heart valve and the SG Model #100 vascular graft, which are CE marked for distribution within the European Community.
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It's like buying on sale now. Good long term buy
Updated: 08:42 AM EST CryoLife Reports Third Quarter 2005 Financial Results
ATLANTA, Nov. 3 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials and biosurgical device company, announced today that revenues for the third quarter of 2005 increased 2% to $16.5 million compared to $16.1 million in the third quarter of 2004. The net loss in the third quarter of 2005 was $3.1 million, or $0.14 per fully diluted common share, compared to a net loss of $6.0 million, or $0.26 per fully diluted common share in the third quarter of 2004.
Excluding a $412,000, or $0.02 per common share, non-cash gain for the change in the value of the derivative related to the Company's 6% convertible preferred stock and a $701,000, or $0.03 per common share, charge related to post employment benefits, the adjusted net loss in the third quarter of 2005 was $2.8 million, or $0.13 per common share.
Revenues for the first nine months of 2005 increased 10% to $51.3 million compared to $46.5 million in the first nine months of 2004. The net loss for the first nine months of 2005 was $18.9 million, or $0.81 per fully diluted common share, compared to a net loss of $16.4 million, or $0.72 per fully diluted common share for the first nine months of 2004.
Excluding an $11.8 million, or $0.49 per common share, charge for settlement of the shareholder class action lawsuit, a $372,000, or $0.02 per common share, non-cash charge for the change in the value of the derivative related to the Company's 6% convertible preferred stock and a $701,000, or $0.03 per common share, charge related to post employment benefits, the adjusted net loss for the first nine months of 2005 was $6.0 million, or $0.28 per common share.
Steven G. Anderson, President and CEO of CryoLife, Inc. stated, "In the third quarter, we settled the securities class action lawsuit and the derivative shareholder litigation, allowing us to focus on the recovery of the Company. We are implementing plans, including realigning sales management responsibilities, increasing our cardiovascular sales force, and seeking approvals for new BioGlue(R) indications, to reinvigorate revenue growth."
BioGlue sales were $8.9 million in the third quarters of 2005 and 2004. BioGlue sales for the first nine months of 2005 increased 7% to $28.3 million compared to $26.5 million in first the nine months of 2004. U.S. BioGlue sales were $6.7 million in the third quarter of 2005 compared to $6.9 million for the same period of 2004. International BioGlue sales were $2.2 million in the third quarter of 2005 compared to $2.0 million for the same period of 2004.
Tissue processing revenues in the third quarter of 2005 increased 5% to $7.3 million compared to $7.0 million in the third quarter of 2004. Tissue processing revenues for the first nine months of 2005 increased 16% to $22.2 million compared to $19.2 million for the first nine months of 2004. Tissue processing revenues for the three and nine month periods increased primarily due to the recovery of the orthopedic program, along with modest revenue growth in the cardiac and vascular programs for the nine-month period.
Total product and tissue processing gross margins in the third quarter of 2005 were 52% compared to 43% in the third quarter of 2004. Total product and tissue processing gross margins for the first nine months of 2005 were 53% compared to 36% for the first nine months of 2004. Tissue processing gross margins in the third quarter of 2005 were 18% compared to negative (2%) in the third quarter of 2004. Tissue processing gross margins for the first nine months of 2005 were 19% compared to negative (24%) for the first nine months of 2004. Tissue processing gross margins improved in 2005 compared to 2004 primarily as a result of the improvement in tissue processing yields.
General, administrative, and marketing expenses in the third quarter of 2005 were $11.1 million compared to $12.1 million in the third quarter of 2004. General, administrative, and marketing expenses in the third quarter of 2005 include a $701,000 charge related to post employment benefits. General, administrative, and marketing expenses for the first nine months of 2005 were $42.7 million compared to $32.0 million for the first nine months of 2004. General, administrative, and marketing expenses for the first nine months of 2005 include an $11.8 million charge related to the settlement of securities litigation, and $701,000 related to post employment benefits.
R&D expenses were approximately $900,000 in the third quarters of 2005 and 2004, and approximately $2.7 million for the first nine-month periods of 2005 and 2004.
As of September 30, 2005, the Company had approximately $16.0 million in cash, cash equivalents, marketable securities (at market) and restricted securities.
2005 Guidance
In the fourth quarter of 2005, BioGlue revenues are expected to be $8.5 to $9.5 million and tissue processing revenues are expected to be $7.0 to $8.0 million. Bioprosthetic, cardiovascular, and vascular device revenues are expected to be between $175,000 and $200,000 in the fourth quarter of 2005.
The Company expects general, administrative, and marketing expenses to be $10.5 to $11.5 million in the fourth quarter of 2005. R&D expenses are expected to be approximately $1.0 million in the fourth quarter
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